CellCept 250mg capsules

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

mycophenolate mofetil

Disponible depuis:

F. Hoffmann-La Roche Ltd.

Code ATC:

L04AA06

DCI (Dénomination commune internationale):

mycophenolate mofetil

Dosage:

250mg

forme pharmaceutique:

capsules

Unités en paquet:

(100/10x10/) blisters

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2015-05-18

Notice patient

other drugs known to undergo renal
tubular secretion may compete with
MPAG and thereby raise plasma
concentrations of MPAG or the other drug undergoing tubular secretion.
Concomitant administration of sevelamer and CellCept in adults and
pediatric patients decreased the MPA C
max
and AUC
0–12
by 30% and
25%, respectively. These data suggest that sevelamer and other
calcium-free phosphate binders preferentially should be given 2 hours
after CellCept intake to minimize the impact on the absorption of MPA.
_Live vaccines:_
Live vaccines should not be given to patients with an
impaired immune response. The antibody response to other vaccines
may be diminished (see 2.4 Warnings and Precautions).
2.5
USE IN SPECIAL POPULATIONS
2.5.1 FEMALES AND MALES OF REPRODUCTIVE POTENTIAL
Fertility
CellCept is contraindicated in women of childbearing potential
not using highly effective contraceptive methods (see
2.3 Contraindications). Malformations (including anophthalmia,
agnathia, and hydrocephaly) occurred in the
first-generation offspring of female rats treated
with oral doses of mycophenolate mofetil in
the absence of maternal toxicity (see
3.3.1 Impairment of Fertility). No effect was
seen on the fertility of male rats treated with
mycophenolate mofetil.
Pregnancy Testing
Prior to starting therapy with CellCept, female
patients of childbearing potential must have a
negative serum or urine pregnancy test with a
sensitivity of at least 25 mIU/ml; the second test should be performed
8–10 days later. Repeat pregnancy tests should be performed during
routine follow-up visits. Results of all pregnancy tests should be
discussed with the patient. Patients should be instructed to consult
their
physician immediately should pregnancy occur.
Contraception
_Females_
CellCept is contraindicated in women of childbearing potential not
using
highly effective contraceptive methods (see 2.3 Contraindications).
Before the start of treatment, female patients of reproductive
potential
must be made aware of the increased risk of pregnancy los

Résumé des caractéristiques du produit

June 2017
Summary of Product Characteristics
Ro106-1443
CellCept capsules, tablets and vials
June 2017
1
CELLCEPT
®
Mycophenolate mofetil
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Immunosuppressant; inosine monophosphate dehydrogenase (IMPDH)
inhibitor.
1.2
TYPE OF DOSAGE FORM
_Oral administration: _
CellCept is supplied as capsules and tablets.
_Intravenous administration: _
CellCept is supplied in single-use vials as powder for solution for
infusion.
1.3
ROUTE OF ADMINISTRATION
Oral administration for the capsules and tablets.
Intravenous administration for the vials.
1.4
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.
_Intravenous administration: _
Each vial contains the equivalent of 500 mg mycophenolate mofetil (as
the hydrochloride
salt).
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
CellCept is indicated for the prophylaxis of acute organ rejection and
for the treatment of
first or refractory organ rejection in patients receiving allogeneic
renal transplants.
CellCept 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.
CellCept is indicated for the prophylaxis of acute organ rejection in
patients receiving
allogeneic hepatic transplants.
June 2017
Summary of Product Characteristics
Ro106-1443
CellCept capsules, tablets and vials
June 2017
2
CellCept should be used concomitantly with ciclosporin and
corticosteroids.
2.2
DOSAGE AND ADMINISTRATION
_Standard dosage for prophylaxis of renal rejection _
A dose of 1 g administered orally or intravenously (over NO LESS THAN
2 HOURS)
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 sh