Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

maxx pharma pty ltd - etanercept, quantity: 50 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; glycine; sucrose; sodium citrate dihydrate; monobasic sodium phosphate dihydrate - nepexto is indicated for the treatment of:,adults,rheumatoid arthritis,active, adult rheumatoid arthritis (ra) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (dmards). nepexto can be used in combination with methotrexate.,severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease.,psoriatic arthritis,the signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. etanercept has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function.,plaque psoriasis,adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.,ankylosing spondylitis,the signs and symptoms of active ankylosing spondylitis in adults.,non-radiographic axial spondyloarthritis,treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or mri change who have had an inadequate response to nsaids.,* active disease is defined as a bath ankylosing spondylitis disease activity index (basdai) score of >= 4.,children and adolescents,children and adolescents weighing less than 62.5 kg should not receive nepexto. these patients should be accurately dosed on a mg/kg basis with other etanercept products.,juvenile idiopathic arthritis,active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more dmards.,active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.,active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy.,active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.,etanercept has not been studied in children aged less than 2 years.,paediatric plaque psoriasis,chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant psoriasis area and severity index (pasi) response is not achieved.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 150 mg - injection, solution - excipient ingredients: polysorbate 20; histidine; arginine hydrochloride; histidine hydrochloride monohydrate; water for injections - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 75 mg - injection, solution - excipient ingredients: arginine hydrochloride; water for injections; histidine; histidine hydrochloride monohydrate; polysorbate 20 - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - octocog alfa, quantity: 2000 iu - injection, diluent for - excipient ingredients: water for injections - kogenate fs is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). it may also be used in patients with factor viii inhibitors (neutralising antibodies) who continue to respond to infused factor viii. kogenate fs does not contain von willebrand factor and hence is not indicated in von willebrands disease.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - octocog alfa, quantity: 3000 iu - injection, diluent for - excipient ingredients: water for injections - kogenate fs is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). it may also be used in patients with factor viii inhibitors (neutralising antibodies) who continue to respond to infused factor viii. kogenate fs does not contain von willebrand factor and hence is not indicated in von willebrands disease.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

intermed medical pty ltd - sodium tetradecyl sulfate, quantity: 5 mg/ml - injection, solution - excipient ingredients: benzyl alcohol; dibasic sodium phosphate dodecahydrate; monobasic potassium phosphate; water for injections; sodium hydroxide - the solution is designed for injection directly into the lumen of the varicose vein and is used as a sclerosant in the treatment of uncomplicated varicose veins of the leg by compression sclerothearpy. the strength of fibrovein selected depends on the size of the veins to be treated. fibrovein 3% is for the treatment of large superficial varicose veins. fibrovein 1% is for the treatment of small varicose veins and the larger venules. minor venules and spider veins (venous flares) should be treated with fibrovein 0.5% or 0.2%. the selection of the incorrect strength particularly in the case of minor venules and spider veins is liable to give risk to adverse reactions.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

australasian medical & scientific ltd - sodium tetradecyl sulfate, quantity: 30 mg/ml - injection, solution - excipient ingredients: benzyl alcohol; water for injections; dibasic sodium phosphate dodecahydrate; monobasic potassium phosphate; sodium hydroxide - indications as at 09 june 2005 : the solution is designed for injection directly into the lumen of the varicose vein and is used as a sclerosant in the treatment of uncomplicated varicose veins of the leg by compression sclerotherapy. the strength of fibrovein selected depends on the size of the veins to be treated. fibrovein 3% is for the treatment of large superficial varicose veins. fibrovein 1% is for the treatment of small varicose veins and the larger venules. minor venules and spider veins (venous flares) should be treated with fibrovein 0.5% or 0.2%. the selection of the incorrect strength particularly in the case of minor venules and spider veins is liable to give rise to adverse reactions.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadoteric acid, quantity: 279.32 mg/ml - injection, solution - excipient ingredients: meglumine; tetraxetan; water for injections - dotagraf is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see section 5.1 pharmacodynamic properties ? clinical trials).

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadoteric acid, quantity: 279.32 mg/ml - injection, solution - excipient ingredients: meglumine; tetraxetan; water for injections - dotagraf is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see section 5.1 pharmacodynamic properties ? clinical trials).

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadoteric acid, quantity: 279.32 mg/ml - injection, solution - excipient ingredients: meglumine; tetraxetan; water for injections - dotagraf is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging (see section 5.1 pharmacodynamic properties ? clinical trials).