DULCOLAX SUPPOSITORY

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
07-11-2017

Viambatanisho vya kazi:

BISACODYL

Inapatikana kutoka:

SANOFI CONSUMER HEALTH INC

ATC kanuni:

A06AB02

INN (Jina la Kimataifa):

BISACODYL

Kipimo:

10MG

Dawa fomu:

SUPPOSITORY

Tungo:

BISACODYL 10MG

Njia ya uendeshaji:

RECTAL

Vitengo katika mfuko:

3/6/100

Dawa ya aina:

OTC

Eneo la matibabu:

CATHARTICS AND LAXATIVES

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0101506002; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2019-12-09

Tabia za bidhaa

                                _ _
_Dulcolax Prescribing Information _
_Page 1 of 12 _
PRESCRIBING INFORMATION
DULCOLAX
®
Bisacodyl
Tablets 5 mg
Suppositories 10 mg
Manufacturer’s Standard
Stimulant Laxative
sanofi-aventis Canada Inc.
2905 Louis-R.-Renaud Place
Laval, Quebec H7V 0A3
Date of Revision:
November 7, 2017
Submission Control No:210082
CCDS: 0074-07
_ _
_Dulcolax Prescribing Information _
_Page 2 of 12 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
...............................................................................4
ADVERSE REACTIONS
....................................................................................................5
DOSAGE AND ADMINISTRATION
................................................................................6
OVERDOSAGE
..................................................................................................................7
STORAGE AND STABILITY
............................................................................................7
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................8
PART III: CONSUMER
INFORMATION................................................................................9
PART III: CONSUMER
INFORMATION..............................................................................11
_ _
_Dulcolax Prescribing Information _
_Page 3 of 12 _
DULCOLAX
®
Bisacodyl
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS
Oral
tablet 5 mg
acacia, white wax, carnauba wax, corn starch
(dried/soluble), methacry
                                
                                Soma hati kamili
                                
                            

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