HYDROMORPHONE HYDROCHLORIDE INJECTION, USP SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

HYDROMORPHONE HYDROCHLORIDE

MAH:

FRESENIUS KABI CANADA LTD

ATC_code:

N02AA03

INN:

HYDROMORPHONE

dosage:

10MG

pharmaceutical_form:

SOLUTION

composition:

HYDROMORPHONE HYDROCHLORIDE 10MG

administration_route:

INTRAMUSCULAR

units_in_package:

15G/50G

prescription_type:

Narcotic (CDSA I)

therapeutic_area:

OPIATE AGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0108698001; AHFS:

authorization_status:

APPROVED

authorization_date:

2019-08-21

SPC

HYDROmorphone Hydrochloride Injection, USP - 2 mg/mL
Page 1 of 34
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N
HYDROMORPHONE HYDROCHLORIDE INJECTION, USP
(Hydromorphone Hydrochloride Injection, USP)
2 mg/mL Sterile Solution for Injection
Intramuscular, Intravenous, Subcutaneous
Opioid Analgesic
NOT A PRODUCT MONOGRAPH
Fresenius Kabi Canada Ltd.
Date of revision:
165 Galaxy Blvd. Suite 100
August 20, 2019
Toronto, Ontario
M9W 0C8
Submission Control No.: 212894
HYDROmorphone Hydrochloride Injection, USP - 2 mg/mL
Page 2 of 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 3
SUMMARY PRODUCT INFORMATION
........................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................................
3
CONTRAINDICATIONS
...................................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................................
4
ADVERSE REACTIONS
.................................................................................................................
12
DRUG INTERACTIONS
..................................................................................................................
15
DOSAGE AND ADMINISTRATION
..............................................................................................
16
OVERDOSAGE
................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................................
20
STORAGE AND STABILITY
.........................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
.....................................................