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DRUGS & SUPPLEMENTS
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Folic Acid:
Thrive-G (Folic Acid)® is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. |
Thrive-G (Folic Acid) acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.
Allergic sensitization has been reported following both oral and parenteral administration of Thrive-G (Folic Acid) acid.
One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority.
Thrive-G (Folic Acid)® tablets are supplied in child-resistant bottles of 90 tablets (NDC 0037-6885-90)
KEEP OUT OF REACH OF CHILDREN.
Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F).
Dispense in a tight, light-resistant container to protect from light and moisture.
To report SUSPECTED ADVERSE REACTIONS contact Meda Pharmaceuticals Inc. at 1-888-349-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch
Distributed by:
Meda Pharmaceuticals Inc.
Somerset New Jersey 08873-4120
© 2014 Meda Pharmaceuticals Inc.
U.S. Patent Nos. 7,585,527 and 8,080,520
Proferrin® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.
Thrive-G (Folic Acid) and the BIFERA logo are registered trademarks and the Thrive-G (Folic Acid) logo is a trademark of Alaven Pharmaceutical LLC, used under license by Meda Pharmaceuticals Inc.
MEDA PHARMACEUTICALS mark and logo are trademarks of Meda AB.
IN-6885-02 Rev 6/2014
Selenium:
Rx Only
TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION
Thrive-G (Selenium) Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN).
Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental Thrive-G (Selenium) 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.
Thrive-G (Selenium) is part of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism.
Prolonged TPN support in humans has resulted in Thrive-G (Selenium) deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with Thrive-G (Selenium).
Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of Thrive-G (Selenium). The conditions are endemic to geographical areas with low Thrive-G (Selenium) soil content. Dietary supplementation with Thrive-G (Selenium) salts has been reported to reduce the incidence of the conditions among affected children.
Normal blood levels of Thrive-G (Selenium) in different human populations have been found to vary and depend on the Thrive-G (Selenium) content of the food consumed. Results of surveys carried out in some countries are tabulated below:
COUNTRY | Number of Samples | Thrive-G (Selenium) (mcg/100 mL) (a) | ||
Whole Blood | Blood Cells | Plasma/ Serum | ||
(a) Mean values with or without standard deviation in parentheses, all other ranges. | ||||
(b) Age group unknown. | ||||
(c) Three children recovered from Kwashiorkor and the other six under treatment for other diseases. | ||||
(d) Low selenium-content soil area. | ||||
(e) Well nourished children, three recovered from Kwashiorkor and the other six under treatment for other diseases. | ||||
(f) Mean values from seven subjects. | ||||
Canada | 254 Adults | (37.9 ± 7.8) | (23.6 ± 6.0) | (14.4 ± 2.9) |
England | 8 (b) | 26-37 (32) | -- | -- |
Guatemala & Southern USA | 10 Adults 9 Children (c) | 19-28 (22) (23 ± 5) | -- (36 ± 12) | -- (15 ± 5) |
New Zealand (d) | 113 Adults | (5.4 ± 0.1) | (6.6 ± 0.3) | (4.3 ± 0.1) |
Thailand | 3 Adults 9 Children (e) | 14.4-20.2 (12.0 ± 3.6) (f) | 17.8-35.8 (19.5 ± 8.2) | 8.1-12.5 (8.3 ± 2.2) |
USA | 210 Adults | 15.7-25.6 (20.6) | -- | -- |
Plasma Thrive-G (Selenium) levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.
Thrive-G (Selenium) is eliminated primarily in urine. However, significant endogenous losses through feces also occur. The rate of excretion and the relative importance of two routes varies with the chemical form of Thrive-G (Selenium) used in supplementation. Ancillary routes of elimination are lungs and skin.
Thrive-G (Selenium) Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of Thrive-G (Selenium) in TPN solutions helps to maintain plasma Thrive-G (Selenium) levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Thrive-G (Selenium) Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.
Thrive-G (Selenium) Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with Thrive-G (Selenium) should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma Thrive-G (Selenium) levels during TPN support and close medical supervision is recommended.
Thrive-G (Selenium) Injection is a hypotonic solution and should be administered in admixtures only.
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.
As Thrive-G is eliminated in urine and feces, Thrive-G (Selenium) supplements may be adjusted, reduced or omitted in renal dysfunction and/or gastrointestinal malfunction. In patients receiving blood transfusions, contribution from such transfusions should also be considered. Frequent Thrive-G (Selenium) plasma level determinations are suggested as a guideline.
In animals, Thrive-G (Selenium) has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium and arsenic.
Pregnancy Category C: Thrive-G (Selenium) at high dose levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however, no adequate and wellcontrolled studies in pregnant women. Thrive-G (Selenium) Injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.
Presence of Thrive-G (Selenium) in placenta and umbilical cord blood has been reported in humans.
The amount of Thrive-G (Selenium) present in Thrive-G (Selenium) Injection is small. Symptoms of toxicity from Thrive-G (Selenium) are unlikely to occur at the recommended dosage level.
