Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - hepatitis a virus antigen, quantity: 320 agu/ml - injection, suspension - excipient ingredients: neomycin; polysorbate 80; formaldehyde; aluminium hydroxide hydrate; phenoxyethanol; hydrochloric acid; sodium hydroxide; ethanol absolute; glucose monohydrate; ascorbic acid; sodium chloride; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - avaxim is indicated for: active immunisation against hepatitis a infections in adults and children 2 years and older who are or will be at increased risk of infection: - travellers to areas of moderate or high endemicity for hepatitis a. - visitors to rural and remote indigenous communities. - child day-care and pre-school personnel. - the intellectually disabled and their carers. -health care providers. - sewerage workers. - men who have sex with men. - injecting drug users. - patients with chronic liver disease. - haemophiliacs who may receive pooled plasma concentrates.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - tetanus immunoglobulin, quantity: 4000 iu; human immunoglobulin g, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: maltose; water for injections; human immunoglobulin a - tetanus immunoglobulin-vf (for intravenous use) is used in the management of clinical tetanus.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 60 mg/ml - injection, solution - excipient ingredients: maltose; water for injections; human immunoglobulin a - intragam p is indicated in replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. indications as at 21 july 2000: replacement igg therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogenic bone marrow transplantation; kawasaki disease. indications as at 25 february 2003: for replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and; congenital acquired immune deficiency syndrome with recurrent infections. for immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogeneic bone marrow transplantation; kawasaki disease, and; guillain-barre syndrome (gbs).

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 60 mg/ml - injection, solution - excipient ingredients: maltose; human immunoglobulin a; water for injections - intragam p is indicated in replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. indications as at 21 july 2000: replacement igg therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogenic bone marrow transplantation; kawasaki disease. indications as at 25 february 2003: for replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and; congenital acquired immune deficiency syndrome with recurrent infections. for immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogeneic bone marrow transplantation; kawasaki disease, and; guillain-barre syndrome (gbs).

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 60 mg/ml - injection, solution - excipient ingredients: water for injections; human immunoglobulin a; maltose - intragam p is indicated in replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. indications as at 21 july 2000: replacement igg therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogenic bone marrow transplantation; kawasaki disease. indications as at 25 february 2003: for replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and; congenital acquired immune deficiency syndrome with recurrent infections. for immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogeneic bone marrow transplantation; kawasaki disease, and; guillain-barre syndrome (gbs).

Stati Uniti - Ingliż - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 100 mg in 1 ml - gammagard liquid is indicated as replacement therapy for primary humoral immunodeficiency (pi) in adult and pediatric patients two years of age or older. this includes, but is not limited to, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies.1,2 gammagard liquid is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with multifocal motor neuropathy (mmn). gammagard liquid is indicated as a therapy to improve neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy (cidp). limitation of use gammagard liquid has not been studied in immunoglobulin-naive patients with cidp. gammagard liquid 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 gammagard liquid in order to remain free of cidp symptoms. individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy. gammagard liquid is contraindicated in patients who have a history of anaphylactic or severe systemic hypersensitivity reactions to administration of human immune globulin. gammagard liquid is contraindicated in iga-deficient patients with antibodies to iga and a history of hypersensitivity. anaphylaxis has been reported with intravenous use of gammagard liquid and is theoretically possible following subcutaneous administration [see warnings and precautions (5.1)] . risk summary animal reproduction studies have not been conducted with gammagard liquid. it is not known whether gammagard liquid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. gammagard liquid should be given to a pregnant woman only if clearly indicated. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of gammagard liquid 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 gammagard liquid and any potential adverse effects on the breastfed infant from gammagard liquid or from the underlying maternal condition. treatment of primary immunodeficiency (pi) gammagard liquid administered intravenously was evaluated in 15 pediatric subjects with pi (7 subjects aged 2 to <12 years and 8 subjects aged 12 to <16 years) in a multicenter clinical study. gammagard liquid administered subcutaneously was evaluated in 18 pediatric subjects with pi (14 subjects aged 2 to <12 years and 4 subject aged 12 to <16 years) in another multicenter clinical study. the safety and efficacy profiles were similar to adult subjects. no pediatric-specific dose requirements were necessary to achieve the desired serum igg levels. safety and efficacy of gammagard liquid in pediatric patients below the age of 2 have not been established. treatment of multifocal motor neuropathy (mmn) and chronic inflammatory demyelinating polyneuropathy (cidp) safety and effectiveness in pediatric patients with mmn and cidp have not been established. treatment of primary immunodeficiency (pi) limited information is available for the geriatric use of gammagard liquid. gammagard liquid administered intravenously and subcutaneously was evaluated in two pi studies with a total of 8 subjects over the age of 65 years. no differences in safety or efficacy were observed for this group. monitor patients who are at an increased risk for developing renal failure or thrombotic events. do not exceed the recommended dose. infuse at the minimum intravenous infusion rate practicable [see boxed warning, warnings and precautions (5.2, 5.4) and dosage and administration (2.5)] . treatment of multifocal motor neuropathy (mmn) gammagard liquid was administered intravenously for treatment of mmn in 5 subjects aged 65 years and above. there was an insufficient number of subjects aged 65 years and above to determine whether they respond differently from younger subjects [see boxed warning, warnings and precautions (5.2, 5.4) and dosage and administration (2.5)] . treatment of chronic inflammatory demyelinating polyneuropathy (cidp) gammagard liquid was administered intravenously for the treatment of cidp in 5 subjects aged 65 years and above and 15 subjects aged below 65 years. there was an insufficient number of subjects aged 65 years and above to determine whether they respond differently from younger subjects. [see boxed warning, warnings and precautions (5.2, 5.4) and dosage and administration (2.5)] .

Stati Uniti - Ingliż - NLM (National Library of Medicine)

grifols usa, llc - 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 vaccine and hyperrab s/d should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. hyperrab s/d should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the u.s. public health service advisory committee on immunization practices (acip). [19] every exposure to possible rabies infection must be individually evaluated. the following factors should be considered before specific antirabies treatment is initiated: carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies

Stati Uniti - Ingliż - NLM (National Library of Medicine)

grifols usa, llc - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - human rabies virus immune globulin 300 [iu] in 1 ml - hyperrab is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. limitations of use persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.(1-3) for unvaccinated persons, the combination of hyperrab and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.(1-3) beyond 7 days (after the first vaccine dose), hyperrab is not indicated since an antibody response to vaccine is presumed to have occurred. none. risk summary there are no data with hyperrab use in pregnant women to inform a drug-associated risk.  animal reproduction studies have not been conducted with hyperrab.  it is not known whether hyperrab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  hyperrab should be given to a pregna

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - hepatitis b surface antigen, recominant - suspension for injection in pre-filled syringe - 10/0.5 microgram(s)/millilitre - hepatitis vaccines; hepatitis b, purified antigen

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - hepatitis b surface antigen, recominant - suspension for injection in pre-filled syringe - 20/1 microgram(s)/millilitre - hepatitis vaccines; hepatitis b, purified antigen