Bravecto Plus for Cats

Bravecto Plus is a safe, easy-to-use topical treatment that protects your cat against fleas, ticks, heartworm and intestinal parasites for up to 2 months. It is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati; 4th stage larvae, immature adults and adults) and hookworm (Ancylostoma tubaeforme; 4th stage larvae, immature adults and adults). Bravecto Plus also kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick) and Dermacentor variabilis (American dog tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater. The 2-month topical combines flea and tick protection, treatment of intestinal parasites, and heartworm prevention, which can be easier than monthly doses of multiple products. Bravecto Plus for cats requires a prescription from your veterinarian.

• Treatment and prevention of flea (Ctenocephalides felis) infestinations for 3 months).
• Treatment and control pf paralysis tick (Ixodes holocyclus) for 10 weeks.
• Rapid onset of action kills newly emerged adult fleas ebfore they lay eggs.
• Reduces incidence of flea allergy dermatitis (FAD) by controlling adult fleas.
• For the prevention of heartworm disease caused by Dirofilaria immitis for 2 months.
• For the treatment and control of roundowrm (immature adults (L5) and adults of Toxocara cati and adults of Toxascaris leonina), and hookworm (4th stage larvae (L4), immature adults (L5) and adults of Ancylostoma tubaeforme and adults of Uncinaria stenocephala).
• Treatment and control of ear mites (Otodectes cynotis).

Key Benefits

BENEFITS:
	It's effective and long-lasting Bravecto works fast and provides your pet with long-lasting protection against fleas and paralysis ticks, so you can both be free to explore and life without interruption.
	It offers peace of mind It's no secret fleas can be a major discomfort for your pet and cause severe irritation. More threatening still, paralysis ticks can be lethal, with just one tick capable of causing death. A single dose of Bravecto provides longer protection than standard monthly doses, so you can enjoy peace of mind with fewer chances to forget a treatment.
	It's simple and convenient With Bravecto's range of chew and spot-on applications, you can treat your pet the way that suits them best. With just a few easy steps every 2, 3 or 6 months, your pets can continue doing what they love - exploring, playing and getting the most out of life.

Animals Treated

Cats and Kittens (6+ months of age, weighing 2.6+ lbs )

How It Works

Bravecto Plus is applied topically to your cat's skin, where active ingredients Fluralaner and Moxidectin are absorbed into the bloodstream. Fluralaner kills flea and ticks when they feed on your cat. Moxidectin kills roundworms, hookworms and heartworms.

Indications

Bravecto Plus is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati; 4th stage larvae, immature adults and adults) and hookworm (Ancylostoma tubaeforme; 4th stage larvae, immature adults and adults). Bravecto Plus kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick) and Dermacentor variabilis (American dog tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

Bravecto Topical Solution is a registered trademark of Intervet Inc., d/b/a Merck Animal Health, a subsidiary of Merck & Co. Inc.

Specifications:

• Brand: Bravecto Plus
• Active Ingredients: Fluralaner, Moxidectin
• Type: Topical solution
• Indicated for: Prevention of heartworm disease in cats
• Dosage Form: Topical solution
• Administration: Apply to the skin on the back of the neck once every 2 months
• Packaging: Available in single-dose pipettes
• Storage: Store at room temperature, away from moisture and heat
• Manufacturer: Merck Animal Health
• Prescription Required: Yes, prescription-only medication. Must be prescribed by a veterinarian.

Bravecto Plus is available in three sizes. The following table indicates the size of pipette to be used according to the body weight of the cat (equivalent to 40-94 mg fluralaner/kg body weight and 2-4.7 mg moxidectin/kg body weight).

Method of Administration:

Step 1: Immediately before use, open the sachet and remove the pipette. The pipette should be held by base or by the upper rigid portion below the cap in an upright position (tip up) for opening it. The twist-and-use 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 cat should be standing or lying with its back horizontal for easy application. Part hair, place the pipette tip on the base of the skull of the cat.

