Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - olodaterol as hydrochloride; tiotropium bromide as monohydrate - solution for inhalation - olodaterol as hydrochloride 2.5 mcg; tiotropium bromide as monohydrate 2.5 mcg - vilanterol and umeclidinium bromide - spiolto respimat is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Ireland - English - HPRA (Health Products Regulatory Authority)

boehringer ingelheim international gmbh - tiotropium; olodaterol - inhalation solution - 2.5 µg/2.5 microgram(s) - anticholinergics; anticholinergics - drugs for obstructive airway diseases, adrenergics in combination with anticholinergics - it is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

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)].

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - pramipexole dihydrochloride monohydrate - restless legs syndrome; parkinson disease - anti-parkinson drugs - mirapexin is indicated for treatment of the signs and symptoms of idiopathic parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).mirapexin is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - pramipexole dihydrochloride monohydrate - restless legs syndrome; parkinson disease - anti-parkinson drugs - sifrol is indicated for treatment of the signs and symptoms of idiopathic parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, though to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).sifrol is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - maximum three of the following purified, inactivated foot-and-mouth disease virus strains: o1 manisa ≥ 6 pd50*; o1 bfs ≥ 6 pd50*; o taiwan 3/97 ≥ 6 pd50*; a22 iraq ≥ 6 pd50*; a24 cruzeiro ≥ 6 pd50*; a turkey 14/98 ≥ 6 pd50*; asia 1 shamir ≥ 6 pd50*; sat2 saudi arabia ≥ 6 pd50*; * pd50 – 50% protective dose in cattle as described in ph. eur. monograph 0063. - immunologicals - pigs; cattle; sheep - active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - eprinomectin, fipronil, praziquantel, (s)-methoprene - antiparasitic products, insecticides and repellents, avermectins, eprinomectin, combinations, - cats - for cats with, or at risk from mixed infestations by cestodes, nematodes and ectoparasites. the veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time.ectoparasitestreatment and prevention of infestations by fleas (ctenocephalides felis). elimination of fleas within 24 hours. one treatment prevents further infestations for at least one month.prevention of environmental flea contamination by inhibiting the development of flea immature stages (eggs, larvae and pupae) for over a month.the product can be used as part of a treatment strategy for the control of flea allergy dermatitis (fad).treatment and prevention of infestations by ticks (ixodes ricinus). elimination of ticks within 48 hours. one treatment prevents further infestations for up to 3 weeks.treatment of notoedric mange (notoedres cati).cestodestreatment of infestations with tapeworms (dipylidium caninum, taenia taeniaeformis, echinococcus multilocularis, joyeuxiella pasqualei (adult), and joyeuxiella fuhrmanni (adult)).nematodestreatment of infestations with gastrointestinal nematodes (l3, l4 larvae and adults of toxocara cati, adults of toxascaris leonina, l4 larvae and adults of ancylostoma tubaeforme and ancylostoma ceylanicum, and adults of ancylostoma brazilienze).treatment of infestations with feline lungworms (l3 larvae, l4 larvae and adults of aelurostrongylus abstrusus, l4 larvae and adults of troglostrongylus brevior).treatment of infestations with vesical worms (capillaria plica).prevention of heartworm disease (dirofilaria immitis larvae) for one month.

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - bluetongue-virus serotype-1 antigen, bluetongue virus serotype 8 antigen - immunologicals - sheep; cattle - sheepactive immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/ or 8 (combination of maximum 2 serotypes), active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1,2, 4 and/ or 8 (combination of maximum 2 serotypes), active immunisation of sheep to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).cattleactive immunisation of cattle to prevent viraemia caused by bluetongue virus serotype 1, 2, 4 and/ or 8, and to reduce clinical signs caused by bluetongue virus serotypes when observed in this species: serotype 1, 4 and / or 8 (combination of maximum 2 serotypes).active immunisation of cattle to prevent viraemia caused by bluetongue virus serotype 1, 2, 4 and/ or 8, and to reduce clinical signs caused by bluetongue virus serotypes when observed in this species: serotype 1, 4 and / or 8 (combination of maximum 2 serotypes).active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - canine herpesvirus (f205 strain) antigens - immunologicals for canidae - dogs - active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life.

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - meloxicam - oxicams - horses; dogs; cattle; cats; pigs; guinea pigs - cats:alleviation of mild to moderate post-operative pain and inflammation following surgical procedures, e.g. orthopaedic and soft tissue surgery.alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders.reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.cattle:for use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs.for use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.for the relief of post-operative pain following dehorning in calves.for adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.dogs:alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.horses:for use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.for the relief of pain associated with equine colic.alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.pigs: for use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.for the relief of post-operative pain associated with minor soft tissue surgery such as castration.for adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.guinea pigs:alleviation of mild to moderate post-operative pain associated with soft tissues surgery such as male castration.