Mofecon-S 180 Capsules

Nazione: Tanzania

Lingua: inglese

Fonte: Tanzania Medicinces & Medical Devices Authority

Principio attivo:

mycophenolic acid

Commercializzato da:

Concord Biotech Limited, INDIA

Codice ATC:

Mycophenolate sodium gastro-resistant tablets

INN (Nome Internazionale):

mycophenolic acid

Dosaggio:

180

Forma farmaceutica:

Capsules

Prodotto da:

Concord Biotech Limited, INDIA

Dettagli prodotto:

Physical description: Lime green colored, enteric coated, round biconvex tablet, debossed with "C1" on one side and plain on other side; Local technical representative: Phillips Distributors Limited (9823)

Stato dell'autorizzazione:

Registered/Compliant

Data dell'autorizzazione:

2021-11-26

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mycophenolic Acid Delayed-Release Tablets USP, 180 mg
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mycophenolic Acid Delayed-Release Tablets USP, 180 mg
Each enteric coated tablet contains:
Mycophenolate sodium USP is equivalent to
Mycophenolic acid .................... 180 mg
Excipients .................................. q.s.
Colours: Titanium dioxide USP, Iron oxide yellow, Indigo carmine
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg
Each enteric coated tablet contains:
Mycophenolate sodium USP is equivalent to
Mycophenolic acid .................... 360 mg
Excipients .................................. q.s.
Colours: Titanium dioxide USP, Iron oxide red, Iron oxide yellow
3.
PHARMACEUTICAL FORM
Delayed-Release Tablets
Mycophenolic Acid Delayed-Release Tablets USP, 180 mg
Lime green colored, enteric coated, round biconvex tablet, debossed
with “C 1” on one side and
plain on other side
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg
Pink to light pink colored, enteric coated, ovaloid biconvex tablet,
debossed with “C 2” on one
side and plain on other side
4.
CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
Mycophenolic Acid Delayed-Release Tablets are indicated in combination
with ciclosporin and
corticosteroids for the prophylaxis of acute transplant rejection in
adult
patients receiving
allogeneic renal transplants.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Mycophenolic Acid should be initiated and maintained by
appropriately
qualified transplant specialists.
Posology
The recommended dose is 720 mg administered twice daily (1,440 mg
daily dose). This dose of
mycophenolate sodium corresponds to 1 g mycophenolate mofetil
administered twice daily
(2g daily dose) in terms of mycophenolic acid (MPA) content.
In
_de _
_novo _
patients,
Mycophenolic
Acid
should
be
initiated
within
72
hours
following
transplantation.
Special population
Paediatric population
Insuffi