MYFORTIC

Țară: Indonezia

Limbă: indoneziană

Sursă: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingredient activ:

MYCOPHENOLATE SODIUM

Disponibil de la:

NOVARTIS INDONESIA - Indonesia

INN (nume internaţional):

MYCOPHENOLATE SODIUM

Dozare:

384.80 MG

Forma farmaceutică:

TABLET SALUT ENTERIK

Unități în pachet:

DUS, 5 BLISTER @ 10 TABLET SALUT ENTERIK

Produs de:

NOVARTIS PHARMA PRODUKTIONS GMBH - Federal Republic of Germany

Data de autorizare:

2021-05-26

Caracteristicilor produsului

1
MYFORTIC
Immunosuppressant
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Myfortic 180 mg enteric coated tablet: comes as a lime green, film
coated round tablet, with
bevelled edges and imprint (debossing) “C” on one side.
Myfortic 360 mg enteric coated tablet comes as a pale orange red
film-coated ovaloid tablet, with
the imprint (debossing) “CT” on one side.
ACTIVE SUBSTANCE
Each enteric coated tablet contains 180 mg or 360 mg mycophenolic
acid/MPA equivalent to 192.4
and 384.4 mycophenolate sodium
.
ACTIVE MOIETY
Mycophenolate sodium is the sodium salt of the active moiety,
mycophenolic acid.
EXCIPIENTS
Maize
starch;
povidone
(K-30);
crospovidone;
lactose;
colloidal
silicon
dioxide;
magnesium
stearate.
The
Myfortic
180
mg
enteric
coated
tablet
containing
consist
of
hypromellose
phthalate/
hydroxypropyl-methylcellulose phthalate; titanium dioxide; iron oxide
yellow; indigotin.
The
Myfortic
360
mg
enteric
coated
tablet
containing
consist
of
hypromellose
phthalate/
hydroxypropyl-methylcellulose phthalate; titanium dioxide; iron oxide
yellow; iron oxide red.
INDICATIONS
Myfortic is indicated in combination with ciclosporin for
microemulsion and corticosteroids for the
prophylaxis of acute transplant rejection in patients receiving
allogenic renal transplants.
Myfortic is indicated for induction and maintenance treatment of adult
patients with WHO Class
III, IV or V lupus nephritis.
This indication is based on the evidence in literature reports of
studies of treatment in patients with
lupus nephritis, the majority of whom were ISN/RPS (2003) Class IV.
The evidence for efficacy
was based on surrogate endpoints.
DOSAGE AND ADMINISTRATION
DOSAGE
The recommended dose is 720 mg (four 180 mg or two 360 mg Myfortic
gastro-resistant tablets)
administered twice daily (1,440 mg daily dose). In patients receiving
mycophenolate mofetil
(MMF) 2 g, treatment can be replaced by 720 mg administered twice
daily (1,440 mg daily dose)
of Myfortic.
DISETUJUI OLEH BPOM : 02/03/2021
ID : EREG100005VR12000200
EREG100005VR12000