GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Paracoxib Sodium Dry Powder for Injection (Lyophilized) 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Paracoxib Sodium Dry Powder for Injection (Lyophilized) 40mg
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.

CAUTION & SCHEDULE:

CAUTION: 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 lyophilized cake may reduce to a powder during shipping.
For single use only.
After reconstitution the product should be use immediately.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber .

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.

Paracoxib Sodium Dry Powder for Injection (Lyophilized) 40mg Technical Specification:

Product Name:
Paracoxib Sodium Dry Powder for Injection (Lyophilized) 40mg
Brand Name:Generics
Strength:40mg
Dosage Form:Dry Powder for Injection (Lyophilized)
Route of Administration:For IV/IM use only
Packing:1 Vial + 1 Ampoule
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:NSAIDs
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 THE MEDICINAL PRODUCT:

  • Paracoxib Sodium Dry Powder for Injection (Lyophilized) 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Paracoxib Sodium Dry Powder for Injection (Lyophilized) 40mg
    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.

CAUTION & SCHEDULE:

CAUTION:
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 lyophilized cake may reduce to a powder during shipping.
For single use only.
After reconstitution the product should be use immediately.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber .

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.