ProHeart 6: Product Information

PROHEART 6- 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 6 (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. No other diluent should be used. A clear or translucent appearance of the vehicle is normal. Each mL of constituted drug product contains 3.4 mg moxidectin, 3.1% glyceryl tristearate, 2.4% hydroxypropyl methylcellulose, 0.87% sodium chloride, 0.17% methylparaben, 0.02% propylparaben and 0.001% butylated hydroxytoluene. Hydrochloric acid is used to adjust pH. The constituted product may appear as a hazy to milky suspension.

INDICATIONS

ProHeart 6 is indicated for use in dogs six months of age and older for the prevention of heartworm disease caused by Dirofilaria immitis for 6 months.
ProHeart 6 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 6. The owner should be advised to observe their dog for adverse drug events including those described on the sheet.

Frequency of Treatment

ProHeart 6 prevents the development of heartworm disease caused by D. immitis for six months. It should be administered within one month of the dog’s first exposure to mosquitoes. Follow-up treatments may be given every six months if the dog has continued exposure to mosquitoes and if the dog continues to be healthy without weight loss. When replacing another heartworm preventive product, ProHeart 6 should be given within one month of the last dose of the former medication.
ProHeart 6 eliminates the larval and adult stages of A. caninum and U. stenocephala present at the time of treatment. However, persistent effectiveness has not been established for this indication. Re-infection with A. caninum and U. stenocephala may occur sooner than 6 months.

Dose

The recommended subcutaneous dose is 0.05 mL of the constituted suspension/kg body weight (0.0227 mL/lb.). This amount of suspension will provide 0.17 mg moxidectin/ kg bodyweight (0.0773 mg/lb.).To ensure accurate dosing, calculate each dose based on the dog’s weight at the time of treatment. Do not overdose growing puppies in anticipation of their expected adult weight. The following dosage chart may be used as a guide.

DOSAGE CHART
Dog Wt. Dose Volume Dog Wt. Dose Volume
lb kg mL/Dog lb kg mL/Dog
11 5 0.25 77 35 1.75
22 10 0.50 88 40 2.00
33 15 0.75 99 45 2.25
44 20 1.00 110 50 2.50
55 25 1.25 121 55 2.75
66 30 1.50 132 60 3.00

Injection Technique

The two-part sustained release product must be mixed at least 30 minutes prior to the intended time of use (see CONSTITUTION PROCEDURES for initial mixing instructions). Once constituted, swirl the bottle gently before every use to uniformly re-suspend the microspheres. Withdraw 0.05 mL of suspension/kg body weight 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 6 and ProHeart 12 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 6 and ProHeart 12. ProHeart 6 and ProHeart 12 are the same formulation, but ProHeart 6 is three times less concentrated than ProHeart 12. ProHeart 6 and ProHeart 12 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 6 and ProHeart 12 web-based training and certification module is available at http://www.proheart6.com. This website has important information on the safe and effective use of ProHeart 6 and ProHeart 12 for veterinarians.
Only veterinarians and veterinary technicians/assistants that have completed the training and are certified can administer ProHeart 6 and ProHeart 12. 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 6 is contraindicated in animals previously found to be hypersensitive to this drug or ProHeart 12.

HUMAN WARNINGS

Not for human use. Keep this and all drugs out of the reach of children.

May be slightly irritating to the eyes. May cause slight irritation to the upper respiratory tract if inhaled. May be harmful if swallowed. If contact with the eyes
occurs, rinse thoroughly with water for 15 minutes and seek medical attention immediately. If accidental ingestion occurs, contact a Poison Control Center
or a physician immediately. The Safety Data Sheet (SDS) contains more detailed occupational safety information.

WARNINGS

Anaphylactic and anaphylactoid reactions may occur in some dogs following administration of ProHeart 6 alone or with vaccines. In some cases, these reactions have resulted in death following administration of moxidectin microspheres (see POST-APPROVAL EXPERIENCE). Anaphylactic and anaphylactoid reactions should be treated immediately with the same measures used to treat hypersensitivity reactions to vaccines and other injectable products.
Always provide Client Information Sheet and review with owners before administering ProHeart 6. The owner should be advised to observe their dog for adverse drug events including those described on the sheet.
Do not administer ProHeart 6 to dogs who are sick, debilitated, underweight or who have a history of weight loss.

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