AURIZON EAR DROPS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MARBOFLOXACIN; CLOTRIMAZOLE; DEXAMETHASONE ACETATE

Available from:

VETOQUINOL AUSTRALIA PTY LTD

INN (International Name):

marbofloxacin(3mg/mL)+clotrimazole(10mg/mL) + others

Pharmaceutical form:

MISC. AURAL, OPHTHALMIC, ORO/NASO PHARYNGEAL

Composition:

MARBOFLOXACIN ANTIBIOTIC Active 3.0 mg/ml; CLOTRIMAZOLE IMIDAZOLE Active 10.0 mg/ml; DEXAMETHASONE ACETATE STEROID-GLUCOCORTICOID Active 1.0 mg/ml

Units in package:

10ml; 20ml

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

EAR,NOSE,THROAT PREPS.

Therapeutic indications:

OTITIS EXTERNA | ACUTE CANINE OTITIS | ASSOCIATED WITH YEAST &/OR BAC | CHRONIC CANINE OTITIS | MALASSEZIA PACHYDERMATIS | OTITIS (CANINE)

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [OTITIS EXTERNA]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [OTITIS EXTERNA]; For the treatment of Otitis externa in dogs of both bacterial & fungal origin respectively due to bacteria sensitive to marbofloxacin & fungi, especially Malassezia pachydermetis, sensitive to clotrimazole.DO NOT USE in food producing animals. USE ONLY in situations where sensitivity testing indicates no alternative antibiotic. See other contraindications in DFU on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
AURIZON EAR DROPS
67225/137718
Label Name:
AURIZON EAR DROPS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
Each mL contains
10 mg CLOTRIMAZOLE
3 mg MARBOFLOXACIN
1 mg DEXAMETHASONE ACETATE
Claims:
For use by or under direction of a registered veterinarian.
AURIZON is indicated for the treatment of otitis externa in dogs of
both bacterial and
fungal origin respectively due to bacteria sensitive to marbofloxacin
and fungi, especially
Malassezia pachydermatis, sensitive to clotrimazole.
Resistance can develop to any antimicrobial. The product should be
used based on
susceptibility testing.
Net Contents:
10 mL
20 mL
Directions for Use:
Use as directed by prescribing veterinarian.
Restraints:
DO NOT USE in food-producing animals.
USE ONLY in situations where sensitivity testing indicates no
alternative antibiotic.
Contraindications:
This product is contraindicated for use in dogs with known perforation
of the eardrum
(tympanic membrane).
Marbofloxacin is contraindicated in immature dogs as it has been shown
to cause
arthropathy. RLP APPROVED
Marbofloxacin is contraindicated in dogs known to be hypersensitive.
Precautions:
Do not use on pregnant or lactating bitches and dogs intended for
breeding purposes.
Do not use in dogs with known hypersensitivity to any of the active
constituents.
Corticosteroids administered to dogs, rabbits and rodents during
pregnancy have resulted
in cleft palate offspring.
Other congenital anomalies including deformed forelegs, phocomelia,
and anasarca have
been reported in offspring of dogs which received corticosteroids
during pregnancy.
Clinical and experimental data have demonstrated that corticosteroids
administered orally
or parenterally to animals may induce the first stage of parturition
if used during the last
trimester of pregnancy and may precipitate premature parturition
followed by dystocia,
foetal death, retained placenta and metritis.
Side Effec

Summary of Product characteristics

PRODUCT NAME: AURIZON® EAR DROPS SUSPENSION
PAGE: 1 OF 5
THIS VERSION ISSUED: OCTOBER, 2015
SAFETY DATA SHEET
Issued by: Vetoquinol Australia Pty Ltd
Phone: [phone]
(BUSINESS HOURS)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETOQUINOL AUSTRALIA PTY LTD
PHONE: [phone] (BUSINESS HOURS)
UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK,
FAX: [phone]
BRISBANE AIRPORT, QLD 4008
CHEMICAL NATURE:
Antibiotic and antifungal ingredients in a suitable medium.
TRADE NAME:
AURIZON® EAR DROPS SUSPENSION
APVMA CODE:
67225
PRODUCT USE:
Antibacterial and antifungal ear drops suspension for dogs.
CREATION DATE:
OCTOBER, 2015
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xn, Harmful. Xi, Irritating. N, Dangerous to the environment.
Hazardous according to
the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
R22, R43, R52. Harmful if swallowed. May cause sensitisation by skin
contact. Harmful to aquatic
organisms.
SAFETY PHRASES:
S20, S28, S36, S24/25. When using, do not eat or drink. After contact
with skin, wash immediately
with plenty of soap and water. Wear suitable protective clothing.
Avoid contact with skin and eyes.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: WARNING
HAZARD STATEMENT:
H302: Harmful if swallowed.
H317: May cause an allergic skin reaction.
H402: Harmful to aquatic life.
PREVENTION
P102: Keep out of reach of children.
P261: Avoid breathing fumes, mists, vapours or spray.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contacted areas thoro

Safety Data Sheet

2
0
M
L
READ
THE
ENCLOSED
LEAFLET BEFORE OPENING
OR USING
DIRECTIONS FOR USE:
RESTRAINT:
DO NOT USE IN FOOD PRODUCING
ANIMALS.
USE
ONLY
IN
SITUATIONS
WHERE
SENSITIVITY
TESTING
INDICATES
NO
ALTERNATIVE ANTIBIOTIC.
This product is contraindicated for use
in dogs with known perforation of the
tympanic membrane. Marbofloxacin is
contraindicated in immature dogs as it
has been shown to cause arthropathy.
Marbofloxacin
is
contraindicated
in
dogs known to be hypersensitive.
Do not use on pregnant or lactating
bitches
and
dogs
intended
for
breeding purposes.
Do
not
use
in
dogs
with
known
hypersensitivity to any of the active
constituents.
FIRST AID: If poisoning occurs,
contact a doctor or Poisons
Information Centre.
Phone Australia 131 126.
DISPOSE
of
empty
container
by
wrapping with paper and putting in
garbage.
STORE below 25°C (Air conditioning).
Protect from light. Do not freeze.
Manufactured by:
VETOQUINOL S.A.,
MAGNY VERNOIS,
70200 Lure (France)
Distributed by:
VETOQUINOL AUSTRALIA PTY LTD
Unit 302/2, 6-12 Boronia Road,
DaVinci Business Park,
Brisbane Airport, Qld, 4008
Phone: [phone]
[e-mail]
APVMA Approval No.: 67225/55519
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE
OPENING OR USING
FOR ANIMAL TREATMENT ONLY
_AURIZON ®_
_EAR DROPS SUSPENSION_
ACTIVE CONSTITUENTS: Each mL contains
3 mg marbofloxacin, 10 mg clotrimazole
and 1 mg dexamethasone acetate.
For the treatment of otitis externa in dogs
of
both
bacterial
and
fungal
origin
respectively due to bacteria sensitive to
marbofloxacin
and
fungi,
especially
_Malassezia _
_pachydermatis_,
sensitive
to
clotrimazole.
20ML
DOSAGE AND ADMINISTRATION
SHAKE WELL BEFORE USE.
Discard
unused
contents
within
2 months of initial opening.
When the product is intended for use in
several dogs, use a single cannula for
each dog.
The
external
ear
canal
should
be
meticulously cleaned and dried before
treatment.
Apply ten drops into the ear once daily
for 7 to 14 days.
After 7 days of treatment, the veterinary
su