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Heartveil Tablets Product Description
okokFor the use only of a RegisteredVeterinary Practitioner only, Hospital or Laboratory or a FarmHEARTVEILPLUS
Ivermectin and Pyrantel Pamoate Tablet
COMPOSITION:
SmallDogs:
Each tablet contains:
Ivermectin BP 68mcg
Pyrantel Pamoate USP
Equivalent to Pyrantel 57 mg
Excipients q.s.
MediumDogs:
Each Chewable tablet contains:
Ivermectin BP 136mcg
Pyrantel Pamoate USP
Equivalent to Pyrantel 114mg
Excipients q.s.
LargeDogs:
Ivermectin BP 272mcg
Pyrantel Pamoate USP
Equivalent to Pyrantel 227mg
Excipients q.s.
INDICATIONS
For use in dogsto prevent canine heartworm disease by eliminating the tissue stage ofheartworm larvae (Dirofilariaimmitis) for a month (30 days) afterinfection and for the treatment and control of ascarids (Toxocaracanis, Toxascarisleonina)and hookworms (Ancylostomacaninum, Uncinariastenocephala, Ancylostomabraziliense).
DOSAGE
HeartVeil Plusshould be administered orally at monthly intervals at the recommended minimumdose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb) and 5 mg ofpyrantel (as pamoate salt) per kg (2.27 mg/lb) of body weight. The recommended dosingschedule for prevention of canine heartworm disease and for the treatment andcontrol of ascarids and hookworms is as follows:
Dog Weight (Kg) | Tablets Per Month | Ivermectin Content | Pyrantel Content |
Upto11 | 1 | 68 mcg | 57 mg |
12 to 22 | 1 | 136 mcg | 114mg |
23 to 45 | 1 | 272 mcg | 227 mg |
HeartVeil Plus isrecommended for dogs 6 weeks of age and older.
For dogs over 100 lb use the appropriatecombination of these tablets.
ADMINISTRATION
Remove only onetablet at a time from the foil-backed blister card. Return the card with theremaining tablets to its box to protect the product from light. Because mostdogs find HeartVeil Plus palatable, the product can be offered to the dog byhand. Alternatively, it may be added intact to a small amount of dog food. Tabletsmay be broken into pieces and fed to dogs that normally swallow treats whole.
Care should betaken that the dog consumes the complete dose, and treated animals should beobserved for a few minutes after administration to ensure that part of the doseis not lost or rejected. If it is suspected that any of the doses has beenlost, re-dosing is recommended.
HeartVeil Plusshould be given at monthly intervals during the period of the year whenmosquitoes (vectors), potentially carrying infective heartworm larvae areactive. The initial dose must be given within a month (30 days) after the dog'sfirst exposure to mosquitoes. The final dose must be given within a month (30days) after the dog's last exposure to mosquitoes.
When replacinganother heartworm preventive product in a heartworm disease preventive program,the first dose of HeartVeil Plus must be given within a month (30 days) of thelast dose of the former medication.
If the intervalbetween doses exceeds a month (30 days), the efficacy of ivermectin can bereduced. Therefore, for optimal performance, the chewable must be given once amonth on or about the same day of the month. If treatment is delayed, whetherby a few days or many, immediate treatment with HeartVeil Plus and resumptionof the recommended dosing regimen minimizes the opportunity for the developmentof adult heartworms.
Monthlytreatment with HeartVeil Plus also provides effective treatment and control ofascarids (T. canis, T. leonina) and hookworms (A. caninum,U. stenocephala, A. braziliense). Clients should be advised ofmeasures to be taken to prevent re-infection with intestinal parasites.
EFFICACY
HeartVeil Plus(ivermectin/pyrantel) Tablets, given orally using the recommended dose andregimen, are effective against the tissue larval stage of D. immitis fora month (30 days) after infection and, as a result, prevent the development ofthe adult stage.
HeartVeil Plus Tablets are alsoeffective against canine ascarids (T. canis, T. leonina) andhookworms (A. caninum, U.stenocephala, A. braziliense).
PRECAUTIONS
All dogs shouldbe tested for existing heartworm infection before starting treatment with HeartVeilPlus which is not effective against adult D. immitis. Infected dogs mustbe treated to remove adult heartworms and microfilariae before initiating aprogram with HeartVeil Plus.
While somemicrofilariae may be killed by the ivermectin in HeartVeil Plus at therecommended dose level, HeartVeil Plus is not effective for microfilariaeclearance. A mild hypersensitivity-type reaction, presumably due to dead ordying microfilariae and particularly involving a transient diarrhea, has beenobserved in reported clinical trials with ivermectin alone after treatment ofsome dogs that have circulating microfilariae.
Keep this andall drugs out of the reach of children. In case of ingestion by humans, clientsshould be advised to contact a physician immediately. Physicians may contact aPoison Control Center for advice concerning cases of ingestion by humans.
Store between 68°F° - 77°F (20° -25°C). Excursions between 59°F - 86°F (15° - 30°C) are permitted. Protectproduct from light.
ADVERSEREACTIONS
In reported clinical field trialswith HeartVeil Plus, vomiting or diarrhea within 24 hours of dosing was rarelyobserved (1.1% of administered doses). The following adverse reactions havebeen reported following the use of HeartVeil Plus: Depression/lethargy, vomiting,anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and hyper-salivation.
SAFETY
Reported Studieswith ivermectin indicate that certain dogs of the Collie breed are more sensitiveto the effects of ivermectin administered at elevated dose levels (more than 16times 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 anddeath. HeartVeil Plus demonstrated no signs of toxicity at 10 times therecommended dose (60 mcg/kg) in sensitive Collies.
Reported resultsof these trials and bioequivalence studies support the safety of HeartVeil Plusproducts in dogs, including Collies, when used as recommended.
HeartVeil Plus hasshown a wide margin of safety at the recommended dose level in dogs, includingpregnant or breeding bitches, stud dogs and puppies aged 6 or more weeks. Inclinical trials, many commonly used flea collars, dips, shampoos, anthelmintics,antibiotics, vaccines and steroid preparations have been administered with HeartVeilPlus in a heartworm disease preventing program.
In one trial,where some pups had parvovirus, there was a marginal reduction in efficacyagainst intestinal nematodes, possibly due to a change in intestinal transittime.
How Supplied: HeartVeil Plus is available inthree dosage strengths (See DOSAGE section) for dogs of different weights. Eachstrength comes in convenient cartons of 6 tablets.
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