Innovax-ND-IBD
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
04-11-2021
Charakterystyka produktu
(SPC)
04-11-2021
Sprawozdanie z oceny publicznego
(PAR)
09-03-2021
Składnik aktywny:
Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus
Dostępny od:
Intervet International B.V.
Kod ATC:
QI01AD16
INN (International Nazwa):
Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)
Grupa terapeutyczna:
Chicken; Embryonated chicken eggs
Dziedzina terapeutyczna:
avian herpes virus (marek's disease) + avian infectious bursal disease virus (gumboro disease) + newcastle disease virus/paramyxovirus
Wskazania:
For active immunisation of one-day-old chicks or 18-19-day-old embryonated chicken eggs:to reduce mortality and clinical signs caused by Newcastle disease (ND) virus,to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (IBD) virus,to reduce mortality, clinical signs and lesions caused by Marek’s disease (MD) virus.
Podsumowanie produktu:
Revision: 5
Status autoryzacji:
Authorised
Data autoryzacji:
2017-08-22
Ulotka dla pacjenta
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
INNOVAX-ND-IBD CONCENTRATE AND SOLVENT FOR SUSPENSION FOR INJECTION
FOR CHICKENS
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:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
THE NETHERLANDS
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Innovax-ND-IBD concentrate and solvent for suspension for injection
for chickens
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of the reconstituted vaccine (0.2 ml for subcutaneous use or
0.05 ml for
_in ovo_
use)
contains:
Cell-associated live recombinant turkey herpesvirus (strain HVP360),
expressing the fusion protein of
Newcastle disease virus and the VP2 protein of infectious bursal
disease virus:
10
3.3
– 10
4.6
PFU
1
.
1
PFU – plaque forming units.
Concentrate and solvent for suspension for injection.
Cell concentrate: off-red to red cell concentrate.
Solvent: clear, red solution.
4.
INDICATION(S)
For active immunisation of one-day-old chicks or 18–19 day-old
embryonated chicken eggs:
-
to reduce mortality and clinical signs caused by Newcastle disease
(ND) virus,
-
to prevent mortality and to reduce clinical signs and lesions caused
by infectious bursal disease
(IBD) virus,
-
to reduce mortality, clinical signs and lesions caused by Marek’s
disease (MD) virus.
Onset of immunity:
ND: 4 weeks of age,
IBD: 3 weeks of age,
MD: 9 days.
Duration of immunity:
ND: 60 weeks,
IBD: 60 weeks,
MD: entire risk period.
5.
CONTRAINDICATIONS
None.
16
6.
ADVERSE REACTIONS
None known.
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 and embryonated chicken eggs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
After dilution, administer 1 dose of 0.2 ml va
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Innovax-ND-IBD concentrate and solvent for suspension for injection
for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of the reconstituted vaccine (0.2 ml for subcutaneous use or
0.05 ml for
_in ovo_
use)
contains:
ACTIVE SUBSTANCE:
Cell-associated live recombinant turkey herpesvirus (strain HVP360),
expressing the fusion protein of
Newcastle disease virus and the VP2 protein of infectious bursal
disease virus:
10
3.3
– 10
4.6
PFU
1
.
1
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.
Cell concentrate: off-red to red cell concentrate.
Solvent: clear, red solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens and embryonated chicken eggs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of one-day-old chicks or 18–19 day-old
embryonated chicken eggs:
-
to reduce mortality and clinical signs caused by Newcastle disease
(ND) virus,
-
to prevent mortality and to reduce clinical signs and lesions caused
by infectious bursal disease
(IBD) virus,
-
to reduce mortality, clinical signs and lesions caused by Marek’s
disease (MD) virus.
Onset of immunity:
ND: 4 weeks of age,
IBD: 3 weeks of age,
MD: 9 days.
Duration of immunity:
ND: 60 weeks,
IBD: 60 weeks,
MD: entire risk period.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
3
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
As this is a live vaccine, the vaccine strain is excreted from
vaccinated birds and may spread to
turkeys. Safety trials have shown that the strain is safe for turkeys.
However, 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 person administering the
veterinary medicinal product to
animals
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