Eye drops for the symptomatic treatment of seasonal allergic conjunctivitis.
Indications
Symptomatic treatment of seasonal allergic conjunctivitis.
Composition
Active ingredients
One ml contains 0.345 mg of ketotifen hydrogen fumarate corresponding to 0.25 mg of ketotifen. Each drop contains 9.5 micrograms of ketotifen fumarate.
Excipients
Sodium hyaluronate, glycerol (E 422), sodium hydroxide (E 524), purified water.
How to use and Dosage
- Dosage: adults, elderly and children (from 3 years and above): one drop of Ketazed 0.25 mg/ml, eye drops solution in the conjunctival sac twice a day.
- Paediatric population: the safety and efficacy of Ketazed 0.25 mg/ml, eye drops solution in children aged from birth to 3 years have not yet been established.
Method of administration: to avoid contamination, do not touch any surface and do not touch the tip of the eye drop. dropper
Warnings
No special warnings or precautions for use.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed.
Interactions with other medicinal products
If Ketazed 0.25 mg/ml, eye drops solution is used together with other ophthalmic drugs, an interval of at least 5 minutes should be observed between the administration of the two drugs. The use of oral dosage forms of ketotifen may potentiate the effect of CNS depressants, antihistamines and alcohol. Although this has not been observed with ketotifen fumarate eye drops, the possibility of such effects cannot be ruled out. be excluded.
Undesirable effects
Adverse reactions are classified under heading of frequency, using the following convention: very common (>=1/10); common (from >=1/1 00 to <1/10); uncommon (from >=1/1,000 to <1/100); rare (from >=1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Immune system disorders
- Uncommon: hypersensitivity reactions.
Nervous system disorders
Ocular disorders
- Common: eye irritation, eye pain, punctate keratitis, punctate erosion of the corneal epithelium;
- Uncommon: blurred vision (during instillation), dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival bleeding.
Gastrointestinal disorders
Skin and subcutaneous tissue disorders
- Uncommon: rash, eczema, urticaria.
General disorders and administration site conditions
Adverse drug reactions from post-marketing experience (Frequency not known): The following post-marketing events have also been observed during post-marketing: hypersensitivity reactions including local allergic reaction (mainly contact dermatitis, eye swelling, eyelid pruritus and oedema), systemic allergic reactions including facial swelling/facial oedema (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions such as asthma and eczema.
Pregnancy and breastfeeding
- Pregnancy: There are insufficient data on the use of ketotifen eye drops during pregnancy. Animal studies using maternally toxic oral doses have shown increased pre- and postnatal mortality, but no teratogenicity. Systemic levels after ocular administration are much lower than those after oral use. Caution is advised when prescribing to pregnant women.
- Breastfeeding: Although animal data after oral administration show excretion in breast milk, topical administration in humans is unlikely to result in detectable amounts in breast milk. Ketazed 0.25 mg/ml, eye drops, solution can be used during pregnancy. be used during breastfeeding.
- Fertility: There are no data available on the effect of ketotifen fumarate on fertility in humans.
Format
10 ml
Product Code:FRCM183605
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