INDAYO TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

LEVONORGESTREL; ETHINYL ESTRADIOL

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

G03AA07

INN (International Name):

LEVONORGESTREL AND ESTROGEN

Dosering :

0.15MG; 0.03MG

Legemiddelform:

TABLET

Sammensetning:

LEVONORGESTREL 0.15MG; ETHINYL ESTRADIOL 0.03MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

CONTRACEPTIVES

Produkt oppsummering:

Active ingredient group (AIG) number: 0220415001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2015-06-02

Preparatomtale

Page 1 of 58
PRODUCT MONOGRAPH
PR
INDAYO
®
Levonorgestrel and Ethinyl Estradiol Tablets, USP
0.15 mg and 0.03 mg
Oral Contraceptive
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Preparation:
March 24, 2016
Date of Revision:
August 18, 2021
Control No.: 252157
Page 2 of 58
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
...................................................................................................11
DRUG
INTERACTIONS....................................................................................................28
DOSAGE
AND
ADMINISTRATION
.................................................................................33
OVERDOSAGE
.................................................................................................................34
ACTION
AND
CLINICAL
PHARMACOLOGY.................................................................34
STORAGE
AND
STABILITY
............................................................................................37
SPECIAL
HANDLING
INSTRUCTIONS
...........................................................................37
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING...................................................37
PART II: SCIENTIFIC INFORMATION
..........................................................................
38
CLINICAL
TRIALS
...........................................................................................................40
COMPARATIVE
BIOAVAILABILITY
STUDY
...................