GETERO gemcitabine (as hydrochloride) 1 g powder for injection vial

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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PAR PAR (PAR)
23-11-2017

active_ingredient:

gemcitabine hydrochloride, Quantity: 1138 mg

MAH:

Hetero Australia Pty Ltd

INN:

Gemcitabine hydrochloride

pharmaceutical_form:

Injection, powder for

composition:

Excipient Ingredients: mannitol; sodium acetate trihydrate; sodium hydroxide

administration_route:

Intravenous Infusion

units_in_package:

1 vial

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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

leaflet_short:

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