TRUST. Easy to give. Protection to live.

Transcription

1 TRUST in Easy to give. Protection to live.

2 HEARTGARD (ivermectin) BEGAN AS AN IDEA an idea that if we could make preventing heartworm disease easier, more convenient* and lower risk**, then more dogs would get the prevention they deserve. HEARTGARD Plus (ivermectin/pyrantel): Dogs prefer it more than any other oral heartworm disease preventive 2-7 The ONLY Real-Beef Chewable Prevents heartworm disease HEARTGARD is still the go-to choice for veterinarians across the country. 1 Treats and controls 2 species of roundworms Treats and controls 3 species of hookworms * Monthly vs. daily ** Severe anaphylaxis not seen when administered to microfilariae positive dogs. 9 1 Vet-dispensed; CMI Data. MDI Data Of dogs showing a preference in two studies conducted, all dogs preferred HEARTGARD Plus Chewables to SENTINEL (milbemycin oxime-lufenuron) chewable tablets; Executive Summary VS-USA and VS-USA Of dogs showing a preference in two studies conducted, dogs preferred HEARTGARD Plus Chewables over IVERHART PLUS (ivermectin/pyrantel) beef-flavored tablets by a margin of 154 to 1; Executive Summary VS-USA and VS-USA Of dogs showing a preference in two studies conducted, dogs preferred HEARTGARD Plus Chewables over IVERHART MAX (ivermectin/pyrantel/praziquantel) beef-flavored tablets by a margin of 210 to 1; Executive Summary VS-USA and VS-USA Of dogs showing a preference in one study conducted, dogs preferred HEARTGARD Plus Chewables over SENTINEL SPECTRUM (milbemycin oxime/praziquantel/lufenuron) beef-flavored tablets by a margin of 19 to 1; Executive Summary VS-USA Of dogs showing a preference in three studies, dogs preferred HEARTGARD Chewables over INTERCEPTOR (milbemycin oxime) Flavor Tabs by a margin of 37 to 1; data on file at Merial. 7 Of dogs showing a preference in one study conducted, dogs preferred HEARTGARD Plus Chewables over INTERCEPTOR PLUS (milbemycin oxime/praziquantel) Flavor Tabs by a margin of 61 to 1; Executive Summary VS- USA and VS-USA Data on file at Merial. 9 Boreham PFL, Atwell RB. Absence of shock-like reactions to ivermectin in dogs infected with Dirofilaria immitis. J of Helm. 1983;57: IMPORTANT SAFETY INFORMATION: HEARTGARD Plus (ivermectin/pyrantel) is well tolerated. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD Plus, digestive and neurological side effects have rarely been reported. For more information, please visit Pet owner satisfaction guaranteed 8 #1 choice of veterinarians 1 and pet owners 8

3 HEARTWORM DISEASE IS A YEAR-ROUND THREAT FOR ALL DOGS, INDOORS AND OUT. DANGER O ALL DOGS 64 PERCENT of dogs leave clinics without a heartworm disease preventive. 10 American Heartworm Society: The severity of heartworm incidence as shown in this map is based on the average number of cases per reporting clinic. Some remote regions of the United States lack veterinary clinics, therefore we have no reported cases from these areas. 10 Data on file at Merial.

4 NE CASE HEARTWORMS Larvae are easy to kill. Adult heartworms are not. S ONE OO ANY 11 TRANSMISSION & DEVELOPMENT SIGNS OF DISEASE Mosquitoes ingest heartworm microfilariae when they feed on a heartworm positive animal. Coughing Difficulty breathing Sluggishness Reduced ability to exercise Loss of consciousness The mosquito then carries the heartworm larvae to its next meal. Larvae deposited on the skin by an infected mosquito develop in dogs. Heartworm larvae migrate through the tissue and into the bloodstream of their new host, continuing to mature as they go. Juvenile and adult heartworms primarily live in the pulmonary blood vessels of an infected dog. Within 6 months of infection, adult heartworms are present in the pulmonary arteries. American Heartworm Society, AAHA, AVMA, CAPC, and Partnership for Preventive Health recommend year-round administration of heartworm prevention Killing adult heartworms poses serious risk and potentially traumatic experiences to an infected dog. The American Animal Hospital Association-American Veterinary Medical Association Preventive Healthcare Guidelines Task Force. Practice Guidelines: Development of new canine and feline preventive healthcare guidelines designed to improve pet health. JAVMA. 2011;239(5): Nelson CT, McCall JW. Carithers DC, ed. Current Canine Guidelines for the Prevention, Diagnosis, and Management of Heartworm (Dirofilaria immitis) Infection in Dogs. American Heartworm Society website. January Accessed June 1, Controlling Internal and External Parasites in U.S. Dogs and Cats. The Companion Animal Parasite Council website at recommendations/guidelines.html Accessed. December 13, 2012.

