Our Vision Is The Science Of Healthier Animals

MSD Animal Health is a global, research-driven company that develops, manufactures and markets a broad range of veterinary vaccines, medicines and services. MSD Animal Health offers one of the industry’s most innovative portfolios, spanning products for prevention, treatment and control of disease in all major farm and companion animal species, and is home to some of the industry’s most trusted brands.

In August 2014, MSD Animal Health brought you the longest- lasting chewable flea and tick treatment. Bravecto® has now extended its portfolio to include the new Bravecto® Spot-On. Now you can provide tick, flea and mite protection in two extraordinary ways, supporting pet and pet owner needs, while ensuring the longer, persistent tick and flea activity. In cats, Bravecto® Spot-On provides immediate and persistent flea and tick activity for 3 months¹. In dogs, Bravecto® Spot-On provides immediate and persistent tick activity for 4 months and flea activity for 6 months¹.

The flexibility provided with the BRAVECTO® product range means that customers can decide which flea, tick and mite protection remedy is right for their pet and their lifestyle. Now, whether your customer has a dog, a cat or both, you can offer all their pets the same long-lasting protection.

Customer Benefits

• One easy way to manage tick, flea and mite infestations
• Higher compliance to veterinary treatment recommendations
• Fast-acting protection and convenience
• Flexibility of appropriate treatment and more quality time with their pet
• Spot-On presentation available for dogs not wanting to freely take the Bravecto® Chew
• Efficacy is unaffected by bathing and swimming for those dogs using the chewable Bravecto®. Water will not affect pets treated with Bravecto® Spot-on but 3 days should be allowed after treatment according to the package insert. However, a recent study has shown that a mere 12 hours between treatment and bathing and/or swimming will ensure pets remain protected for the full treatment period. Efficacies (compared to the untreated control group) were: 99,3 % for no water immersion; 99,6 % for immersion 1 h before treatment; 99,3 % for immersion 12 h after treatment; and, 100 % for immersion 24 h after treatment17.

 BRAVECTO® Spot-On Active Ingredient And Formulation

Fluralaner, the extraordinary ingredient in the Bravecto® chew, is now reformulated in a new spot-on treatment for cats and dogs. This new formulation retains the same potent activity of fluralaner against ticks, fleas and mites, benefiting from its powerful and selective inhibition of the parasite nervous system. Fluralaner blocks two distinct pathways in the parasite nerve cell membrane – the gamma- aminobutyric acid (GABA) receptor and the glutamate receptor^12,13.

Pharmacology

The fluralaner molecule is readily absorbed from the site of topical administration and is then distributed systemically in the pet. The absorption characteristics result in maximum plasma concentrations between 3 and 21 days after administration. A slow rate of excretion from plasma (T1⁄2 = 11 days), which combined with a high level of protein binding leads to persistent systemic activity. These properties result in effective levels of fluralaner to provide extended protection following topical administration. Fluralaner is mainly excreted through the digestive tract.^1,14:

Fast, Persistent Protection

Bravecto® Spot-On and Bravecto® Chew provide high tick and flea control within a short amount of time, persisting for 3-4 months. Clinical trials have confirmed Bravecto®’s extensive efficacy:

Bravecto® offers a speed of kill that provides rapid relief to the animals treated

• A single Bravecto® treatment improved all FAD affected dogs in an Australian field trial⁴
• Just one dose can drive fleas in a household to extinction⁵
• Bravecto® kills ticks before they engorge⁶ and markedly reduces the risk of them transmitting disease.

FLEAS

Continuous protection is essential for flea control

• Flea infestations can occur when pet owners fail to give monthly treatments at the correct interval leaving their pets vulnerable
• Once a flea infestation has been established, it can take 2 months or more to eradicate due to the time required for fleas to pass through the various stages of their life cycle in the environment
• Eradicating an existing infestation and preventing a new one from establishing itself requires continuous protection over the length of the flea life cycle (14-42 days), ensuring all new fleas are killed as they emerge from the surrounding environment and before they lay eggs.

Prevention of tapeworm transmission¹¹

A recent study has shown that the insecticidal efficacy of a single treatment of either orally or topically administered fluralaner (Bravecto®) prevented D. caninum transmission from infected fleas to susceptible dogs for up to 12 weeks following administration. All 8 dogs in the placebo-treated group became infected with D. caninum while no shed proglottids were observed at any point during the post- treatment period from any dog in either fluralaner treated group¹¹.

