IRINOTECAN INTAS irinotecan hydrochloride trihydrate 100 mg/5 mL concentrated injection vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
25-11-2017

Aktivna sestavina:

irinotecan hydrochloride trihydrate, Quantity: 100 mg

Dostopno od:

Accord Healthcare Pty Ltd

INN (mednarodno ime):

irinotecan hydrochloride trihydrate

Farmacevtska oblika:

Injection, concentrated

Sestava:

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

Pot uporabe:

Intravenous Infusion

Enote v paketu:

1 vial

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

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

Status dovoljenje:

Licence status A

Datum dovoljenje:

2014-07-25