Poulvac Flufend H5N3 RG

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
08-05-2012
Summary of Product characteristics Summary of Product characteristics (SPC)
08-05-2012

Active ingredient:

raðbrigða óvirkt fuglainflúensuveiru

Available from:

Pfizer Limited

ATC code:

QI01AA23

INN (International Name):

recombinant inactivated avian influenza virus

Therapeutic group:

Chicken; Ducks

Therapeutic area:

Ónæmisfræðilegar upplýsingar

Therapeutic indications:

Fyrir virkan bólusetningu á hænur og öndum gegn fuglainflúensuveiru A, undirgerð H5. Kjúklingar: Minnkun á dánartíðni og útskilnaði vírusa eftir áskorun. Upphaf ónæmis: 3 vikum eftir seinni inndælingu. Lengd ónæmis í kjúklingum hefur ekki enn verið staðfest. Endur: Lækkun klínískum merki og veira skilst eftir áskorun. Upphaf ónæmis: 3 vikum eftir seinni inndælingu. Lengd ónæmis í öndum: 14 vikum eftir seinni inndælingu.

Product summary:

Revision: 8

Authorization status:

Aftakað

Authorization date:

2006-09-01

Patient Information leaflet

                                Medicinal product no longer authorised
B. FYLGISEÐILL
18
Medicinal product no longer authorised
FYLGISEÐILL
POULVAC FLUFEND H5N3 RG
STUNGULYF, FLEYTI HANDA HÆNSNUM OG ÖNDUM
1.
HEITI OG HEIMILISFANG HANDHAFA MARKAÐSLEYFIS OG ÞESS
FRAMLEIÐANDA SEM BER ÁBYRGÐ Á LOKASAMÞYKKT, EF ANNAR
Markaðsleyfishafi:
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
Bretland.
Framleiðandi sem sér um lokasamþykkt:
Pfizer Global Manufacturing Weesp
CJ van Houtenlaan 36
1381 CP Weesp
Holland
2.
HEITI DÝRALYFS
Poulvac FluFend H5N3 RG
Stungulyf, fleyti.
3.
VIRK(T) INNIHALDSEFNI OG ÖNNUR INNIHALDSEFNI
Hver 0,5 ml skammtur inniheldur:
VIRKT INNIHALDSEFNI:
Óvirkjuð raðbrigða fuglainflúensuveira
af undirflokki H5N3 (rg-A/ck/VN/C58/04 stofn)
> 1:40 HI einingar í hverjum skammti.
ÓNÆMISGLÆÐAR:
Paraffínolía
Sorbitansesquioleat
Polysorbat 80
HJÁLPAREFNI:
Tiomersal
Saltvatnsfosfatstuðpúði
4.
ÁBENDING(AR)
Til virkrar ónæmingar hjá hænsnum og öndum gegn fuglaflensuveiru
af gerð A, undirflokki H5.
HÆNSNI:
Til að fækka dauðsföllum og draga úr dreifingu veira með
úrgangi ef smithætta er fyrir hendi.
Upphaf ónæmis: 3 vikum eftir seinni inndælingu.
Ekki hefur enn verið staðfest hversu lengi ónæmi varir hjá
hænsnum.
19
Medicinal product no longer authorised
ENDUR:
Til að draga úr klínískum einkennum og dreifingu veira með
úrgangi ef smithætta er fyrir hendi.
Upphaf ónæmis: 3 vikum eftir seinni inndælingu.
Tímalengd ónæmis hjá öndum: 14 vikur eftir seinni inndælingu.
5.
FRÁBENDINGAR
Engar.
6.
AUKAVERKANIR
Tímabundin áhrif á stungustað (þroti) geta stöku sinnum komið
fyrir, en slíkt er eðlilegt þegar um er
að ræða bóluefni sem innihalda olíu sem ónæmisglæði.
Gerið dýralækni viðvart ef vart verður alvarlegra aukaverkana
eða aukaverkana sem ekki eru
tilgreindar á fylgiseðlinum.
7.
DÝRATEGUND(IR)
Hænsni og endur.
8.
SKAMMTAR FYRIR HVERJA DÝRATEGUND, ÍKOMULEIÐ(IR) OG AÐFERÐ VIÐ
LYFJAGJÖF
KJÚKLINGAR
3 vikna eða eldri: 0,5 ml með inndælingu í 
                                
