Today's Veterinary Practice

TVP_JUL-AUG2018

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30 mg/mL flavored solution in 10 mL, 15 mL and 30 mL bottles with measuring syringe For oral use in dogs only Appetite Stimulant Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Description: ENTYCE ® (capromorelin oral solution) is a selective ghrelin receptor agonist that binds to receptors and affects signaling in the hypothalamus to cause appetite stimulation and binds to the growth hormone secretagogue receptor in the pituitary gland to increase growth hormone secretion. Indication: ENTYCE (capromorelin oral solution) is indicated for appetite stimulation in dogs. Contraindications: ENTYCE should not be used in dogs that have a hypersensitivity to capromorelin. Warnings: Not for use in humans. Keep this and all medications out of reach of children and pets. Consult a physician in case of accidental ingestion by humans. For use in dogs only Precautions: Use with caution in dogs with hepatic dysfunction. ENTYCE is metabolized by CYP3A4 and CYP3A5 enzymes (See Clinical Pharmacology). Use with caution in dogs with renal insufficiency. ENTYCE is excreted approximately 37% in urine and 62% in feces (See Adverse Reactions and Clinical Pharmacology). The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches. Adverse Reactions: Field safety was evaluated in 244 dogs. The most common adverse reactions were diarrhea and vomiting. Of the dogs that received ENTYCE (n = 171), 12 experienced diarrhea and 11 experienced vomiting. Of the dogs treated with placebo (n = 73), 5 experienced diarrhea and 4 experienced vomiting. To report suspected adverse drug events and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, call Aratana Therapeutics at 1-844-272-8262. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/Animal Veterinary/SafetyHealth NADA 141-457, Approved by FDA US Patent: 6,107,306 US Patent: 6,673,929 Made in Canada Manufactured for: Aratana Therapeutics, Inc. Leawood, KS 66211 ENTYCE is a trademark of Aratana Therapeutics, Inc. © Aratana Therapeutics, Inc. AT2-021-16 August 2016 ® PA100648X_BrS1 P1c Interceptor ™ Plus (milbemycin oxime/praziquantel) Caution Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Before using INTERCEPTOR PLUS, please consult the product insert, a summary of which follows: Indications INTERCEPTOR PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis; and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, Echinococcus granulosus, and Dipylidium caninum) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older. Dosage and Administration INTERCEPTOR PLUS should be administered orally, once every month, at the minimum dosage of 0.23 mg/lb (0.5 mg/kg) milbemycin oxime, and 2.28 mg/lb (5 mg/kg) praziquantel. For heartworm prevention, give once monthly for at least 6 months after exposure to mosquitoes (see EFFECTIVENESS). See product insert for complete dosing and administration information. Contraindications There are no known contraindications to the use of INTERCEPTOR PLUS. Warnings Not for use in humans. Keep this and all drugs out of the reach of children. Precautions Treatment with fewer than 6 monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention (see EFFECTIVENESS). Prior to administration of INTERCEPTOR PLUS, dogs should be tested for existing heartworm infections. At the discretion of the veterinarian, infected dogs should be treated to remove adult heartworms. INTERCEPTOR PLUS is not effective against adult D. immitis. Mild, transient hypersensitivity reactions, such as labored breathing, vomiting, hypersalivation, and lethargy, have been noted in some dogs treated with milbemycin oxime carrying a high number of circulating microfilariae. These reactions are presumably caused by release of protein from dead or dying microfilariae. Do not use in puppies less than six weeks of age. Do not use in dogs or puppies less than two pounds of body weight. The safety of INTERCEPTOR PLUS has not been evaluated in dogs used for breeding or in lactating females. Studies have been performed with milbemycin oxime alone (see ANIMAL SAFETY). Adverse Reactions The following adverse reactions have been reported in dogs after administration of milbemycin oxime or praziquantel: vomiting, diarrhea, depression/lethargy, ataxia, anorexia, convulsions, weakness, and salivation. To report suspected adverse drug events, contact Elanco US Inc. at 1-888-545-5973 or the FDA at 1-888-FDA-VETS. For technical assistance call Elanco US Inc. at 1-888-545-5973. Information for Owner or Person Treating Animal: Echinococcus multilocularis and Echinococcus granulosus are tapeworms found in wild canids and domestic dogs. E. multilocularis and E. granulosus can infect humans and cause serious disease (alveolar hydatid disease and hydatid disease, respectively). Owners of dogs living in areas where E. multilocularis or E. granulosus are endemic should be instructed on how to minimize their risk of exposure to these parasites, as well as their dog's risk of exposure. Although INTERCEPTOR PLUS was 100% effective in laboratory studies in dogs against E. multilocularis and E. granulosus, no studies have been conducted to show that the use of this product will decrease the incidence of alveolar hydatid disease or hydatid disease in humans. Because the prepatent period for E. multilocularis may be as short as 26 days, dogs treated at the labeled monthly intervals may become reinfected and shed eggs between treatments. Effectiveness Heartworm Prevention: In a well-controlled laboratory study, INTERCEPTOR PLUS was 100% effective against induced heartworm infections when administered once monthly for 6 consecutive months. In well-controlled laboratory studies, neither one dose nor two consecutive doses of INTERCEPTOR PLUS provided 100% effectiveness against induced heartworm infections. Intestinal Nematodes and Cestodes Treatment and Control: Elimination of the adult stage of hookworm (Ancylostoma caninum), roundworm (Toxocara canis, Toxascaris leonina), whipworm (Trichuris vulpis) and tapeworm (Echinococcus multilocularis, Echinococcus granulosus, Taenia pisiformis and Dipylidium caninum) infections in dogs was demonstrated in well-controlled laboratory studies. Palatability In a field study of 115 dogs offered INTERCEPTOR PLUS, 108 dogs (94.0%) accepted the product when offered from the hand as if a treat, 1 dog (0.9%) accepted it from the bowl with food, 2 dogs (1.7%) accepted it when it was placed in the dog's mouth, and 4 dogs (3.5%) refused it. Storage Information Store at room temperature, between 59° and 77°F (15-25°C). How Supplied INTERCEPTOR PLUS is available in four strengths, formulated according to the weight of the dog. Each strength is available in color-coded packages of six chewable tablets each. The tablets containing 2.3 mg milbemycin oxime/ 22.8 mg praziquantel or 5.75 mg milbemycin oxime/57 mg praziquantel are also available in color coded packages of one chewable tablet each. Manufactured for: Elanco US Inc. Greenfield, IN 46140, USA Product of Japan NADA #141-338, Approved by FDA Interceptor, Elanco and the diagonal bar logo are trademarks of Eli Lilly and Company or its affiliates.

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