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Heartgard PLUS Chewables for Dogs 1 - 25 lbs 6 Month Supply Blue Rx

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Heartgard Plus 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).
 

 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

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HEARTGARD® PLUS CHEWABLES FOR DOGS

Merial

 

(ivermectin/pyrantel)

NADA 140-971, Approved by the FDA

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:

 

Dog
Weight

Chewables Per Month

Ivermectin
Content

Pyrantel Content

Color Coding
on Foil-Backing
and Carton

Up to 25 lb

1

68 mcg

57 mg

Blue

26 - 50 lb

1

136 mcg

114 mg

Green

51 - 100 lb

1

272 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 minimizes 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°- 77°F (20°- 25°C). Excursions between 59° - 86°F (15° - 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 assistance, please contact Merial at 1-888-637-4251.

Marketed by Merial Limited, Duluth, GA 30096-4640

HEARTGARD is a registered trademark and Dog & Hand logo is a trademark of Merial

Merial Limited, a company limited by shares registered in England and Wales [registered number 3332751] with a registered office at PO Box 327, Sandringham House, Sandringham Avenue, Harlow Business Park, Harlow Essex CM19 5QA, England, and domesticated in Delaware, USA as Merial LLC.

U.S. Pat. 4,199,569

Made in U.S.A.

© 2005 Merial. All Rights Reserved.

Rev. October 2005

1050-1999-00

 

up to 25 lbs.

Product

 

 

37811

6 Chewables

9359801

37811

12 Chewables

9360101

Each chewable contains 68 mcg ivermectin and 57 mg pyrantel as pamoate salt.

26-50 lbs

37812

6 Chewables

9359901

37812

12 Chewables

9360201

Each chewable contains 136 mcg ivermectin and 114 mg pyrantel as pamoate salt.

51-100 lbs

37813

6 Chewables

9360001

37813

12 Chewables

9360301

Each chewable contains 272 mcg ivermectin and 227 mg pyrantel as pamoate salt.

NAC No.: 11110233

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