MINT-LEVOCARB TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

LEVODOPA; CARBIDOPA

Dostępny od:

MINT PHARMACEUTICALS INC

Kod ATC:

N04BA02

INN (International Nazwa):

LEVODOPA AND DECARBOXYLASE INHIBITOR

Dawkowanie:

250MG; 25MG

Forma farmaceutyczna:

TABLET

Skład:

LEVODOPA 250MG; CARBIDOPA 25MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

DOPAMINE PRECURSORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0210315001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2016-09-23

Charakterystyka produktu

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