Porcilis Ery+Parvo+Lepto suspension for injection for pigs

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

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

Boleh didapati daripada:

Intervet International BV

Kod ATC:

QI09AL07

INN (Nama Antarabangsa):

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

Dos:

.

Borang farmaseutikal:

Suspension for injection

Jenis preskripsi:

LM: Licensed Merchant as defined in relevant national legislation

Kumpulan terapeutik:

Pigs

Kawasan terapeutik:

porcine parvovirus + erysipelothrix + leptospira

Tanda-tanda terapeutik:

Immunological - Inactivated Vaccine

Status kebenaran:

Authorised

Tarikh kebenaran:

2016-12-16

Ciri produk

Health Products Regulatory Authority
25 June 2019
CRN0094HY
Page 1 of 4
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-α-tocopheryl acetate
​150 mg
​
EXCIPIENT:
​
​
Formaldehyde (preservative)
0.4 - 1 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.
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.
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
exc