Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL
NOVOPHARM LIMITED
G03AB
PROGESTOGENS AND ESTROGENS, SEQUENTIAL PREPARATIONS
0.180MG; 0.035MG; 0.215MG; 0.035MG; 0.250MG; 0.035MG
TABLET
NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.035MG
ORAL
21
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0636783002; AHFS:
CANCELLED PRE MARKET
2018-07-24
_Page 1_ PRODUCT MONOGRAPH PR TRI-PREVIFEM 0.180 mg norgestimate and 0.035 mg ethinyl estradiol 0.215 mg norgestimate and 0.035 mg ethinyl estradiol 0.250 mg norgestimate and 0.035 mg ethinyl estradiol Tablets Novopharm Standard Oral Contraceptive Novopharm Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Submission Control No: 116255 Date of Preparation: January 31, 2005 Date of revision: December 2, 2008 _Page 2_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS................................................................................. 4 ADVERSE REACTIONS................................................................................................... 8 DRUG INTERACTIONS ................................................................................................. 11 DOSAGE AND ADMINISTRATION............................................................................. 17 OVERDOSAGE ............................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 20 STORAGE AND STABILITY......................................................................................... 21 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 21 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 22 PART II: SCIENTIFIC INFORMATION .............................................................................. 23 PHARMACEUTICAL INFORMATION............................................................. Soma hati kamili