Rapilysin

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

reteplase

Saadav alates:

Actavis Group PTC ehf

ATC kood:

B01AD07

INN (Rahvusvaheline Nimetus):

reteplase

Terapeutiline rühm:

Antithrombotic agents

Terapeutiline ala:

Myocardial Infarction

Näidustused:

Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (AMI) symptoms.

Toote kokkuvõte:

Revision: 27

Volitamisolek:

Authorised

Loa andmise kuupäev:

1996-08-29

Infovoldik

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
RAPILYSIN 10 U POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
reteplase
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 or your pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rapilysin is and what it is used for
2.
What you need to know before Rapilysin is given to you
3.
How to use Rapilysin
4.
Possible side effects
5.
How to store Rapilysin
6.
Contents of the pack and other information
1.
WHAT RAPILYSIN IS AND WHAT IT IS USED FOR
Rapilysin contains the active substance reteplase(a recombinant
plasminogen activator). It is a
thrombolytic medicine used to dissolve blood clots that have formed in
certain blood vessels and to
restore the blood flow in these blocked vessels (=thrombolysis).
Rapilysin is used after an acute myocardial infarction (heart attack)
in order to dissolve the blood clot
causing the heart attack. It is given within 12 hours after the onset
of symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE RAPILYSIN IS GIVEN TO YOU
The doctor will ask you questions before giving you Rapilysin, to find
out if you have an increased
risk of bleeding.
DO NOT USE RAPILYSIN
•
if you are allergic to reteplase or any of the other ingredients of
this medicine (listed in section
6).
•
if you have a bleeding disorder.
•
if you are taking medicine to thin your blood (oral anticoagulants,
e.g. warfarin).
•
if you have a brain tumour or a malformed blood vessel or a vessel
wall dilatation (aneurysm) in
the brain.
•
if you have other tumours associated with an increased risk of
bleeding.
•
if you have had a stroke.
•
if you have had external heart massage within the past 10 days.
•
if you have severe uncontrolled high blood press

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rapilysin 10 U powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 10 U* reteplase ** in 0.56 g powder
1 prefilled syringe contains 10 ml water for injections.
The reconstituted solution contains 1 U reteplase per ml.
For the full list of excipients, see section 6.1.
* Potency of reteplase is expressed in units (U) by using a reference
standard which is specific for
reteplase and is not comparable with units used for other thrombolytic
agents.
** Recombinant plasminogen activator produced in Escherichia coli by
recombinant DNA technology.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White powder and clear colourless liquid (water for injections).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rapilysin is indicated for the thrombolytic treatment of suspected
myocardial infarction with persistent
ST elevation or recent left Bundle Branch Block within 12 hours after
the onset of acute myocardial
infarction AMI symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with reteplase should be initiated as soon as possible after
the onset of AMI symptoms.
Rapilysin should be prescribed by physicians experienced in the use of
thrombolytic treatment and
with the facilities to monitor its use.
Posology
_Dosage of Rapilysin _
Rapilysin is administered as a 10 U bolus dose followed by a second 10
U bolus dose 30 minutes later
(double bolus).
Each bolus is administered as a slow intravenous injection within 2
minutes. Ensure that the injection
is not mistakenly given paravenously.
_HEPARIN AND ACETYLSALICYLIC ACID _
should be administered before and following the administration of
Rapilysin to reduce the risk of re-thrombosis.
_Dosage of Heparin _
The recommended dose of heparin is 5000 I.U. given as a bolus
injection prior to reteplase therapy
followed by an infusion of 1000 I.U. per hour starting after the
second reteplase bolus. Heparin should
3
be admin