TRI-PREVIFEM (28 DAY) TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

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

Prieinama:

NOVOPHARM LIMITED

ATC kodas:

G03AB

INN (Tarptautinis Pavadinimas):

PROGESTOGENS AND ESTROGENS, SEQUENTIAL PREPARATIONS

Dozė:

0.180MG; 0.035MG; 0.215MG; 0.035MG; 0.250MG; 0.035MG

Vaisto forma:

TABLET

Sudėtis:

NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.035MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

28

Recepto tipas:

Prescription

Gydymo sritis:

CONTRACEPTIVES

Produkto santrauka:

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

Autorizacija statusas:

CANCELLED PRE MARKET

Leidimo data:

2018-07-24

Prekės savybės

_Page 1_
PRODUCT MONOGRAPH
PR
TRI-PREVIFEM
0.180 mg norgestimate and 0.035 mg ethinyl estradiol
0.215 mg norgestimate and 0.035 mg ethinyl estradiol
0.250 mg norgestimate and 0.035 mg ethinyl estradiol
Tablets
Novopharm Standard
Oral Contraceptive
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 116255
Date of Preparation:
January 31, 2005
Date of revision:
December 2, 2008
_Page 2_
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...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND
ADMINISTRATION.............................................................................
17
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND
STABILITY.........................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL
INFORMATION.............................................................