Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
APIXABAN 5 mg/stuk
APIXABAN 5 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; 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) ; NATRIUMLAURILSULFAAT (E 487) ; TITAANDIOXIDE (E 171)
Oraal gebruik
2021-09-24
Sandoz B.V. Page 1/10 Abatixent 5 mg filmomhulde tabletten RVG 125877 1313-V3 1.3.1.3 Bijsluiter Mei 2022 _ _ BIJSLUITER: INFORMATIE VOOR DE PATIËNT ABATIXENT 5 MG FILMOMHULDE TABLETTEN apixaban 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 or nurse. • 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 apixaban and belongs to a group of medicines called anticoagulants. This medicine helps to prevent blood clots from forming by blocking Factor Xa, which is an important component of blood clotting. [Nationally Completed Name] is used in adults: • to prevent a blood clot from forming in the heart in patients with an irregular heart beat (atrial fibrillation) and at least one additional risk factor. Blood clots may break off and travel to the brain and lead to a stroke or to other organs and prevent normal blood flow to that organ (also known as a systemic embolism). A stroke can be life-threatening and requires immediate medical attention. • to 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 o Lees het volledige document
Sandoz B.V. Page 1/33 Abatixent 5 mg filmomhulde tabletten RVG 125877 1311-v2 1.3.1.1 Samenvatting van de Productkenmerken Mei 2022 1. NAAM VAN HET GENEESMIDDEL Abatixent 5 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg apixaban. Excipients with known effect Each 5 mg film-coated tablet contains 96 mg lactose (as monohydrate) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Pink, oval, biconvex, film coated tablets, debossed with “AX” on one side and “5” on the other side, with a width of 5.0 – 5.7 mm and a length of 9.6 – 10.3 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) _ The recommended dose of apixaban is 5 mg taken orally twice daily. Sandoz B.V. Page 2/33 Abatixent 5 mg filmomhulde tabletten RVG 125877 1311-v2 1.3.1.1 Samenvatting van de Productkenmerken Mei 2022 _Dose reduction_ The recommended dose of apixaban is 2.5 mg taken orally twice daily in patients with NVAF and at least two of the following characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL (133 micromole/L). Therapy should be continued long-term. _Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTEt)_ The recommended dose of apixaban for the treatment of acute DVT and treatment of PE is 10 mg taken orally twice daily Lees het volledige document