Source: Health Products Regulatory Authority (IE) Revision Year: 2017 Publisher: Pharma Stulln GmbH, Werksstrasse 3, 92551 Stulln, Germany
Ketofall 0.25 mg/ml eye drops, solution in single-dose container.
| Pharmaceutical Form |
|---|
|
Eye drops, solution in single-dose container. Clear, colourless solution, with a pH of 5.0–6.0 and an osmolality of 230–300 mOsm/kg. |
One ml solution contains 0.25 mg ketotifen (as hydrogen fumarate).
Each single-dose container of 0.4 ml solution contains 0.1 mg ketotifen (as hydrogen fumarate).
Each drop contains approximately 6.95 microgram ketotifen (as hydrogen fumarate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ketotifen |
Ketotifen is a histamine H1-receptor antagonist. In vivo animal studies and in vitro studies suggest the additional activities of mast cell stabilisation and inhibition of infiltration, activation and degranulation of eosinophils. |
| List of Excipients |
|---|
|
Glycerol (E422) |
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.
Pharma Stulln GmbH, Werksstrasse 3, 92551 Stulln, Germany
PA1815/002/001
Date of first authorisation: 14th October 2016
Date of last renewal: 4th October 2017
| Drug | Countries | |
|---|---|---|
| KETOFALL | Ireland, United Kingdom |
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