Estados Unidos - inglés - NLM (National Library of Medicine)

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 1000 [iu] in 2.5 ml - kogenate® fs is a recombinant antihemophilic factor indicated for: kogenate fs is not indicated for the treatment of von willebrand disease. kogenate fs is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). there are no data with kogenate fs use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted with kogenate fs. it is also not known whether kogenate fs can cause fetal harm when administered to a pregnant woman or affect reproductive 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 kogenate fs 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 kogenate fs and any potential adverse effects on the breastfed child from kogenate fs or from the underlying maternal condition. safety and efficacy studies have been performed in previously untreated and minimally treated pediatric patients. children, in comparison to adults, present higher factor viii clearance values and, thus, lower half-life and recovery of factor viii. this may be due to differences in body composition.13 account for this difference in clearance when dosing or following factor viii levels in the pediatric population [see clinical pharmacology (12.3)] . routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown to reduce spontaneous joint bleeding and the risk of joint damage. this data can be extrapolated to ages >2.5–16 years for children who have no existing joint damage [see clinical studies (14)] . clinical studies with kogenate fs did not include patients aged 65 and over. dose selection for an elderly patient should be individualized.

Estados Unidos - inglés - NLM (National Library of Medicine)

baxalta us inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 5 ml - adynovate, antihemophilic factor (recombinant), pegylated, is a human antihemophilic factor indicated in children and adults with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management - routine prophylaxis to reduce the frequency of bleeding episodes limitation of use adynovate is not indicated for the treatment of von willebrand disease. adynovate is contraindicated in patients who have had prior anaphylactic reaction to adynovate, to the parent molecule (advate), mouse or hamster protein, or excipients of adynovate (e.g. tris, mannitol, trehalose, glutathione, and/or polysorbate 80). risk summary there are no data with adynovate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with adynovate. it is unknown whether adynovate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. adynovate should be given to a pregnant woman only

Estados Unidos - inglés - NLM (National Library of Medicine)

aptevo biotherapeutics llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - ixinity, coagulation factor ix (recombinant), is a human blood coagulation factor indicated for the treatment of: - adults and children ≥ 12 years of age with hemophilia b for: on-demand treatment and control of bleeding episodes perioperative management - on-demand treatment and control of bleeding episodes - perioperative management - adults with hemophilia b for: routine prophylaxis to reduce the frequency of bleeding episodes - routine prophylaxis to reduce the frequency of bleeding episodes ixinity is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3) ]. ixinity is contraindicated in patients who have known hypersensitivity to ixinity or its excipients, including hamster protein [see warnings and precautions (5.1) ]. risk summary there are no data with ixinity use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with ixinity. in the u.s. general population, the estimated b

Estados Unidos - inglés - NLM (National Library of Medicine)

baxter healthcare corporation - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 25 [iu] in 1 ml - the use of recombinate [antihemophilic factor (recombinant)] is indicated in hemophilia a (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 recombinate is also indicated in the perioperative management of patients with hemophilia a (classical hemophilia). recombinate can be of therapeutic value in patients with acquired factor viii inhibitors not exceeding 10 bethesda units per ml.3   in clinical studies with recombinate, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 bethesda units per ml. however, in such uses, the dosage of recombinate should be controlled by frequent laboratory determinations of circulating factor viii levels as well as the clinical status of the patient. recombinate is not indicated in von willebrand’s disease. recombinate is contraindicated in patients w

Estados Unidos - inglés - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 5 ml - the use of recombinate [antihemophilic factor (recombinant)] is indicated in hemophilia a (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 recombinate is also indicated in the perioperative management of patients with hemophilia a (classical hemophilia). recombinate can be of therapeutic value in patients with acquired factor viii inhibitors not exceeding 10 bethesda units per ml.3   in clinical studies with recombinate, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 bethesda units per ml. however, in such uses, the dosage of recombinate should be controlled by frequent laboratory determinations of circulating factor viii levels as well as the clinical status of the patient. recombinate is not indicated in von willebrand's disease. recombinate is contraindicated in patients w

Estados Unidos - inglés - NLM (National Library of Medicine)

novo nordisk - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 500 [iu] in 1 ml - rebinyn, coagulation factor ix (recombinant), glycopegylated, is a recombinant dna-derived coagulation factor ix concentrate indicated for use in adults and children with hemophilia b (congenital factor ix deficiency) for: limitations of use : rebinyn is not indicated for immune tolerance induction in patients with hemophilia b. rebinyn is contraindicated in patients who have known hypersensitivity to rebinyn or its components (including hamster proteins) [see warnings and precautions (5.1) and description (11) ] risk summary there are no data with rebinyn use in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with rebinyn. it is unknown whether rebinyn can cause fetal harm when administered to a pregnant woman or can affect fertility. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no informati

Estados Unidos - inglés - NLM (National Library of Medicine)

baxter healthcare corporation - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 25 [iu] in 1 ml - the use of recombinate [antihemophilic factor (recombinant)] is indicated in hemophilia a (classical hemophilia) for the prevention and control of hemorrhagic episodes.2 recombinate is also indicated in the perioperative management of patients with hemophilia a (classical hemophilia). recombinate can be of therapeutic value in patients with acquired factor viii inhibitors not exceeding 10 bethesda units per ml.3   in clinical studies with recombinate, patients with inhibitors who were entered into the previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 bethesda units per ml. however, in such uses, the dosage of recombinate should be controlled by frequent laboratory determinations of circulating factor viii levels as well as the clinical status of the patient. recombinate is not indicated in von willebrand’s disease. recombinate is contraindicated in patients w

Estados Unidos - inglés - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 125 [iu] in 1 ml - advate [antihemophilic factor (recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia a (congenital factor viii deficiency) for: - control and prevention of bleeding episodes. - perioperative management. - routine prophylaxis to prevent or reduce the frequency of bleeding episodes. advate is not indicated for the treatment of von willebrand disease. advate is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, tris, calcium chloride, polysorbate 80, and/or glutathione). risk summary there are no data with advate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with advate. it is not known whether advate can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. in the u.s. general popu

Estados Unidos - inglés - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - rixubis (coagulation factor ix [recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia b for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes. rixubis is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . rixubis is contraindicated in patients who have: - known hypersensitivity to rixubis or its excipients including hamster protein - disseminated intravascular coagulation (dic) [see warnings and precautions (5.4)] - signs of fibrinolysis [see warnings and precautions (5.4)] risk summary there are no data with rixubis use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with rixubis. it is also not known whether rixubis can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. in the u.s. general population,

Estados Unidos - inglés - NLM (National Library of Medicine)

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2.5 ml - kovaltry is not indicated for the treatment of von willebrand disease. kovaltry is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins [see description (11)]. there are no data with kovaltry use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using kovaltry. it is not known whether kovaltry 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 kovaltry 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 kovaltry and any potential adverse effects on the breastfed infant from kovaltry or from the underlying maternal condition. safety and efficacy studies with kovaltry have been performed in 51 pediatric ptps ≤12 years of age and 43 pediatric pups/mtps <6 years of age [see clinical studies (14)]. body weight adjusted clearance of factor viii in children ≤12 years of age is higher than in adults and adolescents. consider higher or more frequent dosing in children to account for this difference in clearance [see clinical pharmacology (12.3)] . clinical studies with kovaltry did not include patients aged 65 and over to determine whether or not they respond differently from younger patients. however, clinical experience with other factor viii products has not identified differences between the elderly and younger patients. as with any patient receiving recombinant factor viii, dose selection for an elderly patient should be individualized.