IRINOTECAN INTAS irinotecan hydrochloride trihydrate 40 mg/2 mL concentrated injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
27-11-2017

유효 성분:

irinotecan hydrochloride trihydrate, Quantity: 40 mg

제공처:

Accord Healthcare Pty Ltd

INN (International Name):

irinotecan hydrochloride trihydrate

약제 형태:

Injection, concentrated

구성:

Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid; sorbitol; lactic acid

관리 경로:

Intravenous Infusion

패키지 단위:

1 vial

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

제품 요약:

Visual Identification: A pale yellow clear solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Licence status A

승인 날짜:

2014-06-12