APO-PRAMIPEXOLE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Pieejams no:

APOTEX INC

ATĶ kods:

N04BC05

SNN (starptautisko nepatentēto nosaukumu):

PRAMIPEXOLE

Deva:

1.5MG

Zāļu forma:

TABLET

Kompozīcija:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Produktu pārskats:

Active ingredient group (AIG) number: 0152169004; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2007-02-23

Produkta apraksts

Page 1 of 57
PRODUCT MONOGRAPH
PR
APO-PRAMIPEXOLE
Pramipexole Dihydrochloride Monohydrate Tablets
Apotex Standard
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.5 mg
Antiparkinsonian Agent / Dopamine Agonist
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
March 15, 2021
SUBMISSION CONTROL NO.: 243770
Page 2 of 57
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
.......................................................................................................10
DRUG INTERACTIONS
.......................................................................................................19
DOSAGE AND ADMINISTRATION
......................................................................................22
OVERDOSAGE
....................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
......................................................................25
STORAGE AND STABILITY
................................................................................................29
SPECIAL HANDLING INSTRUCTIONS
................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................29
PART II: SCIENTIFIC INFORMATION .................................................................................31
PHARMACEUTICAL INFORMATION
............................................