MOVAPO SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

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下载 产品特点 (SPC)
19-10-2023

有效成分:

APOMORPHINE HYDROCHLORIDE

可用日期:

PALADIN LABS INC.

ATC代码:

N04BC07

INN(国际名称):

APOMORPHINE

剂量:

10MG

药物剂型:

SOLUTION

组成:

APOMORPHINE HYDROCHLORIDE 10MG

给药途径:

SUBCUTANEOUS

每包单位数:

5 X 2ML

处方类型:

Prescription

治疗领域:

OPIATE AGONISTS

產品總結:

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

授权状态:

CANCELLED PRE MARKET

授权日期:

2023-10-23

产品特点

                                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
                                
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产品特点 产品特点 法文 19-10-2023