Nobilis Ma5 + Clone 30 Lyophilisate for Oculonasal Suspension/use in Drinking Water for Chickens

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Infectious bronchitis virus, Newcastle disease virus

Inapatikana kutoka:

MSD Animal Health UK Limited

ATC kanuni:

QI01AD

INN (Jina la Kimataifa):

Infectious bronchitis virus, Newcastle disease virus

Dawa fomu:

Lyophilisate for oculonasal suspension/use in drinking water

Dawa ya aina:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Kundi la matibabu:

Chickens

Eneo la matibabu:

Live Viral Vaccine

Idhini hali ya:

Authorized

Idhini ya tarehe:

1997-02-20

Tabia za bidhaa

Revised: September 2023
AN: 02901/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Ma5 + Clone 30 lyophilisate for oculonasal suspension/use in
drinking water
for chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
PER DOSE
Live Infectious Bronchitis virus strain Ma5
≥ 10
3.0
EID
50*
Live Newcastle Disease virus Clone 30
≥ 10
6.0
ELD
50**
* egg infective dose 50%
** embryo lethal dose 50%
EXCIPIENTS
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension / use in drinking water.
Vials: white/off-white coloured pellet.
Cups: white/off white, predominantly spherical shaped.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens.
4.2
INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES
For the active immunisation of fowls against Massachusetts type or
serologically
related types of Infectious Bronchitis and against Newcastle Disease.
Duration of immunity: 6 weeks.
4.3
CONTRAINDICATIONS
Only healthy birds should be vaccinated. Sick or weak birds will not
develop
adequate immunity following vaccination.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine viruses spread rapidly to susceptible chicks.
Revised: September 2023
AN: 02901/2022
Page 2 of 7
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
A good immune response is reliant on the reaction of an immunogenic
agent and a
fully competent immune system. Immunogenicity of the vaccine antigen
will be
reduced by poor storage or inappropriate administration.
Immuno-competence of the
animal may be compromised by a variety of factors including poor
health, nutritional
status, genetic factors, concurrent drug therapy and stress. Under
certain conditions,
for example extreme disease pressure and variant challenge, fully
immune birds may
succumb to disease. Therefore, successful vaccination may not be
synonymous with
full protection in the face of a disease challenge.
Special precautions to be taken by the person administer