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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: gelatin; iron oxide black; polysorbate 20; purified water; ethyl lactate; sorbitan oleate; titanium dioxide; peg-40 hydrogenated castor oil; glycerol; tricaprin; lecithin - ciclosporin 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. ciclosporin 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 section 4.4 special warnings and precautions for use). ? 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 quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: gelatin; titanium dioxide; ethyl lactate; tricaprin; glycerol; purified water; sorbitan oleate; polysorbate 20; iron oxide black; peg-40 hydrogenated castor oil; lecithin - ciclosporin 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. ciclosporin 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 section 4.4 special warnings and precautions for use). ? 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 quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: gelatin; ethyl lactate; purified water; lecithin; peg-40 hydrogenated castor oil; iron oxide black; titanium dioxide; polysorbate 20; tricaprin; glycerol; sorbitan oleate - ciclosporin 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. ciclosporin 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 section 4.4 special warnings and precautions for use). ? 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 quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: purified water; gelatin; polysorbate 20; glycerol; lecithin; tricaprin; sorbitan oleate; iron oxide black; titanium dioxide; peg-40 hydrogenated castor oil; ethyl lactate - ciclosporin 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. ciclosporin 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 section 4.4 special warnings and precautions for use). ? 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 quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: gelatin; titanium dioxide; lecithin; peg-40 hydrogenated castor oil; purified water; iron oxide black; sorbitan oleate; polysorbate 20; ethyl lactate; tricaprin; glycerol - ciclosporin 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. ciclosporin 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 section 4.4 special warnings and precautions for use). ? 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 quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 50 mg - capsule, soft - excipient ingredients: gelatin; titanium dioxide; tricaprin; sorbitan oleate; lecithin; purified water; ethyl lactate; polysorbate 20; iron oxide black; peg-40 hydrogenated castor oil; glycerol - ciclosporin 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. ciclosporin 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 section 4.4 special warnings and precautions for use). ? 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 quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 100 mg - capsule, soft - excipient ingredients: gelatin; iron oxide black; ethyl lactate; lecithin; polysorbate 20; glycerol; sorbitan oleate; purified water; tricaprin; peg-40 hydrogenated castor oil; titanium dioxide - ciclosporin 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. ciclosporin 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 section 4.4 special warnings and precautions for use). ? 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 quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).

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

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: titanium dioxide; peg-40 hydrogenated castor oil; propylene glycol; glycerol; corn glycerides; iron oxide black; dl-alpha-tocopherol; gelatin; ethanol; 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: gelatin; peg-40 hydrogenated castor oil; corn glycerides; dl-alpha-tocopherol; titanium dioxide; iron oxide black; ethanol; glycerol; propylene glycol; hypromellose; purified water; isopropyl alcohol; cochineal; aluminium chloride; sodium hydroxide - changes as described in the letter 23 december 1998 from b wall

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 50 mg - capsule, soft - excipient ingredients: purified water; titanium dioxide; lecithin; peg-40 hydrogenated castor oil; gelatin; ethyl lactate; sorbitan oleate; glycerol; tricaprin; iron oxide black; polysorbate 20 - ciclosporin 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. ciclosporin 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 section 4.4 special warnings and precautions for use). ? 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 quality of life. ? for the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.,careful monitoring of all ciclosporin-treated patients is mandatory. ciclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see section 4.4 special warnings and precautions for use).