Conferoport 2 mg, harde capsules met verlengde afgifte

Страна: Нидерландия

Език: нидерландски

Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активна съставка:

TACROLIMUS 1-WATER 2,04 mg/stuk SAMENSTELLING overeenkomend met ; TACROLIMUS 0-WATER 2 mg/stuk

Предлага се от:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

АТС код:

L04AD02

INN (Международно Name):

TACROLIMUS 1-WATER 2,04 mg/stuk SAMENSTELLING overeenkomend met ; TACROLIMUS 0-WATER 2 mg/stuk

Лекарствена форма:

Capsule met verlengde afgifte, hard

Композиция:

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 ; TARTRAZINE (E 102) ; 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 ; TARTRAZINE (E 102) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF (E 110) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110) ; ZWARTE INKT

Начин на приложение:

Oraal gebruik

Терапевтична област:

Tacrolimus

Дата Оторизация:

1900-01-01

Листовка

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

Данни за продукта

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