Vaxxitek HVT+IBD
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
07-01-2022
Summary of Product characteristics
(SPC)
07-01-2022
Public Assessment Report
(PAR)
17-02-2021
Active ingredient:
Recombinant turkey herpesvirus, strain vhvt013-69, live
Available from:
Boehringer Ingelheim Vetmedica GmbH
ATC code:
QI01AD15
INN (International Name):
Infectious bursal disease and Marek's disease vaccine (live recombinant)
Therapeutic group:
Embryonated eggs; Chicken
Therapeutic area:
Immunologicals for aves, Domestic fowl, Immunologicals
Therapeutic indications:
For active immunisation of chickens:To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.To reduce mortality, clinical signs and lesions of Marek's disease.
Product summary:
Revision: 17
Authorization status:
Authorised
Authorization date:
2002-08-09
Patient Information leaflet
13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET
VAXXITEK HVT+IBD SUSPENSION 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
Vaxxitek HVT+IBD Suspension and solvent for suspension for injection
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of vaccine contains:
Active ingredient:
Live vHVT013-69 recombinant virus, at least
....................................................... 3.6 to 4.4
log10 PFU*
Excipient
......................................................................................................................................
qs 1 dose
Diluent:
Diluent
.........................................................................................................................................
qs 1 dose
*Plaque forming unit
4.
INDICATION(S)
For active immunisation of chickens:
•
To prevent mortality and to reduce clinical signs and lesions of
Infectious Bursal disease.
The onset of protection is from 2 weeks and the protection extends to
9 weeks.
•
To reduce mortality, clinical signs and lesions of Marek’s disease.
The onset of protection is from 4 days. A single vaccination is
sufficient to provide protection
during the risk period.
5.
CONTRAINDICATIONS
Do not use in birds in lay and breeding birds.
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6.
ADVERSE REACTIONS
None known.
If you notice any serious effects or other effects not mentioned in
this package leaflet, please inform
your veterinary surgeon.
7.
TARGET SPECIES
Day-old chickens and 18 days embryonated eggs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous or
_in ovo _
route.
For
_in o
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vaxxitek HVT+IBD Suspension and solvent for suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of vaccine contains:
Active substance:
Live vHVT013-69 recombinant virus, at least
....................................................... 3.6 to 4.4
log10 PFU*
Excipient
......................................................................................................................................
qs 1 dose
Diluent:
Diluent
.........................................................................................................................................
qs 1 dose
*Plaque forming unit
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension and solvent for suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Day-old chickens and 18 days embryonated eggs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens:
•
To prevent mortality and to reduce clinical signs and lesions of
Infectious Bursal disease.
The onset of protection is from 2 weeks and the protection extends to
9 weeks.
•
To reduce mortality, clinical signs and lesions of Marek’s disease.
The onset of protection is from 4 days. A single vaccination is
sufficient to provide protection
during the risk period.
4.3
CONTRAINDICATIONS
Do not use in birds in lay and breeding birds.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate only healthy birds.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Apply the usual aseptic precautions to all administration procedures.
As a live vaccine, the vaccine strain is excreted from vaccinated
birds and may spread to turkeys.
Safety and reversion to virulence trials have shown that the strain is
safe for turkeys. However,
3
precautionary measures have to be followed in order to avoid direct or
indirect contact between
vaccinated chickens and turkeys.
Special precautions to be taken by the pe
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