FrancophonIA/ELRC3.0 huggingface dataset:
English: Three clinical studies have evaluated the immunogenicity of a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) in subjects from the age of 18 years onwards following a 0, 21 days schedule.
Slovenian: V treh kliničnih študijah so ovrednostili imunogenost različice cepiva Arepanrix z vsebnostjo 3,75 µg HA pridobljenega iz A/Indonesia/5/2005 (H5N1) pri preiskovancih, starejših od 18 let po shemi 0. in 21. dan.
English: 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Slovenian: 1Delež serološke zaščite (delež preiskovancev s titrom inhibicije hemaglutinacije (HIhaemagglutination inhibition) ≥ 1:40);
English: OTHER SPECIAL WARNING(S), IF NECESSARY Suspension to be exclusively mixed with adjuvant emulsion before administration
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Suspenzijo morate pred uporabo zmešati izključno z emulzijo adjuvansa.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Slovenian: Pri cepljenju je, tako kot pri vseh cepivih, ki se injicirajo, treba zagotoviti ustrezno obliko zdravljenja in zdravniškega nadzora, ki bo v takšnem primeru nemudoma na voljo.
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.
Slovenian: Podatki o imunogenosti, dobljeni tri tedne po uporabi cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, v kliničnih študijah kažejo, da je odmerjanje lahko v skladu s priporočili za odrasle.
English: Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
Slovenian: tiomersal natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) voda za injekcije
English: METHOD OF ADMINISTRATION Mix with adjuvant emulsion before use
Slovenian: POSTOPEK UPORABE Pred uporabo zmešajte skupaj z emulzijo adjuvansa.
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.
Slovenian: Klinični podatki s cepivom z AS03 z vsebnostjo HA iz H1N1v, pridobljenim z drugačnim postopkom, kažejo, da lahko zadošča en sam odmerek.
English: Gastro-intestinal symptoms and shivering were reported at higher rates compared to the rates reported from studies with AS03-containing vaccine containing HA from H5N1 manufactured using a different process.
Slovenian: Pogostnost poročanja o prebavnih simptomih in drgetanju je bila večja v primerjavi s študijami s cepivom z AS03 z vsebnostjo HA iz H5N1, pridobljenega z drugačnim postopkom.
English: Clinical studies with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process currently provide:
Slovenian: Iz kliničnih študij, v katerih so uporabili cepivo z AS03 z vsebnostjo HA iz H1N1v, pridobljeno z drugačnim postopkom so trenutno na voljo:
English: There are limited data available from a clinical study with an AS03containing vaccine containing HA from H1N1v manufactured using a different process in healthy children aged from 10 to 17 years, very limited data with the AS03-containing vaccine containing HA from H1N1v manufactured using a different process in healthy children aged from 6 to 35 months and limited data from a study with a version of an AS03-containing vaccine containing HA from H5N1 manufactured using a different process in children aged from 3 to 9 years.
Slovenian: Zelo malo je podatkov iz kliničnih študij s cepivom z AS03 z vsebnostjo HA iz H1N1v, pridobljenim z drugačnim postopkom, pri zdravih otrocih, starih od 6 do 35 mesecev, malo pa je podatkov iz študije z različico cepiva z AS03 z vsebnostjo HA iz H5N1v, pridobljenega z drugačnim postopkom, pri otrocih, starih od 3 do 9 let.
English: After mixing, the vaccine should be used within 24 hours.
Slovenian: Po premešanju cepiva: Po premešanju morate cepivo uporabiti v 24 urah.
English: The vaccine should be administered in accordance with the recommended posology (see section 3 “How Arepanrix is given”).
Slovenian: Po mešanju je količina cepiva Arepanrix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 3 "Kako uporabljati cepivo Arepanrix").
