Actilyse 20mg powder and solvent for solution for injection vials
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
07-06-2018
Summary of Product characteristics
(SPC)
07-06-2018
Active ingredient:
Alteplase
Available from:
Boehringer Ingelheim Ltd
ATC code:
B01AD02
INN (International Name):
Alteplase
Dosage:
20mg
Pharmaceutical form:
Powder and solvent for solution for injection
Administration route:
Intravenous
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02100200; GTIN: 5012816002036
Patient Information leaflet
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 (myocardial infarction)
• blood clots in the arteries of the lungs (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 blood pressure
- bacteria
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Summary of Product characteristics
OBJECT 1
ACTILYSE
Summary of Product Characteristics Updated 20-Apr-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
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
2. Qualitative and quantitative composition
1 vial with powder contains:
10 mg alteplase (corresponding to 5,800,000 IU) or
20 mg alteplase (corresponding to 11,600,000 IU) or
50 mg alteplase (corresponding to 29,000,000 IU), respectively
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
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 l
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