6 has been safely administered to a wide variety of healthy
dogs six months of age and older, including a wide variety
of breeds, pregnant and lactating females, breeding males,
and ivermectin-sensitive collies. However, in clinical studies,
two geriatric dogs with a history of weight loss after the
initial ProHeart® 6 injection died within
a month of the second 6 month injection. A third dog who was
underweight for its age and breed and who had a history of
congenital problems experienced lethargy following the initial
injection of ProHeart® 6. The dog never
recovered and died 3 months later (see PRECAUTION).
6 administered at 3 times the recommended dose in dogs with
patent heartworm infections and up to 5 times the recommended
dose in ivermectin-sensitive collies did not cause any adverse
reactions. ProHeart® 6 administered at
3 times the recommended dose did not adversely effect the
reproductive performance of male or female dogs. ProHeart®
6 administered up to 5 times the recommended dose in 7-8 month
old puppies did not cause any systemic adverse effects.
In well controlled
clinical field studies, ProHeart® 6 was
safely used in conjunction with a variety of veterinary products
including vaccines, anthelmintics, antiparasitics, antibiotics,
analgesics, steroids, non-steroidal anti-inflammatory drugs
(NSAIDs), anesthetics and flea control products.
Site Reactions: Injection site observations were recorded
during effectiveness and safety studies. In clinical studies,
ProHear®t 6 was administered at six-month
intervals to client-owned dogs under field conditions. There
were no reports of injection site reactions in these field
studies and evaluations of the injection sites revealed no
In a laboratory
safety study, ProHeart® 6 was administered
at 1, 3 and 5 times the recommended dose to 7-8 month old
puppies. Injection sites were clipped to facilitate observation.
Slight swelling/edema at the injection site was observed in
some dogs from all treated groups. These injection site reactions
appeared as quickly as 8 hours post injection and lasted up
to 3 weeks. A three-year repeated injection study was conducted
to evaluate the safety of up to 6 injections of ProHeart®
6 administered at the recommended dose (0.17 mg/kg) every
and localized deep subcuticular thickening were seen in dogs
that received four injections in the same area on the neck
and in one dog that received two injections in the same area
on the neck. Microscopic evaluation on the injection sites
from all dogs 6 months after the last injection consistently
showed mild granulomatous panniculitis with microvacuolation.
The only adverse reaction seen that was not related to the
injection site was weight loss in one dog.
treated with ProHeart® 6 in laboratory
effectiveness studies developed transient, localized inflammatory
injection site reactions. These injection site reactions
were visible grossly for up to 3 weeks after injection. Histologically,
well-defined granulomas were observed in some dogs at approximately
5 months after injection.
ProHeart® 6 product must be mixed at
least 30 minutes prior to the intended time of use.
to constitute ProHeart® 6:
vent needle (25G) Vehicle (vial 2)
20 mL syringe for transfer Transfer needle (18G or 20G)
Constitution of the 20 mL vial product.
1. Shake the microsphere vial to break up any aggregates prior
2. Using an 18G or 20G needle and sterile syringe withdraw
17.0 mL of the unique vehicle from the vial.
There is more vehicle supplied than the 17.0 mL required.
3. Insert the enclosed 25G vent needle into the microsphere
4. Slowly 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
6. Shake the microsphere vial vigorously until a thoroughly
mixed suspension is produced.
7. Record the time and date of mixing on the microsphere vial.
8. Allow suspension to stand for at least 30 minutes to allow
large air bubbles to dissipate.
9. Before every use, gently swirl the mixture to achieve uniform
suspension. The microspheres and vehicle will gradually separate
10. Use a 1 mL or 3 mL syringe and an 18G or 20G needle for
dosing. 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
11. Refrigerate the unused product. The constituted product
remains stable for 4 weeks in a refrigerator. Avoid direct