Purevax FeLV
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-08-2020
Charakterystyka produktu
(SPC)
27-08-2020
Sprawozdanie z oceny publicznego
(PAR)
05-03-2021
Składnik aktywny:
feline leukaemia virus recombinant canarypox virus (vCP97)
Dostępny od:
Boehringer Ingelheim Vetmedica GmbH
Kod ATC:
QI06AD
INN (International Nazwa):
vaccine against feline leukaemia
Grupa terapeutyczna:
Cats
Dziedzina terapeutyczna:
Immunologicals for felidae,
Wskazania:
Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.Onset of immunity has been demonstrated 2 weeks after primary vaccination course.The duration of immunity is one year after the last vaccination.
Podsumowanie produktu:
Revision: 12
Status autoryzacji:
Authorised
Data autoryzacji:
2000-04-13
Ulotka dla pacjenta
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
PUREVAX FELV 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 FeLV suspension for injection
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml or 0.5ml contains:
ACTIVE SUBSTANCE:
FeLV recombinant Canarypox virus (vCP97)
................................................. ≥ 10
7.2
CCID50
1
1
cell culture infective dose 50%
Clear colourless liquid with presence of cell debris in suspension.
4.
INDICATION(S)
Active immunisation of cats of 8 weeks of age or older against feline
leukaemia for the prevention of
persistent viraemia and clinical signs of the related disease.
Onset of immunity: 2 weeks after primary vaccination course.
Duration of immunity: 1 year after the last vaccination.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
A temporary small (< 2 cm) nodule, which regresses within 1 to 4
weeks, was very commonly
observed at the site of injection during safety and field studies.
Transient lethargy and hyperthermia were very commonly observed during
safety and field studies
and lasted usually for 1 day, exceptionally for 2 days.
16
Anorexia and emesis have been reported very rarely based on post
marketing safety experience.
A hypersensitivity reaction may occur in very rare cases. Such
reactions may evolve to a more severe
condition (anaphylaxis). If such reactions occur, appropriate
treatment is recommended.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated
displaying adverse reaction(s))
- common (more than 1
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax FeLV suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml or 0.5 ml contains:
ACTIVE SUBSTANCE:
FeLV recombinant Canarypox virus (vCP97)
................................................. ≥ 10
7.2
CCID50
1
1
cell culture infective dose 50%
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear colourless liquid with presence of cell debris in suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cats of 8 weeks of age or older against feline
leukaemia for the prevention of
persistent viraemia and clinical signs of the related disease.
Onset of immunity: 2 weeks after primary vaccination course.
Duration of immunity: 1 year after the last vaccination.
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
It is recommended that a test for FeLV antigenaemia be carried out
prior to vaccination.
Vaccination of FeLV positive cats is of no benefit.
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.
3
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A temporary small (< 2 cm) nodule, which regresses within 1 to 4
weeks, was very commonly
observed at the site of injection during safety and field studies.
Transient lethargy and hyperthermia were very commonly observed during
safety and field studies
and lasted usually for 1 day, exceptionally for 2 days.
Anorexia and emesis have been reported very rarely based on post
marketing safety experience.
A hypersensitivity reaction may occur in very rare cases. Such
reactions may evolve to a more severe
c
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