Χώρα: Ολλανδία
Γλώσσα: Ολλανδικά
Πηγή: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
GEMCITABINEHYDROCHLORIDE 1140 mg/flacon SAMENSTELLING overeenkomend met ; GEMCITABINE 1000 mg/flacon
Pharmachemie B.V. Swensweg 5 2031 GA HAARLEM
L01BC05
GEMCITABINEHYDROCHLORIDE 1140 mg/flacon SAMENSTELLING overeenkomend met ; GEMCITABINE 1000 mg/flacon
Poeder voor oplossing voor infusie
MANNITOL (D-) (E 421) ; NATRIUMACETAAT 3-WATER (E 262) ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941),
Intraveneus gebruik
Gemcitabine
Hulpstoffen: MANNITOL (D-) (E 421); NATRIUMACETAAT 3-WATER (E 262); NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941);
1900-01-01
Gemcitabine, NL/H/1240/001-002, 26.10.23 1 rvg 101090-1 EU PIL IA/030 met NL info-clean PACKAGE LEAFLET: INFORMATION FOR THE USER GEMCITABINE 200 MG PHARMACHEMIE B.V., POEDER VOOR OPLOSSING VOOR INFUSIE GEMCITABINE 1000 MG PHARMACHEMIE B.V., POEDER 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 Gemcitabine is and what it is used for 2. What you need to know before you use Gemcitabine 3. How to use Gemcitabine 4. Possible side effects 5. How to store Gemcitabine 6. Contents of the pack and other information 1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR Gemcitabine belongs to a group of medicines called “cytotoxics”. These medicines kill dividing cells, including cancer cells. Gemcitabine may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer. Gemcitabine 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 GEMCITABINE DO NOT USE GEMCITABINE: - 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 Gemcitabine. Your do Διαβάστε το πλήρες έγγραφο
Gemcitabine, NL/H/1240/001-002, 26.10.23 1 rvg 101090-1 EU SPC IA/030 met NL info-clean SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gemcitabine 200 mg Pharmachemie B.V., poeder voor oplossing voor infusie Gemcitabine 1000 mg Pharmachemie B.V., poeder voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _GEMCITABINE 200 MG: _ Each vial contains 200 mg of gemcitabine (as hydrochloride). _GEMCITABINE 1 G: _ Each vial contains 1 g of gemcitabine (as hydrochloride). One ml of the reconstituted solution for infusion (see section 6.6) contains 38 mg gemcitabine (as hydrochloride). Excipient with known effect: Each 200 mg vial contains approximately 3.56 mg (0.15 mmol) sodium. Each 1 g vial contains approximately 17.81 mg (0.77 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. White or almost white compact aggregate. After reconstitution in sodium chloride 9 mg/ml (0.9%) the solution is clear to pale opalescent and colourless to pale yellow. The pH of the reconstituted solution in sodium chloride 9 mg/ml (0.9%) solution is 3.0 ± 0.3. The osmolarity of the reconstituted solution (38 mg/ml of gemcitabine (as hydrochloride) in sodium chloride 0.9% solution) is 775 mOsm/l. 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 followin Διαβάστε το πλήρες έγγραφο