Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 10 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 4 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 500 mg - injection, concentrated - excipient ingredients: sorbitol; lactic acid; sodium hydroxide; water for injections - irinotecan injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 300 mg - injection, concentrated - excipient ingredients: sorbitol; lactic acid; sodium hydroxide; water for injections - irinotecan injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - fentanyl citrate, quantity: 0.157 mg - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections - fentanyl gh injection is indicated for: ,- analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises; ,- use as an opioid analgesic supplement in general and regional anaesthesia; ,- administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - fentanyl citrate, quantity: 0.785 mg - injection, solution - excipient ingredients: sodium hydroxide; water for injections; sodium chloride - fentanyl gh injection is indicated for: ,- analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises; ,- use as an opioid analgesic supplement in general and regional anaesthesia; ,- administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - levetiracetam, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: glacial acetic acid; water for injections; sodium chloride; sodium acetate trihydrate - levetiracetam (film-coated tablets and oral solution) is indicated for:,? use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation, ? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. ? add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme),and ? add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (ige).,levetiracetam sun concentrated injection after dilution is an alternative for patients when oral administration is temporarily not feasible.

Australia - English - 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.

Australia - English - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - adalimumab, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium chloride; monobasic sodium phosphate dihydrate; citric acid monohydrate; dibasic sodium phosphate dihydrate; polysorbate 80; water for injections; sodium citrate dihydrate; mannitol - rheumatoid arthritis: humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. humira can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis: - polyarticular juvenile idiopathic arthritis: humira in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. - enthesitis-related arthritis: humira is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis: humira is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis: humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn's disease in adults and children (6 years and older): humira is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; - who have had an inadequate response to conventional therapies or, - who have lost response to or are intolerant of infliximab.,ulcerative colitis: humira is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see clinical trials).,psoriasis in adults and children: humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,,hidradenitis suppurativa in adults and adolescents (from 12 years of age): humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,,uveitis: humira is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.