Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 2.5 g - injection, solution - excipient ingredients: glycine; water for injections - intragam? 10 is indicated for replacement igg therapy in: ?primary immunodeficiency diseases (pid) ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. intragam? 10 is indicated for immunomodulatory therapy in: ?idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count ?kawasaki disease ?guillain-barre syndrome (gbs) ?chronic inflammatory demyelinating polyneuropathy (cidp) ?multifocal motor neuropathy (mmn) ?myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects ?short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients ?treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - anti-d rho immunoglobulin, quantity: 1500 iu - injection, solution - excipient ingredients: chloride; glycine; sodium; albumin - prevention of rh sensitisation in rh(d)-negative females at or below child-bearing age and treatment of rh(d)-negative persons after incompatible transfusions of rh(d)-positive blood or other products containing red blood cells.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - normal immunoglobulin, quantity: 30 g - injection, solution - excipient ingredients: glycine; water for injections - kiovig administered intravenously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid);,? symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,2. immunomodulation indications,? idiopathic thrombocytopenia purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;,? guillain barr? syndrome;,? kawasaki disease;,? chronic inflammatory demyelinating polyradiculoneuropathy (cidp) in adults.,? multifocal motor neuropathy (mmn).,kiovig administered subcutaneously is indicated for:,1. replacement therapy indications,? primary immunodeficiency disorders (pid).

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: water for injections; glycine - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: water for injections; glycine - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 0.05 g in 1 ml - flebogamma 5% dif is an immune globulin intravenous (human) solution indicated in adults and pediatric patients 2 years of age and older for the treatment of primary immunodeficiency (pi), including the humoral immune defects in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and wiskott-aldrich syndrome. - flebogamma 5% dif is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin. - flebogamma 5% dif is contraindicated in iga-deficient patients with antibodies to iga and a history of hypersensitivity. (see warnings and precautions [5.1] ) risk summary there are no studies of flebogamma 5% dif use in pregnant women. animal reproduction studies have not been performed with flebogamma 5% dif. it is also not known whether flebogamma 5% dif can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. flebogamma 5% dif should be given to a pregnant woman only if clearly needed. risk summary there is no information regarding the presence of flebogamma 5% dif in human milk, its effects on the breastfed infant, or its effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for flebogamma 5% dif and any potential adverse effects on the breastfed infant from flebogamma 5% dif or from the underlying maternal condition. flebogamma 5% dif was studied in a multicenter clinical trial for the treatment of pi in 24 subjects aged 2-16 years (seven were 2-5 years of age, seven were 6-11 years, and ten were 12-16 years), and found to be efficacious for the prevention of acute serious bacterial infections. no pediatric-specific dose requirements were necessary to achieve the desired serum igg levels. twenty subjects (83.3%) had at least one adverse reaction at some time during the study that was considered product-related. there were no deaths or serious adverse reactions. treatment-related adverse reactions that occurred with an incidence of at least 5% on a per-subject basis included headache (42%), pyrexia (29%), hypotension (25%), tachycardia (25%), diastolic hypotension (21%), nausea (8%), abdominal pain (8%), diarrhea (8%), pain (8%), and vomiting (8%). safety and efficacy of flebogamma 5% dif in pediatric patients below the age of 2 years have not been established. limited information is available for the geriatric use of flebogamma 5% dif. clinical studies of flebogamma 5% dif did not include sufficient numbers of subjects over the age of 65 to determine whether they respond differently from younger subjects. use caution when administering flebogamma 5% dif to patients age 65 and over who are judged to be at increased risk for developing thrombosis or renal insufficiency. do not exceed recommended dose, and administer flebogamma 5% dif at the minimum dose and infusion rate practicable, and at less than 0.06 ml per kg per minute (3 mg per kg per min). (see boxed warning, warning and precautions [5.2, 5.4], and dosage and administration [2.3] )

Ameerika Ühendriigid - inglise - 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