PROGRESSIS EMULSION FOR INJECTION FOR PIGS (SOWS AND GILTS)
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
29-06-2016
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Ingredient activ:
INACTIVATED PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME (PRRS) VIRUS, P120 STRAIN
Disponibil de la:
Merial Animal Health Limited
Codul ATC:
QI09AA05
INN (nume internaţional):
INACTIVATED PORCINE REPRODUCTIVE AND RESPIRATORY SYNDROME (PRRS) VIRUS, P120 STRAIN
Dozare:
%v/v
Forma farmaceutică:
Emulsion for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Porcine
Zonă Terapeutică:
Porcine reproductive and respiratory syndrome (PRRS) virus vaccine
Indicații terapeutice:
Immunological - Inactivated vaccine
Statutul autorizaţiei:
Authorised
Data de autorizare:
2003-06-06
Caracteristicilor produsului
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 14/06/2016_
_CRN 7023400_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate only healthy animals.
Apply usual procedures for the handling of animals.
SPECIAL PRECAUTIONS
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