ORTHO-CEPT TABLETS (28 DAY)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DESOGESTREL; ETHINYL ESTRADIOL

Tilgængelig fra:

JANSSEN INC

ATC-kode:

G03AA09

INN (International Name):

DESOGESTREL AND ESTROGEN

Dosering:

0.15MG; 0.03MG

Lægemiddelform:

TABLET

Sammensætning:

DESOGESTREL 0.15MG; ETHINYL ESTRADIOL 0.03MG

Indgivelsesvej:

ORAL

Enheder i pakken:

28

Recept type:

Prescription

Terapeutisk område:

CONTRACEPTIVES

Produkt oversigt:

Active ingredient group (AIG) number: 0224591001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2015-04-22

Produktets egenskaber

ORTHO-CEPT 163396 APM.doc
_Page 1 of 51_
PRODUCT MONOGRAPH
PR
ORTHO-CEPT
®
desogestrel and ethinyl estradiol tablets, USP
0.150 mg desogestrel and 0.030 mg ethinyl estradiol tablets
Oral Contraceptive
Janssen Inc.
Toronto, Ontario
M3C 1L9
DATE OF REVISION:
June 25, 2013
www.janssen.ca
SUBMISSION CONTROL NUMBER:
163396
All trademarks used under license.
© 2013 Janssen Inc.
_ORTHO-CEPT 163396 APM.doc_
_Page 2 of 51_
PRODUCT MONOGRAPH
PR
ORTHO-CEPT
®
desogestrel and ethinyl estradiol tablets, USP
0.150 mg desogestrel and 0.030 mg ethinyl estradiol tablets
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
CLINICALLY RELEVANT NON MEDICINAL
INGREDIENTS
Oral
Tablets
0.150 mg desogestrel and
0.030 mg ethinyl estradiol
Lactose
_ _
_For a complete listing see Dosage Forms, _
_Composition and Packaging section. _
PHARMACOLOGICAL CLASSIFICATION
Synthetic steroidal combination oral contraceptive.
CLINICAL PHARMACOLOGY
The primary mechanism of action of ORTHO-CEPT
®
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
ORTHO-CEPT
®
Tablets are indicated for conception control.
_ORTHO-CEPT 163396 APM.doc_
_Page 3 of 51_
CONTRAINDICATIONS

History of or actual thrombophlebitis or thromboembolic disorders

Known thrombophilic conditions

History of or actual cerebrovascular disorders

History of or actual myocardial infarction or coronary arterial
disease

History of or actual prodromi of a thrombosis (e.g., transient
ischaemic attack, angina pectoris)

Active liver disease or history of or actual benign or malignant liver
tumours

Known or suspected carcinoma of the breast

Known or suspected estrogen-dependent neoplasia

Undiagnosed abnormal vaginal bleeding

Any ocular lesion arising from ophthalmic vascular disease, such as
partial or complete loss of
vision or de