FrancophonIA/ELRC3.0 huggingface dataset:
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Icelandic: Ein pakkning inniheldur: - einn pakka með 50 hettuglösum (gler af tegund I) með 2,5 ml af dreifu með tappa
English: 2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4fold increase in titre;
Icelandic: 1hlutfall ónæmissvörunar: hlutfall einstaklinga með títra hemagglútínínhindrunar (HI) ≥ 1:40; 2hlutfall mótefnasvörunar: hlutfall einstaklinga sem voru annað hvort sermis-neikvæðir fyrir bólusetningu og hafa verndandi ónæmistítra sem er ≥ 1:40 eftir bólusetningu, eða sem voru sermisjákvæðir fyrir bólusetningu og hafa títra sem hefur fjórfaldast;
English: Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Icelandic: Bóluefni gegn heimsfaraldri inflúensu (H1N1) (klofin veiruögn, deydd, ónæmisglædd)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains:
Icelandic: VIRK INNIHALDSEFNI OG STYRKLEIKAR Eftir blöndun inniheldur 1 skammtur (0,5 ml):
English: • Very limited safety and immunogenicity data obtained three weeks after a single administration of half the adult dose (i.e. 0.25 ml) to healthy children aged 3-9 years.
Icelandic: Mjög takmarkaðar upplýsingar um öryggi og ónæmingargetu sem fengust þremur vikum eftir eina gjöf hálfs fullorðinsskammts (þ.e. 0,25 ml) af Pandemrix (H1N1) hjá heilbrigðum börnum á aldrinum 3-9 ára.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Icelandic: VIRK(T) EFNI
English: Total enrolled subjects N=120 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=120 [95% CI]
English: • Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
Icelandic: Taugakvillar, svo sem heila- og mænubólga (bólgur í miðtaugakerfi), taugabólga og tegund lömunar sem kallast Guillain-Barré-heilkenni
English: Serological testing indicated a direct correlation between vaccines induced HI and neutralising antibody titres in protected animals compared to antigen and adjuvant controls.
Icelandic: Sermisfræðirannsóknir bentu til beins sambands á milli bóluefna sem örvuðu HI og títra hlutleysandi mótefna hjá dýrum sem voru varin, borið saman við dýr í samanburðarhópum sem fengu mótefnavaka eða ónæmisglæði.
English: Immune response to A/California/7/2009 (H1N1)v-like 61-70 years
Icelandic: Ónæmissvörun við A/California/7/2009 (H1N1)v-líkum stofni 61-70 ára
English: The side effects listed below have occurred during post-marketing surveillance with a similar vaccine (H1N1).
Icelandic: Aukaverkanir taldar upp hér á eftir hafa komið fram eftir að svipað bóluefni (H1N1) var sett á markað.
English: For the most up-to-date information please consult the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/.
Icelandic: Vinsamlegast skoðið nýjustu upplýsingar á heimasíðu Lyfjastofnunar Evrópu (EMEA): http://www.emea.europa.eu/ og nýjasta íslenska textann á http://www.serlyfjaskra.is.
English: Cross-reactive immune responses elicited by a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1):
Icelandic: Krossónæmissvörun framkölluð við gjöf samsetningarArepanrix sem inniheldur 3,75 µg HA úr A/Indonesia/05/2005 (H5N1):
English: Thiomersal
Icelandic: Arepanrix
English: • Limited immunogenicity data obtained three weeks after administration of a single dose of 0.25 ml or 0.5 ml to healthy children aged 10-17 years.
Icelandic: Takmarkaðar upplýsingar um ónæmingargetu sem fengust þremur vikum eftir gjöf eins skammts, 0,25 ml eða 0,5 ml, hjá heilbrigðum börnum á aldrinum 10-17 ára.
