Quốc gia: Hà Lan
Ngôn ngữ: Tiếng Hà Lan
Nguồn: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
RIVAROXABAN 2,5 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
RIVAROXABAN 2,5 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TARTRAZINE ALUMINIUMLAK (E 102) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TARTRAZINE ALUMINIUMLAK (E 102) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110)
Oraal gebruik
2020-12-22
Sandoz B.V. 1313-V10 Rivaroxaban Sandoz ® 2,5 mg, filmomhulde tabletten RVG 125701 1.3.1.3 Bijsluiter juni 2023 BIJSLUITER: INFORMATIE VOOR DE PATIËNT _ _ RIVAROXABAN SANDOZ ® 2,5 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 You have been given [Nationally completed name] because you have been diagnosed with an acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) and have been shown to have had an increase in certain cardiac blood tests. [Nationally completed name] reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to your heart or your blood vessels. [Nationally completed name] will not be given to you on its own. Your doctor will also tell you to take either: - acetylsalicylic acid or - acetylsalicylic acid plus clopidogrel or ticlopidine. or you have been diagnosed with a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms. [Nationally completed name] reduces the risk in adults of getting blot clots (at Đọc toàn bộ tài liệu
Sandoz B.V. Rivaroxaban Sandoz 2,5 mg, filmomhulde tabletten 1311-V6 RVG 125701 1.3.1.1 Samenvatting van de Productkenmerken June 2023 1. NAME OF THE MEDICINAL PRODUCT Rivaroxaban Sandoz 2,5 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg of rivaroxaban. Excipients with known effect: Each film-coated tablet contains 34.46 mg of lactose (as monohydrate), 0.0006 mg of sunset yellow FCF aluminum lake (E 110) and 0.057 mg of tartrazine aluminum lake (E 102). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Yellow coloured, round, biconvex film-coated tablets marked with ‘2.5’ on one side, with a diameter of 6 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name], co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1). [Nationally completed name], co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 2.5 mg twice daily. • _ACS _ Patients taking rivaroxaban 2.5 mg twice daily should also take a daily dose of 75 - 100 mg ASA or a daily dose of 75 - 100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine. Treatment should be regularly evaluated in the individual patient weighing the risk for ischaemic events against the bleeding risks. Extension of treatment beyond 12 months should be done on an individual patient basis as experience up to 24 months is limited (see section 5.1). Sandoz B.V. Rivaroxaban Sandoz 2,5 mg, filmomhulde tabletten 1311-V6 RVG 12 Đọc toàn bộ tài liệu