Porcilis M Hyo ID Once Emulsion for Injection for Pigs

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Mycoplasma hyopneumoniae

Verfügbar ab:

MSD Animal Health UK Limited

ATC-Code:

QI09AB13

INN (Internationale Bezeichnung):

Mycoplasma hyopneumoniae

Darreichungsform:

Emulsion for injection

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Pigs

Therapiebereich:

Inactivated Bacterial Vaccine

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2012-01-24

Fachinformation

Revised: September 2023
AN: 00873/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis M Hyo ID ONCE emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.2 ml contains:
ACTIVE SUBSTANCE:
_Mycoplasma hyopneumoniae_ inactivated, strain 11:

6.5 log
2
Ab titre*
*Mean antibody titre (Ab) obtained after inoculation of mice with a
1/1,000 pig dose.
ADJUVANTS:
light liquid paraffin
34.6 mg
dl-

-tocopheryl acetate
2.5 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White to nearly white emulsion with creamy appearance after shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of pigs to reduce pulmonary lesions and
the decrease in
daily weight gain during the finishing period due to infection caused
by _Mycoplasma _
_hyopneumoniae_.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 22 weeks after vaccination.
4.3
CONTRAINDICATIONS
None.
Revised: September 2023
AN: 00873/2023
Page 2 of 6
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
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 the package leaflet with you. If pain persists for
more than 12 hours
after medical examination, seek medical advice again.
To the physician:
This veterinary medici