Bravecto^® Spot-On Solution for Dogs

There are no breed contraindications for this product. Any contraindications are listed in the product datasheet under summary of product characteristics.

A growing dog should be dosed with a tablet appropriate to the body weight at the time of treatment.

Field studies conducted in support of Bravecto’s marketing authorisation included growing dogs and there was no evidence for a lack of efficacy1,2.  Bravecto showed continuous flea efficacy of >99% throughout the 12-week interval in these dogs. The minimum retreatment interval for dogs is 8 weeks3.

1. Meadows et al. Parasites & Vectors 2014, 7:375
2. Rohdich et al. Parasites & Vectors 2014, 7:83
3. Bravecto chewable tablets summary of product characteristics

As per the Bravecto Chewable tablet SPC and datasheet, use with caution in dogs with pre-existing epilepsy.

The statement was included as it represented a very rare occurrence captured in the Pharmacovigilance data reports. This does not demonstrate a causal relationship between Bravecto and seizures. Breakthrough seizures in animals under treatment for epilepsy is fairly normal according to key opinion1. We have no specific safety or efficacy concerns with these dogs and Bravecto has an established safety profile. Bravecto can be used with caution following a vet assessment as with any prescription. A dog with epilepsy can experience a seizure due to a wide range of stimuli, and thus caution is always in order.

1. Potschka et al., 2015. International veterinary epilepsy task force consensus proposal: outcome of therapeutic interventions in canine and feline epilepsy. BMC Veterinary Research volume 11, Article number: 177.

There are no known incompatibilities with other classes of ectoparasiticides or parasiticide. It would be a reasonable precaution to observe a normal retreatment interval after the use of another product in the isoxazoline class and in the case of other products to not apply two products simultaneously so it was clear which product use was responsible in the unlikely occurrence of an adverse event.

MSD Animal Health conducts environmental risk assessments on its products from the development phase through product launch to understand and manage product impacts from manufacturing and patient use. Our environmental risk assessments are conducted in accordance with applicable stringent global regulations, including the regulatory review processes of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Product environmental safety profiles are reassessed during periodic renewals of product filings and risk mitigation actions are implemented when needed.

The potential transfer of active ingredients used in our spot-on and chew products from the dog into surface water has been assessed in the European environmental risk assessments. Based on their intrinsic properties we are confident in the absence of transfer into surface water for the active ingredients in the registered products in our companion animal line. However, please be aware of the statement on the Summary of Product Characteristics that dogs treated with Bravecto Spot-On should not be allowed to be immersed in water or swim in water courses within 3 days after treatment. There is no specifically identified risk to fish or aquatic species from this activity.

Following oral treatment of dogs fluralaner will mainly be excreted via the faeces, thus exposure of bees to fluralaner is considered very unlikely. Overall, there were no environmental concerns identified in the regulatory submissions or reviews. The environmental exposure through the oral treatment of dogs is considered too low to impact the environment.

The excipients in the Bravecto chewable tablets for Dogs are: pork liver flavour, sucrose, maize starch, sodium lauryl sulfate, disodium pamoate monohydrate, magnesium stearate, aspartame, glycerol, soya-bean oil and macrogol 3350.

The excipients in the Bravecto Spot on solution for Dogs and Cats are dimethylacetamide, glycofurol, acetone.

The expiry date of the product is stated on the packaging and refers to the last day of that month. Do not use the product after the expiry date.