Land: Canada
Taal: Engels
Bron: Health Canada
UREA; HYDROCORTISONE ACETATE
GLAXOSMITHKLINE INC
D07XA01
HYDROCORTISONE
10%; 1%
CREAM
UREA 10%; HYDROCORTISONE ACETATE 1%
TOPICAL
5G/50G/225G
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0231440001; AHFS:
CANCELLED POST MARKET
2014-06-23
_2014-04-15/131-pristine-english-Uremol.doc _ _ _ _ _ _ _ _Page 1 of 22 _ PRESCRIBING INFORMATION PR UREMOL ® HC Hydrocortisone acetate USP 1% (w/w) and Urea USP 10% (w/w) Cream Hydrocortisone acetate USP 1% (w/v) and Urea USP 10% (w/v) Lotion TOPICAL CORTICOSTEROID – EMOLLIENT GlaxoSmithKline Inc. Date of Revision: 7333 Mississauga Road April 16, 2014 Mississauga, Ontario L5N 6L4 www.stiefel.ca Control Number: 170409 _©_ _2014 GlaxoSmithKline Inc., All Rights Reserved _ _®_ _UREMOL is a registered trademark, used under license by GlaxoSmithKline Inc. _ _2014-04-15/131-pristine-english-Uremol.doc _ _ _ _ _ _ _ _Page 2 of 22 _ 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 ......................................................................................................................... 9 DRUG INTERACTIONS ......................................................................................................................... 9 DOSAGE AND ADMINISTRATION ................................................................................................... 10 OVERDOSAGE ..................................................................................................................................... 11 ACTION AND CLINICAL PHARMACOLOGY.................................................................................. 11 STORAGE AND STABILITY ...................................... Lees het volledige document