FrancophonIA/ELRC3.0 huggingface dataset:
English: Post-marketing experience with seasonal T/LAIV Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed.
Slovenian: Izkušnje s sezonskim cepivom T/LAIV iz obdobja po prihodu cepiva na trg Zabeležili so zelo redke primere Guillain-Barréjevega sindroma in poslabšanja simptomov Leighovega sindroma (mitohondrijska encefalomiopatija).
English: In a surveillance study conducted by the US CDC (Griffin, et al, 2011) the effectiveness of the H1N1 pandemic LAIV vaccine in children 2 through 9 years of age was estimated at 81.9% (95% CI:13.6,
Slovenian: V spremljevalni študiji, ki so jo izvedli CDC ZDA (Griffin, et al. 2011), je bila ocenjena učinkovitost pandemskega cepiva LAIV H1N1 pri otrocih od 2. do 9. leta 81,9 % (95 % IZ:
English: The European Medicines Agency will review new information on this medicines at least every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsaj enkrat letno ponovno pregledala nove podatke o tem zdravilu.
English: The study enrolled 69 subjects in 5 groups: Group 1 enrolled 11 subjects who had previously received 2 doses of the A/Vietnam/1203/2004 H5N1 pandemic live attenuated influenza vaccine (P/LAIV) in 2006-2007; Group 2 enrolled 10 subjects who had previously received 2 doses of the A/Hong Kong/213/2003 H5N1 P/LAIV in 2007; Group 3 enrolled 8 subjects who had previously received 2 doses of the A/British Columbia/CN-6/2004 H7N3 P/LAIV in 2010 (as a P/LAIV control group); Groups 4 and 5 each enrolled 20 subjects who had not been previously vaccinated with LAIV and were influenza H5 naïve.
Slovenian: Študija je zajela 69 oseb v 5 skupinah: 1. skupina je vključila 11 preiskovancev, ki so predhodno dobili 2 odmerka pandemskega oslabljenega cepiva proti gripi A/Vietnam/1203/2004 H5N1 (P/LAIV) v letih 2006-2007, 2. skupina je vključila 10 preiskovancev, ki so predhodno dobili 2 odmerka A/Hong Kong/213/2003 H5N1 P/LAIV leta 2007, 3. skupina je vključila 8 preiskovancev, ki so predhodno dobili 2 odmerka A/British Columbia/CN6/2004 H7N3 P/LAIV leta 2010 (kot kontrolno skupino P/LAIV), 4. in 5. skupina pa sta vsaka vključili 20 preiskovancev, ki predhodno niso bili cepljeni z LAIV in so bili naivni za gripo H5.
English: Europe, Asia/ Oceania, Latin America
Slovenian: Evropa, Azija/ Oceanija, Latinska Amerika
English: Clinical studies have evaluated the incidence of adverse reactions in 59 adults from 18 to 49 years of age receiving at least one dose of Pandemic influenza vaccine H5N1 AstraZeneca.
Slovenian: V kliničnih študijah so ocenili pojavnost neželenih učinkov pri 59 odraslih, starih od 18 do 49 let, ki so prejeli vsaj en odmerek Cepiva proti pandemski gripi H5N1 AstraZeneca.
English: Uncommon: Hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions)
Slovenian: Občasni: preobčutljivostne reakcije (vključno z edemom obraza, urtikarijo in zelo redkimi anafilaktičnimi reakcijami)
English: Seroresponse rates were slightly higher among subjects who were seronegative at baseline.
Slovenian: Deleži seropozitivnosti so bili nekoliko večji med preiskovanci, ki so bili izhodiščno seronegativni.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pandemic influenza vaccine H5N1 AstraZeneca in one or more subsets of the paediatric population in prevention of influenza infection.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s Cepivom proti pandemski gripi H5N1 AstraZeneca za eno ali več podskupin pediatrične populacije za preprečevanje okužbe z gripo.
English: The primary circulating strain was antigenically dissimilar from the H3N2 strain represented in the vaccine; efficacy against the mismatched A/H3N2 strain was 85.9% (95% CI: 75.3, 91.9).
Slovenian: Primarni sev v obtoku se je antigensko razlikoval od seva H3N2 v cepivu; učinkovitost proti neujemajočemu se sevu A/H3N2 je bila 85,9 % (95 % IZ: 75,3, 91,9).
