natgillin/translations-raw huggingface dataset:
Side effects from clinical study in children (6 months to 17 years of age) General side effects reported very commonly in the 6 months to 35 months of age group were injection site redness, muscle ache, irritability and unusual crying. 
Splošni neželeni učinki, ki so jih v skupini otrok, starih med 6 in 35 meseci opazili zelo pogosto, so bili pordelost na mestu injiciranja, bolečine v mišicah, razdražljivost in neobičajen jok.
In case of any particles and/or abnormal appearance, the vaccine should be discarded. 
Če v cepivu opazite delce in/ali je njegov videz neobičajen,
1 pre-filled syringe (0.5 ml) 10 pre-filled syringes (0.5 ml) 
suspenzija za injiciranje 1 napolnjena injekcijska brizga (0,5 ml) 10 napolnjenih injekcijskih brizg (0,5 ml)
Cross-reactive immune response elicited by A/turkey/Turkey/1/2005 against A/Indonesia/5/2005 and A/Vietnam/1194/2004 
Navzkrižni imunski odziv, ki ga je izzval A/turkey/Turkey/1/2005, na A/Indonesia/5/2005 in A/Vietnam/1194/2004
The vaccine will be injected into the muscles of the upper arm (deltoid muscle). 
Cepivo se injicira v mišico nadlakti (v deltoidno mišico).
• Urticaria (hives) 
• urtikarija (koprivnica).
Skin and subcutaneous tissue disorders Erythema multiforme. 
Bolezni kože in podkožja Multiformni eritem
V87P11 Elderly (>61-89 years)a N=142 
V87P11 starejši (61-89 let) N = 142
Any Other Adverse Event 
vsi drugi neželeni učinki
The European Medicines Agency has deferred the obligation to submit the results of studies with AFLUNOV in one or more subsets of the paediatric population in active immunisation against H5N1 subtype of Influenza A virus. 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cepivom AFLUNOV za eno ali več podskupin pediatrične populacije za aktivno imunizacijo proti podtipu H5N1 virusa influence A. Za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
Other medicines and AFLUNOV 
Druga zdravila in cepivo AFLUNOV
Blood and lymphatic system disorders Thrombocytopenia (in some cases reversible platelet counts less than 5000 mm3). 
Trombocitopenija (v nekaterih primerih se število trombocitov zmanjša na manj kot 5000/mm³ in je reverzibilno)
Adults (18-60 years) 
Odrasli (18-60 let)
Information from non-clinical studies 
Informacije iz predkliničnih študij
Fainting can occur following, or even before, any needle injection. 
Po katerem koli injiciranju z iglo ali celo pred njim se lahko pojavi omedlevica.
Active immunisation against H5N1 subtype of Influenza A virus. 
Aktivna imunizacija proti virusu influence A podtipa H5N1.
AFLUNOV may be co-administered with non-adjuvanted seasonal influenza vaccines, and immunisation should be carried out on separate limbs. 
Cepivo AFLUNOV se lahko daje sočasno s sezonskimi cepivi proti gripi brez adjuvansa, pri čemer je treba imunizacijo opraviti na drugi okončini.
Some degree of cross-reactive immunity has been observed against H5N1 viruses of clades different to that of the vaccine strain. 
V kliničnih preskušanjih so opazili določeno stopnjo navzkrižnih imunskih odzivov na viruse H5N1 iz gruč, drugačnih kot pri cepilnem sevu.
In this trial no vaccine related SAEs were observed. 
V tem preskušanju niso opazili neželenih učinkov, povezanih s cepivom.
Immune response to AFLUNOV A/Vietnam/1194/2004 (H5N1) and A/turkey/Turkey/1/2005 (H5NI) 
Imunski odziv na AFLUNOV A/Vietnam/1194/2004 (H5N1) in A/turkey/Turkey/1/2005 (H5N1)
Uncommon (≥1/1,000 to 
Redki (≥ 1/10.000 do
One dose of 0.5 ml will be given. 
Prejmejo en odmerek 0,5 ml.
There is limited experience in children between 6 months and 17 years of age. 
Otroci, stari od 6 mesecev do 17 let Pri otrocih, starih med 6 meseci in 17 leti, so izkušnje omejene.
