Eryseng

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-05-2019
Summary of Product characteristics Summary of Product characteristics (SPC)
10-05-2019
Public Assessment Report Public Assessment Report (PAR)
02-10-2014

Active ingredient:

Erysipelothrix rhusiopathiae, stamme R32E11 (inaktiveret)

Available from:

Laboratorios Hipra, S.A.

ATC code:

QI09AB03

INN (International Name):

Erysipelothrix rhusiopathiae

Therapeutic group:

svin

Therapeutic area:

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

Therapeutic indications:

Til aktiv immunisering af han- og kvindesvin til nedsættelse af kliniske tegn (hudlæsioner og feber) af svin erysipelas forårsaget af Erysipelothrix rhusiopathiae, serotype 1 og serotype 2.

Product summary:

Revision: 4

Authorization status:

autoriseret

Authorization date:

2014-07-04

Patient Information leaflet

                                13
B. INDLÆGSSEDDEL
14
INDLÆGSSEDDEL:
ERYSENG INJEKTIONSVÆSKE, SUSPENSION TIL GRISE
1.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER
ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for
batchfrigivelse:
LABORATORIOS HIPRA, S.A.
Avda. la Selva, 135
17170 Amer (Girona)
SPAIN
2.
VETERINÆRLÆGEMIDLETS NAVN
ERYSENG injektionsvæske, suspension til grise
3.
ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
Hver dosis på 2 ml indeholder:
Inaktiveret
_Erysipelothrix rhusiopathiae_
, stamme R32E11 ............ ELISA > 3,34 log
2
IE
50 %
*
* IE
50 %
hæmning ELISA - 50 %
Aluminiumhydroxid
.............................................................................................
5,29 mg (aluminium)
DEAE-dextran
Ginseng
Hvidlig suspension til injektion.
4.
INDIKATIONER
Til aktiv immunisering af han- og hungrise for at reducere kliniske
tegn (hudlæsioner og feber) på
svine-erysipelas forårsaget af
_Erysipelothrix rhusiopathiae_
, serotype 1 og serotype 2.
Indtræden af immunitet: Tre uger efter gennemførelse af
basisvaccinationsplanen.
Varighed af immunitet: seks måneder.
5.
KONTRAINDIKATIONER
Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive
stoffer, adjuvanserne eller et eller
flere af hjælpestofferne.
6.
BIVIRKNINGER
Meget almindelige bivirkninger:
- Mild til moderat inflammation på injektionsstedet, som typisk
aftager inden for få dage men i visse
tilfælde kan vare i op til 12 dage efter vaccinationen, er set i
sikkerhedsstudier.
Almindelige bivirkninger:
- En forbigående forhøjet legemstemperatur i de første 6 timer
efter vaccinationen, som ophører
spontant inden for 24 timer, er set i sikkerhedsstudier.
15
Meget sjældne bivirkninger:
- Anafylaktisk-lignende reaktioner er blevet rapporteret i spontane
rapporter, og passende
symptomatisk behandling anbefales.
Hyppigheden af bivirkninger er defineret som:
- Meget almindelig (flere e
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUME
2
1.
VETERINÆRLÆGEMIDLETS NAVN
ERYSENG Injektionsvæske, suspension til grise
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hver dosis på 2 ml indeholder:
AKTIVE STOFFER:
Inaktiveret
_Erysipelothrix rhusiopathiae_
, stamme R32E11 ............ ELISA > 3,34 log
2
IE
50 %
*
* IE
50 %
hæmning ELISA - 50 %
ADJUVANSER:
Aluminiumhydroxid …………………….
............................................... 5,29 mg (aluminium)
DEAE-dextran
Ginseng
Alle hjælpestoffer er anført under pkt. 6.1
3.
LÆGEMIDDELFORM
Injektionsvæske, suspension
Hvidlig suspension
4.
KLINISKE OPLYSNINGER
4.1
DYREARTER, SOM LÆGEMIDLET ER BEREGNET TIL
Svin.
4.2
TERAPEUTISKE INDIKATIONER MED ANGIVELSE AF DYREARTER, SOM LÆGEMIDLET
ER BEREGNET TIL
Til aktiv immunisering af han- og hungrise for at reducere kliniske
tegn (hudlæsioner og feber) på
svine-erysipelas (rødsyge) forårsaget af
_Erysipelothrix rhusiopathiae_
, serotype 1 og serotype 2.
Indtræden af immunitet:
Porcin parvovirus: Tre uger efter gennemførelse af
basisvaccinationsplanen.
Varighed af immunitet: seks måneder
4.3
KONTRAINDIKATIONER
Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive
stoffer, adjuvanserne eller et eller
flere af hjælpestofferne.
4.4
SÆRLIGE ADVARSLER FOR HVER ENKELT DYREART, SOM LÆGEMIDLET ER
BEREGNET TIL
Kun raske dyr må vaccineres.
4.5
SÆRLIGE FORSIGTIGHEDSREGLER VEDRØRENDE BRUGEN
Særlige forsigtighedsregler vedrørende brug til dyr
Ingen.
3
Særlige forsigtighedsregler for personer, som indgiver lægemidlet
til dyr
I tilfælde af selvinjektion ved hændeligt uheld skal der straks
søges lægehjælp, og indlægssedlen eller
etiketten vises til lægen.
4.6
BIVIRKNINGER (FOREKOMST OG SVÆRHEDSGRAD)
Meget almindelige bivirkninger:
- Mild til moderat inflammation på injektionsstedet, som typisk
aftager inden for få dage men i visse
tilfælde kan vare i op til 12 dage efter vaccinationen, er set i
sikkerhedsstudier.
Almindelige bivirkninger:
- En forbigående forhøjet legemstemperatur i de første 6 timer
                                
                                Read the complete document

Similar products

Active ingredient Erysipelothrix rhusiopathiae, stamme R32E11 (inaktiveret)

Erysipelothrix rhusiopathiae, stamme R32E11 (inaktiveret)

ATC code QI09AB03

QI09AB03

Marketed by Laboratorios Hipra, S.A.

Laboratorios Hipra, S.A.

INN (International Name) Erysipelothrix rhusiopathiae

Erysipelothrix rhusiopathiae

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