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

octapharma usa inc - 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 indicated in children and adults with von willebrand disease for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding wilate is indicated in adolescents and adults with hemophilia a for: - routine prophylaxis to reduce the frequency of bleeding episodes - on-demand treatment and control of bleeding episodes wilate is contraindicated in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reactions, to human plasma-derived products, any ingredient in the formulation [see description (11) ] , or components of the container. risk summary there are no data with wilate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with wilate. wilate was given to four subjects (3 type 3 and 1 type 2b) during labor and delivery in one clinical study. two subjects underwent vaginal delivery (type 3) and two subjects had a cesarean section (type 3/type 2b). in this study all pro

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

octapharma usa inc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - panzyga is indicated for treatment of primary humoral immunodeficiency (pi) in patients 2 years of age and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. panzyga is indicated for the treatment of adult patients with itp to raise platelet counts to control or prevent bleeding. panzyga is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (cidp) to improve neuromuscular disability and impairment. - panzyga is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. - panzyga is contraindicated in iga-deficient patients with antibodies against iga and history of hypersensitivity . risk summary no human data are available to indicate the presence or absence of drug-associated risk. animal reproduction studies have not been conducted

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

octapharma usa inc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - panzyga is indicated for treatment of primary humoral immunodeficiency (pi) in patients 2 years of age and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. panzyga is indicated for the treatment of adult patients with itp to raise platelet counts to control or prevent bleeding. panzyga is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (cidp) to improve neuromuscular disability and impairment. - panzyga is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. - panzyga is contraindicated in iga-deficient patients with antibodies against iga and history of hypersensitivity . risk summary no human data are available to indicate the presence or absence of drug-associated risk. animal reproduction studies have not been conducted

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

octapharma usa inc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - cutaquig (immune globulin subcutaneous (human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (igsc), indicated as replacement therapy for primary humoral immunodeficiency (pi) in adults and pediatric patients 2 years of age and older. this includes, but is not limited to, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. cutaquig is contraindicated: - in patients who have had an anaphylactic or severe systemic reaction to the subcutaneous administration of human immune globulin or to any of the components of cutaquig such as polysorbate 80. - in iga-deficient patients with antibodies against iga and a history of hypersensitivity to human globulin treatment. risk summary no human data are available to indicate the presence or absence of drug-associated risk. animal reproduction studies have not been conducted with cutaquig. it is not known whether cutaquig can cause fet

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

octapharma usa inc - plasma protein fraction (human) (unii: 6d53g0fd0z) (plasma protein fraction (human) - unii:6d53g0fd0z) - plasma protein fraction (human) 11.5 g in 200 ml - octaplas is a solvent / detergent (s/d) treated, pooled human plasma indicated for: - replacement of multiple coagulation factors in patients with acquired deficiencies - due to liver disease - undergoing cardiac surgery and liver transplantation - plasma exchange in patients with thrombotic thrombocytopenic purpura (ttp) do not use octaplas in patients with: - iga deficiency - severe deficiency of protein s - history of hypersensitivity to fresh frozen plasma (ffp) or to plasma-derived products including any plasma protein - history of hypersensitivity reaction to octaplas risk summary animal reproduction studies have not been conducted with octaplas. it is not known whether octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. octaplas should be given to a pregnant woman only if clearly needed. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background

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

octapharma usa inc - plasma protein fraction (human) (unii: 6d53g0fd0z) (plasma protein fraction (human) - unii:6d53g0fd0z) - plasma protein fraction (human) 11.5 g in 200 ml - octaplas is a solvent / detergent (s/d) treated, pooled human plasma indicated for: - replacement of multiple coagulation factors in patients with acquired deficiencies - due to liver disease - undergoing cardiac surgery and liver transplantation - plasma exchange in patients with thrombotic thrombocytopenic purpura (ttp) do not use octaplas in patients with: - iga deficiency - severe deficiency of protein s - history of hypersensitivity to fresh frozen plasma (ffp) or to plasma-derived products including any plasma protein - history of hypersensitivity reaction to octaplas risk summary animal reproduction studies have not been conducted with octaplas. it is not known whether octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. octaplas should be given to a pregnant woman only if clearly needed. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background

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

octapharma usa inc - plasma protein fraction (human) (unii: 6d53g0fd0z) (plasma protein fraction (human) - unii:6d53g0fd0z) - plasma protein fraction (human) 11.5 g in 200 ml - octaplas is a solvent / detergent (s/d) treated, pooled human plasma indicated for: - replacement of multiple coagulation factors in patients with acquired deficiencies - due to liver disease - undergoing cardiac surgery and liver transplantation - plasma exchange in patients with thrombotic thrombocytopenic purpura (ttp) do not use octaplas in patients with: - iga deficiency - severe deficiency of protein s - history of hypersensitivity to fresh frozen plasma (ffp) or to plasma-derived products including any plasma protein - history of hypersensitivity reaction to octaplas risk summary animal reproduction studies have not been conducted with octaplas. it is not known whether octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. octaplas should be given to a pregnant woman only if clearly needed. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background

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

octapharma usa inc - plasma protein fraction (human) (unii: 6d53g0fd0z) (plasma protein fraction (human) - unii:6d53g0fd0z) - plasma protein fraction (human) 11.5 g in 200 ml - octaplas is a solvent / detergent (s/d) treated, pooled human plasma indicated for: - replacement of multiple coagulation factors in patients with acquired deficiencies - due to liver disease - undergoing cardiac surgery and liver transplantation - plasma exchange in patients with thrombotic thrombocytopenic purpura (ttp) do not use octaplas in patients with: - iga deficiency - severe deficiency of protein s - history of hypersensitivity to fresh frozen plasma (ffp) or to plasma-derived products including any plasma protein - history of hypersensitivity reaction to octaplas risk summary animal reproduction studies have not been conducted with octaplas. it is not known whether octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. octaplas should be given to a pregnant woman only if clearly needed. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background

United States - English - 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

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

octapharma usa inc - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibryga is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. fibryga is not indicated for dysfibrinogenemia. fibryga is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to fibryga or its components (sodium citrate dihydrate; glycine; l-arginine hydrochloride). risk summary there are no data with fibryga use in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with fibryga. it is not known whether fibryga 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 defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of fibryga