DUODOPA GEL

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CARBIDOPA (CARBIDOPA MONOHYDRATE); LEVODOPA

Διαθέσιμο από:

ABBVIE CORPORATION

Φαρμακολογική κατηγορία (ATC):

N04BA02

INN (Διεθνής Όνομα):

LEVODOPA AND DECARBOXYLASE INHIBITOR

Δοσολογία:

5MG; 20MG

Φαρμακοτεχνική μορφή:

GEL

Σύνθεση:

CARBIDOPA (CARBIDOPA MONOHYDRATE) 5MG; LEVODOPA 20MG

Οδός χορήγησης:

INTRAINTESTINAL (UPPER)

Μονάδες σε πακέτο:

7 CASSETTES (100G/EA)

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

DOPAMINE PRECURSORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2007-03-01

Αρχείο Π.Χ.Π.

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