natgillin/translations-raw huggingface dataset:
Serological testing indicated a direct correlation between vaccines induced HI and neutralising antibody titres in protected animals compared to antigen and adjuvant controls.
Pri serološkem testiranju so odkrili neposredno povezavo med s cepivom induciranimi HI in titri nevtralizacijskih protiteles pri zaščitenih živalih, v primerjavi s kontrolnimi živalmi, ki so prejele le antigen ali adjuvans.
Suspension and emulsion for emulsion for injection.
suspenzija in emulzija za emulzijo za injiciranje
Areapanrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.
Cepivo Arepanrix je mogoče dati hkrati s sezonskimi cepivi proti gripi, ki ne vsebujejo adjuvansa.
Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Obvestite zdravnika ali medicinsko sestro, če imate kakšno motnjo strjevanja krvi ali ste nagnjeni k podplutbam.
See section 4.4 for Special warnings and special precautions for use.
Za posebna opozorila in previdnostne ukrepe glejte poglavje 4.4.
When Arepanrix is given for the first dose, it is recommended that Arepanrix (and not another vaccine against H1N1) be given for the complete vaccination course.
Če je za prvi odmerek uporabljeno cepivo Arepanrix, je priporočljivo, da se cepljenje tudi dokonča s cepivom Arepanrix (in ne z drugim cepivom proti H1N1).
A dose (0.25 ml) of the vaccine will be given.
Otrok bo dobil en odmerek (0,25 ml) cepiva.
There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
Na voljo ni podatkov o cepljenju s cepivi z adjuvansom AS03, pred ali po cepljenju z drugimi vrstami cepiv proti gripi, ki so namenjena za prepandemsko ali pandemsko uporabo.
Pharmacovigilance The Applicant/MAH commits to establish the mechanisms to promptly investigate issues affecting the benefit-risk balance of the vaccine.
Farmakovigilanca Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo zagotovil mehanizme za takojšnjo proučitev vprašanj v zvezi z razmerjem koristi in tveganj cepiva.
Tell the doctor requesting these tests that you have recently been given Arepanrix.
Zdravnika, ki želi opraviti takšne preiskave opozorite, da ste bili pred kratkim cepljeni s cepivom Arepanrix.
Analysis of a subset of 36 subjects aged 6 months to 35 months old showed that 80.6 % had a 4 fold increase in serum neutralising antibodies 21 days after the first dose (66.7 % in 12 subjects aged 6 to 11 months old, 91.7 % in 12 subjects aged 12 to 23 months old and 83.3 % in 12 subjects aged 24 to 35 months old).
Analiza podskupine 36 otrok, starih od 6 do 35 mesecev, je pokazala, da je imelo 21 dni po prvem odmerku 80,6 % otrok 4-kratno povečanje nevtralizirajočih protiteles v serumu (66,7 % od 12 otrok, starih od 6 do 11 mesecev, 91,7 % od 12 otrok, starih od 12 do 23 mesecev, in 83,3 % od 12 otrok, starih od 24 do 35 mesecev).
In particular rates of fever (axillary temperature ≥38°C) may increase considerably after the second dose.
Še zlasti se lahko po drugem odmerku občutno poveča delež zvišane telesne temperature (aksilarna temperatura ≥ 38 °C).
Day 42 N=1,488
42. dan n=1.488
PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
FARMACEVTSKA OBLIKA IN VSEBINA emulzija adjuvansa za injiciranje 25 vial: emulzija
The suspension and emulsion, once mixed, form a multidose vaccine in a vial.
Po premešanju suspenzije in emulzije nastane večodmerno cepivo v viali.
The European Medicines Agency (EMEA) will review any new information on this medicine and this SPC will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo redno ponovno pregledala vse nove podatke, ki bodo na voljo in posodobila to navodilo za uporabo, če bo potrebno.
Control groups included ferrets immunized with adjuvant alone and non-adjuvanted vaccine (7.5 micrograms HA).
V kontrolnih skupinah so bili beli dihurji, ki so bili cepljeni samo samo z adjuvansom in cepivom brez adjuvansa (7,5 mikrogramov HA).
• Tingling or numbness of the hands or feet
• mravljinčenje ali odrevenelost v rokah ali nogah.
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Cepivo kot konzervans vsebuje tiomersal (organska živosrebrova spojina), ki lahko povzroči preobčutljivostne reakcije (glejte poglavje 4.4).
