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

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Alteplase

Pieejams no:

Boehringer Ingelheim Limited

ATĶ kods:

B01AD; B01AD02

SNN (starptautisko nepatentēto nosaukumu):

Alteplase

Deva:

20 milligram(s)

Zāļu forma:

Powder and solvent for solution for injection/infusion

Receptes veids:

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

Ārstniecības joma:

Enzymes; alteplase

Autorizācija statuss:

Marketed

Autorizācija datums:

1989-06-19

Lietošanas instrukcija

1
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 the active substance
alteplase, to gentamicin (a trace residue
from the manufacturing process), to natural rubber (also called latex
which is part of the packaging
material) 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 blo

Produkta apraksts

Health Products Regulatory Authority
28 November 2018
CRN008R79
Page 1 of 28
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 h after symptom onset
- 3 h dose regimen (see section 4.2): for patients in whom treatment
can be started
between 6 ‑ 12 h 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
Health Products Regulatory Authority
28 November 2018
CRN008R79
Page 2 of 28
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
sy