Aurimic Ear Drops and Cutaneous Suspension 20ml

Aurimic Ear Drops and Cutaneous Suspension for Dogs and Cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml (40 drops) contains:
Active substances:
Miconazole nitrate 23.0 mg
(equivalent to 19.98 mg miconazole)
Prednisolone acetate5.0 mg
(equivalent to 4.48 mg prednisolone)
Polymyxin B sulfate 0.5293 mg
(equivalent to 5500 IU polymyxin B sulfate)

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Ear drops and cutaneous suspension
White suspension

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats

4.2 Indications for use, specifying the target species

For the treatment of otitis externa and small localised superficial skin infections in
dogs and cats caused by infections with the following miconazole and polymyxin B
sensitive bacteria and fungi:
• Gram-positive bacteria
 Staphylococcus spp.
 Streptococcus spp.
• Gram-negative bacteria
 Pseudomonas spp.
 Escherichia coli
• Fungi
 Malassezia pachydermatis
 Candida spp.
 Microsporum spp.
 Trichophyton spp.
Treatment of Otodectes cynotis (ear mites) infestations where there is concurrent
infection with miconazole and polymyxin B sensitive pathogens.

4.3 Contraindications

Do not use:
 in cases of hypersensitivity to the active substances of the veterinary medicinal
product, as well as to other corticosteroids, to other azole antifungal agents, or
to any of the excipients
 in animals with perforation of the tympanic membrane
 in animals, where resistance of causative agents to polymyxin B and/or
miconazole is known
 on the mammary glands of lactating bitches and queens

4.4 Special warnings for each target species

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

Use of the product should be based on susceptibility testing of the bacteria and/or
fungi isolated from the animal. If this is not possible, therapy should be based on
local (regional) epidemiological information about susceptibility of the target
pathogens.
In cases of persistent infestations with Otodectes cynotis (ear mites) systemic
treatment with an appropriate acaricide should be considered.
Before treating with the product, the integrity of the tympanic membrane must be
verified.
Systemic corticosteroid effects are possible, especially when the product is used
under an occlusive dressing, on extensive skin lesions, with increased skin blood
flow, or if the product is ingested by licking.
Oral ingestion of the product by treated animals or animals having contact with
treated animals should be avoided.
Avoid contact with eyes in animals. In case of accidental contact, rinse thoroughly
with water.

Special precautions to be taken by the person administering the veterinary medicinal
product to animals

People with known hypersensitivity to prednisolone, polymyxin B or miconazole
should avoid contact with the veterinary medicinal product.
The veterinary medicinal product may cause irritation to skin and eyes. Avoid contact
with skin or eyes. Always wear single use disposable gloves when applying the
veterinary medicinal product to animals. In case of accidental spillage, skin or eyes
should be rinsed immediately with plenty of water. Wash hands after use.
Take care to avoid accidental ingestion. In case of accidental ingestion, seek medical
advice immediately and show the leaflet or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Use of this veterinary medicinal product may very rarely be associated with the
occurrence of deafness (especially in older dogs), in this case treatment should be
discontinued.
Prolonged and extensive use of topical corticosteroid preparations is known to trigger
local immunosuppression including increased risk of infections, thinning of the
epidermis and delayed wound healing, telangiectasia and increased vulnerability of
the skin to bleeding and systemic effects, including suppression of adrenal function.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during
pregnancy and lactation.
Absorption of miconazole, polymyxin B and prednisolone through the skin being low,
no teratogenic/ embryotoxic/foetotoxic and maternotoxic effects are expected in dogs
and cats. Oral ingestion of the active substances by treated animals when grooming
can possibly occur and appearance of the active ingredients in blood and milk can be
expected.
Use only in accordance with the benefit/risk assessment by the responsible
veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

No data available.

4.9 Amounts to be administered and administration route

For auricular and cutaneous use.
Shake well before use. Any contamination of the dropper should be strictly avoided.
At the beginning of treatment, hair surrounding or covering the lesions must be
clipped; this should be repeated during treatment if necessary.
Infections of the external auditory canal (otitis externa):
Clean the external ear canal and auricle and place 5 drops of the veterinary
medicinal product into the external auditory canal twice a day. Massage the ear and
the auditory canal thoroughly to ensure proper distribution of the active substances,
but gently enough to avoid causing pain to the animal.
Treatment should be continued without interruption until a few days after complete
disappearance of the clinical symptoms, at least for 7 - 10 days up to 14 days. The
success of the treatment should be verified by a veterinarian before discontinuing
treatment.
Skin infections (small localised superficial):
Apply a few drops of the veterinary medicinal product to the skin lesions to be treated
twice a day and rub well.
Treatment should be continued without interruption until a few days after complete
disappearance of the clinical symptoms, up to 14 days.
In some persistent cases (ear or skin infections), treatment may need to be continued
for 2 to 3 weeks. In cases where prolonged treatment is necessary repeated clinical
examinations including a re- assessment of the diagnosis are required.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No other symptoms than those mentioned in section 4.6 are expected.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Otologicals, corticosteroids and antiinfectives in
combination.

5.1 Pharmacodynamic properties

Miconazole belongs to the group of N-substituted imidazole derivatives and inhibits
ergosterol de novo synthesis. Ergosterol is an essential membrane lipid and must be
synthesised by fungi. Ergosterol deficiency impedes numerous membrane functions,
eventually leading to the cell’s death. The spectrum of activities covers nearly all
fungi and yeasts of relevance to veterinary medicine as well as Gram-positive
bacteria. Practically no development of resistance has been reported. Miconazole
has a fungistatic mode of action, but high concentrations are also observed to
produce fungicidal effects.
Polymyxin B belongs to the polypeptide antibiotics which are isolated from bacteria. It
is only active against Gram-negative bacteria. The development of resistance is
chromosomal in nature and the development of resistant Gram-negative pathogens is
a relatively rare event. However, all Proteus species share a natural resistance to
polymyxin B.
Polymyxin B binds to phospholipids in the cytoplasmic membrane to disturb
membrane permeability. This results in autolysis of the bacteria, thus achieving
bactericidal activity.
Prednisolone is a synthetic corticosteroid and is used for its anti-inflammatory, antipruritic,

anti- exudative and anti-proliferative effects. The anti-inflammatory activity of
prednisolone acetate results from reduction of the permeability of capillaries,
improved blood flow and inhibition of fibroblast action.
The exact mechanism of the acaricidal effect is unclear. It is assumed that the mites
are suffocated or immobilised by the oily excipients.

5.2 Pharmacokinetic particulars

Following topical application of polymyxin B, there is virtually no absorption of the
compound through intact skin and mucous membranes, but significant absorption via
wounds.
After topical application of miconazole, there is virtually no absorption of the
compound through intact skin or mucous membranes.
When applied topically to intact skin, prednisolone is subject to limited and delayed
absorption. Greater absorption of prednisolone should be expected in cases of
compromised skin barrier function (e.g. skin lesions).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Silica, colloidal anhydrous
Paraffin liquid

6.2 Major incompatibilities

Not applicable.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 3 months

6.4 Special precautions for storage

Do not store above 30 C.
After first opening do not store above 25 °C.
Keep the container in the outer carton.

6.5 Nature and composition of immediate packaging

Dropper container of white, opaque LDPE with white, opaque HDPE screw cap in a
cardboard box.
Pack size: 1 x 20 ml

6.6 Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal product should be disposed of in accordance with local
requirements.

Sizes:

20ml