TRI-LENA LO 21 TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

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

Inapatikana kutoka:

ACTAVIS PHARMA COMPANY

ATC kanuni:

G03AB11

INN (Jina la Kimataifa):

NORGESTIMATE AND ESTROGEN

Kipimo:

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

Dawa fomu:

TABLET

Tungo:

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

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

21

Dawa ya aina:

Prescription

Eneo la matibabu:

CONTRACEPTIVES

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED PRE MARKET

Idhini ya tarehe:

2017-09-01

Tabia za bidhaa

_ _
_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
.............