Metalyse

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Tenecteplase 40mg (recombinant)

Dostępny od:

Boehringer Ingelheim (NZ) Limited

INN (International Nazwa):

Tenecteplase 40 mg (recombinant)

Dawkowanie:

40 mg

Forma farmaceutyczna:

Powder for injection

Skład:

Active: Tenecteplase 40mg (recombinant) Excipient: Arginine Phosphoric acid Polysorbate 20 Water for injection

Sztuk w opakowaniu:

Combination pack, vial and diluent syringe, 1 dose unit

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

Boehringer Ingelheim Pharma GmbH & Co KG

Wskazania:

METALYSE is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (AMI). Treatment should be initiated as soon as possible after symptom onset. Treatment can be initiated within 12 hours of symptom onset.

Podsumowanie produktu:

Package - Contents - Shelf Life: Combination pack, vial and diluent syringe - 1 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, TopPac, Diluent, ex-BI - 10 mL - 48 months from date of manufacture stored at or below 30°C - Vial, glass, type 1 - 20 mL - 36 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Data autoryzacji:

1999-09-29

Ulotka dla pacjenta

NEW ZEALAND CONSUMER MEDICINE INFORMATION
METALYSE
®
_TENECTEPLASE_
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about METALYSE. 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
using METALYSE against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
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
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 information with the medicine. You may need to read it
again.
WHAT METALYSE IS USED FOR
METALYSE is used during the early stages of a heart attack. METALYSE
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 METALYSE has been
prescribed for you. Your doctor may have prescribed METALYSE for
another
reason.
BEFORE BEING GIVEN METALYSE
_WHEN YOU MUST NOT BE GIVEN IT_
_ _
You must not be given METALYSE if you have or have had:
•
an allergy to any medicine containing tenecteplase; gentamicin (a
trace
residue from the manufacturing process) or to any of the ingredients
listed at the end of this leaflet
•
current bleeding or severe bleeding in the past 6 months
•
current treatment with an anticlotting agent (anticoagulant), such as
warfarin, unless its effect has had time to wear off
•
major surgery, biopsy or significant trauma in the past 2 months
•
a stroke due to bleeding in the brain or a stroke of unknown origin at
any
time
•
a stroke caused by a blood clot or a transient ischaemic attack (TIA)
in
the past 6 months
•
severe and uncontrolled high blood pressure (hypertension)
•
tum

Charakterystyka produktu

METALYSE NZ DS v02
1
NEW ZEALAND DATASHEET
1. PRODUCT NAME
METALYSE 40 mg powder and solvent for solution for injection
METALYSE 50 mg powder and solvent for solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
METALYSE 40 mg:
1 vial containing 8,000 units (40 mg) tenecteplase.1 prefilled syringe
containing 8 mL water for
injection.
(Not marketed)
METALYSE 50 mg:
1 vial contains 10,000 units (50 mg) tenecteplase.
1 prefilled syringe containing 10 mL water for injection.
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 the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White to off-white powder and solvent for solution for injection.
Reconstitution results in a colourless
to pale yellow, transparent, clear solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
METALYSE is indicated for the thrombolytic treatment of the acute
phase of myocardial infarction
(AMI). Treatment should be initiated as soon as possible after symptom
onset. Treatment can be
initiated within 12 hours of symptom onset.
4.2 DOSE AND METHOD OF ADMINISTRATION
METALYSE should be administered as early as possible after symptom
onset on the basis of body
weight, with a maximum dose of 10,000 units (50 mg tenecteplase). The
volume required to administer
the correct dose can be calculated from the following scheme:
Patients' body weight
category
(kg)
Tenecteplase
(U)
Tenecteplase
(mg)
Volume of reconstituted
solution
(mL)
< 60
6,000
30
6
≥
60 to < 70
7,000
35
7
≥
70 to < 80
8,000
40
8
≥
80 to < 90
9,000
45
9
≥
90
10,000
50
10
METALYSE NZ DS v02
2
Adjunctive Therapy
Antithrombotic adjunctive therapy is recommended according to the
current international guidelines