PROGRESSIS
Land: Holland
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
Produktets egenskaber
(SPC)
17-03-2012
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Aktiv bestanddel:
porcine reproductive and respiratory syndrome virus inactivated 2.5 log10 IF Units
Tilgængelig fra:
Merial
ATC-kode:
QI09AA05
Lægemiddelform:
Emulsion for injection
Terapeutisk gruppe:
Porcine reproductive and respiratory syndrome (PRRS) virus
Terapeutisk område:
Pigs
Autorisation dato:
2010-02-18
Produktets egenskaber
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
2
February 2010
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Progressis.
Emulsion for injection for pigs (sows and gilts)
Name in Austria: “Progressis - Emulsion zur Injektion für Schweine“
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 inje ctions 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
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