Hospira Gemcitabine 1g Powder for solution for Infusion

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

gemcitabine hydrochloride, Quantity: 45.54 mg/mL

Disponible des:

Hospira Australia Pty Ltd

Designació comuna internacional (DCI):

Gemcitabine hydrochloride

formulario farmacéutico:

Injection

Composición:

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

Vía de administración:

Intravenous Infusion

Unidades en paquete:

1 x 50 mL

clase:

Medicine Listed (Export Only)

tipo de receta:

(S1) This Schedule is intentionally blank

indicaciones terapéuticas:

Locally advanced or metastatic bladder cancer in combination with other cytostatic medicinal products. - Locally advanced or metastatic breast cancer in combination with paclitaxel in patients experiencing a relapse after adjuvant/neoadjuvant chemotherapy. The preceding chemotherapy should have included an anthracycline unless clinically contraindicated. - Locally advanced or metastatic non-small cell lung cancer in combination with other cytostatic medicinal products. Palliative treatment of adult patients with locally advanced or metastatic nonsmall cell lung cancer. - Locally advanced or metastatic adenocarcinoma of the pancreas in patients who are in good general condition with adequate bone marrow reserves. Patients with 5-fluorouracil refractory pancreatic cancer.

Resumen del producto:

Visual Identification: A clear solution practically free from foreign particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estat d'Autorització:

Listed (Export Only)

Data d'autorització:

2009-07-10