CONFAB DIMENHYDRINATE 100 MG SUPPOSITORY

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DIMENHYDRINATE

Dostopno od:

LABORATOIRES CONFAB INC

Koda artikla:

R06AA11

INN (mednarodno ime):

DIMENHYDRINATE

Odmerek:

100MG

Farmacevtska oblika:

SUPPOSITORY

Sestava:

DIMENHYDRINATE 100MG

Pot uporabe:

RECTAL

Enote v paketu:

15G/50G

Tip zastaranja:

OTC

Terapevtsko območje:

ANTIHISTAMINES

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2021-04-07

Lastnosti izdelka

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