FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts such as: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
Icelandic: ef þú hefur fengið skyndileg lífshættuleg ofnæmisviðbrögð við einhverju innihaldsefni bóluefnisins (talin upp í kafla 6) eða einhverju öðru sem getur verið til staðar í örlitlu magni, svo sem: eggja- og kjúklingapróteinum, eggjahvítu, formaldehýði, gentamisínsúlfati (sýklalyf) eða natríumdeoxýkólati.
English: Full dose (N=34)
Icelandic: Heill skammtur (N=34)
English: Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1)
Icelandic: Gjöf AS03-ónæmisglædds bóluefnis sem inniheldur 3,75 míkróg HA úr A/Víetnam/1194/2004 (H5N1)
English: The anti-HA and neutralising antibody responses to A/Indonesia/05/2005 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain have been shown to be comparable with the immune responses to A/Vietnam/1194/2004 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain.
Icelandic: Sýnt hefur verið fram á að HA-hlutleysandi mótefnasvörun við A/Indónesía/05/2005 framkölluð af AS03-ónæmisglæddu bóluefni sem inniheldur 3,75 míkróg HA úr þessum sama stofni sé sambærileg við ónæmissvörun við A/Víetnam/1194/2004 sem framkölluð er með AS03-ónæmisglæddu bóluefni sem inniheldur 3,75 míkróg HA úr þessum sama stofni.
English: 1 Geometric Mean Titre 2 4-fold increase in serum neutralising antibody titre
Icelandic: 1 Geometric Mean Titre = meðaltalsmótefnastyrkur 2 % einstaklinga með títra ≥1:28
English: Prepandrix may be used in lactating women.
Icelandic: Nota má Prepandrix hjá konum með barn á brjósti.
English: 2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4fold increase in titre;
Icelandic: 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 sermis jákvæðir fyrir bólusetningu og hafa títra sem hefur fjórfaldast;
English: OTHER SPECIAL WARNING(S), IF NECESSARY Suspension and emulsion to be mixed before administration
Icelandic: ÖNNUR SÉRSTÖK VARNAÐARORÐ, EF MEÐ ÞARF Dreifunni og fleytinu skal blandað saman fyrir gjöf.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains:
Icelandic: Eftir blöndun inniheldur 1 skammtur (0,5 ml):
English: Single dose N=91
Icelandic: Stakur skammtur N=91
English: Excipient with known effect The vaccines contains 5 micrograms thiomersal (see section 4.4).
Icelandic: Bóluefnið inniheldur 5 míkróg af tíómersali (sjá kafla 4.4).
English: Immune response against A/Indonesia/05/2005 (H5N1) In a clinical study (Q-Pan-H5N1-001) in which two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 were administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses were as follows: anti-HA antibody
Icelandic: Ónæmissvörun við A/Indónesía/05/2005 (H5N1) Í klínískri rannsókn (Q-Pan-H5N1-001) þar sem 140 einstaklingum á aldrinum 18-60 ára voru gefnir tveir skammtar af AS03-ónæmisglæddu bóluefni sem innihélt 3,75 míkróg HA úr A/Indónesía/05/2005, á degi 0 og 21, kom fram eftirfarandi HA-mótefnasvörun:
English: 2.5 ml per vial
Icelandic: 2,5 ml/hettuglas
English: Month 6 N=48
Icelandic: Mánuður N=48
English: Therefore, the data that have been generated with AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 are considered to be relevant to the use of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Icelandic: Því eru niðurstöður sem varða AS03ónæmisglætt bóluefni sem inniheldur 3,75 míkróg HA úr A/Víetnam/1194/2004 taldar hafa þýðingu við notkun á AS03-ónæmisglæddu bóluefni sem inniheldur 3,75 míkróg HA úr A/Indónesía/05/2005.
English: Full dose (N=29)
Icelandic: Heill skammtur (N=29)
English: Cross-reactive immune response elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
Icelandic: Krossónæmissvörun framkölluð af AS03-ónæmisglæddu bóluefni, sem inniheldur 3,75 míkróg HA úr A/Indónesía/05/2005 (H5N1)
English: There are currently no data available on the use of Prepandrix in pregnancy.
Icelandic: Enn liggja engar upplýsingar fyrir um notkun Prepandrix á meðgöngu.
English: 2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Icelandic: 1Geometric Mean Titre = meðaltalsmótefnastyrkur 24-föld aukning á títra hlutleysandi mótefna 3% einstaklinga sem höfðu títra hlutleysandi mótefna upp á að minnsta kosti 1:80
English: A clinical study (D-H5N1-009) evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of pandemic preparedness vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany).
