CHLORAL HYDRATE SYRUP ODAN

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CHLORAL HYDRATE

Mevcut itibaren:

ODAN LABORATORIES LTD

ATC kodu:

N05CC01

INN (International Adı):

CHLORAL HYDRATE

Doz:

500MG

Farmasötik formu:

SYRUP

Kompozisyon:

CHLORAL HYDRATE 500MG

Uygulama yolu:

ORAL

Paketteki üniteler:

500ML

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Ürün özeti:

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

Yetkilendirme durumu:

MARKETED

Yetkilendirme tarihi:

2003-08-06

Ürün özellikleri

_Product Monograph _
_ _
_CHLORAL HYDRATE SYRUP ODAN _
_Page 1 of 16_
_ _
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
_ _
_Product Monograph _
_ _
_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
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 4
4.4
Administration
..............................................................................................