Suvaxyn PRRS MLV
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
09-09-2020
Fachinformation
(SPC)
09-09-2020
Öffentlichen Beurteilungsberichts
(PAR)
30-07-2019
Wirkstoff:
Modified live porcine respiratory and reproductive syndrome virus
Verfügbar ab:
Zoetis Belgium SA
ATC-Code:
QI09AD03
INN (Internationale Bezeichnung):
porcine respiratory and reproductive syndrome virus, live
Therapiegruppe:
Pigs
Therapiebereich:
Immunologicals for suidae, Live viral vaccines
Anwendungsgebiete:
For active immunisation of clinically healthy pigs from 1 day of age in a porcine respiratory and reproductive syndrome (PRRS) virus contaminated environment, to reduce viraemia and nasal shedding caused by infection with European strains of PRRS virus (genotype 1).Fattening pigs: In addition, vaccination of seronegative 1-day-old piglets was demonstrated to significantly reduce lung lesions against challenge administered at 26 weeks post vaccination. Vaccination of seronegative 2-week-old piglets was demonstrated to significantly reduce lung lesions and oral shedding against challenge administered at 28 days and at 16 weeks post-vaccination.Gilts and sows: In addition, pre-pregnancy vaccination of clinically healthy gilts and sows, either seropositive or seronegative, was demonstrated to reduce the transplacental infection caused by PRRS virus during the third trimester of pregnancy, and to reduce the associated negative impact on reproductive performance (reduction of the occurrence of stillbirths, of piglet viraemia at birth and at weaning, of lung lesions and of viral load in lungs in piglets at weaning).
Produktbesonderheiten:
Revision: 4
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-08-24
Gebrauchsinformation
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET:
SUVAXYN PRRS MLV 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 authorization 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 PRRS MLV lyophilisate and solvent for suspension for injection
for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose (2 ml) contains:
Lyophilisate:
ACTIVE SUBSTANCE:
Modified live PRRSV*, strain 96V198: 10
2.2
– 10
5.2
CCID
50
**
* Porcine respiratory and reproductive syndrome virus
** Cell culture infectious dose 50%
Solvent:
Sodium chloride 0.9% solution: qs 1 dose.
Lyophilisate: off-white freeze-dried pellet.
Solvent: clear, colourless solution.
4.
INDICATION(S)
For active immunisation of clinically healthy pigs from 1 day of age
in a porcine respiratory and
reproductive syndrome (PRRS) virus contaminated environment, to reduce
viraemia and nasal
shedding caused by infection with European strains of PRRS virus
(genotype 1).
Onset of immunity: 21 days after vaccination.
Duration of immunity: 26 weeks after vaccination.
Fattening pigs:
In addition, vaccination of seronegative 1 day-old piglets was
demonstrated to significantly reduce
lung lesions against challenge administered at 26 weeks post
vaccination. Vaccination of seronegative
2 weeks-old piglets was demonstrated to significantly reduce lung
lesions and oral shedding against
challenge administered at 28 days and at 16 weeks post vaccination.
20
Gilts and sows:
In addition, pre-pregnancy vaccination of clinically healthy gilts and
sows, non-PRRS virus-naïve (i.e.
either previously immunised against PRRS virus via vaccination or
exposed to PRRS virus via field
infection) or PRRS virus-naïve, was demonstrated to reduce the
transplacental infection caused by
PRRS viru
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn PRRS MLV lyophilisate and solvent for suspension for injection
for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
Lyophilisate:
ACTIVE SUBSTANCE:
Modified live PRRSV*, strain 96V198: 10
2.2
– 10
5.2
CCID
50
**
* Porcine respiratory and reproductive syndrome virus
** Cell culture infectious dose 50%
Solvent:
Sodium chloride 0.9% solution: qs 1 dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white freeze-dried pellet.
Solvent: clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (pigs for fattening, gilts and sows)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of clinically healthy pigs from 1 day of age
in a porcine respiratory and
reproductive syndrome (PRRS) virus contaminated environment, to reduce
viraemia and nasal
shedding caused by infection with European strains of PRRS virus
(genotype 1).
Onset of immunity: 21 days after vaccination.
Duration of immunity: 26 weeks after vaccination.
Fattening pigs:
In addition, vaccination of seronegative 1-day-old piglets was
demonstrated to significantly reduce
lung lesions against challenge administered at 26 weeks post
vaccination. Vaccination of seronegative
2-week-old piglets was demonstrated to significantly reduce lung
lesions and oral shedding against
challenge administered at 28 days and at 16 weeks post-vaccination.
Gilts and sows:
In addition, pre-pregnancy vaccination of clinically healthy gilts and
sows, non-PRRS virus-naïve (i.e.
either previously immunised against PRRS virus via vaccination or
exposed to PRRS virus via field
3
infection) or PRRS virus-naïve, was demonstrated to reduce the
transplacental infection caused by
PRRS virus during the last third of pregnancy, and to reduce the
associated negative impact on
reproductive performance (reduction of the occurrence
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