CONFAB DIMENHYDRINATE 100 MG SUPPOSITORY

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DIMENHYDRINATE

Dostępny od:

LABORATOIRES CONFAB INC

Kod ATC:

R06AA11

INN (International Nazwa):

DIMENHYDRINATE

Dawkowanie:

100MG

Forma farmaceutyczna:

SUPPOSITORY

Skład:

DIMENHYDRINATE 100MG

Droga podania:

RECTAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

OTC

Dziedzina terapeutyczna:

ANTIHISTAMINES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0102747003; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2021-04-07

Charakterystyka produktu

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