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

saol therapeutics inc. - human rho(d) immune globulin (unii: 48w7181flp) (human rho(d) immune globulin - unii:48w7181flp) - winrho® sdf is a rho (d) immune globulin intravenous (human) (anti-d) product that is indicated for the treatment of itp in rho (d)-positive patients and for the suppression of rh isoimmunization in non-sensitized rho (d)-negative patients. winrho® sdf is indicated for use in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomized, rho (d)-positive - children with chronic or acute itp - adults with chronic itp - children and adults with itp secondary to hiv infection the safety and efficacy of winrho® sdf have not been evaluated in clinical trials for patients with non-itp causes of thrombocytopenia or in previously splenectomized patients or in patients who are rho (d)-negative. pregnancy and other obstetric conditions winrho® sdf is indicated for the suppression of rh isoimmunization in non-sensitized, rho (d)-negative (d-negative) women with a rh-incompatible pregnancy, including: - routine antepartum and postpartum rh prophylax

Israel - English - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 100 g/l - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in• primary immunodeficiency syndromes (pid) such as: – congenital agammaglobulinaemia and hypogammaglobulinaemia – common variable immunodeficiency – severe combined immunodeficiency – wiskott-aldrich syndrome• myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections• children with congenital aids and recurrent infectionsimmunomodulation• immune thrombocytopenic purpura (itp) in children or adults at high risk of bleeding or prior to surgical interventions to correct the platelet count• guillain-barré syndrome• kawasaki disease• chronic inflammatory demyelinating polyneuropathy (cidp)allogeneic bone marrow transplantation

Malta - English - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - immunoglobulin g, human - solution for injection - immunoglobulin g, human 5 % (w/v) - immune sera and immunoglobulins

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

pharmacia & upjohn company llc - equine thymocyte immune globulin (unii: 475247qf1z) (equine thymocyte immune globulin - unii:475247qf1z) - equine thymocyte immune globulin 50 mg in 1 ml - atgam is indicated for the management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection atgam increases the frequency of resolution of the acute rejection episode [see clinical studies (14.1)] . atgam is indicated for the treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation [see clinical studies (14.2)] . the usefulness of atgam has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, fanconi's syndrome, or in patients known to have been exposed to myelotoxic agents or radiation. do not administer atgam to a patient who has had an anaphylactic reaction during prior administration of atgam or any other equine gamma globulin preparation [see warnings and precautions (5.1)]. risk summary there are no adequate and well-controlled studies in pregnant women. there is a limited amount of data from the use of atgam in pregnant women. it is also not known whether atgam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. the outcome of pregnancies cannot be determined. use atgam during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcome. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data in embryo-fetal toxicity studies, atgam was administered to rats and cynomolgus monkeys for 11 and 16 days, respectively during organogenesis. in rats, hypoplastic cervical vertebrae, a finding consistent with delayed skeletal development, were observed in fetuses whose dams received atgam at doses of 100 mg/kg/day during organogenesis. in monkey reproduction studies, maternal toxicity (vaginal bleeding, decreased body weight and loss of appetite) was observed with atgam doses ≥20 mg/kg/day after 16 days of dosing. fetal deaths occurred in dams treated with 20 mg/kg/day atgam earlier in organogenesis (days 20‑35), but not when treatment was given at a later part of organogenesis (days 35-50). the maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share. therefore, this toxicity is not considered relevant to human fetal development. risk summary it is not known if atgam is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding neonates and infants from atgam, a decision should be made whether to discontinue breast-feeding or to discontinue the drug taking into account the importance of the drug to the mother. data in animal studies, a single dose of atgam up to 40 mg/kg was not detected at the limit of quantification in the milk of lactating cynomolgus monkeys. contraception females it is not known if atgam can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with atgam and for at least 10 weeks after cessation of therapy. males advise males with a female partner of reproductive potential to use effective contraception during treatment with atgam and for at least 10 weeks after cessation of therapy. infertility in fertility studies, atgam at doses 10, 20 and 40 mg/kg/day was administered to cynomolgus monkeys (macaca fascicularis) for 14 days either before (male monkeys) or before and after (female monkeys) cohabitation with untreated mates. atgam treatment was not associated with male or female hormonal or copulation behavior changes. a decrease in fertility index in female monkeys receiving atgam was seen. female toxicity, including death, was observed with atgam doses of ≥20 mg/kg/day. while the etiology of this toxicity is uncertain, it may be attributed to hemolytic anemia due to cross-reactivity of atgam to a monkey red blood antigen. experience with children has been limited. atgam has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults. clinical experience in a limited number of elderly patients (≥65 years of age) has not identified differences in responses between the elderly and younger patients. select the dose for an elderly patient with caution, starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of comorbidities or other drug therapy in this age group.

