Felocell FIP is for intranasal (IN) vaccination of healthy
cats 16 weeks of age or older as an aid in preventing feline infectious
peritonitis caused by feline infectious peritonitis virus (FIPV). Felocell
FIP contains an attenuated, temperature-sensitive (TS) strain of FIP virus
propagated on an established feline cell line. The vaccine is freeze-dried
to preserve stability.- Feline Infectious Peritonitis Vaccine
- Modified Live Virus vaccine
- For use in cats only
Cats vaccinated intranasally with
Felocell FIP develop a protective immune response and do not become
hypersensitized. This practical benefit may be attributed to the
temperature-sensitive Felocell FIP vaccine strain, which replicates in the
upper respiratory tract, but does not spread systemically at 39°C, the cat's
body temperature.
DISEASE
DESCRIPTION: FIP is a complex disease of cats caused by FIPV, a
coronavirus related to transmissible gastroenteritis virus (TGEV) of pigs,
enteric coronavirus of dogs, and respiratory coronavirus of humans.
Although scientists do not
completely understand its pathogenesis, they believe that FIP is an
immune-mediated disease. FIPV first multiplies in epithelial cells of the
upper respiratory tract and intestine.
Clinically apparent FIP occurs after the virus crosses the mucosal barrier
and spreads throughout the cat in infected macrophages and monocytes.
Primary FIP may be mild,
consisting of fever and a slight nasal and ocular discharge. While most cats
with the primary form of FIP recover, others become chronically infected
carriers. Secondary FIP may develop following primary infection and appears
in 2 forms: (1) Effusive or wet form, characterized by peritonitis and
pleuritis with ascites and pleural effusion, and (2) Noneffusive or dry
form, characterized by granulomatous inflammation of various organs and
little or no exudate. Both forms may
appear together. Once clinical symptoms occur, FIP usually takes a fatal
course. The most commonly diagnosed clinical manifestation is accumulation
of fluid within the peritoneal cavity with progressive, painless enlargement
of the abdomen. Infected animals also may experience difficult breathing,
have an elevated temperature, appear depressed, and lose weight. Other
clinical symptoms, such as ocular involvement, disseminated intravascular
coagulation, and renal involvement, are observed occasionally.
Exudate obtained from body cavities by paracentesis appears pale yellow or
golden in color and is relatively clear. Hemograms of cats with FIP
typically indicate a stress response. There may be a mild to moderate anemia
and leukocytosis attributed to an increased percentage of neutrophils.
FIP most frequently occurs in
young cats between the ages of 6 months and 2 years of age. Incidence of
disease is also higher in older cats, between 11 and 15 years of age.
SAFETY AND
EFFICACY: Comprehensive tests were conducted to demonstrate the safety
of Felocell FIP.
In these tests, Felocell FIP
did not cause illness in cats when administered intranasally. It did not
cause illness in cats infected with feline leukemia, in cats exposed to
feline enteric coronavirus, in dexamethasone-immunosuppressed cats, in
nonvaccinated cats that survived FIP challenge, or in kittens.
Felocell FIP did not interfere
with the development of an antibody response to any of the following feline
vaccine antigens: feline leukemia virus, feline rhinotracheitis virus,
feline calicivirus, feline panleukopenia virus, and Chlamydia psittaci.
Conversely, none of these vaccine antigens interfered with the
immunogenicity of Felocell FIP.
Efficacy of Felocell FIP also
was demonstrated in a series of tests.
In the first of 2
immunogenicity studies, 20 seronegative cats were vaccinated with a 2-dose
primary regimen (given 3 weeks apart). All vaccinates developed FIPV
antibody titers, and 17 of the 20 (85%) survived an FIPV challenge that
caused FIP in 12 of 12 (100%) nonvaccinated controls. Ten of the 12 controls
died. Sixteen of the 17 (94%) vaccinated cats that survived the first
challenge survived a second challenge, which caused FIP in 4 of 6
nonvaccinated controls. In the second immunogenicity study, 20 of 20
seronegative cats developed FIPV antibody titers after primary vaccination
with 2 doses given 3 weeks apart. Fifteen of 20 (75%) vaccinates were
protected against a challenge of immunity in which 7 of 10 (70%)
nonvaccinated control cats died of FIP. All but 1 of the surviving
vaccinated cats from the first challenge survived a second challenge, which
killed 6 of 6 nonvaccinated controls.
In addition to protecting
against homologous challenge, Felocell FIP also protected cats against a
heterologous challenge strain (WSU-1146). Clinical FIP symptoms of
vaccinated cats were significantly lower (P<0.05) than symptoms of control
cats following WSU-1146 challenge. Eight of 10 (80%) vaccinated cats
survived a challenge of immunity with the WSU-1146 strain of FIP in which 3
of 5 (60%) nonvaccinated controls died of FIP.
DIRECTIONS:
1. General
Directions: Vaccination of healthy cats is recommended. Aseptically
rehydrate the freeze-dried vaccine with the sterile diluent provided. Mix
well. Use dropper to inoculate entire volume into nasal passages (1/2 volume
into each nasal passage). Cats may sneeze or shake their heads at the time
of administration.
2. Primary
Vaccination: Healthy cats 16 weeks of age or older should receive 2 IN
doses administered 3-4 weeks apart.
3.
Revaccination: Annual revaccination with a single dose is recommended.
PRECAUTIONS:
Store at 2°-7°C. Prolonged
exposure to higher temperatures and/or direct sunlight may adversely affect
potency. Do not freeze.
Use entire contents when first
opened.
Burn containers and all unused
contents.
Droppers should be used to
administer this vaccine.
As with many vaccines,
anaphylaxis may occur after use. Initial antidote of epinephrine is
recommended and should be followed with appropriate supportive therapy.
This product has been shown to
be efficacious in healthy animals. A protective immune response may not be
elicited if animals are incubating an infectious disease, are malnourished
or parasitized, are stressed due to shipment or environmental conditions,
are otherwise immunocompromised, or the vaccine is not administered in
accordance with label directions.
For veterinary use only