PRAMIPEXOLE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Tilgængelig fra:

SIVEM PHARMACEUTICALS ULC

ATC-kode:

N04BC05

INN (International Name):

PRAMIPEXOLE

Dosering:

0.5MG

Lægemiddelform:

TABLET

Sammensætning:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Produkt oversigt:

Active ingredient group (AIG) number: 0152169002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2018-01-09

Produktets egenskaber

_ _
_PRAMIPEXOLE Product Monograph _
_Page 1 of 59_
PRODUCT MONOGRAPH
PR
PRAMIPEXOLE
Pramipexole Dihydrochloride Tablets
0.25 mg, 0.5 mg, 1 mg & 1.5 mg
pramipexole dihydrochloride monohydrate
ANTIPARKINSONIAN AGENT / DOPAMINE AGONIST
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Date of Revision:
November 10, 2021
Submission control No.: 257831
_ _
_PRAMIPEXOLE Product Monograph _
_Page 2 of 59_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND PRECAUTIONS
...................................................................................
5
ADVERSE REACTIONS
...................................................................................................
12
DRUG
INTERACTIONS....................................................................................................
21
DOSAGE AND ADMINISTRATION
...............................................................................
23
OVERDOSAGE
..................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 27
STORAGE AND STABILITY
...........................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 31
PART II: SCIENTIFIC INFORMATION
..........................................................................
33
CLINICAL TRIALS
.................