Austrálie - angličtina - 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.

Austrálie - angličtina - 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.

Austrálie - angličtina - 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

lundbeck australia pty ltd - aripiprazole, quantity: 400 mg (equivalent: aripiprazole monohydrate, qty 416.07 mg) - injection, powder for - excipient ingredients: carmellose sodium; mannitol; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - for the acute and maintenance treatment of schizophrenia in adults. for maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar i disorder in adult patients as monotherapy.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

lundbeck australia pty ltd - aripiprazole, quantity: 300 mg (equivalent: aripiprazole monohydrate, qty 312.05 mg) - injection, powder for - excipient ingredients: carmellose sodium; mannitol; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - for the acute and maintenance treatment of schizophrenia in adults. for maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar i disorder in adult patients as monotherapy.

Austrálie - angličtina - 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.

Austrálie - angličtina - 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).

Austrálie - angličtina - 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).

Austrálie - angličtina - 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).

Austrálie - angličtina - 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).