देश: नीदरलैंड
भाषा: डच
स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
GEMCITABINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; GEMCITABINE
Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM
L01BC05
GEMCITABINEHYDROCHLORIDE COMPOSITION corresponding to ; GEMCITABINE
Concentraat voor oplossing voor infusie
DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339) ; ETHANOL 395 mg/ml ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),
Intraveneus gebruik
Gemcitabine
Hulpstoffen: DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339); ETHANOL 395 mg/ml; NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE; ZOUTZUUR (E 507);
2011-03-15
Gemcitabine, NL/H/1647/001, 25.10.22 1 rvg 104284 EU PIL IB/022 met NL info-tracked PACKAGE LEAFLET: INFORMATION FOR THE USER GEMCITABINE TEVA 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 evaluate if you have sufficient kidney and liver function. Before each infusion you will have samples of your blood taken to evaluate 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 low. Periodically you will पूरा दस्तावेज़ पढ़ें
Gemcitabine, NL/H/1647/001, 25.10.22 1 rvg 104284 EU SPC IB/022 met NL info-tracked SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Gemcitabine Teva 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. Clear, colourless or pale yellow solution. pH: 2.0 – 2.8 Osmolality: 270 – 280 mOsmol/kg 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 qual पूरा दस्तावेज़ पढ़ें