CICLOSPORIN GPPL ciclosporin 100 mg soft capsule blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

ciclosporin, Quantity: 100 mg

Disponibil de la:

Arrotex Pharmaceuticals Pty Ltd

Forma farmaceutică:

Capsule, soft

Compoziție:

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

Calea de administrare:

Oral

Unități în pachet:

50, 30, 60

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

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).

Rezumat produs:

Visual Identification: Grey oblong soft gelatin capsules; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2021-02-09