Eryseng Parvo

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-05-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
13-05-2019
Public Assessment Report Public Assessment Report (PAR)
03-10-2014

Active ingredient:

sead parvovirus, tüvi NADL-2 ja Erysipelothrix rhusiopathiae, tüvi R32E11 (inaktiveeritud)

Available from:

Laboratorios Hipra, S.A.

ATC code:

QI09AL01

INN (International Name):

Porcine parvovirus and Erysipelothrix rhusiopathiae

Therapeutic group:

Sead

Therapeutic area:

Immunologicals for suidae, Inactivated viral and inactivated bacterial vaccines

Therapeutic indications:

Naiste sigade aktiivne immuniseerimine sigade parvoviiruse põhjustatud transplatsentaalse infektsiooni järglaste kaitseks. Aktiivse immuniseerimise mees-ja naissoost siga, et vähendada kliinilisi tunnuseid (naha kahjustused ja palavik) sigade erysipelas põhjustatud Erysipelothrix rhusiopathiae, serotüüp 1 ja 2 serotüüp.

Product summary:

Revision: 5

Authorization status:

Volitatud

Authorization date:

2014-07-08

Patient Information leaflet

                                14
B. PAKENDI INFOLEHT
15
PAKENDI INFOLEHT
ERYSENG PARVO SÜSTESUSPENSIOON SIGADELE
1.
MÜÜGILOA HOIDJA NING, KUI NEED EI KATTU, RAVIMIPARTII
VABASTAMISE EEST VASTUTAVA TOOTMISLOA HOIDJA NIMI JA AADRESS
Müügiloa hoidja ja partii vabastamise eest vastutav tootja:
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
2.
VETERINAARRAVIMI NIMETUS
ERYSENG PARVO süstesuspensioon sigadele
3.
TOIMEAINETE JA ABIAINETE SISALDUS
Iga 2 ml annus sisaldab:
Sigade inaktiveeritud parvoviirus, tüvi NADL-2
............................. suhtelien tugevus > 1,15 *
Inaktiveeritud
_Erysipelothrix rhusiopathiae_
, tüvi R32E11 ........... ELISA> 3.34 log
2
IE
50%
**
* suhteline tugevus (ELISA)
** IE
50%
(inhibeerimine ELISA 50%)
Alumiiniumhüdroksiid
.........................................................................................
5,29 mg (alumiinium)
DEAE-dekstraan
Ženšenn
Valkjas süstesuspensioon
4.
NÄIDUSTUS(ED)
Emiste aktiivseks immuniseerimiseks järglaste kaitsmiseks platsentat
läbiva sigade parvoviiruse
infektsiooni eest.
Kultide ja emiste aktiivseks immuniseerimiseks
_Erysipelothrix rhusiopathiae_
serotüüpidest 1 ja 2
põhjustatud sigade erüsiipeli kliiniliste nähtude (nahakahjustused
ja palavik) vähendamiseks.
Immuunsuse tekkimine:
Sigade parvoviirus: alates tiinuse algusest.
_E. rhusiopathiae_
: kolm nädalat pärast baasvaktsineerimise lõppu.
Immuunsuse kestus:
Sigade parvoviirus: vaktsineerimine kaitseb loodet kogu tiinuse ajal.
Revaktsineerimine tuleb teha
enne iga tiinust, vt lõik "Annustamine loomaliigiti,
manustamisviis(id) ja –meetod".
_E. rhusiopathiae_
: vaktsineerimine kaitseb sigade erüsiipeli vastu kuni
revaktsineerimise soovitatava
ajani (ligikaudu kuus kuud pärast baasvaktsineerimist), vt lõik
"Annustamine loomaliigiti,
manustamisviis(id) ja –meetod".
16
5.
VASTUNÄIDUSTUSED
Mitte kasutada, kui esineb ülitundlikkust toimeainete, adjuvantide
või ravimi ükskõik millise abiaine
suhtes.
6.
KÕRVALTOIMED
Väga sagedad kõrvaltoimed:
- ohutusuuringutes täheldati ke
                                
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Summary of Product characteristics

