Nemovac

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: VMD (Veterinary Medicines Directorate)

Aktif bileşen:

Avian pneumovirus

Mevcut itibaren:

Boehringer Ingelheim Animal Health UK Ltd

ATC kodu:

QI01AD01

INN (International Adı):

Avian pneumovirus

Farmasötik formu:

Powder for oral solution

Reçete türü:

POM-V - Prescription Only Medicine – Veterinarian

Terapötik grubu:

Chickens

Terapötik alanı:

Live Viral Vaccine

Yetkilendirme durumu:

Authorized

Yetkilendirme tarihi:

1999-04-16

Ürün özellikleri

Revised November 2023
AN: 02470/2022
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 log10 CCID50*
* CCID50 = 50% cell culture infective dose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension
Pale Pellet
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For broiler chickens:
For active immunisation of chickens between 7 and 14 days to reduce
upper
respiratory signs associated with avian pneumovirus infection (Swollen
Head
Syndrome).
Onset of immunity: 17 days
Duration of immunity: 3 weeks
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 booster vaccine.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Revised November 2023
AN: 02470/2022
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i). Special precautions for use in animals
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 4.5, 4.9, and 6.6.
It is advised not to vaccinate in the presence of other sensitive
species (guinea fowl,
pheasant), taking into account the spread of the vaccine strain and
the lack of safety
data for these species.
ii). Spec