TRI-CYCLEN TABLETS - 21-DAY

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL

Mevcut itibaren:

JANSSEN INC

ATC kodu:

G03AB11

INN (International Adı):

NORGESTIMATE AND ESTROGEN

Doz:

0.18MG; 0.035MG; 0.215MG; 0.035MG; 0.25MG; 0.035MG

Farmasötik formu:

TABLET

Kompozisyon:

NORGESTIMATE 0.18MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG

Uygulama yolu:

ORAL

Paketteki üniteler:

21

Reçete türü:

Prescription

Terapötik alanı:

CONTRACEPTIVES

Ürün özeti:

Active ingredient group (AIG) number: 0636783002; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2020-06-02

Ürün özellikleri

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PRODUCT MONOGRAPH
PR
TRI-CYCLEN
®
norgestimate and ethinyl estradiol tablets, House Std.
0.180 mg norgestimate and 0.035 mg ethinyl estradiol Tablets
0.215 mg norgestimate and 0.035 mg ethinyl estradiol Tablets
0.250 mg norgestimate and 0.035 mg ethinyl estradiol Tablets
Oral Contraceptive
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
March 3, 2020
SUBMISSION CONTROL NO.: 235045
All trademarks used under license.
© 2019 Janssen Inc.
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_Page 2 of 61 _
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
.........................................................................................................
13
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
26
OVERDOSAGE
.......................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 33
STORAGE AND STABILITY
.................................................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 35
PART II: SCIENTIFIC INFORMATION
..............................................................