Iverhart Plus by is a Animal medication manufactured, distributed, or labeled by Virbac AH, Inc, Virbac Corporation, Zhejiang Hisun Pharma, Cosma S.p.A, Eurofins SF Analytical Laboratories Inc, Alcami Carolinas Corporation. Drug facts, warnings, and ingredients follow.
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: IVERHART PLUS® (ivermectin/pyrantel) Flavored Chewables 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||Flavored Chewable Per Month||Ivermectin Content||Pyrantel Content|
|Up to 25 lbs||1||68 mcg||57 mcg|
|26 to 50 lbs||1||136 mcg||114 mcg|
|51 to 100 lbs||1||272 mcg||227 mcg|
IVERHART PLUS Flavored Chewables are recommended for dogs 6 weeks of age and older. For dogs over 100 lbs use the appropriate combination of these flavored chewables.
ADMINISTRATION: Remove only one flavored chewable at a time from the foil-backed blister card. Because most dogs find IVERHART PLUS Flavored Chewables palatable, the product can be offered to the dog by hand. Alternatively, it may be added intact to a small amount of dog 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.
IVERHART PLUS Flavored Chewables 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 IVERHART PLUS Flavored Chewables 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 flavored 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 IVERHART PLUS Flavored Chewables and resumption of the recommended dosing regimen minimizes the opportunity for the development of adult heartworms.
Monthly treatment with IVERHART PLUS Flavored Chewables 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: IVERHART PLUS Flavored 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. IVERHART PLUS Flavored Chewables 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 IVERHART PLUS Flavored Chewables, which are not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with IVERHART PLUS Flavored Chewables.
While some microfilariae may be killed by the ivermectin in IVERHART PLUS Flavored Chewables at the recommended dose level, IVERHART PLUS Flavored Chewables 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.
ADVERSE REACTIONS: In clinical 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: 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.
UP TO 25lbs.
Administer once a month to prevent heartworm disease and to treat and control ascarid and hookworm infections in dogs
Each flavored chewable contains 68 mcg ivermectin and 57 mg pyrantel as pamoate salt.
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
6 | Contains 6 Flavored Chewables
ANADA 200-302 Keep this and all drugs out of the
Approved by FDA reach of children.
Recommended for dogs up to 25 lbs. body weight
6 | Contains 6 Flavored Chewables
Manufactured by: Virbac AH, Inc. Fort Worth, TX 76137, USA
For technical assistance or to report adverse drug reactions, please call 1-800-338-3659
ANADA 200-302, Approved by FDA
Store at 20ºC-25ºC (68ºF-77ºF), excursions permitted between 15ºC-30ºC (59ºF-86ºF). Protect product from light.
MADE IN THE USA
ivermectin/pyrantel tablet, chewable
|Labeler - Virbac AH, Inc (131568396)|
|Registrant - Virbac AH, Inc (131568396)|
|Zhejiang Hisun Pharma||654211754||api manufacture|
|Cosma S.p.A||428655732||api manufacture|
Registration | Serial
76282970 2730166 Live/Registered