FrancophonIA/ELRC3.0 huggingface dataset:
English: A difference in the frequency of local and general solicited adverse reactions between half adult and adult doses was observed after each dose.
Slovenian: Po vsakem odmerku so opazili razliko v pogostnosti lokalno in splošno spodbujenih neželenih učinkov med polovičnim odmerkom za odrasle in polnim odmerkom za odrasle.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti in toksičnosti pri ponavljajočih se odmerkih, lokalne tolerance, plodnosti pri samicah, embrio-fetalne in postnatalne toksičnosti (do konca obdobja laktacije) ne kažejo posebnega tveganja za človeka.
English: Clinical data in children less than 6 years of age who received two doses of pandemic preparedness or zoonotic influenza vaccine (H5N1) indicate an increase in frequency of fever (axillary≥38°C) after the administration of the second dose.
Slovenian: Klinični podatki otrok, mlajših od 6 let, ki so prejeli dva odmerka cepiva za pripravljenost na pandemijo ali cepiva proti zoonotični gripi (H5N1), kažejo večjo pogostnost zvišane telesne temperature (aksilarno ≥ 38 °C) po uporabi drugega odmerka.
English: • From 80 years onwards: you may receive two double injections of Adjupanrix.
Slovenian: • Od 80. leta naprej: morda boste prejeli dve dvojni injekciji cepiva Adjupanrix.
English: The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Slovenian: Delež serološke zaščite proti A/Indonesia je bil 21 dni po obnovitvenem cepljenju 92 % in 180. dan 69,2 %.
English: This medicine has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v 'izjemnih okoliščinah'.
English: The percentage of subjects reaching neutralising antibody titres of >1/80 were 54.9% and 44.9% at months 12 and 24, respectively.
Slovenian: Odstotek preiskovancev, ki so dosegli titre nevtralizirajočih protiteles > 1/80, je bil 12. mesec 54,9 % in 24. mesec 44,9 %.
English: A second dose of 0.5 ml should be given after an interval of at least three weeks and up to twelve months after the first dose for maximum efficacy.
Slovenian: Za največjo učinkovitost je treba drugi odmerek 0,5 ml dati po presledku najmanj treh tednov in do dvanajst mesecev po prvem odmerku.
English: - Convulsion:
Slovenian: - konvulzije:
English: Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment.
Slovenian: V homolognem provokacijskem poskusu so raziskovali odmerke 15, 5, 1,7 ali 0,6 mikrograma HA, v heterolognem provokacijskem poskusu pa odmerke 15, 7,5, 3,8 ali 1,75 mikrograma HA.
English: After two doses administered 6 months apart all subjects had a titre of at least 1:80.
Slovenian: Po dveh odmerkih apliciranih v razmaku 6 mesecev so vsi preiskovanci imeli titre vsaj 1:80.
English: The seroprotection rates were 2.2%, 4.7%, 2.4% and 7.8% at months 6, 12, 24 and 36, respectively.
Slovenian: Deleži serološke zaščite so bili 6. mesec 2,2 %, 12. mesec 4,7 %, 24. mesec 2,4 % in 36. mesec 7,8 %.
English: This can cause skin rashes, joint pain and kidney problems
Slovenian: Ta lahko povzroči izpuščaje na koži, bolečine v sklepih in težave z ledvicami.
English: If any of the side effects below occur, please tell your doctor or nurse immediately:
Slovenian: Če se pojavi kateri od spodaj navedenih neželenih učinkov nemudoma obvestite zdravnika ali medicinsko sestro:
English: Do not have Adjupanrix if any of the above apply to you.
Slovenian: Ne cepite se s cepivom Adjupanrix, če karkoli od naštetega velja za vas.
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Slovenian: Klinični pomen hemaglutininskega inhibicijskega (HI) titra ≥ 1:40 pri otrocih ni znan.
English: 24 months after vaccination
Slovenian: 24 mesecev po cepljenju
English: Redness Swelling Fever (>38°C) Fever (>39°C) - per-dose frequency - per-subject frequency Drowsiness
Slovenian: Polni odmerek za odrasle induracija bolečina pordelost oteklost zvišana telesna temperatura (> 38 °C) zvišana telesna temperatura (> 39 °C) - pogostnost na odmerek - pogostnost na preiskovanca zaspanost
English: Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Slovenian: Kontrolne skupine so vključevale dihurje, ki so prejeli samo adjuvans, cepivo brez adjuvansa (15 mikrogramov
English: Fainting can occur following, or even before, any needle injection.
