DERMOTIC OIL EAR DROPS SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

FLUOCINOLONE ACETONIDE

可用日期:

HILL DERMACEUTICALS INC

ATC代码:

S02BA08

INN（国际名称）:

FLUOCINOLONE ACETONIDE

剂量:

0.01%

药物剂型:

SOLUTION

组成:

FLUOCINOLONE ACETONIDE 0.01%

给药途径:

OTIC

每包单位数:

15G/50G

处方类型:

Prescription

治疗领域:

CORTICOSTEROIDS

產品總結:

Active ingredient group (AIG) number: 0106314002; AHFS:

授权状态:

APPROVED

授权日期:

2007-10-03

产品特点

PRODUCT MONOGRAPH
PR DERMOTIC
® OIL EAR DROPS
Fluocinolone Acetonide Otic Solution, 0.01% w/v
House Standard
Anti-inflammatory, Antipruritic and Vasoconstricting Agent
Manufacturer:
Hill Dermaceuticals, Inc.
2650 South Mellonville Ave.
Sanford, Florida
32773 U.S.A.
www.hillderm.com
Canadian Distributor:
Hill Dermaceuticals, Inc.
3045 Southcreek Road, Unit #4
Mississauga, Ontario L4X 2X6
Canada
Control Number: 220228
Date of Revision:
November 27, 2018
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 1
SUMMARY PRODUCT INFORMATION
................................................................................
1
INDICATIONS AND CLINICAL USE
......................................................................................
1
CONTRAINDICATIONS
............................................................................................................
1
WARNINGS AND PRECAUTIONS
..........................................................................................
2
ADVERSE REACTIONS
.............................................................................................................
5
DRUG INTERACTIONS
...........................................................................................................
11
DOSAGE AND ADMINISTRATION
......................................................................................
11
OVERDOSAGE
..........................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 12
STORAGE AND
STABILITY...................................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 14
PART II: SCIENTIFIC INFORMATION
.................