Hospira Gemcitabine Injection 38 mg/mL, 2 g/52.6 mL vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gemcitabine hydrochloride, Quantity: 43.27 mg/mL

Available from:

Hospira Australia Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

Pharmaceutical form:

Injection, concentrated

Composition:

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

Administration route:

Intravenous

Units in package:

1 x 52.6 mL

Class:

Medicine Listed (Export Only)

Prescription type:

(S1) This Schedule is intentionally blank

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Listed (Export Only)

Authorization date:

2011-04-20