Country: Kanada
Tungumál: enska
Heimild: Health Canada
INGENOL MEBUTATE
LEO PHARMA INC
D06BX02
INGENOL MEBUTATE
0.05%
GEL
INGENOL MEBUTATE 0.05%
TOPICAL
0.47G
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0153650002; AHFS:
CANCELLED POST MARKET
2020-10-14
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 ............................................................................... Lestu allt skjalið