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

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

alphapharm pty ltd - allopurinol, quantity: 300 mg - tablet - excipient ingredients: maize starch; magnesium stearate; povidone; sodium starch glycollate; maltodextrin; microcrystalline cellulose - indications as at 11 may 2001: main clinical manifestations of urate/uric acid deposition. these are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. such clinical manifestations may occur in idiopathic gout, uric acid lithiasis, acute uric acid nephropathy, neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy, certain enzyme disorders which lead to overproduction of urate and involve hypoxanthine guanine phosphoribosyltransferase including lesch-nyhan syndrome, glucose-6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. progout is indicated for the management of 2,8-dihydroxyadenine (2,8-dha) renal stones related to deficient activity of adenine phosphoribosyltransferase. progout is indicated for the management of recurrent mixed calcium oxalate renal stones in the p

Malta - English - Medicines Authority

medicem limited 57a ta’ maggi industrial estate, st. leonard street, xghajra l/o zabbar, zbr 2305, malta - mercaptopurine - tablet - mercaptopurine 50 mg - antineoplastic agents

Malta - English - Medicines Authority

aspen pharma trading limited 3016 lake drive city west businees campus dublin 24, ireland - mercaptopurine - tablet - mercaptopurine 50 mg - antineoplastic agents

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

takeda pharmaceuticals australia pty ltd - vedolizumab, quantity: 119 mg - injection, solution - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; histidine; histidine hydrochloride monohydrate; arginine hydrochloride; polysorbate 80; water for injections - treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist. treatment of adult patients with moderate to severe crohn?s disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.

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

takeda pharmaceuticals australia pty ltd - vedolizumab, quantity: 119 mg - injection, solution - excipient ingredients: citric acid monohydrate; sodium citrate dihydrate; histidine; histidine hydrochloride monohydrate; arginine hydrochloride; polysorbate 80; water for injections - treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.,treatment of adult patients with moderate to severe crohn's disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (tnf-alpha) antagonist.

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

pharmacor pty ltd - colchicine, quantity: 500 microgram - tablet, uncoated - excipient ingredients: magnesium stearate; sodium starch glycollate; microcrystalline cellulose; lactose monohydrate; pregelatinised maize starch - relief of pain in acute gout. colchicine should not be used unless nsaids are contraindicated, or have been used and found to lack analgesic efficacy or to have unacceptable side effects in the individual patient. colchicine is not an analgesic and does not provide relief from other types of pain.

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

pharmacor pty ltd - colchicine, quantity: 500 microgram - tablet, uncoated - excipient ingredients: sodium starch glycollate; pregelatinised maize starch; lactose monohydrate; magnesium stearate; microcrystalline cellulose - relief of pain in acute gout. colchicine should not be used unless nsaids are contraindicated, or have been used and found to lack analgesic efficacy or to have unacceptable side effects in the individual patient. colchicine is not an analgesic and does not provide relief from other types of pain.

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

pharmacor pty ltd - colchicine, quantity: 500 microgram - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; pregelatinised maize starch; microcrystalline cellulose; sodium starch glycollate - relief of pain in acute gout. colchicine should not be used unless nsaids are contraindicated, or have been used and found to lack analgesic efficacy or to have unacceptable side effects in the individual patient. colchicine is not an analgesic and does not provide relief from other types of pain.

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

pharmacor pty ltd - colchicine, quantity: 500 microgram - tablet, uncoated - excipient ingredients: sodium starch glycollate; pregelatinised starch; magnesium stearate; microcrystalline cellulose; lactose monohydrate - relief of pain in acute gout. colchicine should not be used unless nsaids are contraindicated, or have been used and found to lack analgesic efficacy or to have unacceptable side effects in the individual patient. colchicine is not an analgesic and does not provide relief from other types of pain.