DIMENHYDRINATE INJECTION USP SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-04-2022
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Active ingredient:
DIMENHYDRINATE
Available from:
HIKMA CANADA LIMITED
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:
2021-11-04
Summary of Product characteristics
Dimenhydrinate Injection USP
Page 1 of 21
PRODUCT MONOGRAPH
DIMENHYDRINATE INJECTION USP
Dimenhydrinate
Solution for IM administration or IV administration if diluted
50 MG/ML
ANTIEMETIC
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
DATE OF PREPARATION:
April 22, 2022
CONTROL NO:
262693
Dimenhydrinate Injection USP
Page 2 of 21
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
OVERDOSAGE
.......................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 11
STORAGE AND STABILITY
...............................................................................................
11
SPECIAL HANDLING INSTRUCTIONS
............................................................................
12
PART II: SCIENTIFIC INFORMATION
...............................................................................
13
PHARMACEUTICAL INFORMATION
....................................
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