Porcilis APP Suspension for Injection

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Actinobacillus pleuropneumoniae

Verfügbar ab:

MSD Animal Health UK Limited

ATC-Code:

QI09AB07

INN (Internationale Bezeichnung):

Actinobacillus pleuropneumoniae

Darreichungsform:

Suspension for injection

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Pigs

Therapiebereich:

Inactivated Bacterial Vaccine

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2014-02-11

Fachinformation

Revised: August 2020
AN: 00299/2020
Page 1 of 5
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.
Revised: August 2020
AN: 00299/2020
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
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
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/depression may be very commonly observed after vaccination.