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Posted by Deerhounds on January 16, 2003 at 13:28:43:
In Reply to: Heartworm shot posted by Minuet on January 10, 2003 at 15:35:19:
Here is the info from the label on cautions, warnings, and all adverse effects:
Contraindication(s): PROHEART® 6 is contraindicated in animals previously found to be hypersensitive to this drug.
Precaution(s): Storage Information: Store the unconstituted product at or below 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° to 8°C (36° to 46°F).
Caution(s): Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
Use with caution in sick, debilitated or underweight animals (see Safety).
PROHEART® 6 should not be used more frequently than every 6 months.
The safety and effectiveness of PROHEART® 6 has not been evaluated in dogs less than 6 months of age.
Prior to administration of PROHEART® 6, dogs should be tested for existing heartworm infections. At the discretion of the veterinarian, infected dogs should be treated to remove adult heartworms. PROHEART® 6 is not effective against adult D. immitis and, while the number of circulating microfilariae may decrease following treatment, PROHEART® 6 is not effective for microfilariae clearance.
No adverse reactions were observed in dogs with patent heartworm infections when PROHEART® 6 was administered at three times the labeled dose. Higher doses were not tested.
Warning(s): 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 material safety data sheet (MSDS) contains more detailed occupational safety information.
Adverse Reactions: In field studies, the following adverse reactions were observed in approximately 1% of 280 dogs treated with PROHEART® 6: vomiting, diarrhea, listlessness, weight loss, seizures, injection site pruritus, and elevated body temperature.
Post-Approval Experience: Although not all adverse reactions are reported, the following reactions are based on voluntary post-approval drug experience reporting: anaphylaxis/toid reactions, depression/lethargy, urticaria, and head/facial edema. As with anaphylaxis/toid reactions resulting from the use of other injectable products, standard therapeutic intervention should be initiated immediately.
To report suspected adverse reactions or to obtain technical assistance, call (800) 533-8536.
Trial Data: 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 Cautions).
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 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 effectiveness and safety studies. 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, 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 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.
Some dogs 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.
Christie Keith
Caber Feidh Scottish Deerhounds
Holistic Husbandry since 1986
http://www.caberfeidh.com