Baby Sebamed Dermolimpiador Para Bebe

How often in a day do you take medicine? How many times?
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Baby Sebamed Dermolimpiador Para Bebe uses

Baby Sebamed Dermolimpiador Para Bebe consists of Alanine, Cetearyl Alcohol, Cetyl Palmitate, Disodium Lauryl Sulfosuccinate, Fragrance, Glyceryl Stearate, Glycine, Leucine, Lysine, Magnesium Aspartate, PEG-14M, Palmitic Acid, Paraffin, Sodium Cocoyl Isethionate, Sodium Lactate, Starch, Stearic Acid, Titanium Dioxide, Vitamin B5 (Panthenol), Vitamin B6 (Pyridoxine Hydrochloride), Water, Wheat (Triticum Vulgare).

Fragrance:


Pharmacological action

Baby Sebamed Dermolimpiador Para Bebe is an antiseptic. This medication is a quaternary ammonium compound, belongs to the cationic surfactant. Benzalkonium chloride has antimicrobial and antiviral activity against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex Type 2, Staphylococcus aureus, little active against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.

Baby Sebamed Dermolimpiador Para Bebe (Fragrance) is not active against Mycoplasma spp.

This medicine exerts spermicidal action which is due to the ability to damage the sperm membrane; inhibits sperm motility, disrupting electrolyte balance of the aqueous phase of cervical mucus.

Pharmacokinetics

Baby Sebamed Dermolimpiador Para Bebe (Fragrance) for external and local application is practically not absorbed.

Why is Baby Sebamed Dermolimpiador Para Bebe prescribed?

For external use only. Topical solution - a primary and delayed primary wound treatment, prevention of secondary infection of wounds hospital strains of microorganisms (injury of soft and bone tissue, burns), festering wounds, drainage of bone cavities following surgery for osteomyelitis.

Weight thick - superficial thermal burns, trophic ulcers, long-unhealed wounds of soft tissues (including infected), pyo-inflammatory skin diseases and diabetes mellitus; paraproctitis.

Tablets and capsules for intravaginal use, vaginal suppositories, creams, tampons - local contraception for women of reproductive age: for the presence of contraindications to the use of oral contraceptives or intrauterine devices, in the postpartum period, lactation, after the termination of pregnancy in premenopause period at irregular sexual life, omission or delay in receiving consistently used oral contraceptives.

Liquid concentrate - disinfection of facilities and medical products.

Dosage and administration

Topically. The solution was diluted with distilled water to make 1% aqueous solution, impregnated gauze dressings, napkins or tampons and put on the wound daily.

Mass is applied at the rate of 0.2-0.4 g/cm2 of wound surface, pre-clean the wound from the purulent discharge, necrotic tissue, or impose gauze or use turundas impregnated with drugs. The maximum daily dose is 50 g. Ligation is carried out daily, the course of treatment is 14 days.

Intravaginally. Benzalkonium chloride entered deeply into the vagina before coition; in case of repeated sexual intercourse it should be re-imposition of tablets, capsules, suppositories, creams; tampon can be removed not earlier than 3 h after the last sexual intercourse but no later than 24 hours after its installation (with repeated sexual acts for 1 day shift tampon is not required).

Concentrate Liquid. Benzalkonium chloride used for disinfection after prior dilution with water.

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Baby Sebamed Dermolimpiador Para Bebe (Fragrance) side effects, adverse reactions

Contact dermatitis, candidiasis, vulvovaginal and allergic reactions.

With prolonged use of Baby Sebamed Dermolimpiador Para Bebe (Fragrance) it is possible a local irritation.

Baby Sebamed Dermolimpiador Para Bebe contraindications

Hypersensitivity to benzalkonium chloride, contact dermatitis, malignant neoplasm of the skin; for intravaginal use - coleitis, ulceration and irritation of the mucous membrane of the vagina and uterus.

Using during pregnancy and breastfeeding

Baby Sebamed Dermolimpiador Para Bebe has no negative impact on pregnancy. This medicine is not excreted in breast milk and it can be used during lactation.

Special instructions

To improve the efficiency it requires careful observance of the application method. Benzalkonium chloride can be used in conjunction with a vaginal diaphragm or intrauterine device. You should avoid bathing or irrigation of the vagina with soapy water for 2 hours before and within 2 hours after sexual intercourse (this medication is destroyed by soap), outdoor toilet is only possible with clean water.

Benzalkonium chloride is incompatible with soaps and other anionic surfactants as well as citrates, iodides, nitrates, permanganates, salicylates, silver salts and tartrates.

Baby Sebamed Dermolimpiador Para Bebe drug interactions

Any substance introduced intravaginally can reduce local spermicidal action (including soaps and solutions containing it). Iodine solutions inactivate Baby Sebamed Dermolimpiador Para Bebe (Fragrance).

Glycine:


INDICATIONS AND USAGE

1.5% Baby Sebamed Dermolimpiador Para Bebe (Glycine) Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.

CONTRAINDICATIONS

NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.

Do not use in patients with anuria.

WARNINGS

FOR UROLOGIC IRRIGATION ONLY.

Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes. Thus, Baby Sebamed Dermolimpiador Para Bebe (Glycine) irrigating solution must be regarded as a systemic drug. Absorption of large amounts of fluids containing Baby Sebamed Dermolimpiador Para Bebe (Glycine) may significantly alter cardiopulmonary and renal dynamics.

Do not heat container over 66°C (150°F).

PRECAUTIONS

Cardiovascular status, especially of the patient with cardiac disease, should be carefully observed before and during transurethral resection of the prostate when using Baby Sebamed Dermolimpiador Para Bebe (Glycine) irrigating solution, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the extracellular fluid and lead to fulminating congestive heart failure. Shift of sodium free intracellular fluid into the extracellular compartment following systemic absorption of solution may lower serum sodium concentration and aggravate pre-existing hyponatremia.

Care should be exercised if impaired liver function is known or suspected. Under such conditions, ammonia resulting from metabolism of Baby Sebamed Dermolimpiador Para Bebe (Glycine) may accumulate in the blood.

Aseptic technique is essential with the use of sterile solutions for irrigation. The administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure.

Do not administer unless solution is clear, seal is intact and container is undamaged. Discard unused portion.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Baby Sebamed Dermolimpiador Para Bebe (Glycine) Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Nursing Mothers: Caution should be exercised when Baby Sebamed Dermolimpiador Para Bebe (Glycine) Irrigation, USP is administered to a nursing woman.

Pregnancy: Teratogenic Effects.

Pregnancy Category C. Animal reproduction studies have not been conducted with Baby Sebamed Dermolimpiador Para Bebe (Glycine) Irrigation, USP. It is also not known whether Baby Sebamed Dermolimpiador Para Bebe (Glycine) Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Baby Sebamed Dermolimpiador Para Bebe (Glycine) Irrigation, USP should be given to a pregnant woman only if clearly needed.

Pediatric Use: The safety and effectiveness of Baby Sebamed Dermolimpiador Para Bebe (Glycine) Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

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ADVERSE REACTIONS

Adverse reactions may result from intravascular absorption of Baby Sebamed Dermolimpiador Para Bebe (Glycine). Large intravenous doses of Baby Sebamed Dermolimpiador Para Bebe (Glycine) are known to cause salivation, nausea and lightheadedness. Other consequences of absorption of urologic irrigating solutions include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst, dehydration, coma from hyponatremia, secondary hyponatremia due to fluid overload, and hyper- ammonemia with resultant coma and/or encephalopathy; cardiovascular disorders such as hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary congestion; and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, transient blindness and urticaria. Allergic reactions from Baby Sebamed Dermolimpiador Para Bebe (Glycine) are unknown or exceedingly rare.

Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

OVERDOSAGE

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

DOSAGE AND ADMINISTRATION

1.5% Baby Sebamed Dermolimpiador Para Bebe (Glycine) Irrigation, USP should be administered only by transurethral instillation with appropriate urologic instrumentation. A disposable irrigation set should be used. The total volume of solution used for irrigation is solely at the discretion of the surgeon.

Height of container(s) above the operating table in excess of 60 cm (approx. 2 ft.) has been reported to increase intravascular absorption of the irrigating fluid.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.

HOW SUPPLIED

1.5% Baby Sebamed Dermolimpiador Para Bebe (Glycine) Irrigation, USP is supplied in single-dose 3000 mL flexible irrigation container ( List No. 7974).

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F).

Revised: October 2004

©Hospira 2004 EN-0577 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

IM-1453

iv bag ndc 0409-7974-08

2

HDPE

TO OPEN TEAR AT NOTCH

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING

THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.

IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.

RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE

HEAT. PROTECT FROM FREEZING. SEE INSERT.

98-4321-R14-3/98

Lysine:


BOXED WARNING

Pharmacy Bulk Package

Not For Direct Infusion

DESCRIPTION

Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% Amino Acids Injection in a Pharmacy Bulk Package is a sterile, clear, nonpyrogenic solution of essential and nonessential amino acids for intravenous infusion in parenteral nutrition following appropriate dilution.

Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% in a Pharmacy Bulk Package is not for direct infusion. It is a sterile dosage from which contains several single doses for use in a pharmacy admixture program in the preparation of intravenous parenteral fluids.

Each 100 mL contains:


Essential Amino Acids


Baby Sebamed Dermolimpiador Para Bebe (Lysine) (from Baby Sebamed Dermolimpiador Para Bebe (Lysine) Acetate, USP)……………………………………...1.18


g


Leucine, USP……………………………………………………………...1.04


g


Phenylalanine, USP……………………………………...1.04


g


Valine, USP……………………………………………………………...960


mg


Isoleucine, USP………………………………………...749


mg


Methionine, USP………………………………………...749


mg


Threonine, USP………………………………………...749


mg


Tryptophan, USP………………………………………...250


mg


Nonessential Amino Acids


Alanine, USP…………………………………………...2.17


g


Arginine, USP…………………………………………...1.47


g


Glycine, USP…………………………………………...1.04


g


Histidine, USP…………………………………………...894


mg


Proline, USP……………………………………………………………...894


mg


Glutamic Acid…………………………………………...749


mg


Serine, USP……………………………………………...592


mg


Aspartic Acid, USP……………………………………...434


mg


Tyrosine, USP…………………………………………...39


mg


Sodium Metabisulfite, NF added……………………………………………...30


mg


Water for Injection, USP……………………………………………………...


qs


Essential Amino Acids………………………………………………………...6.7


g


Nonessential Amino Acids…………………………………………………...8.3


g


Total Amino Acids…………………………………………………………...15.0


g


Total Nitrogen………………………………………………………………...2.37


g


Acetate*……………………………………………………...151


mEq/L


Osmolarity (calculated)……………………………………...1388


mOsmol/L


pH……………………………………………………………………………...5.6(5.2-6.0)


*Acetate from Baby Sebamed Dermolimpiador Para Bebe (Lysine) Acetate, USP and acetic acid used for pH adjustment.


The formulas for the individual amino acids are as follows:

Formulas for individual amino acids

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CLINICAL PHARMACOLOGY

Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% Amino Acids Injection providesseventeen crystalline amino acids. This completely utilizable substrate promotesprotein synthesis and wound healing and reduces the rate of protein catabolism.

A.Total Parenteral Nutrition (Central Infusion)

When enteralfeeding is inadvisable, Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% given by central venousinfusion in combination with energy sources, vitamins, trace elements andelectrolytes, will completely satisfy the requirements for weight maintenanceor weight gain, depending upon the dose selected. The energy component inparenteral nutrition by central infusion may be derived solely from dextroseor may be provided by a combination of dextrose and intravenous fat emulsion. The addition of intravenous fat emulsion provides essential fatty acids andpermits a dietary balance of fat and carbohydrate, at the same time offeringthe option of reducing the dextrose load and/or increasing the total caloricinput. An adequate energy supply is essential for optimal utilization of aminoacids.

B. Total Parenteral Nutrition (Peripheral Infusion)

Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%can also be administered as part of a total parenteral nutrition program byperipheral vein when the enteral route is inadvisable and use of the centralvenous catheter is contraindicated.

Reduction of proteinloss can be achieved by use of diluted Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% in combinationwith dextrose or with dextrose and intravenous fat emulsion by peripheralinfusion. Complete peripheral intravenous nutrition can be achieved in patientswith low caloric requirements by a Baby Sebamed Dermolimpiador Para Bebe (Lysine)®15%-dextrose-fatregimen.

INDICATIONS AND USAGE

Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% is indicated as an amino acid(nitrogen) source in parenteral nutrition regimens. This use is appropriatewhen the enteral route is inadvisable, inadequate or not possible, as when:

-Gastrointestinal absorption is impaired by obstruction, inflammatory diseaseor its complications, or antineoplastic therapy;

-Bowel rest is needed because of gastrointestinal surgery or its complicationssuch as ileus, fistulae or anastomotic leaks;

-Tube feeding methods alone cannot provide adequate nutrition.

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CONTRAINDICATIONS

This solution should not be used in patients in hepatic coma,severe renal failure, metabolic disorders involving impaired nitrogen utilizationor hypersensitivity to one or more amino acids.

WARNINGS

Administration of amino acids solutions at excessive ratesor to patients with hepatic insufficiency may result in plasma amino acidimbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservativedoses of amino acids should be given to these patients, dictated by the nutritionalstatus of the patient. Should symptoms of hyperammonemia develop, amino acidadministration should be discontinued and the patient’s clinical statusre-evaluated.

Contains sodium metabisulfite, a sulfitethat may cause allergic-type reactions including anaphylactic symptoms andlife-threatening or less severe asthmatic episodes in certain susceptiblepeople. The overall prevalence of sulfite sensitivity in the general populationis unknown and probably low.

Sulfite sensitivity isseen more frequently in asthmatic than in nonasthmatic people.

WARNING: This product contains aluminum that maybe toxic. Aluminum may reach toxic levels with prolonged parenteral administrationif kidney function is impaired. Premature neonates are particularly at riskbecause their kidneys are immature, and they require large amounts of calciumand phosphate solutions, which contain aluminum.

Researchindicates that patients with impaired kidney function, including prematureneonates, who receive parenteral levels of aluminum at greater than 4 to 5mcg/kg/day accumulate aluminum at levels associated with central nervous systemand bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

A. GENERAL

It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis.

The administration of Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% Amino Acids Injection as part of total parenteral nutrition (TPN) with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of hyperosmolarity, hyperglycemia, glycosuria and hypertriglyceridemia.

During parenteral nutrition with concentrated dextrose and amino acids solutions, essential fatty acid deficiency syndrome may develop but may not be clinically apparent. Early demonstration of this condition can only be accomplished by gas liquid chromatographic analysis of plasma lipids. The syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions.

For complete nutritional support, TPN regimens must also include multiple vitamins and trace elements. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate bottles to avoid precipitation. Although the metabolizable acetate ion in Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% diminishes the risk of acidosis, the physician must be alert to the potential appearance of this disorder.

Initiation and termination of infusions of TPN fluids must be gradual to permit adjustment of endogenous insulin release.

Undiluted Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% should not be administered peripherally. When administered centrally, it should be diluted with appropriate diluents, e.g., dextrose, electrolytes and other nutrient components, to at least half strength. See DOSAGE AND ADMINISTRATION.

Caution against volume overload should be exercised.

Drug product contains no more than 25 mcg/L of aluminum.

B. Laboratory Tests

Infusion of Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% without concomitant infusion of an adequate number of non-protein calories may result in elevated BUN. Monitoring of BUN is required and the balance between Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% and the calorie source may require adjustment. Frequent clinical evaluations and laboratory determinations are required to prevent the complications which may occur during the administration of solutions used in TPN. Laboratory tests should include blood glucose, serum electrolytes, liver and kidney function, serum osmolarity, blood ammonia, serum protein, pH, hematocrit, WBC and urinary glucose. When Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% is combined with electrolytes, care should be used in administering this solution to patients with congestive heart failure, renal failure, edema, adrenal hyperactivity, acid-base imbalance and those receiving diuretics or antihypertensive therapy. Total volume infused should be closely monitored. Serum electrolytes should be monitored daily in these patients.

C. Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

D. Pregnancy Category C

Animal reproduction studies have not been conducted with Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%. It is also not known whether Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% should be given to a pregnant woman only if clearly needed.

E. Nursing Mothers

Caution should be exercised when Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% is administered to a nursing woman.

F. Pediatric Use

Safety and effectiveness of Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% Amino Acids Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acids injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature.

G. Special Precautions for Central Infusion

TPN delivered by indwelling catheter through a central or large peripheral vein is a special technique requiring a team effort by physician, nurse and pharmacist. The responsibility for administering this therapy should be confined to those trained in the procedures and alert to signs of complications. Complications known to occur from the placement of central venous catheter are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis, and air/catheter emboli. The risk of sepsis is present during intravenous therapy, especially when using central venous catheters for prolonged periods. It is imperative that the preparation of admixtures and the placement and care of the catheters be accomplished under controlled aseptic conditions.

