Myaccord

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Mycophenolate mofetil 500mg;  

Disponibbli minn:

Douglas Pharmaceuticals Limited

INN (Isem Internazzjonali):

Mycophenolate mofetil 500 mg

Dożaġġ:

500 mg

Għamla farmaċewtika:

Film coated tablet

Kompożizzjoni:

Active: Mycophenolate mofetil 500mg   Excipient: Croscarmellose sodium Hyprolose Magnesium stearate Microcrystalline cellulose Opadry purple 03B50110 Povidone Purified talc

Unitajiet fil-pakkett:

Blister pack, PVC/PVDC/aluminium foil, 50 tablets

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Concord Biotech Limited

Indikazzjonijiet terapewtiċi:

for the prophylaxis of acute organ rejection in patients receiving allogeneic renal transplants.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/aluminium foil - 50 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PVDC/aluminium - 100 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture

Data ta 'l-awtorizzazzjoni:

2006-06-22

Fuljett ta 'informazzjoni

CONSUMER MEDICINE INFORMATION 
MYACCORD 
MYCOPHENOLATE MOFETIL 250 MG CAPSULES AND 500 MG TABLETS  
WHAT IS IN THIS LEAFLET 
•  This leaflet answers some if not all of the common questions about 
MYACCORD capsules and tablets. 
•  It will not have all the available information. 
•  It does not take the place of talking to your doctor or pharmacist. 
•  Your doctor has weighed the risks of you taking MYACCORD against its 
benefits before prescribing it for you.  
•  If you have any concerns about taking this medicine do ask your doctor 
or pharmacist. 
•  Keep this leaflet with the medicine. You may need to read it again. 
WHAT IS MYACCORD USED FOR 
•  MYACCORD contains the active ingredient mycophenolate mofetil which 
belongs to a group of medicines called immunosuppressants. It is these 
immunosuppressants that are used to prevent rejection of transplanted 
organs, and work by stopping your immune system from reacting to the 
transplanted organ. 
•  MYACCORD may be used together with other medicines known as 
ciclosporin and corticosteroids. 
•  At times your doctor may have prescribed MYACCORD for some other 
purpose. 
•  If in doubt, do ask your doctor if you have any questions about 
MYACCORD. 
•  This medicine is available only with a doctor's prescription. 
BEFORE YOU TAKE MYACCORD 
_WHEN YOU MUST NOT TAKE IT _

•  The medicine should not be taken if: 
1.  the package is torn or shows signs of tampering  
2.  the expiry date printed on the pack has passed.  The medicine 
may not work as well if you take it after the expiry date has 
passed.  

   3.   you have had an allergic reaction to MYACCORD or any 
ingredients listed at the end of this leaflet. 
 Allergic r

Karatteristiċi tal-prodott

DATA SHEET
MYACCORD
Mycophenolate mofetil
Immunosuppressant; inosine monophosphate dehydrogenase (IMPDH)
inhibitor
PHARMACEUTICAL FORM
ORAL ADMINISTRATION
Myaccord is supplied as capsules and tablets.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
Mycophenolate mofetil (MMF).
_ _
_ORAL ADMINISTRATION _
Each capsule contains 250 mg mycophenolate mofetil.
Each tablet contains 500 mg mycophenolate mofetil. Do not halve
tablet. Dose
equivalence when the tablet is divided has not been established.
APPEARANCE
_Myaccord capsules 250 mg_: Light blue/peach, hard gelatin capsules
with ‘MMF’
on the cap and ‘250’ on the body containing white to off white
powder.
_Myaccord tablets 500 mg:_ Purple coloured, capsule shaped, biconvex,
film
coated tablets engraved ‘AHI’ on one side and ‘500’ on the
other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Myaccord is indicated for the prophylaxis of acute organ rejection in
patients
receiving allogeneic renal transplants.
Myaccord is indicated for the prophylaxis of acute organ rejection in
patients
receiving allogeneic cardiac transplants. In the treated population,
MMF
improved survival in the first year after transplantation.
Myaccord is indicated for the prophylaxis of acute organ rejection in
patients
receiving allogeneic hepatic transplants.
Myaccord should be used concomitantly with ciclosporin and
corticosteroids.
DOSAGE AND METHOD OF ADMINISTRATION
Do not halve tablet. Dose equivalence when the tablet is divided has
not been
established.
STANDARD DOSAGE
_STANDARD DOSAGE FOR PROPHYLAXIS OF RENAL REJECTION _
_Adults_
A dose of 1 g administered orally twice a day (daily dose of 2 g) is
recommended for use in renal transplant patients. Although a dose of
1.5 g
administered twice daily (daily dose of 3 g) was used in clinical
trials and was
shown to be safe and effective, no efficacy advantage could be
established for
renal transplant patients. Patients receiving 2 g/day of mycophenolate
mofetil
demonstrated an overall better safety profile compared