ACTILYSE 10 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AND INFUSION

Active substance: WATER FOR INJECTIONS

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PACKAGE LEAFLET: INFORMATION FOR
THE USER
304300-01 
a

Actilyse® Powder and
solvent for solution for
injection and infusion
10 mg, 20 mg and 50 mg

ABCD

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

Your doctor will take special care with
Actilyse
- if you have had any allergic reaction other
than a sudden life-threatening allergic
reaction (severe hypersensitivity) 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 any other
conditions that increase your risk of
bleeding, such as:
• small injury
• biopsy (a procedure for obtaining a tissue
specimen)
• puncture of major vessels
• intramuscular injection
- if you have ever received Actilyse before
- if you are over 65 years of age

Taking other medicines
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription. It is particularly important that
you tell your doctor if you are taking or have
recently taken:
­ any medicines which are used to “thin” the
blood, including:
• aspirin
• warfarin
Actilyse is used to treat a number of
• coumarin
conditions caused by blood clots forming
• heparin
within blood vessels, including:
­ certain medicines used to treat high blood
- heart attacks caused by blood clots in the pressure (ACE inhibitors)
arteries of the heart (myocardial infarction)­
- blood clots in the arteries of the lungs
Pregnancy and breast-feeding
(pulmonary embolism)
Ask your doctor for advice before taking any
- stroke caused by a blood clot in an artery of medicine. Your doctor will only give you
the brain (acute ischaemic stroke)
Actilyse if the possible benefit outweighs the
possible risk to your baby.
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.

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
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

(pericarditis)
• inflammation of the pancreas (acute
pancreatitis)
• gastric ulcer or ulcers in the gut
• varicose veins in the gullet (oesophageal
varices)
• abnormalities of the blood vessels, such
as a localised swelling of an artery

(aneurysm)
• certain tumours
• severe liver disease
­ if you are taking a medicine used to “thin”
the blood (oral anticoagulants), unless
appropriate tests confirmed no clinically
relevant activity of such medicine
­ if you have ever had surgery to your brain or
spine
­ if you have had major surgery or significant
injury in the past 3 months
­ if you have been given external heart
massage in the past 10 days
­ if you have had a baby in the past 10 days

Your doctor will also not use Actilyse for the
treatment of heart attacks or blood clots in
the arteries of the lungs
­ if you have or have ever had a stroke caused
by bleeding in the brain (haemorrhagic
stroke)
­ if you have or have ever had a stroke of
unknown cause
­ if you have recently (in the past 6 months)
had a stroke caused by a blood clot in an
artery of the brain (ischaemic stroke),
unless this is the stroke you are about to be
treated for
In addition your doctor will not use Actilyse
for the treatment of a stroke caused by a
blood clot in an artery of the brain (acute
ischaemic stroke)
- if
­­ the symptoms of your stroke began more
than 4.5 hours ago or if it may be possible
that the symptoms began more than 4.5
hours ago, because you do not know when
they began
­ if your stroke is causing only very mild
symptoms
- if
­­ there are signs of bleeding in the brain
- if you have had a stroke within the last
three months
- if
­­ the symptoms are rapidly improving
before receiving Actilyse
- if
­­ you have a very severe stroke
-i
­ ­f you had cramps (convulsions) when your
stroke started
- if
­­ your thromboplastin time (a blood test to
see how well your blood clots) is abnormal.
This test can be abnormal if you have
received heparin (a medicine used to “thin”
the blood) within the previous 48 hours
- if
­­ you are diabetic and have ever had a
stroke before
- if
­­ the number of blood platelets

(thrombocytes) in your blood is very low
-i
­ ­f you have a very high blood pressure
(above 185/110) which can only be reduced
by injection of medicines
- if
­­ the amount of sugar (glucose) in your
blood is very low (under 50 mg/dl)
- if
­­ the amount of sugar (glucose) in your
blood is very high (over 400 mg/dl)
- if
­­ you are under 18 years or over 80 years of
age


3. HOW IS ACTILYSE ADMINISTERED

Actilyse will be administered to you by your
doctor or by a health care professional. It is
not for self-administration.

