PARVOVAX

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Porcine parvovirus inactivated k-22 strain

Available from:

Ceva Santé Animale

ATC code:

QI09AA02

INN (International Name):

Porcine parvovirus inactivated k-22 strain

Dosage:

.

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

porcine parvovirus

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2002-11-06

Summary of Product characteristics

Health Products Regulatory Authority
07 November 2017
CRN000VK9
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PARVOVAX.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2-ml dose of vaccine contains:
Inactivated porcine parvovirus, minimum
2.0 HAI.U
Thiomersal, maximum
0.2 mg
Oily adjuvant which includes light paraffin oil
449.6 to 488.2mg
Benzyl alcohol
10.56mg
1 HAI.U: q.s. to obtain 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
Emulsion for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Breeder pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of breeder pigs (gilts, sows, boars) against
porcine
parvovirus, to reduce the number of stillbirths and mummified foetuses
in vaccinates.
The onset of immunity is obtained from 2 to 3 weeks after the primary
vaccination.
This immunity persists for up to one year.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate only healthy animals. Vaccinate sows during lactation.
Health Products Regulatory Authority
07 November 2017
CRN000VK9
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTRATING THE
MEDICINALPRODUCT TO ANIMALS
Apply usual aseptic procedures.
To the user:
This product contains mineral oil. Accidental injection/self injection
may result in
severe pain and swelling, particularly if injected into a joint or
finger, and in rare
cases could result in the loss of the affected finger if prompt
medical attention is not
given.
If you are accidentally injected with this product, seek prompt
medical advice even if
only a very small amount is injected and take the package leaflet with
you.
If pain persists for more than 12 hours after medical examination,
seek medical
advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been
injected,
accidental injection with