Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL
ACTAVIS PHARMA COMPANY
G03AB11
NORGESTIMATE AND ESTROGEN
0.180MG; 0.025MG; 0.215MG; 0.025MG; 0.250MG; 0.025MG
TABLET
NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.025MG
ORAL
21
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0636783003; AHFS:
CANCELLED PRE MARKET
2017-09-01
_ _ _Tri-Lena™ Lo Product Monograph _ _Page 1 of 66 _ PRODUCT MONOGRAPH PR TRI-LENA ™ LO 21 PR TRI-LENA ™ LO 28 Norgestimate and Ethinyl Estradiol Tablets, USP 0.180 mg norgestimate and 0.025 mg ethinyl estradiol tablets 0.215 mg norgestimate and 0.025 mg ethinyl estradiol tablets 0.250 mg norgestimate and 0.025 mg ethinyl estradiol tablets Oral Contraceptive Actavis Pharma Company 6733 Mississauga Road, Suite 400 Mississauga, ON L5N 6J5 Date of Revision: April 6, 2016 Submission Control No: 193856 _ _ _Tri-Lena™ Lo Product Monograph _ _Page 2 of 66 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................5 WARNINGS AND PRECAUTIONS ..................................................................................6 ADVERSE REACTIONS ..................................................................................................14 DRUG INTERACTIONS ..................................................................................................22 DOSAGE AND ADMINISTRATION ..............................................................................29 OVERDOSAGE ................................................................................................................35 ACTION AND CLINICAL PHARMACOLOGY ............................................................36 STORAGE AND STABILITY ..........................................................................................39 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................39 PART II: SCIENTIFIC INFORMATION ................................................................................41 PHARMACEUTICAL INFORMATION ............. Přečtěte si celý dokument