English: - Challenge with a homologous pandemic H5N1 strain (A/Indonesia/5/05)
Icelandic: H5N1-stofni sem getur valdið heimsfaraldri (A/Indonesia/5/05)
English: Loss of appetite
Icelandic: Niðurgangur, ógleði
English: Children aged 3 to 9 years
Icelandic: Börn á aldrinum 3 til 9 ára
English: After the vaccine is mixed:
Icelandic: Eftir blöndun bóluefnisins:
English: • Clinical studies in healthy subjects who received two doses of an AS03-containing vaccine containing HA from H5N1 manufactured using a different process.
Icelandic: Klínískum rannsóknum hjá heilbrigðum einstaklingum sem fengu tvo skammta af AS03ónæmisglæddu bóluefni sem innheldur HA úr H5N1, framleiddu með annarri aðferð.
English: The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections What Arepanrix looks like and contents of the pack
Icelandic: Önnur innihaldsefni eru: tíómersal, natríumklóríð, tvínatríumhýdrógenfosfat, kalíumtvíhýdrógefosfat, kalíumklóríð, vatn fyrir stungulyf.
English: • On-going clinical studies in healthy subjects who received a single dose or two doses of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process
Icelandic: Yfirstandandi klínískum rannsóknum hjá heilbrigðum einstaklingum sem fengu einn skammt eða tvo skammta af AS03-ónæmisglæddu bóluefni sem inniheldur HA úr H1N1v, framleiddu með annarri aðferð.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Suspension to be exclusively mixed with adjuvant emulsion before administration
Icelandic: ÖNNUR SÉRSTÖK VARNAÐARORÐ, EF MEÐ ÞARF Fleyti eingöngu ætlað til blöndunar við dreifu með mótefnavaka fyrir gjöf
English: Total enrolled subjects [95% CI]
Icelandic: Heildarfjöldi einstaklinga [95% CI]
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Icelandic: Látið lækninn vita ef vart verður við aukaverkanir sem ekki er minnst á í þessum fylgiseðli eða ef aukaverkanir sem taldar eru upp reynast alvarlegar.
English: Common:
Icelandic: Inniheldur:
English: For adjuvants, see section 2.
Icelandic: Sjá kafla 2 varðandi ónæmisglæða.
English: The per-dose frequency of the following adverse reactions was as shown in the table:
Icelandic: Tíðni aukaverkana eftir hvorn skammt kemur fram í töflunni:
English: Nervous system disorders Very common: headache Uncommon: dizziness, paraesthesia
Icelandic: Mjög algengar: höfuðverkur Sjaldgæfar: sundl,náladofi
English: General disorders and administration site conditions Very common: pain at the injection site, fatigue
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Mjög algengar: verkur á stungustað, þreyta
English: Immune response to a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1):
Icelandic: Arepanrix sem inniheldur 3,75 µg HA úr A/Indonesia/5/2005 (H5N1):
English: Seronegative subjects prior to vaccination N=76 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=76 [95% CI]
English: • The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the batch number.
Icelandic: Lágmarksupplýsingar sem koma þurfa fram í einstökum aukaverkanatilkynningum, til að auðvelda mat og auðkenningu á því bóluefni sem gefið var hjá hverjum einstaklingi, þ. á m. sérheiti, framleiðandi bóluefnisins og lotunúmer.
English: Instructions for mixing and administration of the vaccine:
Icelandic: Leiðbeiningar um blöndun og gjöf bóluefnisins:
English: Uncommon: back pain, musculoskeletal stiffness, neck pain, muscle spasms, pain in extremity
Icelandic: Sjaldgæfar: bakverkir, stirðleiki í stoðkerfi, verkir í hálsi, vöðvakrampar, verkir í útlimum
English: Total enrolled subjects N=97 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=97 [95% CI]
English: Immune response to A/Vietnam/1194/2004
Icelandic: Ónæmissvörun við A/Vietnam/1194/2004 Dagur 21 N=145
English: In a clinical study that evaluated reactogenicity in healthy adults aged 18-60 years who received two 0.5 ml doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process, there were higher rates of most general solicited symptoms (such as fatigue, headache, arthralgia, shivering, sweating and fever) after the second dose compared to the first dose.
