Kiwof Hart

COMPOSITION:

Small Dogs:

Each Chewable tablet contains:

Ivermectin BP    68 mcg

Pyrantel Pamoate USP

Equivalent to Pyrantel   57 mg

Excipients            q.s.

Medium Dogs:

Each Chewable tablet contains:

Ivermectin BP    136 mcg

Pyrantel Pamoate USP

Equivalent to Pyrantel   114 mg

Excipients            q.s.

Large 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, Uncinaria stenocephala, Ancylostoma braziliense).

DOSAGE

KIWOF HART 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 Tablet              Ivermectin          Pyrantel

(Kg)        Per Month          Content              Content

Upto 11                1              68 mcg  57 mg

12 to 22                1              136 mcg                114 mg

23 to 45                1              272 mcg                227 mg

KIWOF HART is recommended for dogs 6 weeks of age and older.

For dogs over 100 lb (45kg) 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 KIWOF HART 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 doses has been lost, re-dosing is recommended.

KIWOF HART 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 KIWOF HART 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 KIWOF HART  and resumption of the recommended dosing regimen minimizes the opportunity for the development of adult heartworms.

Monthly treatment with KIWOF HART 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

KIWOF HART (ivermectin/pyrantel) 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.

KIWOF HART Chewable Tablets are also effective against canine ascarids (T. canis, T. leonina) and hookworms (A. caninum, U. stenocephala, A. braziliense).

PRECAUTIONS

All dogs should be tested for existing heartworm infection before starting treatment with KIWOF HART which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with KIWOF HART.

While some microfilariae may be killed by the ivermectin in KIWOF HART at the recommended dose level, KIWOF HART 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 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

In reported clinical field trials with KIWOF HART, 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 KIWOF HART: Depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and hypersalivation.

SAFETY

Reported 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. KIWOF HART demonstrated no signs of toxicity at 10 times the recommended dose (60 mcg/kg) in sensitive Collies.

Results of these trials and reported bioequivalency studies support the safety of KIWOF HART products in dogs, including Collies, when used as recommended.

KIWOF HART 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 KIWOF HART in a heartworm disease preventing 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: KIWOF HART is available in three dosage strengths (See DOSAGE section) for dogs of different weights. Each strength comes in convenient cartons of  6 Chewable Tablets.

PRESENTATION: Blister of 6 Chewable Tablets

Storage: Store at controlled room temperature (15-30°C).

Protect from light.

Keep out of the reach of children.