KYNMOBI FILM, SOLUBLE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

APOMORPHINE HYDROCHLORIDE

Tilgjengelig fra:

SUNOVION PHARMACEUTICALS CANADA INC

ATC-kode:

N04BC07

INN (International Name):

APOMORPHINE

Dosering :

25MG

Legemiddelform:

FILM, SOLUBLE

Sammensetning:

APOMORPHINE HYDROCHLORIDE 25MG

Administreringsrute:

SUBLINGUAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0158570004; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2023-09-29

Preparatomtale

_ _
_KYNMOBI (apomorphine hydrochloride) _
_Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
KYNMOBI
®
apomorphine hydrochloride
Soluble film, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg, Sublingual
USP
Antiparkinson Agent
Sunovion Pharmaceuticals Canada Inc.
7025 Langer Dr. Suite 301
Mississauga, ON L5N 0E8
Date of Initial Authorization:
JUN 12, 2020
Date of Revision:
December 12, 2022
Submission Control Number: 264434
_ _
_KYNMOBI (apomorphine hydrochloride) _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Hematologic, Hemolytic Anemia
12/2022
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
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.2.1
Dosing Overview
..................................