natgillin/translations-raw huggingface dataset:
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.
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.
Table 3 Serum microneutralization (MN) and haemagglutination inhibition (HAI) assay antibody responses on Days 28 and 56 following administration of an inactivated H5N1 vaccine
Preglednica 3 Serumski protitelesni odzivi mikronevtralizacije (MN) in preskus inhibicije hemaglutinacije (HAI) 28. in 56. dan po uporabi inaktiviranega cepiva H5N1
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.
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.
Children and adolescents under 18 years of age receiving salicylate therapy should avoid vaccination with Pandemic influenza vaccine H5N1 AstraZeneca (see section 4.4).
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).
For placebo recipients regardless of baseline serostatus, seroresponse rate was 6.3% on Days 15 and 29 and 14.5% on Day 57.
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 %.
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.
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.
The suspension is colourless to pale yellow, clear to slightly cloudy.
Suspenzija je brezbarvna do bledorumena in bistra do rahlo motna.
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.
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.
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.
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.
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%).
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 %).
TCID50 of the vaccine intranasally in isolation, with 16 of those subjects receiving a second dose 4-8 weeks later.
TCID50 cepiva intranazalno izolirano; 16 od teh preiskovancev je od 4 do 8 tednov pozneje prejelo drugi odmerek.
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.
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.
Study number
Številka študije
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.
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.
PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS
VELIKOST PAKIRANJA S 5 NOSNIKI ZA ENKRATNO UPORABO
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.
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.
Pandemic influenza vaccine H5N1 AstraZeneca is not indicated for use in infants younger than 12 months of age (see section 4.2).
Cepivo proti pandemski gripi H5N1 AstraZeneca ni indicirano za uporabo pri otrocih, mlajših od 12 mesecev (glejte poglavje 4.2).
This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 10.
To cepivo je na voljo kot suspenzija v pršilu za nos v nosniku za enkratno uporabo (0,2 ml) v pakiranjih po 10 nosnikov.
Of the P/LAIV-naïve subjects, only 10% had ≥4-fold rises by Day
Med P/LAIV naivnimi preiskovanci jih je imelo do 7. dne ≥ 4-kraten porast le 10 %.
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).
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).
Pandemic influenza vaccine H5N1 AstraZeneca will be administered under the supervision of a doctor, nurse or pharmacist.
Cepivo proti pandemski gripi H5N1 AstraZeneca boste dobili pod nadzorstvom zdravnika, medicinske sestre ali farmacevta.
The co-administration of Pandemic influenza vaccine H5N1 AstraZeneca with inactivated vaccines or with the seasonal vaccine Fluenz Tetra has not been studied.
Sočasna uporaba Cepiva proti pandemski gripi H5N1 AstraZeneca z inaktiviranimi cepivi ali s sezonskim cepivom Fluenz Tetra ni raziskana.
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.
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.
This section describes the clinical experience observed in three pivotal studies conducted with the Pandemic influenza vaccine H5N1 AstraZeneca in adults.
To poglavje opisuje klinične izkušnje v treh ključnih študijah s Cepivom proti pandemski gripi H5N1 AstraZeneca pri odraslih.
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).
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).
The influenza virus strain in Pandemic influenza vaccine H5N1 AstraZeneca is (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
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).
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.
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).
There are no data with Pandemic influenza vaccine H5N1 AstraZeneca in children and adolescents younger than 18 years of age receiving salicylate therapy.
O Cepivu proti pandemski gripi H5N1 AstraZeneca ni podatkov pri otrocih in mladostnikih, mlajših od 18 let, ki prejemajo zdravljenje s salicilati.
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.
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.
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
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
Pack size of 10.
Pakiranja z 10 nosniki.
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.
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 %.
The recommended dose for children and adolescents is 0.2 ml Pandemic influenza vaccine H5N1 AstraZeneca, administered as 0.1 ml in each nostril.
Priporočeni odmerek za otroke in mladostnike je 0,2 ml Cepiva proti pandemski gripi H5N1 AstraZeneca, po 0,1 ml v vsako nosnico.