Treatment with Actilyse should be initiated
as soon as possible after the start of your
symptoms.

There are three different conditions for which
this medicine can be given:

Heart attack (myocardial infarction)
The dose you are given depends on your
body weight. The maximum dose of Actilyse
is 100 mg but will be lower if you weigh less
than 65 kg. It can be administered in two
different ways:

a) The 90 minute form of administration, for
patients treated within 6 hours after start
of their symptoms. This consists of:
­ an initial injection of part of the dose of
Actilyse into a vein
­ infusions of the remainder of the dose
over the following 90 minutes

b) The 3 hour form of administration, for
patients treated 6 to 12 hours after start of
their symptoms. This consists of:
­ an initial injection of part of the dose of
Actilyse into a vein
- ­nfusions of the remainder of the dose
i
over the following 3 hours

In addition to Actilyse your doctor will give
you another medicine to stop the blood
clotting. This will be given as soon as
possible after your chest pain starts.
Blood clots in the arteries of the lungs
(pulmonary embolism)
The dose you are given depends on your
body weight. The maximum dose of Actilyse
is 100 mg but will be lower if you weigh less
than 65 kg. The medicine is usually given as:
­ an initial injection of part of the dose into a
vein
- ­ n infusion of the remainder of the dose
a
over the following 2 hours
After the treatment with Actilyse, your doctor
will start (or resume) therapy with heparin (a
medicine to “thin” the blood).
Stroke caused by a blood clot in an artery of
the brain (acute ischaemic stroke)
Actilyse must be given within 4.5 hours of
the first symptoms. The earlier you receive
Actilyse, the more you can benefit from the
treatment and the less likely are harmful side
effects to occur. The dose you are given
depends on your body weight. The maximum
dose of this medicine is 90 mg but will be
lower if you weigh less than 100 kg. Actilyse
is given as:
­ an initial injection of part of the dose into a
vein
­ an infusion of the remainder of the dose
over the following 60 minutes

You should not take aspirin for the first
24 hours after your treatment with Actilyse
for a stroke. Your doctor may give you an
injection with heparin if this is necessary.

Method of administration
Actilyse is supplied as a powder and solvent
for solution for injection or infusion. This
means that each pack contains one vial with
powder and one vial with the solvent (water
for injections). Before use, the solvent is
added to the powder to form a solution ready
for administration. This solution is given into
a vein (intravenous injection or infusion).

Actilyse should not be mixed with other
medicines.

If you have any further questions on the use
of Actilyse, ask your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Actilyse can cause side
effects, although not everybody gets them.
The side effects described below have been
experienced by people given Actilyse. Your
treatment may be stopped by your doctor if
any of the following side effects occur:

­ bleeding in the brain (cerebral haemorrhage)
after the treatment of a stroke caused by a
blood clot in an artery of the brain (acute
ischaemic stroke)
­ cessation of heartbeat (cardiac arrest)
­ shock (a very low blood pressure) due to
heart failure
­ bleeding in the respiratory tract, such as
nosebleeds (epistaxis) or blood stained
phlegm (haemoptysis)
­ bleeding in the brain (cerebral haemorrhage)
after the treatment of heart attacks

(myocardial infarction) or blood clots in the
arteries of the lungs (pulmonary embolism)
­ bleeding into the membranous sac

surrounding the heart (haemopericardium)
­ internal bleeding into the back part of the
abdomen (retroperitoneal bleeding)
­ damage to the heart valves (mitral

regurgitation) or to the wall dividing the
heart chambers (ventricular septal defect)
­ bleeding in internal organs, e.g. bleeding in
the liver (hepatic haemorrhage) or in the
lung (pulmonary haemorrhage)
­ formation of cholesterol crystal clots which
can travel to other organs in the body
(cholesterol crystal embolisation). The
symptoms will depend on the organ
affected
­ serious allergic reaction (e.g. life-

