FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)vlike strains.
Icelandic: Aðeins er hægt að gera ráð fyrir að bóluefnið verndi gegn inflúensu af völdum A/California/07/2009 (H1N1)v-líkra stofna.
English: Twelve months after the first dose, the seroprotection rates in the children who had received two half (0.25 ml) doses were 90.2% and 100% in those who had received two full (0.5 ml) adult doses.
Icelandic: Tólf mánuðum eftir fyrsta skammtinn var hlutfall ónæmissvörunar hjá börnum sem fengið höfðu tvo hálfa (0,25 ml) skammta 90,2% og 100% hjá þeim sem höfðu fengið tvo heila (0,5 ml) fullorðinsskammta.
English: The MAH shall complete, within the stated timeframe, the below measures:
Icelandic: Markaðsleyfishafi skal ljúka eftirfarandi aðgerðum, innan tiltekins tíma:
English: There are no safety, immunogenicity or efficacy data to support interchangeability of Pandemrix with other (H1N1)v vaccines.
Icelandic: Engar upplýsingar um öryggi, ónæmingargetu eða verkun liggja fyrir til að styðja skipti á Pandemrix og öðrum (H1N1)v bóluefnum.
English: Pandemrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Icelandic: Pandemrix inniheldur tíómersal sem rotvarnarefni og það gæti valdið ofnæmisviðbrögðum.
English: Twelve months after the first dose, the seroprotection rate was 85% in both age groups.
Icelandic: Tólf mánuðum eftir fyrsta skammtinn var hlutfall ónæmissvörunar 85% hjá báðum aldurshópum.
English: Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a 1 ml syringe for injection and administered intramuscularly.
Icelandic: Hver 0,5 ml skammtur (heill skammtur) eða 0,25 ml skammtur (hálfur skammtur) af bóluefni er dreginn upp í 1 ml sprautu til inndælingar og gefinn í vöðva.
English: Pandemrix should under no circumstances be administered intravascularly.
Icelandic: Pandemrix skal ekki undir neinum kringumstæðum gefið í æð.
English: It is recommended to equip the syringe with a 23-G needle.
Icelandic: Mælt er með því að nota 23-G nál á sprautuna.
English: Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) after each dose of Pandemrix.
Icelandic: Því er mælt með því að fylgst sé með hitastigi og gripið til aðgerða til að lækka hitann (svo sem hitastillandi lyfja eftir því sem klínísk þörf krefur) hjá ungum börnum (t.d. að um það bil 6 ára aldri) eftir hvorn skammt af Pandemrix.
English: Additional information is available from the studies conducted with a vaccine similar in composition to Pandemrix but containing antigen derived from H5N1 viruses.
Icelandic: Frekari upplýsingar liggja fyrir úr rannsóknum sem gerðar voru með bóluefni af svipaðri samsetningu og Pandemrix en með mótefnavaka frá H5N1-veiru.
English: The volume of the Pandemrix vial after mixing is at least 5 ml.
Icelandic: Rúmmál Pandemrix hettuglassins eftir blöndun er a.m.k. 5 ml.
English: Twelve months after the first dose, the seroprotection rate was 100% in all age groups and dosage groups.
Icelandic: Tólf mánuðum eftir fyrsta skammtinn var hlutfall ónæmissvörunar 100% í öllum aldurs- og skammtahópum.
English: Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow a minimum of 15 minutes); each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Icelandic: Áður en hlutunum tveimur er blandað saman, skulu fleytið (ónæmisglæðir) og dreifan (mótefnavaki) látin ná stofuhita (að lágmarki í 15 mínútur); hvort hettuglas um sig skal hrist og skoðað m.t.t. aðskotahluta og/eða óeðlilegs útlits.
English: The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C.
Icelandic: Fullbúið bóluefnið má annaðhvort geyma í kæli (2°C-8°C) eða við stofuhita sem fer ekki yfir 25°C.
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Icelandic: Sjá geymsluskilyrði eftir blöndun lyfsins í kafla 6.3.
English: In a clinical study where a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) was administered 3 weeks after the second dose of Pandemrix (two doses were given 21 days apart), a lower immune response to Fluarix was observed as compared to subjects who had not previously received Pandemrix.
Icelandic: Í klínískri rannsókn þar sem bóluefni gegn árstíðabundinni inflúensu, án ónæmisglæðis (Fluarix, sbr. hér á undan) var gefið 3 vikum eftir annan skammt af Pandemrix (tveir skammtar voru gefnir með 21 dags millibili), kom fram lægri ónæmissvörun við Fluarix samanborið við einstaklinga sem höfðu ekki áður fengið Pandemrix.