5 TRANSMISSION TO DOGS HOOKWORMS Ancylostoma braziliense Ancylostoma caninum Uncinaria stenocephala Hookworm larvae can be transmitted through: Ingestion of contaminated soil Larvae in soil that penetrates the skin The milk of infected mothers nursing their pups TREATS & TRANSMISSION TO DOGS ROUNDWORMS Toxocara canis Toxascaris leonina Roundworm larvae can be transmitted: Through direct contact with the feces of an infected animal The milk of infected mothers nursing their pups Transplacentally CONTROLS SIGNS OF INFECTION Weakness Diarrhea Pale gums Weight loss SIGNS OF INFECTION Diarrhea Weight loss Worms in feces Swollen abdomen Vomiting Malnutrition Weakness Lack of appetite IMPORTANT SAFETY INFORMATION: HEARTGARD Plus (ivermectin/pyrantel) is well tolerated. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD Plus, digestive and neurological side effects have rarely been reported. For more information, please visit Not all heartworm disease preventives treat and control hookworm and roundworm infections. HEARTGARD Plus prevents heartworm disease, PLUS treats and controls 3 species of hookworms and 2 species of roundworms.

6 PREVENTS. TREATS. CONTROLS. ONLY HEARTGARD Plus (ivermectin/pyrantel) prevents heartworm disease & treats & controls pre-existing hookworm & roundworm infections with a Real-Beef Chewable dogs love to take Freedom of Information: NADA (January 15, 1993). IMPORTANT SAFETY INFORMATION: HEARTGARD Plus (ivermectin/pyrantel) is well tolerated. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD Plus, digestive and neurological side effects have rarely been reported. For more information, please visit

7 The ivermectin in HEARTGARD Plus works retroactively, killing L3 and L4 larvae that the dog may have acquired in the previous 30 days. 15 HOW IT Pyrantel pamoate kills roundworms & hookworms as it passes THROUGH the intestinal tract; it is NOT absorbed. 16 WORKS Without a preventive, heartworm larvae will develop to juvenile and adult heartworms that can cause heartworm disease. HEARTGARD Plus should be given every 30 days, all year long. 12 IMPORTANT SAFETY INFORMATION: HEARTGARD Plus (ivermectin/pyrantel) is well tolerated. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD Plus, digestive and neurological side effects have rarely been reported. For more information, please visit 15 HEARTGARD Plus Product Label. 16 Plumb DC. Plumb s Veterinary Drug Handbook. 4th ed. Ames, Iowa;Iowa State University Press (Blackwell); 2002:746.

8 N ASY, UT UICKLY HEARTGARD Plus (ivermectin/pyrantel) USES AN EXTREMELY LOW DOSE OF IVERMECTIN AND IS RAPIDLY EXCRETED FROM THE DOG 17 Daurio CP, Cheung EN, Jeffcoat AR, Skelly BJ. SDG Ef Daurio CP et al. Bioavailability of ivermectin administered orally to dogs. Vet Res Comm. 1992;16(2): days Once consumed ivermectin is quickly excreted in 3 days. 17 IMPORTANT SAFETY INFORMATION: HEARTGARD Plus (ivermectin/pyrantel) is well tolerated. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD Plus, digestive and neurological side effects have rarely been reported. For more information, please visit

9 HEARTGARD (ivermectin) BRAND PRODUCTS HAVE BEEN PREVENTING HEARTWORM DISEASE FOR OVER 25 YEARS BILLIONS OF DOSES SOLD. 18 TRIED AND TRUE APPROVED FOR USE IN Puppies as young as 6 weeks of age Small dogs regardless of weight Pregnant and breeding mothers Studs All breeds, including Collies 18 Data on file at Merial. IMPORTANT SAFETY INFORMATION: HEARTGARD (ivermectin) is well tolerated. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD, digestive and neurological side effects have rarely been reported. For more information, please visit