Icelandic: Í klínískri rannsókn (D-H5N1-009) var lagt mat á hversu miklum aukaverkunum bóluefnið getur valdið, hjá börnum á aldrinum 3 til 5 ára og 6 til 9 ára sem fengu annað hvort tvo fullorðinsskammta (þ.e. 0,5 ml) eða tvo hálfa fullorðinsskammta (þ.e. 0,25 ml) af viðbragðsbóluefni gegn heimsfaraldri (H5N1 A/Vietnam/1194/2004 framleitt í Dresden, Þýskalandi) (með 21 dags millibili).
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1):
Icelandic: Krossónæmissvörun framkölluð af AS03-ónæmisglæddu bóluefni, sem inniheldur 3,75 míkróg HA úr A/Víetnam/1194/2004 (H5N1):
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkusstraße 40, D-01069 Dresden Germany
Icelandic: KG Zirkusstraße 40, D-01069 Dresden Þýskaland
English: In the subjects aged 3 to 5 and 6 to 9 years old who received two doses of either a full or a half dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1), the anti-HA antibody responses against A/Indonesia/5/2005 at day 42 were as follows:
Icelandic: Hjá einstaklingunum á aldrinum 3 til 5 ára og 6 til 9 ára sem fengu tvo skammta, annað hvort heila eða hálfa skammta, af AS03-ónæmisglæddu bóluefni sem innihélt 3,75 míkróg HA úr A/Víetnam/1194/2004 (H5N1) var HA-mótefnasvörun gegn A/Indónesía/5/2005 á degi 42 eftirfarandi:
English: Seroconversion factor3
Icelandic: Hlutfall mótefnasvörunar örvunarskammts2
English: In a clinical study (D-Pan-H5N1-009), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Icelandic: Í klínískri rannsókn (D-Pan-H5N1-009) fengu börn á aldrinum 3 til 5 ára og 6 til 9 ára tvo skammta, annað hvort heila (0,5 ml) eða hálfa (0,25 ml), af AS03-ónæmisglæddu bóluefni sem innihélt 3,75 míkróg HA úr A/Víetnam/1194/2004 (H5N1) á dögum 0 og 21.
English: • Diarrhoea, vomiting, stomach pain, feeling sick
Icelandic: Niðurgangur, uppköst, magaverkir, ógleði
English: Immune response to A/Vietnam/1194/2004 (D42) 61 to 70 years
Icelandic: Ónæmissvörun við A/Víetnam/1194/2004 (D42)
English: Single dose N=48
Icelandic: Stakur skammtur N=48
English: Half dose (N=37)
Icelandic: Hálfur skammtur (N=37)
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: Half dose (N=27)
Icelandic: Hálfur skammtur (N=27)
English: Half dose (N=47)
Icelandic: Hálfur skammtur (N=47)
English: Full dose N=34
Icelandic: Heill skammtur N=34
English: • if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Icelandic: ef þú hefur fengið ofnæmisviðbrögð önnur en skyndileg lífshættuleg ofnæmisviðbrögð við einhverjum af innihaldsefnum bóluefnisins (talin upp í kafla 6) eða tíómersali, eggja- og kjúklingapróteini, eggjahvítu, formaldehýði, gentamisínsúlfati (sýklalyf) eða natríumdeoxýkólati.
English: The per-dose frequency of adverse reactions was as follows:
Icelandic: Tíðni aukaverkana á hvern skammt var eftirfarandi:
English: In another clinical study (D-Pan-H5N1-038), 387 subjects aged 18-60 years received 1 dose of AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 36 months after they had received two doses of A/Vietnam/1194/2004.
Icelandic: Í annarri klínískri rannsókn (D-Pan-H5N1-038) fengu 387 einstaklingar á aldrinum 18-60 ára 1 skammt af AS03-ónæmisglæddu bóluefni sem innihélt 3,75 míkróg HA úr A/Indónesía/05/2005, 36 mánuðum eftir að hafa fengið tvo skammta af A/Víetnam/1194/2004.
English: In clinical trials in which subjects (N=201) received Prepandrix containing 3.75 microgram HA/AS03 of A/Indonesia/05/2005 (H5N1) strain, the types and frequencies of adverse reactions were comparable with those reported below.
Icelandic: Prepandrix sem innihélt 3,75 míkróg HA/AS03 úr A/Indónesía/05/2005 (H5N1), var tíðni og tegund aukaverkana svipuð og greint er frá hér á eftir.
English: Immune response to A/Vietnam/1194/2004 3 to 5 years
Icelandic: Ónæmissvörun við A/Víetnam/1194/2004 3 til 5 ára
English: However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be more serious.
