Syvac Ery Parvo Emulsion for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Erysipelothrix rhusiopathiae, Porcine parvovirus

Available from:

Laboratorios SYVA S.A.U

ATC code:

QI09AL01

INN (International Name):

Erysipelothrix rhusiopathiae, Porcine parvovirus

Pharmaceutical form:

Emulsion 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:

2022-09-23

Summary of Product characteristics

Amended Pages: October 2022
AN: 01464/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Syvac Ery Parvo emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated _Erysipelothrix rhusiopathiae_, serotype 2, strain SE-9
7.4 – 61.0 ELISA
Units*
Inactivated Porcine parvovirus, strain PVP-7
320 – 5120 HIT**
* Serological response in vaccinated mice determined by ELISA
according to Ph.
Eur. 0064
** Titre of antibodies determined in vaccinated guinea-pigs by
haemagglutination
inhibition test according to Ph. Eur. 0965
ADJUVANTS:
Montanide ISA 201 VG
0.91 g
EXCIPIENT:
Thiomersal
0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White homogeneous emulsion in which phase separation is not observed.
Greyish
sediment may form which can be dispersed by shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of gilts, sows and boars to reduce
clinical signs (skin
lesions and fever) of swine erysipelas caused by _Erysipelothrix
rhusiopathiae_,
serotype 2, as shown under experimental challenge conditions in
seronegative pigs.
For the active immunisation of gilts and sows for the reduction of
transplacental
infection in progeny caused by porcine parvovirus.
Amended Pages: October 2022
AN: 01464/2021
Page 2 of 5
Onset of immunity:
_E. rhusiopathiae_: 3 weeks after completion of the primary
vaccination scheme.
Porcine parvovirus: from the beginning of the gestation period after
completion of the
primary vaccination scheme.
Duration of immunity:
_E. rhusiopathiae_: 5 months
Porcine parvovirus: for the duration of gestation.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
No information is available on the use of the vaccine in animals with
maternally
derived antibodies against porcine parvovirus.
4.5
SPECIAL PRECAUTIONS F