Tacrolimus Sandoz 1 mg, capsules, hard

Страна: Нидерландия

Език: нидерландски

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

Активна съставка:

TACROLIMUS 1-WATER SAMENSTELLING overeenkomend met ; TACROLIMUS 0-WATER

Предлага се от:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

АТС код:

L04AD02

INN (Международно Name):

TACROLIMUS 1-WATER COMPOSITION corresponding to ; TACROLIMUS 0-WATER

Лекарствена форма:

Capsule, hard

Композиция:

CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; SORBITANMONOLAURAAT (E 493) ; TITAANDIOXIDE (E 171),

Начин на приложение:

Oraal gebruik

Терапевтична област:

Tacrolimus

Каталог на резюме:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); GELATINE (E 441); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); SORBITANMONOLAURAAT (E 493); TITAANDIOXIDE (E 171);

Дата Оторизация:

2009-12-22

Листовка

Sandoz B.V.
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Tacrolimus Sandoz 0,5/1/5 mg, capsules, hard
RVG 102100-1-2
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1.3.1.3 Bijsluiter
Mei 2020
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TACROLIMUS SANDOZ
® 0,5 MG, CAPSULES, HARD
TACROLIMUS SANDOZ
® 1 MG, CAPSULES, HARD
TACROLIMUS SANDOZ
® 5 MG, CAPSULES, HARD
tacrolimus
_ _
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]
belongs to a group of medicines called
IMMUNOSUPPRESSANTS
.
Following your organ transplant (e.g. liver, kidney, heart), 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. [Nationally completed name] is
often used in
combination with other medicines that also suppress the immune system.
You may also be given
[NATIONALLY COMPLETED NAME]
for an ongoing rejection of your
transplanted liver, kidney, heart or other organ or if any previous
treatment you were taking
was unable to control this immune response after your transplantation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLE

Данни за продукта

Sandoz B.V.
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Tacrolimus Sandoz 0,5 mg/1 mg/5 mg, capsules, hard
RVG 102100-1-2
v11
1.3.1.1 Summary of Product Characteristics
Mei 2020
1
NAME OF THE MEDICINAL PRODUCT
Tacrolimus Sandoz 0,5 mg, capsules, hard
Tacrolimus Sandoz 1 mg, capsules, hard
Tacrolimus Sandoz 5 mg, capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg of tacrolimus (as tacrolimus
monohydrate).
Excipient with known effect:
Each hard capsule contains 46.1 mg lactose (as monohydrate).
Each hard capsule contains 1 mg of tacrolimus (as tacrolimus
monohydrate).
Excipient with known effect:
Each hard capsule contains 45.0 mg lactose (as monohydrate).
Each hard capsule contains 5 mg of tacrolimus (as tacrolimus
monohydrate).
Excipient with known effect:
Each hard capsule contains 225.1 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard
_0.5 mg hard capsules _
Opaque white and ivory hard gelatin capsule containing white to off-
white powder (length: 14.5 mm).
_1 mg hard capsules _
Opaque white and light brown hard gelatin capsule containing white to
off- white powder (length:
14.5 mm).
_5 mg hard capsules _
Opaque white and orange hard gelatin capsule containing white to off-
white powder (length: 15.8
mm).
Sandoz B.V.
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Tacrolimus Sandoz 0,5 mg/1 mg/5 mg, capsules, hard
RVG 102100-1-2
v11
1.3.1.1 Summary of Product Characteristics
Mei 2020
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in liver, kidney or heart
allograft recipients.
Treatment of allograft rejection resistant to treatment with other
immunosuppressive medicinal
products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tacrolimus therapy requires careful monitoring by adequately qualified
and equipped personnel.
The medicinal product should only be prescribed, and changes in
immunosuppressive therapy
initiated, by physicians experienced in immunosuppressive therapy and
the management of transplant
patients.
Inadvertent, unintentional or uns