FIXR MYC-VAC Emulsion for Injection for Chickens

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Mycoplasma gallisepticum

Available from:

Kernfarm B.V.

ATC code:

QI01AB03

INN (International Name):

Mycoplasma gallisepticum

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Inactivated Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2023-04-05

Summary of Product characteristics

Issued: April 2023
AN: 00881/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
FIXR MYC-VAC emulsion for injection for chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of vaccine (0.5 ml) contains:
ACTIVE SUBSTANCES:
Inactivated culture of _ M. gallisepticum_, strain MG-NEV40: 1.5 x 10
10
CFU* before inactivation to induce at least 40 HI** units in chickens.
Inactivated culture of _ M. gallisepticum_, strain MG-NEV45: 1.5 x 10
10
CFU* before inactivation, to induce at least 40 HI** units in
chickens.
•
Colony Forming Unit
**
Mean
hemagglutination
inhibition
units,
5
weeks
after
the
administration of 1 dose to 3-week-old chickens.
ADJUVANT(S):
Light liquid paraffin:
0.337 ml
EXCIPIENT(S):
Thiomersal
0.05 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White oily emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (future layers and breeders)
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens to reduce egg production losses
caused by _Mycoplasma gallisepticum _
Onset of immunity: 10 weeks after completion of the primary
vaccination
schedule
Duration
of
immunity:
42
weeks
after
completion
of
the
primary
vaccination schedule
Issued: April 2023
AN: 00881/2021
Page 2 of 5
A
reduction
of
thoracic
and
abdominal
air
sac
lesions
caused
by
Mycoplasma gallisepticum was demonstrated in vaccinated birds with an
onset of immunity of 4 weeks after completion of the primary
vaccination
schedule, however a duration of immunity has not been investigated
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
Special
precautions
to
be
taken
by
the
person
administering
the
veterinary medicinal product to the animals
To the user:
This
veterinary
medicinal
product
contains
mineral
oil.
Accidental
injection/self-injection may result in severe pain an