DIMENHYDRINATE INJECTION USP SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

DIMENHYDRINATE

Inapatikana kutoka:

SANDOZ CANADA INCORPORATED

ATC kanuni:

R06AA11

INN (Jina la Kimataifa):

DIMENHYDRINATE

Kipimo:

10MG

Dawa fomu:

SOLUTION

Tungo:

DIMENHYDRINATE 10MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Ethical

Eneo la matibabu:

ANTIHISTAMINES

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0102747001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2005-08-08

Tabia za bidhaa

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