Porcilis Ery+Parvo+Lepto Suspension for Injection for Pigs

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

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

Διαθέσιμο από:

MSD Animal Health UK Limited

Φαρμακολογική κατηγορία (ATC):

QI09AL07

INN (Διεθνής Όνομα):

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

Φαρμακοτεχνική μορφή:

Suspension for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Pigs

Θεραπευτική περιοχή:

Inactivated Viral and Bacterial Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2016-12-22

Αρχείο Π.Χ.Π.

Revised: October 2023
AN: 02973/2022
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:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Homogenous white to nearly white suspension after shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs for reproduction.
Revised: October 2023
AN: 02973/2022
Page 2 of 6
4.2
INDICATIONS FOR USE, SPECIFYING THE 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 by _L.
interrogans_
serogroup Canicola serovar Canicola.

to reduce clinical signs (increase of body temperature and red