Porcilis Ery+Parvo+Lepto Suspension for Injection for Pigs

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

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

Dostępny od:

MSD Animal Health UK Limited

Kod ATC:

QI09AL07

INN (International Nazwa):

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

Forma farmaceutyczna:

Suspension for injection

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Pigs

Dziedzina terapeutyczna:

Inactivated Viral and Bacterial Vaccine

Status autoryzacji:

Authorized

Data autoryzacji:

2016-12-22

Charakterystyka produktu

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