Spot-on for Dogs and Cats

NEW Spot-on for Dogs and Cats

INTRODUCING NEW BRAVECTO SPOT-ON FOR DOGS AND CATS You re always looking to provide the best care for your clients and their pets. Since 2015 Bravecto Chew for Dogs has been providing long-lasting protection against fleas and paralysis ticks in a single dose. Now Bravecto is offering you even more long-lasting options for dogs and cats in a spot-on. Bravecto Spot-on for DOGS The cap does not come off 6 MONTHS FLEA PROTECTION Full year flea protection in just two easy doses. 6 MONTHS PARALYSIS TICK PROTECTION Long-lasting protection against deadly paralysis ticks from one dose. SIMPLE SPOT-ON APPLICATION TWIST'N'USE tube makes application easy and convenient. Bravecto Spot-on for CATS The cap does not come off UP TO 3 MONTHS* FLEA PROTECTION Up to a year of flea protection in just four easy doses given quarterly. * Refer to product label for full claim details. 3 MONTHS PARALYSIS TICK PROTECTION Long-lasting protection against deadly paralysis ticks from one dose. SIMPLE SPOT-ON APPLICATION TWIST'N'USE tube makes application easy and convenient.

FLURALANER: INNOVATIVE NOSE-TO-TOES PROTECTION Bravecto Chew and NEW Bravecto Spot-on formulations contain fluralaner, a member of the isoxazoline class of insecticides - the first new insecticide class in a decade. Fluralaner is a potent inhibitor of parts of the arthropod nervous system, killing fleas and ticks at very low concentrations.1,2 There is no known resistance in fleas or ticks to Bravecto and it has been proven to be effective against fipronil-resistant fleas. Once Bravecto Spot-on is administered using the innovative TWIST N USE tube, it is readily absorbed into the dog or cat s bloodstream from the skin where it binds tightly to proteins. It is eliminated slowly resulting in the long persistence in dogs and cats. 3 Due to its systemic nature, it works from the inside, providing nose-to-toes protection. Fluralaner is not extensively metabolised and is excreted mostly unchanged in the faeces and to a very low extent in the urine. 3 FIGURE 1: Transdermal absorption of fluralaner FLEAS CONTINUOUS PROTECTION IS KEY TO FLEA PREVENTION Flea infestations can occur when pet owners fail to give monthly treatments at the correct interval, leaving their pet vulnerable. Once a flea infestation has been established, it can take on average 2 months or more to eradicate it due to the time required for fleas to pass through the various stages of their life cycle in the environment.4 Getting on top of an existing infestation and preventing a new one, requires continuous protection over the length of the flea life cycle, ensuring all new fleas are killed as they emerge from the environment and before they lay eggs. EGGS LARVAE PUPAE ADULT STAGE STAGE STAGE STAGE < 10 days = 10 days 11 days < 3 months 1 2 3 (but can be months) 4 BRAVECTO LASTS FOR THE FULL FLEA LIFE CYCLE fuss-free dose of Bravecto coversthe beyond the length the average One fussone free dose of Bravecto covers length of theofaverage flea life cycle, flea life cycle, providing rapid and persistent protection. providing rapid and long-lasting protection. FIGURE 2: Flea life cycle

