Metalyse
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
02-04-2024
Charakterystyka produktu
(SPC)
02-04-2024
Sprawozdanie z oceny publicznego
(PAR)
29-07-2014
Składnik aktywny:
tenecteplase
Dostępny od:
Boehringer Ingelheim International GmbH
Kod ATC:
B01AD11
INN (International Nazwa):
tenecteplase
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Myocardial Infarction
Wskazania:
Metalyse is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left-bundle-branch block within six hours after the onset of acute-myocardial-infarction symptoms.,
Podsumowanie produktu:
Revision: 22
Status autoryzacji:
Authorised
Data autoryzacji:
2001-02-23
Ulotka dla pacjenta
46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET: INFORMATION FOR THE USER
METALYSE 8 000 UNITS (40 MG) POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
METALYSE 10 000 UNITS (50 MG) POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
tenecteplase
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE 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 pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Metalyse is and what it is used for
2.
What you need to know before you receive Metalyse
3.
How is Metalyse administered
4.
Possible side effects
5.
How to store Metalyse
6.
Contents of the pack and other information
1.
WHAT METALYSE IS AND WHAT IT IS USED FOR
Metalyse is a powder and solvent for solution for injection.
Metalyse belongs to a group of medicines called thrombolytic agents.
These medicines help to
dissolve blood clots. Tenecteplase is a recombinant fibrin-specific
plasminogen activator.
Metalyse is used to treat myocardial infarctions (heart attacks)
within 6 hours after the onset of
symptoms and helps to dissolve the blood clots that have formed in the
blood vessels of the heart. This
helps to prevent the damage caused by heart attacks and has been shown
to save lives.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE METALYSE
METALYSE WILL NOT BE PRESCRIBED AND GIVEN BY YOUR DOCTOR
if you have previously had a sudden life-threatening allergic reaction
(severe hypersensitivity)
to tenecteplase, to any of the other ingredients of this medicine
(listed in section 6) or to
gentamicin (a trace residue from the manufacturing process). If
treatment with Metalyse is
nevertheless considered to be necessary, facilities for reanimation
should be immediately
available in case of need;
if you have, or have recently had, an illness that increases your risk
of bleeding (h
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Metalyse 8 000 units (40 mg) powder and solvent for solution for
injection
Metalyse 10 000 units (50 mg) powder and solvent for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metalyse 8 000 units (40 mg) powder and solvent for solution for
injection
Each vial contains 8 000 units (40 mg) tenecteplase.
Each pre-filled syringe contains 8 mL solvent.
Metalyse 10 000 units (50 mg) powder and solvent for solution for
injection
Each vial contains 10 000 units (50 mg) tenecteplase.
Each pre-filled syringe contains 10 mL solvent.
The reconstituted solution contains 1 000 units (5 mg) tenecteplase
per mL.
Potency of tenecteplase is expressed in units (U) by using a reference
standard which is specific for
tenecteplase and is not comparable with units used for other
thrombolytic agents.
Tenecteplase is a fibrin-specific plasminogen activator produced in a
Chinese hamster ovary cell line
by recombinant DNA technology.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white to off-white.
The solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metalyse is indicated in adults for the thrombolytic treatment of
suspected myocardial infarction with
persistent ST elevation or recent left Bundle Branch Block within 6
hours after the onset of acute
myocardial infarction (AMI) symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Metalyse should be prescribed by physicians experienced in the use of
thrombolytic treatment and
with the facilities to monitor that use.
Treatment with Metalyse should be initiated as early as possible after
onset of symptoms.
The appropriate presentation of tenecteplase product should be chosen
carefully and in line with the
indication. The 40 mg and 50 mg presentations are only intended for
use in acute myocardial
infarction.
3
Metalyse should be administered on the basis of body weight,
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