European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - duloxetine - diabetic neuropathies - psychoanaleptics, - treatment of diabetic peripheral neuropathic pain in adults.

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use jentadueto xr is not recommended in patients with type 1 diabetes mellitus. jentadueto xr has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using jentadueto xr [see warnings and precautions (5.2)]. jentadueto xr is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)]. - acute or chronic metabolic acidosis, including diabetic ketoacidosis [see warnings and precautions (5.1)]. - hypersensitivity to linagliptin, metformin, or any of the excipients in jentadueto xr, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see warnings and precautions (5.4) and adve

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

boehringer ingelheim pharmaceuticals inc. - dabigatran etexilate mesylate (unii: sc7nuw5iit) (dabigatran - unii:i0vm4m70gc) - dabigatran etexilate 75 mg - pradaxa capsules is indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. pradaxa capsules is indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5-10 days. pradaxa capsules is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. pradaxa capsules is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery. pradaxa capsules is indicated for the treatment of venous thromboembolic events (vte) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days [see dosage and administration (2.3)] . pradaxa capsules is indicated to reduce the risk of recurrence of vte in pediatric patients 8 to less than 18 years of age who have been previously treated [see dosage and administration (2.3)] . pradaxa is contraindicated in patients with: - active pathological bleeding [see warnings and precautions (5.2) and adverse reactions (6.1)] - history of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see adverse reactions (6.1)] - mechanical prosthetic heart valve [see warnings and precautions (5.4)] risk summary the limited available data on pradaxa use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. there are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulants (see clinical considerations) . in pregnant rats treated from implantation until weaning, dabigatran increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition at an exposure 2.6 times the human exposure. at a similar exposure, dabigatran decreased the number of implantations when rats were treated prior to mating and up to implantation (gestation day 6). dabigatran administered to pregnant rats and rabbits during organogenesis up to exposures 8 and 13 times the human exposure, respectively, did not induce major malformations. however, the incidence of delayed or irregular ossification of fetal skull bones and vertebrae was increased in the rat (see data) . 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 pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. fetal/neonatal adverse reaction use of anticoagulants, including pradaxa, may increase the risk of bleeding in the fetus and neonate. monitor neonates for bleeding [see warnings and precautions (5.2)]. labor or delivery all patients receiving anticoagulants, including pregnant women, are at risk for bleeding. pradaxa use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. consider discontinuation or use of shorter acting anticoagulant as delivery approaches [see warnings and precautions (5.2, 5.3)] . data animal data dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3.0 times the human exposure at mrhd of 300 mg/day based on area under the curve [auc] comparisons) prior to mating and up to implantation (gestation day 6). treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition. dabigatran administered to pregnant rats and rabbits during organogenesis up to maternally toxic doses of 200 mg/kg (8 and 13 times the human exposure, respectively, at a mrhd of 300 mg/day based on auc comparisons) did not induce major malformations, but increased the incidence of delayed or irregular ossification of fetal skull bones and vertebrae in the rat. death of offspring and mother rats during labor in association with uterine bleeding occurred during treatment of pregnant rats from implantation (gestation day 7) to weaning (lactation day 21) with dabigatran at a dose of 70 mg/kg (about 2.6 times the human exposure at mrhd of 300 mg/day based on auc comparisons). risk summary there are no data on the presence of dabigatran in human milk, the effects on the breastfed child, or on milk production. dabigatran and/or its metabolites were present in rat milk. breastfeeding is not recommended during treatment with pradaxa. females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including pradaxa should be assessed in females of reproductive potential and those with abnormal uterine bleeding. the safety and effectiveness of pradaxa capsules for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients 8 to less than 18 years of age. use of pradaxa for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients. these studies included an open-label, randomized, parallel-group study and an open-label, single-arm safety study [see adverse reactions (6.1) and clinical studies (14.4, 14.5)] . other age-appropriate pediatric dosage forms of dabigatran etexilate are available for pediatric patients less than 8 years of age for these indications. safety and effectiveness of pradaxa capsules have not been established in pediatric patients with non-valvular atrial fibrillation or those who have undergone hip replacement surgery. of the total number of patients in the re-ly study, 82% were 65 and over, while 40% were 75 and over. the risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups [see warnings and precautions (5), adverse reactions (6.1), and clinical studies (14.1)] . reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients no dose adjustment of pradaxa is recommended in patients with mild or moderate renal impairment [see clinical pharmacology (12.3)] . reduce the dose of pradaxa in patients with severe renal impairment (crcl 15-30 ml/min) [see dosage and administration (2.2, 2.4) and clinical pharmacology (12.3)] . dosing recommendations for patients with crcl < 15 ml/min or on dialysis cannot be provided. adjust dose appropriately in patients with renal impairment receiving concomitant p-gp inhibitors [see warnings and precautions (5.5), drug interactions (7.1), and clinical pharmacology (12.3)]. treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients patients with severe renal impairment (crcl ≤ 30 ml/min) were excluded from re-cover. dosing recommendations for patients with crcl ≤ 30 ml/min or on dialysis cannot be provided. avoid use of pradaxa with concomitant p-gp inhibitors in patients with crcl < 50 ml/min [see warnings and precautions (5.5), drug interactions (7.2), and clinical pharmacology (12.3)]. prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients following hip replacement surgery patients with severe renal impairment (crcl < 30 ml/min) were excluded from re-novate and re-novate ii. dosing recommendations for patients with crcl < 30 ml/min or on dialysis cannot be provided. avoid use of pradaxa with concomitant p-gp inhibitors in patients with crcl < 50 ml/min [see warnings and precautions (5.5), drug interactions (7.3), and clinical pharmacology (12.2, 12.3)]. treatment and reduction in the risk of recurrence of vte in pediatric patients pradaxa has not been studied in pediatric patients with egfr < 50 ml/min/1.73 m2 . reduced renal function could increase exposure. dosing recommendations cannot be provided for treatment of these patients. avoid use of pradaxa capsules in these patients [see dosage and administration (2.4)].

