Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Laboratoires Thea, 12, rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France
Symptomatic treatment of seasonal allergic conjunctivitis.
One drop of Zaditen into the conjunctival sac twice a day.
The safety and efficacy of Zaditen in children aged from birth to 3 years have not yet been established.
The contents and dispenser remain sterile until the original closure is broken. To avoid contamination do not touch any surface with the dropper tip.
No case of overdose has been reported.
Oral ingestion of the contents of a 5 ml bottle would be equivalent to 1.25 mg of ketotifen which is 60% of a recommended oral daily dose for a 3 year old child. Clinical results have shown no serious signs or symptoms after oral ingestion of up to 20 mg of ketotifen.
Unopened bottle: 2 years.
After opening: 4 weeks.
Do not store above 25°C.
The container is a white-coloured LDPE bottle with a transparent LDPE dropper and a white HDPE screw cap with an integrated safety ring. One bottle contains 5 ml of the solution.
No special requirements.
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