Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
GEMCITABINE
HOSPIRA UK Ltd
1 Grams
Pdr for Soln for Infusion
2007-11-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gemcitabine 1 g Powder for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains gemcitabine hydrochloride, equivalent to 1 g gemcitabine. After reconstitution, the solution contains 38 mg/ml gemcitabine (as hydrochloride). Excipients Each 1 g vial contains approximately 17.5 mg (0.75 mmol) sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion (powder for infusion) White to off-white plug or powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BLADDER CANCER: Locally advanced or metastatic bladder cancer, in combination with cisplatin. PANCREATIC CANCER: Locally advanced or metastatic adenocarcinoma of the pancreas. NON-SMALL CELL LUNG CANCER: First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, in combination with cisplatin. Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2. OVARIAN CANCER: 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. BREAST CANCER: Unresectable, locally recurrent or metastatic breast cancer, in combination with paclitaxel, in patients experiencing a relapse after adjuvant/neoadjuvant chemotherapy. The preceding chemotherapy should have included an anthracycline, unless clinically contraindicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous infusion, following reconstitution. Upon reconstitution a colourless or slightly yellow solution is produced. GEMCITABINE SHOULD ONLY BE PRESCRIBED BY A PHYSICIAN QUALIFIED IN THE USE OF ANTI-CANCER CHEMOTHERAPY. Perskaitykite visą dokumentą