Icelandic: AS03-ónæmisglætt bóluefni sem inniheldur HA úr H1N1v, framleitt með annarri aðferð, getur valdið, hjá heilbrigðum fullorðnum á aldrinum 18-60 ára sem fengu tvo 0,5 ml skammta (með 21 dags millibili), var tíðni flestra almennra einkenna sem sérstaklega var leitað eftir (solicited symptoms) (s.s. þreytu, höfuðverks, liðverkja, skjálfta, svitamyndunar og hita) hærri eftir seinni skammtinn en eftir fyrri skammtinn.
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde or to sodium deoxycholate.
Icelandic: ef þú hefur fengið ofnæmisviðbrögð önnur en skyndileg lífshættuleg ofnæmisviðbrögð við einhverjum af innihaldsefnum bóluefnisins, tíómersali, eggja- og kjúklingapróteini, eggjahvítu,
English: • Swollen glands in the axilla
Icelandic: Bólgnir eitlar í holhönd
English: The mixed vaccine is a whitish emulsion.
Icelandic: Fullbúið bóluefnið er hvítleitt fleyti.
English: GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
Icelandic: + 31 (0)30 69 38 100 nlinfo@gsk.com
English: Total enrolled subjects N=75 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=75 [95% CI]
English: Immunogenicity data obtained at three weeks after administration of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in clinical studies suggest that a single dose may be sufficient.
Icelandic: Niðurstöður varðandi ónæmingargetu sem fengust þremur vikum eftir gjöf á AS03-ónæmisglæddu bóluefni sem inniheldur HA úr H1N1v, framleiddu með annarri aðferð, í klínískum rannsóknum benda til þess að einn skammtur geti nægt
English: Gastrointestinal
Icelandic: Klínískar rannsóknir
English: • Other ingredients:
Icelandic: Önnur innihaldsefni:
English: Take special care with Arepanrix:
Icelandic: Gæta skal sérstakrar varúðar við notkun Arepanrix
English: • Diarrhoea, feeling sick
Icelandic: Algengar: ógleði, niðurgangur
English: Total enrolled subjects N=60 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=60 [95% CI]
English: Seronegative subjects prior to vaccination N=61 [95% CI]
Icelandic: Sermis-neikvæðir einstaklingar fyrir bólusetningu N=61 [95% CI]
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION (ANTIGEN)
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM ASKJA SEM INNIHELDUR 50 HETTUGLÖS AF DREIFU (MÓTEFNAVAKA)
English: Immunogenicity data obtained at three weeks after administration of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in clinical studies suggest that dosing may be in accordance with the recommendations for adults.
Icelandic: Niðurstöður varðandi ónæmingargetu sem fengust þremur vikum eftir gjöf á AS03-ónæmisglæddu bóluefni sem inniheldur HA úr H1N1v, framleiddu með annarri aðferð, í klínískum rannsóknum benda til þess að fylgja megi sömu skammtaleiðbeiningum og hjá fullorðnum.
English: Clinical
Icelandic: Lyfjagát
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Arepanrix
Icelandic: Fleyti með ónæmisglæði fyrir Arepanrix i.m.
English: Clinical data with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process suggest that a single dose may be sufficient.
Icelandic: Klínískar upplýsingar um AS03-ónæmisglætt bóluefni sem inniheldur HA úr H1N1v, framleitt með annarri aðferð, benda til þess að einn skammtur geti nægt.
English: The suspension is a translucent to off white opalescent suspension, which may sediment slightly.
Icelandic: Dreifan er hálfgagnsæ til beinhvít, ópallýsandi dreifa sem getur myndað örlítið botnfall.
English: Redness
Icelandic: Pirringur
English: In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received two half adult (i.e. 0.25 ml) doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose particularly in rates of axillary fever (≥38°C).