10 TREAT YOUR PATIENTS TO THE MONTHLY HEARTWORM PREVENTION DOGS PREFER. 2-7 In 19 studies, in dogs showing a preference, dogs preferred HEARTGARD Plus (ivermectin/pyrantel): 219 to 0 over SENTINEL to 1 over IVERHART PLUS to 1 over IVERHART MAX 4 19 to 1 over SENTINEL SPECTRUM 5 61 to 1 over INTERCEPTOR PLUS 7 37 to 1 over INTERCEPTOR 6 NO PEANUT BUTTER REQUIRED IMPORTANT SAFETY INFORMATION: HEARTGARD Plus (ivermectin/pyrantel) is well tolerated. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD Plus, digestive and neurological side effects have rarely been reported. For more information, please visit

11 PREVENTING HEARTWORM DISEASE. SATISFACTION GUARANTEED. The Guarantee backs your recommendation by promising outstanding performance. The PLUS Guarantee is the only guarantee of its kind that offers exclusive peace of mind for pet owners with trusted prevention for their pet and it s only available from your veterinary clinic. IMPORTANT SAFETY INFORMATION: HEARTGARD Plus (ivermectin/pyrantel) is well tolerated. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD Plus, digestive and neurological side effects have rarely been reported. For more information, please visit ELIGIBILITY DURATION OF ADMINISTRATION Dogs infected with heartworms after monthly administration with HEARTGARD HEARTGARD Brand Products must be obtained only from you, a licensed practitioner, with a veterinarian/client/ patient relationship 19 Dogs may qualify only once, per lifetime of the dog, for either Level 1 or Level 2 Level 1 9 months continuously,* as recommended by a veterinarian 20 Dogs starting on HEARTGARD between 6 weeks and 4 months of age are covered immediately. Dogs starting on HEARTGARD between 4 and 6 months of age are covered following a negative antigen test 6 months after the first dose is administered. Dogs starting on HEARTGARD after 6 months of age are covered if antigen tests performed prior to the first dose and 6 months following the first dose prove negative. Thereafter, antigen tests must be administered to dogs annually. HEARTWORMS INTESTINAL PARASITES PALATABILITY Level 2 9 months, but with missed dose[s] and/or insufficient negative antigen testing record 20 Dogs infected with roundworms or hookworms after monthly administration with HEARTGARD Plus HEARTGARD Plus must be obtained only from you, a licensed practitioner, with a veterinarian/client/patient relationship 19 The dose must have been taken within 31 days Dogs that do not accept HEARTGARD Real-Beef Chewables HEARTGARD Real-Beef Chewables must be obtained only from you, a licensed practitioner, with a veterinarian/client/ patient relationship 19 QUALIFYING POSITIVE TESTS 2 positive antigen tests performed on 2 separate blood samples 2 positive antigen tests performed on 2 separate blood samples Identification of parasite eggs by fecal flotation in the clinic 19 Dogs starting on HEARTGARD Plus Chewables: between 6 weeks and 4 months of age covered immediately for protection against heartworms; between 4 and 6 months of age covered following a negative antigen test 6 months after the first dose; 6 months of age and older covered if antigen test performed prior to first dose and 6 months following first dose prove negative; 6 months of age or older when switching from another brand of heartworm preventive to HEARTGARD Plus covered if an antigen test performed within 2 weeks prior to the first dose of HEARTGARD Plus proves negative. Thereafter, antigen test must be administered to dogs annually. 20 Proof of purchase required. 21 Vital statistics for your veterinary practice. In: Landeck E, ed. The Veterinary Fee Reference. 3rd ed. Lakewood, CO:AAHA Press; 2003:43-44, 56, 62-63, 71, , Product will be replaced with HEARTGARD (ivermectin) tablets. COMPENSATION Level 1 $500 for veterinary services 21 Complimentary product for treatment of heartworm disease One-year supply of HEARTGARD Level 2 Complimentary product for treatment of heartworm disease One-year supply of HEARTGARD Reimbursement for the cost of positive fecal exam and the cost of treatment based on dog s weight, ** * This guarantee will be honored at Level 1 with administration of 9 doses administered consecutively during peak transmission season (March through October). Dogs housed in intensified population facilities of 6 dogs or more will be covered under this guarantee for heartworms but not for intestinal parasites. ** Reimbursement is based on a set fee schedule and may not equal the amount charged to the client by the veterinary clinic. Product credit or replacement for dogs only with HEARTGARD tablets 22

