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

boehringer ingelheim pty ltd - idarucizumab, quantity: 2500 mg - injection, solution - excipient ingredients: glacial acetic acid; polysorbate 20; sodium acetate trihydrate; sorbitol; water for injections - praxbind is a specific reversal agent for dabigatran and is indicated in patients treated with dabigatran etexilate (pradaxa) when rapid reversal of the anticoagulant effects of dabigatran is required: - for emergency surgery/urgent procedures; - in life-threatening or uncontrolled bleeding.

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

boehringer ingelheim pharmaceuticals, inc. - idarucizumab (unii: 97rwb5s1u6) (idarucizumab - unii:97rwb5s1u6) - idarucizumab 50 mg in 1 ml - praxbind is indicated in patients treated with pradaxa when reversal of the anticoagulant effects of dabigatran is needed: - for emergency surgery/urgent procedures - in life-threatening or uncontrolled bleeding none. risk summary there are no available data on praxbind use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproductive and development studies have not been conducted with idarucizumab. it is also not known whether praxbind can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. praxbind should be given to a pregnant woman only if clearly needed. the background risk of major birth defects and miscarriage for the indicated population is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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. risk summary there are no data on the effects of praxbind on the breastfed child or on milk production. it is not known whether idarucizumab is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when praxbind is administered to a nursing woman. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for praxbind and any potential adverse effects on the breastfed child from praxbind or from the underlying maternal condition. safety and effectiveness have not been established in pediatric patients. a total of 454 (90%) patients treated with idarucizumab in the case series trial were 65 years of age and older, and 318 (63%) were 75 years of age and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Israel - English - Ministry of Health

boehringer ingelheim israel ltd. - idarucizumab - solution for injection / infusion - idarucizumab 50 mg / 1 ml - idarucizumab - idarucizumab is a specific reversal agent for dabigatran and is indicated in patients treated with dabigatran etexilate when rapid reversal of the anticoagulant effects of dabigatran is required:• for emergency surgery/urgent procedures• in life-threatening or uncontrolled bleeding

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) ltd - idarucizumab 50 mg/ml - solution for injection - 50 mg/ml - active: idarucizumab 50 mg/ml excipient: glacial acetic acid polysorbate 20 sodium acetate trihydrate sorbitol water for injection - praxbind is a specific reversal agent for dabigatran and is indicated in patients treated with pradaxa when rapid reversal of the anticoagulant effect of dabigatran is required: - for emergency surgery/urgent procedures - in life-threatening or uncontrolled bleeding.

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - idarucizumab - hemorrhage - all other therapeutic products - praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required:for emergency surgery/urgent procedures;in life-threatening or uncontrolled bleeding.

Canada - English - Health Canada

boehringer ingelheim (canada) ltd ltee - idarucizumab - solution - 50mg - idarucizumab 50mg - antihemorrhagic agents, miscellaneous

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

boehringer ingelheim ltd - idarucizumab - solution for infusion - 50mg/1ml

Singapore - English - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - idarucizumab - injection, solution - idarucizumab 50.00 mg/ml

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

boehringer ingelheim (malaysia) sdn. bhd. - idarucizumab -

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: boehringer ingelheim philippines, inc.; distributor: boehringer ingelheim philippines, inc. - idarucizumab - solution for injection (iv) - 50mg/ml