Страна: Канада
Език: английски
Източник: Health Canada
NORGESTIMATE; ETHINYL ESTRADIOL
PATRIOT A DIVISION OF JANSSEN INC
G03AA11
NORGESTIMATE AND ESTROGEN
0.250MG; 0.035MG
TABLET
NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.035MG
ORAL
21
Prescription
CONTRACEPTIVES
Active ingredient group (AIG) number: 0213627001; AHFS:
CANCELLED PRE MARKET
2017-08-03
_165351.doc _ _Page 1 of 51 _ PRODUCT MONOGRAPH PR SARENSIS ™ 21 AND PR SARENSIS ™ 28 norgestimate and ethinyl estradiol tablets, House Std. 0.250 mg norgestimate and 0.035 mg ethinyl estradiol Tablets Oral Contraceptive Patriot, a Division of Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.patriot-canada.ca Date of Preparation: August 20, 2013 SUBMISSION CONTROL NO.: 165351 All trademarks used under license. © 2013 Patriot, a Division Janssen Inc. _165351.doc _ _Page 2 of 51 _ PRODUCT MONOGRAPH PR SARENSIS ™ 21 AND PR SARENSIS ™ 28 norgestimate and ethinyl estradiol tablets, House Std. 0.250 mg norgestimate and 0.035 mg ethinyl estradiol Tablets PHARMACOLOGICAL CLASSIFICATION Synthetic steroidal combination oral contraceptive. CLINICAL PHARMACOLOGY The primary mechanism of action of SARENSIS ™ Tablets is an inhibition of ovulation. Additionally, other effects caused by the treatment (for example, alteration of the endometrium and the thickening of the cervical mucus) appear to interfere with implantation and conception. INDICATIONS AND CLINICAL USE SARENSIS ™ Tablets are indicated for conception control. _165351.doc _ _Page 3 of 51 _ CONTRAINDICATIONS 1. History of or actual thrombophlebitis or thromboembolic disorders. 2. Known thrombophilic conditions. 3. History of or actual cerebrovascular disorders. 4. History of or actual myocardial infarction or coronary arterial disease. 5. Active liver disease or history of or actual benign or malignant liver tumours. 6. Known or suspected carcinoma of the breast. 7. Known or suspected estrogen-dependent neoplasia. 8. Undiagnosed abnormal vaginal bleeding. 9. Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields. 10. When pregnancy is suspected or diagnosed. 11. Valvular heart disease with complications. 12. Persistent blood pressure values ≥160 mm Hg systolic or ≥100 mm Hg diastolic. 13. Diabetes with vascular involvement. 14. Cholestatic jaundice or history of ja Прочетете целия документ