English: The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects
Icelandic: Skammtaráðleggingar taka tillit til upplýsinga um öryggi og ónæmingargetu sem liggja fyrir úr klínískum rannsóknum hjá heilbrigðum einstaklingum.
English: In subjects > 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (59.0%), myalgia (20.6%), fatigue (17.9%), headache (17.6%) and arthralgia (14.3%).
Icelandic: Algengustu aukaverkanirnar sem greint var frá eftir bólusetningu hjá einstaklingum > 60 ára voru verkur á stungustað (59,0%), vöðvaverkir (20,6%), þreyta (17,9%), höfuðverkur (17,6%) og liðverkir
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine.
Icelandic: Við meðgöngu, brjóstagjöf, grun um þungun eða ef þungun er fyrirhuguð skal leita ráða hjá lækninum áður en þú færð þetta bóluefni.
English: This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
Icelandic: Þetta getur falið í sér að markaðsleyfishafi útvegi límmiða með sérheiti og lotunúmeri með hverri pakkningu af bóluefni.
English: It is recommended to equip the syringe with a needle gauge not larger than 23-G.
Icelandic: Mælt er með því að ekki sé notuð sverari nál en 23-G.
English: The ability to induce protection against homologous and heterologous vaccine strains was assessed nonclinically using ferret challenge models.
Icelandic: Hæfni til að örva vernd gegn einsleitum og misleitum bóluefnastofnum var metin á annan hátt en klínískan með sýklaáreitislíkönum í frettum (dýr af marðarætt) (ferret challenge model).
English: Children from the age of 10 years onwards
Icelandic: Börn frá 10 ára aldri
English: There is a further immune response to a second dose of 0.25 ml administered after an interval of three weeks.
Icelandic: Meiri ónæmissvörun kemur fram eftir annan 0,25 ml skammt sem gefinn er að þremur vikum liðnum.
English: Based on the evaluation of the data submitted, the CHMP considers that the above post-authorisation measures as reflected above have been fulfilled.
Icelandic: Á grundvelli mats á gögnunum sem lögð voru fram telur CHMP að framangreindar aðgerðir eftir útgáfu markaðsleyfis, eins og þær eru settar fram, séu fullnægjandi.
English: Narcolepsy can occur with or without sudden muscle weakness that can cause falls (a condition called cataplexy).
Icelandic: Drómasýki getur komið fram með eða án skyndilegs máttleysis sem getur valdið því að viðkomandi dettur (ástand sem kallast skyndilömun).
English: Rare (≥1/10,000 to <1/1,000)
Icelandic: Sjaldgæfar (≥1/1.000 til <1/100) Mjög sjaldgæfar (≥1/10.000 til <1/1.000)
English: Please consult the Product Information of Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
Icelandic: Sjá nánari upplýsingar í samantekt á eiginleikum lyfs fyrir Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
English: Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).
Icelandic: Pandemrix skal einungis notað ef árleg, þrígild/fjórgild bóluefni gegn árstíðabundinni inflúensu, sem mælt er með, eru ekki fáanleg og ef bólusetning gegn (H1N1)v er talin nauðsynleg (sjá kafla 4.4 og 4.8).
English: Epidemiological studies relating to Pandemrix in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Icelandic: Faraldsfræðirannsóknir í tengslum við Pandemrix í nokkrum Evrópulöndum benda til aukinnar hættu á drómasýki, með eða án máttleysiskasta (cataplexy), hjá bólusettum borið saman við óbólusetta einstaklinga.
English: Pandemrix contains sodium and potassium
Icelandic: Pandemrix inniheldur natríum og kalíum
English: Allergic reactions:
Icelandic: Ofnæmisviðbrögð:
English: Pandemrix may be administered in lactating women.
Icelandic: Pandemrix má gefa konum með barn á brjósti.
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
Icelandic: 3mótefnasvörunarstuðull: hlutfall meðaltalsmótefnastyrks (geometric mean titre (GMT)) eftir og fyrir bólusetningu.
English: Other medicines and Pandemrix
Icelandic: Notkun annarra lyfja samhliða Pandemrix
English: Month N=24
Icelandic: mánuður N=24
English: It is preferable that non-adjuvanted seasonal influenza vaccines should be administered before or with the first dose of Pandemrix.
Icelandic: Æskilegt er að bóluefni gegn árstíðabundinni inflúensu, án ónæmisglæðis sé gefið á undan eða um leið og fyrsti skammturinn af Pandemrix.
English: The anti-HA antibody responses 21 days after the first and the second dose were as follows:
Icelandic: HA-mótefnasvörun 21 degi eftir fyrri og seinni skammt var eftirfarandi:
English: unexpected severe adverse reactions, adverse events of special interest (AESI).
