LEVODOPA, CARBIDOPA AND ENTACAPONE TABLETS

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ENTACAPONE; CARBIDOPA; LEVODOPA

Fáanlegur frá:

STRIDES PHARMA CANADA INC

ATC númer:

N04BA03

INN (Alþjóðlegt nafn):

LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR

Skammtar:

200MG; 37.5MG; 150MG

Lyfjaform:

TABLET

Samsetning:

ENTACAPONE 200MG; CARBIDOPA 37.5MG; LEVODOPA 150MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

CATECHOL-O-METHYLTRANSFERASE (COMT) INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0352427003; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2021-07-07

Vara einkenni

1
PRODUCT
MONOGRAPH
Pr
Levodopa, Carbidopa and Entacapone Tablets
Tablets: 50 mg / 12.5 mg / 200 mg and 150 mg / 37.5 mg / 200 mg
(levodopa / carbidopa / entacapone)
Anti-Parkinsonian Dopaminergic Agent
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet
Varennes, Quebec
Canada, J3X 1P7
DATE OF PREPARATION:
July 6, 2021
SUBMISSION CONTROL NO.: 220776
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.............................................................3
SUMMARY PRODUCT
INFORMATION..............................................................................3
INDICATIONS AND CLINICAL USE
....................................................................................3
CONTRAINDICATIONS........................................................................................................4
WARNINGS AND PRECAUTIONS
......................................................................................4
ADVERSE REACTIONS
.....................................................................................................15
DRUG
INTERACTIONS......................................................................................................25
DOSAGE AND ADMINISTRATION
...................................................................................28
OVERDOSAGE
...................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
...................................................................32
STORAGE AND
STABILITY...............................................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................36
PART II: SCIENTIFIC INFORMATION
..................................................................................37
PHARMACEUTICAL
INFORMATION................................................................................37
CLINICAL
TRIALS.........................................................................