Progressis Emulsion for Injection for Pigs (Sows and Gilts)

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Porcine respiratory and reproductive syndrome virus

Fáanlegur frá:

Ceva Animal Health Ltd

ATC númer:

QI09AA05

INN (Alþjóðlegt nafn):

Porcine respiratory and reproductive syndrome virus

Lyfjaform:

Emulsion for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Pigs

Lækningarsvæði:

Inactivated Viral Vaccine

Leyfisstaða:

Authorized

Leyfisdagur:

2000-09-21

Vara einkenni

Revised: October 2022
AN: 01684/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISITICS
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
White homogeneous 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.
Vaccinate healthy animals only.
Revised: October 2022
AN: 01684/2022
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Apply usual procedures for the handling of animals
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
To the user:
This product contains mineral oil. Accidental injection/self injection
may result in severe
pain and swelling, particularly if injected into a joint or finger,
and in rare cases could result
in the loss