Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Recordati Rare Diseases, Immeuble Le Wilson, 70, avenue du Général de Gaulle, F-92800 Puteaux, France
Pedea 5 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to slightly yellow solution. |
Each ml of the solution contains 5 mg ibuprofen.
Each ampoule of 2 ml contains 10 mg ibuprofen.
Excipients: each ml contains 7.5 mg of sodium.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ibuprofen |
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation. |
| List of Excipients |
|---|
|
Trometamol |
2 ml solution in a colourless type 1 glass ampoule.
Pedea is supplied in packs of 4 × 2 ml ampoules.
Recordati Rare Diseases, Immeuble “Le Wilson”, 70, avenue du Général de Gaulle, F-92800 Puteaux, France
EU/1/04/284/001
Date of first authorisation: 29 July 2004
Date of renewal: 29 July 2009
| Drug | Countries | |
|---|---|---|
| PEDEA | Austria, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa |
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