New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) ltd - alteplase 50mg - injection with diluent - 50 mg - active: alteplase 50mg excipient: arginine nitrogen phosphoric acid polysorbate 80 water for injection - actilyse is indicated for fibrinolytic therapy in acute thrombotic artery occlusion to restore coronary artery patency, reduce infarct size, preserve ventricular function, prevent cardiac insufficiency and reduce mortality · 90 minutes (accelerated) dose regimen: for patients in whom treatment can be started within 6 h of symptom onset; · 3 hour dose regimen: for patients in whom treatment can be started between 6 - 12 hrs after symptom onset.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

boehringer ingelheim scomm-commv - alteplase 50 mg - powder and solvent for solution for injection/infusion - 50 mg/50 ml - alteplase 50 mg - alteplase

Malta - English - Medicines Authority

boehringer ingelheim international gmbh binger strasse 173, 55216 ingelheim am rhein, germany - alteplase - powder and solvent for solution for infusion or injection - alteplase 50 mg - antithrombotic agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - alteplase - powder and solvent for solution for infusion - 50mg

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - alteplase - powder and solvent for solution for injection/infusion - alteplase 50 mg/vial - 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.

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة مستودع الأدوية الأردني - the jordan drugstore co - alteplase 50 mg - 50 mg

Canada - English - Health Canada

hoffmann-la roche limited - alteplase; water - liquid - 50mg; 50ml - alteplase 50mg; water 50ml - thrombolytic agents

United States - English - NLM (National Library of Medicine)

genentech, inc. - alteplase (unii: 1rxs4ue564) (alteplase - unii:1rxs4ue564) - alteplase 50 mg in 50 ml - activase is indicated for the treatment of acute ischemic stroke. exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment [see contraindications (4.1)] . initiate treatment as soon as possible but within 3 hours after symptom onset. activase is indicated for use in acute myocardial infarction (ami) for the reduction of mortality and reduction of the incidence of heart failure. limitation of use: the risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose ami puts them at low risk for death or heart failure. activase is indicated for the lysis of acute massive pulmonary embolism, defined as: - acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments. - acute pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to maintain blood pressure without supportive measures. do not administer activase to treat acute ischemic stroke in the following situations in which the risk of bleedi

Malta - English - Medicines Authority

boehringer ingelheim limited - alteplase - powder and solvent for solution for infusion or injection - alteplase 50 mg - antithrombotic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

boehringer ingelheim limited - alteplase - powder and solvent for solution for injection/infusion - 50 milligram(s) - enzymes; alteplase