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

actavis pharma, inc. - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. - known hypersensitivity to sodium ferric gluconate or any of its components. pregnancy category b there are no adequate and well-controlled studies with sodium ferric gluconate complex in sucrose injection in pregnant women. reproduction studies have been performed in mice at doses up to 100 mg/kg/day (300 mg/m2 /day) and in rats at up to 20 mg/kg/day (120 mg/m2 /day). the doses in mice and rats are 4 and 1.5 times the human dose of 125 mg/day (77 mg/m2 /day) on a body surface area basis and have revealed no evidence of harm to the fetus due to sodium ferric gluconate complex in sucrose injection. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly need

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

actavis pharma, inc. - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. - known hypersensitivity to sodium ferric gluconate or any of its components. pregnancy category b there are no adequate and well-controlled studies with sodium ferric gluconate complex in sucrose injection in pregnant women. reproduction studies have been performed in mice at doses up to 100 mg/kg/day (300 mg/m2 /day) and in rats at up to 20 mg/kg/day (120 mg/m2 /day). the doses in mice and rats are 4 and 1.5 times the human dose of 125 mg/day (77 mg/m2 /day) on a body surface area basis and have revealed no evidence of harm to the fetus due to sodium ferric gluconate complex in sucrose injection. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly ne

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

grifols usa, llc - factor ix complex (unii: fw411qxd5m) (factor ix complex - unii:fw411qxd5m) - factor ix complex 500 [iu] in 5 ml - profilnine, factor ix complex, is indicated for the prevention and control of bleeding in patients with factor ix deficiency (hemophilia b). profilnine contains non-therapeutic levels of factor vii and is not indicated for use in the treatment of factor vii deficiency. none known.

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

takeda pharmaceuticals america, inc. - anti-inhibitor coagulant complex (unii: cs849dun3m) (anti-inhibitor coagulant complex - unii:cs849dun3m) - anti-inhibitor coagulant complex 500 [usp'u] in 20 ml - feiba is an anti-inhibitor coagulant complex indicated for use in hemophilia a and b patients with inhibitors for: - control and prevention of bleeding episodes - perioperative management - routine prophylaxis to prevent or reduce the frequency of bleeding episodes. feiba is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor viii or coagulation factor ix. - known anaphylactic or severe hypersensitivity reactions to feiba or any of its components, including factors of the kinin generating system. - disseminated intravascular coagulation (dic). - acute thrombosis or embolism (including myocardial infarction). risk summary there are no data with feiba use in pregnant women to inform a drug-associated risk. there are no adequate and well-controlled studies in pregnant women. animal reproduction studies have not been conducted with feiba. it is also not known whether feiba can cause fetal harm when administered to a

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

grifols usa, llc - 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 250 [iu] in 5 ml - alphanate, (antihemophilic factor/von willebrand factor complex [human]), is indicated for: - control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with factor viii (fviii) deficiency due to hemophilia a. - surgical and/or invasive procedures in adult and pediatric patients with von willebrand disease (vwd) in whom desmopressin (ddavp) is either ineffective or contraindicated.  it is not indicated for patients with severe vwd (type 3) undergoing major surgery. alphanate is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components [see adverse reactions (6) ]. pregnancy category c.  animal reproduction studies have not been conducted with alphanate.  it is also not known whether alphanate can cause fetal harm when administered to a pregnant woman or affect reproductive capacity.  alphanate should be given to a pregnant woman only if clearly needed.   no human o

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

baxter healthcare corporation - anti-inhibitor coagulant complex (unii: cs849dun3m) (anti-inhibitor coagulant complex - unii:cs849dun3m) - anti-inhibitor coagulant complex 25 [usp'u] in 1 ml

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

hikma pharmaceuticals usa inc. - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. sodium ferric gluconate complex in sucrose injection is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. reactions have included anaphylaxis [see warnings and precautions (5.1) ]. risk summary parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions (5.1) ], which may have serious consequences, such as fetal bradycardia (see clinical considerations ). advise pregnant women of the potential risk to the fetus. available data from postmarketing reports with sodium ferric gluconate complex in sucrose injection use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. sodium ferric gluconate comple

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

hikma pharmaceuticals usa inc. - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. sodium ferric gluconate complex in sucrose injection is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. reactions have included anaphylaxis [see warnings and precautions (5.1) ]. risk summary parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions (5.1) ], which may have serious consequences, such as fetal bradycardia (see clinical considerations ). advise pregnant women of the potential risk to the fetus. available data from postmarketing reports with sodium ferric gluconate complex in sucrose injection use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. sodium ferric gluconate comple

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

Israel - English - Ministry of Health

cts ltd - ferrous as iron iii hydroxide sucrose complex - solution for injection - ferrous as iron iii hydroxide sucrose complex 20 mg/ml - iron-sorbitol-citric acid complex - iron-sorbitol-citric acid complex - venofer is indicated for the treatment of iron deficiency in the following indications:• where there is a clinical need for a rapid iron supply,• in patients who cannot tolerate oral iron therapy or who are non-compliant,• in active inflammatory bowel disease where oral iron preparations are ineffective,• in chronic kidney disease when oral iron preparations are less effective.the diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. hb, serum ferritin, tsat, serum iron, etc.)(hb haemoglobin, tsat transferrin saturation)