Porcilis Ery+Parvo+Lepto Suspension for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Erysipelothrix rhusiopathiae, Leptospira australis, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae, Leptospira pomona, Leptospira tarassovi, Porcine parvovirus

Available from:

MSD Animal Health UK Limited

ATC code:

QI09AL07

INN (International Name):

Erysipelothrix rhusiopathiae, Leptospira australis, Leptospira canicola, Leptospira grippotyphosa, Leptospira icterohaemorrhagiae, Leptospira pomona, Leptospira tarassovi, 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:

2016-12-22

Summary of Product characteristics

Revised: October 2023
AN: 02972/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Ery+Parvo+Lepto suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
ACTIVE SUBSTANCES:
Inactivated strains of:
_Erysipelothrix rhusiopathiae_, serotype 2 (strain M2)
≥ 1 ppd
1
Porcine parvovirus (strain 014)
≥ 130 U
2
_Leptospira interrogans_ serogroup Canicola serovar Portland-Vere
(strain Ca-12-000)
≥ 2816
U
2
_Leptospira interrogans_ serogroup Icterohaemorrhagiae serovar
Copenhageni
(strain Ic-02-001)
≥ 210
U
2
_Leptospira interrogans_ serogroup Australis serovar Bratislava
(strain As-05-073)
≥ 1310 U
2
_Leptospira_ _kirschneri_ serogroup Grippotyphosa serovar Dadas
(strain Gr-01-005) ≥ 648 U
2
_Leptospira_ _interrogans_ serogroup Pomona serovar Pomona (strain
Po-01-000)
≥ 166 U
2
_Leptospira_ _santarosai_ serogroup Tarassovi serovar Gatuni (strain
S1148/02)
≥ 276 U
2
ADJUVANT:
dl-

-tocopheryl acetate
150 mg
1
Pig protective dose as compared to a reference preparation known to be
protective in
pigs.
2
As determined in the _in vitro_ antigenic mass ELISA potency test.
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER
CONSTITUENTS
Polysorbate 80
Simethicone
Sodium chloride
Potassium chloride
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Water for injections
Homogenous white to nearly white suspension after shaking.
Revised: October 2023
AN: 02972/2022
Page 2 of 6
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs for reproduction.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the active immunisation of pigs:
-to reduce clinical signs (skin lesions and fever) of swine erysipelas
caused by_ _
_Erysipelothrix rhusiopathiae_, serotype 1 and serotype 2.
-to reduce transplacental infection, viral load and fetal mortality
caused by Porcine
parvovirus.
-to reduce clinical signs (increase of body temperature and reduction
in feed intake or
activity), infection and bacterial excretion caused