FrancophonIA/ELRC3.0 huggingface dataset:
English: Anti-benralizumab antibodies were associated with increased clearance of benralizumab and increased blood eosinophil levels in patients with high anti-drug antibody titres compared to antibody negative patients; in rare cases, blood eosinophil levels returned to pre-treatment levels.
Slovenian: Protitelesa proti benralizumabu so bila pri bolnikih z visokimi titri protiteles povezana z večjim očistkom benralizumaba in povečanjem števila eozinofilcev v krvi v primerjavi z bolniki, ki niso imeli takšnih protiteles; v redkih primerih se je število eozinofilcev v krvi vrnilo na raven pred zdravljenjem.
English: Adolescent patients aged 12 to 17 (n=86) from Trials 1 and 2 continued treatment with Fasenra in Trial 4 for up to 108 weeks.
Slovenian: Mladostniki, stari od 12 do 17 let (n=86), iz preskušanj 1 in 2 so v preskušanju 4 nadaljevali zdravljenje z zdravilom Fasenra do 108 tednov.
English: Anaphylactic reactions have been reported.
Slovenian: Poročali so o anafilaktičnih reakcijah.
English: The two exacerbation trials, SIROCCO (Trial 1) and CALIMA (Trial 2), enrolled a total of 2,510 patients with severe uncontrolled asthma, 64% females, with a mean age of 49 years.
Slovenian: V dveh preskušanjih poslabšanj SIROCCO (preskušanje 1) in CALIMA (preskušanje 2) je bilo vključenih 2510 bolnikov s hudo, neurejeno astmo; 64 % je bilo žensk in povprečna starost je bila 49 let.
English: It should not be injected into areas where the skin is tender, bruised, erythematous, or hardened.
Slovenian: Zdravila se ne sme injicirati v predele, kjer je koža občutljiva, podpluta, pordela ali zatrdela.
English: Intravenous and subcutaneous administration to cynomolgus monkeys was associated with reductions in peripheral blood and bone marrow eosinophil counts, with no toxicological findings.
Slovenian: Intravenska in subkutana uporaba pri opicah cynomolgus sta bili povezani z zmanjšanjem števila eozinofilcev v periferni krvi in kostnem mozgu, brez toksikoloških ugotovitev.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Fasenra in paediatric population aged from birth to less than 6 years in asthma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Fasenra za pediatrično populacijo v starosti od rojstva do manj kot 6 let pri astmi (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In these studies, Fasenra was administered at a dose of 30 mg once every 4 weeks for the first 3 doses, and then every 4 or 8 weeks thereafter as add-on to background treatment and was evaluated in comparison with placebo.
Slovenian: V teh študijah so zdravilo Fasenra uporabili v odmerku 30 mg enkrat na 4 tedne za prve 3 odmerke, pozneje pa na 4 ali 8 tednov; zdravilo je bilo uporabljeno kot dodatek osnovnemu zdravljenju in so ga ocenjevali v primerjavi s placebom.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Fasenra in one or more subsets of the paediatric population in asthma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Fasenra za eno ali več podskupin pediatrične populacije za astmo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The depletion of blood eosinophils is accompanied by a reduction in serum eosinophil granule proteins eosinophil derived neurotoxin (EDN) and eosinophil cationic protein (ECP) and a reduction in blood basophils.
Slovenian: Izguba eozinofilcev v krvi spremlja znižanje dveh beljakovin eozinofilnih granul (v eozinofilcih nastalega nevrotoksina (EDN - eosinophil derived neurotoxin) in eozinofilne kationske beljakovine (ECP - eosinophil cationic protein)) v serumu in zmanjšanje števila bazofilcev v krvi.
English: In placebo-controlled studies, injection site reactions (e.g. pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with the recommended benralizumab dose compared with 1.9% in patients treated with placebo.
Slovenian: V študijah, kontroliranih s placebom, so se reakcije na mestu injiciranja (npr. bolečina, pordelost, srbenje, papule) pojavile pri 2,2 % bolnikov, ki so prejemali priporočeni odmerek benralizumaba, in pri 1,9 % bolnikov, ki so prejemali placebo.