BRAVECTO: THE LONGEST-LASTING SPOT-ON FLEA TREATMENT FOR CATS FAST AND RELIABLE FLEA CONTROL FOR UP TO 3 MONTHS Bravecto Spot-on for Cats demonstrated % flea efficacy within 8 hours after treatment and at least 97.7% efficacy within 12 hours after re-infestation for up to 3 months. 5 The rapid onset of action kills newly emerged adult fleas before they lay eggs. Two real world field studies 6,7 were conducted in households situated in high flea challenge environments across Australia s eastern seaboard. In Queensland 6 there were 20 cats in 17 households with a mean starting flea count of 25.3 fleas. In New South Wales 9 there were 22 cats in 21 households with a mean starting flea count of 19.2 fleas. A single treatment with Bravecto Spot-on for Cats provided 99.0% efficacy for up to 3 months. 99.9 99.6 99.7 99.2 99.0 99.1 80 Efficacy (%) 60 40 Queensland New South Wales 20 0 Week 4 Week 8 Time (Weeks) Week 12 BRAVECTO SPOT-ON FOR CATS VERSUS REVOLUTION In a study in Tampa 8, Florida, 1 dose of Bravecto resulted in 4x more flea-free cats within 30 days compared to a single dose of Revolution. It also resulted in greater than 2.5x more flea-free cats than 3 doses of Revolution. 40 private residences chosen as study sites near Tampa, Florida, an area with extreme flea pressure. Data obtained through flea counts on pets and in premise traps, dermatology assessments and pruritus assessments. 3 doses of Revolution for cats given to 41 cats in 20 homes, 1 dose each on Study Days 0, 28 30 and 56 60 *. 1 dose of Bravecto given to 59 cats in the other 20 homes on Study Day 0. % of Flea-Free Cats 80 60 40 20 0 Percentage of flea-free cats. 80.7 28 30 82 86 Days Bravecto 17.2 99.9 38.5 Revolution The study ended Days 82 86, after approximately 12 weeks. Bravecto cats treated once: Day 0 Revolution cats treated 3 times: Days 0, 28 30 and 56 60 All percentages are significantly different (P<0.002). Percentage of flea-free households. No fleas on cats, dogs or in premise traps. % of Flea-Free Households 80 60 40 20 0 60.0 6.0^ 95.0 31.0 28 30 82 86 Days Bravecto Revolution Treating both dogs and cats in a multi-pet household with a highly effective flea treatment is necessary for a flea-free home. ^Significantly different percentage of flea-free homes (P 0.021). * Additionally, 45 dogs in these households were administered another flea and tick product on Study Days 0, 28-30 and 56-60. Additionally, 32 dogs in these households were administered Bravecto Chew on Study Day 0.

BRAVECTO: THE LONGEST-LASTING SPOT-ON FLEA TREATMENT FOR DOGS FAST AND RELIABLE FLEA CONTROL FOR 6 MONTHS Bravecto Spot-on for Dogs provides effective control of fleas within 8 hours of administration 9 and subsequently maintains persistent efficacy against flea-reinfestation for 6 months. The rapid onset of action kills newly emerged adult fleas before they lay eggs. 9 Two field studies 6,7 were conducted in households situated in high flea challenge environments across Australia s eastern seaboard in which monthly visits were made to the households for 26 weeks. In Queensland 6 there were 22 dogs in 17 households with an average flea count of 47.4 fleas. In New South Wales 7 there were 27 dogs in 21 households with an average flea count of 36.4 fleas. Outstanding. The fleas died very quickly. I ve never come across a product that works so well. FIGURE 3: Comments from study participants A single treatment with Bravecto Spot-on for Dogs provided 99.6% efficacy for a full 6 months. % reduction in geometric mean flea count over 6 months after a single Bravecto Spot-on for Dogs treatment. 6,7 99.6 99.7 99.9 99.9 99.9 99.9 80 Efficacy (%) 60 40 20 0 1 2 3 4 5 6 Time (Months) Queensland New South Wales

BRAVECTO: THE LONGEST-LASTING SPOT-ON PARALYSIS TICK TREATMENT FOR DOGS AND CATS FACTS ABOUT PARALYSIS TICK Tick paralysis in Australia is caused by the paralysis tick (Ixodes holocyclus). Paralysis ticks are known to cause serious disease and death in domestic dogs and cats along the eastern coast of Australia. 10 Tick paralysis is an acute, progressive, ascending paralysis caused by neurotoxins in tick saliva, which enter the host during feeding. 11 The neurotoxin secretion has a specific timing during the engorgement process and is associated with major physiological changes in tick salivary glands occurring on the third day. 12 To prevent the occurrence of fatal paralysis in tick infested dogs and cats, it is critical to kill the ticks within 72 hours post infestation and prior to the onset of clinical signs. PARALYSIS TICK IN CATS TREATMENT AND CONTROL OF PARALYSIS TICK IN CATS FOR 3 MONTHS An Australian study 13, understood to be the first of its kind, was conducted using 20 cats (10 treated and 10 control) immunized against paralysis tick holocyclotoxin. The cats were treated with the minimum effective dose (40 mg/kg) of Bravecto Spot-on for Cats. Ten Ixodes holocyclus ticks were attached to each cat on Days -1, 14, 28, 42, 56, 70 and 84. The ticks were counted and assessed at 24, 48 and 72 hours post infestation. The efficacy of fluralaner spot-on against an existing Ixodes holocyclus infestation was % at 48 hours post treatment. Following re-infestations, efficacy remained at % at the 48 and 72 hour assessments for all challenges from Day 14 to Day 84. Efficacy (% reduction in geometric mean I. holocyclus tick count) at 24, 48 and 72 hours following infestation on cats treated once with Bravecto Spot-on for Cats on Day 0. 80 Efficacy (%) 60 40 78.4 83.6 97.1 91.7 20 0-1 1 2 3 14 15 16 17 28 29 30 31 42 43 44 45 56 57 58 59 70 71 72 73 84 85 86 87 Study Day

