CONFAB DIMENHYDRINATE 100 MG SUPPOSITORY

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DIMENHYDRINATE

Disponible depuis:

LABORATOIRES CONFAB INC

Code ATC:

R06AA11

DCI (Dénomination commune internationale):

DIMENHYDRINATE

Dosage:

100MG

forme pharmaceutique:

SUPPOSITORY

Composition:

DIMENHYDRINATE 100MG

Mode d'administration:

RECTAL

Unités en paquet:

15G/50G

Type d'ordonnance:

OTC

Domaine thérapeutique:

ANTIHISTAMINES

Descriptif du produit:

Active ingredient group (AIG) number: 0102747003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2021-04-07

Résumé des caractéristiques du produit

_Dimenhydrinate Injection USP and Sandoz Dimenhydrinate _
_ Page 1 of 24 _
PRODUCT MONOGRAPH
DIMENHYDRINATE INJECTION USP
FOR IM ADMINISTRATION OR IV ADMINISTRATION IF DILUTED
50 MG/ML
FOR IV ADMINISTRATION
10 MG/ML
SANDOZ DIMENHYDRINATE
DIMENHYDRINATE SUPPOSITORIES
50 MG AND 100 MG
Antiemetic
Sandoz Canada Inc.
Date of Revision: December 22, 2017
Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control no.: 203644
_Dimenhydrinate Injection USP and Sandoz Dimenhydrinate _
_Page 2 of 24 _
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
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSE
......................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
STORAGE AND STABILITY
..........................................................................................12
AVAILABILITY OF DOSAGE FORMS
.........................................................................14
PART II: SCIENTIFIC INFORMATION
............................................................................