H. Admixtures

Admixtures should be prepared under a laminar flow hood using aseptic technique.

Admixtures should be stored under refrigeration and must be administered within 24 hours after removal from refrigerator.

Filters of less than 1.2 micron pore size must not be used with admixtures containing fat emulsion.

I. Do not administer unless solution is clear and the seal is intact.

IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL, BASED ON CURRENT MEDICAL PRACTICES, BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.

ADVERSE REACTIONS

OVERDOSAGE

In the event of overhydration or solute overload, re-evaluatethe patient and institute appropriate corrective measures. See WARNINGS andPRECAUTIONS.

DOSAGE AND ADMINISTRATION

The appropriate daily dose of amino acids to be used withdextrose or with dextrose and intravenous fat emulsion will depend upon themetabolic status and clinical response of the patient as therapy proceeds. Doses which achieve nitrogen equilibrium or positive balance are the mostdesirable. The dosage on the first day should be approximately half the anticipatedoptimal dosage and should be increased gradually to minimize glycosuria; similarly,withdrawal should be accomplished gradually to avoid rebound hypoglycemia.

Fatemulsion coadministration should be considered when prolonged (more than 5days) parenteral nutrition is required in order to prevent essential fattyacid deficiency (EFAD). Serum lipids should be monitored for evidence of EFADin patients maintained on fat free TPN.

The amount administeredis dosed on the basis of amino acids/kg of body weight/day. In general, twoto three g/kg of body weight for neonates and infants with adequate caloriesare sufficient to satisfy protein needs and promote positive nitrogen balance. In pediatric patients, the final solution should not exceed twice normal serumosmolarity (718 mOsmol/L).

DIRECTIONSFOR PROPER USE OF PHARMACY BULK PACKAGE

Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%in a Pharmacy Bulk Package is not intended for direct infusion. The containerclosure may be penetrated only once using a suitable sterile transfer deviceor dispensing set which allows measured dispensing of the contents. The PharmacyBulk Package is to be used only in a suitable work area such as a laminarflow hood (or an equivalent clean air compounding area). Once the closureis penetrated, the contents should be dispensed as soon as possible; the transferof contents must be completed within 4 hours of closure entry. The bottlemay be stored at room temperature (25°C) after the closure has been entered. Date and time of container entry should be noted in the area designated onthe container label.

When using Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%in patients with a need for fluid volume restriction, it can be diluted asfollows:


Volume


Amount


FinalConcentration


Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%


500 mL


75 g


7.5%


Dextrose 70%


250 mL


175 g


17.5%


Intralipid® 20%


250 mL


50 g


5.0%


This will provide 1395 kilocalories (kcal) per 1000 mLof admixture with a ratio of 118 non-protein calories per gram of nitrogenand an osmolarity of 1561 mOsmol/L.

In patients wherethe need for fluid restriction is not so marked, either of the following regimensmay be used dependent upon the energy needs of the patient.


Volume


Amount


FinalConcentration


Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%


500 mL


75 g


3.75%


Dextrose 50%


1000 mL


500 g


25%


Intralipid® 20%


500 mL


100 g


5%


This will provide 1500 kcal per 1000 mL of admixture witha ratio of 228 non-protein calories per gram of nitrogen and an osmolarityof 1633 mOsmol/L.


Volume


Amount


FinalConcentration


Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%


500 mL


75 g


3.75%


Dextrose 30%


1000 mL


300 g


15%


Intralipid® 10%


500 mL


50 g


2.5%


This will provide 935 kcal per 1000 mL of admixture witha ratio of 158 non-protein calories per gram of nitrogen and an osmolarityof 1128.5 mOsmol/L.

A. Total Parenteral Nutrition (CentralInfusion)

In unstressed adult patients with no unusualnitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%)plus 4.4 grams (15 calories) of dextrose per kilogram of body weight per dayare required to achieve nitrogen balance and weight stability. Intravenousfat emulsion may be used as a partial substitute for dextrose. This regimenprovides a ratio of 150 non-protein calories per gram of nitrogen.

Forpatients stressed by surgery, trauma or sepsis, and those with unusual nitrogenlosses, the dosage required for maintenance may be as high as 0.3 to 0.4 gramsof nitrogen (13 to 17 mL Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%) per kilogram of bodyweight per day, with proportionate increases in non-protein calories. Periodicassessment of nitrogen balance of the individual patient is the best indicatorof proper dosage. Volume overload and glycosuria may be encountered at highdosage, and nitrogen balance may not be achieved in extremely hypermetabolicpatients under these constraints. Concomitant insulin administration may berequired to minimize glycosuria. Daily laboratory monitoring is essential.

Useof an infusion pump is advisable to maintain a steady infusion rate duringcentral venous infusion.

B. Peripheral Nutrition

Inpatients for whom central venous catheterization is not advisable, proteincatabolism can be reduced by peripheral use of diluted Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%plus non-protein calorie sources. Dilution of 250 mL Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15%in 750 mL of 10% dextrose will reduce the osmolarity to a level (724 mOsmol/L)which is more favorable to the maintenance of the integrity of the walls ofthe veins. Intravenous fat emulsion can be infused separately or simultaneously;if infused simultaneously the fat emulsion will provide a dilution effectupon the osmolarity while increasing the energy supply.

Parenteraldrug products should be inspected visually for particulate matter and discolorationprior to administration, whenever solution and container permit.

Toreduce the risk of bacterial contamination, all intravenous administrationsets should be replaced at least every 24 hours. Usage of admixtures mustbe initiated within 24 hours after mixing. If storage is necessary duringthis 24 hour period, admixtures must be refrigerated and completely used within24 hours of beginning administration.

HOW SUPPLIED

Baby Sebamed Dermolimpiador Para Bebe (Lysine)® 15% Amino Acids Injection is suppliedas a Pharmacy Bulk Package in 500 mL containers.

500mL NDC 0409-0468-05

STORAGE

Store inthe closed carton; do not expose solution to light until ready for use. Exposureof pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at 20 to 25°C (68 to 77°F). Brief exposure to temperatures above25°C during transport and storage will not adversely affect the product. Solution that has been frozen must not be used.


©Hospira 2005


EN-1010


Hospira, Inc., Lake Forest, IL 60045 USA

RL-1450

Magnesium Aspartate:



Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) Sulfate

Injection, USP

Ansyr Plastic Syringe

Rx only

Hospira Logo

DESCRIPTION

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) Sulfate Injection, USP is a sterile solution of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate heptahydrate in Water for Injection, USP administered by the intravenous or intramuscular routes as an electrolyte replenisher or anticonvulsant. Must be diluted before intravenous use. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 5.5 to 7.0. The 50% concentration has an osmolarity of 4.06 mOsmol/mL (calc.).

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded with the entire unit.

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) Sulfate, USP heptahydrate is chemically designated MgSO4 - 7H2O with molecular weight of 246.48 and occurs as colorless crystals or white powder freely soluble in water.

The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

CLINICAL PHARMACOLOGY

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) (Mg++) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.

As a nutritional adjunct in hyperalimentation, the precise mechanism of action for Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) is uncertain. Early symptoms of hypomagnesemia (less than 1.5 mEq/liter) may develop as early as three to four days or within weeks.

Predominant deficiency effects are neurological, e.g., muscle irritability, clonic twitching and tremors. Hypocalcemia and hypokalemia often follow low serum levels of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate). While there are large stores of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) is said to have a depressant effect on the central nervous system (CNS), but it does not adversely affect the woman, fetus or neonate when used as directed in eclampsia or pre-eclampsia. Normal plasma Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) levels range from 1.5 to 2.5 mEq/liter.

As plasma Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) rises above 4 mEq/liter, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 mEq/liter. At this level respiratory paralysis may occur. Heart block also may occur at this or lower plasma levels of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate). Serum Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) concentrations in excess of 12 mEq/L may be fatal.

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) acts peripherally to produce vasodilation. With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. The central and peripheral effects of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) poisoning are antagonized to some extent by intravenous administration of calcium.

Pharmacokinetics

With intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following intramuscular administration the onset of action occurs in about one hour and persists for three to four hours. Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/liter. Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

INDICATIONS AND USAGE

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) Sulfate Injection, USP is suitable for replacement therapy in Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) (Mg++) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca++) level is normal (4.3 to 5.3 mEq/liter) or elevated.

In total parenteral nutrition (TPN), Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) Sulfate Injection, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively.

CONTRAINDICATIONS

Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

WARNINGS

FETAL HARM: Continuous administration of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate should be used during pregnancy only if clearly needed. If Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate beyond 5 to 7 days may cause fetal abnormalities.

