bravecto topical for dogs package insert

Bravecto Plus may be administered year-round without interruption or at a … Inactive ingredients: dimethylacetamide, glycofurol, diethyltoluamide, acetone. Keep the product in the original packaging until use in order to prevent children from getting direct access to the product. Bravecto should be administered topically as a single dose every 12 weeks according to the Dosage Schedule below to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. References: 1. 1,2 Bravecto is safe to use and efficacious in adult dogs and puppies over 6 months of age and weighing 4.4 lb. 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This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. endstream endobj 3 0 obj <> endobj 6 0 obj <>/Font<>/ProcSet[/PDF/Text]/Properties<>>>/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 7 0 obj <>stream Ships fast. Bravecto ® Chew: Commonly observed adverse reactions in clinical trials (1,6 % of treated dogs) were mild and transient gastrointestinal effects such as diarrhoea, vomiting, inappetence, and drooling. In dogs older than 8 weeks, treatment every 2 months has been shown to be well … ��, 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. Not for human use. Bodyweight (kg) of dog: Bravecto 112.5 mg: Bravecto 250 mg: Bravecto 500 mg: Bravecto 1000 mg: Bravecto 1400 mg: 2* – 4.5: 1 > 4.5 – 10: 1 > 10 – 20: 1 > 20 – 40: 1 > 40 – 56: 1 *For use in dogs from 8 weeks of age and over 2kg. DATE OF PUBLICATION OF THIS PACKAGE INSERT. Oral Safety Study: In a safety study, one dose of Bravecto topical solution was administered orally to 8- to 10-month-old-puppies at 1× the maximum labeled dose of 56 mg/kg. FOR ANIMAL USE ONLY. / There are no known contraindications for the use of the product. It's as simple as that. Download the Bravecto ® Spot-On owners brochure below. Available in three strengths with an easy to use applicator. BRAVECTO ® SPOT-ON Reg. Bravecto is not effective against lone star ticks beyond 8 weeks of dosing. Bravecto is a chewable tablet and is well accepted by most dogs. Bravecto® provides 12 weeks of protection against fleas and ticks in dogs with the tasty Chew. There are no known contraindications for the use of the product. Do not eat, drink or smoke while handling the product. For topical use only. The dogs in the control group (0X) were untreated. Bravecto Dog PI_155586 R5_8.5x11.indd For the treatment and prevention of tick , flea and mite infestations in dogs. Wenn die Tablette vom Hund nicht freiwillig aufgenommen wird, kann sie auch mit dem Futter oder direkt ins Maul verabreicht werden. BRAVECTO PLUS has not been shown to be effective for 2 months in kittens less than 6 months of age. Bathing or water immersion 3 days after administration will not reduce the effectiveness of Bravecto against fleas and Ixodes ricinus ticks (see Effectiveness). from application/x-indesign to application/pdf 1,2 The Bravecto® Spot-On in dogs provides 4 months of tick protection and 6 months of flea protection. As of November 1, 2020 there have been 1380 reports of human adverse reactions reported to the EMA. Step 1: Immediately before use, open the pouch and remove the tube. application/pdf If your order is more than $39, it ships FREE anywhere in New Zealand, including rural addresses. One dog had two seizures a day apart about 18 days after its first dose. Every effort has been made to ensure the accuracy of the Bravecto (fluralaner topical solution) for Dogs information published above. No. In a well-controlled U.S. field study, which included a total of 165 households and 321 treated dogs (221 with fluralaner and 100 with a topical active control), there were no serious adverse reactions. Keep away from heat, sparks, open flame or other sources of ignition. Avoid oral ingestion. The dog was started on antiepileptic medication and had no additional seizures during the study. Use with caution in dogs with a history of seizures or neurologic disorders. Keep the product in the original packaging until use in order to prevent children from getting direct access to the product. Copyright © 2021 Animalytix LLC. There were no clinically-relevant, treatment-related effects on the body weights, food consumption, reproductive performance, semen analysis, litter data, gross necropsy (adult dogs) or histopathology findings (adult dogs and puppies). The safety of BRAVECTO PLUS has not been established in breeding, pregnant and lactating cats. Applying is easy. One dog with a history of seizures had a seizure the day after the second dose of the active control. Each tube is formulated to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. One treated animal experienced vomiting eight hours after administration. Use caution in dogs with a history of seizures. Indications: Bravecto kills adult fleas and is indicated for the treatment and prevention of flea Hold the tube at the crimped end with the cap in an upright position (tip up). Buy Bravecto - Vet Only Products for your Dog - A great place to buy pet food and pet supplies - Pet.co.nz. Then speak with your vet. In the field study, two dogs treated with Bravecto with no prior history of seizures each experienced a seizure. Bravecto has been approved for use in breeding, pregnant, and lactating female dogs. 1,2,17 No adverse effects with Bravecto Chew for Dogs in MDR-1 gene-deficient collies at 3x the recommended … Bravecto ist eine Kautablette und wird von den meisten Hunden gut angenommen. For prevention of heartworm disease, Bravecto Plus should be administered at 2-month intervals. Dogs with signs of flea allergy dermatitis showed improvement in erythema, alopecia, papules, scales, crusts, and excoriation as a direct