Versifel FeLV,suspension for injection for cats

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Inactivated feline leukaemia virus(FeLV) subtypes A, B and C

Dostupné z:

Zoetis Belgium S.A.

ATC kód:

QI06AA01

INN (Medzinárodný Name):

Inactivated feline leukaemia virus(FeLV) subtypes A, B and C

Dávkovanie:

.

Forma lieku:

Suspension for injection

Typ predpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Cats

Terapeutické oblasti:

feline leukaemia virus

Terapeutické indikácie:

Immunological - Inactivated Vaccine

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2013-08-29

Súhrn charakteristických

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Versifel FeLV suspension for injection for cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Inactivated feline leukaemia virus (FeLV) subtypes A, B and C
(Kawakami-Theilen strain) including
gp70 sub-unit antigen, inducing anti-gp70 antibodies
GMT ≥ 8.1 log
2
*
*
As determined by mouse potency test (anti-gp70 antibodies, GMT
denotes: geometric mean
titre).
ADJUVANTS:
Quil A
20

g.
Cholesterol
20

g.
DDA (Dimethyl-dioctadecyl ammonium bromide)
10

g.
Carbomer
0.5 mg.
EXCIPIENT:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Phosphate buffered saline
Slightly opaque suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For active immunisation of susceptible cats from 9 weeks of age to
reduce the number of cats infected
with FeLV and presenting clinical signs of the related disease.
No data are available in the studies to demonstrate protection against
related clinical disease but
prevention of infection is associated with protection against related
clinical disease.
Onset of immunity: four weeks after the completion of the primary
vaccination course.
Duration of immunity: one year after the primary course and three
years after the booster.
3.3
CONTRAINDICATIONS
None.
2
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
Do not vaccinate FeLV antigen positive cats.
Therefore a test for presence of FeLV before vaccination is
recommended.
No data are available for the efficacy of the product in presence of
maternal derived antibodies.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Not applicable.
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.
Special precautions for the protection of the environment:
Not applicable.
3.6
ADVER