English: • injection site reaction (for example pain, redness, itching, swelling near where the injection was given)
Slovenian: • reakcija na mestu injiciranja (na primer bolečina, pordelost, srbenje, oteklina v bližini mesta,
English: If you have forgotten to inject a dose of Fasenra, talk to your doctor, pharmacist or nurse as soon as possible.
Slovenian: Če ste pozabili injicirati odmerek zdravila Fasenra, se čim prej posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: What Fasenra is and what it is used for What you need to know before you use Fasenra How to use Fasenra Pen Possible side effects
Slovenian: Kaj je zdravilo Fasenra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Fasenra Kako uporabljati zdravilo Fasenra Možni neželeni učinki
English: After removal from the refrigerator, Fasenra must be used within 14 days or discarded.
Slovenian: Ko zdravilo Fasenra vzamete iz hladilnika, ga je treba uporabiti v 14 dneh ali ga zavreči.
English: Do not remove the needle cover until you have reached Step 6 of these instructions and are ready to inject Fasenra.
Slovenian: Ne odstranite pokrovčka igle, dokler ne pridete do 6. koraka teh navodil in ste pripravljeni na injiciranje zdravila Fasenra.
English: Eosinophilic asthma is a type of asthma where patients have too many eosinophils in the blood or lungs.
Slovenian: Eozinofilna astma je vrsta astme, pri kateri imajo bolniki v krvi ali pljučih preveliko število eozinofilcev.
English: Across Trials 1 and 2 combined, there was a numerically greater exacerbation rate reduction and greater improvements in FEV1 with increasing baseline blood eosinophils.
Slovenian: V preskušanjih 1 in 2 skupaj so ugotovili številčno večje zmanjšanje deleža poslabšanj in večje izboljšanje FEV1 z naraščajočim izhodiščnim številom eozinofilcev.
English: Before using your Fasenra Pen, your healthcare provider should show you or your caregiver how to use it correctly.
Slovenian: Preden uporabite peresnik Fasenra Pen, mora zdravnik vam ali vašemu skrbniku pokazati, kako ga pravilno uporabite.
English: Fasenra is a medicine containing the active substance benralizumab, which is a monoclonal antibody, a type of protein that recognises and attaches to a specific target substance in the body.
Slovenian: Zdravilo Fasenra vsebuje učinkovino benralizumab, ki je monoklonsko protitelo, tj. vrsta beljakovine, ki v telesu prepozna posebne ciljne snovi in se nanje veže.
English: Overall, treatment-emergent anti-drug antibody response developed in 107 out of 809 (13%) patients treated with Fasenra at the recommended dosing regimen during the 48 to 56 week treatment period of the phase 3 placebo controlled exacerbation trials.
Slovenian: V celoti se je odziv s protitelesi proti zdravilu med zdravljenjem pojavil pri 107 od 809 (13 %) bolnikov, ki so prejemali zdravilo Fasenra v priporočeni odmerni shemi v obdobju od 48 do 56 tednov zdravljenja v preskušanju poslabšanj faze III, nadzorovanega s placebom.
English: What Fasenra is and what it is used for
Slovenian: Kaj je zdravilo Fasenra in za kaj ga uporabljamo
English: IgG monoclonal antibodies are not primarily cleared via hepatic pathway; change in hepatic function is not expected to influence benralizumab clearance.
Slovenian: Monoklonska protitelesa IgG se ne odstranjujejo v prvi vrsti po jetrni poti in ni pričakovati, da bi spremenjeno delovanje jeter vplivalo na očistek benralizumaba.
English: Additional information and instructions for the preparation and administration of Fasenra using the pre-filled syringe or pre-filled pen (Fasenra Pen) are given in the package leaflet and ‘Instructions for Use'.
