Source: Health Products Regulatory Authority (IE) Revision Year: 2017 Publisher: Pharma Stulln GmbH, Werksstrasse 3, 92551 Stulln, Germany
Symptomatic treatment of seasonal allergic conjunctivitis.
One drop of Ketofall into the conjunctival sac twice a day. The contents of a single-dose container are sufficient for one administration into both eyes.
The contents remain sterile until the original closure is broken. To avoid contamination do not touch the eye or any other surface with the tip of the container.
The safety and efficacy of Ketofall in children below the age of 3 years have not been established.
Ocular use.
No case of overdose has been reported.
Oral ingestion of the contents of a single-dose container would be equivalent to 0.1 mg of ketotifen which is 5% of a recommended oral daily dose for a 3 year old child. Clinical results have shown no serious signs or symptoms of overdose after oral ingestion of up to 20 mg of ketotifen.
In unopened aluminium pouch: 2 years.
In opened aluminium pouch: 28 days (4 weeks).
Ketofall contains no preservative. After opening, the contents of a single-dose container should be used immediately. The solution remaining in the single-dose container after the application has to be discarded.
Do not store above 25°C.
Do not refrigerate or freeze.
Keep the container in the aluminium pouch.
The container is a transparent low-density polyethylene (LDPE) single-dose container. One single-dose container contains 0.4 ml. Either one, or two blocks of 5 single-dose containers each are packed in an aluminium laminated pouch.
Packages with 5, 10, 20, 30, 50 and 60 single-dose containers.
Not all pack sizes may be marketed.
No special requirements for disposal.
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