Riik: Kanada
keel: inglise
Allikas: Health Canada
FENTANYL (FENTANYL CITRATE)
FRESENIUS KABI CANADA LTD
N01AH01
FENTANYL
50MCG
SOLUTION
FENTANYL (FENTANYL CITRATE) 50MCG
INTRAMUSCULAR
15G/50G
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0123302002; AHFS:
APPROVED
2020-07-03
Fentanyl Citrate Injection, USP Page 1 of 46 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N FENTANYL CITRATE INJECTION, USP (fentanyl 50 mcg / mL as fentanyl citrate) Narcotic Analgesic Adjunct to Anesthesia Fresenius Kabi Canada Ltd. Date of Preparation: July 2, 2020 165 Galaxy Blvd, Suite 100 Toronto, ON M9W 0C8 Submission Control No: 222517 Fentanyl Citrate Injection, USP Page 2 of 44 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 ............................................................................................... 14 DOSAGE AND ADMINISTRATION ........................................................................... 16 OVERDOSAGE ............................................................................................................. 21 ACTION AND CLINICAL PHARMACOLOGY ......................................................... 21 STORAGE AND STABILITY ...................................................................................... 24 SPECIAL HANDLING INSTRUCTIONS .................................................................... 25 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 25 PART II : SCIENTIFIC INFORMATION ............................................................................ 26 PHARMACEUTICAL INFORMATION ...................................................................... 26 DETAILED PHARMACOLOGY ...... Lugege kogu dokumenti