English: Reduction in culture-confirmed influenza illness relative to injectable influenza vaccine.
Slovenian: Zmanjšanje s kulturo potrjene gripe v primerjavi s cepivom proti gripi za injiciranje.
English: P/LAIV H5N1 vaccine
Slovenian: Cepivo P/LAIV H5N1
English: 12 to 35 M
Slovenian: 12 do 35 m
English: 6 to 35 M
Slovenian: 6 do 35 m
English: FFU per 0.2 ml dose
Slovenian: enot FFU na 0,2-ml odmerek
English: H5N1 Hong Kong
Slovenian: H5N1 Hong Kong brez brez
English: Data for Group 3, subjects initially vaccinated with an H7N3 P/LAIV are not shown.
Slovenian: Podatki za 3. skupino (preiskovanci, uvodoma cepljeni s P/LAIV H7N3) niso prikazani.
English: In clinical studies, the safety profile of Pandemic influenza vaccine H5N1 AstraZeneca was comparable to the safety profile of the seasonal vaccines T/LAIV and Fluenz Tetra (see section 5.1 for more information).
Slovenian: V kliničnih študijah je bil varnostni profil Cepiva proti pandemski gripi H5N1 AstraZeneca primerljive z varnostnim profilom sezonskih cepiv T/LAIV in Fluenz Tetra (za več informacij glejte poglavje 5.1).
English: Immunocompromised
Slovenian: Imunsko oslabeli
English: Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event or hypersensitivity event following administration of the vaccine.
Slovenian: Vedno morata biti na voljo ustrezna medicinska oskrba in nadzor za primer, da se po dajanju cepiva pojavi anafilaktična ali preobčutljivostna reakcija.
English: Use of salicylates in children and adolescents for 4 weeks after vaccination should be avoided unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection.
Slovenian: Pri otrocih in mladostnikih se 4 tedne po cepljenju ne sme uporabljati salicilatov (razen če so medicinsko indicirani), ker je bil po uporabi salicilatov med okužbo z divjim tipom gripe opisan Reyev sindrom.
English: In a study (D153-P515) of children 6 to 17 years of age with asthma (seasonal T/LAIV: n=1,114, seasonal injectable influenza vaccine: n=1,115), there were no significant differences between treatment groups in the incidence of asthma exacerbations, mean peak expiratory flow rate, asthma symptom scores, or night-time awakening scores.
Slovenian: V študiji (D153-P515), ki je zajela otroke z astmo, stare od 6 do 12 let, (sezonsko cepivo T/LAIV: n = 1.114, sezonsko cepivo proti gripi za injiciranje: n = 1.115), med skupinama niso ugotovili značilnih razlik v pojavnosti poslabšanj astme, povprečnem največjem ekspiracijskem pretoku zraka, ocenah simptomov astme in ocenah prebujanja ponoči.
English: Table 3 Serum microneutralization (MN) and haemagglutination inhibition (HAI) assay antibody responses on Days 28 and 56 following administration of an inactivated H5N1 vaccine
Slovenian: Preglednica 3 Serumski protitelesni odzivi mikronevtralizacije (MN) in preskus inhibicije hemaglutinacije (HAI) 28. in 56. dan po uporabi inaktiviranega cepiva H5N1
English: Although safety in children and adolescents with mild to moderate asthma has been established for T/LAIV, data in children with other pulmonary diseases or with chronic cardiovascular, metabolic or renal diseases are limited.
Slovenian: Varnost in učinkovitost T/LAIV sta sicer ugotovljeni pri mladostnikih z blago do zmerno astmo, a podatkov o otrocih z drugimi boleznimi pljuč ali s kroničnimi srčno-žilnimi, presnovnimi ali ledvičnimi boleznimi je malo.
English: Children and adolescents under 18 years of age receiving salicylate therapy should avoid vaccination with Pandemic influenza vaccine H5N1 AstraZeneca (see section 4.4).
Slovenian: Otroci in mladostniki, mlajši od 18 let, ki prejemajo zdravljenje s salicilati, ne smejo biti cepljeni s Cepivom proti pandemski gripi H5N1 AstraZeneca (glejte poglavje 4.4).
English: For placebo recipients regardless of baseline serostatus, seroresponse rate was 6.3% on Days 15 and 29 and 14.5% on Day 57.
