Hyogen emulsion for injection for pigs

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Inactivated bacterin of mycoplasma hyopneumoniae strain 2940

זמין מ:

Ceva Santé Animale

קוד ATC:

QI09AB13

INN (שם בינלאומי):

Inactivated bacterin of mycoplasma hyopneumoniae strain 2940

כמות:

.

טופס פרצבטיות:

Emulsion for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Pigs

איזור תרפויטי:

mycoplasma

סממני תרפויטית:

Immunological - Inactivated Vaccine

מצב אישור:

Authorised

תאריך אישור:

2015-06-12

מאפייני מוצר

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Hyogen emulsion for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated
_Mycoplasma hyopneumoniae _
2940 strain:
min. 328 Elisa Units
ADJUVANTS:
Light liquid paraffin
187 μl
_Escherichia coli _
J5 LPS
min. 594 - max. 38000 Endotoxin unit
EXCIPIENT:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
Thiomersal
30.6 - 58.5 μg
Sorbitan trioleate
Polysorbate 80
Sodium chloride
Potassium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Off-white, homogeneous emulsion.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs (for fattening)
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the active immunisation of fattening pigs from 3 weeks of age to
reduce the occurrence and
severity of lung lesions caused by
_Mycoplasma hyopneumoniae _
infection.
Onset of immunity: 3 weeks after vaccination
Duration of immunity: 26 weeks after vaccination
3.3
CONTRAINDICATIONS
None.
3.4 SPECIAL WARNINGS
Vaccinate healthy animals only.
The data available are not sufficient to exclude the interaction of
maternally derived antibodies against
_Mycoplasma hyopneumoniae _
with vaccine uptake. Interaction with maternally derived antibodies is
known and should be taken into consideration. It is recommended to
delay vaccination in piglets with
residual MDA against
_Mycoplasma hyopneumoniae _
at the age of 3 weeks.
3.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Not applicable
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or
the label to the physician.
To the user:
This veterinary medicinal product contains mineral oil. Accidental
injection/self-injection may result
in severe pain an