Suvaxyn CSF Marker Lyophilisate and Solvent for Suspension for Injection for Pigs

Ország: Egyesült Királyság

Nyelv: angol

Forrás: VMD (Veterinary Medicines Directorate)

Aktív összetevők:

Classical Swine Fever E2 recombinant BVDV

Beszerezhető a:

Zoetis UK Limited

ATC-kód:

QI09AD04

INN (nemzetközi neve):

Classical Swine Fever E2 recombinant BVDV

Gyógyszerészeti forma:

Lyophilisate and solvent for solution for injection

Recept típusa:

POM-V - Prescription Only Medicine – Veterinarian

Terápiás csoport:

Pigs

Terápiás terület:

Live Viral Vaccine

Engedélyezési státusz:

Authorized

Engedély dátuma:

2015-02-10

Termékjellemzők

Revised: March 2024
AN: 00274/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn CSF Marker lyophilisate and solvent for suspension for
injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
LYOPHILISATE:
Live recombinant E2 gene-deleted bovine viral diarrhoea virus
containing classical swine fever virus E2 gene (CP7_E2alf) 10
4.8
*
to 10
6.5
TCID**
50
*
min 100 PD
50
(protective dose 50%)
**
Tissue culture infectious dose
SOLVENT:
Sodium chloride 9 mg/ml
Water for injections q.s.p. 1 ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate: Off-white.
Solvent: Clear colourless liquid.
After reconstitution, the suspension should be slightly pink clear
liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs from 7 weeks of age onwards to prevent
mortality
and reduce infection and disease caused by classical swine fever virus
(CSFV).
Onset of immunity: 14 days
Duration of immunity: 6 months
Revised: March 2024
AN: 00274/2023
Page 2 of 6
For active immunisation of breeding females to reduce transplacental
infection
caused by CSFV.
Onset of immunity: 21days
Duration of immunity has not been established.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Documentation provided for this vaccine supports that it is only to be
used in an
outbreak situation in herds within restricted control zones.
Protection against transplacental transmission of CSFV was shown 21
days after
vaccination when challenge was applied in 6 pregnant sows with a
moderately
virulent CSFV strain. Partial protection against transplacental
transmission of CSFV
was observed when challenge was applied in 6 pregnant sows with a
highly virulent
CSFV strain.
Birth of persistently infected immunotolerant piglets represent a very
high risk since
they are shedding field virus and