VISANNE TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
22-02-2016
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Aktivna sestavina:
DIENOGEST
Dostopno od:
BAYER INC
Koda artikla:
G03DB08
INN (mednarodno ime):
DIENOGEST
Odmerek:
2MG
Farmacevtska oblika:
TABLET
Sestava:
DIENOGEST 2MG
Pot uporabe:
ORAL
Enote v paketu:
28/84/168
Tip zastaranja:
Prescription
Terapevtsko območje:
PROGESTINS
Povzetek izdelek:
Active ingredient group (AIG) number: 0153021001; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2011-10-12
Lastnosti izdelka
_ _
_VISANNE Product Monograph _
_Page 1 of 40 _
PRODUCT MONOGRAPH
PR
VISANNE
®
dienogest tablets
2 mg
Progestin
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
http://www.bayer.ca
Date of Revision:
February 16, 2016
Submission Control No: 182613
© 2016, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_ _
_VISANNE Product Monograph _
_Page 2 of 40 _
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
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.......................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
................................................................................19
PHARMACEUTICAL INFORMATION
..........................................................................19
CLINICAL TRIALS
..............
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