ALUMINUM TOXICITY: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Parenteral use in the presence of renal insufficiency may lead to Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) intoxication. Intravenous use in the eclampsia should be reserved for immediate control of life-threatening convulsions.

PRECAUTIONS

General

Administer with caution if flushing and sweating occurs. When barbiturates, narcotics or other hypnotics (or systemic anesthetics) are to be given in conjunction with Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate), their dosage should be adjusted with caution because of additive CNS depressant effects of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate).

Because Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. Urine output should be maintained at a level of 100 mL or more during the four hours preceding each dose. Monitoring serum Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) levels and the patient's clinical status is essential to avoid the consequences of overdosage in toxemia. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more/minute). When repeated doses of the drug are given parenterally, knee jerk reflexes should be tested before each dose and if they are absent, no additional Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) should be given until they return. Serum Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/liter). The strength of the deep tendon reflexes begins to diminish when Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) levels exceed 4 mEq/liter. Reflexes may be absent at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) intoxication in eclampsia.

50% Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) Sulfate Injection, USP must be diluted to a concentration of 20% or less prior to intravenous infusion. Rate of administration should be slow and cautious, to avoid producing hypermagnesemia. The 50% solution also should be diluted to 20% or less for intramuscular injection in infants and children.

Laboratory Tests

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) is monitored. The normal serum level is 1.5 to 2.5 mEq/L.

Drug Interactions

CNS Depressants - When barbiturates, narcotics or other hypnotics (or systemic anesthetics), or other CNS depressants are to be given in conjunction with Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate), their dosage should be adjusted with caution because of additive CNS depressant effects of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate). CNS depression and peripheral transmission defects produced by Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) may be antagonized by calcium.

Neuromuscular Blocking Agents - Excessive neuromuscular block has occurred in patients receiving parenteral Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution.

Cardiac Glycosides - Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate should be administered with extreme caution in digitalized patients, because serious changes in cardiac conduction which can result in heart block may occur if administration of calcium is required to treat Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) toxicity.

Pregnancy

Teratogenic Effects

Pregnancy Category D (See WARNINGS and PRECAUTIONS )

See WARNINGS and PRECAUTIONS .

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate can cause fetal abnormalities when administered beyond 5 to 7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization, osteopenia and other skeletal abnormalities with continuous maternal administration of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate for more than 5 to 7 days.1-10 Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate injection should be used during pregnancy only if clearly needed. If this drug is used during pregnancy, the woman should be apprised of the potential harm to the fetus.

Nonteratogenic Effects

When administered by continuous intravenous infusion (especially for more than 24 hours preceding delivery) to control convulsions in a toxemic woman, the newborn may show signs of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) toxicity, including neuromuscular or respiratory depression (See OVERDOSAGE ).

Labor and Delivery

Continuous administration of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate is an unapproved treatment for preterm labor. The safety and efficacy of such use have not been established. The administration of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Nursing Mothers

Since Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) is distributed into milk during parenteral Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate administration, the drug should be used with caution in nursing women.

Geriatrics

Geriatric patients often require reduced dosage because of impaired renal function. In patients with severe impairment, dosage should not exceed 20 grams in 48 hours. Serum Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) should be monitored in such patients.

ADVERSE REACTIONS

The adverse effects of parenterally administered Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) usually are the result of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate therapy for eclampsia has been reported.

OVERDOSAGE

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign to detect the onset of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) intoxication. In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected intravenously to antagonize the effects of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate).

For Treatment of Overdose

Artificial respiration is often required. Intravenous calcium, 10 to 20 mL of a 5% solution (diluted if desirable with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia. Subcutaneous physostigmine, 0.5 to 1 mg may be helpful.

Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.

DOSAGE AND ADMINISTRATION

Dosage of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate must be carefully adjusted according to individual requirements and response, and administration of the drug should be discontinued as soon as the desired effect is obtained.

Both intravenous and intramuscular administration are appropriate. Intramuscular administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas intravenous doses will provide a therapeutic level almost immediately. The rate of intravenous injection should generally not exceed 150 mg/minute (1.5 mL of a 10% concentration or its equivalent), except in severe eclampsia with seizures. Continuous maternal administration of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

Solutions for intravenous infusion must be diluted to a concentration of 20% or less prior to administration. The diluents commonly used are 5% Dextrose Injection, USP and 0.9% Sodium Chloride Injection, USP. Deep intramuscular injection of the undiluted (50%) solution is appropriate for adults, but the solution should be diluted to a 20% or less concentration prior to such injection in children.

In Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) Deficiency

In the treatment of mild Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) deficiency, the usual adult dose is 1 gram, equivalent to 8.12 mEq of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) (2 mL of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total of 32.5 mEq of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) per 24 hours). For severe hypomagnesemia, as much as 250 mg (approximately 2 mEq) per kg of body weight (0.5 mL of the 50% solution) may be given intramuscularly within a period of four hours if necessary. Alternatively, 5 grams, (approximately 40 mEq) can be added to one liter of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP for slow intravenous infusion over a three-hour period. In the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity.

In Hyperalimentation

In total parenteral nutrition, maintenance requirements for Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) are not precisely known. The maintenance dose used in adults ranges from 8 to 24 mEq (1 gram to 3 grams) daily; for infants, the range is 2 to 10 mEq (0.25 gram to 1.25 grams) daily.

In Pre-eclampsia or Eclampsia

In severe pre-eclampsia or eclampsia, the total initial dose is 10 grams to 14 grams of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate. Intravenously, a dose of 4 grams to 5 grams in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused. Simultaneously, intramuscular doses of up to 10 grams (5 grams or 10 mL of the undiluted 50% solution in each buttock) are given. Alternatively, the initial intravenous dose of 4 grams may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 mL of a 10% solution or 20 mL of a 20% solution) may then be injected intravenously over a period of three to four minutes. Subsequently, 4 grams to 5 grams (8 to 10 mL of the 50% solution) are injected intramuscularly into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function. Alternatively, after the initial intravenous dose, some clinicians administer 1 gram to 2 grams/hour by constant intravenous infusion. Therapy should continue until paroxysms cease. A serum Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 grams to 40 grams should not be exceeded. In the presence of severe renal insufficiency, the maximum dosage of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate is 20 grams/48 hours and frequent serum Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) concentrations must be obtained. Continuous use of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

Other Uses

In counteracting the muscle-stimulating effects of barium poisoning, the usual dose of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate is 1 gram to 2 grams given intravenously.

For controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 gram administered intramuscularly or intravenously.

In paroxysmal atrial tachycardia, Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) should be used only if simpler measures have failed and there is no evidence of myocardial damage. The usual dose is 3 grams to 4 grams (30 to 40 mL of a 10% solution) administered intravenously over 30 seconds with extreme caution.

For reduction of cerebral edema, 2.5 grams (25 mL of a 10% solution) is given intravenously.

Incompatibilities

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate in solution may result in a precipitate formation when mixed with solutions containing:

Alcohol (in high Heavy Metals

concentrations) Hydrocortisone sodium

Alkali carbonates and succinate

bicarbonates Phosphates

Alkali hydroxides Polymixin B sulfate

Arsenates Procaine hydrochloride

Barium Salicylates

Calcium Strontium

Clindamycin phosphate Tartrates

The potential incompatibility will often be influenced by the changes in the concentration of reactants and the pH of the solutions.

It has been reported that Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) Sulfate Injection, USP is supplied in single-dose containers as follows:


NDC No.


Container


Total

Amount


Concentration


mEq

Mg++/mL


0409-1754-10


Ansyr

Plastic Syringe


5 g/10 mL


50%


4 mEq/mL


Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Store at 20 to 25°C (68 to 77°F).

