Gemcitabine SUN gemcitabine hydrochloride 1900mg/190mL solution for infusion bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gemcitabine hydrochloride, Quantity: 1900 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous

Units in package:

1 bag, 5 bags, 10 bags

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Gemcitabine SUN 10mg/ml solution for infusion is indicated for treatment of patients with locally advanced or metastatic non-small cell lung cancer. Gemcitabine SUN 10mg/ml solution for infusion is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine SUN 10mg/ml solution for infusion is also indicated for patients with 5-FU refractory pancreatic cancer. Gemcitabine SUN 10mg/ml solution for infusion, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. Gemcitabine SUN 10mg/ml solution for infusion, 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 SUN 10mg/ml solution for infusion, 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: Clear colourless solution in infusion bag with Tube Polyolefins, and minitulip infusion bag stopper; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-06-10