Icelandic: Ef það reynist hins vegar nauðsynlegt verður hitt bóluefnið gefið í hinn handlegginn.
English: • one pack containing 50 vials of 2.5 ml suspension (antigen)
Icelandic: • einn pakka sem inniheldur 50 hettuglös með 2,5 ml af dreifu (mótefnavaki).
English: Full dose N=44
Icelandic: Heill skammtur N=44
English: Full dose (N=27)
Icelandic: Heill skammtur (N=27)
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate against A/Vietnam/1194/2004 in subjects who received the vaccine 6 months apart were 89.6% and 95.7%, respectively.
Icelandic: Tuttugu og einum degi eftir seinni skammtinn var hlutfall ónæmissvörunar 89,6% og svörunarhlutfall bóluefnisins 95,7% gegn A/Víetnam/1194/2004 hjá einstaklingum sem fengu bóluefnið með 6 mánaða millibili.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Icelandic: AS03-ónæmisglæðir sem samanstendur af skvaleni (10,69 mg), DL-α-tókóferóli (11,86 mg) og pólýsorbati 80 (4,86 mg).
English: Immune response to A/Vietnam/1194/2004 6-9 years
Icelandic: Ónæmissvörun við A/Víetnam/1194/2004 6-9 ára
English: Subjects of D-Pan-H5N1-009 were followed up for persistence of the immune response.
Icelandic: Þátttakendum í D-Pan-H5N1-009 var fylgt eftir varðandi endingu ónæmissvörunarinnar.
English: The seroprotection rate, booster seroconversion rate and booster factor against A/Indonesia/5/2005 21 days after booster vaccination was 100%, 99.7% and 123.8, respectively.
Icelandic: Hlutfall ónæmissvörunar var 100%, hlutfall ónæmissvörunar eftir örvun 99,7% og örvunarþáttur 123,8, gegn A/Indónesía/5/2005 21 degi eftir örvunarbólusetningu.
English: Half dose N=49
Icelandic: Hálfur skammtur N=49
English: What you need to know before you receive Prepandrix
Icelandic: Áður en þú færð Prepandrix
English: • Adjuvant:
Icelandic: Innihald:
English: In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21.
Icelandic: Í klínískri rannsókn (D-Pan-H5N1-012) fengu einstaklingar á aldrinum 18-60 ára skammt af AS03ónæmisglæddu bóluefni sem innihélt 3,75 míkróg HA ýmist úr A/Víetnam/1194/2004 eða A/Indónesía/5/2005, sex mánuðum eftir að hafa fengið einn eða tvo hleðsluskammta af AS03ónæmisglæddu bóluefni sem innihélt 3,75 míkróg HA úr A/Víetnam/1194/2004, á degi 0 eða degi 0 og 21.
English: Half dose N=43
Icelandic: Hálfur skammtur N=43
English: Half dose N=42
Icelandic: Hálfur skammtur N=42
English: There are no data on co-administration of Prepandrix with other vaccines.
Icelandic: Engar upplýsingar liggja fyrir um gjöf Prepandrix samhliða öðrum bóluefnum.
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004.
Icelandic: Einn skammtur af AS03-ónæmisglæddu bóluefni sem inniheldur 3,75 míkróg HA úr A/Indónesía/5/2005 gefinn eftir gjöf eins eða tveggja skammta af AS03-ónæmisglæddu bóluefni sem inniheldur 3,75 míkróg HA úr A/Víetnam/1194/2004.
English: Immune response to A/Vietnam/1194/2004 12 months after vaccination
Icelandic: Ónæmissvörun við A/Víetnam/1194/2004 12 mánuðum eftir bólusetningu
English: Full dose N=42
Icelandic: Heill skammtur N=42
English: Month 6 N=40
Icelandic: Mánuður N=40
English: The emulsion is a whitish to yellowish homogeneous milky liquid.
Icelandic: Fullbúið bóluefnið er hvítt til gulleitt mjólkurkennt fleyti.
English: The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.
Icelandic: Fullbúið bóluefnið er hvítt til gulleitt einsleitt mjólkurkennt fleyti.
English: Subjects of D-Pan-H5N1-002 were followed up for persistence of the immune response.
Icelandic: Þátttakendum í D-Pan-H5N1-002 var fylgt eftir varðandi endingu ónæmissvörunar.
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: Half dose N=47
Icelandic: Hálfur skammtur N=47
English: 6-9 years
Icelandic: 6-9 ára Hálfur skammtur
English: • From 18 years onwards: you will receive two doses of Prepandrix.
Icelandic: Þú færð tvo skammta af Prepandrix.