Table 2 T/LAIV relative efficacy in active-controlled paediatric studies with seasonal injectable influenza vaccine
Preglednica 2 Relativna učinkovitost T/LAIV pediatričnih študijah s sezonskim cepivom proti gripi za injiciranje, kontroliranih z aktivno učinkovino
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.
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.
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.
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.
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.
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.
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)
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:
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.
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.
IgA seroresponse and nasal wash response were each detected in 18% of subjects.
Serološki odziv IgA in odziv v nosnem izpirku so vsakega ugotovili pri 18 % preiskovancev.
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.
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).
• 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.
• 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.
The assessment of the safety profile for Pandemic influenza vaccine H5N1 AstraZeneca is based on a limited number of adult subjects.
Ocena varnostnega profila Cepiva proti pandemski gripi H5N1 AstraZeneca temelji na majhnem številu odraslih oseb.
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.
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.
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.
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.
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.
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.
The affinity of antibodies against the HA1 domain of the H5 HA in the H5N1 P/LAIV-primed groups was significantly higher than the 2dose inactivated vaccine group, which correlated with cross-clade H5N1 neutralisation.
Afiniteta protiteles proti domeni HA1 H5 HA v skupini, ki je primarno prejela P/LAIV H5N1, je bila značilno večja kot v skupini z 2 odmerkoma inaktiviranega cepiva, kar je koreliralo z navzkrižno nevtralizacijo med kladi H5N1.
There have been reports of administration of twice the recommended dose of the seasonal vaccine Fluenz Tetra and the seasonal trivalent influenza vaccine live, intranasal (T/LAIV) in the post-marketing setting.
Med obdobjem trženja so poročali o uporabi dvakratnega priporočenega odmerka sezonskega cepiva Fluenz Tetra in sezonskega intranazalnega trivalentnega cepiva proti gripi (T/LAIV).
• if you have previously had a serious allergic reaction (i.e. life-threatening) to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”).
• če ste kdaj imeli resno (tj. smrtno nevarno) alergijsko reakcijo na jajca, jajčne beljakovine, gentamicin ali želatino, ali na katero koli sestavino tega cepiva (navedeno v poglavju 6, "Vsebina pakiranja in dodatne informacije").
H5N1 P/LAIV-primed subjects developed antibody responses that neutralised 2 or more clades of H5N1 viruses from the A/Goose/Guangdong/1996 H5N1 lineage, whereas few subjects even in the 2-dose inactivated H5N1 vaccine group developed cross-clade neutralising antibodies.
Preiskovancem, ki so primarno dobili P/LAIV H5N1, se je razvil odziv protiteles, ki je nevtraliziral 2 ali več kladov virusov H5N1 linije A/Goose/Guangdong/1996 H5N1, medtem ko so se navzkrižna nevtralizacijska protitelesa med kladi razvila pri maloštevilnih preiskovancih celo v skupini z 2 odmerkoma inaktiviranega cepiva H5N1.
• The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff.
• Bolnik lahko med uporabo cepiva diha normalno - ni potrebe za aktivno inhaliranje ali vdihavanje skozi nosnici.
In a study with the seasonal trivalent live attenuated influenza vaccine (T/LAIV), an increased incidence of medically significant wheezing was seen in children 12-23 months of age (see section
V študiji s sezonskim trivalentnim cepivom z živim oslabljenim virusom gripe (T/LAIV) so pri otrocih v starosti 12 do 23 mesecev opažali povečano pogostnost zdravstveno pomembnega piskajočega dihanja (glejte poglavje 4.8).
For the H7N9 P/LAIV, 8 of 14 individuals who received a single dose of vaccine and 13 of 16 individuals who received two doses of vaccine developed strong antibody responses; peak titers were again seen by Day 14.
S P/LAIV H7N9 se je močan odziv protiteles razvil pri 8 od 14 oseb, ki so prejele enkraten odmerek cepiva in pri 13 od 16 oseb, ki so prejele dva odmerka cepiva; največji titri so bili tudi tukaj opazni do 14. dne.
