QISMETTE 21 TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DROSPIRENONE; ETHINYL ESTRADIOL

Pieejams no:

LUPIN LIMITED

ATĶ kods:

G03AA12

SNN (starptautisko nepatentēto nosaukumu):

DROSPIRENONE AND ESTROGEN

Deva:

3.0MG; 0.030MG

Zāļu forma:

TABLET

Kompozīcija:

DROSPIRENONE 3.0MG; ETHINYL ESTRADIOL 0.030MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

21(21 HORMONE-CONTAINING)

Receptes veids:

Prescription

Ārstniecības joma:

CONTRACEPTIVES

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2013-11-21

Produkta apraksts

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