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

csl behring gmbh - human coagulation factor viii/von willebrand factor complex (unii: 5t6b772r4q) (human coagulation factor viii/von willebrand factor complex - unii:5t6b772r4q) - human coagulation factor viii/von willebrand factor complex 80 [iu] in 1 ml - humate-p, antihemophilic factor/von willebrand factor complex (human), is indicated for treatment and prevention of bleeding in adults with hemophilia a (classical hemophilia). humate-p is also indicated in adult and pediatric patients with von willebrand disease (vwd) for: controlled clinical trials to evaluate the safety and efficacy of prophylactic dosing with humate-p to prevent spontaneous bleeding have not been conducted in vwd subjects [see clinical studies (14)]. humate-p is contraindicated in individuals who have had an anaphylactic or severe systemic reaction to antihemophilic factor or von willebrand factor preparations. animal reproduction studies have not been conducted with humate-p. it is also not known whether humate-p can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. humate-p should be given to a pregnant woman only if clearly needed. it is not known whether humate-p can cause harm to the mother or the fetus when administered during labor and deli

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

csl behring llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2.5 ml - helixate® fs is a recombinant antihemophilic factor indicated for: helixate fs is not indicated for the treatment of von willebrand disease. helixate 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). pregnancy category c animal reproduction studies have not been conducted with helixate fs. it is also not known whether helixate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. helixate fs should be given to a pregnant woman only if clearly needed. there is no information available on the effect of factor viii replacement therapy on labor and delivery. helixate fs should be used only if clinically needed. it is not known whether this drug is excreted into human milk. because many drugs are excreted into human milk, caution sho

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

csl behring llc - coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t) - coagulation factor ix human 500 [iu] in 5 ml - mononine is indicated for the prevention and control of bleeding in factor ix deficiency, also known as hemophilia b or christmas disease. mononine is not indicated in the treatment or prophylaxis of hemophilia a patients with inhibitors to factor viii. mononine contains non-detectable levels of factors ii, vii and x (<0.0025 iu per factor ix unit using standard coagulation assays) and is, therefore, not indicated for replacement therapy of these clotting factors. mononine is also not indicated in the treatment or reversal of coumarin-induced anticoagulation or in a hemorrhagic state caused by hepatitis-induced lack of production of liver dependent coagulation factors. known hypersensitivity to mouse protein is a contraindication to mononine.

United States - English - 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

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

bio products laboratory limited - coagulation factor x human (unii: 0p94uqe6sy) (coagulation factor x human - unii:0p94uqe6sy) - coagulation factor x human 100 [iu] in 1 ml - coagadex, coagulation factor x (human), is a plasma-derived human blood coagulation factor indicated in adults and children with hereditary factor x deficiency for: - routine prophylaxis to reduce the frequency of bleeding episodes - on-demand treatment and control of bleeding episodes - perioperative management of bleeding in patients with mild, moderate, and severe hereditary factor x deficiency coagadex is contraindicated in patients who have had life-threatening hypersensitivity reactions to coagadex [see description (11) ]. risk summary there is limited data with coagadex in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using coagadex. it is not known whether coagadex 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. risk summary ther

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

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

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - factor xi - powder and solvent for solution for infusion - 1000unit

United States - English - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c; protein s - powder and solvent for solution for infusion - 1000 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human plasma coagulation factor ii; human plasma coagulation factor vii; human plasma coagulation factor ix; human plasma coagulation factor x; protein c; protein s - powder and solvent for solution for infusion - 500 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination