Hospira Gemcitabine Injection 38 mg/mL, 1 g/26.3 mL vial

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

现在购买

下载 公众评估报告 (PAR)
23-11-2017

有效成分:

gemcitabine hydrochloride, Quantity: 43.27 mg/mL

可用日期:

Hospira Australia Pty Ltd

INN(国际名称):

Gemcitabine hydrochloride

药物剂型:

Injection, concentrated

组成:

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

给药途径:

Intravenous

每包单位数:

1 x 26.3 mL pack

类:

Medicine Listed (Export Only)

处方类型:

(S1) This Schedule is intentionally blank

疗效迹象:

Gemcitabine is indicated for treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelian ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first line therapy. Gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.

產品總結:

Visual Identification: A clear, colourless or light straw-coloured solution, practically free from visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

授权状态:

Licence status A

授权日期:

2011-04-20