Porcilis Ery + Parvo suspension for injection for pigs

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

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

MAH:

Intervet Ireland Limited

ATC_code:

QI09AL01

INN:

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

dosage:

.

pharmaceutical_form:

Suspension for injection

prescription_type:

LR: Licensed Retailer as defined in national legislation

therapeutic_group:

Pigs

therapeutic_area:

porcine parvovirus + erysipelothrix

therapeutic_indication:

Immunological - Inactivated Vaccine

authorization_status:

Authorised

authorization_date:

2001-05-04

SPC

_ _
_ _
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