País: Canadá
Língua: inglês
Origem: Health Canada
NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
WARNER CHILCOTT CANADA CO
G03FA01
NORETHISTERONE AND ESTROGEN
1MG; 5MCG
TABLET
NORETHINDRONE ACETATE 1MG; ETHINYL ESTRADIOL 5MCG
ORAL
5X28
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0206375004; AHFS:
CANCELLED POST MARKET
2016-08-05
PRODUCT MONOGRAPH FEMHRT (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS) 1 MG AND 5 ΜG FEMHRT LO (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS) 0.5 MG AND 2.5 ΜG ESTROGEN-PROGESTIN COMBINATION Warner Chilcott Canada Co. Date of Preparation: March 4, 2011 Toronto, Ontario M5W 3N7 Control #: 143937 - 2 - TABLE OF CONTENTS PAGE PART I: HEALTH PROFESSIONAL INFORMATION ............................................ 3 SUMMARY PRODUCT INFORMATION .................................................................. 3 INDICATIONS AND CLINICAL USE........................................................................ 3 CONTRAINDICATIONS............................................................................................. 4 WARNINGS AND PRECAUTIONS............................................................................ 4 ADVERSE REACTIONS ........................................................................................... 12 DRUG INTERACTIONS............................................................................................ 14 DOSAGE AND ADMINISTRATION........................................................................ 16 OVERDOSAGE.......................................................................................................... 17 ACTIONS AND CLINICAL PHARMACOLOGY .................................................... 17 STORAGE AND STABILITY ................................................................................... 22 DOSAGE FORMS, COMPOSITION, AND PACKAGING....................................... 22 PART II: SCIENTIFIC INFORMATION .................................................................. 24 PHARMACEUTICAL INFORMATION.................................................................... 24 CLINICAL TRIALS ................................................................................................... 25 REFERENCES............................................................................................................ 40 PART III: CONSUMER INFORMATION... Leia o documento completo