Innovax-ND-ILT

Pajjiż: Unjoni Ewropea

Lingwa: Ingliż

Sors: EMA (European Medicines Agency)

Ingredjent attiv:

Cell-associated live recombinant turkey herpesvirus (strain HVT/NDV/ILT) expressing the fusion protein of newcastle disease virus and the glycoproteins gD and gI of infectious laryngotracheitis virus

Disponibbli minn:

Intervet International B.V.

Kodiċi ATC:

QI01AD

INN (Isem Internazzjonali):

Marek's disease vaccine, Newcastle disease vaccine & infectious laryngotracheitis vaccine (live recombinant)

Grupp terapewtiku:

Embryonated chicken eggs; Chicken

Żona terapewtika:

Immunologicals for aves

Indikazzjonijiet terapewtiċi:

For active immunisation of one-day-old chicks or embryonated chicken eggs:to reduce mortality and clinical signs caused by Newcastle disease (ND) virus,to reduce mortality, clinical signs and lesions caused by avian infectious laryngotracheitis (ILT) virus and Marek’s disease (MD) virus.

Sommarju tal-prodott:

Revision: 1

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2020-09-16

Fuljett ta 'informazzjoni

13
B.
PACKAGE LEAFLET
14
PACKAGE LEAFLET:
INNOVAX-ND-ILT 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-ILT concentrate and solvent for suspension for injection
for chickens
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of reconstituted vaccine (0.2 ml for subcutaneous use or
0.05 ml for
_in ovo_
use) contains:
Cell-associated live recombinant turkey herpesvirus (strain
HVT/NDV/ILT), expressing the fusion
protein of Newcastle disease virus and the glycoproteins gD and gI of
infectious laryngotracheitis
virus: 10
3.3
– 10
4.3
PFU
*
.
*
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 reduce mortality, clinical signs and lesions caused by avian
infectious laryngotracheitis (ILT)
virus and Marek’s disease (MD) virus.
Onset of immunity:
ND: 5 weeks of age,
ILT: 4 weeks of age
MD: 9 days.
Duration of immunity:
ND: 62 weeks,
ILT: 62 weeks,
MD: entire risk period.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
15
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 one dose of 0.2 ml vaccine per chicken by
subcutaneous injection in

Karatteristiċi tal-prodott

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Innovax-ND-ILT concentrate and solvent for suspension for injection
for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 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
HVT/NDV/ILT), expressing the fusion
protein of Newcastle disease virus and the glycoproteins gD and gI of
infectious laryngotracheitis
virus: 10
3.3
– 10
4.3
PFU
*
.
*
PFU – plaque forming units.
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 reduce mortality, clinical signs and lesions caused by avian
infectious laryngotracheitis (ILT)
virus and Marek’s disease (MD) virus.
Onset of immunity:
ND: 5 weeks of age,
ILT: 4 weeks of age
MD: 9 days.
Duration of immunity:
ND: 62 weeks,
ILT: 62 weeks,
MD: entire risk period.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
3
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
The handling of liquid nitrogen should take place in a well-