Slovenian: Med prejemniki placeba (ne glede na izhodiščni serološki status) je bil delež serološkega odziva 15. in 29. dan 6,3 % in 57. dan 14,5 %.
English: In a study (AV010) of children and adolescents 9 to 17 years of age with moderate to severe asthma (seasonal T/LAIV: n=24, placebo: n=24), the primary safety criterion, change in percent predicted forced expiratory volume in 1 second (FEV1) measured before and after vaccination, did not differ between treatment arms.
Slovenian: V študiji (AV010) otrok in mladostnikov, starih od 9 do 17 let, z zmerno do hudo astmo (sezonsko cepivo T/LAIV: n = 24, placebo: n = 24) se primarno merilo varnosti - odstotna sprememba predvidenega največjega ekspiracijskega volumna v 1 sekundi (FEV1) - izmerjeno pred cepljenjem in po njem med terapevtskima skupinama ni razlikovalo.
English: The suspension is colourless to pale yellow, clear to slightly cloudy.
Slovenian: Suspenzija je brezbarvna do bledorumena in bistra do rahlo motna.
English: In more than 300 case reports in the AstraZeneca safety database of vaccine administration in pregnant women, no unusual patterns of pregnancy complications or foetal outcomes were observed.
Slovenian: V več kot 300 poročanih primerih v varnostni bazi podatkov družbe AstraZeneca ni bilo mogoče opaziti neobičajnih zapletov v nosečnosti ali izidov za plod pri uporabi cepiva pri nosečnicah.
English: In addition, studies conducted with AstraZeneca's 2009 H1N1 pandemic LAIV and seasonal T/LAIV vaccine are also considered supportive because all these vaccines are manufactured using the same process, administered through the same route, and studied primarily in naïve individuals.
Slovenian: Poleg tega veljajo kot podpora tudi študije z AstraZeneca cepivoma (pandemskim cepivom LAIV 2009 H1N1 in sezonskim cepivom T/LAIV), ker so vsa tri cepiva izdelana po enakem postopku, je pot uporabe enaka in so v prvi vrsti raziskana pri predhodno neizpostavljenih osebah.
English: The most common adverse reactions observed in clinical studies conducted with the Pandemic influenza vaccine H5N1 AstraZeneca in healthy adults was headache (25.4%) and upper respiratory infection (10.2%).
Slovenian: Najpogostejša neželena učinka v kliničnih študijah z Cepivom proti pandemski gripi H5N1 AstraZeneca pri zdravih odraslih sta bila glavobol (25,4 %) in okužba zgornjih dihal (10,2 %).
English: TCID50 of the vaccine intranasally in isolation, with 16 of those subjects receiving a second dose 4-8 weeks later.
Slovenian: TCID50 cepiva intranazalno izolirano; 16 od teh preiskovancev je od 4 do 8 tednov pozneje prejelo drugi odmerek.
English: Clinical study CIR 277 assessed whether prior recipients of pandemic live attenuated influenza H5N1 vaccines were primed or established long-lasting immunity that could be detected following the subsequent administration of an inactivated H5N1 vaccine.
Slovenian: Klinična študija CIR 277 je ocenila, ali so predhodni prejemniki pandemskih živih oslabljenih cepiv proti gripi H5N1 dosegli osnovni odziv (priming) oz. dolgotrajno imunost, ki bi jo bilo mogoče zaznati po nadaljnji uporabi inaktiviranega cepiva H5N1.
English: Study number
Slovenian: Številka študije
English: Similar responses were seen with P/LAIV H7N7- and H7N9-primed subjects who developed vigorous antibody responses to the corresponding wild-type viruses upon subsequent exposure to the inactivated vaccine from the same subtype.
Slovenian: Podobne odzive so ugotovili pri preiskovancih, primarno cepljenih s P/LAIV H7N7 in H7N9, ki se jim je razvil intenziven odziv protiteles proti ustreznim divjim tipom virusov po poznejši izpostavljenosti inaktiviranemu cepivu istega podtipa.
English: PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS
Slovenian: VELIKOST PAKIRANJA S 5 NOSNIKI ZA ENKRATNO UPORABO
English: In a pandemic situation, the use of Pandemic influenza vaccine H5N1 AstraZeneca in mildly to moderately immunosuppressed individuals may be considered after weighing the anticipated benefits against the potential risks for the individual.
