PORCILIS M HYO ID ONCE EMULSION FOR INJECTION FOR PIGS

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

INACTIVATED WHOLE CELL CONCENTRATE OF M. HYOPNEUMONIAE STRAIN 11

Dostupno od:

Intervet Ireland Limited

ATC koda:

QI09AB13

INN (International ime):

INACTIVATED WHOLE CELL CONCENTRATE OF M. HYOPNEUMONIAE STRAIN 11

Doziranje:

Unknown

Farmaceutski oblik:

Emulsion for Injection

Tip recepta:

POM

Terapijska grupa:

Porcine

Područje terapije:

Mycoplasma vaccine

Terapijske indikacije:

Immunological - Inactivated vaccine

Status autorizacije:

Authorised

Datum autorizacije:

2012-01-20

Svojstava lijeka

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
One 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.
ADJUVANT:
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.
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 healthy animals only.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
To the user:
This