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: August 2021
AN: 01653/2020 & 01654/2020
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 dose of 2 ml 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:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Homogenous white to nearly white suspension after shaking.
Revised: August 2021
AN: 01653/2020 & 01654/2020
Page 2 of 6
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pig for reproduction.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunization 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 foetal 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 by_ L.
interrogans _
serogroup Canicola serovar Canicola.
-
to reduce