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Proheart 6 Recall
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Side Effects & Adverse Reactions
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 material safety data sheet (MSDS) contains more detailed occupational safety information.
ProHeart 6 should be administered with caution in dogs with pre-existing allergic disease, including food allergy, atopy, and flea allergy dermatitis. In some cases, anaphylactic reactions have resulted in liver disease and death. Anaphylactic and anaphylactoid reactions should be treated immediately with the same measures used to treat hypersensitivity reactions to vaccines and other injectable products.
Owners should be given the Client Information Sheet for ProHeart 6 to read before the drug is administered and should be advised to observe their dogs for potential drug toxicity described in the sheet.
Do not administer ProHeart 6 to dogs who are sick, debilitated, underweight or who have a history of weight loss.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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History
There is currently no drug history available for this drug.
Other Information
ProHeart 6 (moxidectin) Sustained Release Injectable 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.
Sources
Proheart 6 Manufacturers
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Zoetis Inc.
Proheart 6 | Zoetis Inc.
Owners should be given the Client Information Sheet for ProHeart 6 to read before the drug is administered and should be advised to observe their dogs for potential drug toxicity described in the sheet.
Frequency of Treatment: ProHeart 6 prevents infection 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 3.00Injection 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.
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