FrancophonIA/ELRC3.0 huggingface dataset:
English: However, it is estimated that during the 2009 H1N1 pandemic more than 90,000 women were vaccinated during pregnancy with Focetria (an H1N1 pandemic vaccine similar to AFLUNOV) which contains the same amount of adjuvant MF59C.1 as AFLUNOV.
Slovenian: Vendar se ocenjuje, da je bilo med pandemijo H1N1 leta 2009 med nosečnostjo cepljenih več kot 90.000 žensk s cepivom Focetria (pandemsko cepivo H1N1, podobno cepivu AFLUNOV), ki vsebuje enako količino adjuvansa MF59C.1 kot cepivo AFLUNOV.
English: In these trials, lower levels of antibodies and reduced seroprotection rates against homologous H5N1 A/turkey/Turkey/1/2005 were also measured in healthy elderly subjects, as compared to healthy adults, though previous studies showed induction of sufficiently immunogenic responses against H5N1 strains (see above for information on elderly).
Slovenian: V teh preskušanjih so tudi pri zdravih starejših osebah izmerili nižje ravni protiteles in znižane ravni serozaščite proti homolognemu sevu H5N1 A/turkey/Turkey/1/2005 v primerjavi z zdravimi odraslimi osebami, čeprav so prejšnje študije pokazale vzpostavitev zadostnih imunogenih odzivov proti sevom H5N1 (glejte zgoraj za informacije o starejših osebah).
English: A study in rabbits did not indicate reproductive or developmental toxicity of AFLUNOV (see section 5.3).
Slovenian: Študija pri kuncih ni pokazala vpliva cepiva AFLUNOV na sposobnost razmnoževanja ali razvoja (glejte poglavje 5.3).
English: administered 12 months following the first dose, was higher than after both first and second doses.
Slovenian: Reaktogenost po tretjem odmerku, danem 12 mesecev po prvem odmerku, je bila višja kot po obeh, prvem in drugem odmerku.
English: Subjects with underlying medical or immunosuppressive conditions:
Slovenian: Osebe z osnovnimi bolezenskimi stanji ali zmanjšanim imunskim odzivom:
English: However, in a pandemic situation caused by the strain included in this vaccine, it may be appropriate to give this vaccine to individuals with a history of anaphylaxis as defined above, provided that facilities for resuscitation are immediately available in case of need.
Slovenian: Vendar pa je lahko v pandemski situaciji, ki jo povzroči sev, vključen v to cepivo, posameznika z anafilakso v anamnezi, kot je opredeljeno zgoraj, ustrezno cepiti, če je v takšnem primeru takoj na voljo oprema za reševanje.
English: Limited data were obtained from women who became pregnant during the course of clinical trials with AFLUNOV or similar pandemic H1N1v vaccines adjuvanted with MF59C.1.
Slovenian: Pridobili so omejene podatke pri ženskah, ki so zanosile v teku kliničnih preskušanj s cepivom AFLUNOV ali podobnimi pandemskimi cepivi H1N1v z adjuvansom MF59C.1.
English: Data on safety of a booster dose of AFLUNOV are limited to three trials (V87P1, V87P2 and V87P1E1) that included 116 adults (18-60 years) and 56 elderly subjects (>61 years).
Slovenian: Podatki o varnosti obnovitvenega odmerka cepiva AFLUNOV so omejeni na tri preskušanja (V87P1, V87P2 in V87P1E1), v katera je bilo vključenih 116 odraslih (18-60 let) in 56 starejših oseb (≥ 61 let).
English: The vaccine should under no circumstances be administered intravascularly or intradermally.
Slovenian: V nobenem primeru se ne sme cepiva dati intravaskularno ali intradermalno.