Slovenian: V primeru pandemije pride uporaba Cepiva proti pandemski gripi H5N1 AstraZeneca pri blago do zmerno imunosuprimiranih osebah v poštev po pretehtanju predvidenih koristi v primerjavi z možnimi tveganji za posameznika.
English: Pandemic influenza vaccine H5N1 AstraZeneca is not indicated for use in infants younger than 12 months of age (see section 4.2).
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca ni indicirano za uporabo pri otrocih, mlajših od 12 mesecev (glejte poglavje 4.2).
English: This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 10.
Slovenian: To cepivo je na voljo kot suspenzija v pršilu za nos v nosniku za enkratno uporabo (0,2 ml) v pakiranjih po 10 nosnikov.
English: Of the P/LAIV-naïve subjects, only 10% had ≥4-fold rises by Day
Slovenian: Med P/LAIV naivnimi preiskovanci jih je imelo do 7. dne ≥ 4-kraten porast le 10 %.
English: Pandemic influenza vaccine H5N1 AstraZeneca should not be used in infants below 12 months of age because of safety concerns regarding increased rates of hospitalisation and wheezing in this population (see section 4.8).
Slovenian: Cepiva proti pandemski gripi H5N1 AstraZeneca se ne sme uporabljati pri dojenčkih, mlajših od 12 mesecev zaradi pomislekov glede varnosti zaradi večjega deleža sprejemov v bolnišnico in piskajočega dihanja pri tej populaciji (glejte poglavje 4.8).
English: Pandemic influenza vaccine H5N1 AstraZeneca will be administered under the supervision of a doctor, nurse or pharmacist.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca boste dobili pod nadzorstvom zdravnika, medicinske sestre ali farmacevta.
English: Södertälje Sweden
Slovenian: Södertälje,
English: The co-administration of Pandemic influenza vaccine H5N1 AstraZeneca with inactivated vaccines or with the seasonal vaccine Fluenz Tetra has not been studied.
Slovenian: Sočasna uporaba Cepiva proti pandemski gripi H5N1 AstraZeneca z inaktiviranimi cepivi ali s sezonskim cepivom Fluenz Tetra ni raziskana.
English: For the H7N7 P/LAIV, strong serum antibody responses were detected by both MN and HAI in 9 of 13 individuals, with peak titers achieved by Day 14.
Slovenian: Za P/LAIV H7N7 so ugotovili močan odziv protiteles v serumu tako z MN kot s HAI pri 9 od 13 oseb; največji titri so bili doseženi do 14. dne.
English: This section describes the clinical experience observed in three pivotal studies conducted with the Pandemic influenza vaccine H5N1 AstraZeneca in adults.
Slovenian: To poglavje opisuje klinične izkušnje v treh ključnih študijah s Cepivom proti pandemski gripi H5N1 AstraZeneca pri odraslih.
English: Caution is needed when administering this vaccine to individuals with a known hypersensitivity (other than anaphylactic reaction) to the active substance, or to any of the excipients listed in section 6.1, or to trace residues (gentamicin, eggs or egg proteins, ovalbumin).
Slovenian: Previdnost je potrebna pri uporabi tega cepiva pri osebah z znano preobčutljivostjo (razen anafilaktične reakcije) na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali ostanke v sledeh (gentamicin, jajca ali jajčne beljakovine, ovalbumin).
English: The influenza virus strain in Pandemic influenza vaccine H5N1 AstraZeneca is (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
Slovenian: Sev virusa gripe v Cepivu proti pandemski gripi H5N1 AstraZeneca je (a) prilagojen hladu (coldadapted - ca), (b) občutljiv na temperaturo (temperature-sensitive - ts) in (c) oslabljen (attenuatedatt).
English: Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination.
Slovenian: Če je le mogoče, naj se prejemniki cepiva 1 do 2 tedna po cepljenju izogibajo bližnjim stikom z imunsko zelo oslabelimi osebami (npr. prejemniki presajenega kostnega mozga, ki potrebujejo izolacijo).
English: There are no data with Pandemic influenza vaccine H5N1 AstraZeneca in children and adolescents younger than 18 years of age receiving salicylate therapy.
Slovenian: O Cepivu proti pandemski gripi H5N1 AstraZeneca ni podatkov pri otrocih in mladostnikih, mlajših od 18 let, ki prejemajo zdravljenje s salicilati.
