ProHeart 6 (Canada)

This page contains information on ProHeart 6 for veterinary use.
The information provided typically includes the following:
  • ProHeart 6 Indications
  • Warnings and cautions for ProHeart 6
  • Direction and dosage information for ProHeart 6

ProHeart 6

This treatment applies to the following species:
Manufacturer: Zoetis

(moxidectin)

Sustained Release Antiparasitic Injectable Suspension for Dogs

STERILE

DIN 02245422

VETERINARY USE ONLY

ProHeart 6 Indications

ProHeart 6 is indicated in dogs six months of age and older, for the prevention of canine cardiovascular dirofilariasis (Heartworm disease) caused by Dirofilaria immitis for six months after a single administration. It is also indicated for treatment of parasitic infections due to the adult and developing larval (L4) stages of hookworms, Ancylostoma caninum and Uncinaria stenocephala, in dogs.

Description

The product consists of two separate vials. Vial 1 contains 10% w/w sterile moxidectin microspheres and Vial 2 contains a specifically formulated sterile vehicle for constitution with Vial 1. No other diluent should be used. The translucent appearance of the vehicle is normal. Each mL of constituted 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.

ProHeart 6 Dosage And Administration

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.

Swirl gently to uniformly resuspend microspheres in the constituted product before withdrawing 0.05 mL of the suspension/kg body weight into an appropriate size syringe fitted with a 18G or 20G hypodermic needle. Inject the product subcutaneously in the dorsum of the neck cranial to the scapula. The constituted suspension is for subcutaneous injection at the rate of 0.05 mL/kg body weight to provide 0.17 mg moxidectin/kg. ProHeart 6 can be administered to dogs 6 months of age and older. For growing dogs, dose to the average weight during the 6 month effective period. Administration may be repeated at 6 months intervals.

RECOMMENDED DOSAGE CHART

Dog weight (kg)

Dosage (mL/dog)

Dog weight (kg)

Dosage (mL/dog)

5

0.25

35

1.75

10

0.50

40

2.00

15

0.75

45

2.25

20

1.00

50

2.50

25

1.25

55

2.75

30

1.50

60

3.00

Constitution Procedures

The two-part Sustained Release Injectable product must be mixed at least 30 minutes prior to the intended time of use.

Items needed to constitute Sustained Release Injectable Suspension:

• Microspheres (vial 1) • Enclosed vent needle (25G) • Sterile 20 mL syringe for transfer • Vehicle (vial 2) • Transfer needle (18G or 20G)

Constitution of the 17 mL vial product.

1. Shake microspheres vial to break up aggregates prior to constitution.

2. Using a 18G or 20G needle and sterile syringe, withdraw 17 mL of the unique vehicle from the vial. There is slightly more vehicle supplied than the 17 mL required.

3. Insert the enclosed 25G vent needle into the microsphere vial.

4. Transfer the vehicle into the microsphere vial through the stopper using the transfer needle and syringe.

5. Once the vehicle has been added, remove the vent and transfer needles from the microsphere vial. Discard unused vehicle and needles.

6. Shake the microsphere vial vigorously until a thoroughly mixed suspension is produced.

7. Allow suspension to stand for at least 30 minutes to allow large air bubbles to dissipate.

8. Record the date of mixing on the microsphere vial.

9. Before every use, gently swirl the mixture to achieve uniform suspension. The microspheres and vehicle will gradually separate on standing.

10. Use a 1 mL or 3 mL syringe and a 18G or 20G needle for dosing. Dose promptly after drawing into dosing syringe. If necessary when administration is delayed, gently roll the dosing syringe prior to injection to maintain a uniform suspension and accurate dosing.

11. Refrigerate the unused product. The constituted product remains stable for eight weeks in a refrigerator. Avoid direct sunlight.

Contraindications

Do not use in sick, debilitated or underweight dogs. ProHeart 6 should only be used in dogs testing negative for the presence of existing heartworm infection.

ProHeart 6 Cautions

Prior to administration of ProHeart 6, the health of the patient should be assessed by a thorough medical history and physical examination.

All dogs 6 months of age and older should be tested for latent heartworm infections before beginning treatment with ProHeart 6. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with ProHeart 6. Further re-testing before re-treatment with ProHeart 6 is at the discretion of the veterinarian.

Caution should be used when administering ProHeart 6 concurrently with vaccinations. Adverse reactions, including anaphylaxis, have been reported following the concomitant use of ProHeart 6 and vaccinations.

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.

Warnings

KEEP OUT OF REACH OF CHILDREN. In case of human consumption, contact a Poison Control Center or a physician immediately.

Adverse Reactions

In field studies, the following adverse reactions were observed in dogs treated with ProHeart 6: anaphylaxis, vomiting, diarrhea (with and without blood), listlessness, weight loss, seizures, injection site pruritus, and elevated body temperature. Dogs with clinically significant weight loss (>10%) were more likely to experience a severe adverse reaction.

