CICLOSPORIN-APOTEX ciclosporin 25 mg soft capsule blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

ciclosporin, Quantity: 25 mg

Tillgänglig från:

Arrotex Pharmaceuticals Pty Ltd

Läkemedelsform:

Capsule, soft

Sammansättning:

Excipient Ingredients: Gelatin; titanium dioxide; ethyl lactate; tricaprin; glycerol; purified water; sorbitan oleate; polysorbate 20; iron oxide black; PEG-40 hydrogenated castor oil; lecithin

Administreringssätt:

Oral

Enheter i paketet:

50, 60, 30

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

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).

Produktsammanfattning:

Visual Identification: Grey oval soft gelatin capsules; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

2021-02-09