Actilyse
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
09-05-2022
Summary of Product characteristics
(SPC)
01-05-2023
Active ingredient:
Alteplase 10mg
Available from:
Boehringer Ingelheim (NZ) Ltd
INN (International Name):
Alteplase 10 mg
Dosage:
10 mg
Pharmaceutical form:
Injection with diluent
Composition:
Active: Alteplase 10mg Excipient: Arginine Nitrogen Phosphoric acid Polysorbate 80 Water for injection
Units in package:
Ampoule, 10 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Boehringer Ingelheim Pharma GmbH & Co KG
Therapeutic indications:
ACTILYSE is indicated for fibrinolytic therapy in acute thrombotic artery occlusion to restore coronary artery patency, reduce infarct size, preserve ventricular function, prevent cardiac insufficiency and reduce mortality · 90 minutes (accelerated) dose regimen: for patients in whom treatment can be started within 6 h of symptom onset; · 3 hour dose regimen: for patients in whom treatment can be started between 6 - 12 hrs after symptom onset.
Product summary:
Package - Contents - Shelf Life: Ampoule, - 10 mL - - Combination pack, 1 x ( powder + diluent ) - 10 mg - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted stored at or below 25°C protect from light - Vial, glass, - 10 mg - 24 months from date of manufacture stored at or below 25°C protect from light
Authorization date:
1987-03-19
Patient Information leaflet
ACTILYSE NZ CMI v03
1
ACTILYSE
®
_INJECTION WITH DILUENT _
_alteplase, rch _
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.
IF YOU HAVE ANY CONCERNS ABOUT
BEING TREATED WITH THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
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.medsafe.govt.nz/
Consumers/cmi/CMIForm.asp and
may contain important information
about the medicine and its use of
which you should be aware.
KEEP THIS LEAFLET.
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
lung (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)
•
gentamycin (an antibiotic)
•
any of the ingredients listed at the
end of this leaflet.
Some of the sympto
Read the complete document
Summary of Product characteristics
Actilyse NZ DS v06
1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
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
ACTILYSE 10 mg
1 vial contains: 10 mg alteplase in 466.6 mg dry substance
1 vial of solvent contains: 10 mL sterilised water for injection.
ACTILYSE 20 mg
1 vial contains: 20 mg alteplase in 933.2 mg dry substance
1 vial of solvent contains: 20 mL sterilised water for injection.
(Not marketed)
ACTILYSE 50 mg
1 vial contains: 50 mg alteplase in 2333 mg dry substance
1 vial of solvent contains: 50 mL sterilised water for injection.
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.
The reconstituted solution contains 1 mg alteplase per mL.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection and infusion.
The powder is presented as a colourless to pale yellow lyophilisate
cake.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute Myocardial Infarction
ACTILYSE is indicated for fibrinolytic therapy in acute thrombotic
artery occlusion to restore coronary
artery patency, reduce infarct size, preserve ventricular function,
prevent cardiac insufficiency and
reduce mortality.
•
90 minutes (accelerated) dose regimen (see section 4.2): for patients
in whom treatment can be
started within 6 h of symptom onset;
•
3 hour dose regimen (see section 4.2): for patients in whom treatment
can be started between
6 - 12 hrs after symptom onset.
Acute Massive Pulmonary Embolism
ACTILYSE is also indicated in patients with acute massive pulmonary
em
Read the complete document