12 ASY O GIVE, HEARTGARD Plus (ivermectin/pyrantel) IS AVAILABLE IN 6-PACKS & 12-PACKS & COMES IN THREE SIZES, FOR CONVENIENT DOSING: ASY TO OSE for dogs up to 25 lbs for dogs lbs for dogs lbs Dogs larger than 100 lbs. should receive eive an appropriate combination of sizes. s.

13 ALL OTHER HEARTGARD (ivermectin) PRODUCTS AVAILABLE: IN THE FAMILY IMPORTANT SAFETY INFORMATION: HEARTGARD is well tolerated. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD Plus, digestive and neurological side effects have rarely been reported. For more information, please visit IMPORTANT SAFETY INFORMATION: HEARTGARD (ivermectin) for Cats is well tolerated. In the clinical studies involving more than 3,000 doses of HEARTGARD for Cats, observations reported within 24 hours of treatment included vomiting in 0.3% and diarrhea in 0.2% of the doses administered. There was no statistical difference between HEARTGARD for Cats and the product vehicle (control) for these observations. For more information, please visit Tablets for Heartworm Disease Prevention Only Does Not Contain Beef Available in 6 Packs Real-Beef Chewable for Heartworm Disease Prevention Only Available in 6 Packs Chewable for Heartworm Disease Prevention Treats and Controls Both Adult and Immature Hookworms Available in 6 Packs

14 TOOLS YOU CAN APPRECIATE. SUPPORT YOU CAN TRUST. From our heart to yours. HeartgardClinic.com packs educational tools, ready-made social media content, and online CE courses into one convenient website all completely free to veterinary professionals. IMPORTANT SAFETY INFORMATION: HEARTGARD Plus (ivermectin/pyrantel) is well tolerated. All dogs should be tested for heartworm infection before starting a preventive program. Following the use of HEARTGARD Plus, digestive and neurological side effects have rarely been reported. For more information, please visit

15 WE RE HERE TO HELP YOU PROTECT MORE DOGS. aask your Merial Sales Representative for more details. 1 Consumer Advertising 7 Puppy Kits 2 Consumer Coupons 8 Taste Test Treats CLINIC SUPPORT: 3 4 PLUS Guarantee CLIENT CONNECTION TM 9 10 HEARTGARD Wallets Seasonal Promotions 5 HeartgardClinic.com 11 Reminder App 6 Clinic Merchandising & Educational Tools 12 Local Support

