Balanced Salt Solution

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Balanced Salt Solution uses


Bag Diagram Bag Diagram Label 2 Carton

DESCRIPTION

Balanced Salt Solution® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time. The solution does not contain a preservative and should be prepared just prior to use in surgery.


Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bag to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.


Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.

After addition of Balanced Salt Solution solution Part II to the Part I bag, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm.

CLINICAL PHARMACOLOGY

None of the components of Balanced Salt Solution solution are foreign to the eye, and Balanced Salt Solution solution has no pharmacological action. Human perfused cornea studies have shown Balanced Salt Solution solution to be an effective irrigation solution for providing corneal detumescence and maintaining corneal endothelial integrity during intraocular perfusion. An in vivo study in rabbits has shown the Balanced Salt Solution solution is more suitable than normal saline or Balanced Salt Solution for intravitreal irrigation because Balanced Salt Solution solution contains the appropriate bicarbonate, pH, and ionic composition necessary for the maintenance of normal retinal electrical activity. Human in vivo studies have demonstrated Balanced Salt Solution solution to be safe and effective when used during surgical procedures such as pars plana vitrectomy, phacoemulsification, cataract extraction/lens aspiration, anterior segment reconstruction. No differences have been observed between adults and pediatric patients following use of this drug product.

INDICATIONS AND USAGE

Balanced Salt Solution solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.

CONTRAINDICATIONS

There are no specific contraindications to the use of Balanced Salt Solution solution; however, contraindications for the surgical procedure during which Balanced Salt Solution solution is to be used should be strictly adhered to.

WARNINGS

For IRRIGATION during ophthalmic surgery only. Not for injection or intravenous infusion. Do not use unless product is clear, seal is intact and container is undamaged. Do not use if product is discolored or contains a precipitate.

PRECAUTIONS

DO NOT USE Balanced Salt Solution solution UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. Balanced Salt Solution does not contain a preservative; therefore, do not use this container for more than one patient. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

There have been reports of corneal clouding or edema following ocular surgery in which Balanced Salt Solution solution was used as an irrigating solution. As in all surgical procedures appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

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SPL UNCLASSIFIED SECTION

Preparation

Reconstitute Balanced Salt Solution Intraocular Irrigating Solution just prior to use in surgery. Follow the same strict aseptic procedures in the reconstitution of Balanced Salt Solution solution as is used for intravenous additives. Remove the Balanced Salt Solution solution Part I bag from the clear overwrap. Remove the blue flip-off seal from the Balanced Salt Solution solution Part II (20 mL) vial. Clean and disinfect the rubber stoppers on both containers by using sterile alcohol wipes. Transfer the contents of the Part II vial to the Part I bag using a Balanced Salt Solution solution Dual-Spike Transfer Device (provided). An alternative method of solution transfer may be accomplished by using a 20 mL syringe to remove the Part II solution from the vial and transferring exactly 20 mL to the Part I container through the outer target area of the rubber stopper. An excess volume of Part II is provided in each vial. Gently agitate the contents to mix the solution. Place a sterile cap on the bag. Record the time and date of reconstitution and the patient's name on the bag label.

GERIATRIC USE

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the use of Balanced Salt Solution solution has not been established.

OVERDOSAGE

The solution has no pharmacological action and thus no potential for overdosage. However, as with any intraocular surgical procedure, the duration of intraocular manipulation should be kept to a minimum.

DOSAGE AND ADMINISTRATION

The solution should be used according to the standard technique employed by the operating surgeon. For non-active irrigating system, use an administration set with an air-inlet in the plastic spike since the bag does not contain a separate airway tube. Follow the directions for the particular administration set to be used. Insert the spike aseptically into the bag through the center target area of the rubber stopper. Allow the fluid to flow to remove air from the tubing before intraocular irrigation begins.

HOW SUPPLIED

Balanced Salt Solution solution is supplied in two packages for reconstitution prior to use: a 500 mL bag containing 480 mL and a 20 mL glass vial (Part II); both using grey butyl stoppers and aluminum seals. See the PRECAUTIONS section regarding reconstitution of the solution.

NDC 0065-0800-94

STORAGE AND HANDLING

Store Part I and Part II at 2° - 25°C (36° - 77°F). Discard prepared solution after six hours.