TICKS

Research shows that both dog and cat owners are concerned about ticks – a growing issue in many parts of the world. Inconsistent monthly treatments can leave pets vulnerable, but Bravecto® provides 3-4 months protection, depending on whether we use the chewable option or the top-spot variation of the product, in a single dose. That means there are fewer gaps in treatment.

Flea Control in Cats

Laboratory efficacy testing shows that Bravecto® Spot-On provides cats with at least 95% efficacy against fleas (C. felis) within 12 hours for 12 weeks1.

This graph shows that flea (C. felis) efficacy of Bravecto® Spot-On for cats in this study is constant at 100% at 48 hours following infestation throughout the recommended 3-month treatment interval.⁵

 

• In an in-field study (graph below), a single topical administration of fluralaner to cats was well tolerated and highly effective in controlling flea infestations on cats for 12 weeks following administration under typical household conditions.

Flea Allergy Dermatitis

A portion of the cats (7%) enrolled in an EU field study were affected with clinical signs of Flea Allergy Dermatitis (FAD)15. These cats showed considerable improvement in FAD clinical signs following Bravecto® Spot-On treatment¹. These results are explained by the potent efficacy of Bravecto® Spot-On killing adult fleas and breaking the flea life cycle. Persistent flea control efficacy for 3 months leads to progressive elimination of flea life stages from the household environment. The dramatic reduction in the parasite load in the household is the basis for the control of signs of FAD in affected cats.

Tick Control In Cats

A single topical administration of fluralaner to cats was well tolerated and highly effective in controlling tick infestations with Ixodes scapularis infestations on cats for 3 months (graph below) following administration. Similarly, for Ixodes ricinus and Dermacentor variabilis ticks.¹⁰

Persistent efficacy against ticks in the EU field study

In an EU field trial an efficacy evaluation against ticks was performed15. Tick counts at the time of enrolment of cats into the study showed the following distribution of infesting ticks:

Bravecto® Spot-On demonstrated a high level of tick efficacy on treated cats throughout the 12 weeks of the EU field efficacy study. Bravecto® Spot-On should be applied at 3 month intervals for optimal tick control.¹

The Longest Lasting Spot-On Flea And Tick Treatment For Dogs

• Bravecto® Spot-On for Dogs provides effective control of fleas within 8 hours of administration1 and subsequently maintains persistent efficacy against flea-reinfestation for 6 months¹.

Tick Control In Dogs

In a controlled study continued tick efficacy assessments revealed an excellent effectiveness for Bravecto® Spot- On against H.elliptica and Rhipicephalus sanguineus for a period of 114 days (4 months) after treatment.

Safety Profile

The safety of Bravecto® has been well established with over 80 million doses dispensed worldwide and has received approval by 72 regulatory agencies around the world. As part of the product approval process, regulatory agencies throughout the world have reviewed the Bravecto® research data and have deemed it safe for sale in their countries, when used according to the product label. Global safety surveillance of Bravecto® use has provided additional compelling evidence of the safety of the product.

• Veterinarians now have a feline-friendly way to keep cats protected with Bravecto® Spot-On. It’s the first spot-on to offer persistent efficacy against fleas and ticks on cats.
• Safety was demonstrated in kittens aged 11-13 weeks and weighing between 1,2 and 1,5 kg treated with overdoses of up to 5 times the maximum recommended dose on 3 occasions at shorter intervals than recommended (8-week intervals).¹
• To add to the millions of dogs already treated with Bravecto® Chew, now you can also apply the same great benefits with a spot-on solution.
• Can be used in breeding, pregnant and lactating dogs, as well as MDR1 breeds.¹ Safety not established in breeding or lactating cats.
• In clinical studies, no interactions were observed with concurrent use of fluralaner and other routinely used medications.
• <2.5% of treated cats in clinical trials developed mild and transient skin reactions at the application site such as erythema and itching or hair loss. Uncommonly, the following other signs shortly after administration were observed: apathy, tremours, anorexia, vomiting and hypersalivation. If licking of the application site occurs, transient, mild to moderate salivation and coughing or vomiting may occur.
• <1.5% of dogs in clinical trials had mild, transient application site reactions e.g. erythema or alopecia.
• No adverse events have been seen observed in up to 5 times the recommended dose of Bravecto® Spot-On for Dogs and Bravecto® Spot-On for cats at 8- weekly intervals.¹

Method of Administration For Bravecto® Spot-On

Step 1: Immediately before use, open the sachet and remove the pipette. The pipette should be held by the upper part of the tail base or by the upper rigid portion below the cap in an upright position (tip up) for opening it. The cap should be rotated clockwise or counter clockwise one full turn. The cap will stay on the pipette; it is not possible to remove it. The pipette is open and ready for application when the breaking of the seal is felt.

