Revised: January 2011
AN: 01013/2010
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Katavac CHP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
Combined feline rhinotracheitis virus vaccine (live), freeze dried; feline calicivirus
vaccine (live), freeze dried; and feline panleucopenia virus vaccine (live), freeze
dried; and sterile diluent for veterinary use.
Quantitative composition
1. Freeze-Dried Fraction:
Active Ingredients
Feline rhinotracheitis virus strain 2112
Feline calicivirus, strain 2113
Feline panleucopenia virus strain E
2. Sterile Diluent
Water for injection
Excipients:
For a full list of excipients, see section 6.1.
3.
Per 1 ml dose
104.5 to 106.7 TCID50
105.5 to 107.7 TCID50
105.0 to 106.5 HAID50
1 ml
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4.
CLINICAL PARTICULARS
4.1
Target Species
Cats.
4.2
Indications for use specifying the target species
For the active immunisation of cats and kittens to reduce mortality and clinical
signs caused by feline rhinotracheitis virus; to reduce clinical signs due to feline
calicivirus; to prevent mortality and clinical signs and reduce the adverse effects
on the immune system caused by feline panleucopenia virus infection.
The onset of immunity is from two weeks after the second vaccination. The
duration of immunity is at least one year for all three antigens.
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4.3
Contraindications
Do not vaccinate sick cats.
4.4
Special warnings
The effect of higher levels of maternally derived antibodies on the response to
vaccination is not known. However, on the basis of field use, it is expected that
in the majority of cats, the levels of maternally derived antibodies that will be
present at 9 weeks of age will not interfere with the response to vaccination.
The live vaccine strains may spread to unvaccinated animals, but do not cause
diseases.
4.5
Special precautions for use, including special precautions to be taken by
the person administering the medicinal product to animals
i.
Special precautions for use in animals
None.
ii.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
In case of accidental self-injection/ingestion/spillage on to skin, seek medical
advice immediately and show the package insert or label to the physician.
4.6
Adverse reactions (frequency and seriousness)
Very occasional lethargy, transient fever, coughing, sneezing, localised swelling
and pain have been observed in cats in the field, however, the incidence of these
cases is rare.
4.7
Use during pregnancy, lactation or lay
Do not vaccinate pregnant queens.
4.8
Interactions with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be
administered on the same day as Fevaxyn FeLV. No information is available on
the safety and efficacy of this vaccine when used with any other veterinary
medicinal product except the products mentioned above. A decision to use this
vaccine before or after any other veterinary medicinal product therefore needs to
be made on a case by case basis.
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4.9
Amounts to be administered and administration route
The vaccine is to be administered subcutaneously to cats of 9 weeks of age or
older.
Aseptically reconstitute the contents of the freeze-dried vial using 1 ml sterile
diluent or Fevaxyn FeLV as a diluent.
Vaccination Schedule
Primary vaccination:
A single dose of Katavac CHP should be administered from 9 weeks of age
followed by a second injection after an interval of 3-4 weeks.
Booster vaccination:
Booster vaccinations are recommended every 12 months.
Field experience indicates that a single vaccination can be expected to be
sufficient as an annual booster.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Administration of an overdose does not result in significantly worse adverse
reactions to those seen after administration of a single dose.
4.11 Withdrawal period(s)
Not Applicable.
5.
IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against feline rhinotracheitis virus, feline calicivirus
and feline panleucopenia virus.
ATC Vet Code:
QI06AD04
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
GLS (Glucose, Lactose, Sucrose solution)
Eagles Earles Medium
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6.2
Incompatibilities
Safety and efficacy data are available which demonstrate that this vaccine can be
mixed and administered with Fevaxyn FeLV. Do not mix with any other veterinary
medicinal product, except Fevaxyn FeLV or the diluent supplied for use with the
product.
6.3
Shelf life
21 months for the Katavac CHP cake fraction.
1 year for the sterile diluent.
Use immediately after reconstitution of the freeze-dried vaccine.
6.4
Special precautions for storage
Store and transport refrigerated (2°C - 8°C).
Protect from light.
Do not freeze.
6.5
Nature and composition of immediate packaging
Freeze-dried Fraction
Vial:
Type I (Ph.Eur.) glass. 3 ml capacity.
Closure:
Type I (Ph.Eur.) bromobutyl rubber stoppers sealed with aluminium
crimp caps.
Sterile Diluent
Vial:
Type I (Ph.Eur.) glass. 3 ml capacity.
Contents:
1 ml in a 3 ml vial.
Closure:
Type I (Ph.Eur.) bromobutyl rubber stoppers sealed with aluminium
crimp caps.
Pack Sizes
Packs with 10, 25 or 50 x 1 ml doses. Each dose is a combination of one vial of
freeze-dried vaccine and one vial of sterile diluent.
6.6
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Dispose of waste material by boiling, incineration or immersion in an appropriate
disinfectant approved for use by the competent authorities.
7.
MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
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8.
MARKETING AUTHORISATION NUMBERS
Vm 00057/4304
9.
DATE OF FIRST AUTHORISATION OF THE AUTHORISATION
March 1995
10.
DATE OF REVISION OF THE TEXT
January 2011
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