Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MYCOFENOLAAT NATRIUM SAMENSTELLING overeenkomend met ; MYCOFENOLZUUR
Teva Nederland B.V.
L04AA06
MYCOPHENOLATE SODIUM COMPOSITION corresponding to ; MYCOFENOLZUUR
Maagsapresistente tablet
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZWARTE INKT
Oraal gebruik
Mycophenolic Acid
2015-02-16
Mycophenolic acid, ES/H/0277/001-002, 17.01.18 1 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER ACCEMPA 180 MG MAAGSAPRESISTENTE TABLETTEN Mycophenolic acid 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. Whatis and what it is used for 2. What you need to know before you take Lees het volledige document3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR contains a substance called mycophenolic acid. This belongs to a group of medicines called immunosuppressants. is used to stop the body’s immune system from rejecting a kidney transplant. It is used together with other medicines containing ciclosporin and corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE WARNING Mycophenolic acid causes birth defects and miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor. Your doctor will speak to you and give you written information, particularly on the effects of mycophenolic acid on unborn babies. Read the information carefully and follow the instructions. If you do not fully understand these instructions, please ask your doctor to explain them again before you take . See also further information in this section under “Warnings and precautions”, “Pregnancy and br
Mycophenolic acid, ES/H/0277/001-002, 17.01.18 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Accempa 180 mg maagsapresistente tabletten Accempa 360 mg maagsapresistente tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION180 mg gastro-resistant tablets Each gastro-resistant tablet contains 180 mg mycophenolic acid (as mycophenolate sodium). Excipient with known effect Each tablet contains 13.9 mg (0.61 mmol) sodium. Lees het volledige document360 mg gastro-resistant tablets Each gastro-resistant tablet contains 360 mg mycophenolic acid (as mycophenolate sodium). Excipient with known effect Each tablet contains 27.9 mg (1.21 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet 180 mg gastro-resistant tablets Lime Green colored, round shaped, biconvex, bevelled edged enteric-coated tablets imprinted with M1 on one side with black ink and plain on the other side. Note: Diameter of the tablet is 10.80 ± 0.2 mm 360 mg gastro-resistant tablets Peach colored, oblong shaped, biconvex, enteric-coated tablets imprinted with M2 on one side with black ink and plain on the other side. Note: Length and Width of the tablet is 17.50 ± 0.2 mm and 10.35 ± 0.2 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with should be initiated and maintained by appropriately qualified transplant specialists. POSOLOGY Mycophenolic acid, ES/H/0277/001-002, 17.01.18 2 The recommended dose is 720 mg administered twice daily (1,440 mg daily dose). This dose of mycophenolate sodium corresponds to 1 g mycophenolate mofetil administered twice daily (2 g daily dose) in terms of mycophenolic acid (MPA) content. For additional information about the corresponding therapeutic