AVINEW NEO effervescent tablet for chickens and turkeys

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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DSU DSU (DSU)
17-02-2023

Active ingredient:

Live newcastle disease virus (VG/GA) component

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI01AD06

INN (International Name):

Live newcastle disease virus (VG/GA) component

Dosage:

.

Pharmaceutical form:

Effervescent tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

newcastle disease virus / paramyxovirus

Authorization status:

Authorised

Authorization date:

2015-11-13

Summary of Product characteristics

                                Health Products Regulatory Authority
09 February 2022
CRN00CHGZ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
AVINEW NEO effervescent tablet for chickens and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
ACTIVE SUBSTANCE:
Live Newcastle disease virus, VG/GA-AVINEW strain 5.5 – 7.0 log
10
EID
50
(*)
(*) EID
50
: 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).
Turkeys
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.
In turkeys from the age of one day:
- Active immunisation against Newcastle disease to reduce mortality
and clinical signs associated with the disease.
Onset of immunity: 21 days after primary vaccination.
Duration of immunity: 7 weeks after a single administration.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy birds only.
Health Products Regulatory Authority
09 February 2022
CRN00CHGZ
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccine virus can spread to unvaccinated birds. In turkeys, this
spread has been shown to be less than 21 days aft
                                
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