Nobilis MG 6/85 Lyophilisate for Suspension for Chickens

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Mycoplasma gallisepticum

Available from:

MSD Animal Health UK Limited

ATC code:

QI01AE03

INN (International Name):

Mycoplasma gallisepticum

Pharmaceutical form:

Lyophilisate for suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Live Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2002-02-21

Summary of Product characteristics

Revised: August 2020
AN: 00299/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NOBILIS MG 6/85, lyophilisate for suspension for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S):
Per dose of reconstituted vaccine:
Live attenuated _Mycoplasma gallisepticum_ strain MG 6/85:
10
6.9
- 10
8.5
CFU
1
1
Colony Forming Units
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension
Off-white to yellowish coloured pellet
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (future layers)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of future layers to reduce airsacculitis and
tracheitis lesions
caused by _Mycoplasma gallisepticum_.
Immunity develops within 4 weeks after vaccination. A duration of
immunity of 24
weeks after vaccination was established using a typical batch
containing 7.5 log
10
CFU.
4.3
CONTRAINDICATIONS
Not to be used within four weeks of onset of egg production or during
lay. Not
intended for future breeders.
Revised: August 2020
AN: 00299/2020
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use antibiotics or other substances with any antimicrobial
activity known to
inhibit _M. gallisepticum_.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate healthy chickens only. It is not recommended to vaccinate in
the presence
of (sub-) clinical infection with _M. gallisepticum._
After vaccination the vaccine strain _Mycoplasma gallisepticum_ MG
6/85 can be
isolated in birds for at least 15 weeks. Care should be taken to
prevent spread of the
vaccine strain to other birds than chicken and turkeys, such as game
birds, geese
and ducks. Seroconversion may occur after vaccination.
The vaccine strain can be differentiated from wild _Mycoplasma
gallisepticum_ based
on routine DNA analysis.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
To avoid skin and eye injuries