Երկիր: Նիդերլանդեր
Լեզու: հոլանդերեն
Աղբյուրը: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PANTOPRAZOL NATRIUM 1,5-WATER 45,1 mg/stuk SAMENSTELLING overeenkomend met ; PANTOPRAZOL 40 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
A02BC02
PANTOPRAZOL NATRIUM 1,5-WATER 45,1 mg/stuk SAMENSTELLING overeenkomend met ; PANTOPRAZOL 40 mg/stuk
Maagsapresistente tablet
CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; PONCEAU 4R ALUMINIUMLAK (E 124) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), CALCIUMSTEARAAT (E 470A) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CHINOLINEGEEL ALUMINIUMLAK (E 104) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; NATRIUMCARBONAAT 0-WATER (E 500 (I)) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; PONCEAU 4R ALUMINIUMLAK (E 124) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),
Oraal gebruik
Pantoprazole
Hulpstoffen: CALCIUMSTEARAAT (E 470A); CELLULOSE, MICROKRISTALLIJN (E 460); CHINOLINEGEEL ALUMINIUMLAK (E 104); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); CROSPOVIDON (E 1202); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 400; NATRIUMCARBONAAT 0-WATER (E 500 (I)); NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); PONCEAU 4R ALUMINIUMLAK (E 124); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);
2007-11-23
Sandoz B.V. Page 1/8 Pantoprazol Sandoz 40 mg, maagsapresistente tabletten RVG 33655 1313-V17 1.3.1.3 Package Leaflet November 2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PANTOPRAZOL SANDOZ ® 40 MG, MAAGSAPRESISTENTE TABLETTEN pantoprazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] contains the active substance pantoprazole. Pantoprazole is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine. [Nationally completed name] is used to treat adults and adolescents 12 years of age and above for − Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid. [Nationally completed name] is used to treat adults for − An infection with a bacterium called _Helicobacter pylori _ in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning. − Stomach a Կարդացեք ամբողջական փաստաթուղթը
Sandoz B.V. Page 1/13 Pantoprazol Sandoz 40 mg, maagsapresistente tabletten 1311-V14 RVG 33655 1.3.1.1 Summary of Product Characteristics November 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pantoprazol Sandoz 40 mg, maagsapresistente tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate). Excipient with known effect Each gastro-resistant tablet contains 2 microgram of azo colouring agent Ponceau 4R aluminium lake (E 124). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet A yellow, oval coated tablet, approx. 11.7 x 6.0 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name] is indicated for use in adults and adolescents 12 years of age and above for: − Reflux oesophagitis [Nationally completed name] is indicated in adults for: − Eradication of _Helicobacter pylori _ ( _H. pylori_ ) in combination with appropriate antibiotic therapy in patients with _H. pylori _ associated ulcers − Gastric and duodenal ulcer − Zollinger-Ellison-Syndrome and other pathological hyper secretory conditions 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults and adolescents 12 years of age and above _ _ _ _Reflux oesophagitis _ One tablet of [Nationally completed name] 40 mg per day. In individual cases the dose may be doubled (increase to 2 tablets [Nationally completed name] 40 mg daily) especially when there has been no response to other treatment. A 4-week period is usually required for the treatment of reflux oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks. Sandoz B.V. Page 2/13 Pantoprazol Sandoz 40 mg, maagsapresistente tabletten 1311-V14 RVG 33655 1.3.1.1 Summary of Product Characteristics November 2021 _Adults _ _Eradication of H. pylori in combination with two appropriate antibiotics _ In _H. pylori _ positive patients with gastric and duodenal ulcers, eradication of the Կարդացեք ամբողջական փաստաթուղթը