English: Undesirable effects in patients with underlying long term medical problems such as diabetes, lung disease or heart problems and weakened immune systems (immunocompromised) such as HIV patients
Slovenian: Neželeni učinki pri bolnikih z dolgotrajnimi osnovnimi bolezenskimi stanji, kot so diabetes, pljučna bolezen ali težave s srcem, in oslabljenim imunskim sistemom, kot pri bolnikih, okuženih z virusom HIV (imunsko oslabljenih bolnikih)
English: The adverse reaction rates reported after any vaccination doses (i.e. 1st, 2nd or booster) were similar and are listed according to the following MedDRA frequency convention and system organ class:
Slovenian: Seznam neželenih učinkov Stopnje neželenih učinkov, o katerih so poročali po katerem koli odmerku cepljenja (tj. 1., 2. ali obnovitvenem), so bile podobne in so naštete glede na naslednjo opredelitev pogostnosti in organskih sistemov po MedDRA:
English: • Neuritis (inflammation of nerves)
Slovenian: • nevritis (vnetje živcev).
English: (≥1/10,000 to
Slovenian: (≥ 1/1.000 do
English: 0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber).
Slovenian: 0,5 ml v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom na batu (bromobutilna guma).
English: • Low blood platelet count which can result in bleeding or bruising.
Slovenian: • Zmanjšano število trombocitov v krvi, kar lahko povzroči krvavitve ali modrice.
English: • Headache, dizziness, drowsiness, fainting.
Slovenian: • Glavobol, omotičnost, zaspanost, omedlevica
English: Neurological disorders such as
Slovenian: • Nevrološke motnje, kot so:
English: The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Slovenian: Druge sestavine zdravila so: natrijev klorid; kalijev klorid; kalijev dihidrogen fosfat; dinatrijev fosfat dihidrat; magnezijev klorid heksahidrat; kalcijev klorid dihidrat, natrijev citrat, citronska kislina in voda za injekcije.
English: Efficacy against challenge with virus homologous and heterologous to vaccine strains was evaluated in the ferret model.
Slovenian: Učinkovitost proti provokaciji z virusom, homolognim in heterolognim na cepilne seve, so ocenili pri belem dihurju.
English: In children and adolescents, pain was the most frequently reported solicited local reaction, and fatigue and headache were the most commonly reported solicited systemic reactions.
Slovenian: Pri otrocih in mladostnikih je bila najpogosteje poročana lokalna reakcija bolečina, najpogosteje poročani pričakovani sistemski reakciji pa sta bili utrujenost in glavobol.
English: If they persist, CONSULT YOUR DOCTOR.
Slovenian: Če ne izzvenijo, SE POSVETUJTE
English: SP= seroprotection SC= seroconversion
Slovenian: SK = serokonverzija
English: A third (booster) dose of AFLUNOV was administered 6 months onwards after the primary vaccination.
Slovenian: Tretji (obnovitveni) odmerek cepiva AFLUNOV je bil dan po 6 ali več mesecih po primarnem cepljenju.
English: This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/2005 (H5N1)-like strain (see sections 4.4 and 5.1).
Slovenian: Ta indikacija temelji na podatkih o imunogenosti za zdrave osebe, stare 18 let ali več, po cepljenju z dvema odmerkoma cepiva, ki vsebuje sevu A/turkey/Turkey/1/2005 (H5N1) podoben sev (glejte poglavji 4.4 in 5.1).
English: A slight increase in reactions in adults was reported when a booster dose was administered 18 months after the initial dosing series.
Slovenian: Poročali so o rahlem povečanju reakcij pri odraslih, ki so obnovitveni odmerek prejeli 18 mesecev po prvi seriji odmerkov.
English: Seqirus Netherlands B.V. Paasheuvelweg 28
Slovenian: Seqirus Netherlands B.V.
English: 1.175 milligrams per 0.5 ml
Slovenian: 1,175 miligrama na 0,5 ml
English: The following additional adverse events were reported from post-marketing surveillance with seasonal non-adjuvanted trivalent vaccines in all age groups and a seasonal trivalent MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older:
Slovenian: Pri spremljanju v obdobju trženja so poročali o naslednjih neželenih učinkih pri sezonskih trivalentnih cepivih brez adjuvansov v vseh starostnih skupinah in pri sezonskem trivalentnem komponentnem cepivu z adjuvansom MF59, ki je odobreno za uporabo pri starejših osebah, starih 65 let in več:
English: Immunization shall be postponed in patients with febrile illness or acute infection.
Slovenian: Imunizacijo pri bolnikih s povišano telesno temperaturo ali akutno okužbo je treba preložiti.
English: In the elderly, the reported reactions increased with the third booster dose only when compared with the second dose.
