CICLOSPORIN GPPL ciclosporin 25 mg soft capsule blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

ciclosporin, Quantity: 25 mg

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

formulario farmacéutico:

Capsule, soft

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

50, 60, 30

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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).

Resumen del producto:

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

Estado de Autorización:

Registered

Fecha de autorización:

2021-02-09