Mphetas 500 Film coated tablets

Country: Танзанија

Језик: Енглески

Извор: Tanzania Medicinces & Medical Devices Authority

Активни састојак:

Mycophenolate mofetil

Доступно од:

Intas Pharmaceuticals Limited, INDIA

АТЦ код:

Cytoxic antibiotics

INN (Међународно име):

Mycophenolate mofetil

Дозирање:

500

Фармацеутски облик:

Film coated tablets

Произведен од:

Intas Pharmaceuticals Limited, INDIA

Резиме производа:

Physical description: Purple coloured, oval shaped, biconvex, film coated tablets; Local technical representative: PHARMAJEN LIMITED (61840)

Статус ауторизације:

Registered/Compliant

Датум одобрења:

2020-12-24

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mphetas-500 (Mycophenolate Mofetil Tablets USP 500 mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains Mycophenolate
Mofetil USP 500 mg
See List of Excipients in section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Purple coloured, oval shaped, biconvex, film coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mycophenolate
mofetil
500mg
Tablets
are
indicated
in
combination
with
ciclosporin and corticosteroids for the prophylaxis of acute
transplant rejection in
patients receiving allogeneic renal, cardiac or hepatic transplants.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Mycophenolate mofetil 500mg Tablets should be initiated
and
maintained by appropriately qualified transplant specialists.
Posology
_Use in renal transplant _
_Adults_
_ _
Oral Mycophenolate mofetil 500mg Tablets should be initiated within 72
hours
following transplantation. The recommended dose in renal transplant
patients is
1g administered twice daily (2g daily dose).
_Paediatric population aged 2 to 18 years_
_ _
The recommended dose of mycophenolate mofetil is 600mg/m2 administered
orally twice daily (up to a maximum of 2g daily). Mycophenolate
mofetil 500mg
Tablets should only be prescribed to patients with a body surface area
greater than
1.5 m2, at a dose of 1g twice daily (2g daily dose). As some adverse
reactions occur
with greater frequency in this age group (see section 4.8) compared
with adults,
temporary dose reduction or interruption may be required; these will
need to take
into account relevant clinical factors including severity of reaction.
_Paediatric population < 2 years_
_ _
There are limited safety and efficacy data in children below the age
of 2 years. These
are insufficient to make dosage recommendations and therefore use in
this age
group is not recommended.
_Use in cardiac transplant Adults_
_ _
Oral Mycophenolate mofetil 500mg Tablets should be initiated within 5
days
following transplantation