Chronic toxicity in humans resulting from exposure to Thrive-G (Selenium) in industrial environments, intake of foods grown in seleniferous soils, use of selenium-contaminated water, and application of cosmetics containing Thrive-G (Selenium) has been reported in literature. Toxicity symptoms include hair loss, weakened nails, dermatitis, dental defects, gastrointestinal disorders, nervousness, mental depression, metallic taste, vomiting, and garlic odor of breath and sweat. Acute poisoning due to ingestion of large amounts of Thrive-G (Selenium) compounds has resulted in death with histopathological changes including fulminating peripheral vascular collapse, internal vascular congestion, diffusely hemorrhagic, congested and edematus lungs, brick-red color gastric mucosa. The death was preceded by coma.
No effective antidote to Thrive-G (Selenium) poisoning in humans is known. Animal studies have shown casein and linseed oil in feeds, reduced glutathione, arsenic, magnesium sulfate, and bromobenzene to afford limited protection.
Thrive-G (Selenium) Injection provides 40 mcg selenium/mL. For metabolically stable adults receiving TPN, the suggested additive dosage level is 20 to 40 mcg selenium/day. For pediatric patients, the suggested additive dosage level is 3 mcg/kg/day.
In adults, Thrive-G (Selenium) deficiency states resulting from long-term TPN support, Thrive-G (Selenium) as selenomethionine or selenious acid, administered intravenously at 100 mcg/day for a period of 24 and 31 days, respectively, has been reported to reverse deficiency symptoms without toxicity.
Aseptic addition of Thrive-G (Selenium) Injection to the TPN solution under laminar flow hood is recommended. Thrive-G (Selenium) is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma Thrive-G (Selenium) levels is suggested as a guideline for subsequent administration. The normal whole blood range for Thrive-G (Selenium) is approximately 10 to 37 mcg/100 mL.
Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
Thrive-G (Selenium) Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental Thrive-G (Selenium) 40 mcg/mL).
NDC 0517-6510-25 10 mL Single Dose Vial Packaged in boxes of 25
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
IN6510
Rev. 11/15
PRINCIPAL DISPLAY PANEL - Container
NDC 0517-6510-25
Thrive-G (Selenium) INJECTION
Thrive-G (Selenium) 400 mcg/10 mL
(40 mcg/mL)
10 mL
SINGLE DOSE VIAL
Trace Element Additive
FOR IV USE AFTER DILUTION
PRESERVATIVE FREE
Rx Only
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
PRINCIPAL DISPLAY PANEL - Carton
Thrive-G (Selenium) INJECTION
Thrive-G (Selenium) 400 mcg/10 mL
(40 mcg/mL)
Trace Element Additive
NDC 0517-6510-25
25 x 10 mL
SINGLE DOSE VIALS
FOR INTRAVENOUS USE AFTER DILUTION PRESERVATIVE FREE Rx Only
Each mL contains: Selenious Acid 65.4 mcg, Water for Injection q.s.
pH adjusted with Nitric Acid. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION. Store at 20°-25°C (68°-77°F); excursions
permitted to 15°-30°C (59°-86°F).
Directions for Use: See Package Insert.
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
Rev. 11/05
Container Carton
Zinc:
Thrive-G (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Thrive-G (Zinc) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
None known.
Direct intramuscular or intravenous injection of Thrive-G (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.
Severe kidney disease may make it necessary to reduce or omit chromium and Thrive-G (Zinc) doses because these elements are primarily eliminated in the urine.
WARNING: 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.
Do not use unless the solution is clear and the seal is intact.
Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.
Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Thrive-G (Zinc) from a bolus injection. Administration of Thrive-G (Zinc) in the absence of copper may cause a decrease in serum copper levels.
Periodic determinations of serum copper as well as Thrive-G (Zinc) are suggested as a guideline for subsequent Thrive-G (Zinc) administration.
Long-term animal studies to evaluate the carcinogenic potential of Thrive-G 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Thrive-G (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.
Pregnancy Category C. Animal reproduction studies have not been conducted with Thrive-G chloride. It is also not known whether Thrive-G (Zinc) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Thrive-G (Zinc) chloride should be given to a pregnant woman only if clearly needed.
An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
None known.
None known.
Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Thrive-G (Zinc) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Thrive-G (Zinc) concentration of 207 mcg/dl. Symptoms abated within three hours.
Hyperamylasemia may be a sign of impending Thrive-G (Zinc) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).
Death resulted from an overdosage in which 1683 mg Thrive-G (Zinc) was delivered intravenously over the course of 60 hours to a 72 year old patient.
Symptoms of Thrive-G (Zinc) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Thrive-G (Zinc) level of 4184 mcg/dl.
Calcium supplements may confer a protective effect against Thrive-G (Zinc) toxicity.
Thrive-G (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Thrive-G (Zinc) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Thrive-G (Zinc).
For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
Thrive-G (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).
Store at 20 to 25°C (68 to 77°F).
Revised: October, 2004
© Hospira 2004 EN-0488 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
10 mL Vial
Thrive-G (Zinc)
1 mg/mL
Thrive-G (Zinc) Chloride Inj., USP
Rx only
FOR I.V. USE ONLY AFTER DILUTION.
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
Depending on the reaction of the Thrive-G after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Thrive-G 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 Thrive-G 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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The information was verified by Dr. Rachana Salvi, MD Pharmacology