Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
FENTANYL
SANDOZ CANADA INCORPORATED
N02AB03
FENTANYL
75MCG
PATCH
FENTANYL 75MCG
TRANSDERMAL
5
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0123302013; AHFS:
APPROVED
2009-06-03
_ _ _Sandoz Fentanyl Patch _ _Page 1 of 55_ PRODUCT MONOGRAPH N SANDOZ FENTANYL PATCH Fentanyl Transdermal System 12 mcg/h 25 mcg/h 37 mcg/h 50 mcg/h 75 mcg/h 100 mcg/h Opioid Analgesic Sandoz Canada Inc. Date of Revision: February 26, 2020 110 Rue de Lauzon Boucherville, Quebec, Canada J4B 1E6 Submission Control No.: 236309 _ _ _Sandoz Fentanyl Patch _ _Page 2 of 55_ 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 .......................................................................................................... 17 DRUG INTERACTIONS ........................................................................................................... 20 DOSAGE AND ADMINISTRATION ....................................................................................... 22 OVERDOSAGE ......................................................................................................................... 28 ACTION AND CLINICAL PHARMACOLOGY ..................................................................... 29 STORAGE AND STABILITY................................................................................................... 32 SPECIAL HANDLING INSTRUCTIONS ................................................................................ 32 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................... 33 PART II: SCIENTIFIC INFORMATION ................................................................................ 35 PHARMACEUTIC Perskaitykite visą dokumentą