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K-FEN 0.5

Pack : 5 ml pack

DESCRIPATION:

K-FEN 0.5 is a sterile ophthalmic solution containing ketotifen for topical administration to the eyes. Ketotifen fumarate is a finely crystalline powder with an empirical formula of C23H23NO5S and a molecular weight of 425.50. Each mL of K-FEN 0.5 contains: Active: ketotifen fumarate equivalent to 0.5 mg ketotifen. Preservative: benzalkonium chloride 0.05mg

COMPOSITION:

Label Claim: Each mL Contains :

Ketotifen Fumarate

  • Equivalent to Ketotifen………………………...0.5 mg
  • Benzalkonium chloride solution I.P. …………0.05 mg (As preservative)
  • Aqueous buffered vehicle………………………q.s.

PACKAGING

Primary packing - 5ml Clear Poly bottles White caps &Nozzles.

Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.

SHELF LIFE:

24 months from the date of manufacturing

STORAGE:

Store in Refrigerator after the Container is opened. Keep In Cool & Dark Place

AVAILABILITY:

5ml of solution in Clear poly bottles with white caps & nozzles in properly sealed.

CLINICAL PHARMACOLOGY :

Ketotifen is a relatively selective, non-competitive histamine antagonist (H1-receptor) and mast cell stabilizer. Ketotifen inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and activation of eosinophils has also been demonstrated.

INDICATIONS AND USAGE:

K-FEN 0.5 (ketotifen fumarate ophthalmic solution) is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.

CONTRAINDICATIONS:

K-FEN 0.5 is contraindicated in persons with a known hypersensitivity to any component of this product.

WARNINGS:

For topical ophthalmic use only. Not for injection or oral use.

DOSAGE AND ADMINISTRATION:

The recommended dose is one drop in the affected eye(s) every 8 to 12 hours.

SUPPLY:

K-FEN 0.5 is supplied in one Clear Polethylene Bottle packed with printed labelled & cartons And Such 25 Carton Packed in a Shrink Sleeves & corrugated box.

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