Porcilis M Hyo ID ONCE emulsion for injection for pigs

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Inactivated whole cell concentrate of m. hyopneumoniae strain 11

Διαθέσιμο από:

Intervet Ireland Limited

Φαρμακολογική κατηγορία (ATC):

QI09AB13

INN (Διεθνής Όνομα):

Inactivated whole cell concentrate of m. hyopneumoniae strain 11

Δοσολογία:

.

Φαρμακοτεχνική μορφή:

Emulsion for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Pigs

Θεραπευτική περιοχή:

mycoplasma

Θεραπευτικές ενδείξεις:

Immunological - Inactivated Vaccine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2012-01-20

Αρχείο Π.Χ.Π.

M
SUMMARY OF PRODUCT CHARACTERISTICS
M
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis M Hyo ID ONCE emulsion for injection for pigs
IT: Porsilis M Hyo ID ONCE
HU: Porcilis M Hyo ID ONCE vakcina A.U.V.
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.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
M
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 after
medical examination,