European Union - English - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin human - diabetes mellitus - drugs used in diabetes - diabetes mellitus where treatment with insulin is required. insulin human winthrop rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.

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

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 0.165 g in 1 ml - gamastan is a human immune globulin indicated for: gamastan is indicated for prophylaxis following exposure to hepatitis a.(1,2) the prophylactic value of gamastan is greatest when given before or soon after exposure to hepatitis a. gamastan is not indicated in persons with clinical manifestations of hepatitis a or in those exposed more than 2 weeks previously. gamastan is indicated to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.(3) a susceptible person is one who has not been vaccinated and has not had measles previously. - gamastan may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest.(3) - gamastan is also indicated for pregnant women without evidence of immunity. - do not give gamastan and measles vaccine at the same time. if a child is older than 12 months and has received gamastan, give measles vaccine about five months later when the measles a

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

sanofi pasteur inc. - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - human rabies virus immune globulin 150 [iu] in 1 ml - rabies immune globulin (human) heat treated, imogam rabies – ht, in conjunction with the standard series of rabies vaccine vaccinations, is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with rabies vaccine. previously immunized persons are those who have had a documented rabies virus neutralizing antibody titer and who have completed one of the recommended regimens (pre-exposure or post-exposure) with a cell culture vaccine or another vaccine. administer only vaccine to these persons (i.e., post-exposure for a person previously vaccinated). (1) inject imogam rabies – ht, as promptly as possible after exposure, along with the first dose of vaccine. if initiation of treatment is delayed for any reason, still administer imogam rabies – ht and the first dose of vaccine, regardless of the interval between exposure and treatment. if rabies immune globulin (human) was not administered when vaccination was begun

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)

csl behring ag - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 5 g in 50 ml - privigen is an immune globulin intravenous (human), 10% liquid indicated for the treatment of the following conditions. privigen is indicated as replacement therapy for primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. privigen is indicated for the treatment of patients age 15 years and older with chronic immune thrombocytopenic purpura (itp) to raise platelet counts. privigen is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (cidp) to improve neuromuscular disability and impairment. limitation of use: privigen maintenance therapy in cidp has not been studied for periods longer than 6 months. after responding during an initial treatment period, not all patients require indefinite maintenance therapy with privigen in order to remain free of cidp

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

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

csl behring gmbh - human c1-esterase inhibitor (unii: 6kic4bb60g) (human c1-esterase inhibitor - unii:6kic4bb60g) - human c1-esterase inhibitor 500 [iu] in 10 ml - berinert is a plasma-derived concentrate of c1 esterase inhibitor (human) indicated for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (hae) attacks in adult and pediatric patients. the safety and efficacy of berinert for prophylactic therapy have not been established. berinert is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to c1 esterase inhibitor preparations. risk summary background risk (general population) a review of available data suggests that major birth defects occur in 2-4% of the u.s. general population and that miscarriage occurs in 15-20% of clinically recognized pregnancies, regardless of drug exposure. data risk in berinert patients in a retrospective case collection study, 20 pregnant women ranging in age from 20 to 35 years received berinert with repeated doses up to 3,500 iu per hae attack; these women reported no complications during delivery and no harmful effects on their 34 neonates

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

csl behring ag - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 6 g - carimune® nf is indicated for the maintenance treatment of patients with primary immunodeficiencies (pid), e.g., common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency.30,32-34 carimune® nf is preferable to intramuscular immune globulin (human) preparations in treating patients who require an immediate and large increase in the intravascular immunoglobulin level28 , in patients with limited muscle mass, and in patients with bleeding tendencies for whom intramuscular injections are contraindicated. the infusions must be repeated at regular intervals. please see dosage and administration section. a controlled study was performed in children in which carimune® was compared with steroids for the treatment of acute (defined as less than 6 months duration) itp. in this study sequential platelet levels of 30,000, 100,000, and 150,000/µl were all achieved faster with carimune® than with steroids and without any of the side effects associated with steroids.29,35 howeve

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

aptevo biotherapeutics llc - human hepatitis b virus immune globulin (unii: xii270yc6m) (human hepatitis b virus immune globulin - unii:xii270yc6m) - human hepatitis b virus immune globulin 312 [iu] in 1 ml - hepagam b [hepatitis b immune globulin intravenous (human)] is an intravenous immune globulin indicated for the following: including - acute exposure to hbsag-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc), - perinatal exposure of infants born to hbsag-positive mothers, - sexual exposure to hbsag-positive persons, and - household exposure to persons with acute hbv infection. - individuals known to have anaphylactic or severe systemic reactions to the parenteral administration of human globulin preparations should not receive hepagam b. - individuals who are deficient in iga may have the potential to develop anti-iga antibodies and have an anaphylactoid reaction. hepagam b contains less than 40 micrograms per milliliter of iga. - hepagam b contains less than 40 micrograms per milliliter of iga. - for postexposure prophylaxis indications, hepagam b must be administered intramuscularly only. in patients who have severe thrombocytopenia or any coagulat

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

bio products laboratory limited - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 5 g in 50 ml - gammaplex 10% is an immune globulin intravenous (human), 10% liquid indicated for replacement therapy in primary humoral immunodeficiency (pi) in adults and pediatric patients 2 years of age and older. this includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. gammaplex 10% is indicated for the treatment of chronic immune thrombocytopenic purpura (itp) in adults to raise platelet counts. - gammaplex 10% is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin - gammaplex 10% is contraindicated in iga-deficient patients with antibodies to iga and a history of hypersensitivity risk summary animal reproduction studies have not been conducted with gammaplex 10%. it is also not known whether gammaplex 10% can cause fetal harm when administered to a pregnant woman or can af