GENERIC NAME OF MEDICINAL PRODUCT:

A)Papaverine Hydrochloride Injection USP 30mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Papaverine Hydrochloride Injection USP 30mg/ml
Each ml contains:
Papaverine Hydrochloride USP…………………30mg
Water for Injection USP…………………………...q.s.
Excipients………………………q.s.

THERAPEUTIC INDICATION:

Papaverine Hydrochloride Injection belongs to the group of medicines called vasodilators used to treat circulatory problems, visceral spasms, peripheral vascular disease, vascular spasms associated with angina pectoris, myocardial infarction, and pulmonary and peripheral embolism. It is also used to treat erectile dysfunction (impotence).

CAUTION & WARNING:

CAUTION:
• Do not use if solution is not clear or has suspended matter.
• If you notice bleeding at the site when you inject papaverine, put pressure on the spot until the bleeding stops. If it doesn't stop, check with your doctor.
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°F) excusion permitted to 15°C to 30°C (59°F to 86°F)[see USP Controlled Room Temperature].
Dosage: Parenteral administration of papaverine hydrochloride in doses of 1 to 4ml is repeated every 3 hours as indicated.
Or as directed by Physician.

Papaverine Hydrochloride Injection USP 30mg/ml Technical Specification:

Product Name:Papaverine Hydrochloride Injection USP 
Brand Name:(GENERICS)
Strength:30mg/ml
Dosage Form:Liquid Injection (Sterile)
Packing:10ml vial (Multiple-dose)
Route of Administration:For I.V./I.M. Infusion 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:Cardiovascular System, Cardiology
Indication: Papaverine Hydrochloride Injection belongs to the group of medicines called vasodilators used to treat circulatory problems, visceral spasms, peripheral vascular disease, vascular spasms associated with angina pectoris, myocardial infarction, and pulmonary and peripheral embolism. It is also used to treat erectile dysfunction (impotence).
Storage:Store at 20°C to 25°C (68° to 77°F) excusion permitted to 15°C to 30°C (59°F to 86°F )[see USP Controlled Room Temperature].

GENERIC NAME OF MEDICINAL PRODUCT:

  • Papaverine Hydrochloride Injection USP 30mg/ml 

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Papaverine Hydrochloride Injection USP 30mg/ml
    Each ml contains:
    Papaverine Hydrochloride USP…………………30mg
    Water for Injection USP……………………………q.s.
    Excipients………………………q.s.

THERAPEUTIC INDICATION:

Papaverine Hydrochloride Injection belongs to the group of medicines called vasodilators used to treat circulatory problems, visceral spasms, peripheral vascular disease, vascular spasms associated with angina pectoris, myocardial infarction, and pulmonary and peripheral embolism. It is also used to treat erectile dysfunction (impotence).

CAUTION & Warning:

CAUTION:

  • Do not use if solution is not clear or has suspended matter.
  • If you notice bleeding at the site when you inject papaverine, put pressure on the spot until the bleeding stops. If it doesn’t stop, check with your doctor.
  • DO NOT ACCEPT IF VIAL SEAL IS BROKEN.

WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:  Store at 20°C to 25°C (68° to 77°F) excusion permitted to 15°C to 30°C (59°F to 86°F)[see USP Controlled Room Temperature].
Dosage: Parenteral administration of papaverine hydrochloride in doses of 1 to 4ml is repeated every 3 hours as indicated.
Or as directed by Physician.