PROGRESSIS EMULSION FOR INJECTION FOR PIGS (SOWS AND GILTS)

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

INACTIVATED PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME (PRRS) VIRUS, P120 STRAIN

Dostupno od:

Merial Animal Health Limited

ATC koda:

QI09AA05

INN (International ime):

INACTIVATED PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME (PRRS) VIRUS, P120 STRAIN

Farmaceutski oblik:

Emulsion for Injection

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapijska grupa:

Porcine

Područje terapije:

porcine reproductive and respiratory syndrome (PRRS) virus

Terapijske indikacije:

Immunological - Inactivated vaccine

Status autorizacije:

Authorised

Datum autorizacije:

2003-06-06

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Progressis
Emulsion for injection for pigs (sows and gilts)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2-ml dose of vaccine contains:
ACTIVE SUBSTANCE:
Inactivated Porcine Reproductive and Respiratory Syndrome (PRRS)
virus,
P120 strain
................................................................................................
2.5 log 10 IF* units.
*IF units: ImmunoFluorescence antibody titre obtained after 2
injections in pigs under specific laboratory conditions.
ADJUVANT:
O/w oily excipient (containing hydrogenated polyisobutene as adjuvant)
.... q.s. 1 dose of 2 ml.
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for Injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (sows and gilts).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduction of the reproductive disorders caused by Porcine Reproductive
and Respiratory Syndrome virus (European
strain) in a contaminated environment:
vaccination reduces the number of early farrowings and the number of
still-
births.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In PRRS infected herds, viral infection is heterogeneous and varies
over time. In such context, the implementation of a
vaccination program is a tool to improve the reproductive parameters
and may contribute to the disease control in
conjunction with sanitary measures.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_