Otodex Veterinary Ear Drops Solution for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Chlorbutol, Phenoxyethanol

Available from:

Petlife International Ltd

ATC code:

QS02AA30

INN (International Name):

Chlorbutol, Phenoxyethanol

Pharmaceutical form:

Ear drops, suspension

Prescription type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Therapeutic group:

Cats, Dogs

Therapeutic area:

Ectoparasiticide

Authorization status:

Authorized

Authorization date:

1995-10-04

Summary of Product characteristics

Revised: August 2008
AN: 01064/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Otodex Veterinary Ear Drops Solution for Dogs and Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
Qualitative composition
Quantitative composition
Chlorbutanol hemihydrate
1.1% w/w
Phenoxyethanol
1.0% w/w
EXCIPIENTS
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, solution.
A clear, colourless, slightly viscous liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of ear irritation and otitis externa caused or
complicated by
infection in cats and dogs.
4.3
CONTRAINDICATIONS
Do not use if the eardrum is perforated.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
If symptoms persist or appear, consult your veterinary surgeon.
4.5
SPECIAL PRECAUTIONS FOR USE
_i) Special precautions for use in animals_
For external use only
Revised: August 2008
AN: 01064/2008
_ii) Special precautions to be taken by the person administering the
veterinary _
_medicinal product to animals_
Avoid contact with skin and eyes.
In the event of accidental skin exposure, wash the affected area with
soap and
water.
In the event of accidental eye exposure, flush eye thoroughly with
running water.
If irritation persists, seek medial advice showing the product label
to the doctor.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not contraindicated during pregnancy but should not be used during
lactation.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For topical administration
Any
excess
exudates,
hair
or
debris
should
be
carefully
removed
before
application. Squeeze 3 or 4 drops into the affected ear once a day
holding the
animal’s head still for a few moments to allow thorough penetration
of the solution.
Repeat daily until condition