Страна: Канада
мова: англійська
Джерело: Health Canada
SUFENTANIL (SUFENTANIL CITRATE)
STERIMAX INC
N01AH03
SUFENTANIL
50MCG
SOLUTION
SUFENTANIL (SUFENTANIL CITRATE) 50MCG
INTRAVENOUS
10X1ML/5X5ML
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0144821002; AHFS:
APPROVED
2015-08-12
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N SUFENTANIL CITRATE INJECTION USP Sufentanil Citrate Injection 50 mcg/mL USP Opioid Analgesic SteriMax Inc. 2770 Portland Drive Oakville ON L6H 6R4 Date of Revision: May 22, 2019 Submission Control No: 226452 _Sufentanil Citrate Injection USP _ _Page 2 of 42_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ..................................................................................................13 DRUG INTERACTIONS ..................................................................................................15 DOSAGE AND ADMINISTRATION ..............................................................................17 OVERDOSAGE ................................................................................................................20 ACTION AND CLINICAL PHARMACOLOGY ............................................................21 STORAGE AND STABILITY ..........................................................................................24 SPECIAL HANDLING INSTRUCTIONS .......................................................................24 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................24 PART II: SCIENTIFIC INFORMATION .............................................................................275 PHARMACEUTICAL INFORMATION ........................................................................275 DETAILED PHARMACOLOGY ............................................................ Прочитайте повний документ