FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare (affects 1 to 10 users in 10.000):
Slovenian: Občasni (pojavijo se pri 1 do 10 od 1.000 bolnikov):
English: Blood and lymphatic system disorders Lymphadenopathy.
Slovenian: Bolezni krvi in limfatičnega sistema
English: Headache, dizziness, somnolence, syncope.
Slovenian: Bolezni živčevja Glavobol, omotičnost, zaspanost, sinkopa.
English: Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle.
Slovenian: Imunizacija se opravi z intramuskularnim injiciranjem v deltoidno mišico.
English: 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.
Slovenian: 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).
English: 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.
Slovenian: Poleg tega dve veliki opazovalni študiji, zasnovani za oceno varnosti izpostavljenosti cepivu Focetria med nosečnostjo, nista pokazali zvišanja stopenj gestacijskega diabetesa, preeklampsije, splavov,
English: Nervous system disorders Neurological disorders, such as encephalomyelitis, and Guillain Barré syndrome.
Slovenian: Nevrološke bolezni, kot sta encefalomielitis in Guillain-Barréjev sindrom
English: The potential benefits to the mother and risks to the infant should be considered before administering AFLUNOV during breast-feeding.
Slovenian: AFLUNOV je treba pretehtati možne koristi za mater in tveganja za otroka Plodnost
English: • Rash or swelling of the skin and mucous membranes
Slovenian: • izpuščajem ali oteklino kože in sluznic,
English: 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
Slovenian: Faktor serokonverzije (95-odstotni IZ)*** a Starost 62-88 let; b starost 61-68 let; c starost 61-89 let.
English: Post-marketing surveillance No post-marketing surveillance data are available following AFLUNOV administration.
Slovenian: Podatkov iz spremljanja v obdobju trženja za cepivo AFLUNOV ni.
English: 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
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Adolescents (9-<18 years)
Slovenian: Mladostniki (9-< 18 let)
English: ** 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
Slovenian: ** 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-%)
English: AFLUNOV injection H5N1 Zoonotic influenza vaccine IM
Slovenian: AFLUNOV injekcije zoonotsko cepivo proti gripi (H5N1) i.m.
English: AFLUNOV(A/Vietnam/1194/2004) and an AFLUNOV-like H5N1 vaccine (A/turkey/Turkey/1/2005-like) were tested.
Slovenian: Testirali so cepivo AFLUNOV (A/Vietnam/1194/2004) in cepivo H5N1, podobno cepivu AFLUNOV (sev podoben A/turkey/Turkey/1/2005).
English: Elderly years)*
Slovenian: IZ)**
English: • Disorders of the gut such as
Slovenian: • Črevesne motnje, kot so:
English: • Pain at the site of injection
Slovenian: bolečina na mestu injiciranja,
English: Very commonly reported reactions in the 36 months to 17 years of age group were pain, headache and fatigue.
Slovenian: Neželeni učinki, ki so se v skupini otrok, starih med 36 meseci in 17 leti, opazili zelo pogosto, so bili bolečina,
English: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose
Slovenian: sevu A/turkey/Turkey/1/2005 (H5N1) podobnega seva (NIBRG-23) (gruča 2.2.1) 7,5 mikrogramov** na 0,5 ml odmerek
English: 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.
Slovenian: imunogenosti ali učinkovitosti, ki podpirajo zamenljivost cepiva AFLUNOV z drugimi monovalentnimi cepivi H5N1.
English: Common (≥1/100 to <1/10)
Slovenian: Pogosti (≥ 1/100 do
English: Musculoskeletal and connective tissue disorders
Slovenian: angioedem Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: and a type of paralysis known as Guillain-Barré Syndrome.
Slovenian: • Nevrološke motnje, kot so encefalomielitis (vnetje osrednjega živčevja) in vrsta paralize, znana kot Guillain-Barréjev sindrom.
English: AFLUNOV is a suspension for injection in a pre-filled syringe.
Slovenian: Cepivo AFLUNOV je suspenzija za injiciranje v napolnjeni injekcijski brizgi.
English: To be administered intramuscularly into the deltoid muscle.
Slovenian: Daje se intramuskularno v deltoidno mišico.
English: Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Slovenian: Nevrološke težave, kot so nevralgija, parestezija,
English: 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.
Slovenian: 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.
English: % SC (95% CI) Day 43
Slovenian: % SZ (95-odstotni IZ) 43. dan
English: AFLUNOV suspension for injection in pre-filled syringe.
Slovenian: AFLUNOV suspenzija za injiciranje v napolnjeni injekcijski brizgi.
English: GMR (95% CI) Day 43 to Day 1
Slovenian: GMR (95-odstotni IZ) 43. dan do 1. dan % SK (95-odstotni IZ) 43. dan
English: Medical Conditions N=143
Slovenian: Bolezenska stanja N = 143
English: 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:
Slovenian: (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:
English: There are no data on co-administration of AFLUNOV with vaccines other than non-adjuvanted seasonal influenza vaccines.
Slovenian: Podatkov o sočasni uporabi cepiva AFLUNOV s cepivi, ki niso sezonska cepiva proti gripi brez adjuvansa, ni.
