GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Heparin Sodium Injection USP 1000 IU/ml
B. Heparin Sodium Injection USP 5000 IU/ml
C. Heparin Sodium Injection USP 10,000 IU/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Heparin Sodium Injection USP 1000 IU/ml
Each ml contains:
Heparin Sodium USP………………...1000IU
(Derived From Bovine Intestinal Mucosa)
Benzyl Alcohol USP…………………0.95%w/v
Water for Injection USP…………..q.s

2. Heparin Sodium Injection USP 5000 IU/ml
Each ml contains:
Heparin Sodium USP ………………5000IU
(Derived From Bovine Intestinal Mucosa)
Benzyl Alcohol USP…………………0.95%w/v
Water for Injection USP ………….q.s

3. Heparin Sodium Injection USP 10,000 IU/ml
Each ml contains:
Heparin Sodium USP ………………10,000IU
(Derived From Bovine Intestinal Mucosa)
Benzyl Alcohol USP…………………0.95%w/v
Water for Injection USP ……………q.s

THERAPEUTIC INDICATIONS:

Heparin is used to prevent or treat certain blood vessel, heart, and lung conditions. Heparin is also used to prevent blood clotting during open-heart surgery, bypass surgery, kidney dialysis, and blood transfusions.

DIRECTION OF USE:

For Intravenous, Intramuscular or Subcutaneous use only.
Refer insert for full prescribing information.

CAUTION & WARNING:

CAUTION:
Do not use if the solution is discolored or contains a precipitate.
This product contains benzyl alcohol and is not recommended for use in neonates.
Use only if seal is intact and undamaged.
Warning:
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
NOT FOR LOCK FLUSH.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Should be protected from freezing.
Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Heparin Sodium Injection USP 10,000 IU/ml Technical Specification:

Product Name:Heparin Sodium Injection USP
Brand Name:BEPRIN
Strength:(1000 IU/ml),  (5000 IU/ml),  (10,000 IU/ml)
Dosage Form:Liquid Injection (Sterile and Nonpyrogenic)
Packing:1000 IU/ml (Packing: 1ml, 2ml, 5ml, 10ml, 30ml Ampoule/Vial)
5000 IU /ml (Packing: 1ml, 5ml, 10ml Ampoule/Vial)
10,000 IU/ml (Packing: 4ml Ampoule/Vial)
Derived from:Bovine Intestinal Mucosa
Route of Administration:For I.M./I.V. or S.C. 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:Anti-Coagulant
Indication: Heparin is used to prevent or treat certain blood vessel, heart, and lung conditions. Heparin is also used to prevent blood clotting during open-heart surgery, bypass surgery, kidney dialysis, and blood transfusions.
Storage:Store at 20°C to 25°C (68°F to 77°F). Do not freeze. Should be protected from freezing.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Heparin Sodium Injection USP 10,000 IU/ml (Beprin)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Heparin Sodium Injection USP 10,000 IU/ml
    Each ml contains:
    Heparin Sodium USP…………………10,000IU
    (Derived From Bovine Intestinal Mucosa)
    Benzyl Alcohol USP…………………0.95%w/v
    Water for Injection USP…………..q.s

THERAPEUTIC INDICATIONS:

Heparin is used to prevent or treat certain blood vessel, heart, and lung conditions. Heparin is also used to prevent blood clotting during open-heart surgery, bypass surgery, kidney dialysis, and blood transfusions.

DIRECTION OF USE:

For Intravenous, Intramuscular or Subcutaneous use only.
Refer insert for full prescribing information.

CAUTION & WARNING:

CAUTION:
Do not use if the solution is discolored or contains a precipitate.
This product contains benzyl alcohol and is not recommended for use in neonates.
Use only if seal is intact and undamaged.

Warning:
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
NOT FOR LOCK FLUSH.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Protect from light.
Should be protected from freezing.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.

Note:

Origin: Bovine intestinal mucosa is a natural animal source. It is used in the pharmaceutical industry for the manufacture of the drug heparin. Hydrolysed proteins are a coproduct of this pharmaceutical process.