FrancophonIA/ELRC3.0 huggingface dataset:
English: Belimumab does not bind B cells directly, but by binding BLyS, belimumab inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Slovenian: Belimumab prepreči vezavo topnega BLyS, ki je dejavnik preživetja celic B, na njegove receptorje na celicah B. Belimumab se na celice B ne veže neposredno, toda z vezavo na BLyS zavre preživetje celic B, vključno z avtoreaktivnimi celicami B, in zmanjša diferenciacijo celic B v plazmatke, ki izdelujejo imunoglobuline.
English: They can occasionally be severe (uncommon, affecting up to 1 in 100 people), and could be life-threatening.
Slovenian: Občasno so lahko hudi (občasni neželeni učinki, pojavijo se lahko pri največ 1 od 100 bolnikov ) ter so lahko smrtno nevarni.
English: Patients with hepatic impairment are unlikely to require dose adjustment (see section 5.2).
Slovenian: Ni verjetno, da bi bolniki z okvaro jeter potrebovali prilagoditev odmerka (glejte poglavje 5.2).
English: Special Patient Populations
Slovenian: Posebne skupine bolnikov
English: • Push the plunger all the way down until all of the solution is injected.
Slovenian: • Potisnite bat do konca navzdol, dokler ni injicirana vsa raztopina.
English: If a mechanical reconstitution device is used to reconstitute Benlysta it should not exceed 500 rpm and the vial should be swirled for no longer than 30 minutes.
Slovenian: Če za pripravo zdravila Benlysta uporabljate mehanično napravo za pripravo, njena hitrost ne sme preseči 500 obratov na minuto, viale pa se ne sme vrteti več kot 30 minut.
English: In the event of a severe reaction, Benlysta administration must be interrupted and appropriate medical therapy administered (see section 4.2).
Slovenian: V primeru hude reakcije je treba dajanje zdravila Benlysta prekiniti in uporabiti ustrezna zdravila (glejte poglavje 4.2).
English: The safety of belimumab in patients with SLE has been evaluated in 3 pre-registration, placebo-controlled intravenous studies, 1 placebo-controlled subcutaneous study, and one post-marketing, placebo-controlled intravenous study.
Slovenian: Varnost belimumaba pri bolnikih s SLE so ocenili v 3 s placebom kontroliranih študijah intravenske uporabe pred pridobitvijo dovoljenja za promet, 1 s placebom kontrolirani študiji subkutane uporabe in 1 s placebom kontrolirani študiji intravenske uporabe v obdobju trženja.
English: • Firmly press the pen all the way down onto the injection site and hold in place.
Slovenian: • Trdno pritisnite injekcijski peresnik navzdol na mesto injiciranja in ga tam držite.
English: In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: The risk of hypersensitivity reactions is greatest with the first two doses; however the risk should be considered for every administration.
Slovenian: Tveganje za preobčutljivostne reakcije je največje ob prvih dveh odmerkih, vendar pa je to tveganje treba upoštevati pri vsaki uporabi.
English: After use - needle is covered by needle guard
Slovenian: Po uporabi -ščitnik obdaja iglo
English: • Use your free hand to gently pinch the skin around the injection site.
Slovenian: • S prosto roko rahlo stisnite kožo okrog mesta injiciranja.
English: Elderly: Benlysta has been studied in a limited number of elderly patients.
Slovenian: Starejši: Zdravilo Benlysta so raziskali pri majhnem številu starejših bolnikov.
English: No incompatibilities between Benlysta and polyvinylchloride or polyolefin bags have been observed.
Slovenian: Ugotovljenih ni nobenih inkompatibilnosti med zdravilom Benlysta in polivinilkloridom ali poliolefinom.
English: Odds ratio (95% CI) vs Placebo *The five PRINTO/ACR components were percent change at Week 52 in: Parent's Global Assessment (Parent GA), PGA, SELENA SLEDAI score, 24-hour proteinuria, and, Paediatric Quality of Life Inventory - Generic Core Scale (PedsQL GC) physical functioning domain score.
