ACTILYSE alteplase (rch) 20mg powder for injection, vial with diluent vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

Alteplase, Quantity: 20 mg

Dostupno od:

Boehringer Ingelheim Pty Ltd

Farmaceutski oblik:

Injection, powder for

Sastav:

Excipient Ingredients: phosphoric acid; arginine; polysorbate 80; nitrogen

Administracija rute:

Intravenous

Jedinice u paketu:

1 vial of diluent - 20mL, 1 vial of powder - 20mg

Tip recepta:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Terapijske indikacije:

Myocardial Infarction: ACTILYSE is indicated for intravenous use in adults for the lysis of suspected occlusive coronary artery thrombi associated with evolving transmural myocardial infarction. Treatment should be initiated as soon as possible after the onset of symptoms. The treatment can be initiated within 12 hours of symptom onset.,Pulmonary Embolism:ACTILYSE is also indicated in patients with acute massive pulmonary embolism in whom thrombolytic therapy is considered appropriate.,Acute Ischaemic Stroke:ACTILYSE is indicated for thrombolytic 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 imaging techniques (e.g. cranial computerised tomography or other diagnostic imaging method sensitive for the presence of haemorrhage). The treatment effect is time-dependent; therefore earlier treatment increases the probability of a favourable outcome.

Proizvod sažetak:

Visual Identification: Colourless to pale yellow cake of powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autorizacije:

Registered

Datum autorizacije:

1993-05-06

Uputa o lijeku

ACTILYSE
®
_alteplase_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Actilyse.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being treated with
Actilyse against the benefits they
expect it will have for you.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
IF YOU HAVE ANY CONCERNS ABOUT
BEING TREATED WITH THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS INFORMATION WITH THE
MEDICINE.
You may need to read it again.
WHAT ACTILYSE IS USED
FOR
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).
Actilyse contains the active
ingredient alteplase. It belongs to a
group of medicines called
thrombolytic agents.
Actilyse works by dissolving clots in
the blood vessels. These clots cause
disease by interfering with normal
blood flow.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU ARE GIVEN
ACTILYSE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN ACTILYSE IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing alteplase
(the active ingredient in Actilyse)
•
gentamicin (an antibiotic)
•
natural rubber (also called latex
which is part of the packaging
material)
•
any of the ingredients listed at the
end of this leaflet

Svojstava lijeka

ACTILYSE PI0111-10
1
AUSTRALIAN PRODUCT INFORMATION – ACTILYSE (ALTEPLASE) POWDER FOR
INJECTION
1 NAME OF THE MEDICINE
alteplase (rch)
2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
ACTILYSE is presented as a sterile, white to off-white, lyophilised
powder, intended for intravenous
administration after reconstitution with sterilised Water for
Injections.
ACTILYSE 10 mg
Box containing 1 vial of ACTILYSE_ _10 mg alteplase (corresponding to
5,800,000 IU) in up to 466.6 mg_ _
dry powder, 1 vial of sterilised Water for Injections,_ _10 mL_. _
ACTILYSE 20 mg*
Box containing 1 vial of ACTILYSE 20 mg alteplase (corresponding to
11,600,000 IU) in 933.2 mg dry
powder, 1 vial of sterilised Water for Injections, 20 mL, and 1
transfer cannula for preparing a sterile
solution of ACTILYSE.
ACTILYSE 50 mg
Box containing 1 vial of ACTILYSE 50 mg alteplase (corresponding to
29,000,000 IU) in 2333 mg dry
powder, 1 vial of sterilised Water for Injections, 50 mL, and 1
transfer cannula for preparing a sterile
solution of ACTILYSE.
*Not currently distributed in Australia.
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 List of excipients.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MYOCARDIAL INFARCTION
ACTILYSE is indicated for intravenous use in adults for the lysis of
suspected occlusive coronary artery
thrombi associated with evolving transmural myocardial infarction.
Treatment should be initiated as
soon as possible after the onset of symptoms. The treatment can be
initiated within 12 hours of
symptom onset.
PULMONARY EMBOLISM
ACTILYSE is also indicated in patients with acute massive pulmonary
embolism in whom thrombolytic
therapy is considered appropriate.
ACUTE ISCHAEMIC STROKE
ACTILYSE is indicated for thrombolytic treatment of acute isch