Land: Canada
Språk: engelsk
Kilde: Health Canada
HYDROMORPHONE HYDROCHLORIDE
FRESENIUS KABI CANADA LTD
N02AA03
HYDROMORPHONE
10MG
SOLUTION
HYDROMORPHONE HYDROCHLORIDE 10MG
INTRAMUSCULAR
15G/50G
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0108698001; AHFS:
APPROVED
2019-08-21
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 ..................................................... read_full_document