Slovenian: *Pet komponent PRINTO/ACR so bile odstotne spremembe naslednjih vrednosti po 52 tednih: starševska celotna ocena (Parent's Global Assessment), PGA, SELENA SLEDAI rezultat, 24-urna proteinurija ter ocena domene telesnega delovanja vprašalnika PedsQL GC (Paediatric Quality of Life Inventory - Generic Core Scale).
English: Flares in SLE were defined by the modified SELENA SLEDAI SLE Flare Index.
Slovenian: Poslabšanja SLE so bila opredeljena z modificiranim indeksom poslabšanja SLE SELENA SLEDAI.
English: Table 1: Response rate at week 52
Slovenian: Preglednica 1: Delež odziva po 52 tednih
English: Classical biotransformation studies have not been conducted.
Slovenian: Klasičnih študij presnove niso izvedli.
English: Solution for injection in pre-filled pen (injection) Solution for injection in pre-filled syringe (injection)
Slovenian: Raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija) Raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija)
English: The overall incidence of serious suicidal ideation or behaviour or self-injury without suicidal intent was 0.7% (15/2002) in patients receiving Benlysta and 0.2% (5/2001) in the placebo group.
Slovenian: Skupna incidenca resnih samomorilnih misli ali vedenja ali samopoškodovanja brez samomorilnega namena je bila 0,7 % (15/2002) pri bolnikih, ki so prejemali zdravilo Benlysta in 0,2 % (5/2001) v skupini, ki je prejemala placebo.
English: The adverse reaction profile in paediatric patients is based on 52-week safety data from a placebo-controlled study in which 53 patients (6 to 17 years of age) with SLE received Benlysta (10 mg/kg intravenously on Days 0, 14, 28, and then every 28 days, on a background of concomitant treatments).
Slovenian: Pediatrična populacija Profil neželenih učinkov pri pediatričnih bolnikih temelji na podatkih o varnosti iz 52-tedenske, s placebom kontrolirane študije, v kateri je 53 bolnikov (starih od 6 do 17 let) s SLE ob sočasnem zdravljenju prejemalo zdravilo Benlysta (10 mg/kg intravensko na dan 0, 14, 28, potem pa vsakih 28
English: What you need to know before you are given Benlysta Do not receive Benlysta:
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Benlysta Zdravila Benlysta ne smete dobiti:
English: However, given the small number of subjects ≥65 years, an effect of age cannot be ruled out conclusively.
Slovenian: Toda glede na majhno število preiskovancev, starih ≥ 65 let, vpliva starosti ni mogoče dokončno izključiti.
English: • burning sensation while passing urine.
Slovenian: • pekoč občutek pri uriniranju.
English: Clean the injection site by wiping it with an alcohol swab (Figure 5).
Slovenian: Očistite mesto injiciranja tako, da ga obrišete z alkoholnim lističem (Slika 5).
English: • alcohol swab (not included in the pack)
Slovenian: • alkoholni listič (ni priložen v pakiranju)
English: • Position the pen straight over the injection site (at a 90o angle).
Slovenian: • Postavite injekcijski peresnik naravnost nad mesto injiciranja (pod kotom 90 o).
English: Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian cell line (NS0) by recombinant DNA technology.
Slovenian: Belimumab je humano monoklonsko protitelo IgG1λ, pridobljeno v celični liniji sesalcev (NS0) s tehnologijo rekombinantne DNK.
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must use effective contraception during Benlysta treatment and for at least 4 months after the last treatment.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske v rodni dobi morajo med zdravljenjem z zdravilom Benlysta in vsaj še 4 mesece po koncu zdravljenja uporabljati učinkovito kontracepcijsko zaščito.
English: Benlysta should be infused over a 1-hour period.
Slovenian: Zdravilo Benlysta je treba infundirati v obdobju 1 ure.
English: • Remove the ring cap by pulling or twisting it off.
Slovenian: • Odstranite okrogli pokrovček tako, da ga potegnete ali zasučete.
