Страна: Индонезия
Език: индонезийски
Източник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ALTEPLASE
BOEHRINGER INGELHEIM INDONESIA - Indonesia
ALTEPLASE
50 MG/VIAL
SERBUK INJEKSI
DUS, 1 VIAL @ 50 MG + 1 VIAL PELARUT @ 50 ML
2015-09-22
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 Прочетете целия документ