Nobivac Ducat

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

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Lastnosti izdelka Lastnosti izdelka (SPC)
14-04-2020

Aktivna sestavina:

Feline calicivirus, Feline viral rhinotracheitis virus

Dostopno od:

Intervet International BV

Koda artikla:

QI06AD03

INN (mednarodno ime):

Feline calicivirus, Feline viral rhinotracheitis virus

Farmacevtska oblika:

Lyophilisate for suspension for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Cats

Terapevtsko območje:

Live Viral Vaccine

Status dovoljenje:

Authorized

Datum dovoljenje:

2004-10-18

Lastnosti izdelka

                                Revised: November 2014
Revised pages
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Ducat (DE: Nobivac RC, SE : Nobivac Ducat vet.)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Per dose of 1 ml reconstituted vaccine:
Live attenuated feline viral rhinotracheitis virus, strain G2620A at
least 4.8 log
10
TCID
50
*
,
Live attenuated feline calicivirus, strain F9 at least 4.6 log
10
PFU
**
.
* tissue culture infectious dose
** plaque forming units
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cats against feline viral rhinotracheitis
(feline herpes
virus type I) and feline calicivirus infections. Vaccination reduces
clinical signs
caused by these viral infections.
Onset of immunity: 4 weeks.
Duration of immunity: 1 year.
4.3
CONTRAINDICATIONS
See section 4.7.
4.4
SPECIAL WARNINGS
Vaccination at six weeks of age has been proven to be safe.
Page 1 of 4
Revised: November 2014
Revised pages
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
Vaccinate only healthy animals. 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.
ii.
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.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A slight transient, sometimes painful, swelling (

5mm) may be observed at the
site of injection for one day. A slight temporary rise in rectal
temperature may
occur, while occasionally transient lethargy may be observed 
                                
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