Purevax RCPCh Lyophilisate and Solvent for Suspension for Injection

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

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Fachinformation Fachinformation (SPC)
31-10-2023

Wirkstoff:

Chlamydophila felis, Feline calicivirus, Feline panleukopenia virus, Feline viral rhinotracheitis virus

Verfügbar ab:

Boehringer Ingelheim Vetmedica Gmbh

ATC-Code:

QI06AJ03

INN (Internationale Bezeichnung):

Chlamydophila felis, Feline calicivirus, Feline panleukopenia virus, Feline viral rhinotracheitis virus

Darreichungsform:

Powder and solvent for suspension for injection

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Cats

Therapiebereich:

Live Bacterial and Viral Vaccine

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2005-02-22

Fachinformation

                                Revised: March 2023
AN: 00563/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCPCh lyophilisate and solvent for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml or 0.5 ml:
Lyophilisate:
ACTIVE SUBSTANCES:
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) .....

10
4.9
CCID
50
1
Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ..

2.0 ELISA U.
Attenuated _Chlamydophila felis_ (905 strain)
...................................

10
3.0
EID
50
2
Attenuated feline panleucopenia virus (PLI IV)
............................

10
3.5
CCID
50
1
Solvent:
Water for
injections...................................................................q.s.
1 ml or 0.5 ml.
1
cell culture infective dose 50%
2
egg infective dose 50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: homogeneous beige pellet.
Solvent: clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cats aged 8 weeks and older:
- against feline viral rhinotracheitis to reduce clinical signs,
- against calicivirus infection to reduce clinical signs,
- against _Chlamydophila felis_ infection to reduce clinical signs,
- against feline panleucopenia to prevent mortality and clinical
signs.
Onsets of immunity have been demonstrated 1 week after primary
vaccination
course for rhinotracheitis, calicivirus, _Chlamydophila felis_ and
panleucopenia
components.
Revised: March 2023
AN: 00563/2022
Page 2 of 6
Duration of immunity:
- Rhinotracheitis, calicivirosis and panleucopenia components: 1 year
after
primary vaccination course and 3 years after the last re-vaccination
- Chlamydophila felis component: 1 year after the last re-vaccination.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIO
                                
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