Biosuis ParvoEry Suspension for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Erysipelothrix rhusiopathiae, Porcine parvovirus

Available from:

Bioveta a.s.

ATC code:

QI09AL01

INN (International Name):

Erysipelothrix rhusiopathiae, Porcine parvovirus

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Inactivated Viral and Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2021-05-17

Summary of Product characteristics

Revised: November 2021
AN: 00566/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BIOSUIS ParvoEry suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCES:
Porcine parvovirus, inactivated, strain CAPM V198, S-27
≥ 4 log
2
*)
_Erysipelothrix rhusiopathiae_ inactivated, serotype 2, strain 2-64
RP

1
**)
*)
titre HI antibodies in guinea-pig serum after application of ¼ dose
for pigs.
Antibodies titre 16 and more must be proved in 4 from 5 guinea-pigs.
The resulting
value of HI titre is given by mean of titres of antibodies reached in
5 guinea pigs.
**)
Relative potency (RP) is given by comparison of antibody level in
serum of
vaccinated mice with antibody level in mice serum prepared with
reference vaccine
batch, which complies in challenge test on target animals according to
the Phr.
Eur. requirements.
ADJUVANTS:
Aluminium hydroxide
***)
9.0 mg
***)
Hydrated, for adsorption 2% (expressed as Al
2
O
3
)
EXCIPIENTS:
Formaldehyde
max. 1.0 mg
Thiomersal
0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Milky white up to greyish-white liquid. During longer standing the
content is separates
into clear liquid and milky white to greyish sediment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (gilts, sows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs (gilts, sows) to reduce clinical signs
(skin lesions and
fever) of swine erysipelas caused by _ Erysipelothrix rhusiopathiae_
and to prevent
transplacental infection of embryos and foetuses of gilts and sows
caused by porcine
parvovirus.
Onset of immunity:
Porcine parvovirus:
3 weeks after primary vaccination (from the beginning of
pregnancy)
Revised: November 2021
AN: 00566/2021
Page 2 of 5
_E. rhusiopathiae:_
3 weeks after primary vaccination
Duration of immunity:
Porcine parvovirus:
the vaccination provides the protection of foetuses during the
whole pregnanc