Advagraf 5mg Prolonged-release hard capsules

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

TACROLIMUS

Saadav alates:

Astellas Pharma Malaysia Sdn Bhd

INN (Rahvusvaheline Nimetus):

TACROLIMUS

Ühikuid pakis:

50capsule Capsules

Valmistatud:

ASTELLAS IRELAND CO., LTD.

Infovoldik

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ADVAGRAF
®
PROLONGED-RELEASE HARD
CAPSULES
Tacrolimus (0.5 mg, 1 mg, 5 mg)
1
WHAT IS IN THIS LEAFLET
1. What _Advagraf _ is used for
2. How _Advagraf _works
3. Before you use _Advagraf_
4. How to use _Advagraf_
5. While you are using it
6. Side effects
7. Storage and Disposal of_ Advagraf_
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT _ADVAGRAF_ IS USED FOR
Following your organ transplant (liver,
kidney), 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 or kidney, when any
previous treatment you were taking
was unable to control this immune
response after your transplantation.
Advagraf is used in adults.
HOW _ADVAGRAF_ WORKS
Advagraf contains an active ingredient
called tacrolimus. It belongs to a group
of medicines called
immunosuppressants. Advagraf
reduces your body’s own defense
mechanism to stop you rejecting your
transplanted organ.
BEFORE YOU USE _ADVAGRAF_
_- When you must not use it _
If you are allergic (hypersensitive) to:
-
tacrolimus or any of the other
ingredients of Advagraf.
-
macrolide antibiotics (e.g.
_erythromycin, clarithromycin, _
_josamycin)._
_- Before you start to use it _
Talk to your doctor or pharmacist before
taking Advagraf.
- If you have liver problems or have
had a disease which may have
affected your liver, please tell your
doctor as this may affect the dose of
Advagraf that you receive.
- If you have an alteration of the
electrical activity of your heart called
QT prolongation.
- If you have diarrhoea for more than
one day, please tell your doctor,
because it might be necessary to
adapt the dose of Advagraf that you
receive.
- If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice
before taking this medicine. Advagraf
passes into breast milk. Therefore,

Toote omadused

NAME OF THE MEDICINAL PRODUCT
ADVAGRAF® 0.5 mg prolonged-release hard capsules
ADVAGRAF® 1 mg prolonged-release hard capsules
ADVAGRAF® 5 mg prolonged-release hard capsules
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prolonged-release hard capsule containing 0.5 mg, 1 mg and 5 mg
tacrolimus on anhydrous basis (as
0.51 mg, 1.02 mg and 5.10 mg tacrolimus as monohydrate).
PRODUCT DESCRIPTION
Advagraf 0.5 mg prolonged-release hard capsules are hard gelatin
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 0.5 mg is supplied in blisters containing 10 capsules
within a protective foil wrapper,
including a desiccant. Packs of 50 prolonged-release capsules are
available.
Advagraf 1 mg prolonged-release hard capsules are hard gelatin
capsules imprinted in red with “1 mg”
on the white capsule cap and “
677” on the orange capsule body, containing white powder. Advagraf
1 mg is supplied in blisters containing 10 capsules within a
protective foil wrapper, including a
desiccant. Packs of 50 prolonged-release capsules are available.
Advagraf 5 mg prolonged-release hard capsules are hard gelatin
capsules imprinted in red with “5 mg”
on the greyish red capsule cap and “
687” on the orange capsule body, containing white powder.
Advagraf 5 mg is supplied in blisters containing 10 capsules within a
protective foil wrapper, including
a desiccant. Packs of 50 prolonged-release hard capsules are
available.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in adult kidney or liver allograft
recipients.
Treatment
of
kidney
or
liver
allograft
rejection
resistant
to
treatment
with
other
immunosuppressive medicinal products in adult patients.
POSOLOGY AND METHOD OF ADMINISTRATION
Advagraf is a once-a-day oral formulation of tacrolimus. Advagraf
therapy requires careful monitoring
by adequately qualified and equipped personnel. This medicinal product
should only be prescribed,
and changes in im