Nobivac Ducat lyophilisate and solvent for suspension for injection, for cats

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Live feline calicivirus, strain F9; Live feline rhinotracheitis virus strain G2620A

Inapatikana kutoka:

Intervet Ireland Limited

ATC kanuni:

QI06AD03

INN (Jina la Kimataifa):

Live feline calicivirus, strain F9; Live feline rhinotracheitis virus strain G2620A

Kipimo:

.

Dawa fomu:

Lyophilisate and solvent for suspension for injection

Dawa ya aina:

POM: Prescription Only Medicine as defined in relevant national legislation

Kundi la matibabu:

Cats

Eneo la matibabu:

feline rhinotracheitis virus + feline calicivirus

Matibabu dalili:

Immunological - Live Vaccine

Idhini hali ya:

Authorised

Idhini ya tarehe:

2005-01-14

Tabia za bidhaa

_ _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
Registration file/ November 2022
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Ducat lyophilisate and solvent for suspension for injection,
for cats
Nobivac RC (DE)
Nobivac Ducat vet (SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1 ml) of reconstituted vaccine contains:
ACTIVE SUBSTANCES:
Live attenuated feline calicivirus, strain F9:

10
4.6
PFU
2
.
Live attenuated feline rhinotracheitis virus, strain G2620A:

10
4.8
TCID
50
1
;
1
TCID
50
:Tissue Culture Infectious Dose 50%
2
PFU: Plaque-Forming Units
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _
Lyophilisate:
_ _
Disodium phosphate dihydrate
Hydrolysed gelatin
Sucrose
Solvent:
_ _
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Lyophilisate: off-white pellet.
Solvent: clear colourless solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Active immunisation of cats to reduce the clinical signs caused by
infection with feline rhinotracheitis
virus (FVR) and feline calicivirus infections (FCV).
Onset of immunity: 4 weeks.
Duration of immunity: 1 year.
3.3
CONTRAINDICATIONS
See section 3.7.
3.4
SPECIAL WARNINGS
Registration file/ November 2022
Vaccination at six weeks of age has been proven to be safe.
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Care should be taken that aerosol is not formed when vaccinating the
cat as nasal or oral exposure
could result in clinical respiratory signs including lethargy and
malaise. For the same reason, the cat
should be prevented from licking the injection site.
Special precautions to be taken by 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.
Special precautions for the protection of the environment:
Not applicable.
3.6
ADVE