Elderly (>61 years) 
Starejši (≥ 61 let)
A clinical trial (V87P6) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 471 children from 6 months to 17 years of age. 
Opravili so klinično preskušanje (V87P6) za cepivo AFLUNOV (A/Vietnam/1194/2004) pri 471 otrocih, starih od 6 mesecev do 17 let.
In addition, higher rates of arthralgia (up to 23.3%) were reported in both adult and elderly subjects, who were immunocompromised or with underlying medical conditions. 
Poleg tega so pri odraslih in starejših osebah, ki so imele oslabljen imunski sistem ali z osnovna bolezenska stanja, poročali o višjih stopnjah artralgije (do 23,3 %).
If you have any further questions on the use of this medicinal product, ask your doctor or nurse. 
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali medicinsko sestro.
In a phase I clinical trial (V87P3) adult subjects aged 18-65 years primed 6-8 years previously with 2 doses of MF59-adjuvanted H5N3 vaccine/A/Duck/Singapore/97, were administered 2 booster doses of AFLUNOV (A/Vietnam/1194/2004). 
V kliničnem preskušanju I. faze (V87P3) so odrasle osebe, stare 18-65 let, ki so 6-8 let pred tem prejele 2 primarna odmerka cepiva H5N3 A/Duck/Singapore/97 z adjuvansom MF59, prejele 2 obnovitvena odmerka cepiva AFLUNOV (A/Vietnam/1194/2004).
What you need to know before you receive AFLUNOV You should not receive AFLUNOV: 
Kaj morate vedeti, preden boste cepljeni s cepivom AFLUNOV S cepivom AFLUNOV ne smete biti cepljeni:
In a third clinical trial (V87P11) 194 adult subjects were enrolled and received two doses of AFLUNOV (A/turkey/Turkey/1/2005) administered three weeks apart. 
V tretjem kliničnem preskušanju (V87P11) je bilo vključenih 194 odraslih oseb, ki so prejele dva odmerka cepiva AFLUNOV (A/turkey/Turkey/1/2005), dana s tritedenskim presledkom.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1 and to residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide). 
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) na učinkovino, katerokoli pomožno snov, navedeno v poglavju 6.1, ali snov v sledovi (jajčne ali piščančje beljakovine, ovalbumin, kanamicinsulfat, neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid).
MN results for A/Indonesia/5/2005 revealed a seroprotection rate of 38% (31-45) in adults (18-60 years) and 14% (8-20) in elderly (>61 years); a seroconversion rate of 58% (50-65) in adults and 30% (23-38) in elderly and finally a GMR of 4.67 (3.95-5.56) in adults and 2.19 (1.86-2.58) in elderly. 
Rezultati MN za A/Indonesia/5/2005 so pokazali stopnjo serozaščite 38 % (31-45) za odrasle (18-60 let) in 14 % (8-20) za starejše (≥ 61 let); stopnjo serokonverzije 58 % (50-65) za odrasle in 30 % (23-38) za starejše ter končno GMR 4,67 (3,95-5,56) za odrasle in 2,19 (1,86-2,58) za starejše.
AFLUNOV contains sodium and potassium. 
Cepivo AFLUNOV vsebuje natrij in kalij.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment. 
Če bolnik prejema imunosupresivna zdravila, je lahko imunski odziv manjši.
Immunogenicity of AFLUNOV (A/turkey/Turkey/1/2005) in adults (18 to 60 years) and elderly (>61 years) subjects with underlying medical conditions (Study V87_25) or immunosuppressive conditions (mainly HIV-infected subjects) (Study V87_26) in comparison to healthy adults (18-60 years) and elderly (>61 years), was evaluated in two randomised, phase III controlled clinical trials (with a seasonal trivalent inactivated MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older as a comparator). 
