Porcilis M Hyo, suspension for injection

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Mycoplasma hyopneumoniae strain 11 inactivated whole cell concentrate

Beschikbaar vanaf:

Intervet Ireland Limited

ATC-code:

QI09AB13

INN (Algemene Internationale Benaming):

Mycoplasma hyopneumoniae strain 11 inactivated whole cell concentrate

Dosering:

.

farmaceutische vorm:

Suspension for injection

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutische categorie:

Pigs

Therapeutisch gebied:

mycoplasma

therapeutische indicaties:

Immunological - Inactivated Vaccine

Autorisatie-status:

Authorised

Autorisatie datum:

2005-12-21

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis M Hyo, suspension for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 2 ml
ACTIVE SUBSTANCE
Inactivated whole cell concentrate of_ Mycoplasma hyopneumoniae_
strain 11:
7.0 log
2
Ab titre
* Mean antibody titre (Ab) obtained after inoculation of mice with a
1/20 pig dose.
ADJUVANT
150 mg dl-
-tocopheryl acetate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection; white or nearly white.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pig (finishing pigs).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For finishing pigs:
For the active immunisation of pigs to reduce pulmonary lesions due to
infection by_ Mycoplasma hyopneumoniae._
Onset of immunity: 2 weeks after the second injection
Duration of immunity: at least 20 weeks after the second injection.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate only healthy animals.
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 insert or label to the
physician.
4.6 ADVERSE REACTIONS (FREQ