Auroto Ear Drops

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Neomycin Sulphate, Tetracaine Hydrochloride, Thiabendazole

Available from:

Dechra Limited

ATC code:

QS02AA57

INN (International Name):

Neomycin Sulphate, Tetracaine Hydrochloride, Thiabendazole

Authorization status:

Expired

Summary of Product characteristics

PART 1B:
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE:
1B - 1
PRODUCT:
AUROTO EAR DROPS
COMPANY:
DECHRA LIMITED
DATE:
13.2.07
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Auroto Ear Drops Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES % W/V
Thiabendazole
4.0
Tetracaine Hydrochloride
1.0
Neomycin Sulphate
0.5
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops solution.
A clear, pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Auroto Ear Drops are indicated for the treatment of otitis externa
associated with bacteria, fungi and
ear mites (_Otodectes cynotis)_ in dogs and cats.
4.3
CONTRAINDICATIONS
Do not use concomitantly with drugs known to be ototoxic. Do not use
for longer than 7 days. Do
not use in animals known to be hypersensitive to the active
substances. Do not use if the eardrum is
perforated.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cats: Usage in animals with damaged membranes or perforated tympanum
may result in severe
reactions.
Dogs: Not applicable.
DATE ISSUED: MARCH 07 SUPERSEDES ISSUE: 06/11/06
PART 1B:
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE:
1B - 2
PRODUCT:
AUROTO EAR DROPS
COMPANY:
DECHRA LIMITED
DATE:
13.2.07
4.5
SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For external use only. Discontinue treatment if hypersensitivity
occurs and institute appropriate
therapy. Do not use the same container for more than one patient. Do
not use for longer than 7
days. Do not use if eardrum is perforated. Prolonged usage may lead to
bacterial super infection
and cross resistance to other aminoglycosides.
II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL
PRODUCT TO ANIMALS
Wash hands thoroughly after use.
If any splashes enter the eye, wash immediately with copious water.
In the event of accidental ingestion – seek medical attention
showing the pack leaflet and/or product
label to the doctor or nurse.
III) OTHER PR