PROGRAF CAPSULE 1MG

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

TACROLIMUS

Disponibil de la:

Astellas Pharma Malaysia Sdn Bhd

INN (nume internaţional):

TACROLIMUS

Unități în pachet:

50 Capsules; 50 Capsules

Produs de:

ASTELLAS IRELAND CO., LTD.

Prospect

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PROGRAF
®
Tacrolimus (0.5 mg, 1 mg, 5 mg)
1
WHAT IS IN THIS LEAFLET
1. What _Prograf _ is used for
2. How _Prograf _works
3. Before you use _Prograf_
4. How to use _Prograf_
5. While you are using it
6. Side effects
7. Storage and Disposal of _Prograf_
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT _PROGRAF_ IS USED FOR
Prograf is used to control your
body’s immune response enabling
your body to accept the transplanted
liver or kidney.
Prograf is often used in combination
with other medicines that also suppress
the immune system.
You may also be given Prograf for an
ongoing rejection of your transplanted
liver or kidney, or if any previous
treatment you were taking was unable
to control this immune response after
your transplantation.
HOW _PROGRAF_ WORKS
Prograf contains an active ingredient
called tacrolimus. It belongs to a
group of medicines called
immunosuppressants. Prograf reduces
your body’s own defence mechanism
to stop you rejecting your transplanted
organ.
BEFORE YOU USE _PROGRAF_
-
_When you must not use it _
_- _If you are allergic (hypersensitive) to
tacrolimus or any of the other
ingredients of Prograf.
_- _If you are allergic (hypersensitive) to
macrolide antibiotics (e.g.
_erythromycin, clarithromycin, _
_josamycin). _
_Pregnancy and lactation _
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.
Prograf is excreted into breast milk.
Therefore, you should not breast-feed
whilst receiving Prograf.
Prograf contains lactose. If you have
been told by your doctor that you
have an intolerance to some sugars,
contact your doctor before taking
Prograf.
This medicine contains less than
1 mmol sodium (23 mg) per capsule,
that is to say essentially ‘sodium-free’.
The printing ink used on Prograf
capsules 0.5 mg and 1 mg contains
soya lecithin.
If you are allergic to peanut or soya,
talk t

Caracteristicilor produsului

1
TRADEMARK
PROGRAF
NAME OF PRODUCT
Prograf Capsules 0.5 mg, Prograf Capsules 1 mg, Prograf Capsules 5 mg
and Prograf
Concentrate for Infusion 5 mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hard gelatin capsules containing 0.5 mg,1 mg and 5 mg tacrolimus on
anhydrous basis.
Concentrate for intravenous infusion containing tacrolimus 5 mg per 1
ml.
CLINICAL PARTICULARS THERAPEUTIC INDICATIONS
Primary immunosuppression in liver and kidney allograft recipients and
liver and kidney allograft
rejection resistant to conventional immunosuppressive agents. It is
recommended that Prograf be
used concomitantly with adrenal corticosteroids. Because of the risk
of anaphylaxis, Prograf
Injection should be reserved for patients unable to take Prograf
capsules only.
ONLY FOR PROGRAF CAPSULES 0.5 MG AND 1 MG
Lupus nephritis (in a case where the effect of steroids is
insufficient or administration of steroids is
difficult because of their adverse reactions). For lupus nephritis,
the efficacy and safety of this product
for patients in an acute phase with high disease activity has not been
established.
POSOLOGY AND METHOD OF ADMINISTRATION
Prograf 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.
For patients with lupus nephritis, this product should be prescribed
by physicians experienced in
lupus nephritis therapy.
The dosage recommendations given below for oral and intravenous
administration are intended to
act as a guideline. Prograf doses should be adjusted according to
individual patient requirements.
Dosing should commence orally, if necessary via an intranasal gastric
tube. If the clinical condition of
the patient does not allow oral therapy, initial intravenous dosing
may be necessary.
Dosage Level Recommendations
Initial dose level recommendation.
Primary Immunosuppression Dose Levels – Adu