Suvaxyn CSF Marker
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
03-12-2021
Valmisteyhteenveto
(SPC)
03-12-2021
Julkisesta arviointikertomuksesta
(PAR)
03-12-2021
Aktiivinen ainesosa:
Live Recombinant E2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus E2 gene (CP7_E2alf)
Saatavilla:
Zoetis Belgium SA
ATC-koodi:
QI09AD04
INN (Kansainvälinen yleisnimi):
classical swine fever vaccine (live recombinant)
Terapeuttinen ryhmä:
Pigs
Terapeuttinen alue:
Live viral vaccines, Immunologicals for suidae
Käyttöaiheet:
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 after vaccinationDuration of immunity: at least 6 months after vaccinationFor active immunisation of breeding females to reduce transplacental infection caused by CSFV.Onset of immunity: 21 days after vaccinationDuration of immunity has not been demonstrated.
Tuoteyhteenveto:
Revision: 4
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2015-02-10
Pakkausseloste
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
SUVAXYN CSF MARKER LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR
INJECTION FOR PIGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn CSF Marker lyophilisate and solvent for suspension for
injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
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
** Tissue culture infectious dose
SOLVENT:
Sodium chloride 9 mg/ml
Water for injections q.s.p. 1 ml
Lyophilisate: Off-white pellet
Solvent: Clear colourless liquid
After reconstitution, the suspension should be slightly pink clear
liquid.
4.
INDICATION(S)
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.
Onset of immunity: 14 days after vaccination
Duration of immunity: at least 6 months after vaccination
For active immunisation of breeding females to reduce transplacental
infection caused by CSFV.
Onset of immunity: 21 days after vaccination
Duration of immunity has not been demonstrated.
17
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
In laboratory safety studies in pregnant animals, the following
adverse reactions were observed:
A local and transient tissue reaction in the form of swelling of up to
5 mm in diameter at the injection
site was very common and lasted for up to 1 day. A transient increase
in body temperature of 2.9 °C
was observed commonly 4 hours after vaccination. This resolved
spontaneously within 1 day after
vaccination.
The frequency of adverse reactions is defined using the following
convention:
-
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
**
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 and solvent for suspension for injection.
Lyophilisate: Off-white pellet
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 after vaccination
Duration of immunity: at least 6 months after vaccination
For active immunisation of breeding females to reduce transplacental
infection caused by CSFV.
Onset of immunity: 21 days after vaccination
Duration of immunity has not been demonstrated.
4.3
CONTRAINDICATIONS
None.
3
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 sh
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