Slovenian: Dodatne informacije in navodila za pripravo in dajanje zdravila Fasenra z napolnjeno injekcijsko brizgo ali napolnjenim injekcijskim peresnikom (Fasenra Pen) so podane v priloženem navodilu za uporabo in "Navodilih za uporabo zdravila".
English: e. Baseline is prior to Fasenra treatment in Trial 1 and 2.
Slovenian: e. "Izhodiščno" pomeni pred zdravljenjem z zdravilom Fasenra v preskušanjih 1 in 2.
English: While 2 dosing regimens were studied in Trials 1, 2, and 3, the recommended dosing regimen is Fasenra administered every 4 weeks for the first 3 doses, then every 8 weeks thereafter (see section 4.2) as no additional benefit was observed by more frequent dosing.
Slovenian: V preskušanjih 1, 2 in 3 so uporabljali 2 odmerni shemi, toda priporočeno odmerjanje zdravila Fasenra je na 4 tedne za prve 3 odmerke, pozneje pa na 8 tednov (glejte poglavje 4.2), ker s pogostejšo uporabo niso ugotovili dodatne koristi.
English: Grasp the syringe body (not the plunger) to remove the pre-filled syringe from its tray.
Slovenian: Primite telo injekcijske brizge (ne njenega bata), da boste napolnjeno injekcijsko brizgo vzeli iz podloge.
English: Benralizumab is a humanised IgG1 monoclonal antibody that is degraded by proteolytic enzymes widely distributed in the body and not restricted to hepatic tissue.
Slovenian: Benralizumab je humanizirano monoklonsko protitelo IgG1 in ga razgradijo proteolitični encimi, ki so v telesu široko porazdeljeni in niso omejeni na jetrno tkivo.
English: Effect on blood eosinophils
Slovenian: Vpliv na eozinofilce v krvi
English: Driving and using machines It is unlikely that Fasenra will affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Fasenra vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: Other medicines and Fasenra
Slovenian: Druga zdravila in zdravilo Fasenra
English: (See Step 9 - Dispose the used pre-filled syringe)
Slovenian: (glejte 9. korak - Kako zavreči uporabljeno napolnjeno injekcijsko brizgo)
English: Dispose of the full container as instructed by your healthcare provider or pharmacist.
Slovenian: Celotni vsebnik zavrzite, kot vam je naročil zdravnik ali farmacevt.
English: Step 2 - Prepare to use your Fasenra Pen
Slovenian: 2. korak - Pripravite se za uporabo peresnika Fasenra Pen
English: Trial 4 assessed the long-term effect of Fasenra on annual exacerbation rate, lung function, ACQ-6, AQLQ(S)+12 and maintenance of OCS reduction at the 2 dosing regimens studied in the predecessor studies.
Slovenian: Preskušanje 4 je ocenjevalo dolgoročni učinek zdravila Fasenra na letni delež poslabšanj, pljučno funkcijo, ACQ-6, AQLQ(S)+12 in ohranitev zmanjšanja OCS med uporabo 2 shem odmerjanja, proučevanih v predhodnih študijah.
English: Use a quick, dart-like motion to insert the needle into the pinched skin.
Slovenian: S hitrim, rahlo sunkovitim gibom zabodite iglo v stisnjeno kožo.
English: What Fasenra looks like and contents of the pack Fasenra is a solution which is colourless to yellow.
Slovenian: Izgled zdravila Fasenra in vsebina pakiranja Zdravilo Fasenra je raztopina, ki je brezbarvna do rumena.
English: • if your asthma remains uncontrolled or worsens during treatment with this medicine.
Slovenian: • če ostane astma med zdravljenjem s tem zdravilom neurejena ali se poslabša.
English: Examination of surrogate fertility parameters (including organ weights and histopathology of reproductive tissues) in animals treated with benralizumab suggested no impairment of fertility.
Slovenian: Proučevanje nadomestnih parametrov plodnosti (vključno z maso organov in histopatologijo reproduktivnih tkiv) pri živalih, ki so prejemale benralizumab, ni pokazalo okvare plodnosti.
