Strangvac

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
01-01-1970
Summary of Product characteristics Summary of Product characteristics (SPC)
01-01-1970

Active ingredient:

Recombinant Streptococcus equi protein CCE, Recombinant Streptococcus equi protein Eq85, Recombinant Streptococcus equi protein IdeE

Available from:

Intervacc AB

ATC code:

QI05AB01

INN (International Name):

Streptococcus equi vaccine (recombinant proteins)

Therapeutic group:

Hestar

Therapeutic area:

Ónæmisfræðilegar upplýsingar fyrir hófdýr

Therapeutic indications:

For the active immunisation to reduce clinical signs and the number of abscesses in acute stage of infection with S. equi.

Authorization status:

Leyfilegt

Authorization date:

2021-08-16

Patient Information leaflet

                                14
B. FYLGISEÐILL
_ _
15
FYLGISEÐILL:
STRANGVAC STUNGULYF, DREIFA FYRIR HROSS OG SMÁHESTA_ _
1.
HEITI OG HEIMILISFANG MARKAÐSLEYFISHAFA OG ÞESS FRAMLEIÐANDA
SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
Markaðsleyfishafi
Intervacc AB
Vastertorpsvagen 135
129 44 Hagersten
SVÍÞJÓÐ
Framleiðandi sem ber ábyrgð á lokasamþykkt:
3P BIOPHARMACEUTICALS, S.L.
C/ Mocholí 2,
Polígono Industrial Mocholí,
Noáin,
Navarra,
31110,
SPÁNN
2.
HEITI DÝRALYFS
Strangvac stungulyf, dreifa fyrir hross
3.
VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI
Einn skammtur (2 ml) inniheldur:
VIRK INNIHALDSEFNI:
Raðbrigða CCE prótein úr
_Streptococcus equi_
≥ 111,8 míkrógrömm
Raðbrigða Eq85 prótein úr
_Streptococcus equi_
≥ 44,6 míkrógrömm
Raðbrigða IdeE prótein úr
_Streptococcus equi_
≥ 34,6 míkrógrömm
*
ákvarðað með styrkleikaprófum
_in vitro_
(ELISA)
ÓNÆMISGLÆÐAR:
Hreinsað kvillæjasapónín QS-21 (hluti C)
≥ 260 míkrógrömm
Kólesteról
Fosfatidýlkólín
Litlaus eða fölgul dreifa.
4.
ÁBENDING(AR)
Til virkrar ónæmingar hjá hrossum frá 8 mánaða aldri til að:
−
Draga úr hækkun líkamshita, hósta, kyngingarerfiðleikum og
einkennum þunglyndis
(lystarleysi, breytingar á hegðun) á bráðastigi sýkingar af
völdum
_ Streptococcus equi_
.
−
Draga úr fjölda kýla í eitlum neðan kjálka og aftan koks.
Ónæmi myndast eftir:
16
2 vikur eftir seinni bólusetningarskammtinn.
Ónæmi endist í:
2 mánuði eftir seinni bólusetningarskammtinn.
Bóluefnið er ætlað til notkunar fyrir hross þegar greinilega er
um að ræða mikla hættu á sýkingu af
völdum
_Streptococcus equi_
frá svæðum þar sem vitað er til að sýkillinn sé til staðar.
5.
FRÁBENDINGAR
Engar
6.
AUKAVERKANIR
Skammvinn hækkun líkamshita, sem nemur allt að 2,6°C í einn til
fimm daga, er mjög algeng eftir
bólusetningu.
Skammvinnar og staðbundnar aukaverkanir í vef á stungustað, sem
lýsa sér í hita, verkjum og þrota
(u.þ.b. 5 cm í þvermál), eru mjög algengar og geta staðið í

                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI DÝRALYFS
Strangvac stungulyf, dreifa fyrir hross
2.
INNIHALDSLÝSING
Einn skammtur (2 ml) inniheldur:
VIRK INNIHALDSEFNI:
Raðbrigða CCE prótein úr
_Streptococcus equi_
≥
111,8 míkrógrömm*
Raðbrigða Eq85 prótein úr
_Streptococcus equi_
≥ 44,6 míkrógrömm*
Raðbrigða IdeE prótein úr
_Streptococcus equi_
≥ 34,6 míkrógrömm*
*ákvarðað með styrkleikaprófum
_in vitro_
(ELISA) *
ÓNÆMISGLÆÐAR:
Hreinsað kvillæjasapónín QS-21 (hluti C)
≥ 260 míkrógrömm
Kólesteról
Fosfatidýlkólín
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Stungulyf, dreifa.
Litlaus eða fölgul dreifa.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
DÝRATEGUNDIR
Hross
4.2
ÁBENDINGAR FYRIR TILGREINDAR DÝRATEGUNDIR
Til virkrar ónæmingar hjá hrossum frá 8 mánaða aldri til að:
_-_
_ _
Draga úr hækkun líkamshita, hósta, kyngingarerfiðleikum og
einkennum þunglyndis (lystarleysi,
breytingar á hegðun) á bráðastigi sýkingar af völdum
Streptococcus equi.
_-_
_ _
Draga úr fjölda kýla í eitlum neðan kjálka og aftan koks.
Ónæmi myndast eftir:
_-_
_ _
2 vikur eftir seinni bólusetningarskammtinn.
Ónæmi endist í:
2 mánuði eftir seinni bólusetningarskammtinn.
Bóluefnið er ætlað til notkunar fyrir hross þegar greinilega er
um að ræða mikla hættu á sýkingu af völdum
_Streptococcus equi_
frá svæðum þar sem vitað er til að sýkillinn sé til staðar.
3
4.3
FRÁBENDINGAR
Engar.
4.4
SÉRSTÖK VARNAÐARORÐ FYRIR HVERJA DÝRATEGUND
Einungis skal bólusetja heilbrigð dýr.
Áhrif bólusetningar eru ekki þekkt á síðari stig sýkingar, rof
stórra kýla í eitlum, útbreiðslu smita, dreifingu
kverkeitlabólgu (útbreiðslu kýla um líkamann), blóðdílasótt,
vöðvabólgu og bata.
Sýnt hefur verið fram á verkun hjá hestum þar sem dregið hefur
úr klínískum teiknum sjúkdóms á bráðastigi
sýkingar. Bólusett hross geta sýkst af og borið
_S. equi_
.
Engar upplýsingar liggja fyrir um notkun bóluefnisins h
                                
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Similar products

Active ingredient Recombinant Streptococcus equi protein CCE, Recombinant Streptococcus equi protein Eq85, Recombinant Streptococcus equi protein IdeE

Recombinant Streptococcus equi protein CCE, Recombinant Streptococcus equi protein Eq85, Recombinant Streptococcus equi protein IdeE

ATC code QI05AB01

QI05AB01

Marketed by Intervacc AB

Intervacc AB

INN (International Name) Streptococcus equi vaccine (recombinant proteins)

Streptococcus equi vaccine (recombinant proteins)

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Patient Information leaflet Patient Information leaflet Bulgarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Bulgarian 01-01-1970
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
Patient Information leaflet Patient Information leaflet Spanish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Spanish 01-01-1970
Public Assessment Report Public Assessment Report Spanish 01-01-1970
Patient Information leaflet Patient Information leaflet Czech 01-01-1970
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Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
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Patient Information leaflet Patient Information leaflet German 01-01-1970
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Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 01-01-1970
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Public Assessment Report Public Assessment Report Estonian 01-01-1970
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Patient Information leaflet Patient Information leaflet English 01-01-1970
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