NEMOVAC

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Live pneumovirus, PL21 strain

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI01AD01

INN (International Name):

Live pneumovirus, PL21 strain

Dosage:

.

Pharmaceutical form:

Lyophilisate for oculonasal suspension/use in drinking water

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

avian rhinotracheitis virus

Authorization status:

Authorised

Authorization date:

2000-06-08

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NEMOVAC lyophilisate for oculonasal suspension/use in drinking water
(FR, AT, DE, EL, IE, NL, ES, PT, UK (NI))
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 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
species (guinea fowl, pheasant), taking
into account th