DIACETYLMORPHINE HYDROCHLORIDE POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DIAMORPHINE HYDROCHLORIDE

Διαθέσιμο από:

PHARMASCIENCE INC

Φαρμακολογική κατηγορία (ATC):

N07BC06

INN (Διεθνής Όνομα):

DIAMORPHINE

Δοσολογία:

5000MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

DIAMORPHINE HYDROCHLORIDE 5000MG

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Narcotic (CDSA I)

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2022-02-16

Αρχείο Π.Χ.Π.

_ _
_ _
_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
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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