Descrizione Clinica
KETAZED 0.25 MG/ML COLLECTION
active ingredients
A ml contains 0.345 mg of ketotifene hydrogen smoked corresponding to 0.25 mg of ketotifene. Each drop contains 9.5 micrograms of smoked ketotifene. For the full list of excipients, see paragraph 6.1.Excellent
Sodium hyaluronate, Glicerol (E 422), Sodium Hydroxide (E 524), purified water.Therapeutic indications
Syntomatic treatment of seasonal allergic conjunctivitis.Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.Population
Population Adults, elders and children (from 3 years on): a drop of KETAZED 0.25 mg/ml, colliery solution in the joint sack twice a day. Pediatric population The safety and effectiveness of KETAZED 0.25 mg/ml, colliery solution in children aged between birth and 3 years have not yet been established. Method of administration To avoid contamination do not touch any surface with the tip of the dropper.Conservation
Do not store above 25°C.Warnings
No special warning or precaution for use.Interactions
If KETAZED 0.25 mg/ml, colliery solution is used together with other ophthalmic drugs, a range of at least 5 minutes should be observed between the administration of the two drugs. The use of oral dosage forms of ketotifen can enhance the effect of depressives of SNC, antihistamines and alcohol. Although this has not been observed with the colliary of smoked ketotifen, the possibility of such effects cannot be excluded.Effects
Adverse reactions are classified under the frequency heading, using the following convention: Very common (≥1/10); common (from ≥1/100 to immune system disorders. Not common: hypersensitivity reactions. Disorders of the nervous system. Not common: headache. Ocular disorders. Common: eye irritation, eye pain, pointed keratite, episode erosion of the corneal epithelium; Not common: blurred vision (during instillation), eye dryness, eyelid disorders, conjunctivitis, photophobia, conjunctive bleeding. Gastrointestinal disorders. Not common: dry mouth. Skin and subcutaneous tissue disorders. Not common: rash, eczema, hives. General disorders and conditions of the administration site. Not common: sleepiness. Reactions adverse to the drug from post-marketing experience (Note Frequency): The following post-marketing events were also observed during post-marketing: hypersensitivity reactions including local allergic reaction (mainly contact dermatitis, eye swelling, eyelid itching and edema), systemic allergic reactions including facial/edema swelling of the face (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions such as as asthma and eczema. Reporting of suspicious adverse reactions The indication of suspicious adverse reactions after the authorization of the medicinal product is important. Allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are invited to report any suspected adverse reaction via the listed national reporting system in Appendix V.Overdosing
No overdose cases have been reported. Oral intake of the content of the 10 ml bottle is 2.5 mg ketotifene, which is 125% of an oral daily dose recommended for a 3-year-old. Clinical results showed no serious signs or symptoms after oral ingestion up to 20 mg of ketotifen.Pregnancy
There is no sufficient data on the use of ketotifen colliders during pregnancy. Animal studies using toxic oral doses for the mother showed an increase in pre and postnatal mortality, but no teratogenicity. Systemic levels after eye administration are much lower than those after oral use. It is recommended caution when prescribing to pregnant women.Food
Although the data on animals after oral administration show excretion in breast milk, it is unlikely that the topic administration in man leads to detectable amounts in breast milk. KETAZED 0.25 mg/ml, colliery, solution can be used during breastfeeding.Fertility
There are no data available on the effect of ketotifen smoked on fertility in man.Source: Farmadati