Slovenian: Pri starejših osebah je bilo pri tretjem obnovitvenem odmerku več poročil o reakcijah le v primerjavi z drugim obnovitvenim odmerkom.
English: After 3 weeks from the 2nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below.
Slovenian: Po 3 tednih od 2. cepljenja (43. dan) so vse starostne skupine (tj. 6-35 mesecev, 3-8 let in 9-17 let) dosegle visoko raven protiteles na sev (A/Vietnam/1194/2004), ocenjeno s testoma SRH in HI, kot je predstavljeno v spodnji preglednici.
English: Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če imate motnjo strjevanja krvi ali ste nagnjeni k podplutbam.
English: Immune response to vaccination assessed by MN assay is in line with results obtained with SRH.
Slovenian: Imunski odziv na cepljenje, ocenjeno s testom MN, je v skladu z rezultati, pridobljenimi s SRH.
English: 9.75 milligrams per 0.5 ml polysorbate 80
Slovenian: 9,75 miligrama na 0,5 ml polisorbat 80
English: The vaccine should be allowed to reach room temperature before use.
Slovenian: Pred uporabo počakajte, da cepivo doseže sobno temperaturo.
English: No data are available in children aged less than 6 months.
Slovenian: Podatkov pri otrocih, starih do 6 mesecev, ni na voljo.
English: No increase in reactions was reported when a booster dose was administered 6 months-18 months later, after the initial dosing series.
Slovenian: Niso poročali o povečanju števila neželenih učinkov ob dajanju tretjega odmerka 6 mesecev-18 mesecev kasneje po seriji začetnih odmerkov.
English: Vascular disorders Vasculitis with transient renal involvement.
Slovenian: Žilne bolezni Vaskulitis s prehodno vpletenostjo ledvic
English: Injection 2
Slovenian: 2. injekcija
English: Your doctor needs to assess the benefits and potential risks of giving you the vaccine.
Slovenian: Vaš zdravnik bo presodil razmerje med koristmi in možnimi tveganji cepljenja.
English: If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Slovenian: Če je potrebna sočasna uporaba z drugim cepivom, je treba imunizacijo opraviti na drugi okončini.
English: SRH seroprotection rates ranged from 86% to 98%, seroconversion rated from 64% to 90%, and GMR ranged from 2.92 to 4.57.
Slovenian: 98 %, stopnje serokonverzije so bile v razponu od 64 % do 90 % in GMR je bilo v razponu od 2,92 do 4,57.
English: The incidence of AFLUNOV (A/Vietnam/1194/2004) adverse reactions has been evaluated in one clinical trial (V87P6) in children (6 months to 17 years old).
Slovenian: Pojavnost neželenih učinkov pri cepivu AFLUNOV (A/Vietnam/1194/2004) so ovrednotili v enem kliničnem preskušanju (V87P6) pri otrocih (starih od 6 mesecev do 17 let).
English: Injection 1
Slovenian: 1. injekcija
English: Two doses of AFLUNOV were administered three weeks apart and a third dose 12 months following the first dose.
Slovenian: V časovnem presledku treh tednov so dali dva odmerka cepiva AFLUNOV in tretji odmerek 12 mesecev po prvem odmerku.
English: AFLUNOV has been evaluated in healthy adults (18-60 years of age) and healthy elderly (over 60 years of age) following a 1, 22 day primary vaccination schedule, and booster vaccination (see sections 4.8 and 5.1).
Slovenian: Cepivo AFLUNOV je bilo ovrednoteno pri zdravih odraslih (starih med 18 in 60 let) in zdravih starejših odraslih (starih več kot 60 let) po režimu primarnega cepljenja 1. in 22. dan in obnovitveno cepljenje (glejte poglavji 4.8 in 5.1).
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Slovenian: Tako kot pri vseh cepivih, ki se injicirajo, je treba zagotoviti ustrezno obliko zdravljenja in zdravniškega nadzora, ki bi bila v primeru anafilaktične reakcije na cepljenje nemudoma na voljo.
English: Data obtained in adults showed that AFLUNOV can be given at the same time as non-adjuvanted seasonal influenza vaccines.
