Nazione: Canada
Lingua: inglese
Fonte: Health Canada
MORPHINE SULFATE
PALADIN LABS INC.
N02AA01
MORPHINE
25MG
TABLET
MORPHINE SULFATE 25MG
ORAL
100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0104545005; AHFS:
CANCELLED POST MARKET
2023-02-20
_Product Monograph _ _ _ _STATEX_ _®_ _ (morphine sulfate tablets) _ _Page 1 of 31_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N STATEX® Morphine sulfate tablets Tablets, 5 mg, 10 mg, 25 mg, 50 mg, Oral Opioid Analgesic N02AA01 Paladin Labs Inc. 100 Alexis Nihon Blvd., Suite 600 Saint-Laurent, Quebec H4M 2P2 Date of Initial Authorization: December 04, 1985 Date of Revision: June 28, 2023 Version: 7.0 Submission Control Number: 271305 _ _ _Product Monograph _ _ _ _STATEX_ _®_ _ (morphine sulfate tablets) _ _Page 2 of 31_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Abuse and Misuse 06/2023 7 WARNINGS AND PRECAUTIONS, Neurologic 06/2023 7 WARNINGS AND PRECAUTIONS, Respiratory 06/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 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 Rec Leggi il documento completo