English: The green plunger will move down in the viewing window during the injection.
Slovenian: Zeleni bat se bo med injiciranjem pomikal navzdol v okence za ogled.
English: It binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity and specificity.
Slovenian: Z veliko afiniteto in specifičnostjo se veže na podenoto alfa humanega receptorja interlevkina - 5 (IL - 5Rα).
English: Self-administration should only be considered in patients already experienced with Fasenra treatment.
Slovenian: Samoinjiciranje pride v poštev le pri bolnikih, ki že imajo izkušnje z zdravljenjem z zdravilom Fasenra.
English: Fasenra is used to treat severe eosinophilic asthma in adults.
Slovenian: Zdravilo Fasenra uporabljamo za zdravljenje hude eozinofilne astme pri odraslih bolnikih.
English: Proportional odds model (sensitivity analysis) Percent reduction in OCS from baseline at Week 28 ≥90% reduction ≥75% reduction ≥50% reduction >0% reduction
Slovenian: Vrednost p Wilcoxonovega testa vsot rangov Model sorazmernih obetov (analiza občutljivosti) Odstotno zmanjšanje OCS od izhodišča do 28. tedna ≥ 90 % zmanjšanje ≥ 75 % zmanjšanje ≥ 50 % zmanjšanje > 0 % zmanjšanje
English: Based on the population pharmacokinetic analysis, the pharmacokinetics of benralizumab in adolescents aged 12 to 17 years were consistent with adults.
Slovenian: Glede na populacijsko farmakokinetično analizo se je farmakokinetika benralizumaba pri mladostnikih v starosti od 12 do 17 let skladala s farmakokinetiko pri odraslih.
English: • pharyngitis (sore throat)
Slovenian: • vnetje žrela (faringitis)
English: In this study there was a median reduction from baseline in airway mucosa eosinophils of 96% in the benralizumab treated group compared to a 47% reduction in the placebo group (p=0.039).
Slovenian: V tej študiji so v skupini, ki je prejemala benralizumab, ugotovili mediano zmanjšanje števila eozinofilcev v sluznici dihal od izhodišča za 96 % in v skupini, ki je prejemala placebo, za 47 % (p = 0,039).
English: Based on the population pharmacokinetic analysis, commonly co-administered medicinal products (montelukast, paracetamol, proton pump inhibitors, macrolides and theophylline/aminophylline) had no effect on benralizumab clearance in patients with asthma.
Slovenian: Glede na populacijsko farmakokinetično analizo pogosto sočasno uporabljena zdravila (montelukast, paracetamol, zaviralci protonske črpalke, makrolidi in teofilin/aminofilin) pri bolnikih z astmo niso vplivala na očistek benralizumaba.
English: Throw away the cap and other used supplies in your household waste.
Slovenian: Pokrovček in drug porabljeni pribor zavrzite med gospodinjske odpadke.
English: Before Use
Slovenian: Pred uporabo
English: However, in the offspring of monkeys dosed while pregnant, there was a reduction in eosinophils.
Slovenian: Toda potomci opic, ki so zdravilo prejemale med brejostjo, so imeli zmanjšano število eozinofilcev.
English: A history of anaphylaxis unrelated to benralizumab may be a risk factor for anaphylaxis following Fasenra administration (see section 4.3).
Slovenian: Anamneza anafilaksije, nepovezane z benralizumabom, je lahko dejavnik tveganja za anafilaksijo po uporabi zdravila Fasenra (glejte poglavje 4.3).
English: In both Trials 1 and 2, patients receiving Fasenra experienced statistically significant reductions in asthma symptoms (Total Asthma Score) compared to patients receiving placebo.
Slovenian: Tako v preskušanju 1 kot v preskušanju 2 so se prejemnikom zdravila Fasenra simptomi astme (celotna ocena astme - Total Asthma Score) zmanjšali statistično značilno bolj kot prejemnikom placeba.
English: Elderly No dose adjustment is required for elderly patients (see section 5.2).
