DIACETYLMORPHINE HYDROCHLORIDE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DIAMORPHINE HYDROCHLORIDE

Available from:

PHARMASCIENCE INC

ATC code:

N07BC06

INN (International Name):

DIAMORPHINE

Dosage:

200MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

DIAMORPHINE HYDROCHLORIDE 200MG

Administration route:

INTRAMUSCULAR

Units in package:

15G/50G

Prescription type:

Narcotic (CDSA I)

Product summary:

Active ingredient group (AIG) number: 0117249003; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-02-16

Summary of Product characteristics

_ _
_ _
_Diacetylmorphine Hydrochloride (diamorphine hydrochloride for
injection) _
_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N DIACETYLMORPHINE HYDROCHLORIDE
Diamorphine hydrochloride for injection
Powder, 200 mg per vial, 5 g per vial, intramuscular and intravenous
injection
British Pharmacopoeia
OPIOID AGONIST
PHARMASCIENCE INC.
6111 Royalmount Ave, Suite 100
Montreal, Québec
H4P 2T4
Date of Initial Authorization:
February 14, 2022
Date of Revision:
May 11, 2023
Submission Control Number: 270525
_ _
_Diacetylmorphine Hydrochloride (diamorphine hydrochloride for
injection) _
_Page 2 of 49_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution
05/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
7
4.1
Dosing Considerations
............................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
....................................................... 7
4.3
R