Leucofeligen FeLV/RCP
feline calicivirosis, feline viral rhinotrachieitis, feline infectious enteritis (feline panleucopenia) vaccine (live), feline leukaemia vaccine (inactivated)
Marketing authorisation holder and manufacturer responsible for the batch release:
VIRBAC
1ère avenue 2065 m LID 06516 Carros FRANCE
LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats
Per dose of 1 ml: Lyophilisate:
Live attenuated feline calicivirus (strain F9): 104.6–106.1 CCID50* Live attenuated feline viral rhinotracheitis virus (strain F2): 105.0–106.6 CCID50*
Live attenuated feline panleucopenia virus (strain LR 72): 103.7–104.5 CCID50*
* Cell culture infectious dose 50%.
Stabilizing buffer containing gelatin: to 1.3 ml before freeze-drying
Suspension:
Minimum quantity of purified p45 FeLV-envelope antigen: 102 µg
3% aluminium hydroxide gel expressed as mg Al3+: 1 mg
Purified extract of Quillaja saponaria: 10 µg
Buffered isotonic solution to 1 ml.
Lyophilisate: White pellet. Suspension: Opalescent liquid.
For active immunisation of cats from eight weeks of age against:
feline calicivirosis to reduce clinical signs,
feline viral rhinotracheitis to reduce clinical signs and viral excretion,
feline panleucopenia to prevent leucopenia and to reduce clinical signs,
feline leukaemia to prevent persistent viraemia and clinical signs of the related disease.
The onset of immunity has been demonstrated from:
3 weeks after the first injection of primary vaccination for the calicivirus component
3 weeks after the primary vaccination for the panleucopenia and leukaemia components
4 weeks after the primary vaccination for the rhinotracheitis virus components.
After the primary vaccination course, the duration of immunity lasts for one year for all components. Following a first booster vaccination one year after the primary vaccination course, a duration of
immunity of 3 years has been demonstrated for the leukaemia component.
None.
A moderate and transient local reaction (<2 cm) is commonly observed after the first injection. This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most. After the second injection, and subsequent administrations, this reaction is markedly reduced.
The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed,
Pain at palpation, sneezing or conjunctivitis may be noted in rare cases. This resolves without any
treatment.
Anaphylactic reactions have been reported in very rare cases. In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
Febrile limping syndrome reactions may occur very rarely in kittens, as reported in the literature after
the use of any vaccine containing a Feline Calicivirus component.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reactions)
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Cats
Subcutaneous use (under the skin).
Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Primary vaccination:
first injection in kittens from 8 weeks of age
second injection 3 or 4 weeks later.
Maternally derived antibodies, especially those against feline panleucopenia virus, can negatively influence the immune response to vaccination. In such cases where maternally derived antibodies are expected, a third injection may be appropriate from 15 weeks of age.
Re-vaccinations:
Following a first booster vaccination one year after the primary vaccination course, subsequent vaccinations can be performed at intervals of three years for the leukaemia component.
In this case, since annual revaccination is required for calicivirus, rhinotracheitis virus and panleucopenia virus components, a single dose of FELIGEN RCP can be used annually.
The vaccine can be used as a booster for kittens or cats previously vaccinated with FELIGEN RCP and LEUCOGEN separately.
Reconstitute one dose of lyophilisate with one dose (1ml) of suspension, shake gently and administer immediately.
Not applicable.
Keep out of the sight and reach of children. Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Shelf life after reconstitution according to directions: use immediately.
Special warnings for each target species: Vaccinate healthy animals only.
Maternally derived antibodies, especially those against feline panleucopenia virus, can negatively influence the immune response to vaccination.
Special precautions for use in animals:
De-worming at least 10 days prior to vaccination is recommended.
Only feline leukaemia virus (FeLV) negative cats should be vaccinated. Therefore, a test for presence of FeLV before vaccination is recommended.
The feline calicivirus and feline panleucopenia virus vaccine strains can spread. It has been
demonstrated that this spread did not cause adverse reactions on non-vaccinated cats.
