UROKINASE 50,000 International Unit Pdr for Soln for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

UROKINASE (PURIFIED BULK)

Available from:

Fannin Limited

ATC code:

B01AD04

INN (International Name):

UROKINASE (PURIFIED BULK)

Dosage:

50,000 International Unit

Pharmaceutical form:

Pdr for Soln for Infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

UROKINASE

Authorization status:

Authorised

Authorization date:

2016-04-29

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
UROKINASE FANNIN 10,000 I.U.  
UROKINASE FANNIN 50,000 I.U. 
UROKINASE FANNIN 100,000 I.U.  
UROKINASE FANNIN 250,000 I.U.

UROKINASE FANNIN 500,000 I.U. 

POWDER FOR SOLUTION FOR INFUSION 
[Urokinase] 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR 
YOU. 
Keep this leaflet. You may need to read it again. 
If you have any further questions, ask your doctor. 
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor. 

IN THIS LEAFLET:  
1. 
What Urokinase is and what it is used for 
2. 
What you need to know before use of Urokinase 
3. 
How to use Urokinase 
4. 
Possible side effects 
5. 
How to store Urokinase 
6. 
Further information 

1 
WHAT UROKINASE IS AND WHAT IT IS USED FOR 
Urokinase is a powder for IV infusion (administration into the
veins). Strength of urokinase is given in international units 
(IU). Urokinase contains 10,000,
50,000, 100,000, 250,000 or 500,000 I.U. per vial. Urokinase
is an antithrombotic agent 
which is a preparation that is able to dissolve blood clots.  
Urokinase is indicated for treatment of acute occlusions of blood
vessels caused by blood clots such as: 
peripheral vascular occlusion, i.e. blood clots blocking the blood
vessel system of the extremities. 
Severe pulmonary embolism, i.e blood clots in lungs 
In addition, Urokinase can be used to dissolve blood clots that
develop in shunts of dialysis patients. 

2 
WHAT YOU NEED TO KNOW BEFORE USE OF UROKINASE 
Urokinase is used by doctors in hospitals who have experience in
the treatment of thrombosis disorders. Your general 
state of health and medical history, including previously or
currently used medicines, will be carefully assessed before the 
treatment with Urokinase is c

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Urokinase Fannin 50,000 I.U., powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50,000 I.U. of human uorkinase extracted from human urine.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White, powder for solution for infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of acute vascular occlusions caused by thrombosis or embolism such as:
-
acute occlusive peripheral arterial disease with limb threatening ischaemia.
-
Severe Pulmonary embolism
-
Haemodialysis shunts blocked by fibrin clots.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Urokinase should only be used by physicians experienced in the management of thromboembolic diseases in hospitals
where adequate diagnostic and monitoring techniques are available.
Before starting thrombolytic therapy with urokinase, haemostasis tests should be performed including haematocrit,
platelet count, thrombin time (TT) and activated partial thromboplastin time (aPTT). If heparin has been given, it
should be discontinued and the aPTT should be less than twice the normal control value before urokinase therapy is
initiated.
After reconstitution, the solution should be clear and colourless.
POSOLOGY
ADULTS
Dosage and duration of administration depend on the respective indication. It may be adjusted individually depending
on the clinical condition. The following dose regimens should be used as a guideline.
_ACUTE OCCLUSIVE PERIPHERAL ARTERIAL DISEASE WITH LIMB THREATENING ISCHAEMIA_
Various regimens have been described in the literature, but none has been proven to be superior. However, catheter-
directed local lysis is the preferred method of administration.
4,000 IU/min (240,000 IU/h) is infused through