Purevax RCP Lyophilisate and Solvent for Suspension for Injection

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Feline calicivirus, Feline panleukopenia virus, Feline viral rhinotracheitis virus

Διαθέσιμο από:

Boehringer Ingelheim Vetmedica Gmbh

Φαρμακολογική κατηγορία (ATC):

QI06AH09

INN (Διεθνής Όνομα):

Feline calicivirus, Feline panleukopenia virus, Feline viral rhinotracheitis virus

Φαρμακοτεχνική μορφή:

Powder and solvent for suspension for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Cats

Θεραπευτική περιοχή:

Live and Inactivated Viral Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2005-02-23

Αρχείο Π.Χ.Π.

Revised: March 2023
AN: 01446/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCP 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 feline panleucopenia virus (PLI IV)
....................................

10
3.5
CCID
50
1
EXCIPIENT:
Gentamicin, at most
...........................................................................................16.5
µg
Solvent:
Water for injections
............................................................................q.s.
1 ml or 0.5 ml
1
cell culture 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 feline panleucopenia to prevent mortality and clinical signs.
Onset of immunity: 1 week after primary vaccination course.
Duration of immunity: 1 year after the primary vaccination course and
3 years after
the last re-vaccination.
Revised: March 2023
AN: 01446/2022
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
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 la