ACTILYSE 50 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

ALTEPLASE

Commercializzato da:

BOEHRINGER INGELHEIM ISRAEL LTD.

Codice ATC:

B01AD

Forma farmaceutica:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

Composizione:

ALTEPLASE 50 MG/VIAL

Via di somministrazione:

I.V

Tipo di ricetta:

Required

Prodotto da:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY

Gruppo terapeutico:

ENZYMES

Indicazioni terapeutiche:

Acute myocardial infarction :Actilyse is indicated for use in the management of acute myocardial infraction (AMI) in adults for the lysis of thrombi obstructing coronary arteries, the reduction of infract size, improvement of ventricular function, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI. Treatment should be initiated as soon as possible after the onset of AMI symptoms.Acute massive pulmonary embolism with hemodynamic deprivation:Actylise is indicated in the management of acute massive pulmonary embolism (PE) in adults:- for the lysis of acute pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments of the lung, and- for the lysis of pulmonary emboli accompanied by unstable hemodynamics e.g. failure to maintain blood pressure without supportive measures. The diagnosis should be confirmed by objective means, such as pulmonary angiography or noninvasive procedures such as lung scanning. For 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 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. This treatment is restricted to a prescription by a specialist in neurology.

Data dell'autorizzazione:

2015-02-28

Foglio illustrativo

ילוי
2019
,ה/רקי ה/אפור
ה/רקי ת/חקור
,
וכדע :ןודנה
ן
ולע
ן רישכתה לש
MG
50
MG AND ACTILYSE
20
ACTILYSE
(ALTEPLASE)
תרבח
םייהלגניא רגנירוב
םכעידוהל תשקבמ מ"עב לארשי
וכדע לע
ן
ןולעב
ל
אפור
לש
.ןודנב רישכתה
ה
יוותה
ה
מושרה
ה
לארשיב רישכתל
:
_Acute Myocardial Infarction _
In adults for the lysis of thrombi obstructing coronary arteries, the
reduction of infarct size, the
improvement of ventricular function, the reduction of the incidence of
congestive heart failure and
the reduction of mortality associated with AMI.
Treatment should be initiated as soon as possible after the onset of
AMI symptoms.
_Acute Massive Pulmonary embolism with hemodynamic deprivation. _
Actilyse is indicated in the management of acute massive pulmonary
embolism (PE) in adults:
- for the lysis of acute pulmonary emboli, defined as obstruction of
blood flow to a lobe or multiple
segments of the lung,
and
- for the lysis of pulmonary emboli accompanied by unstable
hemodynamics e.g. failure to maintain
blood pressure without supportive measures.
The diagnosis should be confirmed by objective means, such as
pulmonary angiography or
noninvasive procedures such as lung scanning.
_For 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 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.
This treatment is restricted to a prescription by a specialist in
neurology.
ולעב רתויב םייתועמשמה םייונישה
ן
.הטמ ונמוס
ולעה
ן
כדועמה
ן
לשנ
ח
תואירבה דרשמ רתאבש תופורתה רגאמב
םוסרפל
.
,ןכ

Scheda tecnica

Actilyse
Updated Prescribing Information
20 mg, 50 mg
Feb 2023
1. NAME OF THE MEDICINAL PRODUCT
Actilyse 20 mg. Actilyse 50 mg
Powder and solvent for solution for injection and infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial with powder contains:
20 mg alteplase (corresponding to 11,600,000 IU) or
50 mg alteplase (corresponding to 29,000,000 IU).
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
Acute Myocardial Infarction
In adults for the lysis of thrombi obstructing coronary arteries,
the reduction of infarct size, the
improvement of ventricular function, the reduction of the incidence of
congestive heart failure and the
reduction of mortality associated with AMI.
Treatment should be initiated as soon as possible after the onset of
AMI symptoms.
Acute Massive Pulmonary embolism with hemodynamic deprivation.
Actilyse is indicated in the management of acute massive pulmonary
embolism (PE) in adults:
- for the lysis of acute pulmonary emboli, defined as obstruction of
blood flow to a lobe or multiple
segments of the lung,
and
- for the lysis of pulmonary emboli accompanied by unstable
hemodynamics e.g. failure to maintain
blood pressure without supportive measures.
The diagnosis should be confirmed by objective means, such as
pulmonary angiography or
noninvasive procedures such as lung scanning.
For fibrinolytic treatment of acute ischaemic stroke
Treatment must be started