Co-administration was not associated with higher rates of local or systemic reactions compared to administration of the AS03-containing vaccine containing HA from H1N1v alone.
Sočasne uporabe ni spremljal večji delež lokalnih ali sistemskih reakcij kot uporaba cepiva z AS03 z vsebnostjo HA iz H1N1v samega.
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
• Nevrološke motnje, npr. encefalomielitis (vnetje osrednjega živčevja), nevritis (vnetje živcev) in vrsta ohromitve, imenovana Guillain-Barréjev sindrom.
• Pain in the chest
• bolečina v prsnem košu
Two clinical studies evaluated the immunogenicity of a half (0.25 ml) dose and a full (0.5 ml) adult dose in healthy children 10 to 17 years of age.
Z dvema kliničnima študijama so ocenili imunogenost polovičnega odmerka (0,25 ml) in polnega odmerka (0,5 ml) za odrasle pri zdravih otrocih, starih od 10 do 17 let.
One dose of 0.5 ml at an elected date.
En 0,5 ml odmerek na izbrani datum.
Children aged 6-35 months
Otroci, stari od 6 do 35 mesecev
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION
PAKIRANJE, KI VSEBUJE 1 PAKIRANJE S 50 VIALAMI SUSPENZIJE IN 2 PAKIRANJI S 25 VIALAMI EMULZIJE
Therefore the data indicate that Arepanrix may be administered three weeks after the administration of non-adjuvanted seasonal influenza vaccines.
Podatki torej kažejo, da se cepivo Arepanrix lahko uporabi tri tedne po uporabi cepiva proti sezonski gripi brez adjuvansa.
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02.
FARMAKOLOŠKE LASTNOSTI 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02
Non-clinical data obtained with a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Predklinični podatki, pridobljeni z različico cepiva Arepanrix z vsebnostjo 3,75 µg HA, pridobljenega iz A/Indonesia/05/2005 (H5N1) z uporabo seva H5N1, 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.
In two clinical studies (D-Pan H1N1-007 and D-Pan H1N1-008) that evaluated immunogenicity in healthy subjects aged 18-60 years the anti-HA antibody responses were as follows:
V dveh kliničnih študijah (D-Pan H1N1-007 in D-Pan H1N1-008), s katerima so pri zdravih preiskovancih, starih od 18 do 60 let, ocenili imunogenost, so bili odzivi protiteles na anti-HA naslednji:
Arepanrix consists of two containers:
Cepivo Arepanrix je na voljo v dveh vsebnikih:
A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Arepanrix.
Blažja okužba, npr. prehlad, ne predstavlja težave, vendar se pred cepljenjem s cepivom Arepanrix o tem vseeno posvetujte s svojim zdravnikom.
Study D-Pan H1N1-008 evaluated immunogenicity in healthy subjects (N=120) aged >60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age).
S klinično študijo D-Pan H1N1-008 so ocenili imunogenost pri zdravih preiskovancih (n = 120), starih več kot 60 let (razdeljenih v skupine od 61 do 70, 71 do 80 in > 80 let).
31-January-2010
31. januar 2010
For the most up-to-date information please consult the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/.
Za najnovejše informacije glejte spletno stran Evropske agencije za zdravila (EMEA): http://www.emea.europa.eu/.
- Challenge with a heterologous pandemic H5N1 strain (A/Hong Kong/156/97)
- Heterologni provokacijski poskus s pandemskim sevom H5N1 (A/Hong Kong/156/97)
The side effects listed below have occurred during post-marketing surveillance with a similar vaccine (H1N1).
Neželeni učinki, našteti spodaj, so se pojavili med spremljanjem podobnega cepiva H1N1 po prihodu na trg.
• Redness and swelling at the injection site
• rdečina in oteklina na mestu injiciranja
Blood and lymphatic system disorders Uncommon: lymphadenopathy
Bolezni krvi in limfatičnega sistema Občasni: limfadenopatija
- Challenge with a homologous pandemic H5N1 strain (A/Indonesia/5/05)
- Homologni provokacijski poskus s pandemičnim sevom H5N1 (A/Indonesia/5/05)
Information from non-clinical studies:
Podatki iz predkliničnih študij:
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
How to store Arepanrix Further information
Shranjevanje cepiva Arepanrix Dodatne informacije
Adverse reactions reported are listed according to the following frequency:
Opisani neželeni učinki so navedeni po naslednjih skupinah pogostnosti:
Children and adolescents aged 10-17 years
Otroci in mladostniki, stari od 10 do 17 let
Seroprotection rate1
Delež serološke zaščite1
The mixed vaccine is a whitish emulsion.
