UROKINASE MEDAC 100000 IU

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

UROKINASE

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

B01AD04

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

UROKINASE 100,000 IU

Administration route:

LOCAL INSTILLATION, INTRA-ARTERIAL, I.V

Prescription type:

Required

Manufactured by:

MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY

Therapeutic group:

UROKINASE

Therapeutic area:

UROKINASE

Therapeutic indications:

Peripheral arterial thrombosis ;Acute and subacute deep vein thrombosis ; Acute diagnostically confirmed pulmonary embolism, in particular when associated with unstable haemodynamic status ; Thrombosed arteriovenous shunt.

Authorization date:

2015-06-30

Summary of Product characteristics

The format of this leaflet was determined by the Ministry of Health
and its content
was checked and approved in July 2010.
UROKINASE MEDAC 10,000 I.U, 50,000 I.U,
100,000 I.U, 250,000 I.U, 500,000 I.U
INFORMATION FOR HEALTH PROFESSIONALS
1.
NAME OF THE MEDICINAL PRODUCT
Urokinase medac 10,000 I.U.
Urokinase medac 50,000 I.U.
Urokinase medac 100,000 I.U.
Urokinase medac 250,000 I.U.
Urokinase medac 500,000 I.U.
Powder for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial of Urokinase medac 10,000 I.U. with 24 mg of powder for
solution for injection
or infusion contains 10,000 IU of urokinase.
1 vial of Urokinase medac 50,000 I.U. with 38 mg of powder for
solution for injection
or infusion contains 50,000 IU of urokinase.
1 vial of Urokinase medac 100,000 I.U. with 39 mg of powder for
solution for injection
or infusion contains 100,000 IU of urokinase.
1 vial of Urokinase medac 250,000 I.U. with 63 mg of powder for
solution for injection
or infusion contains 250,000 IU of urokinase.
1 vial of Urokinase medac 500,000 I.U. with 125 mg of powder for
solution for injection
or infusion contains 500,000 IU of urokinase.
For a complete list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Peripheral arterial thrombosis
-
Acute and subacute deep vein thrombosis
-
Acute
diagnostically
confirmed
pulmonary
embolism,
in
particular
when
associated with unstable haemodynamic status
-
Thrombosed arteriovenous shunt
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage:
Dosages are determined in accordance with the respective indication.
Peripheral arterial thrombosis
Systemic lysis:
For the treatment of arterial occlusion, the recommended initial dose
of urokinase is
250,000 ‑ 600,000 IU given intravenously over 10 ‑ 20 minutes,
with 80,000 ‑ 150,000
IU urokinase/h as a maintenance dose.
Simultaneous administration of heparin is generally required to ensure
adequate
protection against recurre