Marbodex Aural Ear Drops, Suspension for Dogs

Riik: Suurbritannia

keel: inglise

Allikas: VMD (Veterinary Medicines Directorate)

Toimeaine:

Clotrimazole, Dexamethasone, Marbofloxacin

Saadav alates:

Norbrook Laboratories Limited

ATC kood:

QS02CA06

INN (Rahvusvaheline Nimetus):

Clotrimazole, Dexamethasone, Marbofloxacin

Ravimvorm:

Ear drops, suspension

Retsepti tüüp:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutiline rühm:

Dogs

Terapeutiline ala:

Antimicrobial

Volitamisolek:

Authorized

Loa andmise kuupäev:

2015-08-24

Toote omadused

Revised: August 2020
AN: 01600/2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbodex Aural Ear Drops, Suspension for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCES:
Marbofloxacin
3.0 mg
Clotrimazole
10.0 mg
Dexamethasone
0.9 mg
(equivalent to dexamethasone acetate
1.0 mg
EXCIPIENTS
Propyl gallate (E310)
1.0 mg
For the 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
susceptible
to
marbofloxacin,
and
fungi
especially
_Malassezia _
_pachydermatis_ susceptible to clotrimazole.
4.3
CONTRAINDICATIONS
Do not use in dogs suffering from perforation of the tympanic
membrane.
Do not use in known cases of hypersensitivity to the active substances
or to any
of the excipients.
See section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Revised: August 2020
AN: 01600/2019
Page 2 of 6
The
external
ear
canal
should
be
meticulously
cleaned
and
dried
before
treatment.
Bacterial and fungal otitis is often secondary in nature. The
underlying cause
should be identified and treated.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
For external use only.
Avoid contact with the eyes in animals. In case of accidental contact,
rinse
thoroughly with water.
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
fluoroquinolones
for the treatment of clinical conditions which have responded poorly,
or are
expected to respond poorly, to other classes of antibiotics.
Before treating with the product, the integrity of the tympanic
membrane must be
verified.
Official and local antimicrobial policies should be taken into account
when the
product is used.
See section 4.4
Quinolo