TRI-CIRA 21 TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

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

Saatavilla:

APOTEX INC

ATC-koodi:

G03AB09

INN (Kansainvälinen yleisnimi):

NORGESTIMATE AND ETHINYLESTRADIOL

Annos:

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

Lääkemuoto:

TABLET

Koostumus:

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

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

CONTRACEPTIVES

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2020-11-18

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
TRI-CIRA 21
PR
TRI-CIRA 28
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS
0.18 mg norgestimate and 0.035 mg ethinyl estradiol
0.215 mg norgestimate and 0.035 mg ethinyl estradiol
0.25 mg norgestimate and 0.035 mg ethinyl estradiol
Apotex Standard
Oral Contraceptive
Apotex. Inc.
150 Signet Drive
Toronto Ontario
M9L 1T9
Date of Preparation:
November 17, 2020
SUBMISSION CONTROL NO.: 230304
Page 2 of 66
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
............................................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................................
4
CONTRAINDICATIONS
.......................................................................................................................
4
WARNINGS AND PRECAUTIONS
......................................................................................................
5
ADVERSE
REACTIONS......................................................................................................................
12
DRUG INTERACTIONS
......................................................................................................................
18
DOSAGE AND ADMINISTRATION
..................................................................................................
27
OVERDOSAGE
....................................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
................................................................................
33
STORAGE AND STABILITY
..............................................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................. 35
PART II: SCIENTIFIC INFORMATION
...........................