Hospira Gemcitabine Injection (38 mg/mL) 2 g/52.6 mL (US)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gemcitabine hydrochloride, Quantity: 43.27 mg/mL

Available from:

Hospira Australia Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

1 x 52.6 mL pack

Class:

Medicine Listed (Export Only)

Prescription type:

(S1) This Schedule is intentionally blank

Therapeutic indications:

Ovarian cancer, breast cancer, non small cell lung cancer, pancreatic cancer

Product summary:

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: Child resistant closure and restricted flow insert

Authorization status:

Licence status A

Authorization date:

2011-11-04