Versifel FeLV Suspension for Injection for Cats

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Feline leukemia virus

Tersedia dari:

Zoetis UK Limited

Kode ATC:

QI06AA01

INN (Nama Internasional):

Feline leukemia virus

Bentuk farmasi:

Suspension for injection

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Cats

Area terapi:

Inactivated Viral Vaccine

Status otorisasi:

Authorized

Tanggal Otorisasi:

2012-12-20

Karakteristik produk

Revised: October 2019
AN: 01048/2019
Page 1 of 6
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:
Quil A
20

g
Cholesterol
20

g
DDA (Dimethyl-dioctadecyl ammonium bromide)
10

g
Carbomer
0.5 mg.
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.
Revised: October 2019
AN: 01048/2019
Page 2 of 6
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.
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 for the efficacy of the product in presence of
maternal derived
antibodies.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
In case of accidental self-injection