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

sandoz pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; mannitol; sodium hydroxide; citric acid monohydrate; water for injections; hydrochloric acid; polysorbate 80; adipic acid - rheumatoid arthritis hyrimoz? 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.,hyrimoz? can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis hyrimoz? 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). hyrimoz? can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis hyrimoz? 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 hyrimoz? 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 hyrimoz? is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (?6 years) hyrimoz? 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 to infliximab.,ulcerative colitis hyrimoz? 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 section 5.1 clinical trials).,psoriasis in adults and children hyrimoz? is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. hyrimoz? 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) hyrimoz? 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 hyrimoz? 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.

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

sandoz pty ltd - methotrexate, quantity: 5000 mg - injection, concentrated - excipient ingredients: sodium hydroxide; water for injections - antineoplastic chemotherapy:,methotrexate has a broad spectrum of antineoplastic activity. it is indicated for the treatment of breast cancer and the palliation of acute and subacute lymphocytic leukaemia (greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias). methotrexate is now most commonly used for the maintenance of drug induced remissions.,high dose therapy:,in high dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic sarcoma. calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy.,psoriasis chemotherapy (see warnings box and section 4.4 special warnings and precautions for use).:,methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of treatment. however, due to the high risk associated with its use, methotrexate should be used after diagnosis has been definitely established , as by biopsy and/or after dermatological consultation.

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

sandoz pty ltd - methotrexate, quantity: 1000 mg - injection, concentrated - excipient ingredients: sodium hydroxide; water for injections - antineoplastic chemotherapy:,methotrexate has a broad spectrum of antineoplastic activity. it is indicated for the treatment of breast cancer and the palliation of acute and subacute lymphocytic leukaemia (greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias). methotrexate is now most commonly used for the maintenance of drug induced remissions.,high dose therapy:,in high dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic sarcoma. calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy.,psoriasis chemotherapy (see warnings box and section 4.4 special warnings and precautions for use):,methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of treatment. however, due to the high risk associated with its use, methotrexate should be used after diagnosis has been definitely established , as by biopsy and/or after dermatological consultation.

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

sandoz pty ltd - methotrexate, quantity: 500 mg - injection, concentrated - excipient ingredients: water for injections; sodium hydroxide - antineoplastic chemotherapy:,methotrexate has a broad spectrum of antineoplastic activity. it is indicated for the treatment of breast cancer and the palliation of acute and subacute lymphocytic leukaemia (greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias). methotrexate is now most commonly used for the maintenance of drug induced remissions.,high dose therapy:,in high dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic sarcoma. calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy.,psoriasis chemotherapy (see warnings box and section 4.4 special warnings and precautions for use):,methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of treatment. however, due to the high risk associated with its use, methotrexate should be used after diagnosis has been definitely established , as by biopsy and/or after dermatological consultation.

Australia - English - 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.

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

seqirus pty ltd - tramadol hydrochloride, quantity: 50 mg/ml - injection, solution - excipient ingredients: water for injections; sodium acetate - tramal solution for injection is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

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

seqirus pty ltd - tramadol hydrochloride, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium acetate; water for injections - tramal solution for injection is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Singapore - English - HSA (Health Sciences Authority)

specialised therapeutics asia pte ltd - trabectedin - injection, powder, for solution - 1.0mg/vial - trabectedin 1.0mg/vial

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

juno pharmaceuticals pty ltd - tramadol hydrochloride, quantity: 100 mg - injection, solution - excipient ingredients: sodium acetate trihydrate; water for injections - tramadol an solution for injection is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

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.