Prevexxion RN+HVT+IBD
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
10-01-2022
Summary of Product characteristics
(SPC)
10-01-2022
Public Assessment Report
(PAR)
15-04-2021
Active ingredient:
Live recombinant Marek’s disease virus, serotype 1, strain RN1250; Live recombinant turkey herpesvirus, expressing the VP2 protein of infectious bursal disease virus, strain vHVT013-69
Available from:
Boehringer Ingelheim Vetmedica GmbH
ATC code:
QI01AD15
INN (International Name):
Infectious bursal disease and Marek's disease vaccine (live recombinant)
Therapeutic group:
Chicken
Therapeutic area:
Immunologicals for aves, Domestic fowl, avian herpes virus (marek's disease) + avian infectious bursal disease virus (gumboro disease) + newcastle disease virus/paramyxovirus
Therapeutic indications:
For active immunisation of one-day-old chicks to prevent mortality and clinical signs and reduce lesions caused by Marek’s disease (MD) virus (including very virulent MD virus), and to prevent mortality, clinical signs and lesions caused by infectious bursal disease (IBD) virus.
Product summary:
Revision: 2
Authorization status:
Authorised
Authorization date:
2020-07-20
Patient Information leaflet
13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET:
PREVEXXION RN+HVT+IBD CONCENTRATE AND SOLVENT FOR SUSPENSION FOR
INJECTION
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’Aviation
69800 Saint-Priest
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PREVEXXION RN+HVT+IBD concentrate and solvent for suspension for
injection
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each 0.2 ml dose of the vaccine suspension contains:
ACTIVE SUBSTANCES:
Cell-associated, live recombinant Marek’s disease (MD) virus,
serotype 1,
strain RN1250:
2.9 to 3.9 log
10
PFU*
Cell-associated, live recombinant turkey herpesvirus (HVT),
expressing the VP2 protein of infectious bursal disease (IBD) virus,
strain vHVT013-69:
3.6 to 4.4 log
10
PFU*
*PFU: plaque forming units
.
Concentrate and solvent for suspension for injection.
Concentrate: yellow to reddish pink opalescent homogeneous suspension
Solvent: red-orange limpid solution.
4.
INDICATION(S)
For active immunisation of one-day-old chicks:
-
to prevent mortality and clinical signs and reduce lesions caused by
MD virus (including very virulent
MD virus), and
- to prevent mortality and clinical signs and lesions caused by IBD
(also known as Gumboro disease)
virus.
Onset of immunity:
MD: 5 days after vaccination.
IBD: 14 days after vaccination.
1
1
1
1
15
Duration of immunity:
MD: A single vaccination is sufficient to provide protection for the
entire
risk period.
IBD: 10 weeks after vaccination.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
None.
If you notice any side effects, even those not already listed in this
package leaflet or you think that the
medicine has not worked, please inform your veterinary surgeon.
7.
TARGET SPECIES
Chickens.
8.
DOSAGE FO
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PREVEXXION RN+HVT+IBD concentrate and solvent for suspension for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.2 ml dose of the vaccine suspension contains:
ACTIVE SUBSTANCES:
Cell-associated, live recombinant Marek’s disease (MD) virus,
serotype 1,
strain RN1250:
2.9 to 3.9 log
10
PFU*
Cell-associated, live recombinant turkey herpesvirus (HVT),
expressing the VP2 protein of infectious bursal disease (IBD) virus,
strain vHVT013-69:
3.6 to 4.4 log
10
PFU*
*PFU: plaque forming units.
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate and solvent for suspension for injection.
Concentrate: yellow to reddish pink opalescent homogeneous suspension.
Solvent: red-orange limpid solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of one-day-old chicks:
- to prevent mortality and clinical signs and reduce lesions caused by
MD virus (including very
virulent MD virus), and
- to prevent mortality and clinical signs and lesions caused by IBD
(also known as Gumboro disease)
virus.
Onset of immunity:
MD: 5 days after vaccination.
IBD: 14 days after vaccination.
Duration of immunity:
MD: A single vaccination is sufficient to provide protection for the
entire
risk period.
IBD: 10 weeks after vaccination.
4.3
CONTRAINDICATIONS
None.
3
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Chickens with maternally derived antibodies against MD when vaccinated
with this veterinary
medicinal product, may have a delayed onset of immunity against IBD.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Apply the usual aseptic precautions to all administration procedures.
As this is a live vaccine, both vaccine strains may be excreted from
vaccinated birds. The RN1250
vaccine strain has not been shown to spread in experimental
conditions. The vHVT013-69 vacci
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