Malta - English - Medicines Authority

sanquin plesmanlaan 125, 1066 cx amsterdam, netherlands - human plasma, protein - solution for infusion - human plasma protein 40 g/l - blood substitutes and perfusion solutions

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)

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 2.5 g in 50 ml - treatment of shock — plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. it is also effective in the emergency treatment of shock due to hemorrhage.(3,4) following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss. in infants and small children, plasmanate has been found to be very useful in the initial therapy of shock due to dehydration and infection. plasmanate is contraindicated for use in patients on cardiopulmonary bypass. severe hypotension has been reported in such patients when given plasma protein fraction.(4) plasma protein fraction is contraindicated in patients with severe anemia, congestive heart failure, or increased blood volume.

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

kedrion biopharma, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 1 g in 10 ml - bivigam is an immune globulin intravenous (human), 10% liquid, indicated for the treatment of patients with primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. - bivigam is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. - bivigam is contraindicated in iga deficiency patients with antibodies to iga and a history of hypersensitivity. pregnancy category c. animal reproduction studies have not been conducted with bivigam. it is not known whether bivigam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. bivigam should be given to pregnant women only if clearly needed.17,18 use of bivigam in nursing mothers has not been evaluated. bivigam should be given to nursing m

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

octapharma usa inc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin (human) 200 g in 1000 ml - albumin (human) 20% is indicated in the emergency treatment of hypovolemia with or without shock. its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. it is most effective in patients who are well hydrated. when blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [ 1 , 2 ] when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [ 1 ] for subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, albumin (human) 20% infusions may be indicated. [ 3 ] when albumin deficit is the result of excessive protein loss, the effect of administration of albumin (human) 20% will be temporary unless the underlying disorder is reversed. albumin (human) 20% may be used to maintain cardiovascular function following the removal of large volumes of ascitic f

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

octapharma usa inc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin (human) 250 g in 1000 ml - albumin (human) 25% is indicated in the emergency treatment of hypovolemia with or without shock. its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. it is most effective in patients who are well hydrated. when blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [ 1 , 2 ] when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [ 1 ] for subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, albumin (human) 25% infusions may be indicated. [ 3 ] when albumin deficit is the result of excessive protein loss, the effect of administration of albumin (human) 25% will be temporary unless the underlying disorder is reversed. albumin (human) 25% may be used to maintain cardiovascular function following the removal of large volumes of ascitic

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

octapharma usa inc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin (human) 50 g in 1000 ml - albumin (human) 5% is indicated in the emergency treatment of hypovolemia with or without shock. its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. it is most effective in patients who are well hydrated. when blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [ 1 , 2 ] albumin (human) 5% should be used when hydration is not adequate. when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [ 1 ] for subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, albumin (human) 5% infusions may be indicated.[ 3 ] when albumin deficit is the result of excessive protein loss, the effect of administration of albumin (human) 5% will be temporary unless the underlying disorder is reversed. albumin (human) 5% may be used to maintain cardiovascular