Target species
Cats.
Indications for use, specifying the target species
For active immunisation of susceptible cats from 9 weeks of age to reduce the number of cats infected with FeLV and presenting clinical signs of the related disease.
No data are available in the studies to demonstrate protection against related clinical disease but prevention of infection is associated with protection against related clinical disease.
Onset of immunity: four weeks after the completion of the primary vaccination course.
Duration of immunity: one year after the primary course and three years after the booster.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Do not vaccinate FeLV antigen positive cats.
Therefore a test for presence of FeLV before vaccination is recommended.
No data are available for the efficacy of the product in presence of maternal derived antibodies.
Special precautions for use
Special precautions for use in animals
Not applicable.
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.
Special precautions for the protection of the environment
Not applicable.
Other precautions
Not applicable.
Adverse reactions (frequency and seriousness)
Cats:
Common (1 to 10 animals / 100 animals treated): | Injection site swelling1 Elevated temperature2,3 |
Rare (1 to 10 animals / 10,000 animals treated): | Enlarged lymph node (localised)4 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site pain Diarrhoea, Vomiting Allergic reaction, Anaphylactic shock5 Anorexia, Depression, Malaise6 |
1Small (diameter usually smaller than 10 mm, maximal diameter 20 mm) very rarely associated with a brief period of discomfort and/or pain. The majority of these swellings resolve within a short period (2 weeks). A small proportion may remain detectable for 1 to 2 months however, by this time they are very small.
2Expected to be of short duration (resolving within 48 hours). Frequency and duration of any temperature rise is usually lower following subsequent administrations.
3When administered concurrently or simultaneously with Zoetis' Versifel CVR transient increases in temperature ( up to 40.5 °C) are frequently observed following first vaccination lasting up to 5 days.
4Transient enlargement of the pre-scapular lymph node following the second dose administration, such enlargements are small in size (0.5 cm diameter) and only detected upon palpation of the area following injection.
5If such a reaction occurs appropriate treatment should be administered.
6Normally resolves within 24 hours.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The use is not recommended during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be either mixed with Zoetis’ Versifel CVR and administered at a single site or administered on the same day as Zoetis’ Versifel CVR but at different sites.
No data are available on the duration of immunity of Versifel FeLV when administered together with Versifel CVR, this should be taken into account when considering re-vaccination intervals.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product 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.
Amount(s) to be administered and administration route
Subcutaneous use.
Shake the vial well immediately before use.
Primary vaccination:
Two doses of 1 ml should be administered subcutaneously to cats from nine weeks of age, with an interval of 3-4 weeks between doses.
Re-vaccination:
A single booster dose should be administered 1 year after the completion of the primary vaccination course. Thereafter a single booster dose should be administered to cats once every 3 years.
For concurrent vaccination with Zoetis' Versifel CVR, a single dose of Versifel FeLV should be administered as described above. A single dose of Zoetis' Versifel CVR should then be administered at a separate site via the subcutaneous route.
For simultaneous vaccination with Zoetis’ Versifel CVR, the contents of a single vial of Zoetis’Versifel CVR should be reconstituted with the contents of a single vial of Versifel FeLV in place of the diluent. Once mixed, the contents of the vial should appear as a slightly coloured (pink/orange) opaque suspension; the mixed vaccines should be injected immediately via the subcutaneous route.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of an overdose a larger proportion of animals might be expected to show a transient rise in rectal temperature (up to 40.5°C). Such transient rises are however expected to be of short duration (resolving within 48 hours). Frequency and duration of any temperature rise is usually lower following subsequent single dose administrations.
In the laboratory overdose study in which twice the recommended dose (2 ml) was administered, a larger proportion of animals developed a swelling at the injection site, (max. diameter up to 21 mm). The majority of these swellings resolved within a short period (within 2 weeks). A slightly larger proportion had swellings which remained detectable for 1 or 2 months however, by this time they were very small.
Withdrawal period(s)
Not applicable.