New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - damoctocog alfa pegol 500 [iu] - powder for injection with diluent - 500 iu - active: damoctocog alfa pegol 500 [iu] excipient: calcium chloride dihydrate glacial acetic acid glycine histidine polysorbate 80 sodium chloride sucrose water for injection - treatment and prophylaxis of bleeding in previously treated patients (ptps) not less than 12 years of age with haemophilia a (congenital factor viii deficiency).

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

bayer healthcare llc, united states - pegylated b domain deleted recombinant human coagulation factor viii damoctocog alfa pegol - powder and solvent for solution for injection - 500 iu

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

bayer healthcare llc, united states - pegylated b domain deleted recombinant human coagulation factor viii damoctocog alfa pegol - powder and solvent for solution for injection - 1000 iu

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

bayer healthcare llc, united states - pegylated b domain deleted recombinant human coagulation factor viii damoctocog alfa pegol - powder and solvent for solution for injection - 2000 iu

United States - English - 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.

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

csl behring australia pty ltd - lonoctocog alfa, quantity: 500 iu - solution - excipient ingredients: - afstyla is indicated in adult and paediatric patients with haemophilia a (congenital fviii deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis) afstyla is not indicated for the treatment of von willebrand disease.