Respiratory, thoracic and mediastinal disorders Very common: Nasal congestion/rhinorrhoea Uncommon: Epistaxis
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti: zamašenost nosu/rinoreja Občasni: epistaksa
T/LAIV demonstrated 64.4% (1.4, 88.8) fewer cases than injectable influenza vaccine in 476 infants and toddlers 6-23 months of age and 48.2% (12.7, 70.0) fewer cases in 1,609 children 24-71 months of age.
S T/LAIV je bilo pri 476 dojenčkih in malčkih v starosti od 6 do 23 mesecev 64,4 % (1,4, 88,8) manj primerov kot s cepivom proti gripi za injiciranje, pri 1.609 otrocih v starosti od 24 do 71 mesecev pa 48,2 % (12,7, 70,0) manj primerov.
In clinical studies with adults who received Pandemic influenza vaccine H5N1 AstraZeneca, the most common side effects were headache and upper respiratory tract infection (inflammation of the nose, throat and sinuses).
V kliničnih študijah pri odraslih, ki so dobili Cepivo proti pandemski gripi H5N1 AstraZeneca, so bili najpogostejši neželeni učinki glavobol in okužbe zgornjih dihal (vnetje nosu, žrela in obnosnih votlin).
History of an anaphylactic (i.e. life-threatening) reaction to the active substance or to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue), to eggs or to egg proteins (e.g. ovalbumin).
Anamneza anafilaktične (tj. smrtno nevarne) reakcije na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (npr. želatino), ali na gentamicin (možna je njegova prisotnost v sledeh), na jajca ali jajčne beljakovine (npr. ovalbumin).
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”).
• če ste kdaj imeli kakršno koli alergijsko reakcijo (razen nenadne, smrtno nevarne alergijske reakcije) na jajca, jajčne beljakovine, gentamicin ali želatino, ali na katero koli sestavino tega cepiva (navedeno v poglavju 6, "Vsebina pakiranja in dodatne informacije").
In previously unvaccinated study participants who received one dose in year 1, efficacy was 57.7% (95% CI: 44.7, 67.9) against matched strains and 56.3% (95% CI: 43.1, 66.7) against all strains regardless of match, respectively, thus supporting the need for two doses of vaccine in previously unvaccinated children.
Pri prej še necepljenih preiskovancih v študiji, ki so dobili en odmerek 1. leto, je bila učinkovitost 57,7 % (95 % IZ: 44,7, 67,9) proti ujemajočim se sevom in 56,3 % (95 % IZ: 43,1, 66,7) proti vsem sevom, ne glede na ujemanje.
The rate of hospitalisations was not increased in T/LAIV recipients 12 months and older and the rates for infants and toddlers 12-23 months of age were 3.2% T/LAIV versus 3.5% injectable influenza vaccine.
Delež sprejemov v bolnišnico ni bil večji pri prejemnikih T/LAIV, starih 12 mesecev ali več; deleža med dojenčki in malčki v starosti od 12 do 23 mesecev sta bila 3,2 % s T/LAIV in 3,5 % s cepivom proti gripi za injiciranje.
T/LAIV demonstrated 55.7% (39.9, 67.6) fewer cases than injectable influenza vaccine in 3,686 infants and toddlers 6-23 months of age and 54.4% (41.8, 64.5) fewer cases in 4,166 children 24-59 months of age.
S T/LAIV je bilo pri 3.686 dojenčkih in malčkih v starosti od 6 do 23 mesecev 55,7 % (39,9, 67,6) manj primerov kot s cepivom proti gripi za injiciranje, pri 4.166 otrocih v starosti od 24 do 59 mesecev pa 54,4 % (41,8, 64,5) manj primerov.
The active substance is: Reassortant influenza virus* (live attenuated) of the following strain**:
Zdravilna učinkovina je: Reasortirani virus gripe* (živ, oslabljen) naslednjega seva**:
Chronic conditions
Kronične bolezni