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Tri-Heart Plus 6PK BLUE <25lbs INTERVET

Tri-Heart Plus 6PK BLUE <25lbs INTERVET
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Tri-Heart Plus 6PK BLUE <25lbs INTERVET Description

A prescription is required to purchase this product. Please visit our Help Section for ordering information.

Have questions about this product?  Please read the Patient Information Sheet.

This monthly oral pet med is used as a combination heartworm preventive and intestinal wormer. Tri-Heart Plus kills the immature form of the heartworm (Dirofilaria immitis), which is transmitted by a mosquito. It is also used for the treatment and control of hookworms (Ancylostoma caninum, A. brasiliense, and Uncinaria stenocephala) and roundworms (ascarids - Toxocara canis, Toxascaris leonina).

Tri-Heart Plus 6PK BLUE <25lbs INTERVET Details
INTERVET/SCHERING-PLOUGH ANIMAL
INTERVET/SCHERING-PLOUGH ANIMAL HEALTH
556 MORRIS AVE., SUMMIT, NJ, 07901
Telephone:  862-245-4321
Order Desk:  800-648-2118
Fax:  862-245-4935
Customer Service:  800-521-5767
Website:  www.intervet.com

  Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the USA product label or package insert.

TRI-HEART® PLUS CHEWABLE TABLETS

Intervet/Schering-Plough Animal Health

(Ivermectin/Pyrantel)

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: Tri-Heart® Plus ivermectin/pyrantel chewable 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) 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

Chewable Tablets per Month

Ivermectin Content

Pyrantel Content

Color Coding on Blister Card and Carton

Up to 25 lbs

1

68 mcg

57 mg

Blue

26 to 50 lbs

1

136 mcg

114 mg

Green

51 to 100 lbs

1

272 mcg

227 mg

Brown

Tri-Heart Plus ivermectin/pyrantel chewable tablets are recommended for dogs 6 weeks of age and older. For dogs over 100 lbs, use the appropriate combination of these tablets.

ADMINISTRATION: Remove only one chewable tablet at a time from the blister card. Because most dogs find Tri-Heart Plus chewable tablets palatable, the product can be offered to the dog by hand. Alternatively, it may be added intact to a small amount of dry food or placed in the back of the dog’s mouth for forced swallowing.

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.

Tri-Heart Plus chewable 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 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 Tri-Heart Plus chewable tablets 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 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 Tri-Heart Plus chewable tablets and resumption of the recommended dosing regimen minimizes the opportunity for the development of adult heartworms.

Monthly treatment with Tri-Heart Plus chewable tablets 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: Tri-Heart® Plus chewable tablets 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. Tri-Heart Plus chewable tablets are also effective against canine ascarids (T. canis, T. leonina) and hookworms (A. caninum. U. stenocephala, A. braziliense).

ACCEPTABILITY: In acceptability trials, Tri-Heart Plus chewable tablets were shown to be a palatable 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 Tri-Heart Plus chewable tablets which are not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with Tri-Heart Plus chewable tablets.

While some microfilariae may be killed by the ivermectin in Tri-Heart Plus chewable tablets at the recommended dose level, Tri-Heart Plus chewable tablets are 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 at controlled room temperature of 59-86° F (15-30° C). Protect product from light.

ADVERSE REACTIONS: In clinical field trials with ivermectin/pyrantel, 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 ivermectin at the recommended dose: depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and hypersalivation.

SAFETY: 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 of 6 mcg/kg) 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. Ivermectin 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 ivermectin products in dogs, including Collies, when used as recommended.

Ivermectin/pyrantel 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 ivermectin/pyrantel 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: Tri-Heart Plus chewable tablets are available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in convenient packs of 6 chewable tablets.

For technical assistance, call Schering-Plough Animal Health Corp. 1-800-224-5318.

Manufactured for: Schering-Plough Animal Health Corp., Union, NJ 07083

Manufactured by: Heska Corporation, Des Moines, IA 50327

©2005 Heska Corporation all rights reserved

Tri-Heart is a registered trademark of Schering-Plough Veterinary Corporation

02240

ANADA 200-338, Approved by FDA.

www.TriHeartPlus.com

NAC No.: 10472383

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