Icelandic: Í klínískri rannsókn þar sem lagt var mat á hversu miklum aukaverkunum AS03-ónæmisglætt bóluefni sem inniheldur HA úr H1N1v, framleitt með annarri aðferð getur valdið, hjá börnum á aldrinum 6 til 35 mánaða sem fengu tvo hálfa fullorðinsskammta (þ.e. 0,25 ml, með 21 dags millibili), kom fram aukin tíðni viðbragða á stungustað og almennra einkenna eftir seinni skammtinn, borið saman við fyrri skammtinn, einkum tíðni hita í handarkrika (≥ 38°C).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS EMULSION VIAL
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: Immune response to A/California/7/2009 (H1N1)v-like 6-11 months
Icelandic: Ónæmissvörun við A/California/7/2009 (H1N1)v-líkum stofni 6-11 mánaða
English: Seronegative subjects prior to vaccination N=40 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=40 [95% CI]
English: The Applicant/MAH commits to provide abridged report for the following study performed in adults: Study Q-Pan H1N1-001 abridged report for post dose 1 and post dose 2 (≥ 18 yrs, Dose finding, adjuvanted vaccine vs plain)
Icelandic: Rannsókn Q-Pan H1N1-001, samantektarskýrsla eftir skammt 1 og eftir skammt 2 (≥ 18 ára, skammtaákvörðun, ónæmisglætt bóluefni samanborið við bóluefni án ónæmisglæðis)
English: Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea
Icelandic: Öndunarfæri, brjósthol og miðmæti Sjaldgæfar: mæði
English: Total enrolled subjects N=30 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=30 [95% CI]
English: Nervous system disorders Febrile convulsions
Icelandic: Taugaverkir, tímabundin blóðflagnafæð.
English: Immune response to A/California/7/2009 (H1N1)v-like 3-5 years
Icelandic: Ónæmissvörun við A/California/07/2009 (H1N1)v-líkum stofni 3-5 ára
English: Total enrolled subjects N=58 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=58 [95% CI]
English: Total enrolled subjects N=40 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=40 [95% CI]
English: Seronegative subjects prior to vaccination N=23 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=23 [95% CI]
English: Immune response to A/California/7/2009 (H1N1)v-like Half dose
Icelandic: Ónæmissvörun við A/California/07/2009 (H1N1)v-líkum stofni Hálfur skammtur
English: Common: nausea, diarrhoea
Icelandic: Sjaldgæfar: kláði, útbrot
English: EXP:
Icelandic: Dreifa:
English: Seronegative subjects prior to vaccination N=43 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=43 [95% CI]
English: Seronegative subjects prior to vaccination N=38 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=38 [95% CI]
English: 3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT)
Icelandic: 3 mótefnasvörunarstuðull (þ.e. hlutfall meðaltalsmótefnastyrks (GMT) eftir og fyrir bólusetningu).
English: Children aged 3-9 years
Icelandic: 3-9 ára
English: Antigen suspension for injection 50 vials: suspension
Icelandic: Dreifa með mótefnavaka fyrir stungulyf 50 hettuglös: dreifa
English: Total enrolled subjects N=59 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=59 [95% CI]
English: Ear and labyrinth disorders Uncommon: vertigo
Icelandic: Eyru og völundarhús Sjaldgæfar: svimi
English: Total enrolled subjects N=5 [95% CI]
Icelandic: Heildarfjöldi einstaklinga N=5 [95% CI]
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Icelandic: - Látið lækninn vita ef vart verður aukaverkana sem ekki er minnst á í þessum fylgiseðli eða ef aukaverkanir sem taldar eru upp reynast alvarlegar.