Icelandic: óvæntar alvarlegar aukaverkanir, aukaverkanir til sérstakrar skoðunar.
English: Very common Swelling and pain at the injection site, fatigue, shivering
Icelandic: Mjög algengar Þroti og verkur á stungustað, þreyta, skjálfti
English: Two clinical studies evaluated the administration of a half (0.25 ml) dose and a full (0.5 ml) adult dose of Pandemrix in healthy children 10 to 17 years of age.
Icelandic: Í tveimur klínískum rannsóknum var lagt mat á gjöf hálfs skammts (0,25 ml) og heils fullorðinsskammts (0,5 ml) af Pandemrix, hjá heilbrigðum börnum á aldrinum 10-17 ára.
English: Prophylaxis of influenza caused by A (H1N1)v 2009 virus.
Icelandic: Fyrirbyggjandi gegn inflúensu af völdum A(H1N1)v 2009 veiru.
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions,
Icelandic: Forgangsröðun á aukaverkanatilkynningum, þ.e. dauðsföll og lífshættulegar aukaverkanir,
English: Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Icelandic: Upplýsingarnar benda því til að gefa megi Pandemrix samhliða bóluefnum gegn árstíðabundinni inflúensu, án ónæmisglæða (sprauta skal bóluefninu í sinn útliminn hvoru).
English: In children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses there was an increase in the rates of injection site reactions and general symptoms after the second dose (see section 4.8).
Icelandic: Hjá börnum á aldrinum 6 til 35 mánaða (N=51), sem fengu tvo 0,25 ml skammta (hálfan fullorðinsskammt) með 3 vikna millibili, kom fram aukin tíðni viðbragða á stungustað og almennra einkenna eftir seinni skammtinn (sjá kafla 4.8).
English: Month N=10
Icelandic: mánuður N=10
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Icelandic: Lestu allan fylgiseðilinn vandlega áður en þú færð bóluefnið.
English: In a clinical study (D-Pan-H1N1-009) in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second half adult dose (i.e. 0.25 ml) or adult dose (i.e. 0.5 ml) of Pandemrix were as follows:
Icelandic: Í klínískri rannsókn (D-Pan-H1N1-009) hjá heilbrigðum börnum á aldrinum 6 mánaða til 35 mánaða (skipt í hópa frá 6-11, 12-23 og 24-35 mánaða) var HA-mótefnasvörun 21 degi eftir fyrri og seinni hálfan fullorðinsskammt (þ.e. 0,25 ml) eða fullorðinsskammt (þ.e. 0,5 ml) af Pandemrix, eftirfarandi:
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Icelandic: Taugasjúkdómar svo sem heila- og mænubólga, taugabólga og Guillain Barré heilkenni
English: If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes) before each withdrawal.
Icelandic: Ef fullbúið bóluefnið er geymt í kæli skal það látið ná stofuhita (að lágmarki í 15 mínútur) í hvert sinn áður en það er dregið upp.
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 2all subjects seronegative prior to vaccination
Icelandic: 1hlutfall ónæmissvörunar: hlutfall einstaklinga með títra hemagglútínínhindrunar (HI) ≥ 1:40 2allir einstaklingar sermisneikvæðir fyrir bólusetningu
English: In children 3 to 9 years of age who received two 0.25 ml doses of Pandemrix (H1N1) the side effects reported were similar to those reported in adults, except for redness at the injection site and gastrointestinal symptoms which were very common and shivering and sweating which were common.
Icelandic: Hjá börnum 3 til 9 ára sem fengu tvo 0,25 ml skammta af Pandemrix (H1N1) voru aukaverkanirnar sem greint var frá svipaðar og þær sem greint var frá hjá fullorðnum, nema roði á stungustað og einkenni frá meltingarvegi sem voru mjög algengar og skjálfti og svitamyndun sem voru algengar.
English: Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see section 4.8).
Icelandic: Pandemrix skal einungis notað ef árleg, þrígild/fjórgild bóluefni, sem mælt er með gegn árstíðabundinni inflúensu, eru ekki fáanleg og ef bólusetning gegn (H1N1)v er talin nauðsynleg (sjá kafla 4.8).
English: Six months after the first dose, the seroprotection rate was as follows:
Icelandic: Sex mánuðum eftir fyrri skammt var hlutfall ónæmissvörunar eftirfarandi:
English: For instructions on mixing of the medicinal product before administration, see section 6.6.
Icelandic: Sjá leiðbeiningar um blöndun lyfsins fyrir gjöf, í kafla 6.6.