16 CHEWABLES FOR CATS TABLETS CHEWABLES CHEWABLES CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONS: For use in cats to prevent feline heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection, and for the removal and control of adult and immature hookworms (Ancylostoma tubaeforme and A. braziliense). DOSAGE: HEARTGARD (ivermectin) for Cats should be administered orally at monthly intervals at the recommended minimum dose level of 24 mcg of ivermectin per kg (10.9 mcg/lb.) of body weight. The recommended dosage schedule for prevention of feline heartworm disease and control of hookworm is as follows: CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. INDICATION: For use in dogs to prevent canine heartworm disease. HEARTGARD prevents heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection. DOSAGE: HEARTGARD Tablets should be administered orally at monthly intervals at the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb) of body weight. (See ADMINISTRATION). The recommended dosage schedule for prevention of canine heartworm disease is as follows: CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. INDICATION: For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection. DOSAGE: HEARTGARD (ivermectin) Chewables should be administered orally at monthly intervals at the recommended minimum dose level of 6.0 mcg of ivermectin per kilogram (2.72 mcg/lb) of body weight. (See ADMINISTRATION). The recommended dosage schedule for prevention of canine heartworm disease is as follows: CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONS: For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of ascarids (Toxocara canis, Toxascaris leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense). DOSAGE: HEARTGARD Plus should be administered orally at monthly intervals at the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb) and 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb) of body weight. The recommended dosing schedule for prevention of canine heartworm disease and for the treatment and control of ascarids and hookworms is as follows: Color Coding 0n Dog Chewables Ivermectin Pyrantel Foil Backing Weight Per Month Content Content and Carton Cat Weight HEARTGARD for Cats Ivermectin lb Chewables per month content up to 5 lb 1 55 mcg 5 to 15 lb mcg For cats over 15 lb., use the appropriate combination of chewables. HEARTGARD for Cats is recommended for use in cats 6 weeks of age and older. ADMINISTRATION: Remove only one chewable at a time from the foil-backed blister card. Return the card with the remaining chewables to its box to protect the product from light. HEARTGARD for Cats can be offered to the cat by hand or may be added to a small amount of cat food. If manual dosing is required, the chewable should be broken into pieces for administration. Food should be routinely available during the day of treatment administration. If cats are fasted, or if the chewable is not broken into pieces for manual dosing, then reduced absorption may result. A relationship between reduced absorption and reduced efficacy has not been established. Care should be taken to see that the cat consumes the complete dose. Treated animals should be observed for a few minutes after administration to ensure that part of the dose is not lost or rejected. If it is suspected that any of the dose has been lost, redosing with a new chewable is recommended. Fragments of chewables have occasionally been observed in the feces of some cats; efficacy of the product was not adversely affected. HEARTGARD for Cats should be given at monthly intervals when mosquitoes potentially carrying infective heartworm larvae are active. The initial dose must be given within a month (30 days) after the cat s first exposure to mosquitoes. The final dose must be given within a month (30 days) after the cat s last exposure to mosquitoes. For optimal performance, HEARTGARD for Cats must be given once a month on or about the same date. If treatment is delayed, whether by a few days or many, immediate treatment with HEARTGARD for Cats and resumption of the recommended dosing regimen will minimize the opportunity for development of adult heartworm. It is recommended that cats should be tested for existing heartworm infection prior to starting treatment with HEARTGARD for Cats. Cats already infected with adult heartworms can be given HEARTGARD for Cats monthly to prevent further infections. Monthly treatment with HEARTGARD for Cats also provides effective removal and control of adult and immature hookworms (A. tubaeforme and A. braziliense). SAFETY: In the clinical studies involving more than 3000 doses of HEARTGARD for Cats, observations reported within 24 hours of treatment included vomition in 0.3% and diarrhea in 0.2% of the doses administered. There were no statistical differences between HEARTGARD for Cats and the product vehicle (control) for these observations. A wide margin of safety was demonstrated in clinical trials at the recommended dose level in cats and kittens 6 weeks of age and older and in laboratory studies in cats with circulating microfilariae of D. immitis. A wide margin of safety has also been demonstrated at 3 times the recommended dose in pregnant or breeding queens and breeding toms. No adverse effects were observed in either male or female cats or their offspring in breeding studies. A 30-fold safety margin over the minimum recommended dosage was