PORCILIS APP SUSPENSION FOR INJECTION

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

CONCENTRATE OF ACTINOBACILLUS PLEUROPNEUMONIAE ANTIGENS CONTAINING, OMP (OUTER MEMBRANE PROTEIN), APXI (105 KILODALTON TYPE I TOXOID), APXII (105 KILODALTON TYPE II TOXOID), APXIII (120 KILODALTON MACROPHAGE TOXOID)

Saadav alates:

Intervet Ireland Limited

ATC kood:

QI09AB07

INN (Rahvusvaheline Nimetus):

CONCENTRATE OF ACTINOBACILLUS PLEUROPNEUMONIAE ANTIGENS CONTAINING, OMP (OUTER MEMBRANE PROTEIN), APXI (105 KILODALTON TYPE I TO

Annus:

%v/v

Ravimvorm:

Suspension for Injection

Retsepti tüüp:

POM(E)

Terapeutiline rühm:

Porcine

Terapeutiline ala:

Actinobacillus/Haemophilus vaccine

Näidustused:

Immunological - Inactivated vaccine

Volitamisolek:

Authorised

Loa andmise kuupäev:

2014-01-31

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis APP Suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (weaned piglets).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunization of weaned piglets to reduce mortality, clinical signs and lesions of pleuropneumonia
caused by _Actinobacillus pleuropneumoniae._
Onset of immunity: 2 weeks after completion of the vaccination scheme.
Duration of immunity: 11 weeks after completion of the vaccination scheme.
4.3 CONTRAINDICATIONS
None.
Each 2 ml dose contains:
ACTIVE SUBSTANCE(S):
600 mg _Actinobacillus pleuropneumoniae _antigen concentrate containing:
OMP [outer membrane protein]
50
units*
Apx I toxoid
50
units
Apx II toxoid
50
units
Apx III toxoid
50
units
*units relative to an internal standard determined to be efficacious in pigs.
ADJUVANT
dl- -tocopherol
150 mg
EXCIPIENTS
Formaldehyde (preservative)
0.02 % w/v
For a full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 01/12/2014_
_CRN 7019273_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Only healthy animals should be vaccinated.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
It is not advisable to vaccinate animals immediately before and after feeding.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the case of accidental self-injection or ingestion seek medical advice immediately and show the package leaflet or
the label to the physician. If spilled on the skin, wash with soap and water.
4.6 ADVE