PARALYSIS TICK IN DOGS TREATMENT AND CONTROL OF PARALYSIS TICK IN DOGS FOR 6 MONTHS An Australian pen study 14 was conducted using 20 dogs (10 treated and 10 control). The dogs were treated with Bravecto Spot-on at the minimum effective dose of 25 mg/kg. Thirty Ixodes holocyclus ticks were attached to each dog on Days -8, -1, 14, 28 and 42, and 20 ticks were attached to each dog on Days 56, 70, 84, 112, 140 and 182. Ticks were counted and assessed at 24, 48 and 72 hours post infestation. Bravecto Spot-on was 99.3% effective against existing infestation in 48 hours and % in 72 hours. The 72 hour assessment was % at all time points apart from Day 115 when 1 tick was found (99.6% efficacy). Efficacy (% reduction in geometric mean I. holocyclus tick count) at 24, 48 and 72 hours following infestation on dogs treated once with Bravecto Spot-on for Dogs on Day 0. 80 Efficacy (%) 60 40 20 99.3 85.1 99.3 99.3 98.2 99.6 99.6 97.1 92.3 99.5 88.9 93.7 52.8 0-1 1 2 3 14 15 16 17 28 29 30 31 42 43 44 45 56 57 58 59 70 71 Study Day 72 73 84 85 86 87 112 113 114 115 140 141 142 143 182 183 184 185

BRAVECTO: THE LONGEST-LASTING SPOT-ON BROWN DOG TICK TREATMENT FOR DOGS FACTS ABOUT BROWN DOG TICK 15,16 The brown dog tick (Rhipicephalus sanguineus) is able to complete all three life stages indoors and on the same pet with an engorged female laying up to 4,000 eggs. 15 Ticks can be found on dogs living in both urban and rural areas, being highly adapted to live within human dwellings. 15 The ticks are active throughout the year not only in tropical and subtropical regions, but also in some temperate areas. 15 Brown dog tick can also be more than just a nuisance, it can be a vector for a whole range of tick borne disease such as babesiosis, anaplasmosis, and haemotrophic mycoplasmosis. 16 A 2015 study revealed canine tick borne disease pathogens in both suspect and control groups of dogs in the Northern Territory and Queensland 18 therefore year round control is recommended. TREATMENT AND CONTROL OF BROWN DOG TICK FOR 12 WEEKS Two negative control studies 17,18 were conducted to assess the immediate and persistent efficacy of Bravecto Spot-on for Dogs. Treated dogs had 25 mg/kg fluralaner administered once on Day 0. Dogs were infested with 50 ticks on Days - 2, 28, 56 and 84 and the ticks were then removed and counted on Days 2, 30, 58, and 86 to assess efficacy. In study one 17 efficacy at Day 2 (immediate efficacy) was % and persistent efficacy at all other time points was % up to 114 days (16 weeks) after treatment. In study two 18 efficacy at Day 2 was 98.4% and persistent efficacy was %, %, % and 99.2%, on Days 9, 30, 58 and 86 days after treatment respectively. BRAVECTO: PROVEN SAFE The safety of Bravecto has been well established with over 80 million doses dispensed globally - across all formulations. Bravecto has gone through a rigorous regulatory approval process. In fact, more than 72 countries around the world have approved the use of Bravecto and have determined that it is safe for use in these countries when used according to the product label: Bravecto Spot-on for Dogs is safe to use in puppies from 8 weeks of age and 2 kg body weight. Bravecto Spot-on for Cats is safe to use in kittens from 11 weeks of age and 1.2 kg body weight. Oral safety studies in dogs and cats resulted in transient hypersalivation when Bravecto Spot-on was given orally at the maximum clinical doses. 19,20 < 2.5% of treated cats in clinical trials developed mild and transient skin reactions at the application site such as erythema (reddened skin) and itching or hair loss. Uncommonly, the following other signs shortly after administration were observed: apathy / tremors / anorexia or vomiting / hypersalivation. If licking of the application site occurs, transient mild to moderate salivation and coughing or vomiting may be observed. <1.5% of dogs in clinical trials had mild, transient application site reactions e.g. erythema or alopecia. No adverse events have been observed with Bravecto Spot-on for Dogs and Bravecto Spot-on for Cats when administered up to 5 times the clinical dose, at 8 weekly intervals. 21,22 Safe for use in breeding, pregnant, lactating dogs and MDR1 deficient dog breeds. Safety not established in breeding, pregnant or lactating cats. In clinical studies no interactions observed with concurrent use of fluralaner and other routinely used medications.

