אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - anti-d rho immunoglobulin, quantity: 250 iu; anti-d rho immunoglobulin, quantity: 10 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - rh(d) immunoglobulin is indicated for the prevention of rh sensitisation in rh(d)negative females at or below child bearing age.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - anti-d rho immunoglobulin, quantity: 625 iu; anti-d rho immunoglobulin, quantity: 30 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - indications as at 6 august 2002 : rh(d) immunoglobulin is indicated for the prevention of rh sensitisation in rh(d) negative females at or below child bearing age.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - human immunoglobulin g, quantity: 0.06 g/ml - injection, solution - excipient ingredients: maltose - replacement therapy in adults and children: ?primary immunodeficiency diseases (pid). ?symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in adults and children: ?idiopathic thrombocytopenic purpura (itp) in patients at high risk of bleeding or prior to surgery to correct the platelet count. ?guillain-barr? syndrome (gbs). ?kawasaki disease.

אירלנד - אנגלית - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human plasma protein >90% gamma globulin - powder and solvent for solution for infusion - 0.5 g/30 m gram(s)/millilitre - immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm. - immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration - primary immunodeficiency syndromes (pid): congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeficiencies severe combined immunodeficiencies wiskott aldrich syndrome myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections children with congenital aids and recurrent infections

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - normal immunoglobulin, quantity: 100 mg/ml - injection, intravenous infusion - excipient ingredients: dilute hydrochloric acid; sodium hydroxide; glycine; water for injections - replacement therapy in. * primary immunodeficiency diseases. * symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation. * idiopathic thrombocytopenic purpura, in adults or children at high risk of bleeding or prior to surgery to correct the platelet count.. * guillain barre syndrome. * kawasaki disease.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - normal immunoglobulin, quantity: 100 mg/ml - injection, intravenous infusion - excipient ingredients: dilute hydrochloric acid; sodium hydroxide; glycine; water for injections - replacement therapy in. * primary immunodeficiency diseases. * symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation. * idiopathic thrombocytopenic purpura, in adults or children at high risk of bleeding or prior to surgery to correct the platelet count.. * guillain barre syndrome. * kawasaki disease.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - normal immunoglobulin, quantity: 100 mg/ml - injection, intravenous infusion - excipient ingredients: dilute hydrochloric acid; sodium hydroxide; glycine; water for injections - replacement therapy in. * primary immunodeficiency diseases. * symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation. * idiopathic thrombocytopenic purpura, in adults or children at high risk of bleeding or prior to surgery to correct the platelet count.. * guillain barre syndrome. * kawasaki disease.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - normal immunoglobulin, quantity: 100 mg/ml - injection, intravenous infusion - excipient ingredients: dilute hydrochloric acid; sodium hydroxide; glycine; water for injections - replacement therapy in. * primary immunodeficiency diseases. * symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation. * idiopathic thrombocytopenic purpura, in adults or children at high risk of bleeding or prior to surgery to correct the platelet count.. * guillain barre syndrome. * kawasaki disease.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 40 g - injection, solution - excipient ingredients: water for injections; proline - replacement therapy for primary immunodeficiency diseases (pid), myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy for idiopathic thrombocytopenic purpura (itp) in patients at high risk of bleeding or prior to surgery to correct the platelet count, guillain-barr syndrome (gbs), kawasaki disease, chronic inflammatory demyelinating polyneuropathy (cidp), multifocal motor neuropathy (mmn), myasthenia gravis (mg) exacerbations, lambert-eaton myasthenic syndrome (lems), stiff person syndrome (sps).

ארצות הברית - אנגלית - 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] )