देश: नीदरलैंड
भाषा: डच
स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CICLOSPORINE
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
L04AD01
CYCLOSPORIN
Capsule, zacht
ALUMINIUM CHLORIDE 6-WATER ; CARMINEZUUR (E 120) ; ETHANOL ; GELATINE (E 441) ; GLYCEROL 85 PER CENT (E 422) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ZWART (E 172) ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MAÏSOLIE, MONO-DI-TRIGLYCERIDE ESTERS ; NATRIUMHYDROXIDE (E 524) ; PROPYLEENGLYCOL (E 1520) ; RODE INKT ; TITAANDIOXIDE (E 171) ; TOCOFEROL, DL-ALFA (E 307) ; WATER, GEZUIVERD
Oraal gebruik
Ciclosporin
2019-08-19
Sandoz B.V. Page 1/13 MENELRI 10, 25, 50, 100 mg, zachte capsules (ciclosporine) RVG 122304-7 1311-v4 1.3.1.3 Package leaflet December 2022 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MENELRI 10 MG, ZACHTE CAPSULES MENELRI 25 MG, ZACHTE CAPSULES MENELRI 50 MG, ZACHTE CAPSULES MENELRI 100 MG, ZACHTE CAPSULES ciclosporin 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 name of your medicine is [Nationally completed name]. It contains the active substance ciclosporin. This belongs to a group of medicines known as immunosuppressive agents. These medicines are used to lower the body’s immune reactions. What [nationally completed name] is used for and how [nationally completed name] works • IF YOU HAVE HAD AN ORGAN TRANSPLANT, BONE MARROW AND STEM CELL TRANSPLANTATION , the function of [nationally completed name] is to control your body’s immune system. [nationally completed name] prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue. • IF YOU HAVE AN AUTOIMMUNE DISEASE , in which your body’s immune response attacks your body’s own cells, [nationally completed nam पूरा दस्तावेज़ पढ़ें
Sandoz B.V. Page 1/30 MENELRI 10, 25, 50, 100 mg, zachte capsules (ciclosporine) RVG 122304-7 1311-v4 1.3.1.1 Summary of Product Characteristics December 2022 1. NAAM VAN HET GENEESMIDDEL MENELRI 10 mg, zachte capsules MENELRI 25 mg, zachte capsules MENELRI 50 mg, zachte capsules MENELRI 100 mg, zachte capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 10 mg of ciclosporin. Excipients with known effect Each soft capsule contains 10 mg of ethanol, 20.84 mg of propylene glycol and 40.5 mg of macrogolglycerol hydroxystearate. Each soft capsule contains 25 mg of ciclosporin. Excipients with known effect Each soft capsule contains 25 mg of ethanol, 46.42 mg of propylene glycol and 101.25 mg of macrogolglycerol hydroxystearate. Each soft capsule contains 50 mg of ciclosporin. Excipients with known effect Each soft capsule contains 50 mg of ethanol, 90.36 mg of propylene glycol and 202.5 mg of macrogolglycerol hydroxystearate. Each soft capsule contains 100 mg of ciclosporin. Excipients with known effect Each soft capsule contains 100 mg of ethanol, 148.31 mg of propylene glycol and 405.0 mg of macrogolglycerol hydroxystearate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sandoz B.V. Page 2/30 MENELRI 10, 25, 50, 100 mg, zachte capsules (ciclosporine) RVG 122304-7 1311-v4 1.3.1.1 Summary of Product Characteristics December 2022 Capsule, soft. _10 mg capsules, soft: _ Yellow-white oval shaped soft gelatin capsule, imprinted with “NVR 10” in red. Length: 7.4 – 8.9 mm Diameter: 5.9 – 6.7 mm _25 mg capsules, soft: _ Blue-grey oval shaped soft gelatin capsule, imprinted with “NVR 25mg” in red. Length: max. 14.0 mm Diameter: max. 8.2 mm _50 mg capsules, soft: _ Yellow-white oblong shaped soft gelatin capsule, imprinted with “NVR 50mg” in red. Length: max. 21.9 mm Diameter: max. 8.5 mm _100 mg capsules, soft: _ Blue-grey oblong shaped soft gelatin capsule, imprinted with “NVR 100mg” in red. Length: max. 27.7 mm Diameter: max. 9.5 mm 4. CLINICAL PARTIC पूरा दस्तावेज़ पढ़ें