FREQUENTLY ASKED QUESTIONS HOW DO I APPLY BRAVECTO SPOT-ON? Bravecto comes with a clever TWIST N USE tube with a non-removable cap. HOW TO USE BRAVECTO S TWIST N USE TUBE Remove Bravecto from its child-safe packaging. Hold the tube straight up, and give the cap one twist to break the seal. PLEASE DO NOT ATTEMPT TO REMOVE THE CAP AS IT DOES NOT COME OFF. Ensure the animal s back is horizontal. Part the hair and apply directly to the skin. For dogs <10 kg, apply in two spots along the back. For dogs >10 20 kg, apply in three spots along the back. For dogs >20 56 kg, apply in four spots along the back. For cats <6.25 kg, apply in one spot at the base of the skull, to ensure the wet product can t be licked. For cats >6.25 kg, apply in two spots at the base of the skull, to ensure the wet product can t be licked. WHY DOES BRAVECTO SPOT-ON FOR DOGS LAST LONGER THAN BRAVECTO CHEW FOR DOGS? IS THE DOSE VERY HIGH / STRONG? The reason Bravecto Spot-on for Dogs lasts longer is not due to the dose, since the dose in Bravecto Spot-on for Dogs and Bravecto Chew are identical. Bravecto Spot-on for Dogs has a unique formulation which leads to differences in absorption when Bravecto is applied topically compared to when it is administered orally. 23 It is this difference that accounts for the extended duration. WHY DOES BRAVECTO SPOT-ON FOR DOGS LAST LONGER THAN BRAVECTO SPOT-ON FOR CATS? The topical absorption profile is different in cats compared to dogs. Fluralaner is also metabolised and excreted more rapidly in cats than dogs. 3,23 CAN I USE BRAVECTO SPOT-ON FOR DOGS IN GROWING, LARGE BREED PUPPIES? MSD recommends the use of Bravecto Chew for rapidly growing, large breed puppies. HOW CAN I HELP MY CLIENTS CHOOSE BETWEEN BRAVECTO CHEW AND SPOT-ON FOR DOGS? Every pet owner and dog has specific needs and preferences. Some dogs are picky eaters, others won t sit still for a spot-on treatment. Some owners prefer the longest possible protection from one treatment, others may prefer to administer flea and tick treatment every 3 months alongside other pet care routines such as intestinal wormers. Bravecto is available in both a spot-on and chew, ensuring there is always long-lasting protection available to suit your client s needs. WHY IS LONG-LASTING PROTECTION BETTER THAN MONTHLY TREATMENTS? 88% of pet owners say Bravecto is more convenient than a monthly treatment. 24 Gaps in protection can occur when pet owners do not administer flea treatments at the correct treatment interval. Bravecto guarantees continuous protection for an extended period with just one dose, helping your clients to drive fleas to extinction in their homes.

SIMPLE, CONVENIENT DOSING BODY WEIGHT OF DOG (KG) BRAVECTO VERY SMALL DOG BRAVECTO SMALL DOG BRAVECTO MEDIUM DOG BRAVECTO LARGE DOG BRAVECTO VERY LARGE DOG 2 4.5 1 chew or tube >4.5 10 1 chew or tube >10 20 1 chew or tube >20 40 1 chew or tube >40 56 1 chew or tube Bravecto Chew and Bravecto Spot-On for Dogs should be used in dogs from 8 weeks of age, weighing at least 2 kg. For dogs above 56 kg, use a combination of two Bravecto chews or two tubes that most closely matches the body weight. BODY WEIGHT OF CAT (KG) BRAVECTO SMALL CAT BRAVECTO MEDIUM CAT BRAVECTO LARGE CAT 1.2 2.8 1 tube >2.8 6.25 1 tube >6.25 12.5 1 tube Bravecto Spot-on for Cats is for use in cats from 11 weeks of age, weighing at least 1.2 kg. For cats above 12.5 kg, use a combination of two tubes that most closely matches the body weight.

