Pays: Canada
Langue: anglais
Source: Health Canada
LEVODOPA; CARBIDOPA
MINT PHARMACEUTICALS INC
N04BA02
LEVODOPA AND DECARBOXYLASE INHIBITOR
100MG; 25MG
TABLET
LEVODOPA 100MG; CARBIDOPA 25MG
ORAL
100/500
Prescription
DOPAMINE PRECURSORS
Active ingredient group (AIG) number: 0210315003; AHFS:
APPROVED
2016-09-23
_Page 1 of 30_ PRODUCT MONOGRAPH Pr MINT-LEVOCARB levodopa and carbidopa tablets, House Std. 100 mg/10 mg 100 mg levodopa and 10 mg carbidopa 100 mg/25 mg 100 mg levodopa and 25 mg carbidopa 250 mg/25 mg 250 mg levodopa and 25 mg carbidopa Antiparkinson Agent Mint Pharmaceuticals Inc. Date of Preparation: 1093 Meyerside Dr., Unit #1 21 September 2016 Mississauga, Ontario L5T 1J6 SUBMISSION CONTROL NO: 188795 _Page 2 of 30_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS....................................................................................................8 DRUG INTERACTIONS ..................................................................................................10 DOSAGE AND ADMINISTATION.................................................................................11 OVERDOSAGE ................................................................................................................13 ACTION AND CLINICAL PHARMACOLOGY ............................................................14 STORAGE AND STABILITY ..........................................................................................15 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................15 PART II: SCIENTIFIC INFORMATION ...............................................................................16 PHARMACEUTICAL INFORMATION..........................................................................16 CLINCIAL TRIALS .............................................................. Lire le document complet