CICLOSPORIN GENPAR ciclosporin 50 mg soft capsule blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
12-04-2021

有効成分:

ciclosporin, Quantity: 50 mg

から入手可能:

Arrotex Pharmaceuticals Pty Ltd

医薬品形態:

Capsule, soft

構図:

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

投与経路:

Oral

パッケージ内のユニット:

50, 60, 30

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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).

製品概要:

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: 24 Months; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Registered

承認日:

2021-02-09