Step 3: Squeeze the pipette gently at least twice, and apply the entire contents directly to the cat's skin. The product should be applied on cats up to 6.25 kg body weight in one spot at the base of the skull, or two spots in the middle line of the base of the skull on cats greater than 6.25 kg body weight. Ingestion may cause adverse reactions and will remove product from the coat. If multiple cats are treated and amy mutually groom, it is recommended that the cats are separated while product dries.

Treatment Schedule

• For the treatment and prevention of flea infestation, the product should be administered at intervals of 3 months.
• For the treatment and control of paralysis ticks, the product should be administered at intervals of 10 weeks.
• For the prevention of heartworm disease caused by Dirofilaria immitis, the product should be administered at intervals of 2 months.
• One dose of Bravecto Plus treats roundworm, hookworm and ear mites and regular dosing with Bravecto Plus provides ongoing control of roundworm, hookworm and ear mites. Consult a veterinarian if worm problems persist.
• Kittens below six months of age should be weighed regularly. Fast growing kittens that are at risk of outgrowing the initial dose unit weight band during the treatment interval should be retreated at 8-week intervals to ensure persistent flea and tick killing activity and continuous prevention of heatworm disease.
• The product should not be administered at intervals shorter that 8 weeks as the safety at shorter intervals has not been tested.
• Bravecto Plus can be used year round.
• The cat's coat over the treatment application site may appear damp, greasy and mildly clumped.

General Directions:

Not to be used for any purpose, or in any manner, contrary to this label unless authorised under appropriate legislation.

• Care should be taken to avoid contact with the eyes of the animal.
• It is recommended not to use directly on skin lesions.
• This product is for topical use and should not be administered orally.
• It is important to apply the dose as indicated to prevent the animal from licking and ingesting the product.
• It is recommended not to allow recently treated animals to groom each other.
• It is recommended not to allow treated animals to come into contact with untreatd animals until the application site is dry.
• The safety of the veterinary medicinal product has not been established in breeding, pregnant or lactating animals and therefore use in such animals is not recommended.
• Efficacy after shampooing and wetting has not been assessed.

Bravecto Plus contains flualaner, a member of the antiparasitic class of isoxazoline-substituted benzamide derivatives. Fluralaner acts antagonistically on arthropods ligand-gated chloride channels (GABA-receptor and glutamate-receptor).

Bravecto Plus is effective against fipronil-resistant strains of fleas.

Bravecto Plus also contains moxidectin, a member of the milbemycin group of macrocyclic lactones. Milbemycins mode of action is based on the binding of ligand-gated chloride channels. This leads to an increased membrane per meability of nematode and arthropod nerve and/or muscle cells for chloride ions and results in hyperpolarization, paralysis and death of the parasites. Binding of glutamate-gated chloride channels, which are specific to invertebrates and do not exist in mammals, is considered the main mechanism for the anthelmintic and insecticidal activity.

Both fluralaner and moxidectin are readily systemically absorbed from the topical administration site.

Macrocyclic lactones including moxidectin have been shown to be substrates for p-glycoprotein. Therefore, during treatment with Bravecto Plus, other products that can inhibit p-glycoprotein (e.g. cyclosporine, ketoconazole, spinosad, verapamil) should only be used concomitantly according to the benefit/risk assessment of the responsible veterinarian.

Flea Treatment, Control and Prevention

The average flea life cycle lasts 3-8 weeks, and following treatment with Bravecto Plus spot-on the life cycle is broken due to the rapid onset of action and the long-lasting efficacy against adult fleas on the animal and the absence of viable egg production.

The product contributes towards the control of the environmental flea populations in areas to which treated cats have access, by killing newly emerged fleas on a cat before viable eggs are produced.

Bravecto Plus reduces the flea challenge experienced by the animal and aids in the treatment strategy for flea allergy dermatitis.

