Valsts: Nīderlande
Valoda: holandiešu
Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
RIVAROXABAN 15 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
RIVAROXABAN 15 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; NATRIUMLAURILSULFAAT ; POLYETHYLEENGLYCOL (E 1521) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; NATRIUMLAURILSULFAAT (E 487) ; POLYETHYLEENGLYCOL (E 1521) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110)
Oraal gebruik
2020-12-18
Sandoz B.V. Page 1/10 Rivaroxaban Sandoz ® 15 mg, 20 mg, filmomhulde tabletten RVG 125800-801 1313-V5 1.3.1.3 Bijsluiter Mei 2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RIVAROXABAN SANDOZ ® 15 MG, FILMOMHULDE TABLETTEN RIVAROXABAN SANDOZ ® 20 MG, FILMOMHULDE TABLETTEN rivaroxaban 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] contains the active substance rivaroxaban and is used in adults to: • prevent blood clots in brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation. • treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re- occurring in the blood vessels of your legs and/or lungs. [Nationally Completed Name] is used in children and adolescents below 18 years and with a body weight of 30 kg or more to: • treat blood clots and prevent re-occurrence of blood clots in the veins or in the blood vessels of the lungs, following initial treatment of at least 5 days with injectable medicines used to treat blood clots. [Nationally C Izlasiet visu dokumentu
Sandoz B.V. Page 1/35 Rivaroxaban Sandoz 15 mg filmomhulde tabletten RVG 125800 1311-V4 1.3.1.1 Samenvatting van de Productkenmerken Mei 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rivaroxaban Sandoz 15 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg of rivaroxaban. Excipients with known effect: Each film-coated tablet contains 43 mg of lactose (as monohydrate) and 0.114 mg of sunset yellow FCF aluminium lake (E 110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light orange coloured, round, biconvex film-coated tablet marked with ‘15’ on one side, with a diameter of 6 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults _ Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) _Paediatric population _ Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Prevention of stroke and systemic embolism in adults_ The recommended dose is 20 mg once daily, which is also the recommended maximum dose. Therapy with rivaroxaban should be continued long term provided the benefit of prevention of Sandoz B.V. Page 2/35 Rivaroxaban Sandoz 15 mg filmomhulde tabletten RVG 125800 1311-V4 1.3.1.1 Samenvatting van de Productkenmerken Mei 2023 stroke and systemic embolism outweighs the risk of bleeding (see section 4.4). If a dose is missed the patient should take rivaroxaban immedia Izlasiet visu dokumentu