Hospira Gemcitabine for Injection 1g/vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

gemcitabine hydrochloride, Quantity: 45.54 mg/mL

Disponível em:

Hospira Australia Pty Ltd

DCI (Denominação Comum Internacional):

Gemcitabine hydrochloride

Forma farmacêutica:

Injection

Composição:

Excipient Ingredients: mannitol; sodium acetate trihydrate; water for injections; hydrochloric acid; sodium hydroxide

Via de administração:

Intravenous Infusion

Unidades em pacote:

1 x 50 mL

Classe:

Medicine Listed (Export Only)

Tipo de prescrição:

(S1) This Schedule is intentionally blank

Indicações terapêuticas:

Gemcitabine for Injection, USP (gemcitabine hydrochloride) is indicated for the: treatment of patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas to achieve a Clinical Benefit Response (a composite measure of clinical imporvement). Treatment of patients with locally advanced or metastatic non-small lung cancer (NSCLC) as either a single agent or in combination with Cisplatin. Treatment of patients with Stage IV (locally advanced or metastatic) transitional cell carcinoma (TCC) of the bladder in combination with Cisplatin. Treatment, in combination with Paclitaxel, of patients with inresectable, locally recurrent or metastatic breast cancer, who have good performance status and have relapsed following adjuvant anthracycline-based chemotherapy.

Resumo do produto:

Visual Identification: A clear solution practically free from foreign particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store between 15-30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Listed (Export Only)

Data de autorização:

2009-08-06