Maa: Kanada
Kieli: englanti
Lähde: Health Canada
REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)
TEVA CANADA LIMITED
N01AH06
REMIFENTANIL
1MG
POWDER FOR SOLUTION
REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 1MG
INTRAVENOUS
1ML
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0133098001; AHFS:
CANCELLED POST MARKET
2021-07-30
_ _ _ _ _Page 1 of 42_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N REMIFENTANIL FOR INJECTION 1 mg/vial, 2 mg/vial of remifentanil Lyophilized Powder for Injection Sterile Opioid Component to Anesthesia Teva Canada Limited Date of Revision: 30 Novopharm Court January 2, 2019 Toronto, Ontario M1B 2K9 Control Number: 221336 _ _ _ _ _Page 2 of 42_ 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 ............................................................................................................. 14 DRUG INTERACTIONS ............................................................................................................. 16 DOSAGE AND ADMINISTRATION ......................................................................................... 17 OVERDOSAGE ........................................................................................................................... 23 ACTION AND CLINICAL PHARMACOLOGY ....................................................................... 24 STORAGE AND STABILITY ..................................................................................................... 28 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................ 28 PART II: SCIENTIFIC INFORMATION ............................................................................... 29 PHARMACEUTICAL INFORMATION ................................................................................... Lue koko asiakirja