English: Day 42 N=145
Slovenian: 42. dan n=145
English: Skin and subcutaneous tissue disorders Common: sweating Uncommon: pruritus, rash
Slovenian: Bolezni kože in podkožja Pogosti: znojenje Občasni: srbenje, izpuščaj
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)
Slovenian: Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo predložil skrajšano poročilo o naslednji študiji, izvedeni pri odraslih: študija Q-Pan H1N1-001 skrajšano poročilo za po 1. in po 2. odmerku (≥ 18 let, določitev odmerka, adjuvantno cepivo v primerjavi z navadnim)
English: The Applicant/MAH commits to provide abridged report for the following study performed in children Study Q-Pan H1N1-031 (9-17 yrs, Safety/ Immunogenicity) - abridged report for post dose 1 & post dose 2 (immuno & solicited and unsolicited symptoms, SAEs )
Slovenian: Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo predložil skrajšano poročilo o naslednji študiji, izvedeni pri otrocih: študija Q-Pan H1N1-031 (od 9 do 17 let, varnost/imunogenost) - skrajšano poročilo po 1. in po 2. odmerku (imunološki podatki ter spontano in nespontano zabeleženi simptomi, resni neželeni učinki)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION (ADJUVANT)
Slovenian: PODATKI NA ZUNANJI OVOJNINI PAKIRANJE S 25 VIALAMI EMULZIJE (ADJUVANS)
English: • Generally feeling unwell
Slovenian: • splošno slabo počutje
English: A 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was achieved in 44.7% of subjects at day 21, 53.2% at day 42 and 38.3% at day 180.
Slovenian: 4-kratno povečanje titra nevtralizacijskih protiteles v serumu proti A/Vietnam/1194/2004 je bilo na 21. dan doseženo pri 44,7 % preiskovancev, na 42. dan pri 53,2 % preiskovancev in na 180. dan pri 38,3 % preiskovancev.
English: Antigen suspension for Arepanrix Pandemic influenza vaccine A/California/7/2009 (H1N1)v-like strain (X-179A) I.M.
Slovenian: Suspenzija antigena za Arepanrix cepivo proti pandemski gripi sev A/California/7/2009 (X-179A) podoben sevu A/California/7/2009 (H1N1)v i.m.
English: Immune response to A/California/7/2009 (H1N1)v-like Arepanrix (H1N1) N=164)
Slovenian: anti-HA protitelesa Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu Arepanrix (H1N1) n=164
English: - abridged report for post dose 2 Waves 1 and 2 (immuno data, solicited and unsolicited symptoms, SAEs )
Slovenian: - skrajšano poročilo po 2. odmerku 1. in 2. vala uporabe (imunološki podatki, spontano in nespontano zabeleženi simptomi ter resni neželeni učinki)
English: Immune response to a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1):
Slovenian: Imunski odziv proti različici cepiva Arepanrix z vsebnostjo 3,75 µg HA pridobljenega iz A/Indonesia/5/2005 (H5N1):
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Slovenian: NAČIN IZDAJANJA ZDRAVILA Izdaja cepiva je le na recept.
English: Headache
Slovenian: Bolečina
English: Cross-reactive immune responses elicited by a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1):
Slovenian: Navzkrižni reaktivni imunski odzivi, povzročeni s cepivom Arepanrix z vsebnostjo 3,75 µg HA, pridobljenega iz A/Indonesia/5/2005 (H5N1):
English: Immune response to A/California/7/2009 (H1N1)v-like D-Pan H1N1-007
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu D-Pan H1N1-007
English: The Applicant/MAH commits to provide abridged report for the following study performed in adults Study Q-Pan H1N1-019 (18-60 yrs, TIV effect and coadministration)
Slovenian: Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo predložil skrajšano poročilo o naslednji študiji, izvedeni pri odraslih: študija Q-Pan H1N1-019 (od 18 do 60 let, učinek TIV [trivalentnega cepiva proti gripi] in sočasna uporaba)
English: • Limited safety and immunogenicity data obtained after administration of two doses to healthy adults aged 18-60 years.
Slovenian: • Malo podatkov o varnosti in imunogenosti, dobljenih po uporabi dveh odmerkov cepiva Pandemrix (H1N1) pri zdravih odraslih, starih od 18 do 60 let.
