Vepured

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

recombinant Verotoxin 2e of E. coli

Fáanlegur frá:

Laboratorios Hipra, S.A.

ATC númer:

QI09AB02

INN (Alþjóðlegt nafn):

E. coli verotoxoid vaccine (inactivated recombinant)

Meðferðarhópur:

Pigs

Lækningarsvæði:

Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium, Immunologicals for suidae

Ábendingar:

Active immunisation of piglets from 2 days of age to prevent mortality and reduce clinical signs of oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain during the finishing period in the face of infections with verotoxin 2e producing E. coli until slaughter from 164 days of age.

Vörulýsing:

Revision: 3

Leyfisstaða:

Authorised

Leyfisdagur:

2017-08-17

Upplýsingar fylgiseðill

10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE
PACKAGE
Cardboard box with vial of 10 x10 doses.
Cardboard box with vials of 10, 50, 100 or 250 doses.
Vial of 100 or 250 doses.
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VEPURED suspension for injection for pigs
recombinant verotoxin 2e of
_E. coli_
2.
STATEMENT OF ACTIVE SUBSTANCES
Each dose of 1 ml contains:
Recombinant verotoxin 2e of
_E. coli_
................................................................ RP
≥ 1.50.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
PACKAGE SIZE
10 doses (10 ml)
50 doses (50 ml)
100 doses (100 ml)
250 doses (250 ml)
10 x 10 doses (10 ml)
5.
TARGET SPECIES
Pigs.
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use.
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD(S)
Withdrawal period: Zero days.
11
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10.
EXPIRY DATE
EXP {month/year}
Once broached use within 10 hours.
11.
SPECIAL STORAGE CONDITIONS
Store and transport refrigerated.
Do not freeze.
Protect from light.
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: read package leaflet.
13.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
For animal treatment only. To be supplied only on veterinary
prescription.
14.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Keep out of the sight and reach of children.
15.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
16.
MARKETING AUTHORISATION NUMBER(S)
EU/2/17/214/001 (10 doses (10 ml))
EU/2/17/214/002 (50 doses (50 ml))
EU/2/17/214/003 (100 doses (100 ml))
EU/2/17/214/004 (250 doses (250 ml))
EU/2/17/214/005 (10 x 10 doses (10 ml))
17.
MANUFACTURER’S BATCH NUMBER
Batch
12
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Vial of 10 or 50 doses
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VEPURED sus

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VEPURED suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Recombinant verotoxin 2e of
_E. coli_
................................................................ RP*
≥ 1.50
* RP – relative potency (ELISA)
ADJUVANTS:
Aluminium hydroxide (Al
3+
)
...........................................................................
2.117 mg
DEAE-dextran
......................................................................................................
10 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Whitish suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of piglets from 2 days of age to prevent mortality
and reduce clinical signs of
oedema disease (caused by verotoxin 2e produced by
_E. coli_
) and to reduce the loss of daily weight
gain during the finishing period in the face of infections with
verotoxin 2e producing
_E. coli _
until
slaughter from 164 days of age.
Onset of immunity:
21 days after vaccination.
Duration of immunity:
112 days after vaccination.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
the adjuvants or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Very common adverse reactions:
- Mild inflammation at the injection site (< 5 cm in diameter) that
typically resolves within three
days post-vaccination without treatment.
- Mild depression during the day of vaccination.
- Temperature rise of maximum 1.1 °C was observed. Temperatures
returned to nor