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

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 100 mg - capsule, soft - excipient ingredients: propylene glycol; iron oxide black; titanium dioxide; corn glycerides; dl-alpha-tocopherol; glycerol; gelatin; ethanol; peg-40 hydrogenated castor oil; hypromellose; purified water; isopropyl alcohol; cochineal; aluminium chloride; sodium hydroxide - cyclosporin sandoz is indicated as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. for induction and/or maintenance of remission in the nephrotic syndrome. cyclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see precautions). for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with the quality of life. for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate. careful monitoring of all cyclosporin-treated patients is mandatory. cyclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see "precautions").

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

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 50 mg - capsule, soft - excipient ingredients: propylene glycol; ethanol; glycerol; titanium dioxide; peg-40 hydrogenated castor oil; gelatin; corn glycerides; dl-alpha-tocopherol; hypromellose; purified water; isopropyl alcohol; cochineal; aluminium chloride; sodium hydroxide - cyclosporin sandoz is indicated as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. for induction and/or maintenance of remission in the nephrotic syndrome. cyclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see precautions). for the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with the quality of life. for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate. careful monitoring of all cyclosporin-treated patients is mandatory. cyclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see "precautions").

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

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: iron oxide red; gelatin; corn oil peg-6 esters; titanium dioxide; glycerol; ethanol; maize oil; purified water; sorbitol; 1,4-sorbitan; mannitol; hydrogenated starch hydrosylate - this product accepted for registration as 'currently supplied' at the time of commencement of the act. new indications were approved as specified in the letter of 16 june 1992 from dr l. hunt. indications: as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. extended indications as at 15 october 1993: for induction and/or maintenance of remission in the nephrotic syndrome. cyclosporin is not a first-line agent. its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired. indications as at 11 february 1994 from dr j. mcginness. 1. as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogenic transplantation. 2. for induction and/or maintenance of remission in the nephrotic syndrome. cyclosporin is not a first-line agent. its use should be restricted to occasions

Israel - English - Ministry of Health

novartis israel ltd - ciclosporin - capsules - ciclosporin 25 mg - cyclosporin - cyclosporin - prophylaxis of organ rejection in kidney liver heart allogenic transplants in conjunction with corticosteroids. may also be used in the treatment of chronic rejection in patients previously treated with other immuno-suppressive agents. bone marrow transplantation. endogenous uveitis. severe psoriasis above age 16 that did not respond to other treatment. atopic dermatitis in adults only up to 8 weeks for severe cases in which conventional therapy is ineffective or inappropriate. rheumatoid arthritis: severe cases in which standard treatments are ineffective or inappropriate. nephrotic syndrom type mcd (minimal change disease) in cases where conventional therapy has failed.

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

alphapharm pty ltd - hydrochlorothiazide, quantity: 25 mg; telmisartan, quantity: 80 mg - tablet, multilayer - excipient ingredients: meglumine; sodium hydroxide; mannitol; povidone; magnesium stearate; lactose monohydrate; purified water; sodium stearylfumarate; colour - mizart hct is indicated for the treatment of hypertension. treatment should not be initiated with these combinations.

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

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 125 mg; lumacaftor, quantity: 200 mg - tablet, film coated - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; microcrystalline cellulose; povidone; magnesium stearate; croscarmellose sodium; titanium dioxide; purified water; purified talc; brilliant blue fcf aluminium lake; polyvinyl alcohol; macrogol 3350; cochineal; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - orkambi is indicated for the treatment of cystic fibrosis (cf) in patients aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

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

arrotex pharmaceuticals pty ltd - hydrochlorothiazide, quantity: 25 mg; telmisartan, quantity: 80 mg - tablet, multilayer - excipient ingredients: meglumine; magnesium stearate; sodium stearylfumarate; povidone; mannitol; purified water; sodium hydroxide; lactose monohydrate; colour - teltartan hct is indicated for the treatment of hypertension. treatment should not be initiated with these combinations.

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

arrotex pharmaceuticals pty ltd - hydrochlorothiazide, quantity: 25 mg; telmisartan, quantity: 80 mg - tablet, multilayer - excipient ingredients: meglumine; sodium hydroxide; mannitol; povidone; magnesium stearate; lactose monohydrate; purified water; sodium stearylfumarate; colour - apo telmisartan hctz is indicated for the treatment of hypertension. treatment should not be initiated with these combinations.

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

sandoz pty ltd - hydrochlorothiazide, quantity: 25 mg; telmisartan, quantity: 80 mg - tablet, film coated - excipient ingredients: meglumine; sodium hydroxide; citric acid monohydrate; lactose; macrogol poly(vinyl alcohol) grafted polymer; povidone; magnesium stearate; colloidal anhydrous silica; iron oxide yellow; lactose monohydrate; crospovidone - telmisartan/hct sandoz? is indicated for the treatment of hypertension. treatment should not be initiated with these combinations.

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

alphapharm pty ltd - hydrochlorothiazide, quantity: 25 mg; valsartan, quantity: 160 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; povidone; pregelatinised maize starch; microcrystalline cellulose; sodium lauryl sulfate; crospovidone; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow; iron oxide red; iron oxide black - dilart?hct is indicated for the treatment of hypertension. treatment should not be initiated with these combinations.