Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
CARBIDOPA (CARBIDOPA MONOHYDRATE); LEVODOPA
ABBVIE CORPORATION
N04BA02
LEVODOPA AND DECARBOXYLASE INHIBITOR
5MG; 20MG
GEL
CARBIDOPA (CARBIDOPA MONOHYDRATE) 5MG; LEVODOPA 20MG
INTRAINTESTINAL (UPPER)
7 CASSETTES (100G/EA)
Prescription
DOPAMINE PRECURSORS
Active ingredient group (AIG) number: 0210315005; AHFS:
APPROVED
2007-03-01
_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 ................................................. Izlasiet visu dokumentu