CHLORAL HYDRATE SYRUP ODAN

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CHLORAL HYDRATE

Available from:

ODAN LABORATORIES LTD

ATC code:

N05CC01

INN (International Name):

CHLORAL HYDRATE

Dosage:

500MG

Pharmaceutical form:

SYRUP

Composition:

CHLORAL HYDRATE 500MG

Administration route:

ORAL

Units in package:

500ML

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Product summary:

Active ingredient group (AIG) number: 0101992002; AHFS:

Authorization status:

MARKETED

Authorization date:

2003-08-06

Summary of Product characteristics

_Product Monograph _
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_CHLORAL HYDRATE SYRUP ODAN _
_Page 1 of 16_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CHLORAL HYDRATE SYRUP ODAN
Chloral Hydrate Oral Solution, Odan Std
Syrup, 500 mg / 5 mL, for oral administration
Sedative - Hypnotic
Odan Laboratories Ltd.
325 Stillview Ave.
Pointe Claire, Quebec
Canada H9R 2Y6
Date of Initial Authorization:
May 13, 2003
Date of Revision:
February 14, 2023
Submission Control Number: 268836
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_Product Monograph _
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_CHLORAL HYDRATE SYRUP ODAN _
_Page 2 of 16_
RECENT MAJOR LABEL CHANGES
None at time of the most recent authorization
06 / 2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
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4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 4
4.4
Administration
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