DIMENHYDRINATE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DIMENHYDRINATE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

R06AA11

INN (International Name):

DIMENHYDRINATE

Dosage:

50MG

Pharmaceutical form:

SOLUTION

Composition:

DIMENHYDRINATE 50MG

Administration route:

INTRAMUSCULAR

Units in package:

15G/50G

Prescription type:

Ethical

Therapeutic area:

ANTIHISTAMINES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2005-08-08

Summary of Product characteristics

_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
............................................................................