CORTIMENT TABLET (DELAYED AND EXTENDED RELEASE)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

BUDESONIDE

Disponibbli minn:

FERRING INC

Kodiċi ATC:

A07EA06

INN (Isem Internazzjonali):

BUDESONIDE

Dożaġġ:

9MG

Għamla farmaċewtika:

TABLET (DELAYED AND EXTENDED RELEASE)

Kompożizzjoni:

BUDESONIDE 9MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

20/30/40/50/60/80

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ADRENALS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0116807012; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2016-06-20

Karatteristiċi tal-prodott

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_CORTIMENT 9mg Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CORTIMENT
® MMX
Budesonide
Delayed and Extended Release Tablets,
9mg
Glucocorticosteroid
Ferring Inc.
200 Yorkland Boulevard, Suite 500
North York, Ontario M2J 5C1
Date of Preparation:
June 17, 2016
Submission Control No:183534
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_CORTIMENT 9mg Page 2 of 25_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................