Porcilis M Hyo ID Once Emulsion for Injection for Pigs

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Mycoplasma hyopneumoniae

Διαθέσιμο από:

MSD Animal Health UK Limited

Φαρμακολογική κατηγορία (ATC):

QI09AB13

INN (Διεθνής Όνομα):

Mycoplasma hyopneumoniae

Φαρμακοτεχνική μορφή:

Emulsion for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Pigs

Θεραπευτική περιοχή:

Inactivated Bacterial Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2012-01-24

Αρχείο Π.Χ.Π.

Revised: September 2023
AN: 00870/2022
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:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Polysorbate 80
Simethicone
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Water for injections
Emulsion for injection.
White to nearly white emulsion with creamy appearance after shaking.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs.
3.2
INDICATIONS FOR USE FOR EACH 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.
Revised: September 2023
AN: 00870/2022
Page 2 of 6
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
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:
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
aft