English: The risk of hypersensitivity reactions is greatest with the first two infusions; however the risk should be considered for every infusion administered.
Slovenian: Tveganje za preobčutljivostne reakcije je največje ob prvih dveh infundiranjih, vendar pa je to tveganje treba upoštevati pri vsakem infundiranju.
English: Table 3 - Paediatric response rate at Week 52 Response
Slovenian: Preglednica 3 - Delež odziva pri pediatričnih bolnikih po 52 tednih
English: What Benlysta is and what it is used for What you need to know before you are given Benlysta How Benlysta is used
Slovenian: Kaj je zdravilo Benlysta in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Benlysta Kako uporabljati zdravilo Benlysta
English: Using the Paediatric Rheumatology International Trials Organisation/American College of Rheumatology (PRINTO/ACR) Juvenile SLE Response Evaluation Criteria, a higher proportion of paediatric patients receiving Benlysta demonstrated improvement compared with placebo (Table 4).
Slovenian: Upoštevaje merila za ovrednotenje odziva juvenilnega SLE po PRINTO/ACR (Paediatric Rheumatology International Trials Organisation/American College of Rheumatology) je bil delež doseženega izboljšanja pri pediatričnih bolnikih, ki so prejemali zdravilo Benlysta, večji kot s placebom
English: • Do not warm the syringe in any other way.
Slovenian: • Ne segrevajte injekcijske brizge na noben drug način.
English: Gather and check supplies Gather supplies
Slovenian: Zberite in preverite ves pribor Zberite pribor
English: It is recommended that the first subcutaneous injection of Benlysta should be under the supervision of a healthcare professional in a setting that is sufficiently qualified to manage hypersensitivity reactions, if necessary.
Slovenian: Prvo subkutano injiciranje zdravila Benlysta je priporočljivo opraviti pod nadzorom zdravnika in v okolju, ki je ustrezno opremljeno za obvladovanje preobčutljivostnih reakcij, če bi se pojavile.
English: You may hear a second “click" a few seconds before the purple indicator stops moving.
Slovenian: Nekaj sekund prej, preden se vijoličasti kazalnik neha premikati, lahko zaslišite drugi "klik".
English: Benlysta has not been studied in combination with other B cell targeted therapy or intravenous cyclophosphamide.
Slovenian: Zdravilo Benlysta ni raziskano v kombinaciji z drugimi zdravili, usmerjenimi na celice B, ali z intravenskim ciklofosfamidom.
English: • Insert the entire needle into the pinched area of the skin at a slight angle (45°), using a dart-like motion.
Slovenian: • Celotno iglo z rahlim sunkom zabodite v stisnjeno kožo pod srednjim naklonom (kot 45°).
English: Infections leading to discontinuation of treatment occurred in 0.7% of patients receiving Benlysta and 1.5% of patients receiving placebo.
Slovenian: Okužbe, ki so povzročile prekinitev zdravljenja, so se pojavile pri 0,7 % bolnikov, ki so prejemali zdravilo Benlysta, in pri 1,5 % bolnikov, ki so prejemali placebo.
English: Thereafter, patients can resume dosing on their usual day of administration, or start a new weekly schedule from the day that the missed dose was administered.
Slovenian: Potem lahko bolnik nadaljuje uporabo na svoj običajni dan dajanja zdravila, ali začne nov tedenski urnik od dne, ko je injiciral pozabljeni odmerek.
English: The recommended dose is 200 mg (complete contents of one syringe) once a week, injected under your skin on the same day each week.
Slovenian: Priporočeni odmerek je 200 mg (celotna vsebina ene injekcijske brizge) enkrat na teden, injiciran pod kožo vsak teden na isti dan.
English: However, consistent with results from other studies, in black patients with high disease activity (low complement and positive anti-dsDNA at baseline, n=141) the SRI-S2K response was 45.1% for Benlysta 10 mg/kg compared with 24.0% for placebo (odds ratio 3.00; 95% CI: 1.35, 6.68).
