Porcilis Ery+Parvo+Lepto Suspension for Injection for Pigs

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

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

Tilgængelig fra:

Intervet International BV

ATC-kode:

QI09AL07

INN (International Name):

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

Lægemiddelform:

Suspension for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Pigs

Terapeutisk område:

Inactivated Viral and Bacterial Vaccine

Autorisation status:

Authorized

Autorisation dato:

2016-12-22

Produktets egenskaber

Revised: September 2019
AN: 01758/2018
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.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pig for reproduction.
Page 1 of 5
Revised: September 2019
AN: 01758/2018
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 clinical signs (increase of body