English: Contents of the pack and other information
Slovenian: Shranjevanje cepiva AFLUNOV Vsebina pakiranja in dodatne informacije
English: 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.
Slovenian: (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.
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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).
English: Adults (18-59 years)a
Slovenian: Odrasli (18-59 let)
English: 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.
Slovenian: 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).
English: Adjuvant MF59C.1 containing: squalene
Slovenian: ** izraženo v mikrogramih hemaglutinina Adjuvans MF59C.1 vsebuje: skvalen
English: 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).
Slovenian: neomicin sulfata, formaldehida in cetiltrimetilamonijevega bromida, ki se uporabljajo v proizvodnem procesu (glejte poglavje 4.3).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms haemagglutinin
Slovenian: sevu A/turkey/Turkey/1/2005 (H5N1) podoben sev (NIBRG-23) (gruča 2.2.1) 7,5 mikrogramov hemaglutinina
English: • Fever and nausea
Slovenian: konvulzije in nevritis
English: Elderly (61-91 years)a
Slovenian: Starejši (61-91 let)
English: ** geometric mean ratios of SRH
Slovenian: *** Razmerja geometričnih srednjih vrednosti (GMR) za SRH.
English: 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.
Slovenian: 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).
English: 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:
Slovenian: 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:
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Slovenian: Površinski antigeni (hemaglutinin in nevraminidaza)* virusa gripe seva:
English: Seroconversion rate (95%CI)°
Slovenian: Faktor serokonverzije (95-odstotni
English: 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.
Slovenian: *** 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.
English: 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.
Slovenian: 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.
English: Elderly (61-84 years)a
Slovenian: Starejši (61-84 let)
English: 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).
Slovenian: so pokazali stopnjo serozaščite in serokonverzije 100 % (74-100) ter 18-kratno povečanje površine
English: Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Slovenian: Generalizirane kožne reakcije, vključno s pruritusom, urtikarijo ali nespecifičnim izpuščajem;
English: Study V87P3 21 days after 2nd dose N=30
Slovenian: Študija V87P3 21. dni po 2. odmerku N = 30
English: 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.
Slovenian: 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).
English: Visually inspect the suspension prior to administration.
Slovenian: Pred dajanjem cepivo vizualno preglejte.
English: Keep this vaccine out of the sight and reach of children.
Slovenian: Cepivo shranjujte nedosegljivo otrokom.
English: 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.
Slovenian: 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.
English: Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=182
Slovenian: Študija V87P11 A/turkey/Turkey/1/2005 21 dni po 2. odmerku N = 182
English: Study V87P13 21 days after 2nd dose N=197
Slovenian: Študija V87P13 21. dni po 2. odmerku N = 197
English: Elderly (61-79 years)a
Slovenian: Starejši (61-79 let)
English: 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).
Slovenian: 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).
English: Reporting of suspected adverse reactions
Slovenian: vsi drugi neželeni učinki Poročanje o domnevnih neželenih učinkih
English: These side effects may occur with AFLUNOV.
Slovenian: Ti neželeni učinki se lahko pojavijo s cepivom AFLUNOV.
English: Like all medicines, AFLUNOV can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa cepiva ima lahko tudi cepivo AFLUNOV neželene učinke, ki pa se ne pojavijo pri vseh ljudeh.
English: • Hardening of the skin at the injection site
Slovenian: • bolečina na mestu injiciranja, • otrdelost kože na mestu injiciranja,
English: There is no information on administration of AFLUNOV with noninfluenza vaccines.
Slovenian: Ni podatkov o dajanju cepiva AFLUNOV s cepivi, ki niso namenjena proti gripi.
English: - Keep this leaflet.
Slovenian: ga zavrzite.
English: assays) and reduced seroprotection rates in adults and elderly (≥ 61 years old) subjects with underlying medical or immunosuppressive conditions, suggest that AFLUNOV may not elicit the same level of protection against A/H5N1 strain as compared to healthy adults (see section 4.4).
Slovenian: V obeh študijah (V87_25 in V87_26) nižje ravni protiteles (izmerjene s testi HI, SRH in MN) in znižane stopnje serozaščite pri odraslih in starejših osebah (starih ≥ 61 let) z osnovnimi bolezenskimi stanji ali zmanjšanim imunskim odzivom kažejo na to, da cepivo AFLUNOV pri teh osebah morda ne vzpostavi enake stopnje zaščite proti sevu A/H5N1 kot pri zdravih odraslih osebah (glejte poglavje 4.4).
