ACTILYSE SERBUK INJEKSI 50 MG/VIAL

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

ALTEPLASE

제공처:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (국제 이름):

ALTEPLASE

복용량:

50 MG/VIAL

약제 형태:

SERBUK INJEKSI

패키지 단위:

DUS, 2 DUS @ 1 VIAL @ 2333 MG + 1 VIAL PELARUT @ 50 ML

Manufactured by:

BOEHRINGER INGELHEIM - West Germany

승인 날짜:

2015-09-22

제품 특성 요약

Actilyse®
Alteplase
Powder and solvent for solution for injection
Composition
ACTILYSE:
1 vial contains:
50 mg alteplase
1 vial of solvent contains:
50 mL sterilised water for injections
excipients:
l-arginine, phosphoric acid, polysorbate 80
Trace residue : gentamicin from manufacturing process
The reconstituted solution contains 1 mg alteplase per mL.
Traceability
In order to improve traceability of biological medicinal products, the
trade name and the batch
number of the administered product should be clearly recorded in the
patient file.
Indications
Thrombolytic treatment in acute myocardial infarction
90 minutes (accelerated) dose regimen (see section DOSAGE AND
ADMINISTRATION):
for patients in whom treatment can be started within 6 hours of
symptom onset;
3 hour dose regimen (see section DOSAGE AND ADMINISTRATION): for
patients in whom
treatment can be started between 6 - 12 hours after symptom onset.
ACTILYSE has proven to reduce 30-day-mortality in patients with acute
myocardial infarction.
Thrombolytic treatment in acute massive pulmonary embolism with
haemodynamic instability
The diagnosis should be confirmed whenever possible by objective means
such as pulmonary
angiography
or
non-invasive
procedures
such
as
lung
scanning.
There are no clinical trials on mortality and late morbidity related
to pulmonary embolism.
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.
Dosage and administration
Dosage
ACTILYSE should be given as early as possible after symptom onset.
Acute myocardial infarction
a)
90 minutes (accelerated) dose regimen
For patients with Acute myocardial infarction, in whom treatment can
b