NOBIVAC TRICAT TRIO, LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION, FOR CATS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FELINE CALICIVRUS, STRAIN F9 LIVE ATTENUATED, FELINE HERPES VIRUS TYPE 1, STRAIN G2620A LIVE ATTENUATED, FELINE PANLEUCOPENIA VIRUS, STRAIN MW-1 LIVE ATTENUATED

Available from:

Intervet Ireland Limited

ATC code:

QI06AD04

INN (International Name):

FELINE CALICIVRUS, STRAIN F9 LIVE ATTENUATED, FELINE HERPES VIRUS TYPE 1, STRAIN G2620A LIVE ATTENUATED, FELINE PANLEUCOPENIA VI

Dosage:

Unknown

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM

Therapeutic group:

Feline

Therapeutic area:

Feline panleucopenia virus / parvovirus vaccine + Feline rhinotracheitis virus vaccine + Feline cal

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2007-02-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Tricat Trio, lyophilisate and solvent for suspension for injection, for cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml:
ACTIVE SUBSTANCES:
Lyophilisate
live attenuated feline calicivirus, strain F9: 4.6 log
10
PFU
1
;
live attenuated feline herpes virus type 1, strain G2620A: 5.2 log
10
PFU
1
;
live attenuated feline panleucopenia virus, strain MW-1: 4.3 log
10
CCID
50
2
1
PFU: Plaque-Forming Units
2
CCID
50:
Cell Culture Infective Dose 50%
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Off-white lyophilisate
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3 CONTRAINDICATIONS
See point 4.7
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/01/2014_
_CRN 7016594_
_page number: 1_
4.4 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 matern