KIDS GRAVOL SUPPOSITORIES SUPPOSITORY
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
29-01-2016
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Aktiv ingrediens:
DIMENHYDRINATE
Tilgjengelig fra:
CHURCH & DWIGHT CANADA CORP
ATC-kode:
R06AA11
INN (International Name):
DIMENHYDRINATE
Dosering :
25MG
Legemiddelform:
SUPPOSITORY
Sammensetning:
DIMENHYDRINATE 25MG
Administreringsrute:
RECTAL
Enheter i pakken:
10/100
Resept typen:
OTC
Terapeutisk område:
ANTIHISTAMINES
Produkt oppsummering:
Active ingredient group (AIG) number: 0102747006; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2013-01-03
Preparatomtale
PRODUCT MONOGRAPH
GRAVOL
™
(Dimenhydrinate)
GRAVOL IM (CHURCH & DWIGHT STD.) 50 MG/ML
GRAVOL KIDS QUICK DISSOLVE CHEWABLE TABLETS 15 MG
GRAVOL QUICK DISSOLVE CHEWABLE TABLETS 50 MG
GRAVOL EASY TO SWALLOW TABLETS 50 MG
GRAVOL IMMEDIATE RELEASE & LONG ACTING CAPLET 100 MG
GRAVOL TASTEFREE LIQUID GEL CAPSULES 50 MG
GRAVOL COMFORT SHAPED SUPPOSITORIES 100 MG
GRAVOL KIDS COMFORT SHAPED SUPPOSITORIES 25 MG
GRAVOL KIDS LIQUID 15MG/5 ML
Antiemetic
CHURCH & DWIGHT CANADA CORP.
Date of Preparation: August 29, 1997
HEAD OFFICE
Date of Revision: January 25, 2016
635 Secretariat Court
Mississauga, ON
L5S 0A5
MANUFACTURING-MEDICAL-REGULATORY
5485 Ferrier Montreal, QC H4P 1M6
SUBMISSION CONTROL NUMBER: 188084
GRAVOL® Product Monograph
Page 2 of 25
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
..............................................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................................
4
CONTRAINDICATIONS
.........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................................
4
ADVERSE REACTIONS
.........................................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................................
8
DOSAGE AND ADMINISTRATION
.....................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................................
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