DUODOPA GEL

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

CARBIDOPA (CARBIDOPA MONOHYDRATE); LEVODOPA

থেকে পাওয়া:

ABBVIE CORPORATION

এটিসি কোড:

N04BA02

INN (আন্তর্জাতিক নাম):

LEVODOPA AND DECARBOXYLASE INHIBITOR

ডোজ:

5MG; 20MG

ফার্মাসিউটিকাল ফর্ম:

GEL

রচনা:

CARBIDOPA (CARBIDOPA MONOHYDRATE) 5MG; LEVODOPA 20MG

প্রশাসন রুট:

INTRAINTESTINAL (UPPER)

প্যাকেজ ইউনিট:

7 CASSETTES (100G/EA)

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

DOPAMINE PRECURSORS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0210315005; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2007-03-01

পণ্য বৈশিষ্ট্য

_DUODOPA (levodopa/carbidopa) _
_Date of Revision: April 4, 2022 _
_Submission Control No.: 252247 _
_Page 1 of 54 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DUODOPA®
levodopa/carbidopa intestinal gel
20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate
Antiparkinson Agent (ATC Code: N04BA02
)
DUODOPA (LEVODOPA/CARBIDOPA INTESTINAL GEL) TREATMENT 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, WHO HAVE COMPLETED
THE DUODOPA EDUCATION
PROGRAM AND ARE FAMILIAR WITH THE DUODOPA EFFICACY AND SAFETY PROFILE.
®Trademark of AbbVie AB; Licensed use by AbbVie Corporation,
Saint-Laurent, QC, H4S 1Z1.
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, QC H4S 1Z1
Date of Initial Authorization:
FEB 20, 2007
Date of Revision:
April 4, 2022
Submission Control Number: 252247
_DUODOPA (levodopa/carbidopa) _
_Date of Revision: April 4, 2022 _
_Submission Control No.: 252247 _
_Page 2 of 54 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
02/2020
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
.................................................