HYDROMORPHONE HYDROCHLORIDE INJECTION, USP SOLUTION
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
20-08-2019
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Ingredient activ:
HYDROMORPHONE HYDROCHLORIDE
Disponibil de la:
FRESENIUS KABI CANADA LTD
Codul ATC:
N02AA03
INN (nume internaţional):
HYDROMORPHONE
Dozare:
10MG
Forma farmaceutică:
SOLUTION
Compoziție:
HYDROMORPHONE HYDROCHLORIDE 10MG
Calea de administrare:
INTRAMUSCULAR
Unități în pachet:
15G/50G
Tip de prescriptie medicala:
Narcotic (CDSA I)
Zonă Terapeutică:
OPIATE AGONISTS
Rezumat produs:
Active ingredient group (AIG) number: 0108698001; AHFS:
Statutul autorizaţiei:
APPROVED
Data de autorizare:
2019-08-21
Caracteristicilor produsului
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
.....................................................
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