Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human plasma protein >90% gamma globulin - powder and solvent for solution for infusion - 0.5 g/30 m gram(s)/millilitre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm. - immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration - primary immunodeficiency syndromes (pid): congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeficiencies severe combined immunodeficiencies wiskott aldrich syndrome myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections children with congenital aids and recurrent infections

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >90% gamma globulin - solution for injection - 1.6g/10ml %w/v

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >90% gamma globulin human tetanus immunoglobulin ph. eur. - solution for injection - %v/v

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >90% gamma globulin - pdr+solv for soln for inf - 0.5 g/30 m micromol

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

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

plasvacc pty ltd - equine gamma globulins - parenteral liquid/solution/suspension - equine gamma globulins vaccine active 22.0 g/l - immunotherapy - horse foal - increase gamma globulin levels of foals

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human plasma protein >90% gamma globulin - solution for injection - 0.8g/5ml %w/v

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