natgillin/translations-raw huggingface dataset:
However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
V pandemskih razmerah bo cepljenje morda vseeno upravičeno, vendar ob zagotovitvi opreme za oživljanje, ki mora biti po potrebi nemudoma na voljo.
Animal studies with Adjupanrix do not indicate reproductive toxicity (see section 5.3).
Študije na živalih, opravljene s cepivom Adjupanrix ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Adults aged 18-60 years
Odrasli, stari do 18 do 60 let
Month 24
24. mesec
• This will usually be in the upper arm.
• Navadno je to mišica na nadlakti.
Uncommon: paraesthesia, somnolence, dizziness
Občasni: parestezije, somnolenca, omotica
Twelve and twenty-four months after vaccination, the neutralising antibody titres were as follows:
Dvanajst in štiriindvajset mesecev po cepljenju so bili titri nevtralizirajočih protiteles naslednji:
Of the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or heterologous challenge, respectively.
Od živali, ki so prejele cepivo z adjuvansom, jih je bilo proti smrtni homologni provokaciji zaščitenih 87 %, proti heterologni pa 96 %.
Epidemiological studies relating to another AS03-adjuvanted vaccine (Pandemrix H1N1, also manufactured in the same facility as Adjupanrix), in several European countries have indicated an increased risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals.
Epidemiološke študije, povezane z drugim cepivom z adjuvansom AS03 (Pandemrix H1N1, ki ga izdeluje isti obrat kot cepivo Adjupanrix), so v več evropskih državah nakazale večje tveganje za narkolepsijo (s katapleksijo ali brez nje) pri cepljenih osebah v primerjavi z necepljenimi.
Adjupanrix is not intended to be given at the same time as some other vaccines.
Cepivo Adjupanrix ni namenjeno za dajanje ob istem času z nekaterimi z drugimi cepivi.
Tell the doctor requesting these tests that you have recently received Adjupanrix.
Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom Adjupanrix.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Po vsakem cepljenju ali celo pred njim se lahko pojavi sinkopa (omedlevica), kot psihološki odziv na injiciranje z iglo.
Additional side effects in children
Dodatni neželeni učinki in otrocih
- Vaccination failure:
- neuspeh cepljenja:
narrow SMQ “Non-infectious encephalitis”
ozka SMQ “neinfekcijski encefalitis”
There are currently no data available on the use of Adjupanrix in pregnancy.
Trenutno ni podatkov o uporabi cepiva Adjupanrix med nosečnostjo.
Based on very limited data, adults aged >80 years may require a double dose of Adjupanrix on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1).
Na podlagi zelo omejenih podatkov kaže, da lahko odrasli, starejši od 80 let, potrebujejo za doseganje imunskega odziva dvojni odmerek cepiva Adjupanrix na izbrani datum in znova po presledku vsaj treh tednov (glejte poglavje 5.1).
Other medicines and Adjupanrix
Druga zdravila in cepivo Adjupanrix
Adjuvants are used to improve the body's response to the vaccine.
Adjuvansi se uporabljajo za izboljšanje imunskega odziva na cepivo.
• Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as ‘GuillainBarré Syndrome'.
• težave z vašimi možgani in živci, kot je vnetje osrednjega živčevja (encefalomielitis), vnetje živcev (nevritis) ali vrsta ohromitve, imenovana Guillain-Barréjev sindrom,
Each vaccine dose of 0.5 ml is withdrawn into a 1 ml syringe for injection and administered intramuscularly.
Vsak odmerek cepiva z 0,5 ml izvlecite v 1-ml injekcijsko brizgo in injicirajte intramuskularno.
The anti-HA responses were as follows:
Odzivi anti-HA so bili naslednji:
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
narrow SMQ “Vasculitis” - Guillain-Barré syndrome: narrow SMQ “Guillain-Barré syndrome” - Demyelination:
ozka SMQ “vaskulitis” - Guillain-Barréjev sindrom: ozka SMQ “Guillain-Barréjev sindrom” - demielinizacija:
1 Geometric Mean Titre
1 Geometrična sredina titrov
The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically using ferret challenge models.
