Purevax RC

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains)

Saatavilla:

Boehringer Ingelheim Vetmedica GmbH

ATC-koodi:

QI06AH08

INN (Kansainvälinen yleisnimi):

vaccine against feline viral rhinotracheitis and feline calicivirosis

Terapeuttinen ryhmä:

Cats

Terapeuttinen alue:

Immunologicals for felidae,

Käyttöaiheet:

Active immunisation of cats aged eight weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs.Onsets of immunity isone week after primary vaccination course.The duration of immunity is one year after primary vaccination course and three years after the last re-vaccination.

Tuoteyhteenveto:

Revision: 16

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2005-02-23

Pakkausseloste

14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET
PUREVAX RC 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
Manufacturing authorisation holder responsible for 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 RC 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:
ACTIVE SUBSTANCES:
LYOPHILISATE:
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.
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.
Onsets 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 well as hyperthermia (lasting usually
for 1or 2 days) were commonly
observed during safety and field studies. A local reaction (slight
pain at palpation, itching or limited
oede

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RC 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.
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.
Onsets of immunity: 1week after primary vaccination course.
Duration of immunity: 1 year after 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 immediately
and show the package leaflet or
the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Transient apathy and anorexia as well as hyperthermia (lasting usually
for 1 or 2 days