Pays: Pays-Bas
Langue: néerlandais
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EVEROLIMUS 1 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
L04AA18
EVEROLIMUS 1 mg/stuk
Tablet
BUTYLHYDROXYTOLUEEN (E 321) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b)
Oraal gebruik
Everolimus
1900-01-01
Sandoz B.V. Page 1/8 Aderolio 0.25, 0.5, 0.75, 1 mg, tabletten RVG 121989-91-92-93 1313-V7 1.3.1.1 Bijsluiter Mei 2023 BIJSLUITER: INFORMATIE VOOR DE PATIËNT ADEROLIO 0,25 MG, TABLETTEN ADEROLIO 0,5 MG, TABLETTEN ADEROLIO 0,75 MG, TABLETTEN ADEROLIO 1 MG, TABLETTEN everolimus 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 The active substance of [Nationally completed name] is everolimus. Everolimus belongs to a group of medicines called immunosuppressants. It is used in adults to prevent the body’s immune system from rejecting a transplanted kidney, heart or liver. [Nationally completed name] is used together with other medicines, such as ciclosporin for kidney and heart transplantation, tacrolimus for liver transplantation, and corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] • if you are allergic (hypersensitive) to everolimus or any of the other ingredients of this medicine (listed in section 6). • if you are allergic (hypersensitive) to sirolimus. IF ANY OF THE ABOVE APPLIES TO YOU, TELL YOUR DOCTOR AND DO NOT TAKE [NATIONALLY COMPLETED NAME]. WARNINGS AND PRECA Lire le document complet
Sandoz B.V. Page 1/29 Aderolio 0,25, 0,5, 0,75, 1 mg, tabletten RVG 121989-91-92-93 1311-V8 1.3.1.1 Samenvatting van de Productkenmerken Augustus 2023 1. NAAM VAN HET GENEESMIDDEL Aderolio 0,25 mg, tabletten Aderolio 0,5 mg, tabletten Aderolio 0,75 mg, tabletten Aderolio 1 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Nationally completed name] 0.25 mg tablets Each tablet contains 0.25 mg of everolimus. [Nationally completed name] 0.5 mg tablets Each tablet contains 0.5 mg of everolimus. [Nationally completed name] 0.75 mg tablets Each tablet contains 0.75 mg of everolimus. [Nationally completed name] 1.0 mg tablets Each tablet contains 1.0 mg of everolimus. Excipient(s) with known effect [Nationally completed name] 0.25 mg tablets Each tablet contains 53 mg of lactose. [Nationally completed name] 0.5 mg tablets Each tablet contains 79 mg of lactose. [Nationally completed name] 0.75 mg tablets Each tablet contains 118 mg of lactose. [Nationally completed name] 1.0 mg tablets Each tablet contains 157 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. The tablets are white to yellowish, marbled, round, flat with a bevelled edge. 0.25 mg (diameter of 6 mm): engraved with “C” on one side and “NVR” on the other. 0.5 mg (diameter of 7 mm): engraved with “CH” on one side and “NVR” on the other. 0.75 mg (diameter of 8.5 mm): engraved with “CL” on one side and “NVR” on the other. 1.0 mg (diameter of 9 mm): engraved with “CU” on one side and “NVR” on the other. Sandoz B.V. Page 2/29 Aderolio 0,25, 0,5, 0,75, 1 mg, tabletten RVG 121989-91-92-93 1311-V8 1.3.1.1 Samenvatting van de Productkenmerken Augustus 2023 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kidney and heart transplantation [Nationally completed name] is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk _ _ receiving an allogeneic renal or cardiac transplant. In kidney and heart transplantation, [Nationally comp Lire le document complet