الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

usv private limited - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with:  - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

usv private limited - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with:  - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

mylan institutional llc - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st- elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide is contraindicated in patients with: risk summary available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of 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) . in animal reproduc

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

slate run pharmaceuticals, llc - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies ( 14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihyperte

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

hainan shuangcheng pharmaceuticals co., ltd. - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke - current o

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

athenex pharmaceutical division, llc. - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies ( 14.1, 14.2)] . treatment with eptifibatide is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke - current or planned administration of another parenteral gp iib/iiia inhibitor - dependency on renal dialysis - hypersensitivity to eptifibatide or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria) risk summary available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of 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) . in animal reproduction studies, there was no evidence of adverse developmental effects when eptifibatide was administered intravenously to pregnant rats and rabbits at approximately 4 times the recommended maximum daily human dose. 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 in pregnancy which can be fatal to the pregnant woman and fetus if left untreated. therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of eptifibatide on the fetus. data animal data embryo-fetal development studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats during the period of organogenesis at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits during the period of organogenesis at total daily doses of up to 36 mg/kg/day (also about 4 times the recommended maximum daily human dose on a body surface area basis). these studies revealed no evidence of harm to the fetus due to eptifibatide. risk summary there are no available data on the presence of eptifibatide in human milk, the effects on the breastfed infant, or the effects on milk production. as eptifibatide is a peptide, it is likely to be destroyed in the infant's gastrointestinal tract and not absorbed orally by the breastfed infant. safety and effectiveness of eptifibatide in pediatric patients have not been studied. the pursuit and impact ii clinical studies enrolled patients up to the age of 94 years (45% were age 65 and over; 12% were age 75 and older). there was no apparent difference in efficacy between older and younger patients treated with eptifibatide. the incidence of bleeding complications was higher in the elderly in both placebo and eptifibatide groups, and the incremental risk of eptifibatide-associated bleeding was greater in the older patients. no dose adjustment was made for elderly patients, but patients over 75 years of age had to weigh at least 50 kg to be enrolled in the pursuit study; no such limitation was stipulated in the esprit study [see adverse reactions ( 6.1)] . approximately 50% of eptifibatide is cleared by the kidney in patients with normal renal function. total drug clearance is decreased by approximately 50% and steady-state plasma eptifibatide concentrations are doubled in patients with an estimated crcl <50 ml/min (using the cockcroft-gault equation). therefore, the infusion dose should be reduced to 1 mcg/kg/min in such patients [see dosage and administration ( 2)] . the safety and efficacy of eptifibatide in patients dependent on dialysis has not been established.

الولايات المتحدة - الإنجليزية - 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.

مالطا - الإنجليزية - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - ibandronic acid - film-coated tablet - ibandronic acid 150 mg - drugs for treatment of bone diseases

كندا - الإنجليزية - Health Canada

teva canada limited - eptifibatide - solution - 2mg - eptifibatide 2mg - platelet aggregation inhibitors

كندا - الإنجليزية - Health Canada

teva canada limited - eptifibatide - solution - 0.75mg - eptifibatide 0.75mg - platelet aggregation inhibitors