TRIQUILAR 28 TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-05-2017
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Active ingredient:
LEVONORGESTREL; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; LEVONORGESTREL; ETHINYL ESTRADIOL; LEVONORGESTREL
Available from:
BAYER INC
ATC code:
G03AB03
INN (International Name):
LEVONORGESTREL AND ESTROGEN
Dosage:
125MCG; 30MCG; 40MCG; 50MCG; 30MCG; 75MCG
Pharmaceutical form:
TABLET
Composition:
LEVONORGESTREL 125MCG; ETHINYL ESTRADIOL 30MCG; ETHINYL ESTRADIOL 40MCG; LEVONORGESTREL 50MCG; ETHINYL ESTRADIOL 30MCG; LEVONORGESTREL 75MCG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
CONTRACEPTIVES
Product summary:
Active ingredient group (AIG) number: 0618648001; AHFS:
Authorization status:
APPROVED
Authorization date:
2007-03-08
Summary of Product characteristics
_TRIQUILAR Product Monograph _
_Page 1 of 54_
PRODUCT MONOGRAPH
PR
TRIQUILAR
® 21
PR
TRIQUILAR
® 28
0.05 mg levonorgestrel and 0.03 mg ethinyl estradiol tablets
0.075 mg levonorgestrel and 0.04 mg ethinyl estradiol tablets
0.125 mg levonorgestrel and 0.03 mg ethinyl estradiol tablets
USP
Oral Contraceptive
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Date of Revision:
May 26, 2017
Submission Control No: 202824
© 2017, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_TRIQUILAR Product Monograph _
_Page 2 of 54_
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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................23
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
.......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
.....................................
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