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Preapproval Challenge Study3
Results
See Study Design
- 32 purpose-bred dogs, ≥8 months old.
- Dogs were assigned to one of four treatment groups (n=8) on Day 0: ProHeart 6, 0.06 mg/kg; ProHeart 6, 0.17 mg/kg; ProHeart 6, 0.50 mg/kg; or placebo.
- Each dog was inoculated SQ with 50 L3 heartworms on Day 180 and examined for heartworm between Days 330 and 331.
Preapproval Field Study2
Results
See Study Design
- 374 client-owned dogs of various breeds ranging from 6 months to 15 years of age.
- Dogs received ProHeart 6 (n=280) at 0.17 mg/kg on Month 0 and Month 6 or tablets of an approved heartworm preventative medication (n=94) every 30 days for 365 days.
- Antigen and microfilaria testing was performed prior to enrollment and at Months 3, 6 and 12.
Six Months of Efficacy
- Slow-dissolving microspheres contain moxidectin and prolong its effects.
- Moxidectin redistributes from plasma to adipose tissue.
- Adipose tissue acts as a reservoir, allowing six months’ protection against heartworm disease.
IMPORTANT SAFETY INFORMATION: PROHEART 6 should be used in healthy dogs. Do not administer to sick, debilitated, underweight dogs or dogs that have a history of weight loss. Prior to administration, PROHEART 6 certified veterinarians should continue to assess patient health through a medical history, physical examination and if deemed appropriate, diagnostic testing. Continue to use caution when administering PROHEART 6 concurrently with vaccinations. Adverse events, including anaphylaxis, have been reported following the concomitant use of PROHEART 6 and vaccines. In some cases, anaphylactic reactions have resulted in death. Use with caution in dogs with pre-existing or uncontrolled allergic disease (food allergy, atopy or flea allergy dermatitis). Dogs receiving PROHEART 6 should be tested for existing heartworms as per the product label. In people, avoid PROHEART 6 contact with eyes. If contact with the eyes occurs, rinse thoroughly with water for 15 minutes and seek medical attention immediately. PROHEART 6 is available only to veterinarians through a restricted distribution program. Only certified veterinarians and staff can administer it. To obtain additional information including a copy of the product labeling,
click here or call 1-888-ZOETIS1 (963-8471).
- Data on file. ProHeart 6 Freedom of Information Summary, NADA 141-189.
- Lok JB, Knight DH, Wang GT, et al. Activity of an injectable, sustained-release formulation of moxidectin administered prophylactically to mixed-breed dogs to prevent infection with Dirofilaria immitis. Am J Vet Res. 2001;62(11):1721-1726.