País: Países Bajos
Idioma: neerlandés
Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TACROLIMUS 1-WATER 1,022 mg/stuk SAMENSTELLING overeenkomend met ; TACROLIMUS 0-WATER 1 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
L04AD02
TACROLIMUS 1-WATER 1,022 mg/stuk SAMENSTELLING overeenkomend met ; TACROLIMUS 0-WATER 1 mg/stuk
Capsule met verlengde afgifte, hard
ALLURAROOD AC (E 129) ; ALLURAROOD AC ALUMINIUM LAK (E 129) ; BRILJANTBLAUW FCF (E 133) ; BRILJANTBLAUW FCF ALUMINIUMLAK (E133) ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SIMETICON ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110) ; ZWARTE INKT, ALLURAROOD AC (E129) ; ALLURAROOD AC ALUMINIUM LAK (E 129) ; BRILJANTBLAUW FCF (E 133) ; BRILJANTBLAUW FCF ALUMINIUMLAK (E133) ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SIMETICON ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110) ; ZWARTE INKT
Oraal gebruik
Tacrolimus
1900-01-01
Sandoz B.V. Page 1/ 13 Conferoport 0,5/1/2/3/5 mg, harde capsules met verlengde afgifte RVG 124871-73-74-75-76 1313-v7 1.3.1.3 Bijsluiter November 2023 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Conferoport 0,5 mg, harde capsules met verlengde afgifte Conferoport 1 mg, harde capsules met verlengde afgifte Conferoport 2 mg, harde capsules met verlengde afgifte Conferoport 3 mg, harde capsules met verlengde afgifte Conferoport 5 mg, harde capsules met verlengde afgifte 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 [Nationally completed name] contains the active substance tacrolimus. It is an immunosuppressant. Following your organ transplant (liver, kidney), your body’s immune system will try to reject the new organ. [Nationally completed name] is used to control your body’s immune response, enabling your body to accept the transplanted organ. You may also be given [Nationally completed name] for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation. [Nationally completed name] is used in adults. San Leer el documento completo
Sandoz B.V. Page 1/25 Conferoport 0,5/1/2/3/5 mg, harde capsules met verlengde afgifte RVG 124871-73-74-75-76 1313-v6 1.3.1.1 SPC Mei 2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Conferoport 0,5 mg, harde capsules met verlengde afgifte Conferoport 1 mg, harde capsules met verlengde afgifte Conferoport 2 mg, harde capsules met verlengde afgifte Conferoport 3 mg, harde capsules met verlengde afgifte Conferoport 5 mg, harde capsules met verlengde afgifte 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release hard capsule contains 0.5 mg of tacrolimus (as monohydrate). Excipient(s) with known effect Each prolonged-release hard capsule contains 51 mg of lactose (as monohydrate). Each prolonged-release hard capsule contains 5.4 microgram of Sunset yellow FCF (E 110). Each prolonged-release hard capsule contains 0.4 microgram of Allura red AC (E 129). Each prolonged-release hard capsule contains 3.4 microgram of tartrazine (E 102). Each prolonged-release hard capsule contains 1 mg of tacrolimus (as monohydrate). Excipient(s) with known effect Each prolonged-release hard capsule contains 102 mg of lactose (as monohydrate). Each prolonged-release hard capsule contains 7.4 microgram of Sunset yellow FCF (E 110). Each prolonged-release hard capsule contains 0.6 microgram of Allura red AC (E 129). Each prolonged-release hard capsule contains 2 mg of tacrolimus (as monohydrate). Excipient(s) with known effect Each prolonged-release hard capsule contains 204 mg of lactose (as monohydrate). Each prolonged-release hard capsule contains 9.3 microgram of Sunset yellow FCF (E 110). Each prolonged-release hard capsule contains 0.8 microgram of Allura red AC (E 129). Each prolonged-release hard capsule contains 17.4 microgram of tartrazine (E 102). Each prolonged-release hard capsule contains 3 mg of tacrolimus (as monohydrate). Sandoz B.V. Page 2/25 Conferoport 0,5/1/2/3/5 mg, harde capsules met verlengde afgifte RVG 124871-73-74-75-76 1313-v6 1.3.1.1 SPC Mei 2022 Excipient(s) with known effec Leer el documento completo