MOVAPO SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

APOMORPHINE HYDROCHLORIDE

Tilgjengelig fra:

PALADIN LABS INC.

ATC-kode:

N04BC07

INN (International Name):

APOMORPHINE

Dosering :

10MG

Legemiddelform:

SOLUTION

Sammensetning:

APOMORPHINE HYDROCHLORIDE 10MG

Administreringsrute:

SUBCUTANEOUS

Enheter i pakken:

3ML

Resept typen:

Prescription

Terapeutisk område:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2023-10-23

Preparatomtale

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MOVAPO
®
Apomorphine hydrochloride injection
Supplied as pre-filled pens and ampoules: 10 mg/mL
For subcutaneous injection
Antiparkinson Agent
TREATMENT WITH MOVAPO (APOMORPHINE HYDROCHLORIDE) SHOULD BE INITIATED
AND SUPERVISED
ONLY BY NEUROLOGISTS AND SPECIALIZED HEALTHCARE PROFESSIONALS
EXPERIENCED AND TRAINED IN THE
DIAGNOSIS AND TREATMENT OF PATIENTS WITH PARKINSON’S DISEASE AND WHO ARE FAMILIAR WITH THE
MOVAPO EFFICACY AND SAFETY PROFILE.
Paladin Labs Inc.
100 Alexis Nihon Blvd., Suite 600
St-Laurent, Quebec
H4M 2P2
Date of Revision:
October 19, 2023
_ _
Version 2.0
Submission Control No: 275253
_Movapo is a registered trademark of Britannia Pharmaceuticals Limited
_
_ _
_MOVAPO - Product Monograph _
_Page 2 of 57_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
SPECIAL HANDLIN