threatening anaphylaxis, difficulty

breathing (bronchospasm), fluid under the
skin (angioedema), low blood pressure or
shock)
­ heart failure
The following are other possible side effects
that may cause your doctor to stop your
treatment but, this will depend on how
severe the side effects are:
Very common (occurs in more than 1 in 10
patients receiving the medicine)
­ fluid on the lungs (pulmonary oedema)
­ bleeding or bruising (haematoma) where
the injection is given
­ low blood pressure (hypotension)
­ irregular heart beat after the blood supply
to the heart has been restored
­ chest pain (angina pectoris)

6. FURTHER INFORMATION

What Actilyse contains

- The active substance is alteplase. Each vial
contains 10 mg (corresponding to

5,800,000 IU), 20 mg (corresponding to
11,600,000 IU) or 50 mg (corresponding to
29,000,000 IU) alteplase. Alteplase is
produced recombinant DNA technique
using a Chinese hamster ovary cell-line
- The other ingredients are arginine,

phosphoric acid (dilute) and polysorbate 80
- The solvent is water for injections
- The rubber stopper of the packaging
material contains natural rubber (latex)
What Actilyse looks like and contents of the
pack
Actilyse is a powder and solvent for solution
for injection and infusion. This means that
each complete pack contains one vial with
powder and one vial with the solvent.
Actilyse is available in the following pack
sizes:
- One vial of powder with 10 mg alteplase
and one vial with 10 ml solvent
- One vial of powder with 20 mg alteplase,
one vial with 20 ml solvent and one transfer
cannula
- One vial of powder with 50 mg alteplase,
one vial with 50 ml solvent and one transfer
cannula
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Boehringer Ingelheim Limited,
Ellesfield Avenue,
Bracknell,
Berkshire, RG12 8YS
United Kingdom
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Birkendorfer Strasse 65
D-88397 Biberach/Riss
Germany
This leaflet was last approved in 08/2013.
© Boehringer Ingelheim Limited 2013

Common (occurs in less than 1 in 10 patients
receiving the medicine)
­ further heart attack
­ bleeding of the gums
­ bleeding in the stomach or gut, including
vomiting blood (haematemesis) or blood in
the stools (melanea or rectal haemorrhage)
­ bleeding into the body tissues causing
purplish bruising (ecchymosis)
­ bleeding from the urinary tract or the
reproductive organs, which may lead to
blood in your urine (haematuria)
­ bleeding which necessitates a blood
transfusion
­ feeling sick (nausea)
­ vomiting
­ fever
Uncommon (occurs in less than 1 in 100
patients receiving the medicine)
­ bleeding from the ear
­ formation of blood clots in the lungs
(pulmonary embolism)
­ formation of blood clots in the blood
vessels which can travel to other organs in
the body (thrombotic embolisation). The
symptoms will depend on the organ
affected
­ allergic reactions, e.g. hives (urticaria) and
rash
Very rare (occurs in less than 1 in 10,000
patients receiving the medicine)
­ bleeding in the eyes (ocular haemorrhage)
­ events which affect the nervous system
such as:
• cramps (convulsions, fits)
• speech problems
• confusion or delirium (very severe

confusion)
• anxiety accompanied by restlessness
(agitation)
• depression
• altered thinking (psychosis)
These disorders often occur in association
with a stroke caused by a blood clot or
bleeding in the brain.
Tell your doctor immediately if you think you
are experiencing any of the side effects.

If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor.
5. HOW TO STORE ACTILYSE

Keep out of the reach and sight of children.

Actilyse should not be used after the expiry
date which is stated on the vial label and the
carton. The expiry date refers to the last day
of that month.

Normally you will not be asked to store
Actilyse as it will be given to you by your
doctor. Do not store above 25°C. Store in the
original package in order to protect from
light.

Once the solution is ready for administration,
it should be used immediately. The solution
may be stored for 24 hours at 2°C ­ 8°C or for
8 hours at up to 25°C.

304300-01

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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