Pripravljeno cepivo je belkasta emulzija.
• Reactions at the injection site such as bruising, hard lump, itching, warmth
• reakcije na mestu injiciranja kot so modrica, zatrdlina, srbenje, občutek toplote
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Arepanrix
IME ZDRAVILA Emulzija za emulzijo za injiciranje za Arepanrix
There are no data on co-administration of Arepanrix with other vaccines.
Podatkov o sočasni uporabi cepiva Arepanrix z drugimi cepivi ni.
In a consistency study, the anti-haemagglutinin (anti-HA) antibody responses twenty-one days and six months after the second dose were as follows:
V študiji konsistentnosti je bil odziv v obliki antihemaglutininskih (anti-HA) protiteles enaindvajseti dan in šest mesecev po cepljenju z drugim odmerkom naslednji:
Adults aged 18-60 years
Odrasli, stari od 18 do 60 let
• one pack containing 50 vials of 2.5 ml suspension (antigen)
• eno pakiranje s 50 vialami po 2,5 ml suspenzije (antigen)
AS03-containing vaccine containing HA from H1N1v manufactured using a different process N=164
cepivo z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom n=164
Suspension vial:
VIALA S SUSPENZIJO
These side effects have also been observed with similar frequencies in clinical studies in adults including the elderly and in children aged 10 to 17 years with a similar vaccine (H1N1), except for redness (uncommon in the adults and common in the elderly) and fever (uncommon in the adults and elderly).
Te neželene učinke so s podobnimi pogostnostmi opažali tudi v kliničnih študijah s podobnim cepivom (H1N1) pri odraslih, vključno s starejšimi osebami, in pri otrocih, starih od 10 do 17 let; izjemi sta pordelost (občasna pri odraslih in pogosta pri starejših osebah) in zvišana telesna temperatura (občasna pri odraslih in starejših).
The vial should be shaken prior to each administration and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Vialo morate pred vsako aplikacijo cepiva pretresti in pregledati, ali morda vsebuje tuje delce in/ali je nenormalnega videza.
Arepanrix has been authorised under “Conditional Approval”.
Cepivo Arepanrix je pridobilo dovoljenje za promet pod «posebnimi pogoji».
Day 180 N=353
180. dan n=353
After mixing, use the vaccine within 24 hours.
Po mešanju morate cepivo uporabiti v 24 urah.
In children aged 3-9 years who received a first half adult dose of a similar vaccine (H1N1), the side effects were similar compared to the side effects reported in adults, with the exception of shivering, sweating and gastro-intestinal symptoms which were reported at a higher rate in children aged 3 to 9 years.
Pri otrocih, starih od 3 do 9 let, ki so prejeli prvi polovični odmerek za odrasle podobnega cepiva (H1N1), so bili neželeni učinki podobni neželenim učinkom poročanih pri odraslih, z izjemo drgetanja, znojenja in prebavnih simptomov, ki so bili pogosteje poročani pri otrocih, starih od 3 do 9 let.
The emulsion presents as a whitish appearance.
Emulzija je belkastega videza.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http://www.emea.europa.eu/
Take special care with Arepanrix:
Bodite posebno pozorni pri cepljenju s cepivom Arepanrix:
Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) after each vaccination.
Zato je mlajšim otrokom (npr. do približno 6. leta starosti) po vsakem cepljenju priporočljivo kontrolirati telesno temperaturo in uporabiti ukrepe za znižanje zvišane telesne temperature (npr. antipiretična zdravila, če se zdi klinično potrebno).
There is no information on administration of Arepanrix with other vaccines and no information on administration of the AS03-containing vaccine containing HA from H1N1v manufactured using a different process with any other vaccines than non-adjuvanted seasonal influenza vaccine.
O uporabi cepiva Arepanrix z drugimi cepivi ni podatkov; prav tako ni podatkov o uporabi cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, z drugimi cepivi kot s sezonskim cepivom proti gripi brez adjuvansa.
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the prevaccination GMT.
3Faktor serokonverzije: razmerje med geometrično sredino (GMT - geometric mean titre) titra po cepljenju in GMT titra pred cepljenjem.
Day 42 N=479
42. dan n=479
Twenty-one days after the second dose, a 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in 94.4% of subjects aged 18-60 years and in 80.4% of subjects over 60 years of age.
