APO-CABERGOLINE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CABERGOLINE

Disponible des:

APOTEX INC

Codi ATC:

G02CB03

Designació comuna internacional (DCI):

CABERGOLINE

Dosis:

0.5MG

formulario farmacéutico:

TABLET

Composición:

CABERGOLINE 0.5MG

Vía de administración:

ORAL

Unidades en paquete:

8

tipo de receta:

Prescription

Área terapéutica:

ERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2016-06-17

Fitxa tècnica

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_APO-CABERGOLINE Product Monograph _
_ _
_Page 1 of 27_
PRODUCT MONOGRAPH
APO-CABERGOLINE
CABERGOLINE TABLETS USP
0.5 MG
DOPAMINE RECEPTOR AGONIST
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
June 16, 2016
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 128573
_____________________________________________________________________________________
_APO-CABERGOLINE Tablets Product Monograph _
_Page 2 of 27_
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
17
SPECIAL HANDLING INSTRUCTIONS
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
17
PART II: SCIENTIFIC INFORMATION
18
PHARMACEUTICAL INFORMATION
18
CLINICAL TRIALS
18
DETAILED PHARMACOLOGY
20
TOXICOLOGY
22
REFERENCES
25
PART III: CONSUMER INFORMATION
26
_____________________________________________________________________________________
_APO-CABERGOLINE Tablets Product Monograph _
_Page 3 of 27_
APO-CABERGOLINE
CABERGOLINE TABLETS USP
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF ADMINISTRATION
DOSAGE FORM / STRENGTH
ALL NONMEDICINAL INGREDIENTS
Oral
Tablet / 0.5 mg
Lactose Anhydrous NF, Leucine USP and
Magnesium Stearate NF. _ _
INDICATIONS AND CLINICAL USE
APO-CABERGOLINE (cabergoline) is indicated for:
•
TREATMENT OF HYPERPROLACTINEMIC DISORDERS:
APO-CABERGOLINE is indicated for the treatment of hyperprolactinemic
disorders, either
idiopathic or due to pituitary adenomas.
•
INHIBITION OF PHYSIOLOGICAL LACTATION:
APO-CABERGOLINE is indicated for the prevention of the onset of
physiological lactation
in the puerperium for clearly defined medical reasons.
These medical reasons may include birth of a still born baby, neonatal
death, conditions
interfering with suckling (cleft lip or palate of the