VERSIFEL FELV, SUSPENSION FOR INJECTION FOR CATS

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

INACTIVATED SUB-UNIT ANTIGEN (GP70) OF FELINE LEUKAEMIA VIRUS (FELV) SUBTYPES A,B&C (KAWAKAMI-THEILEN STRAIN), QUIL A, CHOLESTEROL, DDA (DIMETHYL-DIOCTADECYL AMMONIUM BROMIDE), CARBOPOL

Prieinama:

Zoetis Ireland Limited

ATC kodas:

QI06AA01

INN (Tarptautinis Pavadinimas):

INACTIVATED SUB-UNIT ANTIGEN (GP70) OF FELINE LEUKAEMIA VIRUS (FELV) SUBTYPES A,B&C (KAWAKAMI-THEILEN STRAIN), QUIL A, CHOLESTER

Vaisto forma:

Suspension for Injection

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Farmakoterapinė grupė:

Feline

Gydymo sritis:

feline leukaemia virus

Terapinės indikacijos:

Immunological - Inactivated vaccine

Autorizacija statusas:

Authorised

Leidimo data:

2013-08-29

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
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:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Slightly opaque suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunization 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 occurs within four weeks of the completion of the
primary vaccination course.
The duration of immunity is at least one year after the primary course
and three years after the booster.
4.3 CONTRAINDICATIONS
None.
Quil A
20 µg
Cholesterol
20 µg
DDA (Dimethyl-dioctadecyl ammonium bromide)
10 µg
Carbomer
0.5 mg
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