Purevax RCP

Kraj: Unia Europejska

Język: angielski

Źródło: EMA (European Medicines Agency)

Składnik aktywny:

attenuated feline panleucopenia virus (PLI IV)

Dostępny od:

Boehringer Ingelheim Vetmedica GmbH

Kod ATC:

QI06AH09

INN (International Nazwa):

vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia

Grupa terapeutyczna:

Cats

Dziedzina terapeutyczna:

Immunologicals for felidae,

Wskazania:

Active immunisation of cats aged eight 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 is one week after primary vaccination course The duration of immunity is one year after the primary vaccination course and three years after the last re-vaccination.

Podsumowanie produktu:

Revision: 17

Status autoryzacji:

Authorised

Data autoryzacji:

2005-02-23

Ulotka dla pacjenta

14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET
PUREVAX RCP LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for the batch release:
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’aviation
69800 Saint-Priest
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RCP lyophilisate and solvent for suspension for injection.
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
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 FCV 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 injection q.s.
.............................................................................................
1 ml or 0.5 ml
1
cell culture infective dose 50%.
Lyophilisate: homogeneous beige pellet.
Solvent: clear colourless liquid.
4.
INDICATION(S)
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 primary vaccination course and 3
years after the last re-vaccination.
16
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Transient apathy and anorexia as we

Charakterystyka produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
3
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