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: 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).

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - ciclosporin 10 mg - capsule, soft - 10 mg - ciclosporin 10 mg - ciclosporin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

novartis pharma sa-nv - ciclosporin 10 mg - capsule, soft - 10 mg - ciclosporin 10 mg - ciclosporin

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ciclosporin 10mg;   - soft gelatin capsule - 10 mg - active: ciclosporin 10mg   excipient: corn oil dl-alpha tocopherol ethanol gelatin glycerol polyethylene glycol hydrogenated castor oil propylene glycol   titanium dioxide - solid organ transplantation prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas allogeneic transplantations. treatment of transplant rejection in patients previously receiving other immunosuppressive agents. bone marrow transplantation prevention of graft rejection following bone marrow transplantation. prevention or treatment of graft-versus-host disease (gvhd).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novartis pharmaceuticals uk ltd - ciclosporin - oral capsule - 10mg

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

novartis pharmaceuticals australia pty ltd - ciclosporin, quantity: 10 mg - capsule, soft - excipient ingredients: corn glycerides; ethanol; propylene glycol; dl-alpha-tocopherol; peg-40 hydrogenated castor oil; glycerol; gelatin; titanium dioxide; isopropyl alcohol; hypromellose; purified water; cochineal; aluminium chloride; sodium hydroxide - 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.

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).

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

arrotex pharmaceuticals pty ltd - ciclosporin, quantity: 50 mg - capsule, soft - excipient ingredients: ethyl lactate; gelatin; polysorbate 20; purified water; tricaprin; titanium dioxide; peg-40 hydrogenated castor oil; lecithin; iron oxide black; sorbitan oleate; 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).