Slovenian: Podatki, pridobljeni pri odraslih, kažejo, da se lahko cepivo AFLUNOV daje sočasno s sezonskimi cepivi proti gripi, ki ne vsebujejo adjuvansa.
English: General disorders and administration site conditions Extensive swelling of injected limb lasting more than one week, injection-site cellulitis-like reaction (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week).
Slovenian: Obsežna, več kot 1 teden trajajoča oteklina okončine, v katero je bilo injicirano cepivo; celulitisu podobna reakcija na mestu injiciranja (nekaj primerov otekline, bolečine in rdečine na območju več kot 10 cm in s trajanjem več kot 1 teden).
English: 1.175 milligrams per 0.5 ml sorbitan trioleate
Slovenian: 1,175 miligrama na 0,5 ml sorbitantrioleat
English: Toddlers (6-<36 months)
Slovenian: Malčki (6-< 36 mesecev)
English: * Seroprotection: SRH area ≥ 25 mm2
Slovenian: * Serozaščita: površina SRH ≥ 25 mm2.
English: A single vaccination with AFLUNOV (A/Vietnam/1194/2004) induced high and rapid serological response in subjects primed 6-8 years previously with two doses of a different surrogate H5N vaccine, having same formulation as AFLUNOV but using the strain H5N3.
Slovenian: Eno cepljenjem s cepivom AFLUNOV (A/Vietnam/1194/2004) je povzročilo visok in hiter serološki odziv pri osebah, ki so bile 6-8 let pred tem primarno imunizirane z dvema odmerkoma različnih nadomestnih cepiv za H5N, z enako formulacijo kot cepivo AFLUNOV, a s sevom H5N3.
English: Protection against influenza There is no immune correlate of protection established for influenza A (H5N1).
Slovenian: Povezava med imunskim odzivom in zaščito pred gripo tipa A (H5N1) ni znana.
English: Potassium chloride (E508) Potassium dihydrogen phosphate (E340) Disodium phosphate dihydrate (E339) Magnesium chloride hexahydrate (E511) Calcium chloride dihydrate (E 509) Sodium citrate (E311) Citric acid (E330)Water for injections.
Slovenian: natrijev klorid kalijev klorid (E508) kalijev dihidrogenfosfat (E340) dinatrijev hidrogenfosfat (E339) magnezijev klorid heksahidrat (E511) kalcijev klorid dihidrat (E509) natrijev citrat (E311) citronska kislina (E330) voda za injekcije
English: If administration of AFLUNOV with other vaccines can not be avoided, the vaccines should be injected into separate limbs.
Slovenian: Če se cepljenju s cepivom AFLUNOV hkrati z drugimi cepivi ni mogoče izogniti, je treba cepivi injicirati vsako v svojo okončino.
English: a actual age range of population enrolled
Slovenian: a dejanski razpon starosti vključene populacije
English: Medical Conditions N=140
Slovenian: Bolezenska stanja N = 140
English: What AFLUNOV looks like and contents of the pack
Slovenian: Izgled cepiva AFLUNOV in vsebina pakiranja
English: • Diarrhoea
Slovenian: • diareja.
English: 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.
Slovenian: 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.
English: In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Slovenian: Če v cepivu opazite delce in/ali je njegov videz neobičajen,
English: 1 pre-filled syringe (0.5 ml) 10 pre-filled syringes (0.5 ml)
Slovenian: suspenzija za injiciranje 1 napolnjena injekcijska brizga (0,5 ml) 10 napolnjenih injekcijskih brizg (0,5 ml)
English: Cross-reactive immune response elicited by A/turkey/Turkey/1/2005 against A/Indonesia/5/2005 and A/Vietnam/1194/2004
Slovenian: Navzkrižni imunski odziv, ki ga je izzval A/turkey/Turkey/1/2005, na A/Indonesia/5/2005 in A/Vietnam/1194/2004
English: The vaccine will be injected into the muscles of the upper arm (deltoid muscle).
Slovenian: Cepivo se injicira v mišico nadlakti (v deltoidno mišico).
English: • Urticaria (hives)
Slovenian: • urtikarija (koprivnica).
English: Skin and subcutaneous tissue disorders Erythema multiforme.
