Страна: Нидерланды
Язык: голландский
Источник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ENTECAVIR 1-WATER SAMENSTELLING overeenkomend met ; ENTECAVIR
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
J05AF10
ENTECAVIR 1-WATER COMPOSITION corresponding to ; ENTECAVIR
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Entecavir
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-08-03
Sandoz B.V. Page 1/7 Entecavir Sandoz ® 0,5 mg/1 mg, filmomhulde tabletten RVG 119703-4 1313-V1 1.3.1.3 Bijsluiter September 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Entecavir Sandoz ® 0,5 mg, filmomhulde tabletten Entecavir Sandoz ® 1 mg, filmomhulde tabletten entecavir 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 or 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 or pharmacist. 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] TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS. [Nationally completed name] can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease). [NATIONALLY COMPLETED NAME] TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS . [Nationally completed name] can be used in children whose liver is damaged but still functions properly (compensated liver disease). Infection by the hepatitis B virus can lead to damage to the liver. [Nationally completed name] reduces the amount of virus in your body, and improves the condition of the li Прочитать полный документ
Sandoz B.V. Page 1/28 Entecavir Sandoz 0,5 mg/1 mg, filmomhulde tabletten RVG 119703-4 1311-V1 1.3.1.1 Samenvatting van de Productkenmerken Februari 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Entecavir Sandoz 0,5 mg, filmomhulde tabletten Entecavir Sandoz 1 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Nationally completed name] 0.5 mg film-coated tablets Each film-coated tablet contains 0.5 mg of entecavir (as monohydrate). Excipient with known effect Each 0.5 mg film-coated tablet contains 114.4 mg of lactose (as monohydrate). [Nationally completed name] 1 mg film-coated tablets Each film-coated tablet contains 1 mg of entecavir (as monohydrate). Excipient with known effect Each 1 mg film-coated tablet contains 228.9 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. [Nationally completed name] 0.5 mg film-coated tablets White, round, film-coated tablet with debossment on both sides, “SZ” on one side and “108” on the other side with diameter approximately 8.0 mm. [Nationally completed name] 1 mg film-coated tablets pink, round, film-coated tablet with debossment on both sides, “SZ” on one side and “109” on the other side with diameter approximately 10.0 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entecavir is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: Sandoz B.V. Page 2/28 Entecavir Sandoz 0,5 mg/1 mg, filmomhulde tabletten RVG 119703-4 1311-V1 1.3.1.1 Samenvatting van de Productkenmerken Februari 2021 • compensated liver disease and evidence of active viral replication, persistently elevated s erum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. • decompensated liver disease (see section 4.4) For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg po Прочитать полный документ