DULCOLAX SUPPOSITORY

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BISACODYL

Διαθέσιμο από:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Φαρμακολογική κατηγορία (ATC):

A06AB02

INN (Διεθνής Όνομα):

BISACODYL

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

SUPPOSITORY

Σύνθεση:

BISACODYL 5MG

Οδός χορήγησης:

RECTAL

Μονάδες σε πακέτο:

3

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

CATHARTICS AND LAXATIVES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0101506001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2013-12-05

Αρχείο Π.Χ.Π.

_Dulcolax Prescribing Information _
PRESCRIBING INFORMATION
DULCOLAX
®
Bisacodyl
Tablets 5 mg
Suppositories 5 mg (children) and 10 mg (adult)
Boehringer Ingelheim Std.
Stimulant Laxative
Boehringer Ingelheim Canada Ltd.
5180 South Service Rd.
Burlington, ON L7L 5H4
CCDS: 0074-06
Date of Revision:
August 16, 2013
Submission Control No:
142262, 142263, 142264
_Dulcolax Prescribing Information _
TABLE OF CONTENTS
[To update, right-click anywhere in the Table of Contents and select
“Update Field”, “Update
entire table”, click OK.]
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................5
DOSAGE AND ADMINISTRATION
................................................................................6
OVERDOSAGE
..................................................................................................................6
STORAGE AND STABILITY
............................................................................................7
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................7
PART III: CONSUMER
INFORMATION................................................................................8
_ _
_Dulcolax Prescribing Information Page 3 of 11_
DULCOLAX
®
Bisacodyl
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FOR