TRI-CIRA 28 TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

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

Mevcut itibaren:

APOTEX INC

ATC kodu:

G03AB09

INN (International Adı):

NORGESTIMATE AND ETHINYLESTRADIOL

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:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

CONTRACEPTIVES

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2020-11-18

Ürün özellikleri

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
...........................