TRI-LENA LO 28 TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

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

Dostupné s:

ACTAVIS PHARMA COMPANY

ATC kód:

G03AB11

INN (Mezinárodní Name):

NORGESTIMATE AND ESTROGEN

Dávkování:

0.180MG; 0.025MG; 0.215MG; 0.025MG; 0.250MG; 0.025MG

Léková forma:

TABLET

Složení:

NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.025MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.025MG

Podání:

ORAL

Jednotky v balení:

28

Druh předpisu:

Prescription

Terapeutické oblasti:

CONTRACEPTIVES

Přehled produktů:

Active ingredient group (AIG) number: 0636783003; AHFS:

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2017-09-01

Charakteristika produktu

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_Tri-Lena™ Lo Product Monograph _
_Page 1 of 66 _
PRODUCT MONOGRAPH
PR
TRI-LENA
™ LO 21
PR
TRI-LENA
™ LO 28
Norgestimate and Ethinyl Estradiol Tablets, USP
0.180 mg norgestimate and 0.025 mg ethinyl estradiol tablets
0.215 mg norgestimate and 0.025 mg ethinyl estradiol tablets
0.250 mg norgestimate and 0.025 mg ethinyl estradiol tablets
Oral Contraceptive
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
L5N 6J5
Date of Revision:
April 6, 2016
Submission Control No: 193856
_ _
_Tri-Lena™ Lo Product Monograph _
_Page 2 of 66 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................29
OVERDOSAGE
................................................................................................................35
ACTION AND CLINICAL PHARMACOLOGY
............................................................36
STORAGE AND STABILITY
..........................................................................................39
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................39
PART II: SCIENTIFIC INFORMATION
................................................................................41
PHARMACEUTICAL INFORMATION
.............