Porcilis Ery + Parvo suspension for injection for pigs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Inactivated porcine parvovirus strain 014; Inactivated erysipelothrix rhusiopathiae strain M2 (Serotype 2)

Dostopno od:

Intervet Ireland Limited

Koda artikla:

QI09AL01

INN (mednarodno ime):

Inactivated porcine parvovirus strain 014; Inactivated erysipelothrix rhusiopathiae strain M2 (Serotype 2)

Odmerek:

.

Farmacevtska oblika:

Suspension for injection

Tip zastaranja:

LR: Licensed Retailer as defined in national legislation

Terapevtska skupina:

Pigs

Terapevtsko območje:

porcine parvovirus + erysipelothrix

Terapevtske indikacije:

Immunological - Inactivated Vaccine

Status dovoljenje:

Authorised

Datum dovoljenje:

2001-05-04

Lastnosti izdelka

_ _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
/
109095 /
4
.0
Final
ax22-GD3Aa-dc-Hk-5xM-
5464_113674
Registration file / September 2022
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Ery+Parvo suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCES:
Inactivated strains of:
_Erysipelothrix rhusiopathiae,_ serotype 2 (strain M2)
≥ 1 ppd*
Porcine Parvovirus (strain 014)
≥ 552 EU**
*ppd = pig protective dose as compared to a reference preparation
known to be protective in pigs.
**EU = as determined in the final product by antigenic mass ELISA
ADJUVANT:
dl-

-tocopherol: 150 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Homogenous white to nearly white suspension after shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (Sows and Gilts).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunization of sows and gilts to prevent clinical signs of
Erysipelas disease caused by all
relevant _Erysipelothrix (E.) rhusiopathiae_ serotypes (serotype 1 and
2) and for protection against
embryonal and fetal death caused by porcine parvovirus (PPV)
infection.
_E. rhusiopathiae_:
Onset of immunity (after finished primary vaccination course): 3 weeks
Duration of immunity: 6 months
Porcine parvovirus:
Duration of immunity: 12 months
4.3
CONTRAINDICATIONS
None.
/
109095 /
4
.0
Final
ax22-GD3Aa-dc-Hk-5xM-
5464_113674
Registration file / September 2022
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
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or
label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In laboratory studies and field trials:
Transient increases in body temperature (0.5