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

boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u) - empagliflozin 10 mg - jardiance is indicated: - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. - to reduce the risk of sustained decline in egfr, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. - to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. - as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. limitations of use jardiance is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.1)] . jardiance is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an egfr less than 30 ml/min/1.73 m2 . jardiance is likely to be ineffective in t

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

boehringer ingelheim pharmaceuticals, inc. - empagliflozin (unii: hdc1r2m35u) (empagliflozin - unii:hdc1r2m35u), linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - empagliflozin 10 mg - glyxambi is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see clinical studies (14.2)] . limitations of use glyxambi is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.1)] . glyxambi has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using glyxambi [see warnings and precautions (5.2)]. glyxambi is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an egfr less than 30 ml/min/1.73 m2 . glyxambi is likely to be ineffecti

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use jentadueto is not recommended in patients with type 1 diabetes mellitus. jentadueto has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using jentadueto [see warnings and precautions (5.2)]. jentadueto is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)]. - acute or chronic metabolic acidosis, including diabetic ketoacidosis [see warnings and precautions (5.1)]. - hypersensitivity to linagliptin, metformin, or any of the excipients in jentadueto, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see warnings and precautions (5.4) and adverse reactions (6.1

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - linagliptin 5 mg - tradjenta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use tradjenta is not recommended in patients with type 1 diabetes mellitus as it would not be effective. tradjenta has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using tradjenta [see warnings and precautions (5.1)]. tradjenta is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in tradjenta, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see warnings and precautions (5.3) and adverse reactions (6)]. risk summary the limited data with tradjenta use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated

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

boehringer ingelheim pharmaceuticals, inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 400 mg - viramune xr is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (bsa) of 1.17 m2 or greater [see clinical studies (14.1, 14.2)] . limitations of use: - adult females with cd4+ cell counts greater than 250 cells/mm3 or - adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)]. viramune xr is contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)] . - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. healthcare providers are encouraged to register pat

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

boehringer ingelheim animal health usa inc. - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 40 [iu] in 1 ml - prozinc is contraindicated in cats sensitive to protamine zinc recombinant human insulin or any other ingredients in prozinc. prozinc is contraindicated during episodes of hypoglycemia. prozinc is contraindicated in dogs sensitive to protamine zinc recombinant human insulin or any other ingredients in prozinc. prozinc is contraindicated during episodes of hypoglycemia.

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

boehringer ingelheim pharmaceuticals, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - mobic is indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1) ]. mobic is indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies (14.1) ]. mobic is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [see dosage and administration (2.4) and clinical studies (14.2) ]. mobic is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] risk summa