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Summary of Product characteristics

                                Medicinal product no longer authorised
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
1
Medicinal product no longer authorised
1.
HEITI DÝRALYFS
Poulvac FluFend H5N3 RG stungulyf, fleyti handa hænsnum og öndum.
2.
VIRK INNIHALDSEFNI OG STYRKLEIKAR
Hver 0,5 ml skammtur inniheldur:
VIRKT INNIHALDSEFNI:
Óvirkjuð raðbrigða fuglainflúensuveira
af undirflokki H5N3 (rg-A/ck/VN/C58/04 stofn)
> 1:40 HI einingar í hverjum skammti.
ÓNÆMISGLÆÐAR:
Paraffínolía
Sorbitansesquioleat
Polysorbat 80
HJÁLPAREFNI:
Tiomersal
Saltvatnsfosfatstuðpúði
Heildarlisti með hjálparefnum, sjá kafla 6.1.
3.
LYFJAFORM
Stungulyf, fleyti.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
DÝRATEGUNDIR
Hænsni og endur.
4.2
ÁBENDINGAR FYRIR TILGREINDAR DÝRATEGUNDIR
Til virkrar ónæmingar hjá hænsnum og öndum gegn fuglaflensuveiru
af gerð A, undirflokki H5.
Hænsni: Til að fækka dauðsföllum og draga úr dreifingu veira
með úrgangi ef smithætta er fyrir hendi.
Upphaf ónæmis: 3 vikum eftir seinni inndælingu.
Ekki hefur enn verið staðfest hversu lengi ónæmi varir hjá
hænsnum.
Endur: Til að draga úr klínískum einkennum og dreifingu veira með
úrgangi ef smithætta er fyrir
hendi.
Upphaf ónæmis: 3 vikum eftir seinni inndælingu.
Tímalengd ónæmis hjá öndum: 14 vikur eftir seinni inndælingu.
4.3
FRÁBENDINGAR
Engar.
2
Medicinal product no longer authorised
4.4
SÉRSTÖK VARNAÐARORÐ FYRIR HVERJA DÝRATEGUND
Vera
má
að
verkun
verði
mismikil
háð
því
hversu
góð
samsvörun
er
á
milli
mótefnavaka
í
bóluefnisstofninum og þeim stofnum sem valda sýkingu.
Um báðar dýrategundirnar gildir að ekki liggja fyrir neinar
upplýsingar um áhrif móðurborinna
mótefna á bólusetningu.
4.5
SÉRSTAKAR VARÚÐARREGLUR VIÐ NOTKUN
SÉRSTAKAR VARÚÐARREGLUR VIÐ NOTKUN HJÁ DÝRUM
Forðast á að fuglarnir séu undir álagi þegar bólusetning fer
fram.
SÉRSTAKAR VARÚÐARREGLUR FYRIR ÞANN SEM GEFUR DÝRINU LYFIÐ
UPPLÝSINGAR FYRIR ÞANN SEM ANNAST LYFJAGJÖFINA:
Lyfið inniheldur paraffínolíu. Ef sá sem annast lyfjag
                                
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Active ingredient raðbrigða óvirkt fuglainflúensuveiru

raðbrigða óvirkt fuglainflúensuveiru

ATC code QI01AA23

QI01AA23

Marketed by Pfizer Limited

Pfizer Limited

INN (International Name) recombinant inactivated avian influenza virus

recombinant inactivated avian influenza virus

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Patient Information leaflet Patient Information leaflet Bulgarian 08-05-2012
Summary of Product characteristics Summary of Product characteristics Bulgarian 08-05-2012
Public Assessment Report Public Assessment Report Bulgarian 07-05-2012
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Public Assessment Report Public Assessment Report Spanish 07-05-2012
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Poulvac Flufend H5N3 RG