PMS-BUTORPHANOL SPRAY
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
04-10-2018
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Aktiv ingrediens:
BUTORPHANOL TARTRATE
Tilgjengelig fra:
PHARMASCIENCE INC
ATC-kode:
N02AF01
INN (International Name):
BUTORPHANOL
Dosering :
10MG
Legemiddelform:
SPRAY
Sammensetning:
BUTORPHANOL TARTRATE 10MG
Administreringsrute:
NASAL
Enheter i pakken:
2.5 ML
Resept typen:
Schedule G (CDSA IV)
Terapeutisk område:
OPIATE PARTIAL AGONISTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0112394002; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2018-10-17
Preparatomtale
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
..............................................
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