Sposobnost za indukcijo zaščite proti homolognim in heterolognim cepilnim sevom so ocenili predklinično s provokacijskim modelom pri belem dihurju.
narrow SMQ “Convulsions”
ozka SMQ “konvulzije”
A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Adjupanrix.
Blažja okužba, npr. prehlad, ne bi smela biti težava, vendar se pred cepljenjem s cepivom Adjupanrix o tem vseeno posvetujte s svojim zdravnikom.
- Vasculitis:
- vaskulitis:
What Adjupanrix is and what it is used for What you need to know before you receive Adjupanrix How Adjupanrix is given
Kaj je cepivo Adjupanrix in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili cepivo Adjupanrix Kako uporabljati cepivo Adjupanrix
If you have any further questions on the use of this vaccine, ask your doctor or nurse.
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali z medicinsko sestro.
If you have previously received one or two doses of Prepandrix
Če ste predhodno bili cepljeni z enim ali dvema odmerkoma cepiva Prepandrix
One pack of Adjupanrix consists of:
Eno pakiranje cepiva Adjupanrix vsebuje:
In this study, cross-reactive immune responses against A/Indonesia/5/2005 were also observed.
V tej študiji so opažali tudi navzkrižne imunske odzive proti A/Indonesia/5/2005.
• This vaccine has been prescribed for you only.
• Cepivo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Against A/Indonesia 21 days after boosting with A/Indonesia N=49
Proti A/Indonesia 21 dni po obnovitvi z A/Indonesia n = 49
Adverse reactions from clinical trials with the pandemic preparedness vaccine are listed here below (see section 5.1 for more information on pandemic preparedness vaccines).
Spodaj so navedeni neželeni učinki kliničnih preskušanj s cepivom za pripravljenost na pandemijo (za več informacij o cepivih za pripravljenost na pandemijo glejte poglavje 5.1).
If you are not sure, talk to your doctor or nurse before having this vaccine.
Če niste prepričani, se pred cepljenjem posvetujte z zdravnikom ali z medicinsko sestro.
Adjupanrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Cepivo Adjupanrix vsebuje tiomersal Cepivo Adjupanrix kot konzervans vsebuje tiomersal in možno je, da se vam pojavi alergijska reakcija.
Seroconversion rates for neutralising antibodies against A/Indonesia/5/2005 were 15.7% and 12.2% for months 12 and 24, respectively.
Deleža serokonverzije za nevtralizirajoča protitelesa proti A/Indonesia/5/2005 sta bila 12. mesec 15,7 % in 24. mesec 12,2 %.
Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Med pandemijo bodo zato 6-mesečne ali letne PSUR nadomestila mesečna "poenostavljena
The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen.
Cepivo zmešate tako, da s 5-ml injekcijsko brizgo izvlečete celotno vsebino viale adjuvansa in jo dodate v vialo z antigenom.
The administration of a second half adult or an adult dose did not enhance the reactogenicity, except for rates of general symptoms which were higher after the second dose, particularly for rates of fever in <6 year olds.
Uporaba drugega polovičnega odmerka za odrasle ali polnega odmerka za odrasle ni povečala reaktogenosti, razen stopenj splošnih simptomov, ki so bile višje po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri mlajših od 6 let.
0, 6 months schedule (D-Pan-H5N1-012)
shema 0, 6 mesecev (D-Pan-H5N1-012)
There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study.
V več kot 100 nosečnostih, ki so jih spremljali med prospektivno klinično študijo, ni bilo dokazov o večjem tveganju neželenih izidov.
A difference in the frequency of local and general solicited adverse reactions between half adult and adult doses was observed after each dose.
Po vsakem odmerku so opazili razliko v pogostnosti lokalno in splošno spodbujenih neželenih učinkov med polovičnim odmerkom za odrasle in polnim odmerkom za odrasle.
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).
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.
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.
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.
• From 80 years onwards: you may receive two double injections of Adjupanrix.
• Od 80. leta naprej: morda boste prejeli dve dvojni injekciji cepiva Adjupanrix.
The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Delež serološke zaščite proti A/Indonesia je bil 21 dni po obnovitvenem cepljenju 92 % in 180. dan 69,2 %.
This medicine has been authorised under ‘exceptional circumstances'.
Zdravilo je pridobilo dovoljenje za promet v 'izjemnih okoliščinah'.
