Eryseng
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
10-05-2019
Charakterystyka produktu
(SPC)
10-05-2019
Sprawozdanie z oceny publicznego
(PAR)
02-10-2014
Składnik aktywny:
Erysipelothrix rhusiopathiae, strain R32E11 (inactivated)
Dostępny od:
Laboratorios Hipra, S.A.
Kod ATC:
QI09AB03
INN (International Nazwa):
Erysipelothrix rhusiopathiae
Grupa terapeutyczna:
Pigs
Dziedzina terapeutyczna:
Immunologicals for suidae, Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium
Wskazania:
For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Podsumowanie produktu:
Revision: 4
Status autoryzacji:
Authorised
Data autoryzacji:
2014-07-04
Ulotka dla pacjenta
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE
PACKAGE
CARDBOARD BOX, (20 ML, 50 ML, 100ML, AND 250ML)
BOTTLES (100 ML AND 250 ML) AND VIALS (100 ML)
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ERYSENG suspension for injection for pigs
2.
STATEMENT OF ACTIVE SUBSTANCES
Inactivated
_Erysipelothrix rhusiopathiae_
, strain R32E11, ....................... ELISA > 3.34 log
2
IE
50 %
*
* IE
50%
– Inhibition ELISA 50%.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
PACKAGE SIZE
10 doses (20 ml)
25 doses (50 ml)
50 doses (100 ml)
125 doses (250 ml)
5.
TARGET SPECIES
Pigs
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
Intramuscular use.
8.
WITHDRAWAL PERIOD(S)
Withdrawal period: Zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
10.
EXPIRY DATE
11
EXP {month/year}
Once broached use immediately.
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/2/14/166/001
EU/2/14/166/002
EU/2/14/166/003
EU/2/14/166/004
EU/2/14/166/005
EU/2/14/166/006
EU/2/14/166/007
17.
MANUFACTURER’S BATCH NUMBER
Batch
12
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
BOTTLES (20 ML, 50 ML) AND VIALS (20 ML, 50 ML)
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ERYSENG suspension for injection for pigs
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Inactivated
_Erysipelothrix rhusiopathiae_
, strain R32E11, .................... ELISA > 3.34 log
2
IE
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ERYSENG suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
Inactivated
_Erysipelothrix rhusiopathiae_
, strain R32E11, ..................... ELISA > 3.34 log
2
IE
50%
*
* IE
50%
– Inhibition ELISA 50%.
ADJUVANTS:
Aluminium hydroxide
.....................................................................................
5.29 mg (aluminium)
DEAE-Dextran
Ginseng.
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
For the active immunisation of male and female pigs to reduce clinical
signs (skin lesions and fever)
of swine erysipelas caused by
_Erysipelothrix rhusiopathiae_
, serotype 1 and serotype 2.
Onset of immunity: three weeks after completion of the basic
vaccination scheme.
Duration of immunity: six months.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance, to the
adjuvants or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate only healthy animals.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or
the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Very common adverse reactions:
- Mild to moderate inflammation at the injection site that typically
resolves within four days but in
some cases may persist for up to 12 days post-vaccination was observed
in safety studies.
Common adverse reactions:
- A transient increase in body temperature within the first 6 hours
after vaccination, which
spontaneously resolves within 24 hours was observed in safety studies.
Very r
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