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

boehringer ingelheim scomm-commv - alteplase 20 mg - powder and solvent for solution for injection/infusion - 20 mg/20 ml - alteplase 20 mg - alteplase

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) ltd - alteplase 20mg - injection with diluent - 20 mg - active: alteplase 20mg 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.

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 20 mg - antithrombotic agents

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - alteplase - powder and solvent for solution for injection/infusion - alteplase 20 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.

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

boehringer ingelheim ltd - alteplase - powder and solvent for solution for injection - 20mg

Ireland - English - HPRA (Health Products Regulatory Authority)

boehringer ingelheim limited - alteplase - powder and solvent for solution for injection/infusion - 20 milligram(s) - enzymes; alteplase

Ireland - English - HPRA (Health Products Regulatory Authority)

boehringer ingelheim international gmbh - alteplase - powder and solvent for solution for injection/infusion - 20 milligram(s) - enzymes; alteplase

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - alteplase, quantity: 20 mg - injection, powder for - excipient ingredients: phosphoric acid; arginine; polysorbate 80; nitrogen - myocardial infarction: actilyse is indicated for intravenous use in adults for the lysis of suspected occlusive coronary artery thrombi associated with evolving transmural myocardial infarction. treatment should be initiated as soon as possible after the onset of symptoms. the treatment can be initiated within 12 hours of symptom onset.,pulmonary embolism:actilyse is also indicated in patients with acute massive pulmonary embolism in whom thrombolytic therapy is considered appropriate.,acute ischaemic stroke:actilyse is indicated for 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - alteplase, quantity: 50 mg - injection, powder for - excipient ingredients: phosphoric acid; arginine; polysorbate 80; nitrogen - myocardial infarction: actilyse is indicated for intravenous use in adults for the lysis of suspected occlusive coronary artery thrombi associated with evolving transmural myocardial infarction. treatment should be initiated as soon as possible after the onset of symptoms. the treatment can be initiated within 12 hours of symptom onset. pulmonary embolism: actilyse is also indicated in patients with acute massive pulmonary embolism in whom thrombolytic therapy is considered appropriate. acute ischaemic stroke; actilyse is indicated for 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - alteplase, quantity: 10 mg - injection, powder for - excipient ingredients: - myocardial infarction: actilyse is indicated for intravenous use in adults for the lysis of suspected occlusive coronary artery thrombi associated with evolving transmural myocardial infarction. treatment should be initiated as soon as possible after the onset of symptoms. the treatment can be initiated within 12 hours of symptom onset. pulmonary embolism: actilyse is also indicated in patients with acute massive pulmonary embolism in whom thrombolytic therapy is considered appropriate. acute ischaemic stroke; actilyse is indicated for 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.