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

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 10 g in 100 ml - gamunex-c is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: gamunex-c is indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.(1-4) gamunex-c is indicated for the treatment of adults and children with idiopathic thrombocytopenic purpura to raise platelet counts to prevent bleeding or to allow a patient with itp to undergo surgery.(5,6) gamunex-c is indicated for the treatment of cidp in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. gamunex-c is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. gamunex-c is contraindicated in iga deficient patients with antibodies against iga and history of h

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

kedrion biopharma, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 10 g in 100 ml - gammaked is an immune globulin injection (human) 10% liquid that is indicated for the treatment of: gammaked is indicated for treatment of primary humoral immunodeficiency in patients 2 years of age and older. this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.(1-4) gammaked is indicated for the treatment of adults and children with idiopathic thrombocytopenic purpura to raise platelet counts to prevent bleeding or to allow a patient with itp to undergo surgery.(5,6) gammaked is indicated for the treatment of cidp in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse. gammaked is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. gammaked is contraindicated in iga deficient patients with antibodies against iga and history of hyperse

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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - coral snake (micrurus fulvius) immune globulin antivenin (equine) (unii: y605xbm2gl) (coral snake (micrurus fulvius) immune globulin antivenin (equine) - unii:y605xbm2gl) - coral snake (micrurus fulvius) immune globulin antivenin (equine) 250 [arb'u] in 10 ml - north american coral snake antivenin (equine) is indicated only for the treatment of envenomation caused by bites of north american coral snakes - micrurus (including the eastern and texas varieties). risk summary there are no available human data that establish developmental toxicity related to the use of north american coral snake antivenin (equine). there are no available animal data informing the north american coral snake antivenin (equine)-associated risk. north american coral snake antivenin (equine) should be given to a pregnant woman only if clearly required. in the us general population, the background risk of major birth defects is 2–4% and of miscarriage is 15–20% in clinically recognized pregnancies. risk summary lactation studies have not been conducted with north american coral snake antivenin (equine). it is not known whether north american coral snake antivenin (equine) is excreted in human milk. north american coral snake antivenin (equine) should be administered to lactating women only if

Australia - English - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 20 g - injection, solution - excipient ingredients: human immunoglobulin a; water for injections; sorbitol - replacement therapy indications: - primary immunodeficiency (pi) diseases - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,immunomodulation indications: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - guillain barr? syndrome - kawasaki disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 g - injection, solution - excipient ingredients: human immunoglobulin a; water for injections; sorbitol - replacement therapy indications: - primary immunodeficiency (pi) diseases - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,immunomodulation indications: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count. - guillain barr? syndrome - kawasaki disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - rabbit antithymocyte immunoglobulin, quantity: 25 mg - injection, powder for - excipient ingredients: sodium chloride; glycine; mannitol - thymoglobuline (rabbit anti-human thymocyte immunoglobulin) is indicated for the prophylaxis of graft rejection in renal transplantation; treatment of steroid-resistant or moderate to severe renal transplant rejection: and treatment of refractory or relapsing aplastic anaemia.