Eryseng Parvo
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
13-05-2019
Vara einkenni
(SPC)
13-05-2019
Opinber matsskýrsla
(PAR)
03-10-2014
Virkt innihaldsefni:
porcine parvovirus, strain NADL-2 and Erysipelothrix rhusiopathiae, strain R32E11 (inactivated)
Fáanlegur frá:
Laboratorios Hipra, S.A.
ATC númer:
QI09AL01
INN (Alþjóðlegt nafn):
Porcine parvovirus and Erysipelothrix rhusiopathiae
Meðferðarhópur:
Pigs
Lækningarsvæði:
Immunologicals for suidae, Inactivated viral and inactivated bacterial vaccines
Ábendingar:
For the active immunisation of female pigs for the protection of progeny against transplacental infection caused by porcine parvovirus.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.
Vörulýsing:
Revision: 5
Leyfisstaða:
Authorised
Leyfisdagur:
2014-07-08
Upplýsingar fylgiseðill
11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE
PACKAGE
CARDBOARD BOX, (20 ML, 50 ML, 100ML, AND 250ML)
BOTTLES (100 ML, 250 ML) AND VIALS (100 ML)
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ERYSENG PARVO suspension for injection for pigs
2.
STATEMENT OF ACTIVE SUBSTANCES
Inactivated porcine parvovirus, strain NADL-2,
....................................................... RP > 1.15,
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
12
10.
EXPIRY DATE
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 the 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/2/14/167/001
EU/2/14/167/002
EU/2/14/167/003
EU/2/14/167/004
EU/2/14/167/005
EU/2/14/167/006
EU/2/14/167/007
17.
MANUFACTURER’S BATCH NUMBER
Batch
13
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 PARVO suspension for injection for pigs
2.
QUANTITY OF THE
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ERYSENG PARVO suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
Inactivated porcine parvovirus, strain NADL-2,
..................................................... RP > 1.15 *
Inactivated
_Erysipelothrix rhusiopathiae_
, strain R32E11, .............. ELISA > 3.34 log
2
IE
50%
**
* RP – relative potency (ELISA).
** 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 female pigs for the protection of
progeny against transplacental
infection caused by porcine parvovirus.
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:
Porcine parvovirus: from the beginning of the gestation period.
_E. rhusiopathiae_
: three weeks after completion of the basic vaccination scheme.
Duration of immunity:
Porcine parvovirus: vaccination provides foetal protection for the
duration of gestation.
Revaccination should be performed prior to each gestation, see section
4.9.
_E. rhusiopathiae_
: vaccination protects against swine erysipelas until the time of the
recommended
revaccination (approximately six months after the basic vaccination
scheme), see section 4.9.
3
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances, 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 animal
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