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
GENERIC NAME OF THE MEDICINAL PRODUCT:
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
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.
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.
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.
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 1000 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 1000 IU/ml (Beprin)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- 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
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.
