GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Heparin Sodium Injection USP 5,000 IU/ml (Beprin)
C. Heparin Sodium Injection USP 10,000 IU/ml (Beprin)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each ml contains:
Heparin Sodium USP……1000 IU
(From Porcine Intestinal Mucosa)
Sodium chloride…..........9mg
Methylparaben……………1.5mg
Propylparaben……………..0.15mg
Water for Injection USP…q.s
B. Heparin Sodium Injection USP 5,000 IU/ml
Each ml contains:
Heparin Sodium USP ……5000 IU
(From Porcine Intestinal Mucosa)
Sodium chloride….......9mg
Methylparaben....……..1.5mg
Propylparaben…....…….0.15mg
Water for Injection USP …q.s
C. Heparin Sodium Injection USP 10,000 IU/ml
Each ml contains:
Heparin Sodium USP ……10,000 IU
(From Porcine Intestinal Mucosa)
Sodium chloride….......9mg
Methylparaben…....…..1.5mg
Propylparaben…....…….0.15mg
Water for Injection USP …q.s
THERAPEUTIC INDICATIONS:
DIRECTION OF USE:
Refer insert for full prescribing information.
CAUTION & WARNING:
NOT FOR LOCK FLUSH.
Not to be used in newly born or premature infants.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Use only if seal is intact and undamaged.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Should be protected from freezing.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Note:
Origin: porcine 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.
Heparin Sodium Injection USP 5,000 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: | Porcine 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). Should be protected from freezing. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Heparin Sodium Injection USP 5,000 IU/ml (Beprin)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Heparin Sodium Injection USP 5,000 IU/ml
Each ml contains:
Heparin Sodium USP…….5000 IU
(From Porcine Intestinal Mucosa)
Sodium chloride………….9mg
Methylparaben……………1.5mg
Propylparaben……………..0.15mg
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: The injection should not be used It contains visible particulate matter.
Not to be used in newly born or premature infants.
NOT FOR LOCK FLUSH.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
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°F to 77°F).
Should be protected from freezing.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Note: Origin: porcine 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.