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ERHART MAX
ERHART MAX
ERHART MAX
ERHART MAX
IV (ivermectin/
IV (ivermectin/
IV (ivermectin/
ERHART MAX
ERHART MAX
ERHART MAX
ERHART MAX
IV (ivermectin/
IV (ivermectin/
IV (ivermectin/
ERHART MAX
ERHART MAX
ERHART MAX
ERHART MAX
IV (ivermectin/
IV (ivermectin/
IV (ivermectin/
See your veterinarian for more IVERHART MAX® Chewable Tablets
IVERHART MAX®
While some microfilariae may be killed by the ivermectin in IVERHART MAX Chewable Tablets at the recommended dose level, IVERHART MAX Chewable Tablets are not effective for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to dead or dying Chewable Tablets
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. (ivermectin/pyrantel pamoate/praziquantel) Adverse Reactions: Self-limiting adverse reactions including lethargy, limpness, salivation,
shaking, diarrhea, decreased appetite, licking lips, and belching were reported between
For oral use in dogs only.
20 minutes and 72 hours fol owing treatment in a field study with IVERHART MAX Chewable Tablets.
In clinical field trials with ivermectin/pyrantel pamoate, vomiting or diarrhea within 24 hours of Caution: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
dosing was rarely observed (1.1% of administered doses). The following adverse reactions have Description: IVERHART MAX ® Chewable Tablets is a combination of three anthelmintics
been reported following the use of ivermectin: depression/lethargy, vomiting, anorexia, diarrhea, (ivermectin/pyrantel pamoate/praziquantel). The tablets are available in four sizes in color-coded mydriasis, ataxia, staggering, convulsions and hypersalivation.
packages for oral administration to dogs according to their weight (see Dosage).
Effectiveness: IVERHART MAX Chewable Tablets, given orally using the recommended dose and
Indications: For use in dogs to prevent canine heartworm disease by eliminating the tissue stage
regimen, are effective against the tissue larval stage of D. immitis for a month (30 days) after of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the infection and, as a result, prevent the development of the adult stage. IVERHART MAX Chewable treatment and control of roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma Tablets are also effective against canine roundworms (T. canis, T. leonina), hookworms caninum, Uncinaria stenocephala, Ancylostoma braziliense), and tapeworms (Dipylidium caninum, Taenia (A. caninum, U. stenocephala, A. braziliense), and tapeworms (T. pisiformis, D. caninum). A total of 61 dogs and puppies with naturally acquired or experimental parasite infections treated with IVERHART MAX Chewable Tablets were enrolled in 7 well-controlled laboratory Dosage: IVERHART MAX (ivermectin/pyrantel pamoate/praziquantel) Chewable Tablets should
studies to establish effectiveness. These studies included dogs of various sizes, ages and breeds. be administered oral y at monthly intervals at the recommended minimum dose level of 6 mcg of Data from these studies demonstrated IVERHART MAX Chewable Tablets are safe and effective ivermectin per kilogram (2.72 mcg/lb), 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb) for the removal of the parasite species indicated on the label when used as directed.
and 5 mg of praziquantel per kg (2.27 mg/lb) of body weight, as follows: Chewable
Pyrantel
Palatability: In a field trial, IVERHART MAX was shown to be a palatable oral dosage form for
Dog Weight
Tablet Per
Ivermectin
Praziquantel
Animal 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. No signs of toxicity were seen at 10 times the recommended dose (27.2 mcg/lb) in sensitive Collies. Results of these studies and IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For bioequivalence studies support the safety of ivermectin products in dogs, including Col ies, when dogs over 100 lbs, use the appropriate combination of these Chewable Tablets.