REFERENCES

  • Yokoyama K, Takahashi N, Yada Y. Prolonged maternal Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) administration and bone metabolism in neonates. Early Hum Dev. 2010;86(3):187-91. Epub 2010 Mar 12.
  • Wedig KE, Kogan J, Schorry EK et al. Skeletal demineralization and fractures caused by fetal Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) toxicity. J. Perinatol. 2006; 26(6):371-4.
  • Nassar AH, Sakhel K, Maarouf H, et al. Adverse maternal and neonatal outcome of prolonged course of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate tocolysis. Acta Obstet Gynecol Scan. 2006;85(9):1099-103.
  • Malaeb SN, Rassi A, Haddad MC. Bone mineralization in newborns whose mothers received Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulphate for tocolysis of premature labor. Pediatr Radiol. 2004;34(5):384-6. Epub 2004 Feb 18.
  • Matsuda Y, Maeda Y, Ito M, et al. Effect of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate treatment on neonatal bone abnormalities. Gynecol Obstet Invest. 1997;44(2):82-8.
  • Schanler RJ, Smith LG, Burns PA. Effects of long-term maternal intravenous Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate therapy on neonatal calcium metabolism and bone mineral content. Gynecol Obstet Invest. 1997;43(4):236-41.
  • Santi MD, Henry GW, Douglas GL. Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthrop. 1994;14(2):249-53.
  • Holcomb WL, Shackelford GD, Petrie RH. Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) tocolysis and neonatal bone abnormalities; a controlled study. Obstet Gynecol. 1991; 78(4):611-4.
  • Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate. Am J Roentgenol. 1989; 152(5):1071-2.
  • Lamm CL, Norton KL, Murphy RJ. Congenital rickets associated with Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate infusion for tocolysis. J Pediatr. 1988; 113(6):1078-82.
  • McGuinness GA, Weinstein MM, Cruikshank DP, et al. Effects of Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate treatment on perinatal calcium metabolism. II. Neonatal responses. Obstet Gynecol. 1980; 56(5): 595-600.
  • Riaz M, Porat R, Brodsky NL, et al. The effects of maternal Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) sulfate treatment on newborns: a prospective controlled study. J. Perinatol. 1998;18(6 pt 1):449-54.

Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1024-1.0

April 2017

Hospira Logo

50% Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) Sulfate 5 g/10 mL (500 mg/mL)

Rx only

NDC 0409-1754-10

10 mL Single-dose syringe

50% Baby Sebamed Dermolimpiador Para Bebe (Magnesium Aspartate) Sulfate Injection, USP

5 g/10 mL (500 mg/mL) (4 mEq Mg++/mL)

MUST BE DILUTED FOR INTRAVENOUS USE.

For Intravenous or Intramuscular Use. Sterile. 4.06 mOsmol/mL (calc.).

Contains no more than 75 mcg/L of aluminum.

Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

RL-6891

Sodium Lactate:


1 INDICATIONS AND USAGE

Baby Sebamed Dermolimpiador Para Bebe nitrite is indicated for sequential use with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate for treatment of acute cyanide poisoning that is judged to be life-threatening. (1)

  • Use with caution if the diagnosis of cyanide poisoning is uncertain. (1)

1.1 Indication

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection is indicated for sequential use with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate for the treatment of acute cyanide poisoning that is judged to be life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.

1.2 Identifying Patients with Cyanide Poisoning

Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to Baby Sebamed Dermolimpiador Para Bebe nitroprusside.

The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Thiosulfate Injection should be administered without delay.

Symptoms Signs
  • Headache
  • Confusion
  • Dyspnea
  • Chest Tightness
  • Nausea
  • Altered Mental Status

    (e.g., confusion, disorientation)

  • Seizures or Coma
  • Mydriasis
  • Tachypnea/Hyperpnea (early)
  • Bradypnea/Apnea (late)
  • Hypertension (early)/ Hypotension (late)
  • Cardiovascular Collapse
  • Vomiting
  • Plasma Lactate Concentration ≥ 8 mmol/L

In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well.

The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222.

Smoke Inhalation

Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection, smoke-inhalation victims should be assessed for the following:

  • Exposure to fire or smoke in an enclosed area
  • Presence of soot around the mouth, nose, or oropharynx
  • Altered mental status

Although hypotension is highly suggestive of cyanide poisoning, it is only present in a small percentage of cyanide-poisoned smoke inhalation victims. Also indicative of cyanide poisoning is a plasma lactate concentration greater than or equal to 10 mmol/L (a value higher than that typically listed in the table of signs and symptoms of isolated cyanide poisoning because carbon monoxide associated with smoke inhalation also contributes to lactic acidemia). If cyanide poisoning is suspected, treatment should not be delayed to obtain a plasma lactate concentration.

1.3 Use with Other Cyanide Antidotes

Caution should be exercised when administering cyanide antidotes, other than Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate, simultaneously with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection, as the safety of co-administration has not been established. If a decision is made to administer another cyanide antidote, other than Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate, with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection, these drugs should not be administered concurrently in the same IV line. [see Dosage and Administration (2.2) ]

2 DOSAGE AND ADMINISTRATION

Age Intravenous Dose of Baby Sebamed Dermolimpiador Para Bebe Nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Thiosulfate
Adults
  • Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite -10 mL of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite at the rate of 2.5 to 5 mL/minute
  • Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Thiosulfate - 50 mL of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate immediately following administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite.
Children
  • Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite - 0.2 mL/kg (6 mg/kg or 6-8 mL/m2 BSA) of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL
  • Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Thiosulfate - 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m2 of BSA) not to exceed 50 mL total dose immediately following administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite.

Redosing: If signs of cyanide poisoning reappear, repeat treatment using one-half the original dose of both Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate.

Monitoring: Blood pressure must be monitored during treatment. (2.2)

2.1 Administration Recommendation

Comprehensive treatment of acute cyanide intoxication requires support of vital functions. Administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite, followed by Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate, should be considered adjunctive to appropriate supportive therapies. Airway, ventilatory and circulatory support, and oxygen administration should not be delayed to administer Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate.

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite injection and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate injection are administered by slow intravenous injection. They should be given as early as possible after a diagnosis of acute life-threatening cyanide poisoning has been established. Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite should be administered first, followed immediately by Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate. Blood pressure must be monitored during infusion in both adults and children. The rate of infusion should be decreased if significant hypotension is noted.

Age Intravenous Dose of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Thiosulfate
Adults
  • Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite -10 mL of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite at the rate of 2.5 to 5 mL/minute
  • Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Thiosulfate - 50 mL of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate immediately following administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite.
Children
  • Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite -0.2 mL/kg (6 mg/kg or 6-8 mL/m2 BSA) of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL
  • Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Thiosulfate - 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m2 of BSA) not to exceed 50 mL total dose immediately following administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite.

NOTE: If signs of poisoning reappear, repeat treatment using one-half the original dose of both Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate.

In adult and pediatric patients with known anemia, it is recommended that the dosage of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite should be reduced proportionately to the hemoglobin concentration.

All parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2.2 Recommended Monitoring

Patients should be monitored for at least 24-48 hours after Baby Sebamed Dermolimpiador Para Bebe Nitrite Injection administration for adequacy of oxygenation and perfusion and for recurrent signs and symptoms of cyanide toxicity. When possible, hemoglobin/hematocrit should be obtained when treatment is initiated. Measurements of oxygen saturation using standard pulse oximetry and calculated oxygen saturation values based on measured PO2 are unreliable in the presence of methemoglobinemia.

Methemoglobin level: Administrations of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite solely to achieve an arbitrary level of methemoglobinemia may be unnecessary and potentially hazardous. The therapeutic effects of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite do not appear to be mediated by methemoglobin formation alone and clinical responses to Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite administration have been reported in association with methemoglobin levels of less than 10%. Administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite beyond the initial dose should be guided primarily by clinical response to treatment (i.e., a second dose should be considered only if there is inadequate clinical response to the first dose). It is generally recommended that methemoglobin concentrations be closely monitored and kept below 30%. Serum methemoglobin levels should be monitored during treatment using co-oximetry, and administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite should generally be discontinued when methemoglobin levels exceed 30%. Intravenous methylene blue and exchange transfusion have been reported in the literature as treatments for life-threatening methemoglobinemia.

2.3 Incompatibility Information

Chemical incompatibility has been reported between Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and hydroxocobalamin and these drugs should not be administered simultaneously through the same IV line. No chemical incompatibility has been reported between Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite, when administered sequentially through the same IV line as described in Dosage and Administration.

3 DOSAGE FORMS AND STRENGTHS

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection consists of:

  • One vial of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite injection, USP 300 mg/10mL (30 mg/mL)

Administration of the contents of one vial constitutes a single dose.

