Nemovac

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Compra

Scheda tecnica Scheda tecnica (SPC)
10-11-2023

Principio attivo:

Avian pneumovirus

Commercializzato da:

Boehringer Ingelheim Animal Health UK Ltd

Codice ATC:

QI01AD01

INN (Nome Internazionale):

Avian pneumovirus

Forma farmaceutica:

Powder for oral solution

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Chickens

Area terapeutica:

Live Viral Vaccine

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

1999-04-16

Scheda tecnica

                                Revised November 2023
AN: 02466/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NEMOVAC lyophilisate for oculonasal suspension/use in drinking water
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Live avian pneumovirus, PL21 strain, at least 2.3 log
10
CCID
50
*
* CCID
50
= 50% cell culture infective dose.
QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
_Casein hydrolysate_
_Bovine albumin _
_Povidone_
_Sucrose_
_Mannitol_
_Monopotassium phosphate_
_Dipotassium phosphate_
_Potassium glutamate_
Pale Pellet
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For broiler chickens:
For active immunisation of chickens from 7 to 14 days of age to reduce
upper respiratory
signs associated with avian pneumovirus infection (Swollen Head
Syndrome).
Onset of immunity: 17 days after vaccination.
Duration of immunity: 5 weeks after vaccination.
For breeder and layer pullets:
Priming for active immunisation of pullets from 14 weeks of age before
booster vaccination
with an inactivated vaccine containing avian pneumovirus to reduce
respiratory signs
associated with avian pneumovirus infection.
For onset of immunity and duration of immunity of full schedule, see
SPC of the inactivated
Revised November 2023
AN: 02466/2022
Page 2 of 5
booster vaccine.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
The product is a live vaccine and is excreted from vaccinated birds
and so spreads to
unvaccinated chickens and turkeys. Reversion to virulence trials
carried out in the
laboratory have shown that the strain does not revert to virulence
neither in chickens nor in
turkeys. However, precautionary measures have to be followed in order
to diminish the
spread, see sections 3.9 and 5.5.
It is advised not to vaccinate in the presence of other sensitive
specie
                                
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