Porcilis M Hyo, suspension for injection

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Mycoplasma hyopneumoniae strain 11 inactivated whole cell concentrate

Saadav alates:

Intervet Ireland Limited

ATC kood:

QI09AB13

INN (Rahvusvaheline Nimetus):

Mycoplasma hyopneumoniae strain 11 inactivated whole cell concentrate

Annus:

.

Ravimvorm:

Suspension for injection

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline rühm:

Pigs

Terapeutiline ala:

mycoplasma

Näidustused:

Immunological - Inactivated Vaccine

Volitamisolek:

Authorised

Loa andmise kuupäev:

2005-12-21

Toote omadused

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