English: Immunogenicity data obtained at three weeks after one dose of Pandemrix (H1N1)v suggest that a single dose may be sufficient.
Icelandic: Niðurstöður um ónæmingargetu sem fengust 3 vikum eftir gjöf eins skammts af Pandemrix (H1N1)v benda til að einn skammtur geti nægt.
English: Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Pandemrix alone.
Icelandic: Ekki kom fram hærri tíðni staðbundinna eða almennra viðbragða við samhliða gjöf samanborið við gjöf Pandemrix eins sér.
English: After 1 dose of 0.5 ml
Icelandic: Eftir einn 0,5 ml skammt
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pandemrix in one or more subsets of the paediatric population in the prevention of influenza infection (see section 4.2 for information on paediatric use).
Icelandic: á Pandemrix hjá einum eða fleiri undirhópum barna við fyrirbyggjandi notkun gegn inflúensusýkingu (sjá upplýsingar í kafla 4.2 um notkun handa börnum).
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 Twelve months after the first dose, the seroprotection rate was as follows:
Icelandic: 1hlutfall ónæmissvörunar: hlutfall einstaklinga með títra hemagglútínínhindrunar (HI) ≥ 1:40; Tólf mánuðum eftir fyrri skammt var hlutfall ónæmissvörunar eftirfarandi:
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Icelandic: Þessi ónæmisglæðir inniheldur skvalen (10,69 milligrömm), DL-α-tókóferól (11,86 milligrömm) og pólýsorbat 80 (4,86 milligrömm).
English: A/California/07/2009 (H1N1) derived strain used NYMC X-179A I.M.
Icelandic: A/California/07/2009 (H1N1) afleiddur stofn notaður NYMC X-179A i.m.
English: Redness Swelling Fever (>38°C) axillary
Icelandic: Hiti í handarkrika (>38°C)
English: Total enrolled subjects N=120
Icelandic: Heildarfjöldi einstaklinga N=120
English: Vaccine Response Rate2 1antigenically similar to A/California/7/2009 (H1N1)v-like 2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre
Icelandic: 1mótefnavaki svipaður mótefnavaka A/California/7/2009 (H1N1)v-líks stofns 2hlutfall bólusettra sem voru sermisneikvæðir í upphafi og náðu mótefnatítra ≥32 1/DIL eftir bólusetningu eða, sem voru sermisjákvæðir í upphafi og náðu mótefnatítra sem var ≥ fjórfaldur mótefnatítri fyrir bólusetningu.
English: Anaphylaxis, allergic reactions
Icelandic: Bráðaofnæmi, ofnæmisviðbrögð
English: The relationship between Pandemrix and narcolepsy is still under investigation.
Icelandic: Tengsl Pandemrix við drómasýki eru enn til rannsóknar.
English: The neutralising antibody responses were as follows:
Icelandic: Svörun hlutleysandi mótefna var eftirfarandi:
English: There are no data on co-administration of Pandemrix with other vaccines.
Icelandic: Engar upplýsingar liggja fyrir um gjöf Pandemrix samhliða öðrum bóluefnum.
English: 5all subjects seronegative prior to vaccination anti-HA
Icelandic: 5allir einstaklingar sermisneikvæðir fyrir bólusetningu
English: The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100% in both age groups.
Icelandic: Hlutfall ónæmissvörunar á degi 180 hjá börnum sem höfðu fengið tvo hálfa (0,25 ml) skammta var 100% hjá báðum aldurshópum.
English: Tel: + 420 2 22 00 11 11 cz.info@gsk.com
Icelandic: + 420 222 001 111 cz.info@gsk.com
English: Data obtained on co-administration of Pandemrix (H1N1)v with non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. The immune response to Fluarix was satisfactory.
Icelandic: Upplýsingar sem fengust við samhliða gjöf Pandemrix (H1N1)v og bóluefnis gegn árstíðabundinni inflúensu, án ónæmisglæðis (Fluarix, bóluefni með klofinni veiruögn) hjá heilbrigðum einstaklingum eldri en 60 ára, bentu ekki til neinna marktækra truflana á ónæmissvörun við Pandemrix (H1N1)v.
English: What you need to know before you receive Pandemrix
Icelandic: Áður en þú færð Pandemrix
English: A dose (0.5 ml) of the vaccine will be given.
Icelandic: Einn skammtur (0,5 ml) af bóluefninu verður gefinn.