Slovenian: Omedlevica se lahko pojavi po vsakem injiciranju z iglo ali celo pred njim.
English: If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature (for a minimum of 15 minutes) before each withdrawal.
Slovenian: Če pripravljeno cepivo shranjujete v hladilniku, ga je treba pred odvzemom posameznega odmerka vsaj 15 minut pustiti da doseže sobno temperaturo.
English: These antigens can be considered as “novel” antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Slovenian: “nove” antigene in simulirajo razmere, kjer ciljna populacija za cepljenje še ni bila v stiku z antigenom.
English: Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Slovenian: Suspenzija: večodmerna viala z antigenom Emulzija: večodmerna viala z adjuvansom
English: Adjupanrix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Slovenian: Adjupanrix suspenzija in emulzija za emulzijo za injiciranje cepivo proti pandemski gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
English: narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
Slovenian: ozka SMQ “anafilaktična reakcija” in ozka SMQ “angioedem”
English: It is recommended to equip the syringe with a needle gauge not larger than 23G.
Slovenian: Injekcijsko brizgo je priporočljivo opremiti z iglo, ki ni večja od 23-G.
English: • The double injections will be given in opposite arms.
Slovenian: • Dvojni injekciji boste dobili vsako v eno roko.
English: It is recommended to equip the syringe with a 23-G needle.
Slovenian: Injekcijsko brizgo je priporočljivo opremiti z iglo 23-G.
English: This is as long as medical treatment is available straight away, in case you have an allergic reaction.
Slovenian: Vendar pa je pri tem treba zagotoviti ustrezno obliko zdravljenja, ki mora biti v primeru pojava alergijske reakcije nemudoma na voljo.
English: Neutralising antibody titres of at least 1:40 or at least 1:80 were achieved in 87% and 67%, respectively, of the 87 subjects tested.
Slovenian: testiranih preiskovancih je bil titer nevtralizirajočih protiteles vsaj 1:40 pri 87 % in vsaj 1:80 pri 67 %.
English: The suspension is a colourless light opalescent liquid.
Slovenian: Suspenzija je brezbarvna, rahlo opalescentna tekočina.
English: 0, 21 days schedule (D-Pan-H5N1-002)
Slovenian: shema 0, 21 dni, (D-Pan-H5N1-002)
English: After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres and 98-100% had a titre of at least 1:80.
Slovenian: Po dveh odmerkih apliciranih 21 dni ali 6 mesecev narazen je 96,0 % preiskovancev imelo 4-krat večji titer nevtralizacijskih protiteles v serumu, 98-100 % preiskovancev pa je imelo titer vsaj 1:80.
English: This section describes the clinical experience with the pandemic preparedness vaccines.
Slovenian: Farmakodinamični učinki V tem poglavju so navedene klinične izkušnje pri cepljenju s cepivi za pripravljenost na pandemijo.
English: • you have a bleeding problem or you bruise easily.
Slovenian: • če imate kakšno motnjo strjevanja krvi ali ste nagnjeni k podplutbam.
English: “Possible side effects” may affect your ability to drive or use tools or machines.
Slovenian: Nekateri neželeni učinki, našteti v poglavju 4, "Možni neželeni učinki", lahko vplivajo na vašo sposobnost vožnje in upravljanja z orodji in s stroji.
English: • Diarrhoea, vomiting, stomach pain, feeling sick
Slovenian: • driska, bruhanje, bolečine v želodcu, siljenje na bruhanje,
English: Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Slovenian: metode za odkrivanje protiteles proti virusu humane imunske pomanjkljivosti 1 (HIV-1), virusu hepatitisa C in še posebej proti HTLV-1.
English: There are no data on co-administration of Adjupanrix with other vaccines.
Slovenian: Podatkov o sočasni uporabi cepiva Adjupanrix z drugimi cepivi ni.
English: - Rapporteur's assessment report is circulated to CHMP members on Day 50.
Slovenian: - S-PSUR je poročevalcu in članom CHMP oddano 45. dan. - Poročevalčeva ocena poročila je posredovana članom CHMP 50. dan. - Poročilo CHMP je posredovano izdelovalcu cepiva 55. dan. - Poročanje mora biti prvih 6 mesecev vsak mesec.
