MICTORYL CAPSULE (CONTROLLED-DELIVERY)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

PROPIVERINE HYDROCHLORIDE

Saatavilla:

DUCHESNAY INC

ATC-koodi:

G04BD06

INN (Kansainvälinen yleisnimi):

PROPIVERINE

Annos:

45MG

Lääkemuoto:

CAPSULE (CONTROLLED-DELIVERY)

Koostumus:

PROPIVERINE HYDROCHLORIDE 45MG

Antoreitti:

ORAL

Kpl paketissa:

28

Prescription tyyppi:

Prescription

Terapeuttinen alue:

Antimuscarinics

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0158750002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2017-01-05

Valmisteyhteenveto

_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
........