Source: Health Products Regulatory Authority (ZA) Publisher: Ascendis Pharma (Pty) Ltd, 31 Georgian Crescent East, Bryanston, 2191
PERICOB 40 powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection. PERICOB 40 vial: White to off-white, lyophilised powder in a single use vial. |
Each 5 ml 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.
Sugar free.
When reconstituted in sodium chloride solution (0,9% w/v), PERICOB 40 Injection contains approximately 0,44 mmol/L of sodium per 40 mg vial.
For full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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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 phosphate anhydrous |
PERICOB 40 powder for solution for injection: 5 ml Type I glass vial with bromobutyl rubber stopper and an aluminium flip off seal.
Pack size: 10 × 5 ml vials.
Ascendis Pharma (Pty) Ltd, 31 Georgian Crescent East, Bryanston, 2191
52/2.9/0995
7 June 2022
| Drug | Countries | |
|---|---|---|
| PERICOB | South Africa |
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