Slovenian: A skladno z rezultati drugih študij je bil pri bolnikih črncih, ki so imeli zelo aktivno bolezen (izhodiščno nizek komplement in pozitivna anti-dsDNA, n = 141), odziv SRI-S2K za zdravilo Benlysta v odmerku 10 mg/kg 45,1 % in za placebo 24,0 % (razmerje obetov 3,00, 95 % iZ: 1,35, 6,68).
English: The safety and efficacy of Benlysta subcutaneous administration in children and adolescents (< 18 years of age) has not been established.
Slovenian: Varnost in učinkovitost subkutane uporabe zdravila Benlysta pri otrocih in mladostnikih (mlajših od 18 let) nista ugotovljeni.
English: No treatment-related changes were noted in the male and female reproductive organs of sexually mature animals.
Slovenian: Na reproduktivnih organih spolno zrelih samcev in samic niso ugotovili z zdravljenjem povezanih sprememb.
English: Benlysta is administered by intravenous infusion.
Slovenian: Zdravilo Benlysta se uporablja v intravenski infuziji.
English: • Do not remove the ring cap during this step.
Slovenian: • Ne odstranite okroglega pokrovčka med tem korakom.
English: WARNING: The 5 ml and 20 ml vials are reconstituted with different volumes of diluent, see below: 120 mg vial
Slovenian: OPOZORILO: 5-ml in 20-ml viale je treba pripraviti z različnimi količinami vehikla, glejte spodaj:
English: No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving Benlysta.
Slovenian: O sekundarnem prenosu okužb z oseb, ki so dobile živa cepiva, na bolnike, ki so prejemali zdravilo Benlysta, ni podatkov.
English: Other medicines and Benlysta
Slovenian: Druga zdravila in zdravilo Benlysta
English: The safety and efficacy of Benlysta was evaluated in a randomised, double-blind, placebo-controlled, 52-week study (PLUTO) in 93 paediatric patients with a clinical diagnosis of SLE according to the ACR classification criteria.
Slovenian: Varnost in učinkovitost zdravila Benlysta so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani, 52-tedenski študiji (PLUTO) pri 93 pediatričnih bolnikih s klinično diagnozo SLE po klasifikacijskih merilih ACR.
English: Caution should be exercised when considering Benlysta therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy.
Slovenian: Previdnost je potrebna pri odločanju za zdravljenje z zdravilom Benlysta pri bolnikih z anamnezo malignoma in pri odločanju o nadaljnjem zdravljenju bolnikov, ki se jim pojavi malignom.
English: Dosing is not based on weight (see section 5.2).
Slovenian: Odmerjanje ne temelji na telesni masi (glejte poglavje 5.2).
English: Benlysta demonstrated improvement in fatigue compared with placebo measured by the FACIT-Fatigue Scale.
Slovenian: Z zdravilom Benlysta je bilo v primerjavi s placebom ugotovljeno izboljšanje utrujenosti, merjene z lestvico FACIT-Fatigue.
English: • Do not inject within 5 cm (2 inches) of the navel (belly button).
Slovenian: • Ne injicirajte v predelu 5 cm okrog popka.
English: Protect the reconstituted solution from sunlight.
Slovenian: Pripravljeno raztopino zaščitite pred sončno svetlobo.
English: Patients who had severe active lupus nephritis and patients who had severe active central nervous system (CNS) lupus were excluded.
Slovenian: Bolniki s hudim aktivnim lupusnim nefritisom in bolniki s hudim aktivnim lupusom osrednjega živčevja so bili izključeni.
English: None of these gastrointestinal events in obese patients were serious.
Slovenian: Nobeden od teh neželenih učinkov na prebavila pri debelih bolnikih ni bil resen.
English: Important information about the contents of Benlysta
Slovenian: Pomembne informacije o sestavi zdravila Benlysta
English: Benlysta 200 mg weekly
Slovenian: Benlysta 200 mg/teden
English: Intravenous and subcutaneous administration to monkeys resulted in the expected reduction in the number of peripheral and lymphoid tissue B cell counts with no associated toxicological findings.