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 6-35 months.
Slovenian: • Zelo malo podatkov o varnosti in imunogenosti, dobljenih tri tedne po uporabi enega polovičnega odmerka (tj. 0,25 ml) za odrasle cepiva Pandemrix (H1N1) pri zdravih otrocih, starih od 6 do 35 mesecev.
English: The vaccine may be used during breast-feeding.
Slovenian: Cepivo Arepanrix lahko dobite med dojenjem.
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:
Slovenian: V klinični študiji, s katero so ocenili reaktogenost pri otrocih, starih od 3 do 5 in od 6 do 9 let, ki so dobili en polovični odmerek (tj. 0,25 ml) cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, je bila pogostnost naslednjih neželenih učinkov, kot je prikazano v preglednici:
English: Redness
Slovenian: Prebavni
English: Common: nausea, diarrhoea
Slovenian: Pogosti: navzea, driska
English: Immune response to an AS03-containing vaccine containing HA from H1N1v manufactured using a different process:
Slovenian: Imunski odziv na cepivo z AS03 z vsebnostjo HA iz H1N1v, pridobljeno z drugačnim postopkom
English: There are no safety and immunogenicity data available from clinical studies with Arepanrix or with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in children aged less than 6 months.
Slovenian: Iz kliničnih študij cepiva Arepanrix ali cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, ni podatkov o varnosti in imunogenosti pri otrocih, starih manj kot 6 mesecev.
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.
Slovenian: • Zelo malo podatkov o varnosti in imunogenosti, dobljenih tri tedne po enkratni uporabi polovičnega odmerka za odrasle (tj. 0,25 ml) cepiva Pandemrix (H1N1) pri zdravih otrocih, starih od 3 do 9 let.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
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)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsebina: Adjuvans AS03, sestavljen iz skvalena (10,69 miligramov), DL-α-tokoferola (11,86 miligramov) in polisorbata 80 (4,86 miligramov).
English: Drowsiness
Slovenian: Oteklost
English: Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni: dispneja
English: Common: redness at the injection site, swelling at the injection site, fever, shivering Uncommon: injection site reactions (such as bruising, induration, pruritus, warmth), asthenia, chest pain, malaise
Slovenian: Občasni: reakcije na mestu injiciranja (kot so modrice, zatrdlina, srbenje in občutek toplote), astenija, bolečina v prsnem košu, splošno slabo počutje
English: Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Slovenian: Cepivo Arepanrix je na voljo v dveh vsebnikih: Suspenzija: večodmerna viala z antigenom Emulzija: večodmerna viala z adjuvansom
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.
Slovenian: • če se je pri vas kdaj pojavila kakršnakoli alergijska reakcija (poleg nenadne, življenje ogrožajoče alergijske reakcije) na katerokoli sestavino cepiva, tiomersal, jajčne in piščančje beljakovine, ovalbumin, formaldehid ali natrijev deoksiholat (glejte poglavje 6, Dodatne informacije).
English: have to be provided in the (simplified) PSUR
Slovenian: Rezultati, vključno s celotno preliminarno analizo, morajo biti vključeni v (poenostavljeni) PSUR.
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).
Slovenian: V klinični študiji, s katero so ocenili reaktogenost pri otrocih, starih od 6 do 35 mesecev, ki so dobili dva polovična (tj. 0,25 ml) odmerka za odrasle (21 dni narazen) cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, so opazili več reakcij na mestu injiciranja in splošnih simptomov, po drugem odmerku v primerjavi s prvim odmerkom, zlasti deleža zvišane aksilarne temperature (≥ 38 °C).
English: • Very limited safety and immunogenicity data obtained three weeks after administration of a single dose to healthy adults aged over 80 years.
Slovenian: • Zelo malo podatkov o varnosti in imunogenosti, dobljenih tri tedne po uporabi enega odmerka cepiva Pandemrix (H1N1) pri zdravih odraslih, starih več kot 80 let.