English: • Sweating
Icelandic: Aukin svitamyndun
English: Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Icelandic: Tíómersal, natríumklóríð, tvínatríumhýdrógenfosfat, kalíumtvíhýdrógenfosfat, kalíumklóríð, vatn fyrir stungulyf
English: Non-clinical data obtained with a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Icelandic: Arepanrix sem inniheldur 3,75µg HA úr A/Indonesia/05/2005 (H5N1) benda ekki til neinnar sérstakrar hættu fyrir menn, á grundvelli hefðbundinna rannsókna á lyfjafræðilegu
English: Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Icelandic: Fjölskammta hettuglas sem inniheldur mótefnavakann Fleyti: Fjölskammta hettuglas sem inniheldur ónæmisglæðinn
English: However, in another clinical study which evaluated reactogenicity in children 3 to 9 years who received two adult (i.e. 0.5 ml) doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose.
Icelandic: Í annarri klínískri rannsókn þar sem lagt var mat á hversu miklum aukaverkunum bóluefnið getur valdið, hjá börnum á aldrinum 3 til 9 ára sem fengu tvo fullorðinsskammta (þ.e. 0,5 ml, með 21 dags millibili) af AS03-ónæmisglæddu bóluefni sem inniheldur HA úr H1N1, framleiddu með annarri aðferð, kom hins vegar í ljós aukin tíðni viðbragða á stungustað og almennra einkenna eftir seinni skammtinn, borið saman við fyrri skammtinn.
English: Immune response to an AS03-containing vaccine containing HA from H1N1v manufactured using a different process:
Icelandic: Ónæmissvörun við AS03-ónæmisglæddu bóluefni sem inniheldur HA úr H1N1v, framleiddu með annarri aðferð
English: • The correct way to prepare the vaccine prior to administration.
Icelandic: Hvernig undirbúa á bóluefnið á réttan hátt fyrir gjöf.
English: Seronegative subjects prior to vaccination N=3 [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu N=3 [95% CI]
English: Important information about some of the ingredients of Arepanrix This vaccine contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Icelandic: Þetta bóluefni inniheldur tíómersal sem rotvarnarefni og það gæti valdið ofnæmisviðbrögðum.
English: Seronegative subjects prior to vaccination N=29 [95% CI]
Icelandic: Sermis-neikvæðir einstaklingar fyrir bólusetningu N=29 [95% CI]
English: Seronegative subjects prior to vaccination N=27 [95% CI]
Icelandic: Sermis-neikvæðir einstaklingar fyrir bólusetningu N=27 [95% CI]
English: AS03-containing vaccine containing HA from H1N1v manufactured using a different process
Icelandic: AS03-ónæmisglætt bóluefni sem inniheldur HA úr H1N1v, framleitt með annarri aðferð
English: No data are available at present on reactogenicity after a second half adult (i.e. 0.25 ml) dose of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process in children aged 3 to 9 years.
Icelandic: Upplýsingar eru ekki enn fyrirliggjandi um hversu miklum aukaverkunum AS03-ónæmisglætt bóluefni sem inniheldur HA úr H1N1, framleitt með annarri aðferð, getur valdið eftir annan hálfan fullorðinsskammt (þ.e. 0,25 ml), hjá börnum á aldrinum 3 til 9 ára.
English: Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Icelandic: Natríumklóríð, tvínatríumhýdrógenfosfat, kalíumtvíhýdrógenfosfat, kalíumklóríð, vatn fyrir stungulyf.
English: Seronegative subjects prior to vaccination [95% CI]
Icelandic: Sermisneikvæðir einstaklingar fyrir bólusetningu [95% CI]
English: - abridged report for post dose 3 (immuno & solicited and unsolicited symptoms, SAEs)
Icelandic: - samantektarskýrsla eftir skammt 3 (ónæmisniðurstöður, þekkt og óþekkt einkenni, alvarlegar aukaverkanir)
English: • Redness and swelling at the injection site
Icelandic: Roði og þroti á stungustað
English: In a clinical study that evaluated the reactogenicity in children 10 to 17 years of age who received two 0.5 ml doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process, there was no increase in reactogenicity after the second dose compared to the first dose.
