País: Canadá
Língua: inglês
Origem: Health Canada
DIFLUCORTOLONE VALERATE
GLAXOSMITHKLINE INC
D07AC06
DIFLUCORTOLONE
0.1%
OINTMENT
DIFLUCORTOLONE VALERATE 0.1%
TOPICAL
30G
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0115864001; AHFS:
CANCELLED POST MARKET
2015-11-03
_ _ _ _ _ _ _Page 1 of 20_ PRODUCT MONOGRAPH PR NERISONE ® (DIFLUCORTOLONE VALERATE) Cream 0.1% w/w Oily Cream 0.1% w/w Ointment 0.1% w/w THERAPEUTIC CLASSIFICATION TOPICAL CORTICOSTEROID GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 www.stiefel.ca Date of Revision: October 29, 2014 Submission Control No: 175615 _©2014 GlaxoSmithKline Inc., All Rights Reserved _ _®NERISONE is a trade mark of Bayer Schering Pharma Aktiengesellschaft. _ _ _ _._ _ _ _ _ _ _ _Page 2 of 20_ TABLE OF CONTENTS _ _ _ _ PAGE PART I: HEALTH PROFESSIONAL INFORMATION................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................... 3 INDICATIONS AND CLINICAL USE ......................................................................... 3 CONTRAINDICATIONS .............................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................. 4 ADVERSE REACTIONS ............................................................................................... 8 DRUG INTERACTIONS ............................................................................................... 8 DOSAGE AND ADMINISTRATION ........................................................................... 9 ACTION AND CLINICAL PHARMACOLOGY ....................................................... 11 STORAGE AND STABILITY ..................................................................................... 12 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................ 12 PART II: SCIENTIFIC INFORMATION ........................................................................ 13 PHARMACEUTICAL INFORMATION ..................................................................... 13 REFERENCES ............................................................................................................. 16 PART III: CONSUMER INFORMATION ............ Leia o documento completo