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Date: Monday, May 20, 2024 5:15

Release 2.40
Nobivac® Tricat Trio, lyophilisate and solvent for suspension for injection for cats
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Nobivac® Tricat Trio, lyophilisate and solvent for suspension for injection for cats
Product index: Nobivac® Tricat Trio
Incorporating:
Qualitative and quantitative composition
Each dose (1 ml) of reconstituted vaccine contains:
Active substances:
Live attenuated feline calicivirus, strain F9
≥ 104.6 PFU1
Live attenuated feline rhinotracheitis virus, strain G2620A
≥ 105.2 PFU1
Live attenuated feline panleucopenia virus, strain MW-1
≥ 104.3 CCID502
1PFU: Plaque-Forming Units
2CCID50: Cell Culture Infective Dose 50%
For a full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white pellet.
Solvent: clear colourless solution.
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 rhinotracheitis virus (FVR),
- to prevent the clinical signs, leucopenia and virus excretion caused by infection with feline panleucopenia virus (FPLV).
Onset of immunity:
for FCV and FVR: 4 weeks; for FPLV: 3 weeks.
Duration of immunity:
1 year, for FPLV: 3 years.
Contraindications
See section “Use during pregnancy or lactation"
Special warnings for each target species
Vaccinate healthy animals only.
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.
Operator warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Cats:
Very Common
(> 1 animal / 10 animals treated):
Injection site swelling.1
Sneezing, cough, nasal discharge, dullness, decreased appetite.2
Common
(1 to 10 animals / 100 animals treated):
Elevated temperature.3
Very rare
(< 1 animal / 10,000 animals treated, including isolated reports):
Injection site pain, injection site hair loss, injection site pruritus.
Hypersensitivity reactions (e.g. pruritus, dyspnoea, vomiting, diarrhoea and collapse including anaphylaxis).4
Febrile limping syndrome reactions in kittens.5
1 Local swelling (≤ 5 mm), sometimes painful, may occur at the injection site 1 – 2 days post-vaccination.
2 May be observed for up to 2 days post-vaccination.
3 Elevated body temperature (up to 40 °C) may occur for 1 – 2 days post-vaccination.
4 Sometimes fatal. If such a reaction occurs, appropriate treatment should be administered without delay.
5 As reported in the literature, febrile limping syndrome reactions in kittens may occur after the use of any vaccine containing a feline calicivirus component.
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 its local representative or the national competent authority via the national reporting system. See section “Contact details” of the package leaflet.
Use during pregnancy or lactation
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).
Visual appearance of the reconstituted product: off-pink or pink coloured suspension.
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:
Primary 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 4.4)
Revaccination:
A single dose (1 ml) according to the following schedule:
Revaccination against feline calicivirus and feline rhinotracheitis virus 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 period
Not applicable.
Pharmacological particulars
ATCvet-code: QI06AD04.
Immunological particulars
Live viral vaccine for cats.
To stimulate active immunity against feline calicivirus, feline rhinotracheitis virus and feline panleucopenia virus in cats.
Pharmaceutical particulars
Excipients
Lyophilisate
Disodium phosphate dihydrate
Hydrolysed gelatin
Pancreatic digest of casein
Sorbitol
Solvent:
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injection
Major incompatibilities
Do not mix with any other veterinary medicinal 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: use within: 30 minutes.
Special precautions for storage
Lyophilisate: Store in a refrigerator (2 °C – 8 °C). Protect from light.
Solvent: can be stored 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:
Cardboard or plastic boxes with 5 x 1 dose, 10 x 1 dose, 25 x 1 dose or 50 x 1 dose of lyophilisate and solvent.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
UK(GB): Vm 01708/5070
UK(NI): Vm 01708/3004
Significant changes
Date of the first authorisation or date of renewal
21 June 2011.
Date of revision of the text
February 2023.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Nobivac Tricat Trio 10x1ds:
GTIN:08713184067395
GTIN description:Nobivac Tricat Trio 50x1ds:
GTIN:08713184067401