Ai Cập - Tiếng Anh - EDA (Egyptian Drug Authority)

bio care pharma group-egypt - injection - 250 i.u./10ml

Ai Cập - Tiếng Anh - EDA (Egyptian Drug Authority)

bio care pharma group-egypt - injection - 250 i.u./10ml

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor viii,von willebrand factor -

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor viii,von willebrand factor -

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

blood services group, health sciences authority - coagulation factor viii (human) (freeze-dried); von willebrand factor - injection, powder, for solution - 50 iu/ml - coagulation factor viii (human) (freeze-dried) 50 iu/ml; von willebrand factor 100 iu/ml

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

kedrion biopharma, inc. - antihemophilic factor human (unii: 839moz74gk) (antihemophilic factor human - unii:839moz74gk) - antihemophilic factor human 250 [iu] in 5 ml - koĀte® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia a (hereditary factor viii deficiency). limitation of use koĀte is not indicated for the treatment of von willebrand disease. koĀte is contraindicated in patients who have had hypersensitivity reactions, including anaphylaxis, to koĀte or its components. [see description (11) ] risk summary there are no data with koĀte use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using koĀte. it is not known whether koĀte can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. koĀte should be given to a pregnant woman only if clearly needed. 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 no information regarding the presence of koĀte 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 koĀte and any potential adverse effects on the breast-fed infant from koĀte or from the underlying maternal condition. safety and efficacy studies have been performed in 20 previously treated pediatric patients aged 2.5 to 16 years. subjects received 208 infusions of koĀte for treatment or control of bleeding episodes, including perioperative management, and routine prophylaxis.  children have shorter half-life and lower recovery of factor viii than adults. because clearance of factor viii (based on per kilogram body weight) is higher in children, higher or more frequent dosing may be needed. clinical studies of koĀte did not include any subjects aged 65 and over to determine whether they respond differently from younger subjects. individualize dose selection for geriatric patients.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

octapharma pharmazeutika produktionsgesellschaft m.b.h. - antihemophilic factor human (unii: 839moz74gk) (antihemophilic factor human - unii:839moz74gk), von willebrand factor human (unii: ze22ne22f1) (von willebrand factor human - unii:ze22ne22f1) - antihemophilic factor human 100 [iu] in 1 ml - wilate is a von willebrand factor/coagulation factor viii complex (human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von willebrand disease (vwd) as well as patients with mild or moderate vwd in whom the use of desmopressin is known or suspected to be ineffective or contraindicated. clinical trials to evaluate the safety and efficacy of prophylactic dosing with wilate to prevent spontaneous bleeding have not been conducted in vwd subjects. wilate is not indicated for the prevention of excessive bleeding during and after surgery in vwd patients. wilate is not indicated for hemophilia a. wilate is contraindicated for patients who have known anaphylactic or severe systemic reaction to plasma-derived products, any ingredient in the formulation, or components of the container. for a complete listing of ingredients, see description ( 11 ). pregnancy category c. animal reproduction studies have not been conducted with wilate. it is also not known whether

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor ix, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor ix, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - monofix-vf is indicated for the treatment of haemorrhages, for use in minor surgery, and as a prophylaxis in patients with haemophilia b. it has not been evaluated in major surgery. monofix-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels fo these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors. indications as at 14 may 1999: monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment factor ii, vii or x deficiencies because is does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - factor ix, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.