Special precautions to be taken by 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.
Pregnancy and lactation:
Do not use in pregnant cats. The use is not recommended during lactation.
Interaction with other medicinal products and other forms of interaction:
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.
Overdose (symptoms, emergency procedures, antidotes):
No adverse reactions were observed after an overdose administration (10 doses of lyophilisate and 2 doses of suspension) of the veterinary medicinal product other than those mentioned in section 6
except local reactions that can last longer (from 5 to 6 weeks at the most).
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Detailed information on this product is available on the website of the European Medicines Agency ().
Lyophilisate:
Type I glass vial containing one dose of freeze-dried attenuated live viral components stopped with a butyl elastomer stopper.
Suspension:
Type I glass vial containing one dose (1 ml) of the adjuvanted liquid, with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
Plastic or cardboard box of 10 lyophilisate vials and 10 suspension vials. Plastic or cardboard box of 50 lyophilisate vials and 50 suspension vials. Not all pack sizes may be marketed
For the leukaemia component, protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
VIRBAC BELGIUM NV
Esperantolaan 4 BE-3001 Leuven
Tél/Tel : +32-(0)16 387 260
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Prancūzija
Tel: +33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Франция
Teл: +33-(0)4 92 08 73 00
VIRBAC BELGIUM NV
Esperantolaan 4 BE-3001 Leuven
Belgique / Belgien
Tél/Tel: +32-(0)16 387 260
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francie
Tel: +33-(0)4 92 08 73 00
VIRBAC HUNGARY KFT
Szent Istvàn krt.11.II/21. HU-1055 Budapest
Tel: +36703387177
VIRBAC Danmark A/S
Profilvej 1
DK-6000 Kolding Tlf: +45 75521244
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Franza
Tel: + 33-(0)4 92 08 73 00
VIRBAC Tierarzneimittel GmbH
Rögen 20
DE-23843 Bad Oldesloe Tel: +49-(4531) 805 111
VIRBAC Nederland BV
Hermesweg 15
NL-3771 ND-Barneveld Tel : +31-(0)342 427 127
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Prantsusmaa
Tel: +33-(0)4 92 08 73 00
VIRBAC Danmark A/S Profilvej 1
DK-6000 Kolding Danmark
Tel: + 45 75521244
VIRBAC HELLAS Α.Ε.
13o χλμ Ε.Ο. Αθηνών - Λαμίας
EL-14452, Μεταμόρφωση Τηλ: +30 2106219520
VIRBAC Österreich GmbH Hildebrandgasse 27
A-1180 Wien
Tel: +43-(0)1 21 834 260
VIRBAC ESPAÑA SA
Angel Guimerá 179-181
ES-08950 Esplugues de Llobregat (Barcelona) Tel. : + 34-(0)93 470 79 40
VIRBAC Sp. z o.o.
ul. Puławska 314
PL 02-819 Warszawa
Tel.: + 48 22 855 40 46
France VIRBAC France 13e rue LID
FR-06517 Carros
Tél : +33-(0)805 05 55 55
VIRBAC de Portugal Laboratórios LDA R.do Centro Empresarial
Ed13-Piso 1- Esc.3 Quinta da Beloura
PT-2710-693 Sintra Tel: + 351 219 245 020
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros Francuska
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros Franţa
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065m LID FR-06516 Carros
France
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francija
Tel : + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Frakkland
Sími: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francúzsko
Tel: + 33-(0)4 92 08 73 00
VIRBAC SRL
Via Ettore Bugatti, 15 IT-20142 Milano
Tel: + 39 02 40 92 47 1
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Puh/Tel : + 33-(0)4 92 08 73 00
VIRBAC HELLAS Α.Ε.
13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση Τηλ.: +30 2106219520
VIRBAC Danmark A/S Filial Sverige
c/o Incognito AB | |
Box 1027 | |
SE-171 21 Solna | |
Tel: +45 75521244
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francjia
Tel: +33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065m LID FR-06516 Carros
France
Tel: + 33-(0)4 92 08 73 00