DOLORAL SIROP SYRUP

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MORPHINE HYDROCHLORIDE

Available from:

LABORATOIRE ATLAS INC

ATC code:

N02AA01

INN (International Name):

MORPHINE

Dosage:

5MG

Pharmaceutical form:

SYRUP

Composition:

MORPHINE HYDROCHLORIDE 5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0102476002; AHFS:

Authorization status:

APPROVED

Authorization date:

2024-02-22

Summary of Product characteristics

_Product Monograph _
_ _
_DOLORAL SIROP (morphine hydrochloride syrup) _
_Page 1 of 31 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
DOLORAL SIROP
Morphine hydrochloride syrup
Syrup, 1 mg/mL and 5 mg/mL, Oral
Opioid Analgesic
N02AA01
Laboratoire Atlas Inc.
9600 boul. Des Sciences
Montréal, Québec, Canada
H1J 3B6
Date of Initial Authorization:
FEB 22, 2019
Date of Revision:
FEB 28, 2024
Submission Control Number: 268530
_Product Monograph _
_ _
_DOLORAL SIROP (morphine hydrochloride syrup) _
_Page 2 of 31 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, General, Abuse and Misuse
02/2024
7 Warnings and Precautions, Neurologic
02/2024
7 Warnings and Precautions, Respiratory
02/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
. _ _
TABLE OF
CONTENTS......................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................................
4
1
INDICATIONS......................................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
........................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................................... 4
4
DOSAGE AND ADMINISTRATION
........................................................................................
6
4.1
Dosing Considerations
...............................................................................................
6
4.2
Recommended Dose and Dosage
Adjustment.......................................