Slovenian: Starejši Starejšim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Based on population pharmacokinetic analysis, the estimated absolute bioavailability was approximately 59% and there was no clinically relevant difference in relative bioavailability in the administration to the abdomen, thigh, or upper arm.
Slovenian: Na podlagi populacijske farmakokinetične analize je bila ocenjena absolutna biološka uporabnost približno 59 % in relativna biološka uporabnost se ni razlikovala glede na to, ali je bilo zdravilo injicirano v trebuh, stegno ali nadlaket.
English: The trial included an 8-week run-in period during which the OCS was titrated to the minimum effective dose without losing asthma control.
Slovenian: Preskušanje je obsegalo 8 - tedensko obdobje uvajanja, med katerim so OCS titrirali na najmanjši učinkoviti odmerek, s katerim je bila astma še urejena.
English: Following a second year of treatment of these patients from the phase 3 placebo-controlled trials, an additional 18 out of 510 (4%) had newly developed treatment-emergent antibodies.
Slovenian: Po drugem letu zdravljenja teh bolnikov iz preskušanj faze III, nadzorovanih s placebom, so se med zdravljenjem nastala protitelesa na novo pojavila pri dodatnih 18 od 510 (4 %) bolnikov.
English: Fasenra is administered as a subcutaneous injection.
Slovenian: Zdravilo Fasenra se uporablja kot subkutana injekcija.
English: Solution for injection in pre-filled syringe (injection) Solution for injection in pre-filled pen (injection) (Fasenra Pen)
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija) raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija) (Fasenra Pen)
English: Do not remove the cap until you have reached Step 6 of these instructions and are ready to inject Fasenra.
Slovenian: Ne odstranite pokrovčka, dokler ne pridete do 6. koraka teh navodil in ste pripravljeni na injiciranje zdravila Fasenra.
English: There is no specific treatment for an overdose with benralizumab.
Slovenian: Za preveliko odmerjanje benralizumaba ni specifičnega zdravljenja.
English: There were 108 adolescents aged 12 to 17 with asthma enrolled in the phase 3 trials (Trial 1: n=53, Trial 2: n=55).
Slovenian: V preskušanja faze III je bilo vključenih 108 mladostnikov z astmo, starih od 12 do 17 let (preskušanje 1: n = 53, preskušanje 2: n = 55).
English: *Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Slovenian: *Benralizumab je humanizirano monoklonsko protitelo, pridobljeno v celicah jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA.
English: Clean the injection site with an alcohol wipe in a circular motion.
Slovenian: S krožnim gibom očistite mesto injiciranja z alkoholnim lističem.
English: Do not recycle your used sharps container.
Slovenian: Porabljenega vsebnika za ostre odpadke ne reciklirajte.
English: The primary endpoint was percent reduction from baseline of the final OCS dose during Weeks 24 to 28, while maintaining asthma control.
Slovenian: Primarni cilj študije je bil odstotek zmanjšanja končnega odmerka OCS (od 24. do 28. tedna) v primerjavi z izhodiščem ob ohranjeni urejenosti astme.
English: In patients who received Fasenra in predecessor Trials 1 and 2, 73% were exacerbation-free in the extension Trial 4.
Slovenian: Med bolniki, ki so prejemali zdravilo Fasenra v predhodnih preskušanjih 1 in 2, jih je bilo v podaljšanem preskušanju 4 brez poslabšanj 73 %.
English: Benralizumab is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa).
Slovenian: Benralizumab je antieozinofilno humanizirano afukozilirano monoklonsko protitelo (IgG1, kapa).
English: The active substance is benralizumab.
Slovenian: Učinkovina je benralizumab.
English: • where the skin is tender, bruised, scaly or hard
Slovenian: • v predele, kjer je koža občutljiva, podpluta, se lušči ali je zatrdela,
English: In a prenatal and postnatal development study in pregnant cynomolgus monkeys, there were no benralizumab-related maternal, embryo-foetal, or postnatal effects observed.