English: Half dose N=40
Icelandic: Hálfur skammtur N=40
English: What Prepandrix contains
Icelandic: Prepandrix inniheldur
English: Full dose N=43
Icelandic: Heill skammtur N=43
English: Immune response to A/Vietnam/1194/2004 3-5 years
Icelandic: Ónæmissvörun við A/Víetnam/1194/2004 3-5 ára
English: Subjects of D-Pan-H5N1-010 were followed up for persistence of the immune response.
Icelandic: Þátttakendum í D-Pan-H5N1-010 var fylgt eftir varðandi endingu ónæmissvörunar.
English: Immune response to A/Vietnam/1194/2004 Day 21
Icelandic: Ónæmissvörun við A/Víetnam/1194/2004
English: • Inflammation of your blood vessels (vasculitis).
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: It is essentially sodium- and potassium-free.
Icelandic: Það er nær laust við natríum og kalíum.
English: • This will usually be in the upper arm.
Icelandic: Yfirleitt er gefið í upphandleggsvöðva.
English: Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Icelandic: Einkenni frá meltingarvegi (svo sem niðurgangur, uppköst, kviðverkir, ógleði).
English: Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Icelandic: Prepandrix dreifa og fleyti fyrir stungulyf, fleyti Bóluefni gegn inflúensu sem getur orðið að heimsfaraldri (H5N1) (klofin veiruögn, deydd, ónæmisglætt)
English: Frequencies are reported as:
Icelandic: Tíðnin er skilgreind á eftirfarandi hátt:
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Icelandic: 1hlutfall ónæmissvörunar: hlutfall einstaklinga með títra hemagglútínínhindrunar (HI) ≥ 1:40;
English: • Increased sweating, shivering, flu-like symptoms
Icelandic: Aukin svitamyndun, skjálfti, flensulík einkenni
English: Induration
Icelandic: Lystarleysi
English: The anti-HA responses were as follows:
Icelandic: Hlutleysandi mótefnasvörun var eftirfarandi:
English: Single dose N=49
Icelandic: Stakur skammtur N=49
English: After mixing, the vaccine should be used within 24 hours.
Icelandic: Bóluefnið skal nota innan 24 klst. frá blöndun.
English: Immune response to A/Vietnam/1194/2004 6 months after vaccination
Icelandic: Ónæmissvörun við A/Víetnam/1194/2004 6 mánuðum eftir bólusetningu
English: After mixing, use the vaccine within 24 hours.
Icelandic: Notið bóluefnið innan 24 klst. eftir blöndun.
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 12 months apart were 92.0% and 100%, respectively.
Icelandic: Tuttugu og einum degi eftir seinni skammtinn var hlutfall ónæmissvörunar 92,0% og svörunarhlutfall bóluefnisins 100% hjá þeim sem fengu bóluefnið með 12 mánaða millibili.
English: Common: may affect up to 1 in 10 people
Icelandic: Algengar: geta komið fyrir hjá innan við 1 af hverjum 10 einstaklingum
English: The suspension and emulsion vials once mixed form a multidose container.
Icelandic: Hettuglösin með dreifunni og fleytinu mynda fjölskammta ílát eftir blöndun.
English: METHOD OF ADMINISTRATION Mix with adjuvant emulsion before use
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF Blandist saman við dreifu með mótefnavaka fyrir gjöf
English: There are no data with Prepandrix using the subcutaneous route.
Icelandic: Engar upplýsingar liggja fyrir um notkun Prepandrix undir húð.
English: Тел.
Icelandic: Æðabólga.
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Magnesium chloride Water for injections
Icelandic: Kalíumklóríð Magnesíumklóríð Vatn fyrir stungulyf
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Icelandic: 1hlutfall ónæmissvörunar: hlutfall einstaklinga með títra hemagglútínínhindrunar (HI) ≥ 1:40; HA mótefni
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 12 months apart were 84.0% and 100%, respectively.
Icelandic: Tuttugu og einum degi eftir seinni skammtinn var hlutfall ónæmissvörunar 84,0% og svörunarhlutfall bóluefnisins 100% hjá þeim sem fengu bóluefnið með 12 mánaða millibili.
English: • Feeling tired
Icelandic: C. AÐRAR FORSENDUR
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Prepandrix Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Icelandic: Bóluefni gegn inflúensu sem getur orðið að heimsfaraldri (prepandemic) (H5N1) (klofin veiruögn, deydd, ónæmisglætt)
English: Loss of appetite
Icelandic: Blóð og eitlar
English: Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 6 months apart were 83.3% and 100%, respectively.
Icelandic: Tuttugu og einum degi eftir seinni skammtinn var hlutfall ónæmissvörunar 83,3% og svörunarhlutfall bóluefnisins 100% hjá þeim sem fengu bóluefnið með 6 mánaða millibili.
