VERSIFEL FELV, SUSPENSION FOR INJECTION FOR CATS

Country: Ireland

Language: English

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

Available from:

Zoetis Ireland Limited

ATC code:

QI06AA01

INN (International Name):

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

Dosage:

Unknown

Pharmaceutical form:

Suspension for Injection

Prescription type:

POM

Therapeutic group:

Feline

Therapeutic area:

Feline leukaemia virus vaccine

Therapeutic indications:

Immunological - Inactivated vaccine

Authorization status:

Authorised

Authorization date:

2013-08-29

Summary of Product characteristics

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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 29/01/2016_
_CRN 7020795_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Only healthy animals should be vaccinated.
Do not vaccinate FeLV antigen positive cats.
Therefore a test for presence of FeLV before vaccination is recommended.
No data are available