Enaindvajset dni po cepljenju z drugim odmerkom je bilo 4-kratno povečanje titra nevtralizacijskih protiteles proti A/Indonesia/5/2005 v serumu doseženo pri 94,4 % oseb, starih od 18 do 60 let, in 80,4 % oseb, starejših od 60 let.
In a clinical study in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second half adult dose (i.e. 0.25 ml) were as follows:
V klinični študiji pri zdravih otrocih, starih od 6 do 35 mesecev (razdeljenih v skupine od 6 do 11, 12 do 23 in 24 do 35 mesecev) so bili odzivi anti-HA protiteles 21 dni po prvem in drugem polovičnem odmerku za odrasle (tj. 0,25 ml) naslednji:
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant)
• dve pakiranji s 25 vialami po 2,5 ml emulzije (adjuvans)
One dose of 0.25 ml at an elected date.
En 0,25-ml odmerek na izbrani datum.
• Shortness of breath
• težko dihanje
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).
Količina po premešanju 1 viale suspenzije (2,5 ml) in 1 viale emulzije (2,5 ml) ustreza 10 odmerkom cepiva (5 ml).
Nervous system disorders Very common: headache Uncommon: dizziness, paraesthesia
Bolezni živčevja Zelo pogosti: glavobol Občasni: omotica, parestezije
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.
Zato je otroku po vsakem odmerku cepiva priporočljivo kontrolirati telesno temperaturo in uporabiti ukrepe za njeno znižanje (npr. mu dati paracetamol ali drugo zdravilo za znižanje zvišane telesne temperature).
Day 180 N=104
180. dan n=104
• Generalised skin reactions including facial swelling and urticaria (hives)
• Generalizirane kožne reakcije vključno z otekanjem obraza in urtikarijo (koprivnico).
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
POSTOPEK IN POT(I) UPORABE ZDRAVILA intramuskularna uporaba
There are limited data available from clinical studies with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in adults aged over 60 years and very limited data in adults aged over 80 years.
Malo je podatkov iz kliničnih študij s cepivom z AS03 z vsebnostjo HA iz H1N1v, pridobljenim z drugačnim postopkom, pri odraslih, starejših od 60 let, in zelo malo je podatkov pri odraslih, starejših od 80 let.
After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Po premešanju z emulzijo adjuvansa: 10 odmerkov po 0,5 ml
CLINICAL PARTICULARS
Klinični del
One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Eno pakiranje vsebuje: - eno pakiranje s 50 vialami (steklo tipa I) po 2,5 ml suspenzije z zamaškom iz butilne gume.
Very common (affects more than 1 user in 10) Common (affects 1 to 10 users in 100) Uncommon (affects 1 to 10 users in 1,000) Rare (affects 1 to 10 users in 10,000) Very rare (affects less than 1 user in 10,000)
Zelo pogosti (pojavijo se pri več kot 1 cepljeni osebi od 10 cepljenih oseb) Pogosti (pojavijo se pri 1 do 10 cepljenih osebah od 100 cepljenih oseb) Občasni (pojavijo se pri 1 do 10 cepljenih osebah od 1.000 cepljenih oseb) Redki (pojavijo se pri 1 do 10 cepljenih osebah od 10.000 cepljenih oseb) Zelo redki (pojavijo se pri manj kot 1 od 10.000 cepljenih oseb)
Reactogenicity was also evaluated in healthy adults aged 18-60 years who received a first 0.5 ml dose of either Arepanrix (H1N1) (N=167) or an AS03-containing vaccine containing HA from H1N1v manufactured using a different process (N=167).
Reaktogenost so ocenili tudi pri zdravih odraslih, starih od 18 do 60 let, ki so kot prvi 0,5-ml odmerek cepiva dobili bodisi Arepanrix (H1N1) (n = 167) bodisi cepivo z AS03, z vsebnostjo HA iz H1N1v, pridobljeno z drugačnim postopkom (n = 167).
50 vials: emulsion (adjuvant)
50 vial: suspenzija (antigen) 50 vial: emulzija (adjuvans)
Psychiatric disorders Uncommon: insomnia
Psihiatrične motnje Občasni: nespečnost
• Low blood platelet count which can result in bleeding or bruising
• Znižanje števila trombocitov s posledičnim pojavom krvavitev ali modric.
