DIMENHYDRINATE INJECTION USP SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DIMENHYDRINATE

Dostępny od:

HIKMA CANADA LIMITED

Kod ATC:

R06AA11

INN (International Nazwa):

DIMENHYDRINATE

Dawkowanie:

50MG

Forma farmaceutyczna:

SOLUTION

Skład:

DIMENHYDRINATE 50MG

Droga podania:

INTRAMUSCULAR

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Ethical

Dziedzina terapeutyczna:

ANTIHISTAMINES

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2021-11-04

Charakterystyka produktu

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