CONFAB DIMENHYDRINATE 50 MG SUPPOSITORY

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DIMENHYDRINATE

Disponibbli minn:

LABORATOIRES CONFAB INC

Kodiċi ATC:

R06AA11

INN (Isem Internazzjonali):

DIMENHYDRINATE

Dożaġġ:

50MG

Għamla farmaċewtika:

SUPPOSITORY

Kompożizzjoni:

DIMENHYDRINATE 50MG

Rotta amministrattiva:

RECTAL

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

OTC

Żona terapewtika:

ANTIHISTAMINES

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2021-04-06

Karatteristiċi tal-prodott

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