Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
CABERGOLINE
APOTEX INC
G02CB03
CABERGOLINE
0.5MG
TABLET
CABERGOLINE 0.5MG
ORAL
8
Prescription
ERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Active ingredient group (AIG) number: 0141281001; AHFS:
APPROVED
2016-06-17
_____________________________________________________________________________________ _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 Belgenin tamamını okuyun