Porcilis APP suspension for injection for pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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)

Available from:

Intervet Ireland Limited

ATC code:

QI09AB07

INN (International Name):

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)

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

POM (E): Prescription Only Exempt as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

actinobacillus/haemophilus vaccine

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2014-01-31

Summary of Product characteristics

Health Products Regulatory Authority
21 March 2019
CRN000YQ2
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis APP suspension for injection for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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-α-tocopherol
150
mg
EXCIPIENT:
Formaldehyde (preservative)
0.02
% w/v
For the full list of excipients, see section 6.1
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 immunisation 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.
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
Health Products Regulatory Authority
21 March 2019
CRN000YQ2
Page 2 of 4
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 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In laboratory studies and field trials:
Mild to moderate injection site reactions may very commonly occur in
some animals, these resolve within 5 days
post-vaccination. Anorexia and decreased activity/depre