Clinical particulars
Target species
Cats.
Indications for use
Active immunisation of cats:
- to reduce the clinical signs caused by infection with feline calicivirus and feline herpes virus type 1,
- to reduce the severity of the clinical signs caused by infection with Chalamydophila felis,
- to prevent the clinical signs, leucopenia and virus excretion caused by infection with feline panleucopenia virus.
Onset of immunity: for FCV and FHV: 4 weeks; for FPLV and C. felis: 3 weeks.
Duration of immunity for FCV, FHV, C. felis: 1 year, for FPLV: 3 years.
Contra-indications
See section “Use during pregnancy and lactation”.
Special warnings for each target species
Because antimicrobials may inactivate the live C. felis vaccine strain, systemic antimicrobial therapy should be avoided during vaccination and for a two week period afterwards. Maternal antibodies, which may persist up to the age of 9-12 weeks, can have a negative influence on the efficacy of vaccination. In the presence of maternal antibodies, vaccination may not completely prevent the clinical signs, leucopenia and virus excretion following an FPLV infection, and may reduce the protection against a C. felis infection. In such cases where a high level of maternally derived antibodies is expected, the vaccination schedule should be planned accordingly.
Special precautions for use
Vaccinate only healthy animals. The C. felis vaccine strain may be excreted by vaccinated cats for more than 21 days and may be transmitted to non-vaccinated animals without inducing clinical signs.
User warnings: It is advised that immunodeficient persons or persons taking immunosuppressive drugs do not handle this vaccine. Owners should be made aware that some vaccinated cats may excrete C. felis. In case of accidental self injection, seek medical advice immediately and show the package leaflet or the label to the physician, referring to the live chlamydial component.
Adverse reactions
A slight painful swelling may be observed at the injection site for 1-2 days. A slight transient rise in body temperature (up to 40°C) may occur for 1-2 days. In some cases sneezing, coughing, nasal discharge, and a slight dullness or reduced appetite may be observed for up to 2 days post vaccination.
Use during pregnancy, lactation or lay
Do not use during pregnancy or lactation, as the product has not been tested in pregnant or lactating queens. Live FPL virus can cause reproductive problems in pregnant queens and birth defects in the progeny.
Interactions
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.
Amounts to be administered and administration route
Use 1 ml solvent to reconstitute the lyophilisate (= 1 single dose). Administer 1 ml of the vaccine per animal by subcutaneous injection. Use sterile injection equipment, free from traces of disinfectants.
Vaccination schedule:
Basic vaccination: Two single dose inoculations, 3-4 weeks apart. The first inoculation can be given from the age of 8-9 weeks and the second inoculation from the age of 12 weeks. (See also section “Special warnings”).
Revaccination: A single dose (1 ml) according to the following schedule:
Revaccination against feline calicivirus, feline herpesvirus type 1 and C. felis must be given every year (with Nobivac Forcat or other vaccines containing the F9, G2620 or Baker strains, where available). Revaccination against feline panleucopenia virus can be given every three years (with strain MW-1 as in Nobivac Forcat, where available).
Overdose
At ten-fold overdose, a slight painful swelling may be observed at the injection site for 4-10 days. A slight transient rise in temperature (up to 40.8°C) may occur for 1-2 days. In some cases general discomfort, coughing, sneezing, transient lethargy and reduced appetite may be observed for a few days post vaccination.
Withdrawal periods
Not applicable.
Pharmacological particulars
Immunological properties
Pharmacotherapeutic group: Live bacterial and viral vaccine for cats. ATCvet code: QI06AF01. To stimulate active immunity against feline calicivirus (FCV), feline herpesvirus type 1 (FHV, feline rhinotracheitis virus), feline panleucopenia virus (FPL) and C. felis (formerly called feline Chlamydia psittaci) in cats.
Pharmaceutical particulars
Excipients
Lyophilisate: Gelatin, Sucrose and Disodium phosphate dihydrate.
Solvent: Disodium phosphate dihydrate, Potassium dihydrogen phosphate and Water for injections.
Major incompatibilities
Do not mix with any other veterinary medicinal product, except diluent supplied for use with the product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
- Lyophilisate: 33 months.
- Solvent: 5 years.
Shelf life after reconstitution according to directions: 30 minutes.
Special precautions for storage
Lyophilisate: Store in a refrigerator (2°C - 8°C). Do not freeze. Protect from light.
Solvent: Store below 25°C if stored separately from the lyophilisate. Do not freeze.
Immediate packaging
Lyophilisate: 1 dose vial of glass type I (Ph.Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Solvent: 1 dose vial of glass type I (Ph.Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Pack sizes: Solvent may be packed together with the lyophilisate or separately:
Carton box with 5 doses of lyophilisate and solvent.
Carton box with 10 doses of lyophilisate and solvent.
Carton box with 25 doses of lyophilisate and solvent.
Carton box with 50 doses of lyophilisate and solvent.
Carton box with 5 doses of lyophilisate and carton box with 5 doses of solvent.
Carton box with 10 doses of lyophilisate and carton box with 10 doses of solvent.
Carton box with 25 doses of lyophilisate and carton box with 25 doses of solvent.
arton box with 50 doses of lyophilisate and carton box with 50 doses of solvent.
Not all pack sizes may be marketed.
Disposal
Dispose of waste material by boiling, incineration, or immersion in an appropriate disinfectant approved for use by the competent authorities.
Marketing authorisation number
Vm 06376/4050.
Date of the first authorisation or date of renewal
22 December 2010.
Date of revision of the text
March 2011.
