Страна: Канада
мова: англійська
Джерело: Health Canada
SUFENTANIL (SUFENTANIL CITRATE)
HIKMA CANADA LIMITED
N01AH03
SUFENTANIL
50MCG
SOLUTION
SUFENTANIL (SUFENTANIL CITRATE) 50MCG
INTRAVENOUS
100
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0144821001; AHFS:
APPROVED
2022-06-07
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N SUFENTANIL CITRATE INJECTION 50 mcg/mL sufentanil (as sufentanil citrate) Preservative free sterile aqueous solution For Intravenous and Epidural use Hikma Standard Opioid Analgesic Adjunct to Anesthesia Hikma Canada Limited 5995 Avebury Road, Suite 804 Mississauga, Ontario L5R 3P9 SUBMISSION CONTROL NO.: 264335 Date of Preparation: June 6, 2022 _Sufentanil Citrate Injection _ _ _ _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 ......................................................................................... 4 ADVERSE REACTIONS ......................................................................................................... 13 DRUG INTERACTIONS ......................................................................................................... 15 DOSAGE AND ADMINISTRATION ..................................................................................... 16 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 ......................... Прочитайте повний документ