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
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- Heparin Sodium Injection USP 25000 IU/5ml (BEPRIN)
- Heparin Sodium Injection 25000 IU/5ml
- Heparin Sodium Injection 25000 IU/5ml
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- Heparin Sodium Injection 25000 IU/5ml
- Heparin Sodium Injection 25000 IU/5ml
- Heparin Sodium Injection 25000 IU/5ml
- Heparin Sodium Injection 25000 IU/5ml
- Heparin Sodium Injection 25000 IU/5ml
- Heparin Sodium Injection 25000 IU/5ml
- Heparin Sodium Injection 25000 IU/5ml
- Heparin Sodium Injection 25000 IU/5ml
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Heparin Sodium Injection USP 1000 IU/ml
Each ml contains:
Heparin Sodium USP……1000I.U.
(Derived from Mucosa)
Benzyl Alcohol B.P. …...0.95% v/v.
Water for Injection USP……q.s.
2. Heparin Sodium Injection USP 5000 IU/ml
Each ml contains:
Heparin Sodium USP……5000I.U.
(Derived from Mucosa)
Benzyl Alcohol B.P. …...0.95% v/v.
Water for Injection USP……q.s.
3. Heparin Sodium Injection USP 10,000 IU/ml
Each ml contains:
Heparin Sodium USP……10,000I.U.
(Derived from Mucosa)
Benzyl Alcohol B.P. …...0.95% v/v.
Water for Injection USP……q.s.
Each ml contains:
Heparin Sodium USP……1000I.U.
(Derived from Mucosa)
Benzyl Alcohol B.P. …...0.95% v/v.
Water for Injection USP……q.s.
2. Heparin Sodium Injection USP 5000 IU/ml
Each ml contains:
Heparin Sodium USP……5000I.U.
(Derived from Mucosa)
Benzyl Alcohol B.P. …...0.95% v/v.
Water for Injection USP……q.s.
3. Heparin Sodium Injection USP 10,000 IU/ml
Each ml contains:
Heparin Sodium USP……10,000I.U.
(Derived from Mucosa)
Benzyl Alcohol B.P. …...0.95% v/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 the reconstituted solution if it contains any visible particulate matter.
Not to be used in newly born or premature infants.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
NOT FOR LOCK FLUSH.
Not to be used in newly born or premature infants.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
NOT FOR LOCK FLUSH.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding between 25°C-30°C.
Do not refrigerate.
Keep all medicines out of reach of children.
Dosage: For dosage and administration please see enclosed leaflet or As directed by an Physician.
Do not refrigerate.
Keep all medicines out of reach of children.
Dosage: For dosage and administration please see enclosed leaflet or As directed by an Physician.
Heparin Sodium Injection USP 25000 IU/5ml Technical Specification:
| Product Name: | Heparin Sodium Injection USP 25000 IU/5ml |
| Brand Name: | BEPRIN |
| Strength: | (1000 IU/ml), (25000 IU/5ml), (10,000 IU/1ml) |
| Dosage Form: | Liquid Injection (Sterile and Nonpyrogenic) |
| Packing: | 1000 IU/ml (Packing: 1ml, 2ml, 5ml, 10ml, 30ml Ampoule/Vial) 25000 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 a temperature not exceeding between 25°C-30°C. Do not refrigerate. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Heparin Sodium Injection USP 25000 IU/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Heparin Sodium Injection USP 25000 IU/ml
Each ml contains:
Heparin Sodium USP……5000I.U.
(Derived from Mucosa)
Benzyl Alcohol B.P. ……0.95% v/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 the reconstituted solution if it contains any visible particulate matter.
Not to be used in newly born or premature infants.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
NOT FOR LOCK FLUSH.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding between 25°C-30°C. Do not refrigerate.
Keep all medicines out of reach of children.
Dosage: For dosage and administration please see enclosed leaflet or As directed by an 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.
