VERSIFEL FELV, SUSPENSION FOR INJECTION FOR CATS

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

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

MAH:

Zoetis Ireland Limited

ATC_code:

QI06AA01

INN:

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

pharmaceutical_form:

Suspension for Injection

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Feline

therapeutic_area:

feline leukaemia virus

therapeutic_indication:

Immunological - Inactivated vaccine

authorization_status:

Authorised

authorization_date:

2013-08-29

SPC

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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