ADVERSE REACTIONS
Some
dogs treated with ProHeart®
6 in laborataory effectiveness studies developed transient,
localized inflammatory injections 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.
In
clinical field trials, the following adverse reactions
were observed in approximately 1% of 280 dogs treated
with ProHeart®
6: vomiting, diarrhea, listlessness, weight loss, seizures,
injection site pruritis and elevated body temperature.
To report suspected adverse reactions
or to obtain technical assistance call (800) 533-8536 |
ANIMAL SAFETY
General Safety:ProHeart®
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).
ProHeart®
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.
Injection
Site Reactions: Injection site observations were
recorded during clinical field trials and as part of safety
studies conducted in laboratory dogs. In clinical studies,
ProHeart®
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 abnormalities.
In a laboratory
safety study, ProHear®t
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
6 months. Mild
erythema 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.
CONSTITUTION PROCEDURES
The two-part
ProHeart®
6 product must be mixed at least 30 minutes prior to the intended
time of use.
Items needed
to constitute ProHeart 6:
*Microspheres
(vial 1)
*Enclosed
vent needle (25G) Vehicle (vial 2)
*Sterile
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
to constitution.
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
vial.
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
and needles.
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
on standing.
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
dosing.
11. Refrigerate the unused product. The constituted product
remains stable for 4 weeks in a refrigerator. void direct
sunlight.
Storage Information: Store
the unconstituted product at controlled room temperature 15
- 25° C (77° F). do not expose to light for extended
periods of time. After constitution the product is stable
for 4 weeks stored under refrigeration at 2-8° C (36-46°
F).