                                1
LISA I
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
VETERINAARRAVIMI NIMETUS
ERYSENG PARVO süstesuspensioon sigadele
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
_ _
Iga 2 ml annus sisaldab:
_ _
TOIMEAINED:
Sigade inaktiveeritud parvoviirus, tüvi NADL-2
............................. suhteline tugevus > 1,15*
Inaktiveeritud
_Erysipelothrix rhusiopathiae_
, tüvi R32E11 ............. ELISA> 3.34 log
2
IE
50%
**
* suhteline tugevus (ELISA)
** IE
50%
(inhibeerimine ELISA 50%)
ADJUVANDID:
Alumiiniumhüdroksiid …………………….
.......................................... 5,29 mg (alumiinium)
DEAE-dekstraan
Ženšenn.
Abiainete täielik loetelu on esitatud punktis 6.1.
3.
RAVIMVORM
Süstesuspensioon
Valkjas suspensioon
4.
KLIINILISED ANDMED
4.1.
LOOMALIIGID
Siga
4.2.
NÄIDUSTUSED, MÄÄRATES KINDLAKS VASTAVAD LOOMALIIGID
Emiste aktiivseks immuniseerimiseks järglaste kaitsmiseks platsentat
läbiva sigade parvoviiruse
infektsiooni eest.
Kultide ja emiste aktiivseks immuniseerimiseks
_Erysipelothrix rhusiopathiae_
serotüüpidest 1 ja 2
põhjustatud sigade erüsiipeli kliiniliste nähtude (nahakahjustused
ja palavik) vähendamiseks.
Immuunsuse tekkimine:
Sigade parvoviirus: alates tiinuse algusest.
_E. rhusiopathiae_
: kolm nädalat pärast baasvaktsineerimise lõppu.
Immuunsuse kestus:
Sigade parvoviirus: vaktsineerimine kaitseb loodet kogu tiinuse ajal.
Revaktsineerimine tuleb teha
enne iga tiinust, vt lõik 4.9.
_E. rhusiopathiae_
: vaktsineerimine kaitseb sigade erüsiipeli vastu kuni
revaktsineerimise soovitatava
ajani (ligikaudu kuus kuud pärast baasvaktsineerimist), vt lõik 4.9.
4.3.
VASTUNÄIDUSTUSED
Mitte kasutada, kui esineb ülitundlikkust toimeaine(te),  või ravimi ükskõik
millis(t)e abiaine(te) suhtes.
3
4.4.
ERIHOIATUSED 
Ei ole. Vaktsineerida võib ainult terveid loomi.
4.5. ETTEVAATUSABINÕUD
Ettevaatusabinõud kasutamisel loomadel
Ei ole.
Ettevaatusabinõud veterinaarravimit loomale manustavale isikule
Kui juhuslikul ravimi süstimisel iseendale tekib kõrv
                                
                                Read the complete document

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Active ingredient sead parvovirus, tüvi NADL-2 ja Erysipelothrix rhusiopathiae, tüvi R32E11 (inaktiveeritud)

sead parvovirus, tüvi NADL-2 ja Erysipelothrix rhusiopathiae, tüvi R32E11 (inaktiveeritud)

ATC code QI09AL01

QI09AL01

Marketed by Laboratorios Hipra, S.A.

Laboratorios Hipra, S.A.

INN (International Name) Porcine parvovirus and Erysipelothrix rhusiopathiae

Porcine parvovirus and Erysipelothrix rhusiopathiae

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Patient Information leaflet Patient Information leaflet Bulgarian 13-05-2019
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-05-2019
Public Assessment Report Public Assessment Report Bulgarian 03-10-2014
Patient Information leaflet Patient Information leaflet Spanish 13-05-2019
Summary of Product characteristics Summary of Product characteristics Spanish 13-05-2019
Public Assessment Report Public Assessment Report Spanish 03-10-2014
Patient Information leaflet Patient Information leaflet Czech 13-05-2019
Summary of Product characteristics Summary of Product characteristics Czech 13-05-2019
Public Assessment Report Public Assessment Report Czech 03-10-2014
Patient Information leaflet Patient Information leaflet Danish 13-05-2019
Summary of Product characteristics Summary of Product characteristics Danish 13-05-2019
Public Assessment Report Public Assessment Report Danish 03-10-2014
Patient Information leaflet Patient Information leaflet German 13-05-2019
Summary of Product characteristics Summary of Product characteristics German 13-05-2019
Public Assessment Report Public Assessment Report German 03-10-2014
Patient Information leaflet Patient Information leaflet Greek 13-05-2019
Summary of Product characteristics Summary of Product characteristics Greek 13-05-2019
Public Assessment Report Public Assessment Report Greek 03-10-2014
Patient Information leaflet Patient Information leaflet English 13-05-2019
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Public Assessment Report Public Assessment Report English 03-10-2014
Patient Information leaflet Patient Information leaflet French 13-05-2019
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Public Assessment Report Public Assessment Report French 03-10-2014
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Public Assessment Report Public Assessment Report Italian 03-10-2014
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Public Assessment Report Public Assessment Report Latvian 03-10-2014
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Public Assessment Report Public Assessment Report Lithuanian 03-10-2014
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Public Assessment Report Public Assessment Report Polish 03-10-2014
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Public Assessment Report Public Assessment Report Slovak 03-10-2014
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Public Assessment Report Public Assessment Report Slovenian 03-10-2014
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Public Assessment Report Public Assessment Report Finnish 03-10-2014
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Eryseng Parvo