  • Injection, 300 mg/10 mL (30 mg/mL). (3)

4 CONTRAINDICATIONS

None

  • None. (4)

5 WARNINGS AND PRECAUTIONS

  • Methemoglobinemia: Baby Sebamed Dermolimpiador Para Bebe nitrite reacts with hemoglobin to form methemoglobin and should be used with caution in patients known to have anemia. Monitor oxyhemoglobin and methemoglobin levels by pulse oximetry or other measurements. Optimally, the Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite dose should be reduced in proportion to the oxygen carrying capacity. (5.2)
  • Smoke inhalation: Carbon monoxide contained in smoke can result in the formation of carboxyhemoglobin that can reduce the oxygen carrying capacity of the blood. Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite should be used with caution in patients with smoke inhalation injury because of the potential for worsening hypoxia due to methemoglobin formation. Carboxyhemoglobin and oxyhemoglobin levels should be monitored by pulse oximetry or other measurements in patients that present with evidence of smoke inhalation. Optimally, the Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite dose should be reduced in proportion to the oxygen carrying capacity. (5.4)

5.1 Hypotension

5.2 Methemoglobinemia

Supportive care alone may be sufficient treatment without administration of antidotes for many cases of cyanide intoxication, particularly in conscious patients without signs of severe toxicity. Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with Baby Sebamed Dermolimpiador Para Bebe nitrite.

Methemoglobin levels should be monitored and oxygen administered during treatment with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite whenever possible. When Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite is administered to humans a wide range of methemoglobin concentrations occur. Methemoglobin concentrations as high as 58% have been reported after two 300-mg doses of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite administered to an adult. Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite should be used with caution in the presence of other drugs that may cause methemoglobinemia such as procaine and nitroprusside. Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite should be used with caution in patients who may be particularly susceptible to injury from vasodilation and its related hemodynamic sequelae. Hemodynamics should be monitored closely during and after administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite, and infusion rates should be slowed if hypotension occurs.

5.3 Anemia

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite should be used with caution in patients with known anemia. Patients with anemia will form more methemoglobin (as a percentage of total hemoglobin) than persons with normal red blood cell (RBC) volumes. Optimally, these patients should receive a Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite dose that is reduced in proportion to their oxygen carrying capacity.

5.4 Smoke Inhalation Injury

Baby Sebamed Dermolimpiador Para Bebe nitrite should be used with caution in persons with smoke inhalation injury or carbon monoxide poisoning because of the potential for worsening hypoxia due to methemoglobin formation.

5.5 Neonates and Infants

Neonates and infants may be more susceptible than adults and older pediatric patients to severe methemoglobinemia when Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite is administered. Reduced dosing guidelines should be followed in pediatric patients.

5.6 G6PD Deficiency

Because patients with G6PD deficiency are at increased risk of a hemolytic crisis with Baby Sebamed Dermolimpiador Para Bebe nitrite administration, alternative therapeutic approaches should be considered in these patients. Patients with known or suspected G6PD deficiency should be monitored for an acute drop in hematocrit. Exchange transfusion may be needed for patients with G6PD deficiency who receive Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite.

5.7 Use with Other Drugs

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite should be used with caution in the presence of concomitant antihypertensive medications, diuretics or volume depletion due to diuretics, or drugs known to increase vascular nitric oxide, such as PDE5 inhibitors.

6 ADVERSE REACTIONS

There have been no controlled clinical trials conducted to systematically assess the adverse events profile of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite.

The medical literature has reported the following adverse events in association with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed.

Cardiovascular system: syncope, hypotension, tachycardia, methemoglobinemia, palpitations, dysrhythmia

Hematological: methemoglobinemia

Central nervous system: headache, dizziness, blurred vision, seizures, confusion, coma

Gastrointestinal system: nausea, vomiting, abdominal pain

Respiratory system: tachypnea, dyspnea

Body as a Whole: anxiety, diaphoresis, lightheadedness, injection site tingling, cyanosis, acidosis, fatigue, weakness, urticaria, generalized numbness and tingling

Severe hypotension, methemoglobinemia, cardiac dysrhythmias, coma and death have been reported in patients without life-threatening cyanide poisoning but who were treated with injection of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite at doses less than twice those recommended for the treatment of cyanide poisoning.

Most common adverse reactions are:

  • Syncope, hypotension, tachycardia, palpitations, dysrhythmia, methemoglobinemia, headache, dizziness, blurred vision, seizures, confusion, coma (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hope Pharmaceuticals at 1-800-755-9595 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7 DRUG INTERACTIONS

Formal drug interaction studies have not been conducted with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection.

8 USE IN SPECIFIC POPULATIONS

  • Renal impairment: Baby Sebamed Dermolimpiador Para Bebe nitrite is substantially excreted by the kidney. The risk of toxic reactions to this drug may be greater in patients with impaired renal function. (8.6).

8.1 Pregnancy

Teratogenic Effects. Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women. Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite has caused fetal death in humans as well as animals. There are no studies in humans that have directly evaluated the potential reproductive toxicity of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite. There are two epidemiological studies conducted in Australia that report a statistically significant increase in the risk for congenital malformations, particularly in the CNS, associated with maternal consumption of water containing nitrate levels in excess of 5 ppm. Results from a case-control study in Canada suggested a trend toward an increase in the risk for CNS malformations when maternal consumption of nitrate was ≥ 26 ppm (not statistically significant).

The potential reproductive toxicity of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite exposure restricted to the prenatal period has been reported in guinea pigs, mice, and rats. There was no evidence of teratogenicity in guinea pigs, mice, or rats. However, Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite treatment of pregnant guinea pigs with 60 or 70 mg/kg/day resulted in abortion of the litters within 1-4 days of treatment. All animals treated subcutaneously with 70 mg/kg, Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite died within 60 minutes of treatment. Further studies demonstrated that a dose of 60 mg/kg resulted in measurable blood levels of methemoglobin in the dams and their fetuses for up to 6 hours post treatment. Maternal methemoglobin levels were higher than the levels in the offspring at all times measured. Based on a body surface area comparison, a 60 mg/kg dose in the guinea pig that resulted in death was only 1.7 times higher than the highest clinical dose of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison).

Studies testing prenatal and postnatal exposure have been reported in mice and rats. Treatment of pregnant rats via drinking water with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite at concentrations of either 2000 or 3000 mg/L resulted in a dose-related increased mortality postpartum. This exposure regimen in the rat model would result in dosing of approximately 220 and 300 mg/kg/day (43 and 65 times the highest clinical dose of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite that would be used to treat cyanide poisoning, based on a body surface area comparison).

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite produces methemoglobin. Fetal hemoglobin is oxidized to methemoglobin more easily than adult hemoglobin. In addition, the fetus has lower levels of methemoglobin reductase than adults. Collectively, these data suggest that the human fetus would show greater sensitivity to methemoglobin resulting in nitrite-induced prenatal hypoxia leading to retarded development of certain neurotransmitter systems in the brain and long lasting dysfunction.

Nonteratogenic Effects: Behavioral and neurodevelopmental studies in rats suggest persistent effects of prenatal exposure to Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite that were detectable postnatally. Specifically, animals that were exposed prenatally to Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite demonstrated impaired discrimination learning behavior (both auditory and visual) and reduced long-term retention of the passive-avoidance response compared to control animals. Additional studies demonstrated a delay in the development of AchE and 5-HT positive fiber ingrowth into the hippocampal dentate gyrus and parietal neocortex during the first week of life of prenatal nitrite treated pups. These changes have been attributed to prenatal hypoxia following nitrite exposure.

8.2 Labor and Delivery

Because fetal hemoglobin is more readily oxidized to methemoglobin and lower levels of methemoglobin appear to be fatal to the fetus compared to the adult, Baby Sebamed Dermolimpiador Para Bebe nitrite should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.

8.3 Nursing Mothers

It is not known whether Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite is excreted in human milk. Because Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection may be administered in life-threatening situations, breast-feeding is not a contraindication to its use. Because many drugs are excreted in human milk, caution should be exercised following Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection administration to a nursing woman. There are no data to determine when breastfeeding may be safely restarted following administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite. In studies conducted with Long-Evans rats, Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite administered in drinking water during pregnancy and lactation resulted in severe anemia, reduced growth and increased mortality in the offspring.

8.4 Pediatric Use

There are case reports in the medical literature of Baby Sebamed Dermolimpiador Para Bebe nitrite in conjunction with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite in the pediatric population. As for adult patients, dosing recommendations for pediatric patients have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite must be used with caution in patients less than 6 months of age because they may be at higher risk of developing severe methemoglobinemia compared to older children and adults. The presence of fetal hemoglobin, which is oxidized to methemoglobin more easily than adult hemoglobin, and lower methemoglobin reductase levels compared to older children and adults may contribute to risk.

Mortality attributed to Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite was reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child.

8.5 Geriatric Use

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6 Renal Disease

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

10 OVERDOSAGE

Large doses of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite result in severe hypotension and toxic levels of methemoglobin which may lead to cardiovascular collapse.