Imunogenost cepiva AFLUNOV (A/turkey/Turkey/1/2005) pri odraslih (18-60 let) in starejših osebah (≥ 61 let) z osnovnimi bolezenskimi stanji (študija V87_25) ali zmanjšanim imunskim odzivom (večinoma osebe, okužene s HIV) (študija V87_26) v primerjavi z zdravimi odraslimi (18-60 let) in starejšimi osebami (≥ 61 let) so ocenili v dveh randomiziranih, nadzorovanih kliničnih preskušanjih
Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) 
zoonotsko cepivo proti gripi (H5N1) (s površinskimi antigeni, inaktivirano, z adjuvansom)
Contents of the pack and other information What AFLUNOV contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo AFLUNOV
• Aching muscles 
• bolečine v mišicah,
In such cases, you should be aware that the side effects may be more intense. 
V takih primerih so lahko neželeni učinki okrepljeni.
Rare (affects 1 to 10 users in 10.000): 
Občasni (pojavijo se pri 1 do 10 od 1.000 bolnikov):
Blood and lymphatic system disorders Lymphadenopathy. 
Bolezni krvi in limfatičnega sistema
Headache, dizziness, somnolence, syncope. 
Bolezni živčevja Glavobol, omotičnost, zaspanost, sinkopa.
Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle. 
Imunizacija se opravi z intramuskularnim injiciranjem v deltoidno mišico.
In Study V87P11 MN results against homologous A/turkey/Turkey/1/2005) indicate a seroprotection and seroconversion rate of 85% (79-90) and 93% (89-96), respectively. 
V študiji V87P11 kažejo rezultati MN proti homolognemu A/turkey/Turkey/1/2005 na stopnjo serozaščite 85 % (79-90) in stopnjo serokonverzije 93 % (89-96).
In addition, two large observational studies designed to assess the safety of Focetria exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10,000 vaccinated pregnant women and their offspring compared with unvaccinated controls. 
Poleg tega dve veliki opazovalni študiji, zasnovani za oceno varnosti izpostavljenosti cepivu Focetria med nosečnostjo, nista pokazali zvišanja stopenj gestacijskega diabetesa, preeklampsije, splavov,
Nervous system disorders Neurological disorders, such as encephalomyelitis, and Guillain Barré syndrome. 
Nevrološke bolezni, kot sta encefalomielitis in Guillain-Barréjev sindrom
The potential benefits to the mother and risks to the infant should be considered before administering AFLUNOV during breast-feeding. 
AFLUNOV je treba pretehtati možne koristi za mater in tveganja za otroka Plodnost
• Rash or swelling of the skin and mucous membranes 
• izpuščajem ali oteklino kože in sluznic,
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)*** a Ages 62-88 years; b Ages 61-68 years; c Ages 61-89 years * Seroprotection: SRH area ≥ 25 mm2 
Faktor serokonverzije (95-odstotni IZ)*** a Starost 62-88 let; b starost 61-68 let; c starost 61-89 let.
Post-marketing surveillance No post-marketing surveillance data are available following AFLUNOV administration. 
Podatkov iz spremljanja v obdobju trženja za cepivo AFLUNOV ni.
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Adolescents (9-<18 years) 
Mladostniki (9-< 18 let)
** Seroconversion was defined as an SRH area ≥25 mm2 for subjects who were seronegative at baseline (Day 1 SRH area ≤4 mm2) or a significant (at least 50%) increase in SRH area for subjects who were seropositive at baseline (Day 1 SRH area >4 mm2) *** GMRs of SRH 
** Serokonverzija je bila opredeljena kot površina SRH ≥ 25 mm2 pri osebah, ki so bile ob izhodišču seronegativne (1. dan površina SRH ≤ 4 mm2), ali kot pomembno (vsaj 50-%)
AFLUNOV injection H5N1 Zoonotic influenza vaccine IM 
AFLUNOV injekcije zoonotsko cepivo proti gripi (H5N1) i.m.
AFLUNOV(A/Vietnam/1194/2004) and an AFLUNOV-like H5N1 vaccine (A/turkey/Turkey/1/2005-like) were tested. 
Testirali so cepivo AFLUNOV (A/Vietnam/1194/2004) in cepivo H5N1, podobno cepivu AFLUNOV (sev podoben A/turkey/Turkey/1/2005).
Elderly years)* 
IZ)**
• Disorders of the gut such as 
• Črevesne motnje, kot so:
• Pain at the site of injection 
bolečina na mestu injiciranja,
Very commonly reported reactions in the 36 months to 17 years of age group were pain, headache and fatigue. 
