New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) ltd - alteplase 2mg (per vial) - powder for injection - 2 mg - active: alteplase 2mg (per vial) excipient: arginine phosphoric acid polysorbate 80 - actilyse cathflo is indicated for thrombolytic treatment of occluded central venous access devices including those used for haemodialysis. the 2 mg strength of alteplase (actilyse cathflo) is the only recommended presentation for use in this indication.

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: arginine; phosphoric acid; 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: 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.

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

genentech, inc. - alteplase (unii: 1rxs4ue564) (alteplase - unii:1rxs4ue564) - alteplase 2.2 mg in 2 ml - cathflo® activase® (alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood. cathflo activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation (see description).

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 10 mg - antithrombotic agents

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

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

Ireland - English - HPRA (Health Products Regulatory Authority)

boehringer ingelheim international gmbh - alteplase - powder and solvent for solution for injection/infusion - 2 milligram(s) - alteplase

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

boehringer ingelheim pty ltd - alteplase, quantity: 2 mg - injection, powder for - excipient ingredients: phosphoric acid; polysorbate 80; arginine; nitrogen - actilyse cathflo is indicated for the thrombolytic treatment of occluded central venous access devices including those used for haemodialysis. the 2 mg strength of alteplase (actilyse cathflo) is the only recommended presentation for use in this indication. see also precautions - use in children.