DERMOTIC OIL EAR DROPS SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

FLUOCINOLONE ACETONIDE

Доступна з:

HILL DERMACEUTICALS INC

Код атс:

S02BA08

ІПН (Міжнародна Ім'я):

FLUOCINOLONE ACETONIDE

Дозування:

0.01%

Фармацевтична форма:

SOLUTION

Склад:

FLUOCINOLONE ACETONIDE 0.01%

Адміністрація маршрут:

OTIC

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Терапевтична области:

CORTICOSTEROIDS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2007-10-03

Характеристики продукта

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