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite administration has been reported to cause or significantly contribute to mortality in adults at oral doses as low as 1 g and intravenous doses as low as 600 mg. A death attributed to Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite has been reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child.

Cyanosis may become apparent at a methemoglobin level of 10-20%. Other clinical signs and symptoms of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite toxicity (anxiety, dyspnea, nausea, and tachycardia) can be apparent at methemoglobin levels as low as 15%. More serious signs and symptoms, including cardiac dysrhythmias, circulatory failure, and central nervous system depression are seen as methemoglobin levels increase, and levels above 70% are usually fatal.

Treatment of overdose involves supplemental oxygen and supportive measures such as exchange transfusion. Treatment of severe methemoglobinemia with intravenous methylene blue has been described in the medical literature; however, this may also cause release of cyanide bound to methemoglobin. Because hypotension appears to be mediated primarily by an increase in venous capacitance, measures to increase venous return may be most appropriate to treat hypotension.

11 DESCRIPTION

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite has the chemical name nitrous acid Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) salt. The chemical formula is NaNO2 and the molecular weight is 69.0. The structural formula is:

Structure of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite Injection is a cyanide antidote which contains one 10 mL glass vial of a 3% solution of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite injection.

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 300 mg of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite in 10 mL solution (30 mg/mL). Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite injection is a clear solution with a pH between 7.0 and 9.0.

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria. Inhibition of cytochrome a3 prevents the cell from using oxygen and forces anaerobic metabolism, resulting in lactate production, cellular hypoxia and metabolic acidosis. In massive acute cyanide poisoning, the mechanism of toxicity may involve other enzyme systems as well.

The synergy resulting from treatment of cyanide poisoning with the combination of Baby Sebamed Dermolimpiador Para Bebe nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate is the result of differences in their primary mechanisms of action as antidotes for cyanide poisoning.

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite is thought to exert its therapeutic effect by reacting with hemoglobin to form methemoglobin, an oxidized form of hemoglobin incapable of oxygen transport but with high affinity for cyanide. Cyanide preferentially binds to methemoglobin over cytochrome a3, forming the nontoxic cyanomethemoglobin. Methemoglobin displaces cyanide from cytochrome oxidase, allowing resumption of aerobic metabolism. The chemical reaction is as follows:

NaNO2 + Hemoglobin → Methemoglobin

HCN + Methemoglobin → Cyanomethemoglobin

Vasodilation has also been cited to account for at least part of the therapeutic effect of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite. It has been suggested that Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite-induced methemoglobinemia may be more efficacious against cyanide poisoning than comparable levels of methemoglobinemia induced by other oxidants. Also, Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite appears to retain some efficacy even when the formation of methemoglobin is inhibited by methylene blue.

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Thiosulfate

The primary route of endogenous cyanide detoxification is by enzymatic transulfuration to thiocyanate (SCN-), which is relatively nontoxic and readily excreted in the urine. Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate is thought to serve as a sulfur donor in the reaction catalyzed by the enzyme rhodanese, thus enhancing the endogenous detoxification of cyanide in the following chemical reaction:

Chemical Structure

12. 2 Pharmacodynamics

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite

When 4 mg/kg Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite was administered intravenously to six healthy human volunteers, the mean peak methemoglobin concentration was 7%, achieved at 30-60 minutes after injection, consistent with reports in cyanide poisoning victims. Supine systolic and diastolic blood pressures dropped approximately 20% within 10 minutes, a drop which was sustained throughout the 40 minutes of testing. This was associated with a 20 beat per minute increase in pulse rate that returned to baseline in 10 minutes. Five of these subjects were unable to withstand orthostatic testing due to fainting. One additional subject, who received a 12 mg/kg dose of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite, experienced severe cardiovascular effects and achieved a peak methemoglobin concentration of 30% at 60 minutes following injection.

Oral doses of 120 to 180 mg of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite administered to healthy volunteers caused minimal cardiovascular changes when subjects were maintained in the horizontal position. However, minutes after being placed in the upright position subjects exhibited tachycardia and hypotension with syncope.

The half life for conversion of methemoglobin to normal hemoglobin in a cyanide poisoning victim who has been administered Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite is estimated to be 55 minutes.

12.3 Pharmacokinetics

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite is a strong oxidant, and reacts rapidly with hemoglobin to form methemoglobin. The pharmacokinetics of free Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite in humans have not been well studied. It has been reported that approximately 40% of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite is excreted unchanged in the urine while the remaining 60% is metabolized to ammonia and related small molecules.

Cyanide

The apparent terminal elimination half life and volume of distribution of cyanide, in a patient treated for an acute cyanide poisoning with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate administration, have been reported to be 19 hours and 0.41 L/kg, respectively. Additionally, an initial elimination half life of cyanide has been reported to be approximately 1-3 hours.

Thiocyanate

After detoxification, in healthy subjects, thiocyanate is excreted mainly in the urine at a rate inversely proportional to creatinine clearance. In healthy subjects, the elimination half-life and volume of distribution of thiocyanate have been reported to be 2.7 days and 0.25 L/kg, respectively. However, in subjects with renal insufficiency the reported elimination half life is approximately 9 days.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The potential benefit of an acute exposure to Baby Sebamed Dermolimpiador Para Bebe nitrite as part of a cyanide antidote outweighs concerns raised by the equivocal findings in chronic rodent studies. Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 35, 70, or 130 mg/kg for males and 0, 40, 80, or 150 mg/kg for females) was orally administered to rats (Fischer 344 strain) for 2 years via drinking water. There were no significant increases in the incidence of tumor in either male or female rats. Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 60, 120, or 220 mg/kg for males and 0, 45, 90, or 165 mg/kg for females) was administered to B6C3F1 mice for 2 years via the drinking water. Equivocal results were obtained in female mice. Specifically, there was a positive trend toward an increase in the incidence of squamous cell papilloma or carcinoma in the forestomach of female mice. Although the incidence of hyperplasia of the glandular stomach epithelium was significantly greater in the high-dose male mice compared to controls, there were no significant increases in tumors in the male mice. Numerous reports in the published literature indicate that Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite may react in vivo with secondary amines to form carcinogenic nitrosamines in the stomach. Concurrent exposure to Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and secondary amines in feed or drinking water resulted in an increase in the incidence of tumors in rodents.

Mutagenesis

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite is mutagenic in S. typhimurium strains TA100, TA1530, TA1535 with and without metabolic activation; however, it was negative in strain TA98, TA102, DJ460 and E. coli strain WP2UVRA/PKM101. Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite has been reported to be genotoxic to V79 hamster cells in vitro and in the mouse lymphoma assay, both assays conducted in the absence of metabolic activation. Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite was negative in the in vitro chromosomal aberrations assay using human peripheral blood lymphocytes. Acute administration of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite to male rats or male mice did not produce an increased incidence of micronuclei in bone marrow. Likewise, Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite administration to mice for 14-weeks did not result in an increase in the incidence of micronuclei in the peripheral blood.

Fertility

Clinical studies to evaluate the potential effects of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite intake on fertility of either males or females have not been reported. In contrast, multigenerational fertility and reproduction studies conducted by the National Toxicology Program did not detect any evidence of an effect of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite (0.0, 0.06, 0.12, and 0.24% weight/volume) on either fertility or any reproductive parameter in Swiss CD-1 mice. This treatment protocol resulted in approximate doses of 125, 260, and 425 mg/kg/day. The highest exposure in this mouse study is 4.6 times greater than the highest clinical dose of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison).

13.2 Animal Pharmacology

Due to the extreme toxicity of cyanide, experimental evaluation of treatment efficacy has predominantly been completed in animal models. The efficacy of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate treatment alone to counteract the toxicity of cyanide was initially reported in 1895 by Lang. The efficacy of amyl nitrite treatment in cyanide poisoning of the dog model was first reported in 1888 by Pedigo. Further studies in the dog model, which demonstrated the utility of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite as a therapeutic intervention, were reported in 1929 by Mladoveanu and Gheorghiu. However, Hugs and Chen et al. independently reported upon the superior efficacy of the combination of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate in 1932-1933. Treatment consisted of intravenously administered 22.5 mg/kg (half the lethal dose) Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite or 1 g/kg Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate alone or in sequence immediately after subcutaneous injection of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) cyanide into dogs over a range of doses. Subsequent doses of 10 mg/kg Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and/or 0.5 g/kg Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate were administered when clinical signs or symptoms of poisoning persisted or reappeared. Either therapy administered alone increased the dose of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) cyanide required to cause death, and when administered together, Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate resulted in a synergistic effect in raising the lethal dose of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) cyanide. The combined therapy appeared to have reduced efficacy when therapy was delayed until signs of poisoning (e.g. convulsions) appeared; however, other investigators have reported survival in dogs that were administered antidotal treatment after respiratory arrest had occurred.