Slovenian: Intravenska in subkutana uporaba je pri opicah povzročila pričakovano zmanjšanje števila celic B v periferni krvi in limfatičnem tkivu, brez s tem povezanih toksikoloških izsledkov.
English: Benlysta subcutaneous injection must not be injected into a vein (intravenously).
Slovenian: Zdravila Benlysta za subkutano injiciranje ne smete injicirati v veno (intravensko).
English: The pre-filled pen or pre-filled syringe should be used for subcutaneous injection only.
Slovenian: Napolnjen injekcijski peresnik oziroma napolnjeno injekcijsko brizgo se sme uporabljati le za subkutano injiciranje.
English: In clinical studies, serious infusion and hypersensitivity reactions affected approximately 0.9% of adult patients, and included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnoea.
Slovenian: V kliničnih študijah so se resne infuzijske in preobčutljivostne reakcije pojavile pri približno 0,9 % odraslih bolnikov; obsegale so anafilaktično reakcijo, bradikardijo, hipotenzijo, angioedem in dispnejo.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca, odgovornega za sproščanje serije
English: The efficacy of Benlysta administered subcutaneously was evaluated in a randomised, double-blind, placebo-controlled 52-week Phase III study (HGS1006-C1115; BEL112341) in 836 adult patients with a clinical diagnosis of SLE according to the American College of Rheumatology classification criteria.
Slovenian: Učinkovitost subkutano uporabljanega zdravila Benlysta so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani 52-tedenski študiji III. faze (HGS1006-C1115; BEL112341) pri 836 odraslih bolnikih s klinično diagnozo SLE po klasifikacijskih merilih American College of Rheumatology.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Allow 10 to 15 minutes for the vial to warm to room temperature (15°C to 25°C).
Slovenian: Vialo pustite 10 do 15 minut, da se ogreje na sobno temperaturo (15 °C do 25 °C).
English: Among patients experiencing a severe flare, the median study day of the first severe flare was Day 159.5 in the Benlysta group and Day 82 in the placebo group.
Slovenian: Med bolniki, ki se jim je pojavil hud zagon bolezni, je bila mediana dneva v študiji, ko je pojavilo prvo hudo poslabšanje 159,5. dan v skupini, ki je prejemala zdravilo Benlysta in 82. dan v skupini s placebom.
English: Patients should remain under clinical supervision for a prolonged period of time (for several hours), following at least the first 2 infusions, taking into account the possibility of a late onset reaction.
Slovenian: Upoštevaje možnost reakcij s poznim začetkom morajo bolniki ostati pod kliničnim nadzorom daljši čas (vsaj nekaj ur), vsaj po prvih 2 infundiranjih.
English: Infections: The overall incidence of infections in intravenous and subcutaneous studies was 63% in both groups receiving Benlysta or placebo.
Slovenian: Okužbe: Celotna pojavnost okužb v študijah intravenske in subkutane uporabe je bila 63 % tako v skupini, ki je prejemala zdravilo Benlysta, kot v skupini, ki je prejemala placebo.
English: On the basis of the available information, dose adjustment is not required in patients with mild, moderate or severe renal impairment.
Slovenian: Na podlagi informacij, ki so na voljo, bolnikom z blago, zmerno ali hudo okvaro ledvic odmerka ni treba prilagoditi.
English: Physicians should assess the risk of depression and suicide considering the patient's medical history and current psychiatric status before treatment with Benlysta and continue to monitor patients during treatment.
Slovenian: Zdravniki morajo pred začetkom zdravljenja z zdravilom Benlysta na podlagi bolnikove zdravstvene anamneze in trenutnega psihiatričnega stanja oceniti tveganje za depresijo in samomor ter nadaljevati s spremljanjem bolnikov med zdravljenjem.
English: The recommended dose is 200 mg once weekly, administered subcutaneously.