The per-dose frequency of the following adverse reactions was as shown in the table:
Pogostnost naslednjih neželenih učinkov na odmerek je prikazana v preglednici:
2.5 ml After mixing with adjuvant emulsion: 10 doses of 0.5 ml
2,5 ml Po premešanju z emulzijo adjuvansa: 10 odmerkov po 0,5 ml
Preliminary immunogenicity data obtained with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in a limited number of children aged 6-35 months show that there is a further immune response to a second dose of 0.25 ml administered after an interval of three weeks.
Preliminarni podatki o imunogenosti, pridobljeni s cepivom z AS03 z vsebnostjo HA iz H1N1v, pridobljenim z drugačnim postopkom, pri majhnem številu otrok, starih od 6 do 35 mesecev, kažejo dodaten imunski odziv na drugi odmerek 0,25 ml, uporabljen po presledku treh tednov.
Immunogenicity data obtained at three weeks after administration of Arepanrix (H1N1) in clinical studies suggest that a single dose may be sufficient.
Podatki o imunogenosti, dobljeni tri tedne po uporabi cepiva Arepanrix (H1N1) v kliničnih študijah kažejo, da morda lahko zadošča en sam odmerek.
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Arepanrix (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde or sodium deoxycholate.
• če ste kdaj imeli nenadno, življenje ogrožajočo alergijsko reakcijo na katerokoli sestavino cepiva Arepanrix (sestavine so navedene na koncu tega navodila) ali katerokoli snov, ki je lahko prisotna v sledovih, in sicer: jajčne in piščančje beljakovine, ovalbumin, formaldehid ali natrijev deoksiholat.
- two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
- dve pakiranji s 25 vialami (steklo tipa I) po 2,5 ml emulzije z zamaškom iz butilne gume.
If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Če je potrebna sočasna uporaba z drugim cepivom, je treba cepljenje opraviti na drugi okončini.
In children aged 6-35 months who received a half of the adult dose (0.25 ml) of a similar vaccine (H1N1), fever and irritability occurred more often compared to the children 3-9 years who received a half of the adult dose (0.25 ml) of a similar vaccine (H5N1).
Pri otrocih, starih od 6 do 35 mesecev, ki so dobili polovični odmerek podobnega cepiva (H1N1) za odrasle, sta se zvišana telesna temperatura in razdražljivost pojavili pogosteje kot pri otrocih, starih od 3 do 9 let, ki so dobili polovični odmerek podobnega cepiva (H5N1) za odrasle (0,25 ml).
No data are available at present on reactogenicity after a second half adult (i.e. 0.25 ml) dose of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process in children aged 3 to 9 years.
Trenutno ni podatkov o reaktogenosti po drugi uporabi polovičnega odmerka (tj. 0,25 ml) za odrasle cepiva z AS03 z vsebnostjo HA iz H1N1v, pridobljenega z drugačnim postopkom, pri otrocih, starih od 3 do 9 let.
26-February-2010
26. februar 2010
Therefore the data indicate that Arepanrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Podatki torej kažejo, da je mogoče cepivo Arepanrix uporabiti hkrati s cepivi proti sezonski gripi brez adjuvansa (vendar je cepivi treba injicirati v različni okončini).
The vaccine should not be administered intravascularly.
Cepiva se ne sme dajati v žilo (intravaskularno).
Day 21 N=145
21. dan n=145
Post dose 2
Po 2. odmerku
2seroconversion rate: 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 4fold increase in titre;
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;
Very limited data with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses indicate an increase in the rates of injection site reactions and general symptoms (see section 4.8).
Zelo omejeni podatki s cepivom z AS03 z vsebnostjo HA iz H1N1v, pridobljenim z drugačnim postopkom, pri otrocih, starih od 6 do 35 mesecev (n = 51), ki so dobili dva odmerka 0,25 ml (polovični odmerek za odrasle) v presledku 3 tednov med odmerkoma, kažejo večji delež reakcij na mestu injiciranja in splošnih simptomov (glejte poglavje 4.8).
In another clinical study, anti-HA responses against A/Vietnam/1194/2004 following administration of a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) were as follows:
V drugi klinični študiji so bili odzivi anti-HA protiteles proti A/Vietnam/1194/2004 po cepljenju z različico cepiva Arepanrix z vsebnostjo 3,75 µg HA, pridobljenega iz A/Indonesia/5/2005, naslednji:
Seroconversion rate2
Delež serokonverzije2