Animal studies conducted in other species (e.g., rat, guinea pig, sheep, pigeon and cat) have also supported a synergistic effect of intravenous Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate in the treatment of cyanide poisoning.

While intravenous injection of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite and Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate was effective in reversing the effects of lethal doses of cyanide in dogs, intramuscular injection of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite, with or without Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate, was found not to be effective in the same setting.

14 CLINICAL STUDIES

The human data supporting the use of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite for cyanide poisoning consists primarily of published case reports. There are no randomized controlled clinical trials. Nearly all the human data describing the use of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) thiosulfate report its use in conjunction with Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite. Dosing recommendations for humans have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.

There have been no human studies to prospectively and systematically evaluate the safety of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite in humans. Available human safety information is based largely on anecdotal case reports and case series of limited scope.

16 HOW SUPPLIED/STORAGE AND HANDLING

Each Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite carton (NDC 60267-311-10) consists of the following:

  • One 10 mL glass vial of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite injection 30 mg/mL (containing 300 mg of Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) nitrite);

Storage

Store at controlled room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted from 15 to 30°C (59 to 86°F). Protect from direct light. Do not freeze.

(Note: Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Thiosulfate must be obtained separately.)

17 PATIENT COUNSELING INFORMATION

Baby Sebamed Dermolimpiador Para Bebe Nitrite Injection is indicated for acute cyanide poisoning that is judged to be life-threatening and in this setting, patients will likely be unresponsive or may have difficulty in comprehending counseling information.

17.1 Hypotension and Methemoglobin Formation

When feasible, patients should be informed of the possibility of life-threatening hypotension and methemoglobin formation.

17.2 Monitoring

Where feasible, patients should be informed of the need for close monitoring of blood pressure and oxygenation.

Manufactured by Cangene BioPharma, Inc., Baltimore, Maryland 21230 for

Hope Pharmaceuticals, Scottsdale, Arizona 85260

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

NDC 60267-311-10

Rx Only

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Nitrite

Injection, USP

300 mg/10 mL

(30 mg/mL)

FOR INTRAVENOUS USE

SINGLE USE ONLY

Any unused portion of a vial

should be discarded.

Use with

Baby Sebamed Dermolimpiador Para Bebe (Sodium Lactate) Thiosulfate

for Treatment of

Cyanide Poisoning

Manufactured by

CANGENE bioPharma, Inc.

Baltimore, MD for

HOPE

PHARMACEUTICALS®

Scottsdale, AZ 85260 U.S.A.

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

Starch:


ACTIVE INGREDIENT

Topical Baby Sebamed Dermolimpiador Para Bebe (Starch), 51%

PURPOSE

Protectant

USE

  • Provides temporary relief of the itching, burning and discomfort associated with hemorrhoids and other anorectal disorders
  • Provides a coating to protect irritated tissue

WARNINGS

For rectal use only.

When using this product

do not exceed the recommended daily dosage unless directed by a doctor.

Stop use and ask a doctor

  • in case of bleeding
  • if condition worsens or does not improve within 7 days.


If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Adults:
  • When practical, cleanse the affected area with mild soap and warm water. Rinse thoroughly.
  • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.
  • Detach one suppository from strip of suppositories.
  • Remove film before inserting into the rectum by holding the suppository upright. Carefully separate film by inserting tip of fingernail at film split.
  • Carefully peel film slowly and evenly down both sides to expose suppository
  • Avoid excessive handling of suppository, which is designed to melt at body temperature. If suppository seems soft, hold in film wrapper under cold water for 2 or 3 minutes.
  • Insert one suppository rectally up to 6 times daily or after each bowel movement
Children under 12 years: ask a doctor.

OTHER INFORMATION

Store below 86° F (30° C).

INACTIVE INGREDIENTS

benzyl alcohol, hydrogenated vegetable oil, tocopheryl acetate

Compare to the active ingredient in TUCKS®*

HEMORRHOIDAL

SUPPOSITORIES

TOPICAL Baby Sebamed Dermolimpiador Para Bebe (Starch)

  • Relieves itching, burning and discomfort
  • Protects and soothes irritated tissue
12 SUPPOSITORIES

*This product is not manufactured or distributed by Pfizer consumer Healthcare, Inc., owner of the registered trademark TUCKS®.

box

Stearic Acid:



Baby Sebamed Dermolimpiador Para Bebe (Stearic Acid) ACID 12.00%

Cleansing

Excellent in deep cleansing and refines your skin clear

and clean by removing impurities from inside of the

skin.

Rub against the soap until bubbles appear and gently massage all over the skin and rinse off with water.

The soap contains moisturizing agents so it will easily become runny if it comes in contact with water. Keep it

away from water after use.

Hand-made soap may collect water bubbles on its surface if the air is humid, as the moisture in soap meets humidity and expanding. This is a natural phenomenon, so do not be concerned.

For external use only.

Do not eat, and do not use for purposes other than for skin cleansing.

Do not use on areas with wound, eczema, dermatitis...etc.

Immediately stop using in case of problems such as redness, swelling, itchiness, irritation…etc.

Immediately rinse with clean water if product gets in eyes.

Store away from UV rays.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Mineral Water, Myristic Acid, Lauric Acid, Triethanolamine, Propylene Glycol, Germanium Ferment, Bentonite, Chrysanthemum Morifolium Flower Extract, Ricinus Communis (Castor) Seed Oil, Evening Primrose Oil, Citric Acid, Fragrance

image description

Titanium Dioxide:


Sunscreens are used to protect the skin from the harmful effects of the sun. They help to prevent sunburn and premature aging (e.g., wrinkles, leathery skin). Sunscreens also help to decrease the risk of skin cancer and also of sunburn-like skin reactions (sun sensitivity) caused by some medications (e.g., tetracyclines, sulfa drugs, phenothiazines such as chlorpromazine ). The active ingredients in sunscreens work either by absorbing the sun's ultraviolet (UV) radiation, preventing it from reaching the deeper layers of the skin, or by reflecting the radiation. Wearing sunscreen does not mean that you can stay out longer in the sun. Sunscreens cannot protect against all of the sun's radiation. There are various types of sunscreens available in many forms (e.g., cream, lotion, gel, stick, spray, lip balm). See the Notes section for information about selecting a sunscreen.

Water:


Active ingredient

Baby Sebamed Dermolimpiador Para Bebe (Water) 99.8%

Purpose

Emergency eyewash

Uses

  • for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination.

Warnings

For external use only

Do not use

  • if solution changes color or gets cloudy
  • with contact lenses
  • if twist-off top is broken or missing
  • in open wounds in or near the eyes

When using this product

  • avoid contamination, do not touch tip of container to any surface

When using this product

  • avoid contamination, do not touch tip of container to any surface

Stop use and consult a doctor if you have

  • changes in vision
  • eye pain
  • continued redness or irritation of the eye, or if the condition worsens or persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • remove contacts before using
  • twist top to remove
  • flush the affected eye as needed, controlling the rate of flow of the solution by pressure on the bottle

  • if necessary, continue flushing with emergency eyewash or shower

  • do not reuse
  • once opened, discard

  • obtain medical treatment

Other information

  • store at room temperature, 15o to 30o C (59o to 86o F)
  • do not freeze

Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Questions?

1-800 - 430-5490

Sperian Eye and Face Protection, Inc.

(a Honeywell Company)

825 East Highway 151

Platteville, WI 53818 USA

Baby Sebamed Dermolimpiador Para Bebe pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Baby Sebamed Dermolimpiador Para Bebe available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Baby Sebamed Dermolimpiador Para Bebe destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Baby Sebamed Dermolimpiador Para Bebe Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Baby Sebamed Dermolimpiador Para Bebe pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."SPERIAN EYESALINE EYEWASH (WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."JINHWAGWANGSU BUBBLE (STEARIC ACID) SOAP [CPBIO CO., LTD]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."GLYCINE IRRIGANT [HOSPIRA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Baby Sebamed Dermolimpiador Para Bebe?

Depending on the reaction of the Baby Sebamed Dermolimpiador Para Bebe after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Baby Sebamed Dermolimpiador Para Bebe not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Baby Sebamed Dermolimpiador Para Bebe addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Baby Sebamed Dermolimpiador Para Bebe, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Baby Sebamed Dermolimpiador Para Bebe consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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