GENERIC NAME OF MEDICINAL PRODUCT:
B) Urokinase for Injection 5000IU
C) Urokinase for Injection 50,000IU
D) Urokinase for Injection 1,00,000IU
E) Urokinase for Injection 2,50,000IU
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Urokinase USP…………….……………5,00,000IU
Excipients:
Human Albumin B.P...............................20mg
Sodium Citrate B.P...................................24mg
Disodium Hydrogen Phosphate Dihydrate B.P..........7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P..............20mg
B) Urokinase for Injection 5000IU Each vial contains:
Urokinase USP…………….……………5000IU
Excipients:
Human Albumin B.P...............................20mg
Sodium Citrate B.P...................................24mg
Disodium Hydrogen Phosphate Dihydrate B.P..........7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P..............20mg
C) Urokinase for Injection 50,000IU Each vial contains:
Urokinase USP…………….……………50,000IU
Excipients:
Human Albumin B.P...............................20mg
Sodium Citrate B.P...................................24mg
Disodium Hydrogen Phosphate Dihydrate B.P..........7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P..............20mg
D) Urokinase for Injection 1,00,000IU Each vial contains:
Urokinase USP…………….……………1,00,000 I.U.
Excipients:
Human Albumin B.P...............................20mg
Sodium Citrate B.P...................................24mg
Disodium Hydrogen Phosphate Dihydrate B.P..........7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P..............20mg
E) Urokinase for Injection 2,50,000IU Each vial contains:
Urokinase USP…………….……………2,50,000IU
Excipients:
Human Albumin B.P...............................20mg
Sodium Citrate B.P...................................24mg
Disodium Hydrogen Phosphate Dihydrate B.P..........7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P..............20mg
THERAPEUTIC INDICATION:
It is used to treat large blood clots formed in the lungs. This medicine may be used for other purposes.
Urokinase is a physiologic thrombolytic agent that is produced in renal parenchymal cells.
Unlike streptokinase, urokinase directly cleaves plasminogen to produce plasmin. When it is purified from human urine.
CAUTION & WARNING:
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Dosage: As directed by Physician.
Urokinase for Injection 1,00,000 I.U. Technical Specification:
Product Name: | Urokinase for Injection |
Brand Name: | Generic |
Strength: | 5,00,000IU(300mg), 5000IU(3mg), 50,000IU (30mg), 1,00,000UI(60mg), 2,50,000IU(150mg) |
Dosage Form: | Lyophilized Powder Injection (Sterile) *Pyrogen Free |
Packing: | 1 Vial |
Route of Administration: | For I.V. 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 (thrombolytic) |
Indication: | UROKINASE breaks up blood clots. It is used to treat large blood clots formed in the lungs. This medicine may be used for other purposes. Urokinase is a physiologic thrombolytic agent that is produced in renal parenchymal cells. Unlike streptokinase, urokinase directly cleaves plasminogen to produce plasmin. When it is purified from human urine. |
Storage: | Store at 2°C to 8°C. Protect from light |
GENERIC NAME OF MEDICINAL PRODUCT:
- Urokinase for Injection 1,00,000 I.U.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Urokinase for Injection 1,00,000 I.U.
Each vial contains:
Urokinase USP…………….……………1,00,000 I.U.
Excipients:
Human Albumin B.P………………………….20mg
Sodium Citrate B.P……………………………..24mg
Disodium Hydrogen Phosphate Dihydrate B.P……….7.8mg
Sodium Dihydrogen Phosphate Dihydrate B.P…………..20mg - Tested negative for HBsAg, HIV-1,2 and HCV antibodies
THERAPEUTIC INDICATION:
UROKINASE breaks up blood clots. It is used to treat large blood clots formed in the lungs. This medicine may be used for other purposes. Urokinase is a physiologic thrombolytic agent that is produced in renal parenchymal cells. Unlike streptokinase, urokinase directly cleaves plasminogen to produce plasmin. When it is purified from human urine.
CAUTION & WARNING:
CAUTION: The Injection should not be used if it contains visible particulate matter after reconstitution
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 2°C to 8°C. Protect from light
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Dosage: As directed by the Physician.