Malta - English - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - human plasma, protein - solution for infusion - human plasma protein 200 g/l - blood substitutes and perfusion solutions

Ireland - English - HPRA (Health Products Regulatory Authority)

biotest pharma gmbh - human plasma protein >96% immunoglobulins - solution for infusion - 50 gram(s)/litre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.

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

Malta - English - Medicines Authority

octapharma (ip) limited - human plasma protein >95% immunoglobulins - solution for infusion - human plasma protein >95% immunoglobulins 50 mg/ml - immune sera and immunoglobulins

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human plasma protein >95% immunoglobulins - solution for injection - 160 gram(s)/litre - immunoglobulins, normal human; immunoglobulins, normal human, for extravascular adm. - immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration - replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency - igg subclass deficiencies with recurrent infections

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - human cytomegalovirus immunoglobulin in 50mg/ml human plasma protein (igg ≥ 96%) - injection - 100 u/ml - human cytomegalovirus immunoglobulin in 50mg/ml human plasma protein (igg ≥ 96%) 100 u/ml

Israel - English - Ministry of Health

kamada ltd, israel - cytomegalovirus antibody; human plasma protein; immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 96 %; human plasma protein 50 mg/ml; cytomegalovirus antibody 100 u/ml - cytomegalovirus immunoglobulin - prophylaxis of clinical manifestations of cytomegalovirus infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.the concomitant use of adequate virostatic agents should be considered for cmv-prophylaxis.