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

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Classical Swine Fever E2 recombinant BVDV

Διαθέσιμο από:

Zoetis UK Limited

Φαρμακολογική κατηγορία (ATC):

QI09AD04

INN (Διεθνής Όνομα):

Classical Swine Fever E2 recombinant BVDV

Φαρμακοτεχνική μορφή:

Lyophilisate and solvent for solution for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Pigs

Θεραπευτική περιοχή:

Live Viral Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2015-02-10

Αρχείο Π.Χ.Π.

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