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Osurnia Otic Ear Gel

Osurnia Otic Ear Gel
1ml Pipette » Pack of 20

  • 1ml Pipette » Pack of 20 £268.00
  • 1ml Pipette » Priced per Pipette £13.49

Selection of 2 products from

£13.49 to £268.00

Description

Osurnia otic ear gel is a revolutionary new ear treatment for ear infections in dogs (‘otitis externa’). It comes in the form of a pipette containing gel which is applied to the ear.

Osurnia otic ear gel contains the active ingredients terbinafine (an anti-fungal agent), florfenicol (an antibiotic) and betamethasone acetate (a steroid). The antibiotic and anti-fungal treat and kill many of the bacteria and yeast common in ear infections. The steroid helps to reduce the swelling, pain and redness associated with an ear infection.

Osurnia otic ear gel is given as two simple treatments one week apart, removing the need to clean the ear or apply medicated drops on a daily basis and making treatment of ear infections much easier!

Need help or advice? Contact us:

  • Landline: 01582 842096
  • Mon - Fri: 8:30am - 5:00pm
  • Sat: 9:00am - 1:00pm (Collections only)
  • Email: [email protected]

All prices include VAT where applicable.

Medication Datasheets

1ml Pipette » Priced per Pipette

Osurnia ear gel for dogs

Qualitative and quantitative composition

Active substances:

1 dose (1.2 g) contains:

Terbinafine: 10 mg

Florfenicol: 10 mg

Betamethasone acetate: 1 mg

equivalent to Betamethasone base 0.9 mg

Excipient:

Butylhydroxytoluene (E321): 1 mg

For the full list of excipients, see Pharmaceutical particulars.

Pharmaceutical form

Ear gel. Off-white to slightly yellow translucent gel.

Clinical particulars

Target species

Dogs

Indications for use, specifying the target species

Treatment of acute otitis externa and acute exacerbation of recurrent otitis externa associated with Staphylococcus pseudintermedius and Malassezia pachydermatis.

Contraindications

Do not use in case of hypersensitivity to the active substances, to other corticosteroids or to any of the excipients. Do not use if the eardrum is perforated. Do not use in dogs with generalised demodicosis. Do not use in pregnant or breeding animals.

Special warnings for each target species

Special precautions for use

Special precautions for use in animals

If hypersensitivity to any of the components occurs, the ear should be thoroughly washed. The safety of the product has not been established in dogs less than 2 months of age or weighing less than 1.4 kg. Whenever possible the use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing. Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine and may decrease the effectiveness of treatment with other antibiotics and antifungal agents. In case of parasitic otitis, an appropriate acaricidal treatment should be implemented. Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated. Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function. Decreased cortisol levels were observed after product instillation in tolerance studies (before and after ACTH stimulation), indicating that betamethasone is absorbed and enters the systemic circulation. The finding was not correlated with pathological or clinical signs and was reversible. Additional corticosteroid treatments should be avoided. Use with precaution in dogs with suspected or confirmed endocrine disorder (i.e. diabetes mellitus; hypo- or hyper-thyroid disease, etc.).

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

In case of accidental eye contact, rinse thoroughly with water. In case of accidental skin contact wash exposed skin thoroughly with water. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions (frequency and seriousness)

Post authorisation experience indicates that very rare cases of deafness or impaired hearing, usually temporary, in dogs have been reported after use, mainly in elderly animals.

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).

Use during pregnancy, lactation or lay

Betamethasone is known to be teratogenic in laboratory species. The safety of the veterinary medicinal product has not been established in pregnant and lactating bitches; therefore, the product should not be used during pregnancy and lactation. Fertility Do not use in breeding animals.

Interaction with other medicinal products and other forms of interaction

Compatibility with ear cleaners, other than saline, has not been demonstrated.

Amounts to be administered and administration route

Auricular use. Administer one tube per infected ear. Repeat the administration after 7 days. The maximum clinical response may not be seen until 21 days after the second administration. Instructions for proper use:

It is recommended to clean and dry the external ear canal before the first administration of the product. It is recommended not to repeat ear cleaning until 21 days after the second administration of the product. If treatment with this product is discontinued, the ear canals should be cleaned before treatment with an alternative product is initiated. 1. Open the tube by twisting the soft tip. 2. Introduce this flexible soft tip into the ear canal. 3. Apply the product into the ear canal by pressing it between two fingers. 4. After application, the base of the ear may be massaged briefly and gently to facilitate even distribution of the veterinary medicinal product into the ear canal. Keep out of the sight and reach of children.

