Land: Nederländerna
Språk: nederländska
Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
GEMCITABINEHYDROCHLORIDE 45,6 mg/ml SAMENSTELLING overeenkomend met ; GEMCITABINE 40 mg/ml
Actavis Group PTC ehf Reykjavikurvegur 76-78 220 HAFNARFJÖRDUR (IJSLAND)
L01BC05
GEMCITABINEHYDROCHLORIDE 45,6 mg/ml SAMENSTELLING overeenkomend met ; GEMCITABINE 40 mg/ml
Concentraat voor oplossing voor infusie
STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),
Intraveneus gebruik
Gemcitabine
Hulpstoffen: STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE; ZOUTZUUR (E 507);
2016-09-13
Gemcitabine, NL/H/3383/001, 26.10.23 1 rvg 116660 EU PIL IA-015 met NL info-clean PACKAGE LEAFLET: INFORMATION FOR THE USER GEMCITABINE RATIOPHARM 40 MG/ML, CONCENTRAAT VOOR OPLOSSING VOOR INFUSIE gemcitabine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What /…/ is and what it is used for 2. What you need to know before you use /…/ 3. How to use /…/ 4. Possible side effects 5. How to store /…/ 6. Contents of the pack and other information 1. WHAT /…/ IS AND WHAT IT IS USED FOR /…/ belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells. /…/ may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer. /…/ is used in the treatment of the following types of cancer: - Non-small cell lung cancer (NSCLC), alone or together with cisplatin - Pancreatic cancer. - Breast cancer, together with paclitaxel. - Ovarian cancer, together with carboplatin. - Bladder cancer, together with cisplatin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE /…/ DO NOT USE /…/: - if you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6). - if you are breast-feeding WARNINGS AND PRECAUTIONS Before the first infusion you will have samples of your blood taken to check if your liver and kidneys are working well enough for you to receive this medicine. Before each infusion you will have samples of your blood taken to check if you have enough blood cells to receive /.../. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too Läs hela dokumentet
Gemcitabine, NL/H/3383/001, 26.10.23 1 Rvg 116660 EU SPC IA-015 met NL info tracked SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gemcitabine ratiopharm 40 mg/ml, concentraat voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 40 mg gemcitabine (as gemcitabine hydrochloride). Each 5 ml vial contains 200 mg gemcitabine (as gemcitabine hydrochloride) Each 25 ml vial contains 1 g gemcitabine (as gemcitabine hydrochloride) Each 50 ml vial contains 2 g gemcitabine (as gemcitabine hydrochloride) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. The pH of the concentrate is 2.4 ± 0.4 and the osmolarity is 270-280 mOsmol/kg. Clear, colourless or pale yellow solution. 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 on Läs hela dokumentet