catridecacog - search results

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

novothirteen catridecacog (rys) 2500 iu powder for injection vial with diluent vial

novo nordisk pharmaceuticals pty ltd - catridecacog, quantity: 5.25 mg/ml - drug delivery system - excipient ingredients: - novothirteen is indicated for routine prophylaxis of bleeding in patients with congenital factor xiii a-subunit deficiency.

European Union - English - EMA (European Medicines Agency)

novothirteen

novo nordisk a/s - catridecacog - blood coagulation disorders, inherited - antihemorrhagics - long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-xiii-a-subunit deficiency.

Canada - English - Health Canada

tretten powder for solution

novo nordisk canada inc - catridecacog - powder for solution - 2500unit - catridecacog 2500unit - hemostatics

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

tretten (coagulation factor xiii a-subunit- recombinant kit

novo nordisk - catridecacog (unii: nu23q531g1) (catridecacog - unii:nu23q531g1) - factor xiii concentrate (human) 2500 [iu] in 3 ml - tretten, coagulation factor xiii a-subunit (recombinant), is indicated for routine prophylaxis for bleeding in patients with congenital factor xiii a-subunit deficiency. tretten is not for use in patients with congenital factor xiii b‑subunit deficiency tretten is contraindicated in patients who have known hypersensitivity to the active substance or to any of the excipients [see description (11)]. risk summary there are no adequate and well-controlled studies using tretten in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with tretten. 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. miscarriage is a known complication of congenital fxiii deficiency. pooling data from 39 publications, the miscarriage rate was 66% in 63 patients with 192 pregnancies (70% in 179 pregnancies in fxiii a-subunit deficiency women). miscar