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

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

gemcitabine hydrochloride, Quantity: 43.27 mg/mL

זמין מ:

Hospira Australia Pty Ltd

INN (שם בינלאומי):

Gemcitabine hydrochloride

טופס פרצבטיות:

Injection, concentrated

הרכב:

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

מסלול נתינה (של תרופות):

Intravenous

יחידות באריזה:

1 x 26.3 mL pack

סיווג:

Medicine Listed (Export Only)

סוג מרשם:

(S1) This Schedule is intentionally blank

סממני תרפויטית:

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.

leaflet_short:

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

מצב אישור:

Licence status A

תאריך אישור:

2011-04-20