TRI-CIRA 28 TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
17-11-2020
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Aktivní složka:
NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL
Dostupné s:
APOTEX INC
ATC kód:
G03AB09
INN (Mezinárodní Name):
NORGESTIMATE AND ETHINYLESTRADIOL
Dávkování:
0.18MG; 0.035MG; 0.215MG; 0.035MG; 0.25MG; 0.035MG
Léková forma:
TABLET
Složení:
NORGESTIMATE 0.18MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG
Podání:
ORAL
Jednotky v balení:
15G/50G
Druh předpisu:
Prescription
Terapeutické oblasti:
CONTRACEPTIVES
Přehled produktů:
Active ingredient group (AIG) number: 0636783002; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2020-11-18
Charakteristika produktu
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
...........................
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