PROGRESSIS
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
17-03-2012
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Active ingredient:
porcine reproductive and respiratory syndrome virus inactivated 2.5 log10 IF Units
Available from:
Merial
ATC code:
QI09AA05
Pharmaceutical form:
Emulsion for injection
Therapeutic group:
Porcine reproductive and respiratory syndrome (PRRS) virus
Therapeutic area:
Pigs
Authorization date:
2010-02-18
Summary of Product characteristics
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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