Actilyse 50mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALTEPLASE

Available from:

Boehringer Ingelheim Limited

ATC code:

B01AD02

INN (International Name):

ALTEPLASE

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

ALTEPLASE 50 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2007-05-16

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.
- Keep this leaflet. You may need to read it
 again.
- If you have any further questions, ask your
 doctor.
- This medicine has been prescribed for you.
 Do not pass it on to others. It may harm
 them, even if their symptoms are the same
 as yours.
- If any of the side effects gets serious, or if
 you notice any side effects not listed in this
 leaflet, please tell your doctor.
IN THIS LEAFLET: 
1. What Actilyse is and what it is used for
2. Before you receive Actilyse
3. How is Actilyse administered
4. Possible side effects
5. How to store Actilyse
6. Further information
1. WHAT ACTILYSE IS AND WHAT IT IS    
  USED FOR
The active substance in Actilyse is alteplase
(see section 6: “Further information”). It
belongs to a group of medicines called
thrombolytic agents. These medicines act by
dissolving blood clots that have formed in
blood vessels.
Actilyse is used to treat a number of
conditions caused by blood clots forming
within blood vessels, including:
- heart attacks 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. BEFORE YOU RECEIVE ACTILYSE

ACTILYSE WILL NOT BE GIVEN BY YOUR DOCTOR
- 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

Summary of Product characteristics

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.
- Keep this leaflet. You may need to read it
 again.
- If you have any further questions, ask your
 doctor.
- This medicine has been prescribed for you.
 Do not pass it on to others. It may harm
 them, even if their symptoms are the same
 as yours.
- If any of the side effects gets serious, or if
 you notice any side effects not listed in this
 leaflet, please tell your doctor.
IN THIS LEAFLET: 
1. What Actilyse is and what it is used for
2. Before you receive Actilyse
3. How is Actilyse administered
4. Possible side effects
5. How to store Actilyse
6. Further information
1. WHAT ACTILYSE IS AND WHAT IT IS    
  USED FOR
The active substance in Actilyse is alteplase
(see section 6: “Further information”). It
belongs to a group of medicines called
thrombolytic agents. These medicines act by
dissolving blood clots that have formed in
blood vessels.
Actilyse is used to treat a number of
conditions caused by blood clots forming
within blood vessels, including:
- heart attacks 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. BEFORE YOU RECEIVE ACTILYSE

ACTILYSE WILL NOT BE GIVEN BY YOUR DOCTOR
- 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