Zoetis Inc.
PROHEART 12- moxidectin
Zoetis Inc.
CAUTION
Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION
ProHeart 12 (moxidectin) for extended-release injectable suspension consists of two separate vials: one vial contains 10% moxidectin sterile microspheres; and the second vial contains a specifically formulated sterile vehicle for constitution with the microspheres. A clear or translucent appearance of the vehicle is normal. Each mL of constituted drug product contains 10 mg moxidectin, 9% glyceryl tristearate, 2.25% hydroxypropyl methylcellulose, 0.81% sodium chloride, 0.16% methylparaben, 0.02% propylparaben and 0.004% butylated hydroxytoluene. Hydrochloric acid is used to adjust pH. The constituted product may appear as a hazy to milky suspension.
INDICATIONS
ProHeart 12 is indicated for use in dogs 12 months of age and older for the prevention of heartworm disease caused by Dirofilaria immitis for 12 months.
ProHeart 12 is indicated for the treatment of existing larval and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections.
DOSAGE AND ADMINISTRATION
Always provide Client Information Sheet and review with owners before administering ProHeart 12. The owner should be advised to observe their dog for adverse drug events including those described on the sheet. The Client Information Sheet is attached to this package insert and available online at http://www.proheart12.com for reprinting to provide to the owner.
Frequency of Treatment:
ProHeart 12 prevents the development of heartworm disease caused by D. immitis for 12 months. For dogs not previously on heartworm preventive or having lapsed beyond 12 months of a prior ProHeart 12 dose, the product should be given within 1 month of exposure to mosquitoes. Follow-up treatments may be given every 12 months, if the dog continues to be healthy and without weight loss, to provide continuous year-round protection. When replacing a monthly heartworm preventive product, ProHeart 12 should be given within one month of the last dose of the former medication to avoid a gap in protection.
ProHeart 12 eliminates the larval and adult stages of A. caninum and U. stenocephala present at the time of treatment. Re-infection with A. caninum and U. stenocephala may occur sooner than 12 months.
Dose:
The recommended subcutaneous dose is 0.05 mL of the constituted suspension/kg body weight (0.023 mL/lb). This amount of suspension will provide 0.5 mg moxidectin/kg body weight (0.23 mg/lb). To ensure accurate dosing, calculate each dose based on the dog’s weight at the time of treatment. The following table provides a guide for weight specific dose volumes.
Table 1: Dosage Guide
| Dog Weight | Dose Volume* mL/Dog | |
| Pounds (lb) | Kilograms (kg) | |
| 11 lb | 5 kg | 0.25 |
| 22 lb | 10 kg | 0.50 |
| 33 lb | 15 kg | 0.75 |
| 44 lb | 20 kg | 1.00 |
| 55 lb | 25 kg | 1.25 |
| 66 lb | 30 kg | 1.50 |
| 77 lb | 35 kg | 1.75 |
| 88 lb | 40 kg | 2.00 |
| 99 lb | 45 kg | 2.25 |
| 110 lb | 50 kg | 2.50 |
| 121 lb | 55 kg | 2.75 |
| 132 lb | 60 kg | 3.00 |
*All dogs should be dosed at 0.05 mL suspension/kg body weight (0.023 mL /lb).
Injection Technique:
ProHeart 12 must be prepared at least 30 minutes prior to the first use by adding the sterile vehicle to the microspheres. (See CONSTITUTION PROCEDURES for initial mixing instructions.)
Swirl the constituted product vial gently before every use to uniformly re-suspend the microspheres.
Withdraw 0.05 mL of suspension/kg body weight (0.023 mL/lb) into an appropriately sized syringe fitted with an 18G or 20G hypodermic needle. Dose promptly after drawing into dosing syringe. If administration is delayed, gently roll the dosing syringe prior to injection to maintain a uniform suspension and accurate dosing.
Using aseptic technique, inject the product subcutaneously in the left or right side of the dorsum of the neck cranial to the scapula. No more than 3 mL should be administered in a single site. The location(s) of each injection (left or right side) should be noted so that prior injection sites can be identified and the next injection can be administered on the opposite side.
RISK MINIMIZATION ACTION PLAN
The ProHeart 12 and ProHeart 6 Risk Minimization Action Plan (RiskMAP) provides educational materials to the veterinarian, veterinary staff, and the dog owner explaining the risks and proper use of ProHeart 12 and ProHeart 6. ProHeart 12 and ProHeart 6 are the same formulation, but ProHeart 12 is three times the concentration of ProHeart 6. ProHeart 12 and ProHeart 6 are for use in dogs only and are available through a restricted distribution program to veterinarians that have completed the RiskMAP training and certification module.
The ProHeart 12 and ProHeart 6 web-based training and certification module is available at http://www.proheart12.com. This website has important information on the safe and effective use of ProHeart 12 and ProHeart 6 for veterinarians.
Only veterinarians and veterinary technicians/assistants that have completed the training and are certified can administer ProHeart 12 and ProHeart 6.
Veterinarians are expected to report all adverse events that occur in animals or humans to the manufacturer. Important safety information is included below:
CONTRAINDICATIONS
ProHeart 12 is contraindicated in animals previously found to be hypersensitive to this drug or ProHeart 6.
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