Hospira Gemcitabine for IV Infusion 200 mg

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gemcitabine hydrochloride, Quantity: 45.54 mg/mL

Available from:

Hospira Australia Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: mannitol; sodium acetate trihydrate

Administration route:

Intravenous Infusion

Units in package:

1 X 10 mL vial

Class:

Medicine Listed (Export Only)

Prescription type:

(S1) This Schedule is intentionally blank

Therapeutic indications:

Non-small cell lung cancer, pancreatic cancer, biliary tract cancer, uroepithelial cancer, inoperable or recurrent breast cancer, ovarian cancer progressing after chemotherapy.

Product summary:

Visual Identification: A white to off white lyophilized powder in a clear glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store between 15-25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Listed (Export Only)

Authorization date:

2013-01-07