GEMCITABINE HETERO gemcitabine (as hydrochloride) 200 mg powder for injection vial

Active ingredient:

gemcitabine hydrochloride, Quantity: 228 mg

Available from:

Hetero Australia Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide; mannitol; sodium acetate trihydrate

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Gemcitabine is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine is also indicated for patients with 5-FU refractory pancreatic cancer.,Gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,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.,Gemcitabine, 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 lyophilised powder to be reconstituted for intravenous use.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-03-03