Nemovac

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Avian pneumovirus

Available from:

Boehringer Ingelheim Animal Health UK Ltd

ATC code:

QI01AD01

INN (International Name):

Avian pneumovirus

Pharmaceutical form:

Powder for oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

1999-04-16

Summary of Product characteristics

Revised: November 2018
AN: 01034/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NEMOVAC
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Live pneumovirus, PL21 strain, at least 2.3 log
10
CCID
50
CCID
50
= 50% cell culture infective dose.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Broiler chickens between 7 and 14 days.
Breeder and layer pullets from 14 weeks of age.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For broiler chickens:
For active immunisation of chickens to reduce upper respiratory signs
associated with
avian pneumovirus infection (Swollen Head Syndrome).
Immunity has been demonstrated 17 days after vaccination and has been
shown to persist
for a further three weeks.
For breeder and layer pullets:
Priming for active immunisation of pullets 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
Do not vaccinate unhealthy birds.
Do not use in chickens in lay.
4.4
SPECIAL WARNINGS FOR EACH 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
Revised: November 2018
AN: 01034/2018
Page 2 of 5
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 4.3, 4.5, 4.9, and 6.6.
The safety studies were carried out by oculo-nasal and oral
administration and no side
effects were observed.
It is advised not to vaccinate in the presence of other sensitive
species (guinea fowl,
pheasant), taking into account the s