English: How AFLUNOV is given
Slovenian: Kako se daje cepivo AFLUNOV
English: Baseline Serostatus
Slovenian: OVOJNINA ZA BRIZGE
English: The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows:
Slovenian: Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelo proti HA na H5N1 A/Vietnam/1194/2004, izmerjeno s testi SRH, so bili kot sledi:
English: The seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 and to H5N1 A/turkey/Turkey/1/2005 in the adults measured by SRH assay was as follows:
Slovenian: Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelo proti HA na H5N1 A/Vietnam/1194/2004 in na H5N1 A/turkey/Turkey/1/2005 pri odraslih, izmerjeno s testom SRH, so bili, kot sledi:
English: Geometric mean area*, seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/turkey/Turkey/1/2005 measured by SRH assays 21 days after the 2nd dose were as follows:
Slovenian: Geometrijska sredina površine*, stopnja serozaščite*, stopnja serokonverzije* in faktor serokonverzije** za protitelo proti HA na H5N1 A/turkey/Turkey/1/2005, izmerjeni s testi SRH 21 dni po 2. odmerku, so bili naslednji:
English: Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/turkey/Turkey/1/2005 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Slovenian: Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelesa proti HA na sev H5N1 A/turkey/Turkey/1/2005 po 2. odmerku pri odraslih, starih od 18 do 60 let, izmerjeno s testoma SRH in HI, so bili, kot sledi:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Talk to your doctor or nurse before having this vaccine
Slovenian: Pred cepljenjem s tem cepivom se posvetujte z zdravnikom ali medicinsko sestro.
English: Nausea, aching joints, diarrhoea and loss of appetite were reported very commonly in this population.
Slovenian: Pri teh bolnikih so zelo pogosto poročali o siljenju na bruhanje, bolečinah v sklepih, driski in izgubi apetita.
English: Adults from 18 onwards:
Slovenian: Odrasli, stari 18 let ali več:
English: Seroprotection rate*, seroconversion rate** and the seroconversion factor*** for anti-HA antibodies to H5N1 A/ Indonesia/5/2005 and A/Vietnam/1194/2004 after the 2nd dose in adults (18-60 years) and elderly (> 61years), measured by SRH and HI assays were as follows: Anti-HA antibody
Slovenian: Stopnja serozaščite*, stopnja serokonverzije** in faktor serokonverzije*** za protitelesa proti HA na H5N1 A/Indonesia/5/2005 in A/Vietnam/1194/2004 po 2. odmerku pri odraslih (18-60 let) in starejših (≥ 61 let), izmerjeno s testoma SRH in HI, so bili, kot sledi:
English: Influenza like illness
Slovenian: trepetanje gripi podobna bolezen anafilaksa
English: Two doses of AFLUNOV were administered three weeks apart to 156 healthy adultsImmunogenicity was assessed in 149 subjects.
Slovenian: S 3-tedenskim presledkom so 156 zdravih odraslih oseb cepili z dvema odmerkoma cepiva AFLUNOV.
English: Study V87P2 Adults booster after 2nd dose
Slovenian: Študija V87P2 odrasli obnovitev po 2. odmerku
English: • Nausea
Slovenian: • krči,
English: °° GMRs of HI
Slovenian: ** GMR za SRH
English: Based on humoral immune responses to the vaccine strain A/turkey/Turkey/1/2005 after two doses of AFLUNOV, a protective immune response may not be elicited in all vaccinees.
Slovenian: Na podlagi humoralnih imunskih odzivov na cepilni sev A/turkey/Turkey/1/2005 po dveh odmerkih cepiva
English: Name and address of the manufacturers of the biological active substance Seqirus Vaccines Ltd
Slovenian: Ime in naslov izdelovalcev biološke učinkovine
English: Study V87P1 Elderly booster after 2nd dose
Slovenian: Študija V87P1 starejše osebe obnovitev po 2. odmerku
English: Study V87P11 A/turkey/Turkey/1/2005 21 days after 2nd dose N=132c
Slovenian: Študija V87P11 A/turkey/Turkey/1/2005 21. dni po 2. odmerku N = 132
English: • Injection site redness
Slovenian: • pordečeno mesto injiciranja,
English: Study V87P1 Adults booster after 2nd dose
Slovenian: Študija V87P1 odrasli obnovitev po 2. odmerku
English: A phase II clinical trial (V87P1) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 312 healthy adults.
Slovenian: faze (V87P1) s cepivom AFLUNOV (A/Vietnam/1194/2004).
English: Adults (19- 60 years)a
Slovenian: Odrasli (19-60 let)
English: Adverse reactions in special populations have been evaluated in two clinical trials, V87_25 and V87_26, involving adult (18-60 years) and elderly (≥ 61 years) subjects who were either healthy or with underlying medical conditions or immunosuppressive conditions.
Slovenian: V87_26, z odraslimi (18-60 let) in starejšimi osebami (≥ 61 let), ki so bile zdrave ali pa so imele osnovna bolezenska stanja ali oslabljen imunski odziv.
English: Nervous system disorders
Slovenian: Bolezni živčevja glavobol konvulzije
English: Injection site swelling, Injection site pain, Injection site induration, Injection site redness, Fatigue
Slovenian: rdečina na mestu injiciranja, utrujenost ekhimoza na mestu injiciranja, zvišana telesna temperatura, splošno slabo počutje,
English: Medical conditions
Slovenian: UPORABO ZDRAVILA
English: Seroprotection rate (95%CI) ° Seroconversion rate (95%CI) ° Seroconversion factor (95%CI) °°
Slovenian: (95-odstotni IZ)° Stopnja serokonverzije (95-odstotni IZ)° Faktor serokonverzije (95-odstotni IZ)°°