English: Excipient with known effect The vaccine contains 5 micrograms thiomersal (see section 4.4).
Slovenian: Cepivo vsebuje 5 mikrogramov tiomersala (glejte poglavje 4.4).
English: Name and address of the manufacturer responsible for batch release
Slovenian: Nemčija Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
English: Against A/Vietnam 21 days after boosting with A/Vietnam N=46
Slovenian: anti-HA protitelesa Proti A/Vietnam 21 dni po obnovitvi z A/Vietnam n = 46
English: At day 42, the anti-HA antibody responses were as follows:
Slovenian: Na dan 42 so bili odzivi protiteles anti-HA naslednji:
English: Adjupanrix should under no circumstances be administered intravascularly.
Slovenian: Cepiva Adjupanrix se v nobenem primeru ne sme injicirati v žilo.
English: In each experiment, four groups of six ferrets were immunised intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14).
Slovenian: V vsakem poskusu so štiri skupine s šestimi živalmi intramuskularno cepili s cepivom, ki je imelo kot adjuvans AS03 in je vsebovalo HA, pridobljen iz H5N1/A/Vietnam/1194/04 (NIBRG-14).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Adjupanrix in one or more subsets of the paediatric population in influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine (see section 4.2 for information on paediatric use).
Slovenian: Adjupanrix pri eni ali več podskupinah pediatrične populacije za okužbo z gripo, povzročeno s sevom v cepivu, ali s sevom, sorodnim sevu v cepivu (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: 3-5 years
Slovenian: 3-5 let
English: AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1) From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported: Immune system disorders
Slovenian: Cepiva z AS03 z vsebnostjo 3,75 µg HA pridobljenega iz A/California/7/2009 (H1N1) Po pridobitvi dovoljenja za promet s cepivi z AS03 z vsebnostjo 3,75 µg HA, pridobljenimi iz A/California/7/2009 (H1N1), so bili opisani naslednji neželeni učinki: Bolezni imunskega sistema anafilaksa, alergijske reakcije
English: 12 months after vaccination
Slovenian: 12 mesecev po cepljenju
English: Rare (≥1/10,000 to <1/1,000)
Slovenian: Pogosti (≥ 1/100 do < 1/10) Občasni (≥ 1/1.000 do < 1/100) Redki (≥ 1/10.000 do < 1/1.000) Zelo redki (< 1/10.000)
English: Day 180 N=138
Slovenian: 180. dan n=138
English: The neutralising antibody responses were as follows:
Slovenian: Odzivi nevtralizirajočih protiteles so bili naslednji:
English: Adjupanrix contains sodium and potassium
Slovenian: Cepivo Adjupanrix vsebuje natrij in kalij
English: Adjupanrix consists of two containers:
Slovenian: Cepivo Adjupanrix je na voljo v dveh vsebnikih:
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Slovenian: GBS, bo prišlo do prekrivanja v številu primerov za ti dve kategoriji)
English: • From 18 years onwards: you will receive two doses of Adjupanrix.
Slovenian: • Od 18. leta naprej: prejeli boste dva odmerka cepiva Adjupanrix.
English: Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous H5N1/A/Indonesia/5/05.
Slovenian: Dihurje so cepili na 0. in 21. dan, nato pa so 49. dan intratrahealno prejeli letalen odmerek bodisi H5N1/A/Vietnam/1194/04 bodisi heterolognega H5N1/A/Indonesia/5/05.
English: Subjects from study D-Pan-H5N1-002 were followed up for persistence of anti-HA antibodies against A/Indonesia/5/2005.
Slovenian: Preiskovance v študiji D-Pan-H5N1-002 so spremljali glede trajanja prisotnosti anti-HA protiteles proti A/Indonesia/5/2005.
English: 2 % of subjects with titre ≥1:28
Slovenian: 1 geometrična sredina titrov 2% preiskovancev s titri ≥1:28
English: Common: lymphadenopathy
Slovenian: Pogosti: limfadenopatija
English: Month N=38
Slovenian: mesec n=38
English: 3 to 5 years
Slovenian: 3 do 5 let
English: GMT1 Seroconversion rate2
Slovenian: GMT1 Delež serokonverzije2
English: Suspension and emulsion for emulsion for injection.
Slovenian: suspenzija in emulzija za emulzijo za injiciranje.
