Hyogen Emulsion for Injection for Pigs

País: Regne Unit

Idioma: anglès

Font: VMD (Veterinary Medicines Directorate)

ingredients actius:

Mycoplasma hyopneumoniae

Disponible des:

Ceva Animal Health Ltd

Codi ATC:

QI09AB13

Designació comuna internacional (DCI):

Mycoplasma hyopneumoniae

formulario farmacéutico:

Emulsion for injection

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Pigs

Área terapéutica:

Inactivated Bacterial Vaccine

Estat d'Autorització:

Authorized

Data d'autorització:

2015-06-11

Fitxa tècnica

Revised: October 2022
AN: 01665/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Hyogen emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated
_Mycoplasma hyopneumoniae _2940 strain: min. 5.5 EU *
ADJUVANTS:
Light liquid paraffin
187 μl
_Escherichia coli_ J5 LPS
max. 38000 Endotoxin unit
EXCIPIENT:
Thiomersal
50 µg
* Mean antibody titre – expressed in _M. hyopneumoniae_ ELISA Unit
– obtained 28
days after the immunisation of rabbits with half of pig vaccine dose
(1ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection
Off-white, homogeneous emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs for fattening
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunization 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 the vaccination
Duration of immunity: 26 weeks after vaccination
Revised: October 2022
AN: 01665/2022
Page 2 of 6
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
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 and swelling, particularly if
injected into a joint or
finger, and in rare cases could result in the loss of the affected
finger if prompt
medical attention is not given. If you are accidentally injected with
this veterinary
medicinal product, seek prompt medical advice even if only a very
small amount is
injected and take