established in a single dose tolerance study. In growing kittens dosed monthly for 8 consecutive doses, one cat given 5 times the market dose vomited and a second cat in this group experienced diarrhea within 24 hours of the initial treatment. In clinical trials, many commonly used flea control products, anthelmintics, vaccines, antibiotics and steroid preparations were administered with HEARTGARD for Cats without incident. Keep this and all drugs out of the reach of children. In case of ingestion by humans, clients should be advised to contact a physician immediately. STABILITY: HEARTGARD Chewables for Cats are stable for 3 years when stored below 77 F (25 C) and protected from light. Store at controlled room temperature of 68 F - 77 F (20 C - 25 C). Excursions between 59 F - 86 F (15 C - 30 C) are permitted. HOW SUPPLIED: HEARTGARD for Cats is available in two dosage strengths (see DOSAGE section) for cats of different weights. Each strength comes in a convenient carton of 6 chewables, packed 10 cartons per tray. For customer assistance, please contact Merial at Merial is now part of Boehringer Ingelheim. HEARTGARD, the Dog & Hand Logo and the Cat & Hand logo are registered trademarks, and CLIENT CONNECTION is a trademark, of Merial. All other marks are the property of their respective owners Merial, Inc., Duluth, GA. All rights reserved. HGD17COMPDETAILER (02/17). Dog Tablets Ivermectin Color Weight PerMonth Per Tablet on Carton Up to 25 Ib 1 68 mcg Blue 26 to 50 Ib mcg Green 51 to 100 lb mcg Brown Give dogs over 100 Ib the appropriate combination of tablets. HEARTGARD is recommended for use in dogs 6 weeks of age and older. ADMINISTRATION: The HEARTGARD tablet should be given so that dogs swallow the whole tablet. (The tablet may be wrapped in food to encourage consumption.) Care should be taken to see that the dog consumes the complete dose, and treated animals should be observed for a few minutes after administration to ensure that part of the dose is not lost or rejected. If it is suspected that any of the dose has been lost, redosing is recommended. HEARTGARD Tablets should be given at monthly intervals during the period of the year when mosquitoes (vectors), potentially carrying infective heartworm larvae, are active. The initial dose must be given within a month (30 days) after the first exposure to mosquitoes. The final dose must be given within a month (30 days) after the last exposure to mosquitoes. When replacing another heartworm preventive in a heartworm disease preventive program, the first dose of HEARTGARD must be given within a month (30 days) after the last dose of the former medication. If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be reduced. For optimal performance, the tablet must be given once a month on or about the same day of the month. If treatment is delayed, whether by a few days or many, immediate treatment with HEARTGARD and resumption of the recommended dosing regimen minimizes the opportunity for the development of adult heartworms. EFFICACY: HEARTGARD Tablets, given orally using the recommended dose and regimen, are effective against the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection and, as a result, prevent the development of the adult stage. PRECAUTIONS: All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD (ivermectin) Tablets, which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae prior to initiating a program with HEARTGARD. While some microfilariae may be killed by the ivermectin in HEARTGARD at the recommended dose level, HEARTGARD is not effective for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to dead or dying microfilariae and particularly involving a transient diarrhea, has been observed in clinical trials with ivermectin after the treatment of some dogs that have circulating microfilariae. Keep this and all drugs out of the reach of children. In case of ingestion by humans, clients should be advised to contact a physician immediately. Physicians may contact a Poison Control Center for advice concerning cases of ingestion by humans. ADVERSE REACTIONS: The following adverse reactions have been reported following the use of HEARTGARD: Depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and hypersalivation. SAFETY: HEARTGARD has shown a wide margin of safety at the recommended dose level in dogs (See PRECAUTIONS for exceptions) including pregnant or breeding bitches, stud dogs, and puppies aged 6 or more weeks. In clinical trials, many commonly used flea collars, dips, shampoos, anthelmintics, antibiotics, vaccines, and steroid preparations have been administered with HEARTGARD in a heartworm disease preventive program. Studies with ivermectin indicate that certain dogs of the Collie breed are more sensitive to the effects of ivermectin administered at elevated dose levels (more than 16 times the target use level) than dogs of other breeds. At elevated doses, sensitive dogs showed adverse reactions which included mydriasis, depression, ataxia, tremors, drooling, paresis, recumbency, excitability, stupor, coma and death. HEARTGARD demonstrated no signs of toxicity at 10 times the recommended dose (60 mcg/kg) in sensitive Collies. Results of these trials support the safety of HEARTGARD products in dogs, including Collies, when used as recommended. HOW SUPPLIED: HEARTGARD is available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in a convenient carton of 6 tablets, packed 