Nobivac Tricat Trio Data Sheet

Qualitative and quantitative composition

For a full list of excipients, see section “Pharmaceutical particulars”.

Pharmaceutical form

Lyophilisate and solvent for suspension for injection. Off-white lyophilisate.

Clinical particulars

Target species
Cats

Indications for use
Active immunisation of cats:

• to reduce the clinical signs caused by infection with feline calicivirus (FCV) and feline herpes virus type 1
  (FHV),
• to prevent the clinical signs, leucopenia and virus excretion caused by infection with feline panleucopenia virus (FPLV). Onset of immunity: for FCV and FHV: 4 weeks; for FPLV: 3 weeks.
  
  Duration of immunity for FCV and FHV: 1 year, for FPLV: 3 years.

Contra-indications
See section “Use during pregnancy”.

Special warnings for each target species
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. In such cases where a relatively high
level of maternally derived antibodies is expected, the vaccination schedule should be planned accordingly.

Special precautions for use
Only healthy animals should be vaccinated.

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

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. In very rare cases, the
vaccine may cause hypersensitivity reactions (pruritus, dyspnoea, vomiting, diarrhoea and collapse).

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). Bring the vaccine to room temperature and
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 and feline herpesvirus type 1 must be given every year (with vaccines
containing the F9 and G2620 strains, where available). Revaccination against feline panleucopenia virus can
be given every three years (with strain MW-1 as in Nobivac Tricat Trio, 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

ATCvet-code: QI06AD04. Pharmacotherapeutic group: Live viral vaccine for cats.

Immunological properties
To stimulate active immunity against feline calicivirus, feline herpesvirus type 1 (feline rhinotracheitis virus)
and feline panleucopenia virus in cats.

Pharmaceutical particulars

Excipients
Lyophilisate: Disodium phosphate dehydrate, Hydrolised gelatine, Pancreatic digest of casein and Sorbitol.
Solvent: Disodium phosphate dehydrate, Potassium dihydrogen phosphate and Water for injection.

Major incompatibilities
Do not mix with any other veterinary medicinal product.

Shelf life
Shelf life of the veterinary medicinal product as packed for sale:
Lyophilisate: 33 months and Solvent: 5 years.

Shelf life after reconstitution according to directions: use within 30 minutes.

Special precautions for storage
Lyophilisate: Store in a refrigerator (2°C to 8°C). Protect from light.
Solvent: can be kept 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: Carton boxes with 5, 10, 25 or 50 doses of vaccine and 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 Holder (if different from distributor)

Marketing Authorisation number

Vm 01708/4533.

Date of the first authorisation or date of renewal

21 June 2011.

Date of revision of the text

12 October 2011.

Any other information

Nil

Legal category

POM-V