PMS-BUTORPHANOL SPRAY

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BUTORPHANOL TARTRATE

Saatavilla:

PHARMASCIENCE INC

ATC-koodi:

N02AF01

INN (Kansainvälinen yleisnimi):

BUTORPHANOL

Annos:

10MG

Lääkemuoto:

SPRAY

Koostumus:

BUTORPHANOL TARTRATE 10MG

Antoreitti:

NASAL

Kpl paketissa:

2.5 ML

Prescription tyyppi:

Schedule G (CDSA IV)

Terapeuttinen alue:

OPIATE PARTIAL AGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0112394002; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2018-10-17

Valmisteyhteenveto

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
..............................................