Irinotecan hydrochloride Injection 100 mg in 5 mL (10)

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
29-09-2019

有効成分:

irinotecan hydrochloride trihydrate, Quantity: 20 mg/mL

から入手可能:

Pfizer (Perth) Pty Ltd

医薬品形態:

Injection, concentrated

構図:

Excipient Ingredients: sorbitol; water for injections; lactic acid

投与経路:

Intravenous

パッケージ内のユニット:

1 X 5 mL

処方タイプ:

(S1) This Schedule is intentionally blank

適応症:

Irinotecan is indicated for single-agent or combination treatment of patients with: ? Metastatic carcinoma of the colon or rectum that has recurred or progressed following 5-fluorouracil (5-FU)-based therapy ? Irinotecan in combination with cetuximab is indicated for the treatment of patients with epidermal growth receptor (EGFR)-expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy. ? Previously untreated metastatic carcinoma of the colon or rectum ? Advanced cervical squamous cell carcinoma ? Irinotecan in combination with 5-FU, folinic acid (FA) and bevacizumab is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.

製品概要:

Visual Identification: Clear, light yellow solution, free from visible particles.; Container Type: Vial; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Listed (Export Only)

承認日:

2019-09-03