HYDROMORPHONE HYDROCHLORIDE INJECTION, USP SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

HYDROMORPHONE HYDROCHLORIDE

Tillgänglig från:

FRESENIUS KABI CANADA LTD

ATC-kod:

N02AA03

INN (International namn):

HYDROMORPHONE

Dos:

10MG

Läkemedelsform:

SOLUTION

Sammansättning:

HYDROMORPHONE HYDROCHLORIDE 10MG

Administreringssätt:

INTRAMUSCULAR

Enheter i paketet:

15G/50G

Receptbelagda typ:

Narcotic (CDSA I)

Terapiområde:

OPIATE AGONISTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2019-08-21

Produktens egenskaper

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
.....................................................