Neželeni učinki, ki so se v skupini otrok, starih med 36 meseci in 17 leti, opazili zelo pogosto, so bili bolečina,
A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose 
sevu A/turkey/Turkey/1/2005 (H5N1) podobnega seva (NIBRG-23) (gruča 2.2.1) 7,5 mikrogramov** na 0,5 ml odmerek
Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of AFLUNOV with other H5N1 monovalent vaccines. 
imunogenosti ali učinkovitosti, ki podpirajo zamenljivost cepiva AFLUNOV z drugimi monovalentnimi cepivi H5N1.
Common (≥1/100 to <1/10) 
Pogosti (≥ 1/100 do
Musculoskeletal and connective tissue disorders 
angioedem Bolezni mišično-skeletnega sistema in vezivnega tkiva
Based on data obtained from trials V87P1, V87P11 and V87_13, persistence of antibodies after primary vaccination in elderly subjects as assessed by HI, SRH, and MN tests reduced from 1/2 to 1/5th of their post-vaccination level at day 202 as compared to day 43 after completion of primary schedules. 
Na podlagi podatkov, pridobljenih iz preskušanj V87P1, V87P11 in V87_13 so ocenili obstojnost protiteles po primarnem cepljenju pri starejših osebah, in sicer s testi HI, SRH in MN.
AFLUNOV is a vaccine for use in adults from 18 onwards, intended to be given in the context of outbreaks of zoonotic influenza viruses (coming from birds) with pandemic potential to prevent flu caused by H5N1 viruses similar to the vaccine strain reported in section 6. 
Cepivo AFLUNOV je namenjeno za uporabo pri odraslih osebah, starih 18 let ali več, ki se daje v primeru izbruhov zoonotskih virusov gripe (ki jih prenašajo ptice), ki bi lahko povzročili pandemijo.
and a type of paralysis known as Guillain-Barré Syndrome. 
• Nevrološke motnje, kot so encefalomielitis (vnetje osrednjega živčevja) in vrsta paralize, znana kot Guillain-Barréjev sindrom.
AFLUNOV is a suspension for injection in a pre-filled syringe. 
Cepivo AFLUNOV je suspenzija za injiciranje v napolnjeni injekcijski brizgi.
To be administered intramuscularly into the deltoid muscle. 
Daje se intramuskularno v deltoidno mišico.
Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis. 
Nevrološke težave, kot so nevralgija, parestezija,
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide) of this vaccine. 
Anafilaktične (tj. življenjsko nevarne) reakcije v anamnezi na katerokoli sestavino cepiva ali ostanke v sledeh (jajčne in kokošje beljakovine, ovalbumin, kanamicinsulfat, neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid) v cepivu.
% SC (95% CI) Day 43 
% SZ (95-odstotni IZ) 43. dan
AFLUNOV suspension for injection in pre-filled syringe. 
AFLUNOV suspenzija za injiciranje v napolnjeni injekcijski brizgi.
GMR (95% CI) Day 43 to Day 1 
GMR (95-odstotni IZ) 43. dan do 1. dan % SK (95-odstotni IZ) 43. dan
Medical Conditions N=143 
Bolezenska stanja N = 143
The following adverse events were reported from post-marketing surveillance with Focetria (an H1N1 pandemic vaccine similar to AFLUNOV) which contains the same amount of adjuvant MF59C.1 as AFLUNOV, approved for use in children 6 months of age and above, adults and the elderly: 
(pandemsko cepivo H1N1, podobno cepivu AFLUNOV), ki vsebuje enako količino adjuvansa MF59C.1 kot cepivo AFLUNOV in je odobreno za uporabo pri otrocih, starih6 mesecev in več, odraslih in starejših bolnikih:
There are no data on co-administration of AFLUNOV with vaccines other than non-adjuvanted seasonal influenza vaccines. 
Podatkov o sočasni uporabi cepiva AFLUNOV s cepivi, ki niso sezonska cepiva proti gripi brez adjuvansa, ni.
