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……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.

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.

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 5000 IU/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • 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.

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.