BUTORPHANOL NASAL SPRAY SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BUTORPHANOL TARTRATE

Dostupné s:

AA PHARMA INC

ATC kód:

N02AF01

INN (Mezinárodní Name):

BUTORPHANOL

Dávkování:

10MG

Léková forma:

SOLUTION

Složení:

BUTORPHANOL TARTRATE 10MG

Podání:

NASAL

Jednotky v balení:

2.5ML

Druh předpisu:

Schedule G (CDSA IV)

Terapeutické oblasti:

OPIATE PARTIAL AGONISTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2000-08-01

Charakteristika produktu

_BUTORPHANOL Nasal Spray (butorphanol tartrate) _
_Page 1 of 58_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
BUTORPHANOL NASAL SPRAY
Butorphanol Tartrate Nasal Spray
Solution, 10 mg/mL (1 mg per spray), Nasal
USP
Analgesic
AA PHARMA INC.
1165 Creditstone Road Unit #1,
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
MAR 24, 2015
Date of Revision:
JAN 26, 2023
Submission Control Number: 266559
_ _
_BUTORPHANOL Nasal Spray (butorphanol tartrate) _
_Page 2 of 58_
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box, Cytochrome P450
3A4 Interaction
01/2023
4 Dosage and Administration, 4.1 Dosing Considerations
01/2023
7 Warnings and Precautions, General
01/2023
7 Warnings and Precautions, Cardiovascular
01/2023
7 Warnings and Precautions, Dependence/Tolerance
01/2023
7 Warnings and Precautions, Gastrointestinal
01/2023
7 Warnings and Precautions, Neurologic
01/2023
7 Warnings and Precautions, Respiratory
01/2023
7 Warnings and Precautions, 7.1.1 Pregnant women
01/2023
7 Warnings and Precautions, 7.1.2 Breast-feeding
05/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics
.............................................................................................................4
2
CONTRAINDICATIONS
...............................