English: Arepanrix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Slovenian: Arepanrix suspenzija in emulzija za emulzijo za injiciranje cepivo proti pandemski gripi (H1N1)v z delci virionov, inaktivirano (z adjuvansom)
English: In addition, one group of six ferrets were immunized with vaccine candidate containing 3.75 µg H5N1 + full dose of AS03 and one control group included ferrets immunized with non-adjuvanted vaccine (3.75 micrograms HA).
Slovenian: Razen tega pa so eno skupino šestih belih dihurjev cepili s kandidatnim cepivom, ki je vsebovalo 3,75 H5N1 + celoten odmerek AS03.
English: Very common: • Pain at the injection site
Slovenian: • bolečina na mestu injiciranja
English: • Limited safety and immunogenicity data obtained three weeks after administration of a single dose to healthy adults aged 18-79 years.
Slovenian: • Malo podatkov o varnosti in imunogenosti, dobljenih tri tedne po uporabi enega odmerka cepiva Pandemrix (H1N1) pri zdravih odraslih, starih od 18 do 79 let.
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.
Slovenian: • Malo podatkov o imunogenosti, dobljenih tri tedne po uporabi enega 0,25-ml odmerka ali 0,5ml odmerka cepiva Pandemrix (H1N1) pri zdravih otrocih, starih od 10 do 17 let.
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.
Slovenian: Podatki o imunogenosti, dobljeni tri tedne po uporabi cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, v kliničnih študijah kažejo, da morda lahko zadošča en sam odmerek.
English: - abridged report for post dose 3 (immuno & solicited and unsolicited symptoms, SAEs)
Slovenian: - skrajšano poročilo po 3. odmerku (imunološki podatki ter spontano in nespontano zabeleženi simptomi, resni neželeni učinki)
English: • Being sick, stomach pain, acid indigestion
Slovenian: • slabost, bolečine v želodcu, dispepsija
English: • Limited safety data obtained after administration of 0.25 ml or two doses of 0.5 ml to healthy children aged 10-17 years.
Slovenian: • Malo podatkov o varnosti, dobljenih po uporabi 0,25-ml ali dveh 0,5-ml odmerkov cepiva Pandemrix (H1N1) pri zdravih otrocih, starih od 10 do 17 let.
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde and sodium deoxycholate) of this vaccine.
Slovenian: Anafilaktična reakcija v anamnezi (tj. življenjsko nevarna) na katerokoli sestavino cepiva ali ostanke v sledeh (jajčne in piščančje beljakovine, ovalbumin, formaldehid in natrijev deoksiholat).
English: • Fits due to fever
Slovenian: • zvišana telesna temperatura
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to: 3.75 micrograms haemagglutinin/dose *Antigen: A/California/7/2009 (H1N1)v-like strain (X-179A)
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN inaktivirani delci virusa gripe, ki vsebujejo antigene*, ki ustrezajo 3,75 mikrogramom hemaglutinina/odmerek *Antigen: sev A/California/7/2009 (X-179A) podoben sevu A/California/7/2009 (H1N1)v
English: Total enrolled subjects N=120 [95% CI]
Slovenian: Skupno vključeni preiskovanci n=120 [95% IZ]
English: Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Slovenian: Pomožne snovi: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, voda za injekcije
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.
Slovenian: V klinični študiji, s katero so ocenili reaktogenost pri otrocih, starih od 10 do 17 let, ki so dobili dva 0,5-ml odmerka (21 dni narazen) cepiva cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, po drugem odmerku niso opazili povečanja reaktogenosti v primerjavi s prvim odmerkom.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Slovenian: Kako uporabljati cepivo Arepanrix V skladu z uradnimi priporočili vas bo cepil zdravnik ali medicinska sestra.
English: • Post-marketing surveillance
Slovenian: • Spremljanje cepiva po pridobitvi dovoljenja za promet
English: • Diarrhoea, feeling sick
Slovenian: • driska, siljenje na bruhanje
English: Additional data on reactogenicity are available from clinical studies in healthy subjects of various age groups from 6 months of age upwards who received an AS03-containing vaccine containing HA from H1N1v manufactured using a different process.
