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

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

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Download Productkenmerken (SPC)
11-01-2023
Download DSU (DSU)
11-01-2023

Werkstoffen:

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

Beschikbaar vanaf:

Intervet Ireland Limited

ATC-code:

QI06AD03

INN (Algemene Internationale Benaming):

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

Dosering:

.

farmaceutische vorm:

Lyophilisate and solvent for suspension for injection

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutische categorie:

Cats

Therapeutisch gebied:

feline rhinotracheitis virus + feline calicivirus

therapeutische indicaties:

Immunological - Live Vaccine

Autorisatie-status:

Authorised

Autorisatie datum:

2005-01-14

Productkenmerken

                                _ _
_ _
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
                                
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