Australië - Engels - 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

Ierland - Engels - HPRA (Health Products Regulatory Authority)

novartis ireland limited - ciclosporin - capsule, soft - 25 milligram(s) - calcineurin inhibitors; ciclosporin

Ierland - Engels - HPRA (Health Products Regulatory Authority)

novartis ireland limited - ciclosporin - capsule, soft - 25 milligram(s) - calcineurin inhibitors; ciclosporin

Australië - Engels - Department of Health (Therapeutic Goods Administration)

gm pharma international pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: gelatin; peg-40 hydrogenated castor oil; sorbitan oleate; iron oxide black; lecithin; purified water; ethyl lactate; titanium dioxide; polysorbate 20; glycerol; tricaprin - 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).

Australië - Engels - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: purified water; gelatin; sorbitan oleate; lecithin; ethyl lactate; iron oxide black; tricaprin; glycerol; peg-40 hydrogenated castor oil; titanium dioxide; 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).

Australië - Engels - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 25 mg - capsule, soft - excipient ingredients: peg-40 hydrogenated castor oil; polysorbate 20; titanium dioxide; gelatin; iron oxide black; tricaprin; lecithin; glycerol; sorbitan oleate; purified water; 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).

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

hexal new zealand pty limited (ceased trading 31.12.2006) - ciclosporin 25mg - soft gelatin capsule - 25 mg - active: ciclosporin 25mg excipient: ethanol glycerol iron oxide red macrogol 400 polyethylene glycol hydrogenated castor oil purified water sorbitol succinylated gelatin tocofersolan

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

abbott laboratories (nz) ltd - ciclosporin 25mg - capsule - 25 mg - active: ciclosporin 25mg excipient: ethanol gelatin     indigo carmine macrogol 3350 macrogol glycerol ricinoleate polysorbate 80 propylene glycol sorbitan oleate

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ciclosporin 25mg - capsule - 25 mg - active: ciclosporin 25mg excipient: gelatin

Ierland - Engels - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - ciclosporin - capsule, soft - 25 milligram(s) - calcineurin inhibitors; ciclosporin