MICTORYL CAPSULE (CONTROLLED-DELIVERY)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

PROPIVERINE HYDROCHLORIDE

Доступна з:

DUCHESNAY INC

Код атс:

G04BD06

ІПН (Міжнародна Ім'я):

PROPIVERINE

Дозування:

30MG

Фармацевтична форма:

CAPSULE (CONTROLLED-DELIVERY)

Склад:

PROPIVERINE HYDROCHLORIDE 30MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

28

Тип рецепту:

Prescription

Терапевтична области:

Antimuscarinics

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2017-01-05

Характеристики продукта

_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
........