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

juno pharmaceuticals pty ltd - tirofiban hydrochloride, quantity: 14.05 mg (equivalent: tirofiban, qty 12.5 mg) - injection, concentrated - excipient ingredients: mannitol; sodium hydroxide; hydrochloric acid; dibasic sodium phosphate dihydrate; water for injections - tirofiban juno, in combination with heparin, is indicated for patients with unstable angina or non-q-wave myocardial infarction to prevent cardiac ischaemic events. (see pharmacology and dosage and administration.)

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

gland pharma limited - tirofiban hydrochloride (unii: 6h925f8o5j) (tirofiban - unii:ggx234si5h) - tirofiban hydrochloride injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-st elevation acute coronary syndrome (nste-acs). tirofiban hydrochloride injection is contraindicated in patients with: - severe hypersensitivity reaction to tirofiban hydrochloride injection (i.e.,anaphylactic reactions) [see adverse reactions (6.2)]. - a history of thrombocytopenia following prior exposure to tirofiban hydrochloride injection [see adverse reactions (6.1)]. - active internal bleeding or a history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month [see adverse reactions (6.1)]. risk summary while published data cannot definitively establish the absence of risk, available published case reports have not established an association with tirofiban use during pregnancy and major birth defects, miscarriage, or adverse maternal or

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

nexus pharmaceuticals llc - tirofiban hydrochloride (unii: 6h925f8o5j) (tirofiban - unii:ggx234si5h) - tirofiban hydrochloride injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-st elevation acute coronary syndrome (nste-acs). tirofiban hydrochloride injection is contraindicated in patients with: - severe hypersensitivity reaction to tirofiban hydrochloride injection (i.e., anaphylactic reactions) [see adverse reactions (6.2)] . - a history of thrombocytopenia following prior exposure to tirofiban hydrochloride injection [see adverse reactions (6.1)] . - active internal bleeding or a history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month [see adverse reactions (6.1)] . risk summary while published data cannot definitively establish the absence of risk, available published case reports have not established an association with tirofiban use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. untreated myocardial infarction can be fatal to the pregnant woman and fetus (see clinical considerations). studies with tirofiban hcl at intravenous doses up to 5 mg/kg/day (about 5 and 13 times the maximum recommended daily human dose for rat and rabbit, respectively, when compared on a body surface area basis) have revealed no harm to the fetus. 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 2–4% and 15–20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk myocardial infarction is a medical emergency in pregnancy which can be fatal to the pregnant woman and fetus if left untreated. data animal data there was no evidence of maternal or developmental toxicity in any of the studies in table 5. *5 mg/kg/day is ~5 and 13 times the maximum recommended daily human dose for rat and rabbit, respectively, when compared on a body surface area basis. risk summary there is no data on the presence of tirofiban in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on human milk production. however, tirofiban is present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tirofiban hydrochloride injection and any potential adverse effects on the breastfed child from tirofiban hydrochloride injection or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the total number of patients in controlled clinical studies of tirofiban hydrochloride injection, 43% were 65 years and over, while 12% were 75 years and over. with respect to efficacy, the effect of tirofiban hydrochloride injection in the elderly (≥ 65 years) appeared similar to that seen in younger patients (< 65 years). elderly patients receiving tirofiban hydrochloride injection with heparin or heparin alone had a higher incidence of bleeding complications than did younger patients, but the incremental risk of bleeding in patients treated with tirofiban hydrochloride injection in combination with heparin compared to the risk in patients treated with heparin alone was similar regardless of age. no dose adjustment is recommended for the elderly population [see dosage and administration (2)] . patients with moderate to severe renal insufficiency have decreased plasma clearance of tirofiban hydrochloride. reduce the dosage of tirofiban hydrochloride injection in patients with severe renal insufficiency [see dosage and administration (2.3) and clinical pharmacology (12.3)] . safety and efficacy of tirofiban hydrochloride injection has not been established in patients on hemodialysis.

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

eugia us llc - tirofiban hydrochloride (unii: 6h925f8o5j) (tirofiban - unii:ggx234si5h) - tirofiban hydrochloride injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-st elevation acute coronary syndrome (nste-acs). tirofiban hydrochloride injection is contraindicated in patients with: - severe hypersensitivity reaction to tirofiban hydrochloride (i.e., anaphylactic reactions) [see adverse reactions (6.2)] . - a history of thrombocytopenia following prior exposure to tirofiban hydrochloride [see adverse reactions (6.1)] . - active internal bleeding or a history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month [see adverse reactions (6.1)]. risk summary while published data cannot definitively establish the absence of risk, available published case reports have not established an association with tirofiban use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Malta - English - Medicines Authority

ibigen s.r.l via fossignano, 2, 04011 aprilia (lt), italy - tirofiban - solution for infusion - tirofiban 50 µg/ml - antithrombotic agents

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

aspire pharma ltd - tirofiban - infusion - 50microgram/1ml

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

bowmed ibisqus ltd - tirofiban - infusion - 50microgram/1ml

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

medicure international inc - tirofiban hydrochloride (unii: 6h925f8o5j) (tirofiban - unii:ggx234si5h) - tirofiban 5 mg in 100 ml - aggrastat® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-st elevation acute coronary syndrome (nste-acs). aggrastat is contraindicated in patients with: - severe hypersensitivity reaction to aggrastat (i.e., anaphylactic reactions) [see adverse reactions (6.2)] . - a history of thrombocytopenia following prior exposure to aggrastat [see adverse reactions (6.1)] . - active internal bleeding or a history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month [see adverse reactions (6.1) ]. risk summary while published data cannot definitively establish the absence of risk, available published case reports have not established an association with tirofiban use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. untreated myocardial infarction can be fatal to the pregnant woman and f

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

amdipharm limited - tirofiban hydrochloride (unii: 6h925f8o5j) (tirofiban - unii:ggx234si5h) -

Canada - English - Health Canada

correvio (uk) ltd - tirofiban (tirofiban hydrochloride) - liquid - 0.25mg - tirofiban (tirofiban hydrochloride) 0.25mg - platelet aggregation inhibitors