Mofecon-S 180 Capsules

Land: Tanzania

Språk: engelsk

Kilde: Tanzania Medicinces & Medical Devices Authority

Aktiv ingrediens:

mycophenolic acid

Tilgjengelig fra:

Concord Biotech Limited, INDIA

ATC-kode:

Mycophenolate sodium gastro-resistant tablets

INN (International Name):

mycophenolic acid

Dosering :

180

Legemiddelform:

Capsules

Produsert av:

Concord Biotech Limited, INDIA

Produkt oppsummering:

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)

Autorisasjon status:

Registered/Compliant

Autorisasjon dato:

2021-11-26

Preparatomtale

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