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AN: 02047/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Katavac Eclipse
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
Combined feline rhinotracheitis virus vaccine (live), freeze dried; feline
calicivirus vaccine (live), freeze dried; feline panleucopenia virus
vaccine (live), freeze dried; and feline leukaemia virus inactivated
vaccine for veterinary use.
Quantitative composition
1. Freeze-Dried Fraction (Katavac CHP):
Active Ingredients
Feline rhinotracheitis virus strain 2112
Feline calicivirus, strain 2113
Feline panleucopenia virus strain E
Per 1ml dose
104.5 to 106.7 TCID50
105.5 to 107.7 TCID50
105.0 to 106.5 HAID50
2. Liquid Fraction (Fevaxyn FeLV)
Active Ingredients
Per 1ml dose
Inactivated Feline Leukaemia Virus
>1.0 RP*
*RP = Relative Potency unit of FeLV antigen gp70
Adjuvant
Carbopol
1 mg
Excipients:
Formaldehyde
For a full list of excipients, see section 6.1.
3.
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
Revised: April 2010
AN: 02047/2009
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.
For the prevention of persistent viraemia associated with feline
leukaemia 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 four antigens.
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.
Vaccination has no known beneficial effect in cats already infected with
FeLV. Therefore, diagnostic testing of cats for the presence of feline
leukaemia (FeLV) core protein p27 in serum prior to vaccination may
be advisable.
The live vaccine strains may spread to unvaccinated animals, but do
not cause diseases.
4.5
Special precautions for use
i. Special precautions for use in animals
In the event of allergic reaction, immediate treatment should be given
using epinephrine (adrenaline) intramuscularly and/or a short acting
glucocorticoid (e.g. dexamethasone sodium phosphate) intravenously.
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, fever, anorexia, vomiting, coughing, sneezing,
localised swelling, pain, pruritus or hair loss may occur post vaccination.
Hypersensitivity reactions such as urticaria or facial oedema,
sometimes accompanied by respiratory signs have been reported.
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AN: 02047/2009
4.7
Use during pregnancy, lactation or lay
Do not vaccinate cats during pregnancy.
4.8
Interactions with other medicinal products and other forms
of interaction
Animals that have received immunosuppressive drugs should not be
vaccinated until an interval of at least four weeks has elapsed.
No information is available on the effects of concurrent use of this
vaccine with any other product. It is therefore recommended that no
other vaccine should be administered within 14 days before or after
vaccination with this product.
4.9
Amounts to be administered and administration route
The vaccination of female cats prior to mating is recommended to
provide maternally derived antibody for the kittens.
The vaccine is to be administered subcutaneously to cats of 9 weeks of
age or older.
Aseptically reconstitute the contents of the Katavac CHP freeze-dried
vial using Fevaxyn FeLV as a diluent.
Section 1.01 Vaccination Schedule
Primary vaccination:
A single dose of Katavac Eclipse 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.
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, feline panleucopenia virus and feline leukaemia virus antigen
gp70.
FeLV antigen gp70 was selected on its immunogenic property. The
FeLV subgroup-A Rickard strain is known to cause the typical
symptoms of Feline Leukaemia. Subgroup-B and subgroup-C are
recombinations of subgroup-A with cat genome sequences. SubgroupA and B are part of Fevaxyn FeLV vaccine antigen and should also
immunise against subgroup-C.
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After infection with FeLV, cats develop either a transient or persistent
viraemia. Persistent viraemia is strongly correlated with degenerative,
proliferative or neoplastic changes of cells of the haemopoietic system
resulting in immunosuppression, leukaemia or tumours. On the other
hand, transiently viraemic cats may develop a protective immunity
resulting in either the elimination of cells with integrated FeLV genome
or a persistent, non-productive latent infection.
ATC Vet Code:
6.
QI06AH07
PHARMACEUTICAL PARTICULARS
6.0
List of excipients
GLS (Glucose, Lactose, Sucrose solution)
Eagle’s Earle’s Medium
Phosphate buffered saline
Formaldehyde
6.1
Incompatibilities
Do not mix with any other vaccine or immunological product.
6.2
Shelf life
12 months
Use immediately after reconstitution of the freeze-dried vaccine.
6.3
Special precautions for storage
Store and transport refrigerated (2°C - 8°C).
Protect from light.
Do not freeze.
6.4
Nature and composition of immediate packaging
1) Freeze-dried Fraction
Vial:
Closure:
Type I (Ph.Eur.) glass. 3 ml capacity
Type I (Ph.Eur.) bromobutyl rubber stoppers sealed with
aluminium crimp caps
2) Liquid Fraction
Vial:
Type I (Ph.Eur.) borosilicate glass. 2 ml capacity
Closure:
Type I (Ph.Eur.) bromobutyl rubber stoppers sealed with
aluminium crimp caps Pack Sizes
a) Pack Sizes
Packs with 10 or 25 x 1 ml doses.
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AN: 02047/2009
Each dose is a combination of one vial of freeze-dried vaccine (Katavac
CHP) and one vial of liquid vaccine (Fevaxyn FeLV).
6.5
Special precautions for the disposal of unused veterinary
medicinal product or waste materials derived from the use
of such products
Any unused vaccine or waste material should be disposed of in
accordance with local requirements.
7.
MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
8.
MARKETING AUTHORISATION NUMBERS
Vm 00057/4319
9.
DATE OF FIRST AUTHORISATION OF THE AUTHORISATION
June 1995
10.
DATE OF REVISION OF THE TEXT
April 2010