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

Auricular administration of five times the recommended dose, one week apart, for 5 consecutive weeks (a total six administrations of 5 tubes per ear or 10 tubes per dog) to mixed breed dogs weighing 10 to 14 kg resulted in clinical signs of wetness of the inner and outer pinna (attributed to presence of the product). There were no clinical signs associated with unilateral vesicle formation within the epithelium of the tympanic membrane (also observed after six administrations, one week apart, of 1 tube per ear or 2 tubes per dog), unilateral mucosal ulceration in the lining of the middle ear cavity, or decrease in serum cortisol response below normal reference range in ACTH stimulation testing. The decreased adrenal and thymus weights accompanied by atrophy of the adrenal cortex and lymphoid depletion of the thymus correlated with the decreased cortisol levels, and were consistent with the pharmacologic effects of betamethasone. These findings are considered reversible. Reversibility of the epithelial tympanic membrane blistering is also likely through epithelial migration, a natural self-cleaning and self–repair mechanism for the tympanic membrane and ear canal. Additionally, dogs showed slightly elevated red blood cell count, hematocrit, total protein, albumin and alanine aminotransferase. These findings were not associated with clinical signs.

Withdrawal period(s)

Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Otologicals – Corticosteroids and anti-infectives in combination.

ATC-vet code: QS02CA90.

Pharmacodynamic properties

The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):

Betamethasone acetate belongs to the diesters class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which relieves both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa. 5

Terbinafine is an allylamine with a pronounced fungicidal activity. It selectively inhibits the early synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis (MIC90 of 2 μg/ml). Terbinafine has a different mode of action than azole antifungals, therefore there is no cross resistance with azole antifungals.

Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 8 μg/ml).

Due to the high antimicrobial concentrations achieved in the ear canal and the multifactorial nature of otitis externa, in vitro susceptibility may not be directly correlated with clinical success.

Pharmacokinetic particulars

The formulation dissolves in ear wax and is slowly eliminated from the ear mechanically.

Systemic absorption of all active substances was determined in multiple-dose studies after placing the veterinary medicinal product into both ear canals of healthy mixed breed dogs. Absorption occurred primarily during the first two to four days after administration, with low plasma concentrations (1 to 42 ng/ml) of active substances.

The extent of percutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier. Inflammation can increase the percutaneous absorption of veterinary medicinal products.

Pharmaceutical particulars

List of excipients

Butylhydroxytoluene (E 321)

Hypromellose

Lecithin

Oleic acid

Propylene carbonate

Glycerol formal

Major incompatibilities

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).

Nature and composition of immediate packaging

Single-use multi-layered aluminium and polyethylene tube with a polypropylene thermoplastic elastomer tip.

Cardboard box containing 2, 12, 20 or 40 tubes (each containing 2.05 g).

Not all pack sizes may be marketed. 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.

Marketing Authorisation Holder (if different from distributor)

Elanco Europe Ltd. Lilly House, Priestley Road Basingstoke RG24 9NL UNITED KINGDOM

Marketing Authorisation Number

EU/2/14/170/0001 (2 tubes)

EU/2/14/170/0002 (12 tubes)

EU/2/14/170/0003 (20 tubes)

EU/2/14/170/0004 (40 tubes)

Date of the first authorisation or date of renewal

Date of first authorisation: 31/07/2014

Date of revision of the text

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ .

Any other information

Legal category

Delivery Information

How quickly do you deliver?

Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.

What do you charge for delivery?

For UK delivery, we charge the following:

Order Total Weight Delivery
£0-£28.99 Under 2kg £2.99
2kg+ £4.99
£29-£38.99 Under 2kg Free
2kg+ £4.99
£39+ Under 2kg Free
2kg+ Free

Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.

For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.

We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.

Delivery of aerosols

Due to restrictions aerosols can't be sent by Royal Mail. We appreciate your understanding.

Delivery of temperature controlled items

Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.

How do I cancel or return an order?

Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.

To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.

*For full details on returns, see our terms and conditions page.

Reviews

Q & A

Below are some recent questions we've received regarding Osurnia Otic Ear Gel, including answers from our team.

28 April 2018 at 10:39am

Is a prescription required?

Karen Moreton

  • VioVet customer since 2016
  • From: Derbyshire, United Kingdom

Will I need a prescription for the Osurnia Otic Ear Gel?

  • Website Content Developer

Hi Karen,

Yes you will as this is a controlled medication.

Best wishes,

VioVet.