Slovenian: Iz kliničnih študij pri zdravih preiskovancih različnih starostnih skupin od 6 mesecev starosti dalje, ki so prejeli cepivo z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, so na voljo dodatni podatki o reaktogenosti.
English: Immune response to A/California/7/2009 (H1N1)v-like 61-70 years
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 61-70 let
English: Seronegative subjects prior to vaccination N=61 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n=61 [95% IZ]
English: Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Slovenian: Zvišana telesna temperatura >39°C
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)
Slovenian: Dodatni podatki o varnosti in imunogenosti pri zdravih odraslih, vključno s starejšimi so na voljo iz kliničnih študij z različico cepiva Arepanrix z vsebnostjo 3,75 µg HA pridobljenega iz A/Indonesia/05/2005 (H5N1).
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.
Slovenian: Toda v drugi klinični študiji, ki je ocenjevala reaktogenost pri otrocih, starih od 3 do 9 let po dveh odmerkih (tj. 0,5 ml) za odrasle (21 dni narazen) cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, so po drugem odmerku v primerjavi s prvim odmerkom opazili več reakcij na mestu injiciranja in splošnih simptomov.
English: Arepanrix may be used in lactating women.
Slovenian: Cepivo Arepanrix se lahko uporabi v obdobju dojenja.
English: Immune response to A/California/7/2009 (H1N1)v-like 6-11 months
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 6-11 mesecev
English: Split influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75 micrograms** per 0.5 ml dose *propagated in eggs ** expressed in microgram haemagglutinin
Slovenian: • Zdravilna učinkovina: inaktivirani delci virusa gripe, ki vsebujejo antigene*, ki ustrezajo: sevu A/California/7/2009 (X-179A) podobnemu sevu A/California/7/2009 (H1N1)v 3,75 mikrogramov**na 0,5 ml odmerek
English: Immune response to A/California/7/2009 (H1N1)v-like Half dose
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu Polovični odmerek
English: Total enrolled subjects [95% CI]
Slovenian: Skupno vključeni preiskovanci [95% IZ]
English: 2seroconversion rate (i.e. 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 4-fold increase in titre);
Slovenian: 2Delež serokonverzije (delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra); 3Faktor serokonverzije (razmerje med geometrično sredino (GMT - geometric mean titre) titra po cepljenju in GMT titra pred cepljenjem).
English: Immune response to A/California/7/2009 (H1N1)v-like 3-5 years
Slovenian: Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu 3-5 let
English: Total enrolled subjects N=75 [95% CI]
Slovenian: Skupno vključeni preiskovanci n=75 [95% IZ]
English: There are no data with Arepanrix using the subcutaneous route.
Slovenian: Podatkov o subkutani uporabi cepiva Arepanrix ni.
English: Total enrolled subjects N=40 [95% CI]
Slovenian: Skupno vključeni preiskovanci n=40 [95% CI]
English: Seronegative subjects prior to vaccination N=76 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n=76 [95% IZ]
English: Total enrolled subjects N=97 [95% CI]
Slovenian: Skupno vključeni preiskovanci n=97 [95% IZ]
English: • Dizziness
Slovenian: • drgetanje
English: Before you are given Arepanrix
Slovenian: Kaj morate vedeti, preden boste dobili cepivo Arepanrix
English: Total enrolled subjects N=60 [95% CI]
Slovenian: Skupno vključeni preiskovanci n=60 [95% IZ]
English: Seronegative subjects prior to vaccination N=40 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n=40 [95% IZ]
English: After mixing: Use within 24 hours and do not store above 25°C.
Slovenian: Po premešanju: Uporabite v 24 urah.
English: Seronegative subjects prior to vaccination N=29 [95% CI]
Slovenian: Preiskovanci, ki so bili pred cepljenjem seronegativni n=29 [95% IZ]