GRAVOL CHEWABLES TABLET (CHEWABLE)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

DIMENHYDRINATE

Dostupno od:

CHURCH & DWIGHT CANADA CORP

ATC koda:

R06AA11

INN (International ime):

DIMENHYDRINATE

Doziranje:

50MG

Farmaceutski oblik:

TABLET (CHEWABLE)

Sastav:

DIMENHYDRINATE 50MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

OTC

Područje terapije:

ANTIHISTAMINES

Proizvod sažetak:

Active ingredient group (AIG) number: 0102747004; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2020-02-13

Svojstava lijeka

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
...................................................................