Unshakeable confidence

Transcription

1 NEW PRODUCT OF THE YEAR as voted by vets for the 2nd year running** Unshakeable confidence Osurnia is the only otitis externa* treatment that applies like a liquid and stays like a gel. Right where you need it. Make the right start with targeted treatment for otitis externa*

2 WHAT MAKES THE PATENTED GEL DIFFERENT? Osurnia is uniquely designed to maximise contact time with the site of infection, remaining in place for 28 days. Choosing a gel that goes and stays exactly where it s needed supports a successful outcome for otitis externa* cases. The gel formulation that applies like a liquid and stays like a gel: 1 Applies as gently and easily as a liquid, but sets like a gel 2 Coats and adheres to the entire ear canal as a gel Delivers three active ingredients to the infection site A FIRST LINE TREATMENT THAT YOU CAN PRESCRIBE WITH CONFIDENCE FOR YOUR OTITIS EXTERNA* CASES. Osurnia is a unique sustained release gel: 3 4 Active ingredients stay and work for 28 days 5 Osurnia works with the ear s natural cleaning process and is gradually eliminated over time via epithelial migration Antibacterial Florfenicol First line spectrum of activity Antifungal Terbinafine Effective against Malassezia spp Anti-inflammatory Betamethasone Acetate Helps to relieve discomfort

3 STAYS AND WORKS Adaptable gel squeezes out of the tube and applies like a liquid, spreading through the ear canal. The unique formulation then acts like a gel, staying put and making it harder for dogs to shake out of their ears, meaning less mess. OSURNIA GIVES YOU UNSHAKEABLE CONFIDENCE IN YOUR OTITIS EXTERNA* TREATMENT. The lipophilic formulation spreads through the ear canal, dissolving in ear wax and is slowly eliminated from the ear. Therapeutic concentrations are therefore achieved and maintained in the ear canal. 1 Traditional eardrops Osurnia is different

4 IMPROVING QUALITY OF LIFE FOR DOGS AND OWNERS Otitis externa* is the most common reason that dogs visit the vet in the UK 2 and administering treatment at home can cause significant distress for dogs and their owners. 3 Improvement of dogs and owners Quality of Life (QoL) scores 4 DOGS Osurnia Gel OWNERS Osurnia Gel Qol Score Qol Score Days Days Results By Day 7: 57% 33% increase in QoL for dogs compared to 9.8% in daily treatment group increase in QoL for owners compared to 4% in daily treatment group KEY Osurnia Gel Daily ear drop Normal quality of life

5 OSURNIA ear gel for dogs Active substances: 1 dose (1.2 g) contains: Terbinafine: 10 mg, Florfenicol: 10 mg, Betamethasone acetate: 1mg equivalent to Betamethasone base 0.9 mg 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 cases 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: Clean the ears before the initial treatment is applied. Ear cleaning should not be repeated until 21 days after the second administration. In clinical trials, saline only was used for ear cleaning. Transient wetness of the inner and outer pinna can be observed. This observation is attributed to presence of product and is not of clinical concern. Bacterial and fungal otitis is often secondary to other conditions. Appropriate diagnosis should be used and therapy of causative conditions should be investigated before antimicrobial treatment is considered. In animals with a history of chronic or recurrent otitis externa, efficacy of the product may be affected if the underlying causes of the condition such as allergy or anatomical conformation of the ear are not addressed. 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). * For the treatment of acute otitis externa and acute exacerbation of recurrent otitis externa associated with Staphylococcus pseudintermedius and Malassezia pachydermatis in dogs. Bacterial and fungal otitis is often secondary to other conditions. Appropriate diagnosis should be used and therapy of causative conditions should be investigated. ** Results based on an online survey with 321 vets in March 2017, conducted by CM Research. References: 1. T. Nuttall and S. Forster, Terbinafine and florfenicol concentrations in the canine ear exceed minimum inhibitory concentrations for common otic pathogens after treatments with Osurnia (Elanco Animal Health), British Veterinary Dermatology Study Group, April Royal Veterinary College. Vet Compass: Disease prevalence data for UK pet dogs (accessed Jan 2018) 3. OnePoll survey of 402 UK dog owners who had administered ear drops to their pet, February 2016, commissioned by Elanco Animal Health 4. Noli, C et al. Vet Derm. Impact of a terbinafine florfenicol betamethasone acetate otic gel on the quality of life of dogs with acute otitis externa and their owners Volume 28, Issue 4 August Pages Elanco, Osurnia and the Diagonal Bar are trademarks owned by or licensed to Eli Lilly & Company, its affiliates or subsidiaries. Osurnia ear gel for dogs legal category POM-V UK, POM IE. Further information can be found in the Summary of Product Characteristics and the CVMP Assessment Report. Advice should be sought from the medicine prescriber. For further information, call Elanco Animal Health on +44 (0) or write to Elanco Animal Health (the animal health division of Eli Lilly and Company Limited), Lilly House, Priestley Road, Basingstoke RG24 9NL. Use medicines responsibly: Eli Lilly and Company UKCACOSU00142

6 CHOOSE THE GEL TREATMENT THAT GOES AND STAYS WHERE YOU NEED IT Adaptable gel coats and adheres to the entire ear canal. Patented formulation is uniquely designed to maximise contact time at the site of infection and inflammation. The gel supports a successful resolution by remaining in place to fight otitis externa for 28 days. FOR MORE COMFORTABLE DOGS AND HAPPIER OWNERS, CHOOSE OSURNIA. Clean the ear just once 1 week later apply second dose Watch case study videos and find other Osurnia resources at Register at MyElanco.co.uk to learn more