Progressis Emulsion for injection for pigs (sows and gilts)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Inactivated porcine reproductive and respiratory syndrome (prrs) virus, p120 strain

Available from:

Ceva Santé Animale

ATC code:

QI09AA05

INN (International Name):

Inactivated porcine reproductive and respiratory syndrome (prrs) virus, p120 strain

Dosage:

.

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

porcine reproductive and respiratory syndrome (PRRS) virus

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2003-06-06

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Progressis emulsion for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated porcine reproductive and respiratory syndrome virus, type
1,
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.
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Polyoxyethylene fatty acids
Ether of fatty alcohols and of polyols
Benzyl alcohol
Triethanolamine
Potassium chloride
Sodium chloride
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Magnesium chloride
Calcium chloride
Water for injections
White homogeneous emulsion.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs (sows and gilts).
3.2
INDICATIONS FOR USE FOR EACH 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.
Onset of immunity: has not been established
Duration of immunity: has not been established
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
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.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person admi