MICTORYL CAPSULE (CONTROLLED-DELIVERY)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

PROPIVERINE HYDROCHLORIDE

Disponibbli minn:

DUCHESNAY INC

Kodiċi ATC:

G04BD06

INN (Isem Internazzjonali):

PROPIVERINE

Dożaġġ:

30MG

Għamla farmaċewtika:

CAPSULE (CONTROLLED-DELIVERY)

Kompożizzjoni:

PROPIVERINE HYDROCHLORIDE 30MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

28

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

Antimuscarinics

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0158750001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2017-01-05

Karatteristiċi tal-prodott

_Mictoryl_
_®_
_/Mictoryl_
_®_
_ Pediatric Product Monograph _
_Page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MICTORYL
®
Propiverine hydrochloride modified-release capsules
30 mg and 45 mg
Pr
MICTORYL
® PEDIATRIC
Propiverine hydrochloride tablets
5 mg
ATC Code: G04BD06
Anticholinergic and antispasmodic agent
Duchesnay Inc.
950, boul. Michèle-Bohec
Blainville, Québec
Canada, J7C 5E2
Date of Revision:
January 15, 2018
Submission Control No: 210208
_ _
_Mictoryl_
_®_
_/Mictoryl_
_® _
_Pediatric Product Monograph _
_Page 2 of 39 _
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
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
........