Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Dynastat 40 mg powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection (powder for injection). White to off-white powder. |
Each vial contains 40 mg parecoxib (as 42.36 mg parecoxib sodium). After reconstitution, the concentration of parecoxib is 20 mg/ml. Each 2 ml of reconstituted powder contains 40 mg of parecoxib.
Excipient with known effect:
This medicinal product contains less than 1 mmol sodium (23 mg) per dose.
When reconstituted in sodium chloride 9 mg/ml (0.9%) solution, Dynastat contains approximately 0.44 mmol of sodium per vial.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Parecoxib |
Parecoxib is a prodrug of valdecoxib. Valdecoxib is a selective COX-2 inhibitor within the clinical dose range. Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. |
| List of Excipients |
|---|
|
Disodium hydrogen phosphate |
Type I colourless glass vials (5 ml) with a butyl rubber stopper, sealed with a purple polypropylene flip-off cap on the aluminium overseal.
Dynastat is available in packs containing 10 vials.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/02/209/005
Date of first authorisation: 22 March 2002
Date of latest renewal: 24 January 2012
| Drug | Countries | |
|---|---|---|
| DYNASTAT | Austria, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom |
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