Porcilis Ery+Parvo Suspension for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Erysipelothrix rhusiopathiae, Porcine parvovirus

Available from:

MSD Animal Health UK Limited

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:

1997-07-16

Summary of Product characteristics

Amended pages: February 2023
AN: 01579/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Ery+Parvo suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCES:
- Inactivated lysed antigen concentrate of _ Erysipelothrix
rhusiopathiae_ strain M2
(serotype 2):

1 pig protective dose (ppd)*
- Inactivated porcine parvovirus (PPV) strain 014: ≥ 552 EU**
* as measured in the Ph. Eur. potency test
** as determined in the final product by antigenic mass ELISA
ADJUVANT:
dl-

-tocopherol: 150 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Aqueous white or nearly white liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (sows and gilts).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of sows and gilts to prevent clinical signs of
Erysipelas
disease caused by all relevant _ Erysipelothrix rhusiopathiae_
serotypes (serotype 1
and 2) and for protection against embryonal and foetal death caused by
porcine
parvovirus (PPV) infection.
_E. rhusiopathiae_:
Onset of immunity: 3 weeks.
Duration of immunity: 6 months.
Porcine parvovirus (PPV):
Duration of immunity: 12 months.
Amended pages: February 2023
AN: 01579/2022
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Sick and weak animals should not be vaccinated.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
In case of accidental self-injection, seek medical advice immediately
and show the
package leaflet or label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In laboratory studies and field trials
Transient
increases
in
body
temperature
(0.5 °C)
within
24
hours
may
very
commonly occur.
Mild transient local swelling (Ø 1 – 10 mm) until 8 day