Source: Medicines Authority (MT) Revision Year: 2023 Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg
Keral 50 mg/2 ml Solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Clear and colourless solution. pH (7.0-8.0). Osmolarity (270-328 mOsmol/l). |
Each ampoule of 2 ml contains: dexketoprofen 50 mg (as dexketoprofen trometamol). Each ml of solution for injection/infusion contains dexketoprofen 25 mg (as dexketoprofen trometamol)
Excipients with known effects: Each ampoule of 2 ml contains 200 mg ethanol (96 per cent).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dexketoprofen |
Dexketoprofen belongs to the non-steroidal anti-inflammatory group of drugs. The mechanism of action of Dexketoprofen is related to the reduction of prostaglandin synthesis by the inhibition of cyclooxygenase pathway. Furthermore, the inhibition of the synthesis of prostaglandins could affect other inflammation mediators such as kinins, causing an indirect action which would be additional to the direct action. |
| List of Excipients |
|---|
|
Ethanol (96 per cent) |
Type I glass coloured ampoules containing 2 ml of Solution for injection/infusion.
Packs containing: 1, 5, 6, 10, 20, 50 or 100 ampoules. Not all pack sizes may be marketed.
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg
MA204/00103
Date of first authorisation: 21st March 2006
Date of latest renewal: 03rd August 2007
| Drug | Countries | |
|---|---|---|
| KERAL | Ireland, Malta, United Kingdom, South Africa |
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