DERMOTIC OIL EAR DROPS SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FLUOCINOLONE ACETONIDE

Tilgjengelig fra:

HILL DERMACEUTICALS INC

ATC-kode:

S02BA08

INN (International Name):

FLUOCINOLONE ACETONIDE

Dosering :

0.01%

Legemiddelform:

SOLUTION

Sammensetning:

FLUOCINOLONE ACETONIDE 0.01%

Administreringsrute:

OTIC

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

CORTICOSTEROIDS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2007-10-03

Preparatomtale

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
.................