A. Streptokinase Injection BP (15,00,000IU)
B. Streptokinase Injection BP (7,50,000IU)
GENERIC NAME OF MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Streptokinase Injection BP (15,00,000IU)
Composition:
Each vial contains:
Streptokinase BP ………………………15,00,000IU
Excipients…………………………………q.s.
B. Streptokinase Injection BP (7,50,000IU)
Composition:
Each vial contains:
Streptokinase BP ………………………7,50,000IU
Excipients…………………………………q.s.
Composition:
Each vial contains:
Streptokinase BP ………………………15,00,000IU
Excipients…………………………………q.s.
B. Streptokinase Injection BP (7,50,000IU)
Composition:
Each vial contains:
Streptokinase BP ………………………7,50,000IU
Excipients…………………………………q.s.
THERAPEUTIC INDICATIONS:
Acute Evolving Myocardial Infarction
Acute Massive Pulmonary Embolism
Deep Vein Thrombosis
Arterial Thrombosis or Embolism
Arteriovenous Cannulae Occlusion.
Acute Massive Pulmonary Embolism
Deep Vein Thrombosis
Arterial Thrombosis or Embolism
Arteriovenous Cannulae Occlusion.
DIRECTION OF USE:
For IV infusion only.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store the vial in original carton at 2° to 8°C. Use reconstituted preparation within 24 hours.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.
Streptokinase Injection BP 7,50,000IU Technical Specification:
| Product Name: | Streptokinase Injection BP |
| Brand Name: | Generic |
| Strength: | 15,00,000IU, 7,50,000IU |
| Dosage Form: | Lyophilized Dry Powder Injection (Sterile) *Preservative Free |
| Packing: | 1 Vial + 1 Ampule + WFI Tray |
| Route of Administration: | For IV infusion 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 the vial in the original carton at 2° to 8°C. Use reconstituted preparation within 24 hours. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Streptokinase Injection BP (7,50,000IU)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Streptokinase Injection BP (7,50,000IU)
Composition:
Each vial contains:
Streptokinase BP ………………………7,50,000IU
Excipients…………………………………q.s.
THERAPEUTIC INDICATIONS:
- Acute Evolving Myocardial Infarction
- Acute Massive Pulmonary Embolism
- Deep Vein Thrombosis
- Arterial Thrombosis or Embolism
- Arteriovenous Cannulae Occlusion.
DIRECTION OF USE:
For IV infusion only.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store the vial in the original carton at 2° to 8°C. Use reconstituted preparation within 24 hours.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
