Ország: Kanada
Nyelv: angol
Forrás: Health Canada
FENTANYL (FENTANYL CITRATE)
PFIZER CANADA ULC
N01AH01
FENTANYL
50MCG
SOLUTION
FENTANYL (FENTANYL CITRATE) 50MCG
INTRAMUSCULAR
2ML/20ML
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0123302002; AHFS:
CANCELLED POST MARKET
2020-01-06
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N FENTANYL CITRATE INJECTION USP 50 mcg/mL Fentanyl (as Fentanyl Citrate) Sterile Solution THERAPEUTIC CLASSIFICATION Narcotic Analgesic Adjunct to Anesthesia Pfizer Canada Inc. 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Revision: October 3, 2018 Submission Control No.: 219701 _Product Monograph - _ _N_ _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 ..................................................................................................15 DOSAGE AND ADMINISTRATION ..............................................................................16 OVERDOSAGE ................................................................................................................21 ACTION AND CLINICAL PHARMACOLOGY ............................................................22 STORAGE AND STABILITY ..........................................................................................25 SPECIAL HANDLING INSTRUCTIONS .......................................................................25 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................25 PART II: SCIENTIFIC INFORMATION ...............................................................................27 PHARMACEUTICAL INFORMATION ............................................. Olvassa el a teljes dokumentumot