“Composition
Active ingredients
Ketoftil 0.5 mg/ml eye drops, solution. 1 ml contains 0.69 mg ketotifen fumarate, equivalent to 0.5 mg ketotifen. Ketoftil 0.5 mg/g eye gel. 1 g contains 0.69 mg ketotifen fumarate, equivalent to 0.5 mg ketotifen. Excipient with known effect. Multi-dose vial and eye gel contain benzalkonium chloride.
Excipients
Ketoftil 0.5 mg/ml eye drops, solution (multi-dose vial): sorbitol, benzalkonium chloride, TS-polysaccharide and water for injection. Ketoftil 0.5 mg/ml eye drops, solution (single-dose vials): TS-polysaccharide, sorbitol and water for injection. Ketoftil 0.5 mg/g ophthalmic gel: hydroxyethylcellulose, sorbitol, benzalkonium chloride and water for injection.
Directions
Acute and chronic conjunctivitis and keratoconjunctivitis of allergic origin (spring, atopic, etc.).
Method of administration and dosage
Ketoftil 0.5 mg/ml eye drops, solution: 1 drop in the conjunctival sac 2 or more times a day as prescribed by a doctor. Ketoftil 0.5 mg/g eye gel: 1 drop in the conjunctival sac 2 times a day.
Warnings
Ketoftil eye drops, solution (multi-dose container) and Ketoftil gel: Ketoftil multi-dose eye drops and Ketoftil gel contain benzalkonium chloride as a preservative, which may precipitate on soft contact lenses; therefore, Ketoftil should not be used if the patient wears lenses of this type. Before use, lenses should be removed and wait 15 minutes before putting them back on. Products containing benzalkonium chloride as a preservative may discolor soft contact lenses. Benzalkonium chloride may cause eye irritation, dry eyes, and changes in the surface and film of the cornea. Use with caution in patients with dry eye syndrome and corneal damage. Patients should be monitored during prolonged use. Ketoftil in various pharmaceutical forms may cause a slight and short-term burning sensation when applied. Ketoftil eye gel, due to the nature of its excipients, may cause mild and transient blurred vision upon application. Ketoftil eye drops, solution and gel: No special warnings.
Contraindications
Hypersensitivity to ketotifen or any of the excipients of the product or closely related chemicals. Generally contraindicated in pregnancy.”
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