English: Nervous system disorders
Icelandic: Ónæmiskerfi Bráðaofnæmi, ofnæmisviðbrögð.
English: GlaxoSmithKline Pharmaceuticals s.a./n.v.
Icelandic: GlaxoSmithKline Pharma A/S Tlf:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 50 VIALS OF SUSPENSION
Icelandic: INNRI UMBÚÐUM PAKKI MEÐ 50 HETTUGLÖSUM MEÐ DREIFU
English: In another clinical study (D-Pan-H5N1-010), 297 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Icelandic: > 60 ára (skipt í aldursbilin frá 61 til 70, 71 til 80 og > 80 ára) stakan eða tvöfaldan skammt af AS03-ónæmisglæddu bóluefni sem innihélt 3,75 míkróg HA úr A/Víetnam/1194/2004 (H5N1) á degi 0 og 21.
English: Prepandrix should not be given:
Icelandic: Prepandrix:
English: General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue, Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Icelandic: Herslismyndun, bólga, verkur og roði á stungustað, hiti, þreyta.
English: After two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses to A/Vietnam/1194/2004 were as follows:
Icelandic: HA-mótefnasvörun við A/Víetnam/1194/2004 eftir gjöf tveggja skammta af AS03-ónæmisglæddu bóluefni sem innihélt 3,75 míkróg HA úr A/Indónesía/5/2005, á degi 0 og 21, hjá 140 einstaklingum á aldrinum 18-60 ára, var eftirfarandi:
English: Immune response to A/Vietnam/1194/2004 0, 21 days schedule
Icelandic: Ónæmissvörun við A/Víetnam/1194/2004 Dagur 21 N=140
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 25 VIALS OF EMULSION
Icelandic: INNRI UMBÚÐUM PAKKI MEÐ 25 HETTUGLÖSUM MEÐ FLEYTI
English: Uncommon: may affect upt o 1 in 100 people
Icelandic: Sjaldgæfar: geta komið fyrir hjá innan við 1 af hverjum 100 einstaklingum
English: Shake before use
Icelandic: Hristið fyrir notkun.
English: Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Water for injections
Icelandic: Kalíumklóríð Vatn fyrir stungulyf
English: (D-Pan-H5N1-002)
Icelandic: Í annarri klínískri rannsókn (D-Pan-H5N1-010) fengu 297 einstaklingar
English: Before the vaccine is mixed:
Icelandic: Eftir blöndun bóluefnisins:
English: Paediatric population
Icelandic: Almenn vanlíðan
English: In another clinical study (D-Pan-H5N1-015), 39 subjects aged 18-60 years received a dose of AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Icelandic: Í annarri klínískri rannsókn (D-Pan-H5N1-015) fengu 39 einstaklingar á aldrinum 18-60 ára skammt af AS03-ónæmisglæddu bóluefni sem innihélt 3,75 míkróg HA úr A/Indónesía/05/2005, fjórtán mánuðum eftir að hafa fengið tvo skammta af AS03-ónæmisglæddu bóluefni sem innihélt 3,75 míkróg HA úr A/Víetnam/1194/2004, á degi 0 og degi 21. Hlutfall ónæmissvörunar við A/Indónesíu 21 degi eftir gjöf örvunarskammtsins var 92% og 69,2% á degi 180.
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 í sinn útliminn hvort.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Icelandic: Bóluefni gegn inflúensu sem getur orðið að heimsfaraldri (H5N1) (klofin veiruögn, deydd, ónæmisglætt)
English: Fertility
Icelandic: Herslismyndun
English: Suspension and emulsion for emulsion for injection.
Icelandic: Prepandrix dreifa og fleyti fyrir stungulyf, fleyti.
English: Irritability
Icelandic: Flogaköst
English: Prepandrix contains thiomersal
Icelandic: Prepandrix inniheldur tíómersal
English: Seroconversion rate2
Icelandic: Hlutfall mótefna-svörunar2
English: Very rare: may affect up to 1 in 10,000 people
Icelandic: Koma örsjaldan fyrir: geta komið fyrir hjá innan við 1 af hverjum 10.000 einstaklingum
English: Seroconversion rate
Icelandic: LYFJAFORM
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Prepandrix
Icelandic: HEITI LYFS Fleyti fyrir Prepandrix stungulyf, fleyti.
English: If any of the side effects below occur, please tell your doctor or nurse immediately:
Icelandic: Láttu lækninn eða hjúkrunarfræðinginn strax vita ef einhverjar af eftirtöldum aukaverkunum koma fram: