Țară: Canada
Limbă: engleză
Sursă: Health Canada
HYDROMORPHONE HYDROCHLORIDE
APOTEX INC
N02AA03
HYDROMORPHONE
4.5MG
CAPSULE (EXTENDED RELEASE)
HYDROMORPHONE HYDROCHLORIDE 4.5MG
ORAL
60/100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0108698018; AHFS:
APPROVED
2018-05-31
_Page 1 of 46_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N APO-HYDROMORPHONE CR HYDROmorphone* Hydrochloride Controlled Release Capsules 3 mg, 4.5 mg, 6 mg, 9 mg, 12 mg, 18 mg, 24 mg and 30 mg Opioid Analgesic APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Revision: April 9, 2021 Control No: 246549 *HYDROmorphone is the name of the active chemical ingredient (hydromorphone) and is not a brandname/tradename. _Page 2 of 46_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Neonatal Opioid Withdrawal Syndrome (NOWS), April 2021 7 WARNINGS AND PRECAUTIONS, Respiratory, Sleep Apnea, April 2021 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES..............................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................4 1 INDICATIONS....................................................................................................................4 1.1 Pediatrics ................................................................................................................4 1.2 Geriatrics ................................................................................................................4 2 CONTRAINDICATIONS .....................................................................................................4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX............................................................5 4 DOSAGE AND ADMINISTRATION ....................................................................................6 4.1 Dosing Considerations.............................................................................................6 4.2 Recommended Dose and Dosage Adjustment .........................................................7 4.3 Administration .........................................................................................................9 4.4 Missed Dose ........................................................................ Citiți documentul complet