国: カナダ
言語: 英語
ソース: Health Canada
METRONIDAZOLE
GALDERMA CANADA INC
D06BX01
METRONIDAZOLE
.75%
CREAM
METRONIDAZOLE .75%
TOPICAL
3/60G
Prescription
ANTIBIOTICS
Active ingredient group (AIG) number: 0102572005; AHFS:
CANCELLED POST MARKET
2017-08-01
_ _ _METROGEL 0.75% and 1%, METROCREAM, METROLOTION Page 1 of 24_ PRODUCT MONOGRAPH PR METROGEL metronidazole topical gel USP, 0.75% metronidazole topical gel Galderma Std , 1% PR METROCREAM metronidazole topical cream, 0.75% PR METROLOTION™ metronidazole topical lotion, 0.75% FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE) Anti-Rosacea Agent D06BX01 GALDERMA CANADA INC. 105 Commerce Valley Drive W., Suite 300 Thornhill, ON L3T 7W3 Date of Preparation: July 17, 2007 Date of Revision: January 7, 2014 Submission Control No: 169473 _ _ _METROGEL 0.75% and 1%, METROCREAM, METROLOTION Page 2 of 24_ 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 ....................................................................................................5 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION ................................................................................9 OVERDOSAGE ................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ............................................................10 STORAGE AND STABILITY ..........................................................................................10 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................10 PART II: SCIENTIFIC INFORMATION .............................................................................. 完全なドキュメントを読む