Contents of the pack and other information 
Shranjevanje cepiva AFLUNOV Vsebina pakiranja in dodatne informacije
MN results for A/Vietnam/1194/2004 revealed a seroprotection rate of 10% (6-16) in adults (18-60 years) and 6% (3-11) in elderly (>61 years); a seroconversion rate of 19% (13-25) in adults and 7% (4-13) in elderly and finally a GMR of 1.86 (1.63-2.12) in adults and 1.33 (1.17-1.51) in elderly. 
(18-60 let) in 6 % (3-11) za starejše (≥ 61 let); stopnjo serokonverzije 19 % (13-25) za odrasle in 7 % (4-13) za starejše ter končno GMR 1,86 (1,63-2,12) za odrasle in 1,33 (1,17-1,51) za starejše.
In Study V87P11, MN results against homologous A/turkey/Turkey/1/2005 indicate a seroprotection and seroconversion rate of 68% (59-75) and 81% (74-87), respectively. 
V študiji V87P11 kažejo rezultati MN proti homolognemu A/turkey/Turkey/1/2005 na stopnjo serozaščite 68 % (59-75) in stopnjo serokonverzije 81 % (74-87).
In phase III clinical trial (V87P13) 2693 adult subjects were enrolled and 2566 received two doses of AFLUNOV (A/Vietnam/1194/2004) administered three weeks apart. 
V kliničnem preskušanju III. faze (V87P13) so vključili 2.693 odraslih oseb, od katerih je 2.566 oseb s 3-tedenskim presledkom prejelo dva odmerka cepiva AFLUNOV (A/Vietnam/1194/2004).
Adults (18-59 years)a 
Odrasli (18-59 let)
MN results against homologous A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69), respectively. 
Rezultati MN za homologni A/Vietnam/1194/2004 kažejo na stopnjo serozaščite v razponu od 57 % (50-64) do 79 % (68-87) in stopnjo serokonverzije v razponu od 55 % (48-62) do 58 % (47-69).
Adjuvant MF59C.1 containing: squalene 
** izraženo v mikrogramih hemaglutinina Adjuvans MF59C.1 vsebuje: skvalen
AFLUNOV may contain trace residues of egg and chicken proteins, ovalbumin, kanamycin, neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide which are used during the manufacturing process (see section 4.3). 
neomicin sulfata, formaldehida in cetiltrimetilamonijevega bromida, ki se uporabljajo v proizvodnem procesu (glejte poglavje 4.3).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms haemagglutinin 
sevu A/turkey/Turkey/1/2005 (H5N1) podoben sev (NIBRG-23) (gruča 2.2.1) 7,5 mikrogramov hemaglutinina
• Fever and nausea 
konvulzije in nevritis
Elderly (61-91 years)a 
Starejši (61-91 let)
** geometric mean ratios of SRH 
*** Razmerja geometričnih srednjih vrednosti (GMR) za SRH.
MicroNeutralisation (MN) results against homologous A/Vietnam/1194/2004) indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively. 
Rezultati mikronevtralizacije (MN) za homologni A/Vietnam/1194/2004 kažejo na stopnjo serozaščite v razponu od 67 % (60-74) do 85 % (78-90) in stopnjo serokonverzije v razponu od 65 % (58-72) do 83 % (77-89).
The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 (A/Vietnam/1194/2004 and to A/ turkey/Turkey/1/2005) in subjects aged 61 years and older (limited number of subjects were above 70 years of age; n=123) measured by SRH assay assessed in three clinical studies were as follows: 
Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelo proti HA na H5N1 (A/Vietnam/1194/2004 in A/turkey/Turkey/1/2005) pri osebah, starih 61 let ali več (manjše število oseb je bilo starih nad 70 let, N = 123), izmerjeno s testom SRH in ocenjeno v treh kliničnih preskušanjih, so bili, kot sledi:
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: 
Površinski antigeni (hemaglutinin in nevraminidaza)* virusa gripe seva:
Seroconversion rate (95%CI)° 
Faktor serokonverzije (95-odstotni
Some heterologous immune response against A/turkey/Turkey/1/2005 (NIBRG23; clade 2.2.1) and A/ Indonesia/5/2005 (clade 2.1) was detectable both after the second and third vaccinations, indicating cross-reactivity of the clade 1 vaccine against clade 2 strains. 