10 cartons per tray. Store at controlled room temperature F (20-25 C). For customer assistance, please contact Merial at Marketed by Merial, Inc. Duluth, GA Made in U.S.A. Rev Color Coding 0n Dog Chewables Ivermectin Foil Backing Weight Per Month Content and Carton Up to 25 lb 1 68 mcg Blue 26 to 50 lb mcg Green 51 to 100 lb mcg Brown Give dogs over 100 Ibs the appropriate combination of these chewables. HEARTGARD Chewables are recommended for use in dogs 6 weeks of age and older. ADMINISTRATION: Remove only one chewable at a time from the foil-backed blister card. Return the card with the remaining chewables to the box to protect the product from light. Because most dogs find HEARTGARD Chewables palatable, the product can be offered to the dog by hand. Alternatively, it may be added to a small amount of dog food. The chewable should be administered in a manner that encourages the dog to chew, rather than to swallow without chewing. Chewables may be broken into pieces and fed to dogs that normally swallow treats whole. Care should be taken to see that the dog consumes the complete dose, and treated animals should be observed for a few minutes after administration to ensure that part of the dose is not lost or rejected. If it is suspected that any of the dose has been lost, redosing is recommended. HEARTGARD Chewables should be given at monthly intervals during the period of the year when mosquitoes (vectors), potentially carrying infective heartworm larvae, are active. The initial dose must be given within a month (30 days) after the dog s first exposure to mosquitoes. The final dose must be given within a month (30 days) after the dog s last exposure to mosquitoes. When replacing another heartworm preventive in a heartworm disease preventive program, the first dose of HEARTGARD must be given within a month (30 days) after the last dose of the former medication. If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be reduced. For optimal performance, the chewable must be given once a month on or about the same day of the month. If treatment is delayed, whether by a few days or many, immediate treatment with HEARTGARD and resumption of the recommended dosing regimen minimizes the opportunity for the development of adult heartworms. EFFICACY: HEARTGARD Chewables, given orally using the recommended dose and regimen, are effective against the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection and, as a result, prevent the development of the adult stage. ACCEPTABILITY: In acceptability and field trials, HEARTGARD Chewables were shown to be an acceptable oral dosage form that was consumed at the first offering by the majority of dogs. PRECAUTIONS: All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD, which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae prior to initiating a program with HEARTGARD. While some microfilariae may be killed by the ivermectin in HEARTGARD at the recommended dose level. HEARTGARD is not effective for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to dead or dying microfilariae and particularly involving a transient diarrhea, has been observed in clinical trials with ivermectin after treatment of some dogs that have circulating microfilariae. Keep this and all drugs out of the reach of children. In case of ingestion by humans, clients should be advised to contact a physician immediately. Physicians may contact a Poison Control Center for advice concerning cases of ingestion by humans. Store between 68 F 77 F (20 C 25 C). Excursions between 59 F 86 F (15 C 30 C) are permitted. Protect product from light. ADVERSE REACTIONS: The following adverse reactions have been reported following the use of HEARTGARD: Depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and hypersalivation. SAFETY: HEARTGARD has shown a wide margin of safety at the recommended dose level in dogs (See PRECAUTIONS for exceptions) including pregnant or breeding bitches, stud dogs and puppies aged 6 or more weeks. ln clinical trials, many commonly used flea collars, dips, shampoos, anthelmintics, antibiotics, vaccines, and steroid preparations have been administered with HEARTGARD Chewables in a heartworm disease preventive program. Studies with ivermectin indicate that certain dogs of the Collie breed are more sensitive to the effects of ivermectin administered at elevated dose levels (more than 16 times the target use level) than dogs of other breeds. At elevated doses, sensitive dogs showed adverse reactions, which included mydriasis, depression, ataxia, tremors, drooling, paresis, recumbency, excitability, stupor, coma and death. HEARTGARD demonstrated no signs of toxicity at 10 times the recommended dose (60 mcg/kg) in sensitive Collies. Results of these trials support the safety of HEARTGARD products in dogs, including Collies, when used as recommended. HOW SUPPLIED: HEARTGARD Chewables are available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in convenient cartons of 6 chewables, packed 10 cartons per tray. For customer assistance, please contact Merial at Up to 25 lb 1 68 mcg 57 mg Blue 26 to 50 lb mcg 114 mg Green 51 to 100 lb mcg 227 mg Brown HEARTGARD Plus is recommended for dogs 6 weeks of age and older. For dogs over 100 lb use the appropriate combination of these chewables. ADMINISTRATION: Remove only one chewable at a time from the foil-backed blister card. Return the card with the remaining chewables to its box to protect the product from light. Because most dogs find HEARTGARD Plus palatable, the product can be offered to the dog by hand. Alternatively, it may be added intact to a small amount of dog food.the chewable should be administered in a manner that encourages the dog to chew, rather than to swallow without chewing. Chewables may be broken into pieces and fed to dogs that normally swallow treats whole. Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes after administration to ensure that part of the dose is not lost or rejected. If it is suspected that any of the dose has been lost, redosing is recommended. HEARTGARD Plus should be given at monthly intervals during the period of the year when mosquitoes (vectors), potentially carrying infective heartworm larvae, are active. The initial dose must be given within a month (30 days) after the dog s first exposure to mosquitoes. The final dose must be given within a month (30 days) after the dog s last exposure to mosquitoes. When replacing another heartworm preventive product in a heartworm disease preventive program, the first dose of HEARTGARD Plus must be given within a month (30 days) of the last dose of the former medication. If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be reduced. Therefore, for optimal performance, the chewable must be given once a month on or about the same day of the month. If treatment is delayed, whether by a few days or many, immediate treatment with HEARTGARD Plus and resumption of the recommended dosing regimen will minimize the opportunity for the development of adult heartworms. Monthly treatment with HEARTGARD Plus also provides effective treatment and control of ascarids (T. canis, T. leonina) and hookworms (A. caninum, U. stenocephala, A. braziliense). Clients should be advised of measures to be taken to prevent reinfection with intestinal parasites. EFFICACY: HEARTGARD Plus (ivermectin/pyrantel) Chewables, given orally using the recommended dose and regimen, are effective against the tissue larval stage of D.immitis for a month (30 days) after infection and, as a result, prevent the development of the adult stage. HEARTGARD Plus Chewables are also effective against canine ascarids (T. canis, T. leonina) and hookworms (A. caninum, U. stenocephala, A. braziliense). ACCEPTABILITY: In acceptability and field trials, HEARTGARD Plus was shown to be an acceptable oral dosage form that was consumed at first offering by the majority of dogs. PRECAUTIONS: All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus. While some microfilariae may be killed by the ivermectin in HEARTGARD Plus at the recommended dose level, HEARTGARD Plus is not effective for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to dead or dying microfilariae and particularly involving a transient diarrhea, has been observed in clinical trials with ivermectin alone after treatment of some dogs that have circulating microfilariae. Keep this and all drugs out of the reach of children. In case of ingestion by humans, clients should be advised to contact a physician immediately. Physicians may contact a Poison Control Center for advice concerning cases of ingestion by humans. Store between 68 F - 77 F (20 C - 25 C). Excursions between 59 F - 86 F (15 C - 30 C) are permitted. Protect product from light. ADVERSE REACTIONS: In clinical field trials with HEARTGARD Plus, vomiting or diarrhea within 24 hours of dosing was rarely observed (1.1% of administered doses). The following adverse reactions have been reported following the use of HEARTGARD: Depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and hypersalivation. SAFETY: HEARTGARD Plus has been shown to be bioequivalent to HEARTGARD, with respect to the bioavailability of ivermectin. The dose regimens of HEARTGARD Plus and HEARTGARD are the same with regard to ivermectin (6 mcg/kg). Studies with ivermectin indicate that certain dogs of the Collie breed are more sensitive to the effects of ivermectin administered at elevated dose levels (more than 16 times the target use level) than dogs of other breeds. At elevated doses, sensitive dogs showed adverse reactions which included mydriasis, depression, ataxia, tremors, drooling, paresis, recumbency, excitability, stupor, coma and death. HEARTGARD demonstrated no signs of toxicity at 10 times the recommended dose (60 mcg/kg) in sensitive Collies. Results of these trials and bioequivalency studies, support the safety of HEARTGARD products in dogs, including Collies, when used as recommended. HEARTGARD Plus has shown a wide margin of safety at the recommended dose level in dogs, including pregnant or breeding bitches, stud dogs and puppies aged 6 or more weeks. In clinical trials, many commonly used flea collars, dips, shampoos, anthelmintics, antibiotics, vaccines and steroid preparations have been administered with HEARTGARD Plus in a heartworm disease preventive program. In one trial, where some pups had parvovirus, there was a marginal reduction in efficacy against intestinal nematodes, possibly due to a change in intestinal transit time. HOW SUPPLIED: HEARTGARD Plus is available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in convenient cartons of 6 and 12 chewables. For customer service, please contact Merial at

17 The client-friendly website for general information regarding HEARTGARD brand products. A wealth of online resources to help veterinary clinics and their staff educate their clients.