In a laboratory effectiveness study, dogs with 4- and 6-month-old-heartworm infections experienced vomiting, lethargy and bloody diarrhea. These signs were more severe in the dogs with 4-month-old heartworm infections, including one dog that was recumbent and required supportive care, than in the dogs with older (6-month-old) infections.

Post Approval Experience

Although all adverse reactions are not reported, the following adverse reactions are based on voluntary post-approval adverse drug experience reporting to the Center for Veterinary Medicine in the United States. The categories of adverse reactions are listed in decreasing order of frequency by body system.

Gastrointestinal: vomiting (with or without blood), diarrhea with or without blood, hypersalivation.

Hepatic: elevated liver enzymes, hypoproteinemia, hyperbilirubinemia.

Neurological: seizures, ataxia, trembling, hind limb paresis.

Urinary: elevated BUN, elevated creatinine, hematuria, polydipsia, polyuria.

Hematological: leukocytosis, anemia, thrombocytopenia.

Dermatological: injection site pruritus/swelling, erythema multiforme.

Immune: anaphylaxis and/or anaphylactoid reactions, urticaria, head/facial edema, pruritus, pale mucous membranes, collapse, cardiovascular shock, erythema, immune-mediated hemolytic anemia, immune-mediated thrombocytopenia (signs reflected in other system categories, i.e., gastrointestinal, dermatologic, and hematologic, could be related to allergic reactions).

Respiratory: dyspnea, tachypnea, coughing.

Cardiopulmonary signs such as coughing and dyspnea rarely may occur in heartworm positive dogs treated with ProHeart 6.

Systemic: depression, lethargy, anorexia, fever, weight loss, weakness.

In rare situations, death has been associated with some of the adverse reactions listed above.

To report adverse reactions in users or to obtain a copy of the material safety data sheet (MSDS) for this product call 1-800-461-0917.

Information For Dog Owners

Always provide Client Information Sheet and review with owners before administering ProHeart 6. Owners should be advised of the potential for adverse reactions, including anaphylaxis, and be informed of the clinical signs associated with drug toxicity (see CAUTIONS and ADVERSE REACTIONS sections). Owners should be advised to contact their veterinarian immediately if signs of toxicity are observed. The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized and veterinary care, if appropriate, is initiated.

Pharmacology

Moxidectin is a semi-synthetic methoxime derivative of nemadectin which is a fermentation product of Streptomyces cyaneogriseus subsp noncyanogenus. Moxidectin is a pentacyclic 16-membered lactone macrolide. Moxidectin has activity resulting in paralysis and death of affected parasites. The stage of the canine heartworm affected at the recommended dose rate of 0.17 mg/kg body weight is the tissue larval stage. There is no measurable effect against the adult heartworm at this dose rate. Both larval and adult stages of hookworms are susceptible.

Animal Safety

ProHeart 6 has been safely administered to a wide variety of dog breeds. The target animal safety testing program for ProHeart 6 included field tests at the recommended dose level, a margin of safety study, tests with ivermectin-sensitive collie dogs, tests with dogs known to have patent heartworm infections, and reproductive studies with breeding bitches and stud dogs. The results of these studies showed that ProHeart 6 was safe at all doses tested in target animals six months of age and older, including administration at five times the recommended dose level.

As part of the field-testing program, ProHeart 6 was safely used in conjunction with a variety of veterinary products commonly used in dogs. These products included vitamins and nutritional supplements, anthelmintics, antiparasitics, steroids, antibiotics, anesthetics, analgesics, nonsteroidal anti-inflammatory drugs, and flea control products.

Storage

Store the unconstituted product at 25°C or lower. Do not expose to light for extended periods of time. After constitution, the product is stable for 8 weeks stored under refrigeration at 2° to 8°C.

Presentation

ProHeart 6 (moxidectin) Sustained Release Injectable Suspension for Dogs comes in a single pack that contains:

1 vial of moxidectin microspheres [10% w/w] (598 mg)

1 vial of constitution vehicle (17 mL)

1 vent needle

Zoetis Canada Inc., Kirkland QC H9H 4M7

Zoetis is a trademark and ProHeart is a registered trademark of Zoetis or its licensors, used under license by Zoetis Canada Inc.

May 16, 2014 v.02

NAC No.: 1198421.3

ZOETIS CANADA
16,740 TRANS-CANADA HIGHWAY, KIRKLAND, QC, H9H 4M7
Order Desk:   800-663-8888
Technical Services Canada:   800-461-0917
Technical Services USA:   800-366-5288
Website:   www.zoetis.ca
Every effort has been made to ensure the accuracy of the ProHeart 6 information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-12-03

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