English: Fever (>39°C) axillary
Icelandic: Hiti í handarkrika (>39°C)
English: Immune response to A/California/7/2009 (H1N1)v-like Half dose (D-Pan-H1N1-023)
Icelandic: Ónæmissvörun við A/California/7/2009 (H1N1)v-líkum stofni Hálfur skammtur (D-Pan-H1N1-023)
English: Post-marketing experience with trivalent seasonal influenza vaccines Blood and lymphatic system disorders
Icelandic: Aukaverkanir eftir markaðssetningu þrígildra bóluefna gegn árstíðabundinni inflúensu
English: Month 6 N=22
Icelandic: Mánuður 6 N=22
English: How to store Pandemrix
Icelandic: Hvernig geyma á Pandemrix
English: In children aged 6-35 months who received two doses of 0.25 ml of Pandemrix (H1N1), there was an increase in reports of pain, redness and swelling at the injection site as well as fever (>38°C), drowsiness, irritability and loss of appetite after the second dose compared to the first dose.
Icelandic: Hjá börnum á aldrinum 6-35 mánaða sem fengu tvo 0,25 ml skammta af Pandemrix (H1N1), var oftar greint frá verkjum, roða og þrota á stungustað auk hita (>38°C), svefnhöfga, pirringi og lystarleysi eftir seinni skammtinn samanborið við fyrri skammtinn.
English: • Reactions at the injection site such as pain, redness, bruising, swelling and heat (inflammation),
Icelandic: Viðbrögð á stungustað svo sem verkur, roði, mar, þroti og hiti (bólga), harður hnútur
English: Month 12 N=31
Icelandic: 12. mánuður N=31
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Icelandic: Upplýsingar sem hægt er að nálgast annars staðar Ítarlegar upplýsingar um lyfið eru birtar á vef Lyfjastofnunar Evrópu: http://www.ema.europa.eu/ Upplýsingar á íslensku eru á http://www.serlyfjaskra.is.
English: Children and adolescents aged 10-17 years Dosing may be in accordance with the recommendations for adults.
Icelandic: Skammtar geta verið í samræmi við ráðleggingar fyrir fullorðna.
English: Total enrolled subjects2
Icelandic: Hlutfall mótefnasvörunar 2
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 D-Pan H1N1-007
English: Total enrolled subjects N=33
Icelandic: Heildarfjöldi einstaklinga N=33
English: anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like >80 years Month 12 after 2 doses of 0.5 ml
Icelandic: Ónæmissvörun við A/California/7/2009 (H1N1)v-líkum stofni >80 ára Mánuður 12 eftir tvo 0,5 ml skammta Mánuður 12 eftir einn 0,5 ml skammt
English: Month 12 N=28
Icelandic: 12. mánuður N=28
English: Half adult dose (D-Pan-H1N1-023)
Icelandic: Hálfur fullorðinsskammtur (D-Pan-H1N1-023)
English: The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100%.
Icelandic: Hlutfall ónæmissvörunar á degi 180 hjá börnum sem höfðu fengið tvo hálfa (0,25 ml) skammta var
English: Immune response to A/California/7/2009 (H1N1)v-like >80 years
Icelandic: Ónæmissvörun við A/California/7/2009 (H1N1)v-líkum stofni >80 ára
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Icelandic: Saga um bráðaofnæmi (þ.e. lífshættulegt) af völdum einhvers innihaldsefnanna eða efnaleifa (eggjaog kjúklingapróteinum, eggjahvítu, formaldehýði, gentamisínsúlfati og natríumdeoxýkólati) í bóluefninu.
English: Month 6 N=17
Icelandic: Mánuður 6 N=17
English: Immunisation should be postponed in subjects with a severe febrile illness or acute infection.
Icelandic: Fresta skal ónæmisaðgerð hjá einstaklingum með háan sótthita eða bráða sýkingu.
English: Seroconversion factor3
Icelandic: Mótefnasvörunar stuðull3
English: Thiomersal
Icelandic: Algengar
English: Post dose N=59
Icelandic: Heildarfjöldi einstaklinga N=59
English: The anti-HA antibody responses in healthy subjects aged >60 years who received either one or two doses of 0.5 ml 21 days apart were as follows:
Icelandic: > 60 ára sem fengu annaðhvort einn eða tvo 0,5 ml skammta með 21 dags millibili var eftirfarandi:
English: Month 6 N=18
Icelandic: Mánuður 6 N=18
English: Vasculitis with transient renal involvement 1frequency based on estimated attributable risk from epidemiological studies in several European countries (see section 4.4) 2Reported in patients with narcolepsy and as a temporary event following vaccination
Icelandic: 1tíðni byggð á áætlaðri hættu vegna bóluefnisins úr faraldsfræðilegum rannsóknum í nokkrum Evrópulöndum (sjá kafla 4.4)