USA - engelsk - NLM (National Library of Medicine)

csl behring lengnau ag - lonoctocog alfa (unii: vq723r7o8r) (lonoctocog alfa - unii:vq723r7o8r) - lonoctocog alfa 250 [iu] in 2.5 ml - afstyla, antihemophilic factor (recombinant), single chain is a recombinant, antihemophilic factor indicated in adults and children with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes, - routine prophylaxis to reduce the frequency of bleeding episodes, - perioperative management of bleeding. limitation of use afstyla is not indicated for the treatment of von willebrand disease. afstyla is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to afstyla or its excipients (e.g., polysorbate 80) [see description (11)] , or hamster proteins [see warnings and precautions (5.1)] . risk summary there are no data with afstyla use in pregnant women to inform on drug-associated risk. no developmental or animal reproduction toxicity studies were conducted with afstyla. thus, the risk of developmental toxicity including, structural abnormalities, embryo-fetal and/or infant mortality, functional impairment,

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

takeda pharmaceuticals australia pty ltd - susoctocog alfa, quantity: 500 u/ml - injection - excipient ingredients: - for the treatment of bleeding episodes in adults with acquired haemophilia a.,safety and efficacy of obizur have not been established in patients with baseline anti- porcine factor viii inhibitor titre greater than 20 bu.,obizur is not indicated for the treatment of congenital haemophilia a or von willebrand disease.

USA - engelsk - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - susoctocog alfa (unii: 6892uqt2gk) (susoctocog alfa - unii:6892uqt2gk) - susoctocog alfa 500 [usp'u] in 1 ml - obizur, antihemophilic factor (recombinant), porcine sequence, is a recombinant dna derived, antihemophilic factor indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia a. limitations of use: - safety and efficacy of obizur has not been established in patients with baseline anti-porcine factor viii inhibitor titer greater than 20 bu. - obizur is not indicated for the treatment of von willebrand disease. obizur is contraindicated in patients: - who have had life-threatening hypersensitivity reactions to obizur or its components (including traces of hamster proteins). - with congenital hemophilia a with inhibitors (chawi) due to the high incidence of anamnestic reactions to human factor viii (hfviii) and porcine factor viii (pfviii) [see adverse reactions (6.1)] . risk summary there are no data with obizur use in pregnant women to inform a drug-associated risk. there are no adequate and well-controlled studies in pregnant women. animal reproduction studies ha

USA - engelsk - NLM (National Library of Medicine)

bayer healthcare llc - damoctocog alfa pegol (unii: by4tsk952y) (damoctocog alfa pegol - unii:by4tsk952y) - jivi, antihemophilic factor (recombinant), pegylated-aucl, is a recombinant dna-derived, factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia a (congenital factor viii deficiency) for: limitations of use jivi is not indicated for use in children < 12 years of age due to greater risk for hypersensitivity reactions [see use in specific populations (8.4)] . jivi is not indicated for use in previously untreated patients (pups). jivi is not indicated for the treatment of von willebrand disease. jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (peg), mouse or hamster proteins, or other constituents of the product [see description (11)]. there are no data with jivi use in pregnant women to inform on drug-associated risk. animal developmental and reproductive toxicity studies have not been conducted with jivi. it is not known whether jivi can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 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. there is no information regarding the presence of jivi in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for jivi and any potential adverse effects on the breastfed infant from jivi or from the underlying maternal condition. the safety and effectiveness in patients below the age of 12 have not been established. jivi is not indicated for use in previously untreated patients. jivi is not indicated for use in children below 12 years of age [see clinical studies (14)] .  in completed clinical studies with 73 pediatric previously treated patients (ptps) < 12 years of age (44 ptps < 6 years, 29 ptps 6 to < 12 years), adverse reactions due to immune response to peg were observed in children less than 6 years of age. in 23% of subjects in the age group < 6 years of age, loss of drug effect due to neutralizing anti-peg igm antibodies during the first 4 exposure days (eds) was observed. in 7% of the subjects < 6 years of age, loss of drug effect was combined with hypersensitivity reactions [see warnings and precautions (5.3)] . clinical studies of jivi did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease and other drug therapy.

USA - engelsk - NLM (National Library of Medicine)

wyeth biopharma division of wyeth pharmaceuticals llc - moroctocog alfa (unii: 113e3z3cjj) (moroctocog alfa - unii:113e3z3cjj) - antihemophilic factor, human recombinant residues 743-1636 deleted 1000 [iu] in 4 ml - xyntha, antihemophilic factor (recombinant), is indicated for use in adults and children with hemophilia a (congenital factor viii deficiency) for: xyntha does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand's disease. xyntha is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins. risk summary it is not known whether xyntha can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. animal reproduction studies have not been conducted with xyntha. there is no information available on the effect of factor viii replacement therapy on labor and delivery. xyntha should be used only if clinically indicated. 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 is

USA - engelsk - NLM (National Library of Medicine)

octapharma usa inc - simoctocog alfa (unii: u50vww6xh6) (simoctocog alfa - unii:u50vww6xh6) - simoctocog alfa 4000 [iu] in 2.5 ml - nuwiq is a recombinant antihemophilic factor [blood coagulation factor viii (factor viii)] indicated in adults and children with hemophilia a for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes nuwiq is not indicated for the treatment of von willebrand disease. nuwiq is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components. risk summary there are no data with nuwiq use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with nuwiq. it is not known whether nuwiq can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. nuwiq should be given to a pregnant woman only if clearly needed. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnan

USA - engelsk - NLM (National Library of Medicine)

bioverativ therapeutics inc. - efmoroctocog alfa (unii: 7pcm518ylr) (efmoroctocog alfa - unii:7pcm518ylr) - (1-743)-(1638-2332)-blood-coagulation factor viii (synthetic human) fusion protein with immunoglobulin g1 (synthetic human fc domain fragment), (1444-6'),(1447-9')-bis(disulfide) with immunoglobulin g1 (synthetic human fc domain fragment) 250 [iu] in 3 ml - eloctate, antihemophilic factor (recombinant), fc fusion protein, is a recombinant dna derived, antihemophilic factor indicated in adults and children with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes, - perioperative management of bleeding, - routine prophylaxis to reduce the frequency of bleeding episodes. limitation of use eloctate is not indicated for the treatment of von willebrand disease. eloctate is contraindicated in patients who have had life-threatening hypersensitivity reactions to eloctate or its excipients (sucrose, sodium chloride, l-histidine, calcium chloride and polysorbate 20). risk summary there are no studies of eloctate use in pregnant women to inform a drug-associated risk. the background risk of major birth defects and miscarriage in the indicated population is unknown; however, the background risk of major birth defects in the u.s. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnanci

Israel - engelsk - Ministry of Health

takeda israel ltd - octocog alfa (antihemophilic factor recombinant) - powder for solution for injection - octocog alfa (antihemophilic factor recombinant) 500 iu/vial - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).

Israel - engelsk - Ministry of Health

takeda israel ltd - octocog alfa (antihemophilic factor recombinant) - powder for solution for injection - octocog alfa (antihemophilic factor recombinant) 1000 iu/vial - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).

Israel - engelsk - Ministry of Health

takeda israel ltd - octocog alfa (antihemophilic factor recombinant) - powder for solution for injection - octocog alfa (antihemophilic factor recombinant) 1500 iu/vial - coagulation factor viii - coagulation factor viii - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).