Modigraf

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

tacrolimus

Available from:

Astellas Pharma Europe B.V.

ATC code:

L04AD02

INN (International Name):

tacrolimus

Therapeutic group:

Immunosuppressants

Therapeutic area:

Graft Rejection

Therapeutic indications:

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

Product summary:

Revision: 19

Authorization status:

Authorised

Authorization date:

2009-05-15

Patient Information leaflet

33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
MODIGRAF 0.2 MG, GRANULES FOR ORAL SUSPENSION
MODIGRAF 1 MG, GRANULES FOR ORAL SUSPENSION
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 Modigraf is and what it is used for
2.
What you need to know before you take Modigraf
3.
How to take Modigraf
4.
Possible side effects
5.
How to store Modigraf
6.
Contents of the pack and other information
1.
WHAT MODIGRAF IS AND WHAT IT IS USED FOR
Modigraf contains the active substance tacrolimus. It is an
immunosuppressant. Following your organ
transplant (e.g., liver, kidney, heart), your body’s immune system
will try to reject the new organ.
Modigraf is used to control your body’s immune response enabling
your body to accept the
transplanted organ.
You may also be given Modigraf 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.
Modigraf is used in adults and children.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MODIGRAF
DO NOT TAKE MODIGRAF
-
If you are allergic to tacrolimus or any of the other ingredients of
this medicine (listed in
section 6).
-
If you are allergic to sirolimus (another substance used to prevent
rejection of your transplanted
organ) or to any macrolide antibiotic (e.g., erythromycin,
clarithromycin, josamycin).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Modigraf
-
if you have or have

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Modigraf 0.2 mg granules for oral suspension
Modigraf 1 mg granules for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Modigraf 0.2 mg granules for oral suspension
Each sachet contains 0.2 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each sachet contains 94.7 mg lactose (as monohydrate).
Modigraf 1 mg granules for oral suspension
Each sachet contains 1 mg tacrolimus (as monohydrate).
Excipient with known effect:
Each sachet contains 473 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral suspension.
White granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in adult and paediatric, kidney,
liver or heart allograft recipients.
Treatment of allograft rejection resistant to treatment with other
immunosuppressive medicinal
products in adult and paediatric patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should only be prescribed, and changes in
immunosuppressive therapy
initiated, by physicians experienced in immunosuppressive therapy and
the management of transplant
patients. Modigraf is a granular formulation of tacrolimus, for
twice-a-day administration. Modigraf
therapy requires careful monitoring by adequately qualified and
equipped personnel.
Posology
The recommended initial doses presented below are intended to act
solely as a guideline. Modigraf is
routinely administered in conjunction with other immunosuppressive
agents in the initial
post-operative period. The dose may vary depending upon the
immunosuppressive regimen chosen.
Modigraf dosing should primarily be based on clinical assessments of
rejection and tolerability in each
patient individually aided by blood level monitoring (see below under
“Therapeutic drug monitoring”).
If clinical signs of rejection are apparent, alteration of the
immunosuppressive regimen should be
considered.
Careful and frequent mo