natgillin/translations-raw huggingface dataset:
The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown. 
Klinični pomen titra inhibicije hemaglutinacije (HI) ≥ 1:40 pri otrocih ni znan.
Rare: Neuralgia, transient thrombocytopenia. 
Redki: Nevralgija, prehodna trombocitopenija.
The side effects listed below have occurred with Arepanrix (H5N1) in clinical studies in adults, including the elderly. 
Neželeni učinki, ki so navedeni spodaj, so se pojavili v kliničnih študijah s cepivom Arepanrix (H5N1) pri odraslih, vključno s starejšimi osebami.
You should not receive Arepanrix: 
Cepiva Arepanrix ne smete dobiti:
21 days after 1st dose 
21 dni po 1. odmerku
Read the package leaflet before use 
Pred uporabo preberite priloženo navodilo.
Immune response to A/Indonesia/5/2005 18-60 years 
Imunski odziv proti A/Indonesia/5/2005 18-60 let
04 June 2010 
04. junij 2010
05 March 2010 
05. marec 2010
The MAH must ensure that the system of pharmacovigilance, as described in version 3.05 (dated September 2009) presented in Module 1.8.1 of the marketing authorisation application, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use. 
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3,05 (September 2009), predstavljeni v modulu 1.8.1 vloge za pridobitev dovoljenja za promet, vzpostavljen in da deluje preden začne tržiti zdravilo in ves čas uporabe cepiva.
If you are not sure, talk to your doctor or nurse before having this vaccine. 
Če ste negotovi, se pred cepljenjem posvetujte z zdravnikom ali s farmacevtom.
If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose. 
Če je uporabljen drugi odmerek (0,25 ml), ga bo otrok dobil vsaj tri tedne po prvem odmerku.
The frequency of possible side effects listed below is defined using the following convention: 
Pogostnost neželenih učinkov, navedenih spodaj, je določena po naslednjem dogovoru:
Immune response to A/Indonesia/5/2005 
Imunski odziv proti A/Indonesia/5/2005
The European Medicines Agency (EMEA) will regularly review any new information on the medicine and this package leaflet will be updated as necessary. 
Evropska agencija za zdravila (EMEA) bo redno ponovno pregledala vse nove podatke, o tem zdravilu in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Biologicals, Rixensart - Belgium 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GSK Biologicals, Rixensart - Belgija
Skin and subcutaneous tissue disorders Angioedema, generalised skin reactions, urticaria 
Bolezni kože in podkožja angioedem, generalizirane kožne reakcije, urtikarija
• Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems) 
• Vaskulitis (vnetje žil, ki lahko povzroči izpuščaje na koži, bolečine v sklepih in težave z ledvicami).
There are no safety, immunogenicity or efficacy data to support interchangeability of Arepanrix with other H1N1 pandemic vaccines. 
Ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi potrjevali zamenljivost cepiva Arepanrix z drugimi pandemskimi cepivi proti H1N1.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 (dated January 2010) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP. 
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici 4 (januar 2010) načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
3-5 years 
3 do 5 let
What Arepanrix is and what it is used for Before you receive Arepanrix How Arepanrix is given Possible side effects 
Kaj je cepivo Arepanrix in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili cepivo Arepanrix Kako uporabljati cepivo Arepanrix Možni neželeni učinki
In the event of other variation being observed, discard the vaccine. 
Če opazite kakšno drugo spremembo, morate cepivo zavreči.
The MAH should provide an inventory of all valuable database ready to be use to promptly investigate issues affecting the benefit-risk balance of the vaccine. 
Imetnik dovoljenja za promet mora posredovati seznam vseh pomembnih podatkovnih baz, pripravljenih za uporabo za takojšnjo proučitev vprašanj, ki zadevajo razmerje koristi in tveganj cepiva.
• Pain in the back or neck, stiffness in the muscles, muscle spasms, pain in extremity such as leg or hand 
• bolečina v hrbtu ali vratu, mišična okorelost, mišični krči, bolečina v rokah ali nogah.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a syringe and by adding it to the vial containing the antigen. 
Cepivo zmešate tako, da z injekcijsko brizgo izvlečete celotno vsebino viale adjuvansa in jo dodate v vialo z antigenom.
Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for injection and administered intramuscularly. 
Vsak odmerek cepiva z 0,5 ml (polni odmerek) ali z 0,25 ml (polovični odmerek) izvlecite v injekcijsko brizgo in injicirajte intramuskularno.
One pack of Arepanrix consists of: 
Eno pakiranje cepiva Arepanrix vsebuje:
Arepanrix should under no circumstances be administered intravascularly. 
Cepiva Arepanrix se v nobenem primeru ne sme injicirati v žilo.
Gastro-intestinal symptoms and shivering were at a higher rate in the children 10-17 years of age. 
Prebavni simptomi in drgetanje so bili pogostejši pri otrocih, starih od 10 do 17 let.
Adults aged 18-60 years: 
Odrasli, stari od 18 do 60 let:
The Applicant/MAH commits to provide abridged report for the following study performed in children 
Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo predložil skrajšano poročilo o naslednji študiji, izvedeni pri otrocih:
Conversely the combination of a range of doses of H5N1 antigen with AS03 adjuvant was able to protect against mortality and to reduce lung virus loads and viral shedding after intra-tracheal challenge with a homologous wild type H5N1 virus. 
Nasprotno pa je kombinacija različnih odmerkov antigena H5N1 z adjuvansom AS03 bele dihurje zaščitila pred poginom in zmanjšala virusno breme v pljučih ter izločanje virusa po intratrahealni provokaciji s homolognim divjim tipom virusa H5N1.
The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically with A/Indonesia/05/05 (H5N1) using ferret challenge models. 
Sposobnost za indukcijo zaščite proti homolognim in heterolognim cepilnim sevom so ocenili predklinično z A/Indonesia/05/05 (H5N1) s provokacijskim modelom pri belem dihurju.
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