Urokinase medac 250,000 IU powder for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Urokinase

Available from:

Medac Gesellschaft fur Klinische Spezialpraparate mbH

ATC code:

B01AD; B01AD04

INN (International Name):

Urokinase

Dosage:

250,000 international unit(s)

Pharmaceutical form:

Powder for solution for infusion

Prescription type:

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

Therapeutic area:

Enzymes; urokinase

Authorization status:

Not marketed

Authorization date:

2016-04-29

Patient Information leaflet

Urokinase medac · 82100-VBIL · AA · 09.18 · Pharma-Code: 276
(Dummy)
Format: 592 x 150 mm · Template: VP_592x150_V02 · HKS 44 ·
Corrective action: KV01_osc_08.08.17 / KV02_jem_16.05.18 /
KV03_osc_08.06.18 / KV04_osc_27.09.18 / KV05_osc_02.10.18
PACKAGE LEAFLET: INFORMATION FOR THE USER
UROKINASE MEDAC 10,000 IU,
POWDER FOR SOLUTION FOR INFUSION
UROKINASE MEDAC 50,000 IU,
POWDER FOR SOLUTION FOR INFUSION
UROKINASE MEDAC 100,000 IU,
POWDER FOR SOLUTION FOR INFUSION
UROKINASE MEDAC 250,000 IU,
POWDER FOR SOLUTION FOR INFUSION
UROKINASE MEDAC 500,000 IU,
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,
pharmacist or nurse.
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Urokinase is and what it is used for
2. What you need to know before you use Urokinase
3. How to use Urokinase
4. Possible side effects
5. How to store Urokinase
6. Contents of the pack and other information
1. WHAT UROKINASE IS AND WHAT IT IS USED FOR
Urokinase medac contains human urokinase extracted
from human urine. Urokinase is an antithrombotic agent
and is indicated for the 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, and 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.
Urokinase is a powder for intravenous 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 IU per vial.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE UROKINASE
Urokina

Summary of Product characteristics

Health Products Regulatory Authority
06 November 2018
CRN008JX2
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Urokinase medac 250,000 IU powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250,000 IU of human urokinase extracted from human
urine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White powder for solution for infusion
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Urokinase is indicated 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.
Posology
Dose and duration of administration depend on the respective
indication. They may
be adjusted individually depending on the clinical condition. The
following dose
regimens should be used as a guideline.
Health Products Regulatory Authority
06 November 2018
CRN008JX2
Page 2 of 11
_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 an intra-arterial
catheter for the first
2 – 4 hours or until restoration of antegrade flow and 1,000 –
2,000 I