RECONSTITUTION INSTRUCTIONS

DIRECTIONS: Use Aseptic Technique

Remove the Balanced Salt Solution® solution Part I (480 mL) bag from the clear overwrap. Remove the blue flip-off seal from the Balanced Salt Solution solution Part II (20 mL) vial. Prepare the stoppers on both parts by using sterile alcohol wipes. Peel open a Balanced Salt Solution solution Dual-Spike Transfer Device package (supplied) and remove the sterile transfer spike. NOTE: This device is vented permitting air to enter vial during solution transfer, thereby preventing the creation of a vacuum inside the vial. Remove protector from the white plastic piercing pin of the Dual-Spike Transfer Device. Firmly grasp device from behind the flange and insert the white plastic piercing pin into the upright rubber stopper of the Balanced Salt Solution solution Part II (20 mL) vial. Remove guard from filter needle. Firmly grasp vial in the palm of one hand and with thumb and index finger, hold plastic flange against top of vial. Hold the vial in the upright position, incline and immediately insert the transfer device into the center target of rubber stopper of the Balanced Salt Solution solution Part I (480 mL) bag. NOTE: Do not invert Part II (20mL) vial before or during spiking of the Balanced Salt Solution solution Part I bag rubber stopper, until ready to initiate transfer. Invert vial to initiate the transfer of Part II into Part I. If transfer does not occur immediately, gentle manipulation of the bag can initiate transfer. NOTE: An excess amount of Balanced Salt Solution solution Part II is provided in each vial. A non-transferred solution residual of approximately 0.3 mL can be expected to remain in the vial. Immediately remove vial (with spike attached) from the Balanced Salt Solution solution Part I container and discard it after solution transfer has been completed. Place a sterile safety cap over the rubber stopper of Part I if the solution is not going to be used immediately. Mix the solution gently until uniform. Record the patient’s name and the date and time of reconstitution. Balanced Salt Solution solution is now ready for use.

CAUTION: Reconstituted Balanced Salt Solution solution must be used within six hours of mixing.

Discard any solution which has aged beyond that time. Never use the same bag of Balanced Salt Solution solution on more than one patient.


Alternative Transfer Method

If preferred, the contents of the Balanced Salt Solution Part II component may be aspirated with an 18-gauge cannula attached to a 20 mL syringe and then transferred into the Part I bag.

9012648-1115


Alcon®

a Novartis company

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

© 2013, 2015 Novartis

PRINCIPAL DISPLAY PANEL

NDC 0065-0800-94

Balanced Salt Solution® PART I 480 mL

STERILE SOLUTION

(For Reconstitution by Addition of Balanced Salt Solution ®

Concentrate Part II, 20 mL)*

SINGLE PATIENT USE ONLY


*Reconstitute just prior to use in Surgery.


BSS PLUS* 500 mL

STERILE INTRAOCULAR IRRIGATING SOLUTION

(balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

After addition of Balanced Salt Solution – Part II (20 mL), each mL contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

pH Approx. 7.4. Osmolality Approx. 305 mOsm/kg

Rx Only

NOT FOR INJECTION OR

INTRAVENOUS INFUSION

STORAGE: Store at 36° - 77°F (2° - 25°C)

See Warnings, Precautions

and Preparation sections of

package insert.

Alcon®

a Novartis company

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

© 2013, 2015 Novartis

LOT:

EXP.:

MFD.:


9012637-1115

Patient_

Reconstituted at_

AM/PM on_


NDC 0065-0800-94 20mL

Balanced Salt Solution®

CONCENTRATE PART II

(Sterile Solution for Reconstitution)

Alcon®

Alcon Laboratories Inc.

Fort Worth, Texas 76134 USA

Each mL contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.

For Addition to Balanced Salt Solution® - Part I (480 mL) only.

See Preparation section of package insert.

WARNINGS: Not for injection or intravenous infusion – for reconstitution of irrigation solution only. Do not use unless product is clear, seal is intact and container is undamaged. Do not use if product is discolored or contains a precipitate.

PRECAUTIONS: Discard unused contents. Do not use this container for more than one patient.

Storage: Store at 2-25°C (36-77°F).

Rx Only


© 2002-2003, 2013, 2015 Novartis

H14141-1115

LOT:

EXP.:

MFD.:


Balanced Salt Solution ®

STERILE INTRAOCULAR

IRRIGATING SOLUTION

(balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

1 Vial Balanced Salt Solution® Concentrate Part II Sterile Solution for Reconstitution with BSS PLUS solution Part 1 Only

1 Balanced Salt Solution solution Dual Spike Transfer Device

1 Balanced Salt Solution solution Product Package Insert

WARNINGS: For IRRIGATION during ophthalmic surgery only. Not for injection or intravenous infusion. Do not use unless product is clear, seal is intact and container is undamaged. Do not use if product is discolored or contains a precipitate.

Store at 2° - 25°C (36° - 77°F).

Alcon®

a Novartis company

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

© 2013, 2014, 2015 Novartis

9012660-1115

PRECAUTIONS: DO NOT USE BSS PLUS* Sterile Intraocular Irrigating Solution, UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. Balanced Salt Solution solution does not contain a preservative; therefore, do not use this container for more than one patient. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

There have been reports of corneal clouding or edema following ocular surgery in which Balanced Salt Solution solution was used as irrigating solution. As in all surgical procedures, appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

LOT:

EXP:

MFD:



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Balanced Salt Solution 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.


Balanced Salt Solution 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.


Balanced Salt Solution 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.


Balanced Salt Solution 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.


Balanced Salt Solution 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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Frequently asked Questions

Can i drive or operate heavy machine after consuming Balanced Salt Solution?

Depending on the reaction of the Balanced Salt Solution after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Balanced Salt Solution 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 Balanced Salt Solution 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 Balanced Salt Solution, 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 Balanced Salt Solution 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. Arunabha Ray, MD Pharmacology

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