Actilyse 20 mg powder and solvent for solution for injection and infusion

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Alteplase

Tillgänglig från:

Boehringer Ingelheim International GmbH

ATC-kod:

B01AD; B01AD02

INN (International namn):

Alteplase

Dos:

20 milligram(s)

Läkemedelsform:

Powder and solvent for solution for injection/infusion

Terapiområde:

Enzymes; alteplase

Bemyndigande status:

Marketed

Tillstånd datum:

1989-06-19

Bipacksedel

1
A1/IE MT/PI/155/G
19/01/2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTILYSE
® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AND INFUSION 10 MG, 20
MG AND 50 MG
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 or inflammation of the heart (endocarditis), or
inflammation of the membranes
around the heart (peri

Produktens egenskaper

Health Products Regulatory Authority
10 May 2023
CRN00DJFG
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actilyse 20 mg powder and solvent for solution for injection and
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial with powder contains:
20 mg alteplase (corresponding to 11,600,000 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
intracranial haemorrhage by appropriate i