Porcilis Parvo

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Inactivated porcine parvovirus strain 014

Fáanlegur frá:

Intervet Ireland Limited

ATC númer:

QI09AA02

INN (Alþjóðlegt nafn):

Inactivated porcine parvovirus strain 014

Skammtar:

.

Lyfjaform:

Suspension for injection

Gerð lyfseðils:

LR: Licensed Retailer as defined in national legislation

Meðferðarhópur:

Pigs

Lækningarsvæði:

porcine parvovirus

Ábendingar:

Immunological - Inactivated Vaccine

Leyfisstaða:

Authorised

Leyfisdagur:

2001-04-25

Vara einkenni

Health Products Regulatory Authority
24 June 2019
CRN0094NR
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Parvo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (2 ml) contains:
Active substance
Inacivated porcine parvovirus (PPV) strain 014 ≥ 552 EU*
Adjuvant:
dl-α-tocopherol acetate 150 mg
Excipients:
Formaldehyde 1.08 mg
For a full list of excipients, see section 6.1.
*as determined in the final product antigenic mass ELISA
3 PHARMACEUTICAL FORM
Suspension for injection.
Nearly white liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sows and gilts
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of sows and gilts to prevent or reduce
mortality and clinical signs of porcine parvovirus infection
on embryos and foetuses during pregnancy.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Only healthy animal_S_ should be vaccinated.
After vaccination with Porcilis Parvo, animals may seroconvert and
detectable levels of antibody to PPV may persist.
PPV infection is not the only cause of reproductive failure in pigs.
A good immune response is reliant on the reaction of an immunogenic
agent and a fully competent immune system.
Immunogenicity of the vaccine antigen will be reduced by poor storage
or inappropriate administration. Immunocompetence
of the animal may be compromised by a variety of factors including
poor health, nutritional status, genetic factors, concurrent
drug therapy and stress.
Health Products Regulatory Authority
24 June 2019
CRN0094NR
Page 2 of 3
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 or the label to the
physician. If spilled on the skin, wash with soap and water. If
ingested, drink water. If symptoms develop, seek medical advice.
4.6 ADVERSE REACTI