Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gemcitabine hydrochloride
Sun Pharmaceutical Industries Europe B.V.
L01BC05
Gemcitabine hydrochloride
200mg
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300; GTIN: 8718104050075
OBJECT 1 GEMCITABINE 200MG POWDER FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 10-May-2018 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company 1. Name of the medicinal product Gemcitabine 200 mg, powder for solution for infusion 2. Qualitative and quantitative composition Each vial contains 200 mg gemcitabine (as hydrochloride) Excipient with known effect: Each vial contains 3.5 mg sodium. One ml of the reconstituted solution for infusion contains 38 mg gemcitabine (as hydrochloride). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for solution for infusion. White to off-white lyophilized cake. 4. Clinical particulars 4.1 Therapeutic indications Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2. Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy. 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. 4.2 Posology and method of administration Gemcitabine should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy. Posology _Bladder cancer_ _Combination use_ The recommended dose for gemcitabine is 1000 mg/m Læs hele dokumentet