English: Subjects in Groups 1 to 4 received a single 45-μg dose of the A/Vietnam/1203/2004 pandemic inactivated influenza vaccine (P/IIV) while subjects in Group 5 received 2 doses, approximately 28 days apart.
Slovenian: Preiskovanci od 1. do 4. skupine so dobili en 45-µg odmerek pandemskega inaktiviranega cepiva proti gripi A/Vietnam/1203/2004 (P/IIV), preiskovanci v 5. skupini pa so prejeli 2 odmerka v presledku približno 28 dni.
English: What Pandemic influenza vaccine H5N1 AstraZeneca is and what it is used for What you need to know before you are given Pandemic influenza vaccine H5N1 AstraZeneca How Pandemic influenza vaccine H5N1 AstraZeneca is given Possible side effects
Slovenian: Kaj je Cepivo proti pandemski gripi H5N1 AstraZeneca in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili Cepivo proti pandemski gripi H5N1 AstraZeneca Kako se daje Cepivo proti pandemski gripi H5N1 AstraZeneca Možni neželeni učinki
English: Pack size of 10.
Slovenian: Pakiranja z 10 nosniki.
English: For children regardless of baseline serostatus, seroresponse rates after receipt of monovalent vaccine were 7.8% and 11.1% for Days 15 and 29, respectively, and 32.0% on Day 57.
Slovenian: Pri otrocih (ne glede na izhodiščni serološki status), ki so prejeli monovalentno cepivo, je bil delež serološkega odziva 15. dan 7,8 %, 29. dan 11,1 % in 57. dan 32,0 %.
English: The recommended dose for children and adolescents is 0.2 ml Pandemic influenza vaccine H5N1 AstraZeneca, administered as 0.1 ml in each nostril.
Slovenian: Priporočeni odmerek za otroke in mladostnike je 0,2 ml Cepiva proti pandemski gripi H5N1 AstraZeneca, po 0,1 ml v vsako nosnico.
English: Table 2 T/LAIV relative efficacy in active-controlled paediatric studies with seasonal injectable influenza vaccine
Slovenian: Preglednica 2 Relativna učinkovitost T/LAIV pediatričnih študijah s sezonskim cepivom proti gripi za injiciranje, kontroliranih z aktivno učinkovino
English: Seven of 11 (64%) subjects in Group 1 (ca A/Vietnam/1204/2004 [H5N1]) had ≥4-fold rises in HAI antibody titer by Day 7 following receipt of the inactivated vaccine, with a geometric mean titer (GMT) of 165 and a titer range of 20 to 1280 in responders.
Slovenian: Sedem od 11 (64 %) preiskovancev v 1. skupini (ca A/Vietnam/1204/2004 [H5N1]) je do 7. dne po prejemu inaktiviranega cepiva imelo ≥ 4-kraten porast titra protiteles HAI; pri tistih, ki so se odzvali, je bila geometrična sredina titrov 165, razpon titrov pa od 20 do 1280.
English: In clinical study MI-CP217, the safety and descriptive immunogenicity of a live attenuated monovalent influenza virus vaccine (derived from A/California/7/2009) developed for the 2009 H1N1 pandemic were evaluated in a total of 326 randomised subjects (259 subjects monovalent vaccine; 65 subjects placebo) and 324 subjects received one dose of investigational product.
Slovenian: V klinični študiji MI-CP217 so varnost in opisno imunogenost živega oslabljenega monovalentnega cepiva proti virusu gripe (pridobljenem iz A/California/7/2009), razvitega za pandemijo H1N1 2009, ocenili pri skupaj 326 randomiziranih preiskovancih (259 jih je prejelo monovalentno cepivo, 65 placebo) in 324 preiskovancev je prejelo en odmerek raziskovanega cepiva.
English: If influenza antiviral agents and Pandemic influenza vaccine H5N1 AstraZeneca are administered concomitantly, timing and the need for revaccination should be considered based on clinical judgement.
Slovenian: Če so protivirusna zdravila proti gripi in Cepivo proti pandemski gripi H5N1 AstraZeneca uporabljeni sočasno, je treba na podlagi klinične presoje razmisliti o potrebi po ponovnem cepljenju.
