TRI-CYCLEN TABLETS - 21-DAY

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

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

Inapatikana kutoka:

JANSSEN INC

ATC kanuni:

G03AB11

INN (Jina la Kimataifa):

NORGESTIMATE AND ESTROGEN

Kipimo:

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

Dawa fomu:

TABLET

Tungo:

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

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

21

Dawa ya aina:

Prescription

Eneo la matibabu:

CONTRACEPTIVES

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2020-06-02

Tabia za bidhaa

_ _
_ _
_Page 1 of 61 _
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.
_ _
_ _
_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
..............................................................