Step 2: The dog/cat should be standing or lying with its back horizontal during application. Place the pipette tip vertically against the skin between the shoulder blades of the dog or pipette tip on the base of the skull of the cat.

Step 3: Squeeze the pipette gently and apply the entire contents directly to the dog’s skin in 1 (when volume is small) or several spots along the dog’s dorsal line from the shoulder to the base of the tail. It should be avoided to apply an excessive amount of solution at any one spot that could cause some of the solution to run or drip off the dog.

Squeeze the pipette gently and apply the entire contents directly to the cat’s skin. The product should be applied in 1 or 2 spots, depending on the volume.

Bravecto® Now Offers Flexible Tick, Flea And Mite Control Options Suited To Each Pet

Simple And Convenient Dosing In Cats

Bravecto® Spot-On for Cats should be administered in accordance with the following table (corresponding to a dose of 40 – 94 mg fluralaner/kg body weight):

For cats above 12.5 kg body weight, use a combination of two pipettes that most closely matches the body weight.

Bravecto® Chew and Bravecto® Spot-On for Dogs should be administered in accordance with the following table (corresponding to a dose of 25–56 mg fluralaner/kg bodyweight within one weight band):

For dogs above 56 kg bodyweight, use a combination of two tablets that most closely matches the bodyweight.

References

1. South African Bravecto Spot-On Package Insert
2. Rohdich N, Roepke RKA, Zschiesche E. A randomized, blinded, controlled and multi-centered field study comparing the efficacy and safety of BravectoTM (fluralaner) against FrontlineTM (fipronil) in flea- and tick-infested dogs. Parasites & Vectors 2014, 7:83
3. European Public Assessment Report (EMEA/V/C/002526/0000) for Bravecto, 12 December 2013 EMA/18748/2014 Veterinary Medicines Division.
4. Fisara P, Shipstone M, von Berky A, von Berky J. A small-scale open-label study of the treatment of canine flea allergy dermatitis with fluralaner. Vet Dermatol 2015 22 Jun.
5. Williams H, Young DR, Qureshi T, Zoller H, Heckeroth AR. Fluralaner, a novel isoxazoline, prevents flea (Ctenocephalides felis) reproduction in vitro and in a simulated home environment. Parasites & Vectors 2014, 7:275
6. Williams H, Demeler J, Taenzler J, Roepke RKA, Zschiesche E, Heckeroth AR. A quantitative evaluation of the extent of fluralaner uptake by ticks (Ixodes rici nus, Ixodes scapularis) in fluralaner (Bravecto) treated vs. untreated dogs using the parameters tick weight and coxal index. Parasites & Vectors 2015 8:352.
7. Dryden 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
8. Meadows C, Guerino F, Sun F. A randomized, blinded, controlled USA field study to assess the use of fluralaner topical solution in controlling feline flea infestations. Parasites & Vectors. 2017; 10:37.
9. Taenzler et al. Efficacy of fluralaner spot-on solution against induced infestations with Rhipicephalus sanguineus on dogs Parasites & Vectors 2016; 9:276
10. http://www.fda.gov/downloads/animalveterinary/products/approvedanimaldrugproducts/foiadrugsummaries/ucm399075.pdf
11. Gopinath D, Meyer L, Smith J and Armstrong R. Topical or oral fluralaner efficacy against flea (Ctenocephalides felis) transmission of Dipylidium caninum infection to dogs. Parasites & Vectors. (2018) 11:557
12. Gassel M et al. Insect Biochemistry and Molecular Biology 2014 45:111-124
13. Ozoe Y. Advances in Insect Physiology 2013 44:211-286
14. Kilp et al. Parasites & Vectors (2016) 9:296
15. CVMP assessment report for Bravecto for spot-on solution for dogs and cats
16. Data on file
17. Heide Dongus, Leon Meyer and Rob Armstrong. Parasites & Vectors 2017 10:441. Water immersion of dogs close to the time of topical fluralaner treatment does not reduce efficacy against a subsequent experimental challenge with Rhipicephalus sanguineus (sensu lato).