Porcilis Ery+Parvo+Lepto suspension for injection for pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

E.rhusiopathiae strain m2; Porcine parvo virus; Leptospira canicola; Leptospira icterohaemorrhagiae; Leptospira australis; Leptospira grippotyphosa; Leptospira pomona; Leptospira tarassovi

Available from:

Intervet Ireland Limited

ATC code:

QI09AL07

INN (International Name):

E.rhusiopathiae strain m2; Porcine parvo virus; Leptospira canicola; Leptospira icterohaemorrhagiae; Leptospira australis; Leptospira grippotyphosa; Leptospira pomona; Leptospira tarassovi

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

LR: Licensed Retailer as defined in national legislation

Therapeutic area:

porcine parvovirus + erysipelothrix + leptospira

Authorization status:

Authorised

Authorization date:

2016-12-16

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.
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 by
_ L. interrogans _
serogroup Canicola serovar Canicola.
-to reduce clinical signs (increase of body temperature and reduction