Država: Kanada
Jezik: angleščina
Source: Health Canada
FENTANYL (FENTANYL CITRATE)
JAMP PHARMA CORPORATION
N01AH01
FENTANYL
50MCG
SOLUTION
FENTANYL (FENTANYL CITRATE) 50MCG
INTRAMUSCULAR
15G/50G
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0123302002; AHFS:
APPROVED
2020-10-23
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION FENTANYL CITRATE INJECTION Solution for injection fentanyl 50 mcg / mL as fentanyl citrate For epidural, intramuscular or slow intravenous administration USP Narcotic Analgesic Adjunct to Anesthesia Jamp Pharma Corporation Date of Preparation: October 21, 2019 1310 rue Nobel Boucherville, Québec, Canada J4B 5H3 Submission Control No: 230156 _Fentanyl Citrate Injection. _ _Page 2 of 45_ 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 ................................................................................................................. 22 ACTION AND CLINICAL PHARMACOLOGY ............................................................. 22 STORAGE AND STABILITY .......................................................................................... 26 SPECIAL HANDLING INSTRUCTIONS ........................................................................26 DOSAGE FORMS, COMPOSITION AND PACKAGING ..............................................26 PART II: SCIENTIFIC INFORMATION ................................................................................28 PHARMACEUTICAL INFORMATION ................ Preberite celoten dokument