The percentage of subjects reaching neutralising antibody titres of >1/80 were 54.9% and 44.9% at months 12 and 24, respectively.
Odstotek preiskovancev, ki so dosegli titre nevtralizirajočih protiteles > 1/80, je bil 12. mesec 54,9 % in 24. mesec 44,9 %.
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.
Za največjo učinkovitost je treba drugi odmerek 0,5 ml dati po presledku najmanj treh tednov in do dvanajst mesecev po prvem odmerku.
- Convulsion:
- konvulzije:
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.
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.
After two doses administered 6 months apart all subjects had a titre of at least 1:80.
Po dveh odmerkih apliciranih v razmaku 6 mesecev so vsi preiskovanci imeli titre vsaj 1:80.
The seroprotection rates were 2.2%, 4.7%, 2.4% and 7.8% at months 6, 12, 24 and 36, respectively.
Deleži serološke zaščite so bili 6. mesec 2,2 %, 12. mesec 4,7 %, 24. mesec 2,4 % in 36. mesec 7,8 %.
This can cause skin rashes, joint pain and kidney problems
Ta lahko povzroči izpuščaje na koži, bolečine v sklepih in težave z ledvicami.
If any of the side effects below occur, please tell your doctor or nurse immediately:
Če se pojavi kateri od spodaj navedenih neželenih učinkov nemudoma obvestite zdravnika ali medicinsko sestro:
Do not have Adjupanrix if any of the above apply to you.
Ne cepite se s cepivom Adjupanrix, če karkoli od naštetega velja za vas.
The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Klinični pomen hemaglutininskega inhibicijskega (HI) titra ≥ 1:40 pri otrocih ni znan.
24 months after vaccination
24 mesecev po cepljenju
Redness Swelling Fever (>38°C) Fever (>39°C) - per-dose frequency - per-subject frequency Drowsiness
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
Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution.
Kontrolne skupine so vključevale dihurje, ki so prejeli samo adjuvans, cepivo brez adjuvansa (15 mikrogramov
Fainting can occur following, or even before, any needle injection.
Omedlevica se lahko pojavi po vsakem injiciranju z iglo ali celo pred njim.
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.
Če pripravljeno cepivo shranjujete v hladilniku, ga je treba pred odvzemom posameznega odmerka vsaj 15 minut pustiti da doseže sobno temperaturo.
These antigens can be considered as “novel” antigens and simulate a situation where the target population for vaccination is immunologically naïve.
“nove” antigene in simulirajo razmere, kjer ciljna populacija za cepljenje še ni bila v stiku z antigenom.
Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Suspenzija: večodmerna viala z antigenom Emulzija: večodmerna viala z adjuvansom
Adjupanrix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Adjupanrix suspenzija in emulzija za emulzijo za injiciranje cepivo proti pandemski gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
ozka SMQ “anafilaktična reakcija” in ozka SMQ “angioedem”
It is recommended to equip the syringe with a needle gauge not larger than 23G.
Injekcijsko brizgo je priporočljivo opremiti z iglo, ki ni večja od 23-G.
• The double injections will be given in opposite arms.
• Dvojni injekciji boste dobili vsako v eno roko.
It is recommended to equip the syringe with a 23-G needle.
Injekcijsko brizgo je priporočljivo opremiti z iglo 23-G.
This is as long as medical treatment is available straight away, in case you have an allergic reaction.
Vendar pa je pri tem treba zagotoviti ustrezno obliko zdravljenja, ki mora biti v primeru pojava alergijske reakcije nemudoma na voljo.
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.
testiranih preiskovancih je bil titer nevtralizirajočih protiteles vsaj 1:40 pri 87 % in vsaj 1:80 pri 67 %.
The suspension is a colourless light opalescent liquid.
Suspenzija je brezbarvna, rahlo opalescentna tekočina.
0, 21 days schedule (D-Pan-H5N1-002)
shema 0, 21 dni, (D-Pan-H5N1-002)
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.
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.
This section describes the clinical experience with the pandemic preparedness vaccines.
Farmakodinamični učinki V tem poglavju so navedene klinične izkušnje pri cepljenju s cepivi za pripravljenost na pandemijo.
