Feligen RCP

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 PARTICULARS4.1Target species
Cats.
4.2Indications for use, specifying the target species
The vaccine is intended for the active immunisation of healthy cats of minimum 9 weeks
of age against:
-
excretion;
-
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.
4.3Contraindications
None.
4.4Special warnings for each target species
High level of maternal antibodies can interfere with the response to vaccination.
Maternally derived antibodies, especially those against feline panleucopenia virus, can
negatively influence the immune response to vaccination.
4.5Special 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.4.6Adverse reactions (frequency and seriousness)
Some transient post-vaccinal digestive disturbances were very commonly
observed in safety studies. A slight and transient oedema which disappears
spontaneously within 2 days was commonly observed during the days following
vaccination in safety studies. Some transient and self-resolving post-vaccinal signs
such as a slight hyperthermia and lethargy were commonly observed in safety
studies.
Hypersensitivity reactions (e.g. emesis, diarrhoea, dyspnoea, allergic oedema)
have been reported in very rare cases from spontaneous reports.
In case of such an allergic or anaphylactic reaction, appropriate symptomatic
treatment should be administered.
As reported in the literature, after the use of any vaccine containing a Feline
Calicivirus component, febrile limping syndrome reactions may occur very rarely in
kittens.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- 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).
4.7Use during pregnancy, lactation or lay
Do not use during pregnancy and lactation.
4.8Interaction 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.
4.9Amounts 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.
-
-
-
-
response to vaccination.
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injection may be appropriate from 15 weeks of age.
-
4.10Overdose (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