result of eliminating flea infestations. Made in Japan. Bravecto demonstrated ≥90% effectiveness against Amblyomma americanum 72 hours post-infestation for 8 weeks, but failed to demonstrate ≥90% effectiveness beyond 8 weeks. Fluralaner (active ingred.) Topical flea and tick control kills for 30 days. (fluralaner topical solution) for Dogs BRIEF SUMMARY (For full Prescribing Information, see package insert) Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Cats and dogs may be exposed to fleas when they go outside and they can carry these back into the home. The dogs in the control group (0×) were administered saline orally. Reproductive Safety Study: Reproductive safety was evaluated with the oral tablet formulation of fluralaner (see Clinical Pharmacology). Place the tube tip vertically against the skin between the shoulder blades of the dog. Free Shipping over $39. It contains fluralaner as a long-acting insecticide to not only kill but also help break the life cycle. The pouch should only be opened immediately prior to use. proof:pdf Avoid contact with skin and eyes. BRAVECTO PLUS reducesthe flea challenge experienced by the animaland aids in the treatment strategy for flea allergy dermatitis. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. RotisSansSerif-Light Kills fleas and ticks For dogs and puppies 6 months of age and older Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Bravecto Plus should be administered topically as a single dose every 2 months according to the Dosage Schedule below to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin. 1,2 It has been tested and found safe in puppies at least 8 to 9 weeks of age at 5x the clinical dose. Bravecto Topical Solution for Dogs: The most common adverse reactions recorded in clinical trials were vomiting, hair loss, diarrhea, lethargy, decreased appetite, and moist dermatitis/rash. There were no clinically-relevant, treatment-related effects on physical examination, body weights, food consumption, clinical pathology (hematology, clinical chemistries, coagulation tests, and urinalysis), gross pathology, histopathology, or organ weights. 1,2 The Bravecto® Spot-On in dogs provides 4 months of tick protection and 6 months of flea protection. uuid:c31aeb85-d228-d84e-94db-e35d08d0e1f9 During veterinary examination at Week 7, two pups from the control group had inguinal testicles, and two and four pups from the treated group had inguinal and cryptorchid testicles, respectively. Keep this and all drugs out of the reach of children. Product may be supplied in 1 or 2 tubes per box. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Bravecto® provides 12 weeks of protection against fleas and ticks in dogs with the tasty Chew. 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. Additional information can be found at www.bravecto.com. Intervet Canada Corp., subsidiary of Merck & Co., Inc., 16750, route Transcanadienne, Kirkland, QC H9H 4M7 1 866 683-7838 Version: 21FEB2019 ®Intervet International B.V. Used under license. Avoid oral ingestion. :n���E{#�������:��.�A������-�쑞,��j8A/�/T�;�d�a_�$��'x�Z5������,ˍ�I�:}�vj�Y#O�F2-�X�b��˾��[\�w;��k� Nr. xmp.did:A6150B3F132068118083C6B6E3A95A4D Each chew is formulated to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight.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. In a European field study in 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 store above 86°F (30°C). Bravecto is also designed to eliminate fleas in as little as 8 hours. Percentage of Dogs with Adverse Reactions in the Field Study, Bravecto Group: Percentage of Dogs with the AR During the 105-Day Study, Active Control Group: Percentage of Dogs with the AR During the 84-Day Study. Find the size that’s right for your pet. default Each tube is packaged individually in a pouch. False 2017-07-12T12:56:09-04:00 The dogs in the control group (0X) were administered mineral oil. Avoid applying an excessive amount of solution in any one spot which may cause some solution to run or drip off of the dog. In a European laboratory study, Bravecto demonstrated ≥98.2% effectiveness against fleas and Ixodes ricinus ticks after multiple water immersion or shampooing occasions, the first occurring 3 days after application, for 12 weeks. PDF/X-1a:2001 The cap should be rotated clockwise or counter clockwise one full turn. BRAVECTO ® (fluralaner) Topical Solution >88-123 lb 1 Tube. Copyright © 2016, 2019 Intervet Inc, a subsidiary of Merck & Company Inc. All rights reserved. 2017-07-12T12:56:12-04:00 In a well-controlled U.S. field study, a single dose of Bravecto reduced fleas by ≥99.8% for 12 weeks. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. Bravecto 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), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or … Bravecto tablets were administered to intact, reproductively- sound male and female Beagles at a dose of up to 168 mg/kg (equivalent to 3X the maximum treatment dose) on three to four occasions at 8-week intervals. That's easy and convenient treating, fewer chances to forget and a better experience for you and your pet, all taken care of with … In a well-controlled field study Bravecto was used concurrently with other medications, such as vaccines, anthelmintics, antibiotics, steroids and sedatives. Watch the slide show to learn how easy it is to apply FRONTLINE Plus onto your pet. Bravecto has not been shown to be effective for 12-weeks duration in puppies less than 6 months of age. Bravecto (Fluralaner) is a Topical Solution for Dogs that kills 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), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks. Peak fluralaner concentrations are achieved between 7 and 42 