• you have a bleeding problem or you bruise easily.
• če imate kakšno motnjo strjevanja krvi ali ste nagnjeni k podplutbam.
“Possible side effects” may affect your ability to drive or use tools or machines.
Nekateri neželeni učinki, našteti v poglavju 4, "Možni neželeni učinki", lahko vplivajo na vašo sposobnost vožnje in upravljanja z orodji in s stroji.
• Diarrhoea, vomiting, stomach pain, feeling sick
• driska, bruhanje, bolečine v želodcu, siljenje na bruhanje,
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.
metode za odkrivanje protiteles proti virusu humane imunske pomanjkljivosti 1 (HIV-1), virusu hepatitisa C in še posebej proti HTLV-1.
There are no data on co-administration of Adjupanrix with other vaccines.
Podatkov o sočasni uporabi cepiva Adjupanrix z drugimi cepivi ni.
- Rapporteur's assessment report is circulated to CHMP members on Day 50.
- 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.
Excipient with known effect The vaccine contains 5 micrograms thiomersal (see section 4.4).
Cepivo vsebuje 5 mikrogramov tiomersala (glejte poglavje 4.4).
Name and address of the manufacturer responsible for batch release
Nemčija Ime in naslov izdelovalca, odgovornega za sproščanje serije
The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
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.
Against A/Vietnam 21 days after boosting with A/Vietnam N=46
anti-HA protitelesa Proti A/Vietnam 21 dni po obnovitvi z A/Vietnam n = 46
At day 42, the anti-HA antibody responses were as follows:
Na dan 42 so bili odzivi protiteles anti-HA naslednji:
Adjupanrix should under no circumstances be administered intravascularly.
Cepiva Adjupanrix se v nobenem primeru ne sme injicirati v žilo.
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).
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).
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).
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).
3-5 years
3-5 let
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
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
12 months after vaccination
12 mesecev po cepljenju
Rare (≥1/10,000 to <1/1,000)
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)
Day 180 N=138
180. dan n=138
The neutralising antibody responses were as follows:
Odzivi nevtralizirajočih protiteles so bili naslednji:
Adjupanrix contains sodium and potassium
Cepivo Adjupanrix vsebuje natrij in kalij
Adjupanrix consists of two containers:
Cepivo Adjupanrix je na voljo v dveh vsebnikih:
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).
GBS, bo prišlo do prekrivanja v številu primerov za ti dve kategoriji)
• From 18 years onwards: you will receive two doses of Adjupanrix.
• Od 18. leta naprej: prejeli boste dva odmerka cepiva Adjupanrix.
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.
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.
Subjects from study D-Pan-H5N1-002 were followed up for persistence of anti-HA antibodies against A/Indonesia/5/2005.
Preiskovance v študiji D-Pan-H5N1-002 so spremljali glede trajanja prisotnosti anti-HA protiteles proti A/Indonesia/5/2005.
2 % of subjects with titre ≥1:28
1 geometrična sredina titrov 2% preiskovancev s titri ≥1:28
Common: lymphadenopathy
Pogosti: limfadenopatija
Month N=38
mesec n=38
3 to 5 years
3 do 5 let
GMT1 Seroconversion rate2
GMT1 Delež serokonverzije2
Suspension and emulsion for emulsion for injection.
suspenzija in emulzija za emulzijo za injiciranje.
- Neuritis:
- nevritis:
What Adjupanrix looks like and contents of the pack
Izgled cepiva Adjupanrix in vsebina pakiranja
Month 6 N=48
mesec 6 n=48
6 to 9 years
6 do 9 let
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.
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).
Double dose (N=131)
Dvojni odmerek (n=131)
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.
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.
The following side effects may happen with this medicine:
Med uporabo tega cepiva se lahko pojavijo naslednji neželeni učinki:
• From 18 years onwards: you will receive one dose of Adjupanrix.
• Od 18. leta naprej: prejeli boste en odmerek cepiva Adjupanrix.
Double dose (N=81)
Dvojni odmerek (n=81)
• 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.
• 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.
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).
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).
METHOD OF ADMINISTRATION Mix into Antigen suspension before use
POSTOPEK UPORABE Pred uporabo zmešajte skupaj s suspenzijo antigena