Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
ALTEPLASE
BOEHRINGER INGELHEIM ISRAEL LTD.
B01AD
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
ALTEPLASE 50 MG/VIAL
I.V
Required
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY
ENZYMES
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.
2015-02-28
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 Прочитайте повний документ
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 Прочитайте повний документ