days following topical administration and the elimination half-life ranges between 14 and 29 days. The fluoxetine was discontinued and the dog experienced no additional seizures during the study. One treated animal experienced loose feces with blood three hours after administration. Ships Free . Bravecto® Spot-On is well tolerated in MDR1 dogs. Step 2: The dog should be standing or lying with its back horizontal during application. PDF/X-1:2001 In well-controlled laboratory studies, Bravecto demonstrated ≥93.3% effectiveness against Dermacentor variabilis, Ixodes scapularis and Rhipicephalus sanguineus 48 hours post-infestation for 12 weeks. To obtain maximum flea control, it is recommended that all cats and dogs in the same environment are treated. In two well-controlled laboratory dose confirmation studies, one dog developed mild to moderate redness, flaking, crusts/scabs and alopecia at the treatment site from Day 1 through 14 after application of Bravecto on Day 0, and one dog developed self-limiting generalized erythema (possible allergic reaction) one day after treatment with Bravecto. 17 January 2017 . Bravecto 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), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. The Bravecto topical solution for dogs and cats is included in the report mentioned in this story. Bravecto is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert. 1,2 The Bravecto® Spot-On in dogs provides 4 months of tick protection and 6 months of flea protection. SLEGS VIR DIEREGEBRUIK . Distributed by: Intervet, Inc., (d/b/a Merck Animal Health), Madison, NJ 07940. The cap is designed to stay on the tube for dosing and should not be removed. No undescended testicles were observed at the time of necropsy (days 50 to 71). For dogs weighing more than 56 kg, use a combination of two tablets that most closely matches the body weight. For a copy of the Safety Data Sheet (SDS) or to report suspected adverse drug events, contact Merck Animal Health at 1-800-224-5318. Stop a flea infestation with the mighty killing ... Plus, it works non-stop for 30 days on dogs and cats. 2017-07-12T12:56:12-04:00 xmp.did:A6150B3F132068118083C6B6E3A95A4D In cats, Bravecto® Spot On provides 3 months of protection against fleas and ticks. Avoid oral ingestion. If your dog has a history of seizures or you have a lactating dog, you should talk with your vet about the proper medication that kills ticks effectively. Dosage and Administration: Bravecto should be administered orally as a single dose every 12 weeks according to the Dosage Schedule (see Animal Safety). Step 3: Squeeze the tube and gently apply Bravecto in one or more spots starting between the shoulder blades and continuing along the dog’s back. Oral Safety Study: In a safety study, one dose of Bravecto topical solution was administered orally to 8- to 10-month-old-puppies at 1X the maximum labeled dose of 56 mg/kg. UniversLTStd-Light Margin of Safety Study: In a margin of safety study, Bravecto was administered topically to 8- to 9-week-old-puppies at 1, 3, and 5X the maximum labeled dose of 56 mg/kg at three, 8-week intervals (8 dogs per group). In a well-controlled laboratory studies, Bravecto killed fleas and reduced the numbers of live fleas on dogs by >99% and 100% within 24 and 48 hours, respectively, post-infestation for 12 weeks. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 3 Dec 2020) and others. Keep this and all drugs out of the reach of children. Convulsions and lethargy have been reported very rarely in spontaneous (pharmacovigilance) reports. Five of the six treated dogs experienced salivation immediately after administration. Bravecto gives your cat protection against fleas and black-legged ticks (deer ticks) for 12 weeks, and dog ticks for 8 weeks. If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth. If contact with eyes occurs, then flush eyes slowly and gently with water. BRAVECTO kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) for 12 weeks. BRAVECTO (Fluralaner Topical Solution) is available in five strengths for use in dogs (112.5 mg, 250 mg, 500 mg, 1000 mg, and 1400 mg fluralaner per tube). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. One adult treated dog suffered a seizure during the course of the study (46 days after the third treatment). Do not eat, drink or smoke while handling the product. Bravecto is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. xmp.id:7c5f6bcd-df26-4d51-89d6-297831264b00 Store in the original package in order to protect from moisture. Bravecto (fluralaner topical solution) for Dogs. %PDF-1.3 %���� One dog treated with Bravecto was observed by the owner to be off balance for about 30 minutes five days after its first dose and had no similar observations after the second dose. There were no clinically-relevant, treatment-related effects on physical examination, body weights, food consumption, clinical pathology (hematology, clinical chemistries, coagulation tests, and urinalysis), gross pathology, histopathology, or organ weights. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. 1 0 obj <>]/Pages 3 0 R/Type/Catalog/ViewerPreferences<>>> endobj 2 0 obj <>stream For optimal control of tick and flea infestation, the Bravecto chewable tablet should be administered at 3 monthly intervals. Bravecto Kautabletten zum oder um den Zeitpunkt der Fütterung verabreichen. We comply with the HONcode standard for trustworthy health information -, Bravecto (fluralaner topical solution) for Dogs Indications, Warnings and cautions for Bravecto (fluralaner topical solution) for Dogs, Direction and dosage information for Bravecto (fluralaner topical solution) for Dogs. 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