Nobilis MS Live, Lyophilisate for Oculonasal Suspension for Chickens

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Mycoplasma synoviae

Inapatikana kutoka:

MSD Animal Health UK Limited

ATC kanuni:

QI01AE03

INN (Jina la Kimataifa):

Mycoplasma synoviae

Dawa fomu:

Lyophilisate for oculonasal suspension

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Chickens

Eneo la matibabu:

Live Bacterial Vaccine

Idhini hali ya:

Authorized

Idhini ya tarehe:

2014-04-04

Tabia za bidhaa

Revised: August 2020
AN: 00299/2020
Page 1 of 5
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
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
Revised: August 2020
AN: 00299/2020
Page 2 of 5
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.
Special pre