Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - dabigatran etexilate as mesilate - capsules - dabigatran etexilate as mesilate 150 mg - dabigatran etexilate - prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults.

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - dabigatran etexilate as mesilate - capsules - dabigatran etexilate as mesilate 150 mg - dabigatran etexilate - prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults.

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - dabigatran etexilate as mesilate - capsules - dabigatran etexilate as mesilate 75 mg - dabigatran etexilate - primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - dabigatran etexilate as mesilate - capsules - dabigatran etexilate as mesilate 75 mg - dabigatran etexilate - primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

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

sandoz pty ltd - dabigatran etexilate mesilate, quantity: 126.83 mg (equivalent: dabigatran etexilate, qty 110 mg) - capsule - excipient ingredients: hyprolose; tartaric acid; hypromellose; purified talc; croscarmellose sodium; magnesium stearate; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see section 4.2 dose and method of administration for details of treatment duration).,prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and for the prevention of recurrent dvt and pe in adults.

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

sandoz pty ltd - dabigatran etexilate mesilate, quantity: 172.95 mg (equivalent: dabigatran etexilate, qty 150 mg) - capsule - excipient ingredients: hyprolose; tartaric acid; hypromellose; purified talc; croscarmellose sodium; magnesium stearate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide - prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see section 4.2 dose and method of administration for details of treatment duration).,prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and for the prevention of recurrent dvt and pe in adults.

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

sandoz pty ltd - dabigatran etexilate mesilate, quantity: 86.475 mg (equivalent: dabigatran etexilate, qty 75 mg) - capsule - excipient ingredients: hyprolose; tartaric acid; hypromellose; purified talc; croscarmellose sodium; magnesium stearate; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see section 4.2 dose and method of administration for details of treatment duration).,prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and for the prevention of recurrent dvt and pe in adults.

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

a-s medication solutions - dabigatran etexilate mesylate (unii: sc7nuw5iit) (dabigatran - unii:i0vm4m70gc) - 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. - dabigatran etexilate mesylate (unii: sc7nuw5iit) (dabigatran - unii:i0vm4m70gc) - pradaxa oral pellets are indicated for the treatment of venous thromboembolic events (vte) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days. pradaxa oral pellets are indicated to reduce the risk of recurrence of vte in pediatric patients aged 3 months to less than 12 years of age who have been previously treated. 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 moth

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - dabigatran etexilate mesilate 86,475 mg - eq. dabigatran etexilate 75 mg - capsule, hard - dabigatran etexilate