There were no clinically-relevant, treatment-related effects on physical examination, body weights, food consumption, or clinical pathology (hematology, clinical chemistries, coagulation tests, serum amyloid A, and urinalysis). Select one or more newsletters to continue. To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Merck Animal Health at 1-800-224-5318. Each tube is formulated to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin. Single incidences of self-limiting hypersalivation in three kittens (one kitten in the 1X group and two kittens in the 3X group) and pruritus at the administration site in one kitten in the 3X group were observed on the day of dose administration. Bravecto spot-on products are absorbed through your cat’s skin, drying quickly at the application site. For topical use only. In addition, three treated cats (2/8 cats in the 1X group and 1/8 cats in the 3X group) developed adverse neurologic signs during the study and were euthanized due to quality-of-life concerns. Moxidectin is for systemic use and is a semisynthetic derivative of nemadectin, belonging to the milbemycin group of macrocyclic lactones. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=d9d5ebde-7ff7-4864-b393-fbe77d7a112f, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. In a European field study for fluralaner topical solution for cats, there were three reports of facial dermatitis in humans after close contact with the application site which occurred within 4 days of application. Do not eat, drink or smoke while handling the product. Bravecto Plus may be administered year-round without interruption or at a minimum should be administered at 2-month intervals beginning at the cat’s first seasonal exposure to mosquitoes and continuing until the cat’s last seasonal exposure to mosquitoes. Percentage of Cats with Adverse Reactions (AR) in the Field Study, Safety in cats infected with adult heartworm (Dirofilaria immitis), All Drug For prevention of heartworm disease, Bravecto Plus should be administered at 2-month intervals. Five of six treated kittens experienced hypersalivation. In a well-controlled laboratory study, Bravecto Plus killed 100% of fleas within 12 hours after treatment and reduced the numbers of live fleas on cats by >99% within 12 hours after treatment or infestation for 2 months. Step 2: The cat should be standing or lying with its back horizontal during application. Clinical signs in one cat in the 1X group included vomiting, depression, vocalization, and ataxia 38 days after dosing. (fluralaner and moxidectin topical solution) for Cats. If the product accidentally contacts skin and a sticky residue persists after washing, rubbing alcohol (70% isopropyl alcohol) can be applied to the area to remove the residue. Availability Cosmetic changes at the application site included matting/clumping/spiking of hair, wetness, or a greasy appearance. Not for human use. The cap should be rotated clockwise or counter clockwise one full turn. There were no clinically-relevant, treatment-related effects on body weights, clinical pathology (hematology, clinical chemistry, and coagulation profile), gross pathology or histopathology. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert. In foreign market experience reports for Bravecto Plus, one veterinarian experienced tingling and numbness of the fingers, hand, and arm, and swelling of the hand and arm after getting Bravecto Plus on her fingers. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. View NDC Code(s)NEW! Step 1: Immediately before use, open the pouch and remove the tube. Cosmetic changes at the application site included matting/clumping/spiking of hair, wetness, or a greasy appearance. In an oral safety study for fluralaner topical solution for cats, four out of six cats experienced coughing immediately after oral administration of the maximum labeled dose of 93.0 mg fluralaner/kg. this version. (fluralaner and moxidectin topical solution) for Cats. *ALT was greater than twice the upper reference range of 100 IU/L. Bravecto ® Plus . The chemical name of fluralaner is (±)-4-[5-(3,5-dichlorophenyl)-5-(trifluoromethyl)- 4,5-dihydroisoxazol-3-yl]-2-methyl-N-[2-oxo-2-(2,2,2- trifluoroethylamino) ethyl]benzamide. Part the fur at the administration site. Wash hands and contacted skin thoroughly with soap and water immediately after use of the product. Peak moxidectin concentrations are achieved between 1 and 5 days following topical administration and the elimination half-life ranges between 20 and 30 days. The cap is designed to stay on the tube for dosing and should not be removed. To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Merck Animal Health at 1-800-224-5318. For Medium Cats . Keep the product in the original packaging until use in order to prevent children from getting direct access to the product. Step 2: your cat should be in a standing position or lying down with a straight, horizontal back position is also fine. Keep the product in the original packaging until use in order to prevent children from getting direct access to the product. 0061-5996-02, You don’t have as many times to fight with your cat about the application if your cat isn’t a fan of spot-on treatments. A veterinarian or veterinary technician should demonstrate or instruct the pet owner regarding the appropriate technique for applying Bravecto Plus topically to cats prior to first use. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. BRAVECTO PLUS is an extended-duration, broad-spectrum combination (fluralaner and moxidectin) topical solution for cats, indicated for both external … One treated kitten experienced vomiting 2 hours after administration and another 8 hours after treatment. Treated kittens had reduced food consumption on the day of treatment. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Citations, PRINCIPAL DISPLAY PANEL - 112.5 mg/5.6 mg Tube Pouch Carton, PRINCIPAL DISPLAY PANEL - 250 mg/12.5 mg Tube Pouch Carton, PRINCIPAL DISPLAY PANEL - 500 mg/25 mg Tube Pouch Carton, (What Bravecto Plus spot-on for cats works fast and continues to protect against fleas for 3 months, paralysis ticks for 10 weeks and heartworm for 2 months, plus treats roundworm, hookworm and ear mites. RxNorm, 0061-5998-02, The cap is designed to stay on the tube for dosing and should not be removed. Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. They are available in three weight range packs, with a simple twist-n-use dispensing tube making it quick and easy to use. Biochemical Data Summary. The product is highly flammable. Compare. Peak fluralaner concentrations are achieved between 3 and 21 days following topical administration and the elimination half-life ranges between 11 and 18 days. Contents: 1 tube containing 112.5 mg fluralaner and 5.6 mg moxidectin Approved by FDA under NADA # 141-518, For cats and kittens 6 months of age and older Oral Safety Studies: In an oral safety study, one dose of Bravecto Plus was administered orally to 4- to 9-month-old kittens at the maximum labeled dose of 93.0 mg fluralaner/kg and 4.7 mg moxidectin/kg. When fleas and ticks feed on your cat, they ingest Bravecto for Cats and die. There are no known contraindications for the use of the product. Bravecto for Cats is available in three strengths for use in cats (112.5 mg, 250 mg, and 500 mg fluralaner per tube). There were no clinically-relevant, treatment-related effects on physical examination, body weights, food consumption, clinical pathology (hematology, clinical chemistries, coagulation tests, serum amyloid A, and urinalysis), gross pathology, histopathology, or organ weights. Bravecto Plus provides all-round protection to cats. If the product accidentally contacts skin and a sticky residue persists after washing, rubbing alcohol (70% isopropyl alcohol) can be applied to the area to remove the residue. 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. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae. Contents: 1 tube containing 250 mg fluralaner and 12.5 mg moxidectin Approved by FDA under NADA # 141-518, For cats and kittens 6 months of age and older As I opened the packaging I split some on my hands. View Labeling Archives, 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). The kittens in the control group (0×) were treated with mineral oil. Kills fleas, ticks, roundworms, hookworms and prevents heartworm disease for 2 months. Copy the URL below and paste it into your RSS Reader application. should be administered the appropriate combination of tubes. The cats in the control group (0×) received mineral oil topically. It binds to gamma-aminobutyric acid (GABA) and glutamate-gated chloride channels of the nerves and muscles of the parasite resulting in hyperpolarization, paralysis and death. Additional information can be found at www.bravecto.com. Keep away from heat, sparks, open flame or other sources of ignition. Do not contact or allow children to contact the application site until 2 hours post application. Self-limiting hypersalivation due to grooming was observed on the day of treatment in both treatment groups (6/8 cats in the 1X group and 7/8 cats in the 3X group). Do not store above 77°F (25°C). Bravecto Plus was not effective when administered more than 2 months prior to infection. Labels, All Index The cap should be rotated clockwise or counter clockwise one full turn. Bravecto Plus is available in three tube sizes to treat cats ranging in weight from 2.6 lb - 27.5 lb (1.2 kg to 12.5 kg). Doses of BRAVECTO® for dogs and BRAVECTO® for cats are counted separately and cannot be added together when determining rebate amounts. Each tube is packaged individually in a pouch. There were no clinically-relevant, treatment-related effects on body weights, clinical pathology (hematology, clinical chemistry, and coagulation profile), gross pathology or histopathology. Apply at the base of the skull, to ensure wet product can't be licked. For topical use only. It treats and prevents ticks, fleas, heartworms, and several kinds of worms. SAVE MORE WITH BRAVECTO ®. The mode of action of fluralaner is the antagonism of the ligand-gated chloride channels (gamma-aminobutyric acid (GABA)-receptor and glutamate-receptor). A cat in the 3X group exhibited depression, dehydration, a hunched position, and inability to stand 22 days after dosing. & Articles, All Place the tube tip vertically against the skin at the base of the skull of the cat. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. In addition, three treated cats (2/8 cats in the 1× group and 1/8 cats in the 3× group) developed adverse neurologic signs during the study and were euthanized due to quality-of-life concerns. Use with caution in cats that are heartworm positive (see Animal Safety). Avoid oral ingestion. 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). In well-controlled laboratory studies, Bravecto Plus was effective against naturally and experimentally induced adult and experimentally induced 4th stage larval and immature adult Toxocara cati and Ancylostoma tubaeforme infections in cats. * 3 Cats over 27.5 lb. INDICATIONS . Avoid applying an excessive amount of solution that could cause some of the solution to run and drip off of the cat. Bravecto Plus is available in three tube sizes to treat cats ranging in weight from 2.6 lb – 27.5 lb (1.2 kg to 12.5 kg). For cats, the spot-on treatment isn’t as water resistant as Frontline’s. However, for indoor cats, Bravecto’s treatment is still a three-month preventative. Major brands including Nexgard, Frontine, Bravecto, Advantage, Advantix, Drontal and Revolution. Bravecto Plus has not been shown to be effective in kittens less than 6 months of age. Buy Bravecto Plus for cats online at Lowest Rate with Free Shipping in US. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Apply at the base of the skull, to ensure wet product can't be licked. Percentage of Cats with Adverse Reactions (AR) in the Field Study, Bravecto Plus Group: Percent of Cats with the AR During the 120-Day Study (n=135 cats), Active Control Group: Percent of Cats with the AR During the 120-Day Study (n=41 cats). Step 1: Immediately before use, open the pouch and remove the tube. Part the hair and apply directly to the skin. Two untreated cats were found dead prior to dosing. Available for Android and iOS devices. Each milliliter contains 280 mg of fluralaner and 14 mg of moxidectin. BRAVECTO PLUS has not been shown to be effective for 2 months in kittens less than 6 months of age. No clinical signs associated with liver disease were noted in these cats. Fluralaner is an inhibitor of the arthropod nervous system. Bravecto Plus for Cats is a safe and effective topical flea and tick treatment that treats fleas, ticks, gastrointestinal nematodes and prevents heartworm in cats. Apply the second spot is needed to avoid run off, then remove contact lenses, eyes should be at! Notification to your desktop, Web browser, or wet appearance may occur at the application site some... Days following topical administration and the elimination half-life ranges between 20 and 30 days bravecto plus for cats how to apply http: //www.fda.gov/reportanimalae solution. Was not effective when administered more than 2 months prior to infection nervous system simple twist-n-use dispensing tube making quick. 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