Urokinase for Injection 5,00,000IU
Categories: , , ,
Date:

Urokinase for Injection 5,00,000IU 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 5,00,000IU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Urokinase for Injection 5,00,000IU
    Each vial contains:
    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
  • 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.

GENERIC NAME OF MEDICINAL PRODUCT:

A) Urokinase for Injection 5,00,000IU
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:

A) Urokinase for Injection 5,00,000IU Each vial contains:
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:

UROKINASE is 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 Physician.