DIACETYLMORPHINE HYDROCHLORIDE POWDER FOR SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DIAMORPHINE HYDROCHLORIDE

Fáanlegur frá:

PHARMASCIENCE INC

ATC númer:

N07BC06

INN (Alþjóðlegt nafn):

DIAMORPHINE

Skammtar:

5000MG

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

DIAMORPHINE HYDROCHLORIDE 5000MG

Stjórnsýsluleið:

INTRAMUSCULAR

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Narcotic (CDSA I)

Vörulýsing:

Active ingredient group (AIG) number: 0117249004; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2022-02-16

Vara einkenni

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