TRI-CYCLEN TABLETS - 21-DAY

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

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

Dostopno od:

JANSSEN INC

Koda artikla:

G03AB11

INN (mednarodno ime):

NORGESTIMATE AND ESTROGEN

Odmerek:

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

Farmacevtska oblika:

TABLET

Sestava:

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

Pot uporabe:

ORAL

Enote v paketu:

21

Tip zastaranja:

Prescription

Terapevtsko območje:

CONTRACEPTIVES

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2020-06-02

Lastnosti izdelka

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_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.
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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
..............................................................