DUODOPA GEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CARBIDOPA (CARBIDOPA MONOHYDRATE); LEVODOPA

Available from:

ABBVIE CORPORATION

ATC code:

N04BA02

INN (International Name):

LEVODOPA AND DECARBOXYLASE INHIBITOR

Dosage:

5MG; 20MG

Pharmaceutical form:

GEL

Composition:

CARBIDOPA (CARBIDOPA MONOHYDRATE) 5MG; LEVODOPA 20MG

Administration route:

INTRAINTESTINAL (UPPER)

Units in package:

7 CASSETTES (100G/EA)

Prescription type:

Prescription

Therapeutic area:

DOPAMINE PRECURSORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2007-03-01

Summary of Product characteristics

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