To obtain maximum flea control, it is recommended that all cats and dogs in the same environment are treated. Cats and dogs may be exposed to fleas when they go outside and they can carry these back into the home

Heartworm Disease Prevention

To ensure continuous prevention of hearworm disease a repetition of treatment is necessary at 2-month intervals. At the time of treatment Bravecto Plus is effective against D.immitis larvae (L2 and L4) which have developed in the previous 30 days and against incoming D.immitis larvae (L3 and L4) for the subsequent 60 days.

Prevention of heartworm disease in cats that are oly temporarily in endemic areas should start at the latest within 1 month after the first expected exposure to mosquitoes and should be continued at 2-month intervals untul return to an non-endemic area.

Fluralaner is part of the isoxazoline family of chemicals. Adverse reaction so this family of chemical are rarely observed but may include vomiting, diarrhea, lethargy, inappetence, itching and very rarely, seizures. Most adverse reactions are self-limiting and of short duration. If you have any concerns, please speak to your veterinarian.

SAFETY DIRECTIONS: Will irritate the eyes, Avoid cotnact with the eyes. If product in eyes, wash it out immediately with water. Wash hands after use.

FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. If skin contact occurs, remove contaminated clothing and wash skin thoroughly.

CONTRAINDICATIONS: Bravecto Plus must not be used in case of hypersensitivity to the active constituents or to any of the excipients.

PRECAUTIONS: Bravecto Plus should not be used on kittens less than 9 weeks of age or cats weighing less than 1.2 kg.

SIDE EFFECTS: Mild and transient skin reactions at the application site may be seen such as flaking skin, itching or har loss. Shortly after application, the following signs were observed in clinical trials, but were uncommon: breathing discomfort after licking the application site, vomiting, vomiting of blood, diarrhea, lethargy, hypersalivation, fever, rapid breathing, and dilated pupils.

Additional User Safety Information

Rehandling Statements Do not contact, or allow children to contact the application site until it is dry; it is therefore recommended to treat the animal in the evening. On the day of treatment, treated animals should not be permitted to sleep with their owner, especially children.

Disposal Dispose immediately of empty pipette, sachet and carton by wrapping in paper and putting in garbage.

Storage Store below 30°C (room temperature). The pipettes should be kept in the sachets to prevent solvent loss or moisture uptake. The sachets should only be opened immediately prior to use.

LONG DURATION

Bravecto's rapid and persistent protection agains fleas and paralysis ticks is due to its breakthrough molecule: fluralaner. This active ingredient is a unique member of the isoxazoline family, the first new insecticide class in over a decade, and it has no know flea or tick resistance. Once Bravecto Plus is administered, it is readily absorbed transdermally and systemically distributed to provide long-lasting nose-to-toes protection.

Rapid and long-lasting flea control

Bravecto Plus kills 100% of fleas within 12 hours of application.³

• Australian field studies for Bravecto Plus showed ›98.9% flea kill efficacy for the entire 3 month period.⁴
• Bravecto Plus reduces the incidence of Flea Allergy Dermatitis (FAD) by rapidly killing adult fleas.

Protection against deadly paralysis ticks

• Bravecto Plus kills pre-existing and new infestations f paralysis ticks (Ixodes holocyclus) for 10 weeks.
• ›98.7% of paralysis ticks (Ixodes holocyclus) were killed within 72 hours of tick infestations for a full 10 weeks.⁵

BROAD SPECTRUM

Moxidextin is a proven and trusted endoparasiticide of the milbemycin group of macrocyclic lactones. Moxidectin is an agonist (stimulates activity) at ligand-gated chloride channels in the nematode nervous system leadign to hyperpolarisation, paralysis and death of the intestinal worms and heartworms.

Bravecto Plus treats infestations of roundworm and hookworm
• Roundworm (immature adults L5) and adults of Toxocara cati and adults of Toxascaris leonina),
• Hookworm (4th stage larvae (L4), immature adults (L5) and adults of Ancylostoma tubaeforme and adults of Uncinaria stenocephala).