Hospira Gemcitabine Injection 38 mg/mL, 200 mg/5.3 mL vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

gemcitabine hydrochloride, Quantity: 43.27 mg/mL

Disponível em:

Hospira Australia Pty Ltd

DCI (Denominação Comum Internacional):

Gemcitabine hydrochloride

Forma farmacêutica:

Injection, concentrated

Composição:

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

Via de administração:

Intravenous

Unidades em pacote:

1 x 5.3 mL pack

Classe:

Medicine Listed (Export Only)

Tipo de prescrição:

(S1) This Schedule is intentionally blank

Indicações terapêuticas:

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.

Resumo do produto:

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

Status de autorização:

Listed (Export Only)

Data de autorização:

2011-04-20