MYLAN-MYCOPHENOLATE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

MYCOPHENOLATE MOFETIL

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

L04AA06

DCI (Dénomination commune internationale):

MYCOPHENOLIC ACID

Dosage:

250MG

forme pharmaceutique:

CAPSULE

Composition:

MYCOPHENOLATE MOFETIL 250MG

Mode d'administration:

ORAL

Unités en paquet:

50/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0128158001; AHFS:

Statut de autorisation:

MARKETED

Date de l'autorisation:

2011-11-30

Résumé des caractéristiques du produit

Page 1 of 65
PRODUCT MONOGRAPH
PR
MYLAN-MYCOPHENOLATE
Mycophenolate Mofetil Capsules, USP
250 mg
Mycophenolate Mofetil Tablets, USP
500 mg
Immunosuppressive Agent
Mylan Pharmaceuticals ULC
85 Advance Rd.,
Etobicoke, ON M8Z 2S6
Submission Control No: 194495
Date of Revision:
May 13, 2016
Page 2 of 65
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
.................................................................................................
4
WARNINGS AND PRECAUTIONS
.............................. ERROR! BOOKMARK NOT DEFINED.
ADVERSE REACTIONS
..................................................................................................
9
DRUG INTERACTIONS
................................................................................................
18
DOSAGE AND ADMINISTRATION
...........................................................................
23
OVERDOSAGE
...............................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 25
STORAGE AND STABILITY
.......................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
....................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 32
PART II: SCIENTIFIC INFORMATION .............................................................................
31
PHARMACEUTICAL INFORMATION
......................................................................
34
CLINICAL TRIALS
........................................................................................................
35
DETAILED PHARMACOLOGY
...