Actilyse powder lyophilized for solution for infusion with solvent

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

alteplase

可用日期:

Boehringer Ingelheim Pharma GmbH & Co. KG

ATC代码:

B01AD02

INN（国际名称）:

alteplase

剂量:

50mg

药物剂型:

powder lyophilized for solution for infusion with solvent

每包单位数:

glass vial and glass vial with solvent 50ml

处方类型:

Prescription

授权状态:

Registered

授权日期:

2018-03-26

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产品特点

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Actilyse
Lyophilizate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial with powder contains:
50 mg alteplase (corresponding to 29,000,000 IU), respectively
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.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection and infusion.
The powder is presented as a colourless to pale yellow lyophilizate
cake. The reconstituted preparation is a
clear and colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thrombolytic treatment in acute myocardial infarction
•
90 minutes (accelerated) dose regimen (see section 4.2): for patients
in whom treatment can be started
within 6 hours after symptom onset
•
3 hour dose regimen (see section 4.2): for patients in whom treatment
can be started between 6 - 12
hours after symptom onset provided that the diagnosis has been clearly
confirmed.
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 is no evidence
for positive effects on mortality and
late morbidity related to pulmonary embolism.
Fibrinolytic 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 diagnosti