Recombinant Streptokinase for Injection BP 7,50,000IU (0.75MIU) Technical Specification:

Product Name:Recombinant Streptokinase for Injection BP
Brand Name:Generic
Strength:15,00,000IU (1.5MIU), 7,50,000IU (0.75MIU), 2,50,000IU(0.25MIU), 5,00,000 IU (0.5MIU), 1,00,000 IU (0.1MIU)
Dosage Form:Lyophilized
Dry Powder Injection (Sterile) *Preservative Free
*Albumin-free preparation
Packing:5ml Single Use Vial
Route of Administration:For IV 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:Thrombolytic Agent
Indication: Acute Evolving Myocardial Infarction,  Acute Massive Pulmonary Embolism, Deep Vein Thrombosis, Arterial Thrombosis or Embolism, Arteriovenous Cannulae Occlusion
Storage:Store at a temperature between 2°C to 8°C. Protect from light and moisture.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Recombinant Streptokinase for Injection BP (7,50,000IU)

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Recombinant Streptokinase for Injection BP (7,50,000IU)
    a) Each lyophilized vial (Upon adding 2ml of WFI) contains:
    Streptokinase B.P………………………7,50,000IU
    Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer

THERAPEUTIC INDICATIONS:

  • Acute Evolving Myocardial Infarction
  • Acute Massive Pulmonary Embolism
  • Deep Vein Thrombosis
  • Arterial Thrombosis or Embolism
  • Arteriovenous Cannulae Occlusion.

DIRECTION OF USE:

For Intravenous use only.
The solution should be used within 24 hours following reconstitution.
Roll and tilt the vial gently to reconstitute. Avoid shaking as it may cause foaming.
Do not add other medication to the container of the Product.
The unused reconstituted drug should be discarded.
Reconstitute with Sterile Sodium Chloride Injection USP.
For more information refer pack insert.

CAUTION & WARNING:

CAUTION: The injection should not be used if it contains visible solid particles after reconstitution. Please do not use the solution and return the vial for a free replacement.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

WARNING:  Not to be sold by retail without the prescription of a Registered Medical Practitioner only.

Kindly do not self-administer

STORAGE & DOSAGE:

Storage: Store at a temperature between 2°C to 8°C. Protect from light and moisture.
Do not freeze.
Keep all medicines out of reach of children.
Purified Lyophilized vial sealed in a vacuum.
Discard any unused portion.

Dosage: As directed by the Physician.

GENERIC NAME OF MEDICINAL PRODUCT:

A. Recombinant Streptokinase for Injection BP (15,00,000IU)
B. Recombinant Streptokinase for Injection BP (7,50,000IU)
C. Recombinant Streptokinase for Injection BP (2,50,000IU)
D. Recombinant Streptokinase for Injection BP (5,00,000 IU)
E. Recombinant Streptokinase for Injection BP (1,00,000 IU)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Recombinant Streptokinase for Injection BP (15,00,000IU)
a) Each lyophilized vial (Upon adding 2ml of WFI) contains:
Streptokinase B.P………………………15,00,000IU
Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer

B. Recombinant Streptokinase for Injection BP (7,50,000IU)
Each lyophilized vial (Upon adding 2ml of WFI) contains:
Streptokinase B.P………………………7,50,000IU
Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer


C. Recombinant Streptokinase for Injection BP (2,50,000IU)
Each lyophilized vial (Upon adding 2ml of WFI) contains:
Streptokinase B.P………………………2,50,000IU
Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer

D. Recombinant Streptokinase for Injection BP (5,00,000 IU)
Each lyophilized vial (Upon adding 2ml of WFI) contains:
Streptokinase B.P………………………5,00,000 IU
Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer

E. Recombinant Streptokinase for Injection BP (1,00,000 IU)
Each lyophilized vial (Upon adding 2ml of WFI) contains:
Streptokinase B.P………………………1,00,000 IU
Excipients: Glycine, Sodium L Glutamate, Phosphate Buffer

THERAPEUTIC INDICATIONS:

Acute Evolving Myocardial Infarction
Acute Massive Pulmonary Embolism
Deep Vein Thrombosis
Arterial Thrombosis or Embolism
Arteriovenous Cannulae Occlusion. 

DIRECTION OF USE:

For Intravenous use only.
The solution should be used within 24 hours following reconstitution.
Roll and tilt the vial gently to reconstitute. Avoid shaking as it may cause foaming.
Do not add other medication to the container of Product.
Unused reconstituted drug should be discarded.
Reconstitute with Sterile Sodium Chloride Injection USP.
For more information refer pack insert.

CAUTION & WARNING:

CAUTION: The injection should not be used if it contains visible solid particles after reconstitution. Please do not use the solution and return the vial for free replacement.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
Kindly do not self-administer

STORAGE & DOSAGE:

Storage: Store at a temperature between 2°C to 8°C. Protect from light and moisture.
Do not freeze.
Keep all medicines out of reach of children.
Purified Lyophilized vial sealed in vacuum.
Discard any unused portion.
Dosage: As directed by the Physician.