AVINEW NEO EFFERVESCENT TABLET FOR CHICKENS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

LIVE NEWCASTLE DISEASE VIRUS (VG/GA) COMPONENT

Available from:

Merial Animal Health Limited

ATC code:

QI01AD06

INN (International Name):

LIVE NEWCASTLE DISEASE VIRUS (VG/GA) COMPONENT

Dosage:

Unknown

Pharmaceutical form:

Tablets Effervescent

Prescription type:

POM

Therapeutic group:

Fowl - Chicken

Therapeutic area:

Newcastle disease virus / paramyxovirus vaccine

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2015-11-13

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
AVINEW NEO effervescent tablet for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
ACTIVE SUBSTANCE:
Live Newcastle disease virus, VG/GA-AVINEW strain
5.5 log
10
EID
50
(*)
(*) EID50: Egg Infective Dose 50 per cent.
EXCIPIENTS:
Brilliant blue FCF (E 133)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet.
Blue mottled, round tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broiler, future layer and future breeder pullets).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In broiler chickens from the age of one day:
- Active immunisation against Newcastle disease to reduce mortality and clinical signs associated with the disease.
Onset of immunity: 14 days after primary vaccination.
Duration of immunity induced by the vaccination scheme described under section 4.9: protection until the age of 6
weeks.
In future layer and future breeder pullets from the age of 4 weeks:
- Priming for active immunisation against egg drop caused by Newcastle disease before vaccination with an inactivated
vaccine (strain Ulster 2C) prior to the beginning of lay.
For duration of immunity of full schedule, see the leaflet of the inactivated booster vaccine.
4.3 CONTRAINDICATIONS
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 06/10/2016_
_CRN 7024898_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccine virus can spread to unvaccinated birds. Infection of unvaccinated birds with the vaccine virus from vaccinated
birds does not induce any sign of disease. Moreover, a reversion to virulence trial carried out in the laboratory has
sh
                                
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