ACT CABERGOLINE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CABERGOLINE

Pieejams no:

TEVA CANADA LIMITED

ATĶ kods:

G02CB03

SNN (starptautisko nepatentēto nosaukumu):

CABERGOLINE

Deva:

0.5MG

Zāļu forma:

TABLET

Kompozīcija:

CABERGOLINE 0.5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

8/30

Receptes veids:

Prescription

Ārstniecības joma:

ERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Produktu pārskats:

Active ingredient group (AIG) number: 0141281001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2007-11-01

Produkta apraksts

PRODUCT MONOGRAPH
Pr
ACT CABERGOLINE
Cabergoline Tablets USP
0.5 mg Tablets
Dopamine Receptor Agonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
CONTROL NO. 232990
Date of Revision:
November 21, 2019
- 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
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
13
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 15
STORAGE AND STABILITY
.........................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
......................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 17
PART II: SCIENTIFIC INFORMATION
..............................................................................
18
PHARMACEUTICAL INFORMATION
.........................................................................
18
CLINICAL TRIALS
.........................................................................................................
19
DETAILED PHARMACOLOGY
.........................