MINT-LEVOCARB TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
06-10-2016
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Aktiva substanser:
LEVODOPA; CARBIDOPA
Tillgänglig från:
MINT PHARMACEUTICALS INC
ATC-kod:
N04BA02
INN (International namn):
LEVODOPA AND DECARBOXYLASE INHIBITOR
Dos:
250MG; 25MG
Läkemedelsform:
TABLET
Sammansättning:
LEVODOPA 250MG; CARBIDOPA 25MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
DOPAMINE PRECURSORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0210315001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2016-09-23
Produktens egenskaper
_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
..............................................................
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