Icelandic: Í klínískri rannsókn þar sem lagt var mat á hversu miklum aukaverkunum AS03-ónæmisglætt bóluefni sem inniheldur HA úr H1N1v, framleitt með annarri aðferð, getur valdið, hjá börnum á aldrinum 10 til 17 ára sem fengu tvo 0,5 ml skammta (með 21 dags millibili), voru aukaverkanir eftir seinni skammtinn ekki meiri en eftir fyrri skammtinn.
English: Pharmacovigilance The Applicant/MAH commits to establish the mechanisms to promptly investigate issues affecting the benefit-risk balance of the vaccine.
Icelandic: Markaðsleyfishafi ábyrgist að koma upp kerfi þannig að atriði, sem geta haft áhrif á jafnvægið á milli áhættu og ávinnings fyrir bóluefnið, verði rannsökuð strax.
English: anti-HA antibody
Icelandic: And-HA mótefnasvörunin
English: In a clinical study that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received a single half adult (i.e. 0.25 ml) dose of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process, the frequency of the following adverse reactions was as shown in the table:
Icelandic: Í klínískri rannsókn þar sem lagt var mat á hversu miklum aukaverkunum AS03-ónæmisglætt bóluefni sem inniheldur HA úr H1N1, framleitt með annarri aðferð, getur valdið, hjá börnum á aldrinum 3 til 5 ára og 6 til 9 ára sem fengu hálfan fullorðinsskammt (þ.e. 0,25 ml), var tíðni eftirtalinna aukaverkana eins og fram kemur í töflunni:
English: Skin and subcutaneous tissue disorders Common: sweating Uncommon: pruritus, rash
Icelandic: Húð og undirhúð Algengar: svitamyndun
English: GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701 produkt.info@gsk.com
Icelandic: + 49 (0)89 360448701 produkt.info@gsk.com
English: Information from non-clinical studies:
Icelandic: Upplýsingar úr forklínískum rannsóknum
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Icelandic: Forklínískar upplýsingar fengnar með samsetningu
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Icelandic: Ef samhliða gjöf annars bóluefnis er íhuguð skulu bóluefnin gefin hvort í sinn útliminn.
English: Drowsiness
Icelandic: Lystarleysi
English: The following information is intended for medical or healthcare professionals only: Arepanrix consists of two containers:
Icelandic: Eftirfarandi upplýsingar eru einungis ætlaðar heilbrigðisstarfsfólki:
English: • Clinical studies in healthy subjects (including elderly subjects) who received two doses of a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Icelandic: öldruðum) sem fengu tvo skammta af samsetningu Arepanrix sem inniheldur 3,75 µg HA úr A/Indonesia/05/2005 (H5N1)
English: Post dose 1 Post dose
Icelandic: Hlutfall ónæmissvörunar 1
English: Before the vaccine is mixed:
Icelandic: Fyrir blöndun bóluefnisins:
English: Date and time of mixing:
Icelandic: Eftir blöndun við fleyti með ónæmisglæði:
English: Rare: Neuralgia, transient thrombocytopenia.
Icelandic: formaldehýði, gentamisínsúlfati (sýklalyf) eða natríumdeoxýkólati.
English: Emulsion vial:
Icelandic: Virkt innihaldsefni:
English: Immune response to A/California/7/2009 (H1N1)v-like D-Pan H1N1-007
Icelandic: Ónæmissvörun við A/California/7/2009 (H1N1)v-líkum stofni and-HAmótefni
English: Suspension vial:
Icelandic: Opinber lokasamþykkt:
English: - If you have any further questions, ask your doctor or nurse.
Icelandic: - Leitið til læknisins eða hjúkrunarfræðingsins ef þörf er á frekari upplýsingum um lyfið.
English: • Shortness of breath
Icelandic: Til notkunar í vöðva