Actilyse 10mg Powder and Solvent for solution for injection and infusion (10mg vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALTEPLASE

Available from:

Boehringer Ingelheim International GmbH Binger Strasse 173, 55216 Ingelheim am Rhein, Germany

ATC code:

B01AD02

INN (International Name):

ALTEPLASE 10 mg

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

ALTEPLASE 10 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2019-05-06

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTILYSE 10 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AND
INFUSION
ACTILYSE 20 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AND
INFUSION
ACTILYSE 50 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AND
INFUSION
alteplase
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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Actilyse is and what it is used for
2.
What you need to know before you receive Actilyse
3.
How is Actilyse administered
4.
Possible side effects
5.
How to store Actilyse
6.
Contents of the pack and other information
1.
WHAT ACTILYSE IS AND WHAT IT IS USED FOR
The active substance in Actilyse is alteplase. It belongs to a group
of medicines called thrombolytic agents.
These medicines act by dissolving blood clots that have formed in
blood vessels.
Actilyse 10, 20 or 50 mg are used to treat a number of conditions
caused by blood clots forming within blood
vessels, including:
•
heart attack caused by blood clots in the arteries of the heart (acute
myocardial infarction)
•
blood clots in the arteries of the lungs (acute massive pulmonary
embolism)
•
stroke caused by a blood clot in an artery of the brain (acute
ischaemic stroke).
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ACTILYSE
YOU SHOULD NOT RECEIVE ACTILYSE
•
if you are allergic (hypersensitive) to alteplase or to any of the
other ingredients of this medicine
(listed in section 6).
•
if you have, or have recently had, an illness that increases your risk
of bleeding, including:
-
a bleeding disorder or tendency to bleed
-
a severe or dangerous bleed in any part of the body
-
bleeding within the brain or skull
-
uncontrolled, very high blood pressure
-
bacterial infection o

Summary of Product characteristics

A1(10 MG)/MT/SPC/4
ACTILYSE 10 MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AND INFUSION
Malta
alteplase
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Actilyse 10 mg powder and solvent for solution for injection and
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial with powder contains:
10 mg alteplase (corresponding to 5,800,000 IU)
Alteplase is produced by recombinant DNA technique using a Chinese
hamster ovary cell-line. The
specific activity of alteplase in-house reference material is 580,000
IU/mg. This has been confirmed by
comparison with the second international WHO standard for t-PA. The
specification for the specific
activity of alteplase is 522,000 to 696,000 IU/mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection and infusion.
The powder is presented as a colourless to pale yellow lyophilizate
cake. The reconstituted preparation
is a clear and colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thrombolytic treatment in acute myocardial infarction
-
90 minutes (accelerated) dose regimen (see section 4.2): for patients
in whom treatment can be
started within 6 hours after symptom onset
-
3 hour dose regimen (see section 4.2): for patients in whom treatment
can be started between
6 - 12 hours after symptom onset provided that the diagnosis has been
clearly confirmed.
Actilyse has proven to reduce 30-day-mortality in patients with acute
myocardial infarction.
Thrombolytic treatment in acute massive pulmonary embolism with
haemodynamic instability
The diagnosis should be confirmed whenever possible by objective means
such as pulmonary
angiography or non-invasive procedures such as lung scanning. There is
no evidence for positive effects
on mortality and late morbidity related to pulmonary embolism.
Fibrinolytic treatment of acute ischaemic stroke
Treatment must be started as early as possible within 4.5 hours after
onset of stroke symptoms and after
exclusion of int