SavaVet Strongheart Plus (generic )

COMPOSITION:

STRONGHEART PLUS [FOR SMALL SIZE DOGS]

Each Chewable Tablet Contains:

Ivermectin BP 68 mcg

Pyrantel Pamoate USP equivalent to Pyrantel 57 mg

Excipients q.s.

STRONGHEART PLUS [FOR MEDIUM SIZE DOGS]

Each Chewable Tablet Contains:

Ivermectin BP 136 mcg

Pyrantel Pamoate USP equivalent to Pyrantel 114 mg

Excipients q.s.

STRONGHEART PLUS [FOR LARGE SIZE DOGS]

Each Chewable Tablet Contains:

Ivermectin BP 272 mcg

Pyrantel Pamoate USP equivalent to Pyrantel 227 mg

Excipients q.s.

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, Undnaria stenocephala, Ancylostoma braziliense).

DOSAGE:

Strongheart 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:

Strongheart Plus is recommended for dogs 6 weeks of age and older.

For dogs over 100 lbs use the appropriate combination of these Chewable Tablets.

ADMINISTRATION:

Remove only one Chewable Tablet at a time from the foil-backed blister card. Return the card with the remaining chewable tablets to its box to protect the product from light. Because most dogs find Strongheart 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 tablet should be administered in a manner that encourages the dog to chew, rather than to swallow without chewing. Chewable Tablets 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.

Strongheart 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) afterthe dog's last exposure to mosquitoes.

When replacing another heartworm preventive product in a heartworm disease preventive program, the first dose of Strongheart 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 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 Strongheart Plus and resumption of the recommended dosing regimen minimizes the opportunity forthe development of adult heartworms.

Monthly treatment with Strongheart 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:

Strongheart Plus Chewable Tablet, given orally using the recommended dose and regimen, are effective against the tissue larval stage of D. immitisfora month (30 days) after infection and, as a result, prevent the development of the adult stage. Strongheart Plus chewable tablets are also effective against canine ascarids (T. canis, T. leonina) and hookworms (A. caninum, U. stenocephala, A. braziliense).

ACCEPTABILITY:

In acceptability and field trials, Strongheart 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 Strongheart 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 Strongheart Plus.

While some microfilariae may be killed by the ivermectin in Strongheart Plus at the recommended dose level, Strongheart 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.

WARNINGS:

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 Strongheart Plus: Depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and hypersalivation.

PRESENTATION:

Strongheart Plus is available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in convenient cartons of 6 Chewable Tablet.

STORAGE:

Store at controlled room temperature (15-30°C). Protect from light.

Keep out of reach of children.