MICTORYL PEDIATRIC TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

PROPIVERINE HYDROCHLORIDE

可用日期:

DUCHESNAY INC

ATC代码:

G04BD06

INN（国际名称）:

PROPIVERINE

剂量:

5MG

药物剂型:

TABLET

组成:

PROPIVERINE HYDROCHLORIDE 5MG

给药途径:

ORAL

每包单位数:

28

处方类型:

Prescription

治疗领域:

Antimuscarinics

產品總結:

Active ingredient group (AIG) number: 0158750003; AHFS:

授权状态:

APPROVED

授权日期:

2017-01-05

产品特点

_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
........