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

genentech, inc. - tenecteplase (unii: wgd229o42w) (tenecteplase - unii:wgd229o42w) - tenecteplase 52.5 mg in 50 mg - tnkase® is indicated for use in the reduction of mortality associated with acute myocardial infarction (ami). treatment should be initiated as soon as possible after the onset of ami symptoms [see clinical studies (14.1)] . tnkase therapy in patients with acute myocardial infarction is contraindicated in the following situations because of an increased risk of bleeding [see warnings and precautions (5.1)] : - active internal bleeding - history of cerebrovascular accident - intracranial or intraspinal surgery or trauma within 2 months - intracranial neoplasm, arteriovenous malformation, or aneurysm - known bleeding diathesis - severe uncontrolled hypertension risk summary tnkase has been shown to elicit maternal and embryo toxicity in rabbits given multiple iv administrations. in rabbits administered 0.5, 1.5, and 5.0 mg/kg/day during organogenesis, vaginal hemorrhage resulted in maternal deaths. subsequent embryonic deaths were secondary to maternal hemorrhage and no fetal anomalies were observed. tnkase

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

boehringer ingelheim pty ltd - tenecteplase, quantity: 50 mg - injection, powder for - excipient ingredients: arginine; phosphoric acid; polysorbate 20 - metalyse is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (ami). treatment should be initiated as soon as possible after the onset of symptoms. treatment can be initiated within 12 hours of symptom onset.

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

boehringer ingelheim pty ltd - tenecteplase, quantity: 40 mg - injection, powder for - excipient ingredients: polysorbate 20; arginine; phosphoric acid - metalyse is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (ami). treatment should be initiated as soon as possible after the onset of symptoms. treatment can be initiated within 12 hours of symptom onset.

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

genentech, inc. - tenecteplase (unii: wgd229o42w) (tenecteplase - unii:wgd229o42w) - tnkase® is indicated to reduce the risk of death associated with acute st elevation myocardial infarction (stemi). tnkase is contraindicated in patients with [see warnings and precautions (5.1)] : - active internal bleeding - history of cerebrovascular accident - intracranial or intraspinal surgery or trauma within 2 months - intracranial neoplasm, arteriovenous malformation, or aneurysm - known bleeding diathesis - severe uncontrolled hypertension risk summary there are risks to the mother and fetus from acute st elevation myocardial infarction, which is a medical emergency in pregnancy and can be fatal if left untreated (see clinical considerations). published data consisting of a small number of case reports involving the use of related thrombolytic agents in pregnant women have not identified an increased risk of major birth defects. there are no data on the use of tenecteplase during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outco

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

genentech, inc. - tenecteplase (unii: wgd229o42w) (tenecteplase - unii:wgd229o42w) - tnkase® is indicated to reduce the risk of death associated with acute st elevation myocardial infarction (stemi). tnkase is contraindicated in patients with [see warnings and precautions (5.1)] : - active internal bleeding - history of cerebrovascular accident - intracranial or intraspinal surgery or trauma within 2 months - intracranial neoplasm, arteriovenous malformation, or aneurysm - known bleeding diathesis - severe uncontrolled hypertension risk summary there are risks to the mother and fetus from acute st elevation myocardial infarction, which is a medical emergency in pregnancy and can be fatal if left untreated (see clinical considerations). published data consisting of a small number of case reports involving the use of related thrombolytic agents in pregnant women have not identified an increased risk of major birth defects. there are no data on the use of tenecteplase during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. tnkase does not elicit maternal and direct embryo toxicity in rabbits following a single iv administration. in developmental toxicity studies conducted in rabbits, the no observable effect level (noel) of a single iv administration of tnkase on maternal or developmental toxicity (5 mg/kg) was approximately 7 times human exposure (based on auc) at the dose for stemi. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk myocardial infarction is a medical emergency which can be fatal if left untreated. life-sustaining therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of tenecteplase on the fetus. risk summary there are no data on the presence of tenecteplase in either human or animal milk, the effects on the breastfed infant, or the effect on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tnkase and any potential adverse effects on the breastfed infant from the tnkase or from the underlying maternal condition. the safety and effectiveness of tnkase in pediatric patients have not been established. in the assent-2 study, 41% (3500/8458) of patients who were treated with tnkase were aged 65 years or older. in this population, rates of 30-day mortality, stroke, intracranial hemorrhage and major bleeds requiring blood transfusion or leading to hemodynamic complications were higher than in those aged less than 65 years.

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - tenecteplase 30mg (recombinant) - powder for injection - 30 mg - active: tenecteplase 30mg (recombinant) excipient: arginine phosphoric acid polysorbate 20 water for injection - metalyse is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (ami). treatment should be initiated as soon as possible after symptom onset. treatment can be initiated within 12 hours of symptom onset.

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - tenecteplase 40mg (recombinant) - powder for injection - 40 mg - active: tenecteplase 40mg (recombinant) excipient: arginine phosphoric acid polysorbate 20 water for injection - metalyse is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (ami). treatment should be initiated as soon as possible after symptom onset. treatment can be initiated within 12 hours of symptom onset.

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - tenecteplase 50mg (recombinant) - powder for injection - 50 mg - active: tenecteplase 50mg (recombinant) excipient: arginine phosphoric acid polysorbate 20 water for injection - metalyse is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (ami). treatment should be initiated as soon as possible after symptom onset. treatment can be initiated within 12 hours of symptom onset.

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - tenecteplase - myocardial infarction - antithrombotic agents - metalyse is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent st elevation or recent left-bundle-branch block within six hours after the onset of acute-myocardial-infarction symptoms.,

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

boehringer ingelheim ltd - tenecteplase - powder and solvent for solution for injection - 10000unit