PARVORUVAX

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Porcine parvovirus inactivated k-22 strain; Erysipelothrix rhusiopathiae (lysed bacterial cells), serotype 2

Available from:

Ceva Santé Animale

ATC code:

QI09AL01

INN (International Name):

Porcine parvovirus inactivated k-22 strain; Erysipelothrix rhusiopathiae (lysed bacterial cells), 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 indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2002-05-01

Summary of Product characteristics

Health Products Regulatory Authority
28 September 2020
CRN009H8D
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PARVORUVAX
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2-ml dose of vaccine contains:
​
​
​
​
Inactivated Porcine Parvovirus, K-22 strain
≥ 2
HAI.U​
_Erysipelothrix rhusiopathiae_(lysed bacterial cells), serotype 2 ≥1
​Elisa U
Aluminium hydroxide (expressed in Al
+++
)
4.2
​mg
Thiomersal
0.2
​mg
1 HAI.U: equivalent to HAI antibody titres of 1 log10 in guinea-pigs
after administration of the vaccine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Gilts, sows and boars.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of breeding pigs(sows, gilts and boars)
against porcine parvovirosis, to reduce the number of stillbirths
and mummified piglets, and against erysipelas to reduce or prevent
clinical symptoms. The onset of immunity is obtained from
2 to 3 weeks after the primary vaccination. A duration of immunity up
to 9 months and 11 months following vaccination has
been proven for the parvovirus component and the erysipelas component,
respectively.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Primary vaccination against porcine parvovirosis should not be carried
out in the presence of maternally derived
antibodies.Vaccinate only healthy animals.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
In the case of accidental self-injection, seek medical advice
immediately and show the package insert to the physician.
Health Products Regulatory Authority
28 September 2020
CRN009H8D
Page 2 of 3
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Vaccination can occasionally cause reactions of hypersensitivity in
some animals, particularly in those animals sensitised by the
er