A BROAD RANGE FOR LONG-LASTING BENEFITS A great choice for multi-pet households. Bravecto allows you to provide a range of options to satisfy differing client needs. BRAVECTO CHEW FOR DOGS BRAVECTO SPOT-ON FOR DOGS BRAVECTO SPOT-ON FOR CATS Fleas 3 months 6 months Up to 3 months Paralysis tick 3 months 6 months 3 months Brown dog tick 8 weeks 12 weeks Highly effective against fipronil resistant fleas Reduces incidence of FAD Sarcoptes - mange mite Otodectes - ear mite Demodex - mange mite Safe for use in breeding, pregnancy and lactation Safety not established Safe for use in MDR1 breeds Suitable for swimming * Not applicable * It is not recommended to wash or allow the dog to become immersed or swim in water within 3 days after treatment.

Ask your MSD Animal Health Representative about the NEW Bravecto Spot-on range for dogs and cats or call the Bravecto hotline on 1800 230 833. bravectoaustralia@merck.com www.bravecto.com.au BravectoAU BravectoAU 1. Gassel M, Wolf C, Noack S, Williams H, Ilg T. The novel isoxazoline ectoparasiticide fluralaner: elective inhibition of arthropod g-aminobutyric acid- and L-glutamate-gated chloride channels and insecticidal/acaricidal activity. Insect Biochem Mol Biol. (2014), 45:111 124. 2. Ozoe Y, Asahi M, Ozoe F, Nakahira K and Mita T. The antiparasitic isoxazoline A1443 is a potent blocker of ligand-gated chloride channels. Biochemical and Biophysical Research Communications (2010), 391:744 749. 3. Bravecto EPAR Summary of Product Characteristics 27/11/2017. 4. Ross DH, Arthur, et al. Evaluation of the efficacy of topically administered imidacloprid + pyriproxyfen and orally administered spinosad against cat fleas (Ctenocephalides felis): Impact of treated dogs on flea life stages in a simulated home environment. Parasites & Vectors (2012), 5:192. 5. MSD data on file. Speed of kill for fleas in cats. (2013), V-0084-0198. 6. MSD data on file. QLD field flea study for cats and dogs. 2015; 15/0005. 7. MSD data on file. NSW field flea study for cats and dogs. 2015; 15/0008. 8. Dryden, Canfield et al. In-home assessment of either topical fluralaner or topical selamectin for flea control in naturally infested cats in West Central Florida, USA. Parasites & Vectors (2018) 11:422. 9. Bravecto Spot-on for Dogs product label. 10. Atwell RB, Campbell FE, Evans EA. Prospective survey of tick paralysis in dogs. Aust Vet J (2001), 79:412 418. 11. Padula A. Tick paralysis of animals in Australia. In: Gopalakrishnakone P, Faiz S and Gnanathasan C (eds). Clinical Toxinology: clinical toxinology. Dordrecht: Springer Netherlands, (2016), pp 1 20. 12. Goodrich BS and Murray MD. Factors influencing the toxicity of salivary gland extracts of Ixodes holocyclus Neumann. lnt J Parasitol (1977). 13. Fisara P et al. Investigation of the efficacy of Fluralaner spot-on (Bravecto ) against infestations of Ixodes holocyclus on cats. Parasites & Vectors (2018). 14. MSD data on file. Paralysis tick study in dogs. 2015; 15/0017. 15. Dantas-Torres. Biology and ecology of the brown dog tick, Rhipicephalus sanguineus. Parasites & Vectors (2010), 3:26. 16. Hii et al. Canine tick-borne pathogens and associated risk factors in dogs presenting with and without clinical signs consistent with tick-borne disease in northern Australia. Australian Veterinary Journal. (2015) Vol 93, No 3. 17. MSD data on file. Brown dog tick study in dogs. 2012; V-0084-0146. 18. MSD data on file. Brown dog tick study in dogs. 2012; V-0084-0107. 19. MSD data on file. Oral safety study in dogs. 2012; V-0084-0177. 20. MSD data on file. Oral safety study in cats. 2012; V-0084-0151. 21. MSD data on file. Margin of safety study in cats. 2013; V-0084-014 & V-0084-0289. 22. MSD data on file. Margin of safety study in dogs V-0084-0139 & V-0084-0288. MSD data on file. 23. Kilp et al. Comparative pharmacokinetics of Fluralaner in dogs and cats following single topical or intravenous administration. Parasites & Vectors (2016), 9:296. 24. Lavan et al. Results from a U.S. Dog owner survey on the treatment satisfaction and preference for fluralaner against flea and tick infestations. J Vet Sci Technol (2017), 8:3. Bravecto is the registered trademark of Intervet International B.V., The Netherlands. MSD Animal Health. ABN 79 008 467 034. Toll free: 1800 230 833. Copyright (2018) Intervet International B.V., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. All rights reserved. S02147/AU/BRV/0218/0002o