Slovenian: Priporočeni odmerek je 200 mg enkrat na teden subkutano.
English: Benlysta can have side effects which may make you less able to drive or use machines.
Slovenian: Zdravilo Benlysta ima lahko možne neželene učinke, ki lahko zmanjšajo sposobnost za upravljanje vozil in strojev.
English: Allow the vial to sit at room temperature (15°C to 25°C) during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved.
Slovenian: Med pripravo vialo pustite na sobni temperaturi (15°C do 25 °C) in jo vsakih 5 minut za 60 sekund nežno vrtite, dokler se prašek ne raztopi.
English: The recommended dose regimen is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter.
Slovenian: Priporočena shema odmerjanja je 10 mg/kg zdravila Benlysta na dan 0, 14 in 28, potem pa v 4
English: BLISS-76 Study only
Slovenian: Samo študija BLISS-76
English: Within the overall SLE intravenous study population, age did not affect belimumab exposure in the population pharmacokinetic analysis.
Slovenian: Znotraj celotne intravenske raziskovane populacije s SLE starost v populacijski farmakokinetični analizi ni vplivala na izpostavljenost belimumabu.
English: Benlysta is administered intravenously by infusion, and must be reconstituted and diluted before administration.
Slovenian: Zdravilo Benlysta je treba dati intravensko v infuziji in ga je treba pred uporabo pripraviti in razredčiti.
English: Infusion or injection-related systemic reactions*, pyrexia
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti z infundiranjem ali injiciranjem povezane sistemske reakcije*, pireksija
English: Following intravenous administration of 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter, belimumab exposures were similar between paediatric and adult SLE subjects.
Slovenian: mg/kg na dan 0, 14 in 28, potem pa v 4-tedenskih presledkih, je bila izpostavljenost belimumabu pri pediatričnih bolnikih s SLE podobna kot pri odraslih bolnikih s SLE.
English: Your doctor may decide to give you medicines which help to reduce any infusion reactions before you are given Benlysta.
Slovenian: Zdravnik se lahko odloči in vam pred uporabo zdravila Benlysta da zdravila, ki pomagajo zmanjšati infuzijske reakcije.
English: A patient may self-inject or the patient caregiver may administer Benlysta after the healthcare professional determines that it is appropriate.
Slovenian: Bolnik si lahko sam injicira zdravilo Benlysta, ali mu ga injicira njegov negovalec, ko zdravnik presodi, da je to primerno.
English: These adverse events of special interest include serious infections (including nonserious and serious opportunistic infections and PML, malignancies (including nonmelanoma skin cancer), serious infusion and hypersensitivity reactions, and serious psychiatric events including mood disorders, anxiety and suicide.
Slovenian: Ti izbrani neželeni učinki obsegajo hude okužbe (vključno z oportunističnimi okužbami in PML, ki niso resni in takšnimi, ki so resni), malignomi vključno z nemelanomskim kožnim rakom) resne infuzijske in preobčutljivostne reakcije ter resne psihiatrične motnje vključno z motnjami razpoloženja, anksioznostjo in samomorom.
English: Treatment-related findings were limited to the expected reversible reduction of B cells in both dams and infants and reversible reduction of IgM in infant monkeys.
Slovenian: Z zdravljenjem povezani izsledki so bili omejeni na pričakovana reverzibilno zmanjšanje števila celic B pri samicah-materah in mladičih ter reverzibilno znižanje IgM pri opičjih mladičih.
English: • Clean the injection site by wiping it with an alcohol swab (Figure 5).
Slovenian: • Očistite mesto injiciranja tako, da ga obrišete z alkoholnim lističem (Slika 5).
English: There were too few patients ≥65 years of age enrolled in the controlled clinical trials to draw meaningful conclusions about the effects of age on clinical outcomes.
Slovenian: V kontrolirana klinična preskušanja je bilo vključenih premalo bolnikov, starih 65 let ali več, da bi bilo mogoče smiselno sklepati o vplivu starosti na klinične izide.