NADA Number: 141-257

Proprietary Name Iverhart Max®
Iverhart Max™
Sponsor Virbac AH, Inc.
Sponsor Address 3200 Meacham Blvd
Ft. Worth, Tx    76137
Ingredients Ivermectin
Praziquantel
Pyrantel Pamoate
Species Dog, no use class stated or implied
Routes of Administration Per Os
Dose Form Tablet (chewable)
Drug Form Tablet (chewable)
Dispensing Status RX
Exclusivity Additional (lower) weight range allowed.
Exclusivity was granted based on studies conducted to support substantial evidence of effectiveness and target animal safety.
Withdrawal Time Withdrawal times do not apply to the species listed for this product.
Dosage Amount,
Indications
& Limitations

520.1199 Ivermectin, pyrantel, and praziquantel tablets.

Specifications: Each chewable tablet contains: (1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel; (2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel; (3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or (4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel.

Conditions of use: Dogs

Amount: Administer monthly according to body weight as follows: 6 to 12 lb: one tablet containing 34 micrograms (mcg) ivermectin. 12.1 to 25 lb: one tablet containing 68 micrograms (mcg) ivermectin. 25.1 to 50 lb: one tablet containing 136 micrograms (mcg) ivermectin. 50.1 to 100 lb: one tablet containing 272 micrograms (mcg) ivermectin. Greater than 100 lb: use the appropriate combination of tablets.

Indications: Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonina), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm (Dipylidium caninum, Taenia pisiformis) infections.

Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Tolerances

A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in liver (target tissue) as follows: a. In cattle 100 parts per billion. b. In swine 20 parts per billion. c. In sheep 30 parts per billion. d. In reindeer 15 parts per billion. e. In American bison 15 parts per billion. Muscle residues are not indicative of the safety of other edible tissues. A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in muscle as follows: a. Swine 20 parts per billion b. Cattle 10 parts per billion