Slovenian: Bolezni kože in podkožja Multiformni eritem
English: V87P11 Elderly (>61-89 years)a N=142
Slovenian: V87P11 starejši (61-89 let) N = 142
English: Any Other Adverse Event
Slovenian: vsi drugi neželeni učinki
English: 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.
Slovenian: 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.
English: Other medicines and AFLUNOV
Slovenian: Druga zdravila in cepivo AFLUNOV
English: Blood and lymphatic system disorders Thrombocytopenia (in some cases reversible platelet counts less than 5000 mm3).
Slovenian: Trombocitopenija (v nekaterih primerih se število trombocitov zmanjša na manj kot 5000/mm³ in je reverzibilno)
English: Adults (18-60 years)
Slovenian: Odrasli (18-60 let)
English: Information from non-clinical studies
Slovenian: Informacije iz predkliničnih študij
English: Fainting can occur following, or even before, any needle injection.
Slovenian: Po katerem koli injiciranju z iglo ali celo pred njim se lahko pojavi omedlevica.
English: Active immunisation against H5N1 subtype of Influenza A virus.
Slovenian: Aktivna imunizacija proti virusu influence A podtipa H5N1.
English: AFLUNOV may be co-administered with non-adjuvanted seasonal influenza vaccines, and immunisation should be carried out on separate limbs.
Slovenian: Cepivo AFLUNOV se lahko daje sočasno s sezonskimi cepivi proti gripi brez adjuvansa, pri čemer je treba imunizacijo opraviti na drugi okončini.
English: Some degree of cross-reactive immunity has been observed against H5N1 viruses of clades different to that of the vaccine strain.
Slovenian: V kliničnih preskušanjih so opazili določeno stopnjo navzkrižnih imunskih odzivov na viruse H5N1 iz gruč, drugačnih kot pri cepilnem sevu.
English: In this trial no vaccine related SAEs were observed.
Slovenian: V tem preskušanju niso opazili neželenih učinkov, povezanih s cepivom.
English: Immune response to AFLUNOV A/Vietnam/1194/2004 (H5N1) and A/turkey/Turkey/1/2005 (H5NI)
Slovenian: Imunski odziv na AFLUNOV A/Vietnam/1194/2004 (H5N1) in A/turkey/Turkey/1/2005 (H5N1)
English: Uncommon (≥1/1,000 to
Slovenian: Redki (≥ 1/10.000 do
English: One dose of 0.5 ml will be given.
Slovenian: Prejmejo en odmerek 0,5 ml.
English: There is limited experience in children between 6 months and 17 years of age.
Slovenian: Otroci, stari od 6 mesecev do 17 let Pri otrocih, starih med 6 meseci in 17 leti, so izkušnje omejene.
English: Elderly (>61 years)
Slovenian: Starejši (≥ 61 let)
English: A clinical trial (V87P6) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 471 children from 6 months to 17 years of age.
Slovenian: Opravili so klinično preskušanje (V87P6) za cepivo AFLUNOV (A/Vietnam/1194/2004) pri 471 otrocih, starih od 6 mesecev do 17 let.
English: 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.
Slovenian: 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 %).
English: If you have any further questions on the use of this medicinal product, ask your doctor or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali medicinsko sestro.
English: 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).
Slovenian: 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).
English: What you need to know before you receive AFLUNOV You should not receive AFLUNOV:
Slovenian: Kaj morate vedeti, preden boste cepljeni s cepivom AFLUNOV S cepivom AFLUNOV ne smete biti cepljeni:
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: AFLUNOV contains sodium and potassium.
Slovenian: Cepivo AFLUNOV vsebuje natrij in kalij.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Slovenian: Če bolnik prejema imunosupresivna zdravila, je lahko imunski odziv manjši.
English: 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).
Slovenian: 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
English: Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Slovenian: zoonotsko cepivo proti gripi (H5N1) (s površinskimi antigeni, inaktivirano, z adjuvansom)
English: Contents of the pack and other information What AFLUNOV contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo AFLUNOV
English: • Aching muscles
Slovenian: • bolečine v mišicah,
English: In such cases, you should be aware that the side effects may be more intense.
Slovenian: V takih primerih so lahko neželeni učinki okrepljeni.