Nobilis MS Live, lyophilisate for oculonasal suspension for chickens

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Live attenuated mycoplasma synoviae strain ms1

Inapatikana kutoka:

Intervet Ireland Limited

ATC kanuni:

QI01AE03

INN (Jina la Kimataifa):

Live attenuated mycoplasma synoviae strain ms1

Kipimo:

.

Dawa fomu:

Lyophilisate for oculonasal suspension/use in drinking water

Dawa ya aina:

POM: Prescription Only Medicine as defined in relevant national legislation

Kundi la matibabu:

Chickens

Eneo la matibabu:

mycoplasma

Matibabu dalili:

Immunological - Live Vaccine

Idhini hali ya:

Authorised

Idhini ya tarehe:

2014-04-04

Tabia za bidhaa

Health Products Regulatory Authority
21 March 2019
CRN000Z30
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis MS Live, lyophilisate for oculonasal suspension for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of reconstituted vaccine:
ACTIVE SUBSTANCE:
Live attenuated _Mycoplasma synoviae _strain MS1: >10
6.5
and <10
8.0
CFU
1
1
Colony Forming Units
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension.
Lyophilisate: Off-white to yellowish-coloured pellet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (layers).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of chickens (layers) from 6 weeks of age
to reduce air sac lesions, ovary lesions, and a drop in egg
production due to infection caused by _Mycoplasma synoviae_.
Onset of immunity: 4 weeks.
Duration of immunity: 44 weeks.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Do not use antibiotics or other substances with any antimicrobial
activity known to inhibit _Mycoplasma synoviae_.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
It is not recommended to vaccinate in the presence of (sub-) clinical
infection with _Mycoplasma synoviae_.
The vaccine strain has been detected in the respiratory tract of
vaccinated chickens by PCR at 34 weeks after vaccination.
Taking into account the potential spread of the vaccine strain by
direct or indirect transmission, all chickens in the chicken
house should be vaccinated. Adequate biosecurity measures should be in
place, such as change of clothing and boots and the
use of properly disinfected equipment.
After vaccination interference with serological screening methods for
_Mycoplasma_ infections may occur, but the vaccine strain
can be differentiated from wildtype _Mycoplasma synoviae_ by PCR or by
culture in _Mycoplasma_ growth medium containing
nicotinamide instead of NAD.
Health Produc