*** GMR za SRH Podatki o navzkrižni odzivnosti pri odraslih Navzkrižni imunski odziv, ki ga je izzval A/Vietnam/1194/2004, na A/turkey/Turkey/1/2005 in A/Indonesia/5/2005 Nekaj heterolognega imunskega odziva proti sevu A/turkey/Turkey/1/2005 (NIBRG23; gruča 2.2.1) in A/Indonesia/5/2005 (gruča 2.1) so zaznali tako po drugem kot po tretjem cepljenju, kar kaže na križno reaktivnost cepiva gruče 1 proti sevom gruče 2.
Seroconversion rates against homologous A/turkey/Turkey/1/2005 ranged from 37.50% to 43.10% in healthy adults, and from 19.18% to 26.47% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 21.43% to 30.65% in healthy elderly subjects, and from 24.49% to 27.86% in elderly subjects with immunosuppressive or underlying medical conditions. 
Stopnje serokonverzije proti homolognemu sevu A/turkey/Turkey/1/2005 so bili v razponu od 37,50 % do 43,10 % pri zdravih odraslih osebah ter od 19,18 % do 26,47 % pri odraslih osebah z zmanjšanim imunskim odzivom ali osnovnimi bolezenskimi stanji.
Elderly (61-84 years)a 
Starejši (61-84 let)
SRH results after the first dose, that mimic prepandemic priming plus single heterologous booster dose, revealed seroprotection and seroconversion rates of 100% (74100) and an 18-fold increase in SRH area (GMR). 
so pokazali stopnjo serozaščite in serokonverzije 100 % (74-100) ter 18-kratno povečanje površine
Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema. 
Generalizirane kožne reakcije, vključno s pruritusom, urtikarijo ali nespecifičnim izpuščajem;
Study V87P3 21 days after 2nd dose N=30 
Študija V87P3 21. dni po 2. odmerku N = 30
MN results for the three clinical studies in the Table above revealed a seroprotection rate and seroconversion rate against A/turkey/Turkey/2005 ranging from 10% (2-27) to 39% (32-46) and 10% (2-27) to 36% (29-43) respectively. 
A/turkey/Turkey/2005 v razponu od 10 % (2-27) do 39 % (32-46) in na stopnjo serokonverzije proti temu sevu med 10 % (2-27) in 36 % (29-43).
Visually inspect the suspension prior to administration. 
Pred dajanjem cepivo vizualno preglejte.
Keep this vaccine out of the sight and reach of children. 
Cepivo shranjujte nedosegljivo otrokom.
MN results against homologous A/turkey/Turkey/1/2005 indicate a seroconversion rate of 66.67% in healthy adults, and ranging from 33.57% to 54.14% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 24.39% to 29.03% in healthy elderly subjects, and from 31.65% to 39.42% in elderly subjects with immunosuppressive or underlying medical conditions. 
Rezultati testov MN proti homolognemu sevu A/turkey/Turkey/1/2005 kažejo na stopnjo serokonverzije 66,67 % pri zdravih odraslih osebah ter od 33,57 % do 54,14 % pri odraslih osebah z zmanjšanim imunskim odzivom ali osnovnimi bolezenskimi stanji.
Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=182 
Študija V87P11 A/turkey/Turkey/1/2005 21 dni po 2. odmerku N = 182
Study V87P13 21 days after 2nd dose N=197 
Študija V87P13 21. dni po 2. odmerku N = 197
Elderly (61-79 years)a 
Starejši (61-79 let)
MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58). 
94-100), stopnjo serokonverzije v razponu od 97 % (95-odstotni IZ: 91-99) do 99 % (95-odstotni IZ: 96-100) in GMR v razponu od 29 (95-odstotni IZ: 25-35) do 50 (95-odstotni IZ: 44-58).
Reporting of suspected adverse reactions 
vsi drugi neželeni učinki Poročanje o domnevnih neželenih učinkih
These side effects may occur with AFLUNOV. 
Ti neželeni učinki se lahko pojavijo s cepivom AFLUNOV.
Like all medicines, AFLUNOV can cause side effects, although not everybody gets them. 
Možni neželeni učinki Kot vsa cepiva ima lahko tudi cepivo AFLUNOV neželene učinke, ki pa se ne pojavijo pri vseh ljudeh.