DIMENHYDRINATE INJECTION USP SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DIMENHYDRINATE

זמין מ:

HIKMA CANADA LIMITED

קוד ATC:

R06AA11

INN (שם בינלאומי):

DIMENHYDRINATE

כמות:

50MG

טופס פרצבטיות:

SOLUTION

הרכב:

DIMENHYDRINATE 50MG

מסלול נתינה (של תרופות):

INTRAMUSCULAR

יחידות באריזה:

15G/50G

סוג מרשם:

Ethical

איזור תרפויטי:

ANTIHISTAMINES

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2021-11-04

מאפייני מוצר

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