English: From clinical studies and post-marketing surveillance with T/LAIV and Fluenz Tetra in over 110,000 children and adolescents 2 to 17 years of age, the following adverse reaction frequencies are reported: Very common (≥ 1/10)
Slovenian: V kliničnih študijah in med spremljanjem po prihodu cepiva na trg so za T/LAIV in Fluenz Tetra pri več kot 110.000 otrocih in mladostnikih v starosti od 2 do 17 let poročali o naslednjih pogostnostih neželenih učinkov:
English: Non-interventional post-authorisation safety study (PASS) in order to further investigate the tolerability of Pandemic influenza vaccine H5N1 AstraZeneca and estimate the incidence of adverse reactions of special interest in children and adolescents.
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS) za dodatno proučitev prenašanja Cepiva proti pandemski gripi H5N1 AstraZeneca in oceno pojavnosti neželenih učinkov posebnega pomena pri otrocih in mladostnikih.
English: IgA seroresponse and nasal wash response were each detected in 18% of subjects.
Slovenian: Serološki odziv IgA in odziv v nosnem izpirku so vsakega ugotovili pri 18 % preiskovancev.
English: In study participants who received 2 doses in year 1 and placebo in year 2, efficacy in year 2 was 56.2% (95% CI: 30.5, 72.7) against matched strains and 44.8% (95% CI: 18.2, 62.9) against all strains regardless of match, respectively, in D153-P501, thus supporting the need for second-season revaccination.
Slovenian: Pri preiskovancih v študiji, ki so dobili 2 odmerka 1. leto ter placebo 2. leto, je bila učinkovitost 2. leto 56,2 % (95 % IZ: 30,5, 72,7) proti ujemajočim se sevom in 44,8 % (95 % IZ: 18,2, 62,9) proti vsem sevom, ne glede na ujemanje (v D153-P501).
English: • Do not use Pandemic influenza vaccine H5N1 AstraZeneca if the expiry date has passed or if the sprayer appears damaged, for example, if the plunger is loose or displaced from the sprayer or if there are any signs of leakage.
Slovenian: • Cepiva proti pandemski gripi H5N1 AstraZeneca ne smete uporabljati, če mu je potekel rok uporabnosti ali če opazite, da je pršilnik poškodovan, na primer če bat ne tesni ali izpade iz pršilnika ali opazite kakršnekoli znake iztekanja tekočine.
English: The assessment of the safety profile for Pandemic influenza vaccine H5N1 AstraZeneca is based on a limited number of adult subjects.
Slovenian: Ocena varnostnega profila Cepiva proti pandemski gripi H5N1 AstraZeneca temelji na majhnem številu odraslih oseb.
English: Pandemic influenza vaccine H5N1 AstraZeneca is supplied as a 0.2 ml suspension in a single-use nasal applicator (Type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector cap (synthetic rubber), plunger rod, plunger-stopper (butyl rubber), and a dose-divider clip.
Slovenian: Cepivo proti pandemski gripi H5N1 AstraZeneca je na voljo kot 0,2-ml suspenzija v nosniku (steklo tipa 1) za enkratno uporabo z nastavkom (polipropilen s polietilensko prehodno zaklopko), pokrovčkom za zaščito konice nastavka (sintetična guma), nosilcem bata, zamaškom bata (butilna guma) in delilno zaponko odmerka.
English: Subjects who were primed with either the A/Vietnam/1203/2004 P/LAIV or the A/Hong Kong/213/2003 P/LAIV had a significantly better response to a single dose of inactivated H5N1 vaccine than P/LAIV-naïve subjects.
Slovenian: Preiskovanci, ki so primarno prejeli ali P/LAIV A/Vietnam/1203/2004 ali P/LAIV A/Hong Kong/213/2003, so imeli na enkraten odmerek inaktiviranega cepiva H1N1 značilno boljši odziv kot preiskovanci, ki prej niso dobili P/LAIV.
English: Overall, the safety profile of T/LAIV in a limited number of subjects with mildly to moderately nonHIV related compromised immune function, asymptomatic or mildly symptomatic HIV infection, or cancer (solid tumors and haematological malignancies) was comparable to that in healthy individuals and does not indicate any untoward effect.
Slovenian: Pri majhnem številu preiskovancev, ki so imeli blago do zmerno oslabelo imunsko delovanje (nepovezano s HIV), asimptomatsko ali blago simptomatsko okužbo s HIV ali raka (parenhimske tumorje in hematološke malignome) so bile varnostne značilnosti T/LAIV v celoti podobne kot pri zdravih osebah in ne kažejo nobenih neugodnih učinkov.