SARENSIS 28 TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

NORGESTIMATE; ETHINYL ESTRADIOL

Beschikbaar vanaf:

PATRIOT A DIVISION OF JANSSEN INC

ATC-code:

G03AA11

INN (Algemene Internationale Benaming):

NORGESTIMATE AND ESTROGEN

Dosering:

0.250MG; 0.035MG

farmaceutische vorm:

TABLET

Samenstelling:

NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.035MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

CONTRACEPTIVES

Product samenvatting:

Active ingredient group (AIG) number: 0213627001; AHFS:

Autorisatie-status:

CANCELLED PRE MARKET

Autorisatie datum:

2017-08-03

Productkenmerken

_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