SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Feligen^® RCP

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

2.1

2.2

Freeze-Dried component

- Live feline calicivirosis (strain F9) ……………………..

- Live feline viral-rhinotracheitis virus (strain F2) ……...

- Live feline viral-panleucopenia virus (strain LR 72) …

Diluent

Water for injection …………………………………...

formula and titre per dose

10^4.6 - 10^6.1 TCID₅₀

10^5.0 - 10^6.6 TCID₅₀

10^3.7 - 10^4.5 TCID₅₀

1 ml

For a full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Solution for injection after reconstitution of the freeze-dried component in the diluent.

4.

CLINICAL PARTICULARS

4.1

Target species

Cats.

4.2

Indications for use, specifying the target species

The vaccine is intended for the active immunisation of healthy cats of minimum 9 weeks of age against:

• feline calicivirosis and feline viral rhinotracheitis to reduce clinical signs and viral excretion;

• feline panleucopenia to prevent leucopenia and to reduce clinical signs.

Onset of immunity is established four weeks after vaccination for calici virus and rhinotracheitis and three weeks for panleucopenia virus. This immunity lasts for 12 months.

4.3

Contraindications

None.

4.4

Special warnings for each target species

High level of maternal antibodies can interfere with the response to vaccination.

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

Vaccinate only healthy animals.

ii.

Special precautions for the person administering the veterinary medicinal product to animals

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

4.6

Adverse reactions (frequency and seriousness)

In a small proportion of animals, transient pain and pruritus are noted at the time of vaccination. Transient hyperthermia and apathy may be observed within 24 hours. A limited and transient skin thickening may occur between days 6 and 9 post vaccination at the injection point.

When the vaccine is administered with Leucogen®, the reactions which can be expected are those observed after vaccination with Leucogen®.

In a small proportion of animals, a slight eye watering is sometimes noted during the days following vaccination that decreases spontaneously within a few days without any treatment.

4.7

Use during pregnancy, lactation or lay

Do not use during pregnancy and lactation.

4.8

Interaction with other medicinal products and other forms of interaction

Safety and/or efficacy data are available which demonstrate that this vaccine can be mixed with Leucogen. 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 decided on a case by case basis.

4.9

Amounts to be administered and administration route

Shake gently the vial after reconstitution of the freeze-dried component in the diluent. Administer immediately via the subcutaneous route 1 dose of Feligen® RCP according to the following regimen of vaccination.

• Basic vaccination scheme:

• a first injection into cats from minimum 9 weeks of age;

• a second injection 3 to 4 weeks later.

• Re-vaccination scheme: annual re-vaccination of cats.

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary

No undesirable effects have been seen after the administration of an overdose of Feligen® RCP except those indicated in section 4.6 Adverse reactions

4.11

Withdrawal period

Not applicable

5.

IMMUNOLOGICAL PROPERTIES

ATC Vet Code: QI06AD04

Stimulation of the active immunity against feline calicivirus, feline rhinotracheitis virus and feline panleucopenia virus.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Potassium hydroxide

Lactose monohydrate

L-glumatic acid

Potassium dihydrogen phosphate

Dipotassium phosphate

Gelatin

Water for injections

Sterile diluent

6.2

Incompatibilities

Safety and/or efficacy data are available which demonstrate that this vaccine can be mixed and administered with Leucogen. Do not mix with any other veterinary medicinal product, except the diluent supplied for use with the product or Leucogen.

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

The product should be used immediately after reconstitution

6.4

Special precautions for storage

Store and transport at 2°C-8°C. Protect from light. Do not freeze.

Use immediately after reconstitution.

6.5

Nature and composition of immediate packaging

Feligen® RCP – 3 ml glass type-1 vial containing freeze-dried attenuated live viral components stopped with an elastomer stopper.

Diluent – 3 ml glass type-1 vial containing 1 ml of water for injection stopped with an elastomer stopper.

Pack sizes : 10 x 1 and 50 x 1 dose

6.6

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Any unused product or waste material should be disposed of in accordance with national requirements.

7.

MARKETING AUTHORISATION HOLDER

Virbac S.A.

1ère avenue - 2065 m – L.I.D.

06516 Carros Cedex

France

8.

MARKETING AUTHORISATION NUMBER

Vm 05653/4048

9.

DATE OF RENEWAL OF AUTHORISATION

28 October 2010

10.

DATE OF REVISION OF THE TEXT

December 2010