Porcilis PCV M Hyo Emulsion for Injection for Pigs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Mycoplasma hyopneumoniae, Porcine circovirus-2

Commercializzato da:

MSD Animal Health UK Limited

Codice ATC:

QI09AL08

INN (Nome Internazionale):

Mycoplasma hyopneumoniae, Porcine circovirus-2

Forma farmaceutica:

Emulsion for injection

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Pigs

Area terapeutica:

Inactivated Viral and Bacterial Vaccine

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2014-11-07

Scheda tecnica

Issued: September 2023
AN: 02291/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PCV M Hyo emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 ml contains:
ACTIVE SUBSTANCES:
Porcine circovirus type 2 (PCV2) ORF2 subunit antigen
≥ 2 828 AU
1
_Mycoplasma hyopneumoniae _J strain inactivated
≥ 2.69 RPU
2
ADJUVANTS:
Light mineral oil
0.268 ml
Aluminium (as hydroxide)
2.0 mg
1
Antigenic units as determined in the in vitro potency test (ELISA).
2
Relative potency units defined against a reference vaccine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
Homogenous white to nearly white emulsion after shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (for fattening).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of pigs to reduce viraemia, virus load in
lungs and
lymphoid tissues, virus shedding caused by porcine circovirus type 2
(PCV2)
infection, and severity of lung lesions caused by _Mycoplasma
hyopneumoniae _
infection. To reduce the loss of daily weight gain during the
finishing period in face of
infections with _Mycoplasma hyopneumoniae _and/or PCV2 (as observed in
field
studies).
Onset of immunity with single dose vaccination:
Issued: September 2023
AN: 02291/2022
Page 2 of 7
PCV2: 2 weeks after vaccination
_M. hyopneumoniae_: 4 weeks after vaccination.
Onset of immunity with two dose vaccination:
PCV2: 18 days after first vaccination
_M. hyopneumoniae_: 3 weeks after the second vaccination.
Duration of immunity (both vaccination schedules):
PCV2: 22 weeks after (the last) vaccination
_M. hyopneumoniae_: 21 weeks after (the last) vaccination.
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
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
To t