Innovax-ILT

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus

Available from:

Intervet International B.V.

ATC code:

QI01AD03

INN (International Name):

avian infectious laryngotracheitis and Marek’s disease vaccine (live)

Therapeutic group:

Chicken

Therapeutic area:

Immunologicals for aves, Live viral vaccines

Therapeutic indications:

For active immunisation of one-day-old chicks to reduce mortality, clinical signs and lesions due to infection with avian infectious laryngotracheitis (ILT) virus and Marek’s disease (MD) virus.

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2015-07-03

Patient Information leaflet

13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET:
INNOVAX-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-ILT concentrate and solvent for suspension for injection for
chickens
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose (0.2 ml) of reconstituted vaccine contains:
Cell-associated live recombinant turkey herpesvirus (strain
HVT/ILT-138), expressing the glycoproteins
gD and gI of infectious laryngotracheitis virus:
10
3.1
– 10
4.1
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 immunization of one-day-old chicks to reduce mortality,
clinical signs and lesions due to
infection with avian infectious laryngotracheitis (ILT) virus and
Marek’s disease (MD) virus.
Onset of immunity:
ILT: 4 weeks,
MD: 9 days.
Duration of immunity:
ILT: 60 weeks,
MD: entire risk period.
5.
CONTRAINDICATIONS
None.
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.
15
7.
TARGET SPECIES
Chickens.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
After dilution, administer 1 dose of 0.2 ml of vaccine per chicken by
subcutaneous injection in the
neck.
9.
ADVICE ON CORRECT ADMINISTRATION
The bag of vaccine should be gently swirled frequently during
vaccination to guarantee that the
vaccine suspension remains homogenous and that the correct vaccine
virus titre is administered (e.g.
during long vaccination sessions).
Preparation

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Innovax-ILT concentrate and solvent for suspension for injection for
chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.2 ml) of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Cell-associated live recombinant turkey herpesvirus (strain
HVT/ILT-138), expressing the
glycoproteins gD and gI of infectious laryngotracheitis virus:
10
3.1
– 10
4.1
PFU
1
.
1
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.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of one-day-old chicks to reduce mortality,
clinical signs and lesions due to
infection with avian infectious laryngotracheitis (ILT) virus and
Marek’s disease (MD) virus.
Onset of immunity:
ILT: 4 weeks,
MD: 9 days.
Duration of immunity:
ILT: 60 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
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
3
have to be followed in order to avoid direct or indirect contact
between vaccinated chickens and
turkeys.
During subcutaneous vaccination, care should be taken to prevent
damage of the blood vessels in the
neck of the chickens.
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-ventilated
area.
Innovax-ILT is a virus suspension packed in glass ampoules and stored
in liquid nitrogen. Before
withdrawing ampoules from the liquid nitrogen ca