Parecoxib sodium powder for solution for injection (40mg/2ml)
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- Parecoxib Sodium powder for solution for Injection 40mg/2ml
- Parecoxib sodium powder for solution for injection
- Parecoxib sodium powder for solution for injection
- Parecoxib sodium powder for solution for injection
- Parecoxib sodium powder for solution for injection
- Parecoxib sodium powder for solution for injection
GENERIC NAME OF MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Parecoxib sodium powder for solution for injection (40mg/2ml) Composition:
Each vial contains:
Parecoxib……………..40mg
Equivalent to Parecoxib sodium……42.36mg
Excipients…………….q.s.
Also contains Dibasic sodium phosphate heptahydrate, Phosphoric acid and/or sodium hydroxide.
2ml solvent ampule contains sodium chloride, hydrochloride acid, sodium hydroxide and water for injections.
Each vial contains:
Parecoxib……………..40mg
Equivalent to Parecoxib sodium……42.36mg
Excipients…………….q.s.
Also contains Dibasic sodium phosphate heptahydrate, Phosphoric acid and/or sodium hydroxide.
2ml solvent ampule contains sodium chloride, hydrochloride acid, sodium hydroxide and water for injections.
THERAPEUTIC INDICATIONS:
Parecoxib is now increasingly used in ambulatory or day-case surgery because it reduces opioid consumption, improves pain scores, and results in earlier hospital discharge and return to normal function.
DIRECTION OF USE:
When reconstituted with 2ml solvent provides 40mg/ml of parecoxib.
After reconstitution, the product should be used immediately.
After reconstitution, the product should be used immediately.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution. Please do not use the solution and return the vial for free replacement.
For single use only. After reconstitution the product should be use immediately.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
For single use only. After reconstitution the product should be use immediately.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 25°C. Protect from light.
Keep all medicines out of reach of children.
Purified vial sealed in vacuum.
Dosage: As directed by the Physician.
Keep all medicines out of reach of children.
Purified vial sealed in vacuum.
Dosage: As directed by the Physician.
Parecoxib sodium powder for solution for injection 40mg/2ml Technical Specification:
| Product Name: | Parecoxib sodium powder for solution for injection |
| Brand Name: | Generic |
| Strength: | 40mg/2ml |
| Dosage Form: | Lyophilized Dry Powder Solution |
| Packing: | 1 Vial + 1 Ampule |
| Route of Administration: | For IV/IM use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | COX-2 inhibitor & NSAID |
| Indication: | Parecoxib is used for the short-term treatment of pain in adults after an operation. |
| Storage: | Store below 25°C. Protect from light. Keep out reach of children. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Parecoxib sodium powder for solution for injection (40mg/2ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Parecoxib sodium powder for solution for injection (40mg/2ml)
Composition:
Each vial contains:
Parecoxib……………..40mg
Equivalent to
Parecoxib sodium……42.36mg
Excipients…………….q.s.
Also contains Dibasic sodium phosphate heptahydrate, Phosphoric acid and/or sodium hydroxide.
2ml solvent ampule contains sodium chloride, hydrochloride acid, sodium hydroxide and water for injections.
THERAPEUTIC INDICATIONS:
Parecoxib is used for the short-term treatment of pain in adults after an operation. It is one of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors). Pain and swelling are sometimes caused by substances in the body called prostaglandins.
DIRECTION OF USE:
When reconstituted with 2ml solvent provides 40mg/ml of parecoxib.
After reconstitution, the product should be used immediately.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution.
Please do not use the solution and return the vial for free replacement.
THE LYOPHILLIZED CAKE MAY REDUCE TO A POWDER DURING SHIPING.
For single use only. After reconstitution the product should be use immediately.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 25°C. Protect from light.
Keep all medicines out of reach of children.
Purified vial sealed in vacuum.
Dosage: As directed by the Physician.