Administration: Remove only one tablet at a time from the foil-backed blister card. Return the
In a target animal safety study, IVERHART MAX Chewable Tablets were administered to 8-week- remaining tablets to their box to protect the product from light. IVERHART MAX Chewable old Beagle puppies at one, three and five times the maximum recommended dose of 12.5 mcg/kg Tablets can be offered to the dog by hand or be added intact to a small amount of dog food. ivermectin, 10.47 mg/kg pyrantel and 10.47 mg/kg praziquantel. The dogs were treated every 30 Care should be taken that the dog consumes the complete dose, and the dog should be observed days for 6 months. Vomiting within 6 hours of dosing and soft or watery feces within 24 hours of for a few minutes after administration to ensure that part of the dose is not lost or rejected. If it dosing were observed. Other observations during the study were: anogenital swelling, lethargy, is suspected that any of the dose has been lost, redosing is recommended.
head movements, shallow, audible or difficult breathing, and salivation. One dog in the 5X group IVERHART MAX Chewable Tablets should be given at monthly intervals during the period of the had tremors and decreased activity. All these signs were transient. No treatment was required. year when mosquitoes (vectors), potentially carrying infective heartworm larvae, are active. The Pathology showed testicular hypoplasia in the 3 and 5X groups (see Warnings).
initial dose must be given within a month (30 days) after the dog's first exposure to mosquitoes. In a laboratory safety study, 12-week-old Beagle puppies receiving 3 and 5 times the The final dose must be given within a month (30 days) after the dog's last exposure to recommended dose once weekly for 13 weeks demonstrated a dose-related decrease in testicular maturation compared to controls. In this study, all treated puppies had significantly higher When replacing another heartworm preventive product in a heartworm disease prevention cholesterol levels compared to untreated controls.
program, the first dose of IVERHART MAX Chewable Tablets must be given within a month In a reproductive safety study, adult males were treated at 37.5 mcg/kg ivermectin, 31.4 mg/kg (30 days) of the last dose of the former medication. A heartworm test should be performed pyrantel and 31.4 mg/kg praziquantel every 14 days during two ful spermatogenic cycles (112 days). prior to switching heartworm preventive products. The quality of semen and reproductive health were not affected by treatment. Treatment-related If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be vomiting and soft feces were reported during this study.
reduced. Therefore, for optimal performance, the tablet must be given once a month on or In a study of the effectiveness of IVERHART MAX Chewable Tablets for treatment of T. canis, one about the same day of the month. If treatment is delayed, whether by a few days or many, 8.1 lb, 72-day-old puppy died 6 days after administration of IVERHART MAX Chewable Tablets immediate treatment with IVERHART MAX Chewable Tablets and resumption of the at the label dose. This puppy and many of the other puppies in the study had high worm burdens recommended dosing regimen wil minimize the opportunity for the development of adult heartworms. and were reported to have diarrhea, sometimes bloody, frequently before and after treatment WARNING:
with IVERHART MAX Chewable Tablets or the placebo. Dehydration and signs of anemia (pale For use in dogs only. Keep this and all drugs out of reach of children. In safety studies,
mucous membranes) were the only abnormal gross necropsy findings observed. No definitive testicular hypoplasia was observed in some dogs receiving 3 and 5 times the maximum
cause of death was determined. In a 90-day field study, the most serious ADEs (lethargy, recommended dose monthly for 6 months (see Animal Safety).
limpness, and salivation) were seen in dogs weighing less than 10 lbs (see Precautions).
In case of ingestion by humans, clients should be advised to contact a physician immediately. Storage Information: Store at controlled room temperature of 59˚- 86˚F (15˚- 30˚C). Protect
Physicians may contact a Poison Control Center for advice concerning cases of ingestion by How Supplied: IVERHART MAX Chewable Tablets are available in four dosage strengths (see
For a copy of the Material Safety Data Sheet (MSDS), or to report adverse reactions, call dosage section) for dogs of different weights. Each strength comes in a box of 6 chewable tablets and in a box of 12 chewable tablets, packed 10 boxes per display box.
Precautions: Use with caution in sick, debilitated, or underweight animals and dogs weighing less
than 10 lbs (see Animal Safety). The safe use of this drug has not been evaluated in pregnant or
All dogs should be tested for existing heartworm infection before starting treatment with IVERHART MAX Chewable Tablets, which are not effective against adult D. immitis. Infected dogs should be treated to remove adult heartworms and microfilariae before initiating a heartworm prevention program.
IVERHART MAX is a registered trademark of Virbac Corporation. 301734-02

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