Conferoport 3 mg, harde capsules met verlengde afgifte

Страна: Нідерланди

мова: голландська

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

Активний інгредієнт:

TACROLIMUS 1-WATER 3,06 mg/stuk SAMENSTELLING overeenkomend met ; TACROLIMUS 0-WATER 3 mg/stuk

Доступна з:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Код атс:

L04AD02

ІПН (Міжнародна Ім'я):

TACROLIMUS 1-WATER 3,06 mg/stuk SAMENSTELLING overeenkomend met ; TACROLIMUS 0-WATER 3 mg/stuk

Фармацевтична форма:

Capsule met verlengde afgifte, hard

Склад:

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

Адміністрація маршрут:

Oraal gebruik

Терапевтична области:

Tacrolimus

Дата Авторизація:

1900-01-01

інформаційний буклет

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

Характеристики 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