QISMETTE 28 TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DROSPIRENONE; ETHINYL ESTRADIOL

Prieinama:

LUPIN LIMITED

ATC kodas:

G03AA12

INN (Tarptautinis Pavadinimas):

DROSPIRENONE AND ESTROGEN

Dozė:

3.0MG; 0.030MG

Vaisto forma:

TABLET

Sudėtis:

DROSPIRENONE 3.0MG; ETHINYL ESTRADIOL 0.030MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

28 (21 HORMONE-CONTAINING, 7 HORMONE-FREE)

Recepto tipas:

Prescription

Gydymo sritis:

CONTRACEPTIVES

Produkto santrauka:

Active ingredient group (AIG) number: 0250430001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2013-11-15

Prekės savybės

_ _
_Page 1 of 55_
PRODUCT MONOGRAPH
PR
QISMETTE 21 PR
QISMETTE 28
3.0 mg drospirenone and 0.030 mg ethinyl estradiol tablets
USP
Oral Contraceptive
Acne Therapy
MANUFACTURER:
Lupin Limited
Date of Revision:
159, CST Road, Kalina, Santacruz (East)
March 06, 2015
Mumbai, India
400098
DISTRIBUTOR:
Accuristix
2844 Bristol Circle
Oakville, Ontario, L6H 6G4
Submission Control No: 182225
_ _
_Page 2 of 55_
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
...............................................................................................
14
DRUG INTERACTIONS
................................................................................................
18
DOSAGE AND ADMINISTRATION
............................................................................
23
OVERDOSAGE
..............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 26
STORAGE AND STABILITY
........................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
....................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 30
PART II: SCIENTIFIC INFORMATION
..............................................................................
31
PHARMACEUTICAL INFORMATION
.......................................................................
31
CLINICAL
TRIALS...........