Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation); fluticasone propionate, quantity: 500 microgram/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include:,*patients on effective maintenance doses of long-acting beta2-agonists and inhaled corticosteroids.,*patients who are symptomatic on current inhaled corticosteroid therapy.,for the symptomatic treatment of patients with severe copd (fev1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. pavtide is not indicated for the initiation of bronchodilator therapy in copd.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 250 microgram/actuation; salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation) - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include:,*patients on effective maintenance doses of long-acting beta2-agonists and inhaled corticosteroids.,*patients who are symptomatic on current inhaled corticosteroid therapy.,for the symptomatic treatment of patients with severe copd (fev1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. pavtide is not indicated for the initiation of bronchodilator therapy in copd.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation); fluticasone propionate, quantity: 100 microgram/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include:,*patients on effective maintenance doses of long-acting beta-2-agonists and inhaled corticosteroids.,*patients who are symptomatic on current inhaled corticosteroid therapy.,*initiation of maintenance therapy in those patients with moderate persistent asthma not adequately controlled on "as needed" reliever medication, and who have moderate/severe airway limitation and daily symptoms requiring medication every day (see clinical trials).,for the symptomatic treatment of patients with severe copd (fev1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. pavtide is not indicated for the initiation of bronchodilator therapy in copd.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - tetanus toxoid, quantity: 20 lfu/ml; poliovirus, quantity: 80 agu/ml; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; poliovirus, quantity: 16 agu/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 64 agu/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 50 lfu/ml - injection, solution - excipient ingredients: aluminium hydroxide hydrate; water for injections; neomycin sulfate; polymyxin b sulfate; sodium chloride; glucose monohydrate; ascorbic acid; polysorbate 80; 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 - 1. infanrix-ipv is indicated for use in a three dose primary schedule for immunisation of infants from 6 weeks of age and over, against diphtheria, tetanus, pertussis and poliomyelitis. infanrix-ipv is also indicated as a single booster dose for children, up to and including 6 years of age, who have previously been immunised against diphthereia, tetanus, pertussis and polio.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - benzoyl peroxide, quantity: 50 mg/g; clindamycin phosphate, quantity: 11.9 mg/g (equivalent: clindamycin, qty 10 mg/g) - gel - excipient ingredients: silicon dioxide; purified water; glycerol; sodium hydroxide; disodium lauril sulfosuccinate; dimeticone 100; carbomer 980; poloxamer; disodium edetate - for the topical treatment of comedo, papules and pustular acne vulgaris.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - neisseria meningitidis group b neisseria heparin binding antigen fusion protein, quantity: 50 microgram; neisseria meningitidis serogroup b outer membrane vesicles, quantity: 25 microgram; neisseria meningitidis group b factor h binding protein fusion protein, quantity: 50 microgram; neisseria meningitidis group b neisseria adhesin a protein, quantity: 50 microgram - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; histidine; sodium chloride; sucrose - bexsero is indicated for active immunisation against invasive disease caused by n. meningitidis group b strains. for information on protection against specific group b strains see section 5.1 pharmacodynamic properties. bexsero is indicated for vaccination of individuals from 2 months of age and older.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - neisseria meningitidis group b factor h binding protein fusion protein, quantity: 50 microgram; neisseria meningitidis group b neisseria adhesin a protein, quantity: 50 microgram; neisseria meningitidis serogroup b outer membrane vesicles, quantity: 25 microgram; neisseria meningitidis group b neisseria heparin binding antigen fusion protein, quantity: 50 microgram - injection, suspension - excipient ingredients: sucrose; histidine; water for injections; aluminium hydroxide hydrate; sodium chloride - bexsero is indicated for active immunisation against invasive disease caused by n. meningitidis group b strains. for information on protection against specific group b strains see section 5.1 pharmacodynamic properties. bexsero is indicated for vaccination of individuals from 2 months of age and older.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - belimumab, quantity: 400 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; sucrose; citric acid monohydrate; polysorbate 80 - benlysta is indicated for:,add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (sle) with a high degree of disease activity (e.g. ana titre greater than or equal to 1:80 and/or anti-dsdna titre greater than or equal to 30 iu/ml) despite standard therapy.,treatment of active lupus nephritis in adult patients who are receiving standard therapy.,the safety and efficacy of benlysta have not been evaluated in patients with severe active central nervous system lupus.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - belimumab, quantity: 120 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; sucrose; citric acid monohydrate; polysorbate 80 - benlysta is indicated for:,add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (sle) with a high degree of disease activity (e.g. ana titre greater than or equal to 1:80 and/or anti-dsdna titre greater than or equal to 30 iu/ml) despite standard therapy.,treatment of active lupus nephritis in adult patients who are receiving standard therapy.,the safety and efficacy of benlysta have not been evaluated in patients with severe active central nervous system lupus.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - diphtheria toxoid, quantity: 2 iu; pertussis toxoid, quantity: 8 microgram; tetanus toxoid, quantity: 20 iu; pertactin, quantity: 2.5 microgram; pertussis filamentous haemagglutinin, quantity: 8 microgram; poliovirus, quantity: 32 agu - injection, suspension - excipient ingredients: polysorbate 80; aluminium hydroxide hydrate; sodium chloride; neomycin sulfate; water for injections; aluminium phosphate; polymyxin b sulfate; glucose monohydrate; ascorbic acid; 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 - boostrix-ipv is indicated for booster vaccination against diphtheria, tetanus, pertussis and polio of individuals from the age of four years onwards.,boostrix-ipv is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see section 4.2 dose and method of administration, section 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties).,the nhmrc currently recommends only 4 doses of polio vaccines in childhood, and that polio boosters for adults are not necessary unless they are at special risk, such as:,? travellers to areas or countries where poliomyelitis is epidemic or endemic;,? health care workers in possible contact with poliomyelitis cases.,for those exposed to continuing risk of infection a single booster dose is desirable every 10 years.,the nhmrc currently recommends boosting against diphtheria, tetanus and pertussis using an adolescent/adult formulation dtpa at 15 to 17 years of age. before the eighth birthday, dtp-containing vaccines should be given, as they contain a larger dose of diphtheria toxoid. after the eighth birthday, smaller doses of toxoid (adult/adolescent formulation dtpa or dt-containing vaccines) should be given.,a booster dose of dtpa is also recommended:,? before planning pregnancy, or for both parents as soon as possible after delivery of an infant,? for adults working with young children,? for any adult expressing an interest in receiving a booster dose of dtpa, provided that a primary course of dtp vaccine has been given in the past.,clinical data has demonstrated that in adults with an unknown history of pertussis vaccination, the majority had an immunogenic response to pertussis when given boostrix-ipv (see section 5.1 pharmacodynamic properties).,finally, all adults who reach the age of 50 years without having received a boosting dose of dt in the previous 5 years should receive a further boosting dose of dt, where the adult/adolescent formulation dtpa can be used instead.,boostrix-ipv is not intended for primary immunisation.