AURIZON EAR DROPS, SUSPENSION

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Предлага се от:

Vetoquinol UK Limited

АТС код:

QS02CA06

INN (Международно Name):

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

дозиране:

Unknown

Лекарствена форма:

Ear Drops Suspension

Вид предписание :

POM

Терапевтична група:

Canine

Терапевтична област:

Dexamethasone and antiinfectives

Терапевтични показания:

Antibacterial

Статус Оторизация:

Authorised

Дата Оторизация:

2016-03-24

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
AURIZON ear drops, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ML OF AURIZON CONTAINS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ear drops, suspension
Homogenous beige to yellow oily suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
-
Treatment
of
otitis
externa of
both bacterial
and fungal
origin -
respectively due to bacteria sensitive to
marbofloxacin, and fungi especially_ Malassezia pachydermatis_
sensitive to clotrimazole.
The product should be used based on susceptibility testing.
4.3 CONTRAINDICATIONS
Do not
administer to dogs suffering from perforation of the tympanic
membrane.
Do not
administer to dogs with
known hypersensitivity to any of the ingredients.
Do not administer to pregnant or lactating bitches.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
ACTIVE SUBSTANCES:
Marbofloxacin
3.0
mg
Clotrimazole
10.0 mg
Dexamethasone acetate
1.0
mg
(equivalent to dexamethasone 0.9
mg)
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4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Heavy reliance on a single class of antibiotic may result in the
induction of resistance in a bacterial population.
It is
prudent to reserve the fluoroquinolo