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(ivermectin/pyrantel pamoate/praziquantel) AIDS & RESOURCES
CAUTION: Federal (US) law restricts this drug to use by or on
the order of a licensed veterinarian.
BRIEF SUMMARY: Please consult package insert for com-
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 roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense), and tapeworms (Dipylidium caninum, Taenia pisiformis).
WARNINGS: For use in dogs only. Keep this and all drugs
out of reach of children. In safety studies, testicular hypoplasia was observed in some dogs receiving 3 and 5 times the maximum recommended dose monthly for 6 months (see Animal Safety). 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 PRECAUTIONS: Use with caution in sick, debilitated, or
underweight animals and dogs weighing less than 10 lbs. The safe use of this drug has not been evaluated in preg- 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 heart- worms and microfilariae before initiating a heartworm preven- 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 effec-tive for microfilariae clearance. A mild hypersensitivity-type reaction, presumably due to dead or dying microfilariae and particularly involving transient diarrhea, has been observed in clinical trials with ivermectin alone after treatment of some dogs that have circulating microfilariae.
ADVERSE REACTIONS: In clinical field trials with ivermectin/
pyrantel pamoate, 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.
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 bioequivalence
studies support the safety of ivermectin products in dogs,
including Collies, when used as recommended by the label.
In a laboratory safety study, 12-week-old Beagle puppies receiving 3 and 5 times the recommended dose once weekly for 13 weeks demonstrated a dose-related decrease in testicular maturation compared to controls.
HOW SUPPLIED: IVERHART MAX Chewable Tablets are
available in four dosage strengths (see 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.
STORAGE CONDITIONS: Store at controlled room temper-
ature of 59°-86° F (15°-30° C). Protect product from light.
For technical assistance or to report adverse drug reactions, please call 1-800-338-3659.
Manufactured by: Virbac AH, Inc. Fort Worth, TX 76137 NADA 141-257, Approved by FDAIVERHART MAX is a registered trademark of Virbac Corporation in the US and a trademark of Virbac Corporation in Canada.
40 |myEVT.comIexceptional veterinary teamISeptember/October 2011 2011 Virbac AH, Inc. All Rights Reserved. 8/11

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