Purevax RC Lyophilisate and Solvent for Suspension for Injection

Country: United Kingdom

Bahasa: Inggeris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Feline calicivirus, Feline viral rhinotracheitis virus

Boleh didapati daripada:

Boehringer Ingelheim Vetmedica Gmbh

Kod ATC:

QI06AH08

INN (Nama Antarabangsa):

Feline calicivirus, Feline viral rhinotracheitis virus

Borang farmaseutikal:

Powder and solvent for suspension for injection

Jenis preskripsi:

POM-V - Prescription Only Medicine – Veterinarian

Kumpulan terapeutik:

Cats

Kawasan terapeutik:

Live and Inactivated Viral Vaccine

Status kebenaran:

Authorized

Tarikh kebenaran:

2005-02-23

Ciri produk

Revised: July 2023
AN: 02300/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Purevax RC lyophilisate and solvent for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 1 ml or 0.5 ml:
ACTIVE SUBSTANCES:
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)

10
4.9
CCID
50
1
Inactivated feline calicivirus (FCV 431 and G1 strains) antigens

2.0 ELISA U.
1
cell culture infective dose 50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: homogeneous beige pellet.
Solvent: clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cats aged 8 weeks and older:
-
against feline viral rhinotracheitis to reduce clinical signs,
-
against calicivirus infection to reduce clinical signs.
Onset of immunity: 1 week after primary vaccination course.
Duration of immunity: 1 year after primary vaccination course and 3
years after the
last re-vaccination.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Revised: July 2023
AN: 02300/2022
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
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.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Cats:
Common
(1 to 10 animals / 100 animals
treated):
Apathy, anorexia, and hyperthermia
1
Injection site reactions (pain, itching,
oedema)
2
.
Uncommon
(1 to 10 animals / 1,000 animals
treated):
Hypersensitivity reaction
3
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Emesis
4
1 lasting usually for 1 or 2 days.
2 slight pain at palpation, itching or limited oedema disappearing