GEMCITABINE AN gemcitabine (as hydrochloride) 2 g powder for injection vial

Active ingredient:

gemcitabine hydrochloride, Quantity: 2.28 g (Equivalent: gemcitabine, Qty 2 g)

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide; sodium acetate; hydrochloric acid; mannitol

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Gemcitabine Injection is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,Gemcitabine Injection is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine AN for Injection is also indicated for patients with 5-FU refractory pancreatic cancer.,Gemcitabine Injection, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,Gemcitabine Injection, 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.,Gemcitabine Injection, in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum? based therapy.

Product summary:

Visual Identification: White to off-white solid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-04-17