Advagraf

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

tacrolimus

Διαθέσιμο από:

Astellas Pharma Europe BV

Φαρμακολογική κατηγορία (ATC):

L04AD02

INN (Διεθνής Όνομα):

tacrolimus

Θεραπευτική ομάδα:

Immunosuppressants

Θεραπευτική περιοχή:

Graft Rejection

Θεραπευτικές ενδείξεις:

Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.

Περίληψη προϊόντος:

Revision: 26

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2007-04-23

Φύλλο οδηγιών χρήσης

48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADVAGRAF 0.5 MG PROLONGED-RELEASE HARD CAPSULES
ADVAGRAF 1 MG PROLONGED-RELEASE HARD CAPSULES
ADVAGRAF 3 MG PROLONGED-RELEASE HARD CAPSULES
ADVAGRAF 5 MG PROLONGED-RELEASE HARD CAPSULES
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 and 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 Advagraf is and what it is used for
2.
What you need to know before you take Advagraf
3.
How to take Advagraf
4.
Possible side effects
5.
How to store Advagraf
6.
Contents of the pack and other information
1.
WHAT ADVAGRAF IS AND WHAT IT IS USED FOR
Advagraf 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.
Advagraf is
used to control your body’s immune response, enabling your body to
accept the transplanted organ.
You may also be given Advagraf 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.
Advagraf is used in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADVAGRAF
DO NOT TAKE ADVAGRAF
-
if you are allergic (hypersensitive) to tacrolimus or any of the other
ingredients of Advagraf (see
section 6).
-
if you are allergic to sirolimus or to any macrolide-antibiotic (e.g.,
erythromycin,
clarithromycin, josamycin).
WARNINGS AND PRECAUTIONS
Prograf and Advagraf both contain the active substance, tacrolimus.
How

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Advagraf 0.5 mg prolonged-release hard capsules
Advagraf 1 mg prolonged-release hard capsules
Advagraf 3 mg prolonged-release hard capsules
Advagraf 5 mg prolonged-release hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Advagraf 0.5 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as
monohydrate).
Excipients with known effect: Each capsule contains 51.09 mg lactose.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of
total printing ink composition).
Advagraf 1 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 1 mg tacrolimus (as
monohydrate).
Excipients with known effect:
Each capsule contains 102.17 mg lactose.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of
total printing ink composition).
Advagraf 3 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 3 mg tacrolimus (as
monohydrate).
Excipients with known effect: Each capsule contains 306.52 mg lactose.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of
total printing ink composition).
Advagraf 5 mg prolonged-release hard capsules
Each prolonged-release hard capsule contains 5 mg tacrolimus (as
monohydrate).
Excipients with known effect: Each capsule contains 510.9 mg lactose.
The printing ink used to mark the capsule contains trace amounts of
soya lecithin (0.48% of
total printing ink composition).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release hard capsule.
Advagraf 0.5 mg prolonged-release hard capsules
G
elatin capsules imprinted in red with “0.5 mg” on the light yellow
capsule cap and “

647” on
the
orange capsule body, containing white powder.
Advagraf 1 mg prolonged-release hard capsules
Gelatin capsules imprint
ed in red with “1 mg” on the white capsule cap and “

677” o