English: - Neuritis:
Slovenian: - nevritis:
English: What Adjupanrix looks like and contents of the pack
Slovenian: Izgled cepiva Adjupanrix in vsebina pakiranja
English: Month 6 N=48
Slovenian: mesec 6 n=48
English: 6 to 9 years
Slovenian: 6 do 9 let
English: In other clinical studies where children 6 months to 17 years received zoonotic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
Slovenian: V drugih kliničnih študijah, v katerih so otroci v starosti od 6 mesecev do 17 let dobili cepivo proti zoonotični gripi (H5N1 A/Indonesia/05/2005, izdelano v Dresdnu v Nemčiji), so pri otrocih, mlajših od 6 let, po drugem odmerku opažali večjo pogostnost nekaterih neželenih učinkov (vključno z bolečino na mestu injiciranja, pordelostjo in zvišano telesno temperaturo).
English: A.
Slovenian: E.
English: Double dose (N=131)
Slovenian: Dvojni odmerek (n=131)
English: Subjects from study D-Pan-H5N1-010 who received a single dose were followed-up for persistence of anti-HA antibodies against A/Indonesia/5/2005.
Slovenian: Preiskovance v študiji D-Pan-H5N1-010, ki so prejeli en odmerek, so spremljali glede trajanja prisotnosti anti-HA protiteles proti A/Indonesia/5/2005.
English: The following side effects may happen with this medicine:
Slovenian: Med uporabo tega cepiva se lahko pojavijo naslednji neželeni učinki:
English: • From 18 years onwards: you will receive one dose of Adjupanrix.
Slovenian: • Od 18. leta naprej: prejeli boste en odmerek cepiva Adjupanrix.
English: Double dose (N=81)
Slovenian: Dvojni odmerek (n=81)
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.
Slovenian: • če ste kdaj imeli nenadno, življenjsko ogrožajočo alergijsko reakcijo na katerokoli sestavino tega cepiva (navedene so v poglavju 6) ali na karkoli, kar je lahko prisotno v zelo majhnih količinah, kot so: jajčne in piščančje beljakovine, ovalbumin, formaldehid, gentamicinijev sulfat (antibiotik) ali natrijev deoksiholat.
English: Very limited data in seronegative subjects >80 years of age (N=5) showed that no subject achieved seroprotection rate following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1).
Slovenian: Zelo omejeni podatki pri seronegativnih preiskovancih, starejših od 80 let (n = 5) so pokazali, da noben preiskovanec ni dosegel serološke zaščite po dvakratni uporabi enega odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 (H5N1).
English: METHOD OF ADMINISTRATION Mix into Antigen suspension before use
Slovenian: POSTOPEK UPORABE Pred uporabo zmešajte skupaj s suspenzijo antigena
English: For instructions on mixing of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila o mešanju zdravila pred uporabo glejte poglavje 6.6. 4.3 Kontraindikacije
English: 2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
Slovenian: 2 4-kratno povečanje serumskih titrov nevtralizirajočih protiteles 3 % preiskovancev, ki so dosegli serumski titer nevtralizirajočih protiteles vsaj 1:80
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA intramuskularna uporaba.
English: What Adjupanrix is and what it is used for
Slovenian: Kaj je cepivo Adjupanrix in za kaj ga uporabljamo Kaj je cepivo Adjupanrix in za kaj ga uporabljamo
English: Serum neutralising antibody
Slovenian: Serumska nevtralizirajoča protitelesa
English: • Feeling tired
Slovenian: • glavobol, • občutek utrujenosti,
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of 0.5 ml vaccine
Slovenian: Količina, dobljena z mešanjem 1 viale suspenzije (2,5 ml) in 1 viale emulzije (2,5 ml), ustreza 10 odmerkom z 0,5 ml cepiva.
English: The emulsion is a whitish to yellowish homogeneous milky liquid.
Slovenian: Emulzija je belkasta do rumenkasta homogena mlečna tekočina.
English: Immune response against A/Vietnam/1194/2004 (H5N1):
Slovenian: Imunski odziv proti A/Vietnam/1194/2004 (H5N1):
English: Month N=47
Slovenian: mesec n=47
English: The suspension and emulsion vials once mixed form a multidose container.
Slovenian: Viala, v kateri zmešate suspenzijo in emulzijo, je večodmerni vsebnik.
English: The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
Slovenian: Pomožne snovi so: polisorbat 80, oktoksinol 10, tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, magnezijev klorid in voda za injekcije.
