KYNMOBI FILM, SOLUBLE

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

APOMORPHINE HYDROCHLORIDE

Pieejams no:

SUNOVION PHARMACEUTICALS CANADA INC

ATĶ kods:

N04BC07

SNN (starptautisko nepatentēto nosaukumu):

APOMORPHINE

Deva:

10MG

Zāļu forma:

FILM, SOLUBLE

Kompozīcija:

APOMORPHINE HYDROCHLORIDE 10MG

Ievadīšanas:

SUBLINGUAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Produktu pārskats:

Active ingredient group (AIG) number: 0158570001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2023-09-29

Produkta apraksts

_ _
_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
..................................