PICATO GEL
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
20-02-2020
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
INGENOL MEBUTATE
Fáanlegur frá:
LEO PHARMA INC
ATC númer:
D06BX02
INN (Alþjóðlegt nafn):
INGENOL MEBUTATE
Skammtar:
0.015%
Lyfjaform:
GEL
Samsetning:
INGENOL MEBUTATE 0.015%
Stjórnsýsluleið:
TOPICAL
Einingar í pakka:
0.47G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0153650001; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2020-10-14
Vara einkenni
LEO®
_ _
_PICATO® (ingenol mebutate) Product Monograph, version 5.0 _
_Page 1 of 29_
PRODUCT MONOGRAPH
Pr
PICATO®
ingenol mebutate
Topical Gel
0.015% and 0.05%
Chemotherapeutic for topical use (D06BX02)
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.com/canada
Date of Revision:
February 20, 2020
Control No.: 233545
® Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
LEO®
_ _
_PICATO® (ingenol mebutate) Product Monograph, version 5.0 _
_Page 2 of 29_
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
....................................................................................................7
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL INFORMATION
..........................................................................16
CLINICAL TRIALS- 15-Nov-20192
...............................................................................
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