English: In other clinical studies where children 6 months to 17 years received a similar vaccine containing A/Indonesia/05/2005, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
Slovenian: V drugih kliničnih študijah, v katerih so otroci v starosti od 6 mesecev do 17 let dobili podobno cepivo, ki je vsebovalo A/Indonesia/05/2005, so pri otrocih, mlajših od 6 let, po drugem odmerku opažali večjo pogostnost nekaterih neželenih učinkov (vključno z bolečino na mestu injiciranja,
English: There are limited safety and immunogenicity data available on the administration of Adjupanrix and on administration of half a dose of the vaccine (i.e. 1.875 µg HA and half the amount of AS03 adjuvant) at 0 and 21 days in children aged 3 to 9 years.
Slovenian: Pri otrocih, starih od 3 do 9 let, je malo podatkov o varnosti in imunogenosti cepiva Adjupanrixin polovičnega odmerka istega cepiva (tj. 1,875 µg HA in pol količine adjuvansa AS03), uporabljenih na dan 0 in 21.
English: Month 6 N=40
Slovenian: mesec 6 n=40
English: The seroprotection rates 6, 12, 24 and 36 months after the first dose were as follows:
Slovenian: Deleži serološke zaščite 6, 12, 24 in 36 mesecev po prvem odmerku so bili:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPPRABE C.
English: • Other ingredients:
Slovenian: • Pomožne snovi:
English: After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Slovenian: Po premešanju z emulzijo adjuvansa: 10 odmerkov po 0,5 ml.
English: Immune response against A/Indonesia/05/2005 (H5N1)
Slovenian: Imunski odziv proti A/Indonesia/05/2005 (H5N1)
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) post-vaccination.
Slovenian: Zato je mlajšim otrokom (npr. do približno 6. leta starosti) po cepljenju priporočljivo kontrolirati telesno temperaturo in uporabiti ukrepe za znižanje zvišane telesne temperature (npr. antipiretična zdravila, če se zdi klinično potrebno).
English: Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended.
Slovenian: Zato je otroku po vsakem odmerku cepiva priporočljivo spremljati telesno temperaturo in uporabiti ukrepe za njeno znižanje, če je zvišana (npr. otroku dati paracetamol ali drugo zdravilo za znižanje zvišane telesne temperature).
English: An overview for all spontaneous cases per country, stratified according to type of report (medically confirmed or non-medically confirmed) and seriousness, for the period covered by the report and cumulatively.
Slovenian: Pregled vseh spontano prijavljenih primerov na državo, stratificiranih po vrsti prijave (medicinsko potrjena ali ni medicinsko potrjena) in resnosti, za obdobje, ki ga zajema poročilo, in kumulativno.
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.
Slovenian: Če pa je to potrebno, vam bodo drugo cepivo injicirali v drugo roko.
English: 50 vials: suspension (antigen) 50 vials: emulsion (adjuvant)
Slovenian: 50 vial: suspenzija (antigen)
English: What Adjupanrix is and what it is used for Adjupanrix is a vaccine for use in adults from 18 years old to prevent pandemic flu (influenza).
Slovenian: Cepivo Adjupanrix uporabljamo za preprečevanje pandemije gripe pri odraslih, starejših od 18 let.
English: In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult (0.25 ml) doses.
Slovenian: V klinični študiji so otroci, stari od 3 do 9 let, prejeli dvakrat bodisi odmerek za odrasle (0,5 ml) bodisi polovični odmerek za odrasle (0,25 ml).
English: In addition, 44.8% and 56.1% of subjects in respective dose groups had a 4-fold increase in serum neutralising antibody titres from day 0 to day 42 and 96.6% and 100% of subjects had a titre of at least 1:80 at day 42.
Slovenian: Poleg tega je imelo v posameznih odmernih skupinah na 42. dan 4-kraten porast titrov nevtralizirajočih protiteles v serumu 44,8 % in 56,1 % preiskovancev in titer vsaj 1:80 96,6 % in 100 % preiskovancev.
English: Your doctor or nurse will give you Adjupanrix.
Slovenian: S cepivom Adjupanrix vas bo cepil zdravnik ali medicinska sestra.
English: - Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
Slovenian: - Razpored (periodičnost) morata imetnik dovoljenja za promet in (so)poročevalec pregledovati v
English: The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.
Slovenian: Pripravljeno cepivo je belkasta do rumenkasta homogena mlečna tekoča emulzija.