Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
CICLOPIROX OLAMINE
GLAXOSMITHKLINE INC
D01AE14
CICLOPIROX
1.5%
SHAMPOO
CICLOPIROX OLAMINE 1.5%
TOPICAL
10ML/100ML
Prescription
HYDROXYPYRIDONES
Active ingredient group (AIG) number: 0115999002; AHFS:
CANCELLED POST MARKET
2024-01-31
_ _ _September 08, 2014 _ _ _ _Page 1 of 23_ PRODUCT MONOGRAPH Pr STIEPROX ® ciclopirox olamine (shampoo) 1.5% w/w Topical Antifungal GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 www.stiefel.ca Date of Revision: September 8, 2014 Submission Control No: 168647 _©_ _ 2014 GlaxoSmithKline Inc. All Rights Reserved _ _ _ _®_ _STIEPROX is_ _a registered trade-mark, used under license by GlaxoSmithKline Inc. _ _ _ _September 08, 2014 _ _ _ _Page 2 of 23_ TABLE OF CONTENTS PAGE PART I: HEALTH PROFESSIONAL INFORMATION ................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................ 3 CONTRAINDICATIONS ........................................................................................... 3 WARNINGS AND PRECAUTIONS ............................................................................ 4 ADVERSE REACTIONS ............................................................................................ 5 DRUG INTERACTIONS ............................................................................................ 6 DOSAGE AND ADMINISTRATION .......................................................................... 7 OVERDOSAGE ......................................................................................................... 7 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 8 STORAGE AND STABILITY ..................................................................................... 8 SPECIAL HANDLING INSTRUCTIONS .................................................................... 8 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 8 PART II: SCIENTIFIC INFORMATION ...................................................................... 10 PHARMACEUTICAL INFORMATION ........................................................ Přečtěte si celý dokument