B-Sol N/A

INDICATIONS

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

PHARMACOLOGY

This sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.Calcium chloride is used to prevent or treat negative calcium balance. It also regulates action potential excitation threshold to facilitate nerve and muscle performance.Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion. Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.Magnessium Chloride: Acts as cofactor in numerous enzymatic reactions involving protein synthesis and carbohydrate metabolism; depresses CNS, blocks peripheral neuromuscular transmission, produces anticonvulsant effects.Sodium chloride plays an important role in controlling the total body water and its distribution. Sodium is the main cation in the extracellular fluid and comprises >90% of total cations. The acetate component is an alternate source of bicarbonate by metabolic conversion in the liver.

DOSAGE & ADMINISTRATION

This irrigating solution should be used according to standard format for each surgical procedure. Note: Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow directions of the particular administration set to be used. Remove the blue flip-off cap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.

SIDE EFFECTS

Irrigation or any other trauma may result in corneal swelling or bullous keratopathy. Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

PREGNANCY & LACTATION

Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

PRECAUTIONS & WARNINGS

Not for injection or intraveous infusion.
Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged.
Do not use if product is discolored or contains a precipitate.
Single patient use only. The contents of this bottle should not be used in more than one patient.
The use of additives with this solution may cause corneal decompensation.
This solution contains no preservative, unused contents should be discarded.

THERAPEUTIC CLASS

Irrigation during various surgical procedures

STORAGE CONDITIONS

Avoid freezing. Store at below 30°C in a dry place protected from light. Keep out of reach of children.