Država: Kanada
Jezik: engleski
Izvor: Health Canada
BUTORPHANOL TARTRATE
PHARMASCIENCE INC
N02AF01
BUTORPHANOL
10MG
SPRAY
BUTORPHANOL TARTRATE 10MG
NASAL
2.5 ML
Schedule G (CDSA IV)
OPIATE PARTIAL AGONISTS
Active ingredient group (AIG) number: 0112394002; AHFS:
CANCELLED POST MARKET
2018-10-17
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PMS-BUTORPHANOL (Butorphanol Tartrate Nasal Spray) 10 mg/mL (1 mg/spray) ANALGESIC PHARMASCIENCE INC. DATE OF REVISION: October 04, 2018 6111 Royalmount Avenue, Suite 100October 04, 2018 Montréal, Québec H4P 2T4 www.pharmascience.com CONTROL NO.: 217221 _pms-BUTORPHANOL Product Monograph _ _Page 2 of 43_ 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 ..................................................................................................... 12 DRUG INTERACTIONS ...................................................................................................... 17 DOSAGE AND ADMINISTRATION .................................................................................. 18 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 .............................................. Pročitajte cijeli dokument