Slovenian: V študiji prenatalnega in postnatalnega razvoja pri brejih opicah cynomolgus niso opazili z benralizumabom povezanih učinkov na mater, zarodek oz. plod ali postnatalnih učinkov.
English: Do not touch the cleaned area before injecting.
Slovenian: Očiščenega predela se pred injiciranjem ne dotikajte več.
English: Patients had a history of 2 or more asthma exacerbations requiring oral or systemic corticosteroid treatment (mean of 3) in the past 12 months, ACQ-6 score of 1.5 or more at screening, and reduced lung function at baseline (mean predicted pre-bronchodilator forced expiratory volume in 1 second [FEV1] of 57.5%), despite regular treatment with high-dose inhaled corticosteroid (ICS) (Trial 1) or with medium or high-dose ICS (Trial 2) and a long-acting β-agonist (LABA); at least one additional controller was administered to 51% and 41% of these patients, respectively.
Slovenian: Bolniki so imeli anamnezo 2 ali več poslabšanj astme, ki so zahtevala zdravljenje s peroralnimi ali sistemskimi kortikosteroidi (povprečno 3), v zadnjih 12 mesecih, oceno ACQ-6 1,5 ali več ob presejanju, izhodiščno zmanjšano pljučno funkcijo (povprečni predvideni forsirani ekspiracijski volumen v 1 sekundi (FEV1) pred bronhodilatatorjem 57,5 %) kljub rednemu zdravljenju z velikim odmerkom inhalacijskega kortikosteroida (ICS - inhaled corticosteroid) (preskušanje 1) oziroma s srednjim do velikim odmerkom ICS (preskušanje 2) ter dolgodelujočim agonistom β (LABA - Long-Acting β-Agonist); vsaj eno dodatno zdravilo za obvladovanje je prejemalo 51 % bolnikov med prvimi oz. 41 % bolnikov med drugimi.
English: Based on population pharmacokinetic analysis, central and peripheral volume of distribution of benralizumab was 3.1 L and 2.5 L, respectively, for a 70 kg individual.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da je za osebo s telesno maso 70 kg centralni volumen porazdelitve benralizumaba 3,1 l in periferni volumen porazdelitve 2,5 l.
English: For the oral corticosteroid (OCS) reduction trial ZONDA (Trial 3), a total of 220 asthma patients (61% female; mean age of 51 years) were enrolled; they were treated with daily OCS (8 to 40 mg per day; median of 10 mg) in addition to regular use of high-dose ICS and LABA with at least one additional controller to maintain asthma control in 53% of the cases.
Slovenian: V preskušanje zmanjšanja peroralnih kortikosteroidov (OCS - oral corticosteroid) ZONDA (preskušanje 3) je bilo vključenih 220 bolnikov z astmo (61 % je bilo žensk, povprečna starost je bila 51 let), ki so vsakodnevno prejemali OCS (od 8 do 40 mg na dan, mediano 10 mg) poleg redne uporabe velikega odmerka ICS in LABA z vsaj enim dodatnim zdravilom za obvladovanje vzdrževanja urejenosti astme v 53 % primerov.
English: Pre-bronchodilator FEV1 (L)
Slovenian: FEV1 pred bronhodilatatorjem (l)
English: Trial 1, 2 & 4
Slovenian: Preskušanje 4 Preskušanja 1, 2 in 4
English: Do not warm the pre-filled syringe in any other way.
Slovenian: Ne segrevajte napolnjene injekcijske brizge na noben drug način.
English: Step 5 - Clean the injection site
Slovenian: 5. korak - Očistite mesto injiciranja
English: Put the needle cover aside to throw away later.
Slovenian: Pokrovček igle odložite, da ga boste pozneje zavrgli.
English: Prior to administration, warm Fasenra by leaving carton at room temperature.
Slovenian: Zdravilo Fasenra pred uporabo ogrejte tako, da pustite škatlo na sobni temperaturi.
English: Based on population pharmacokinetic analysis, age did not affect benralizumab clearance.
Slovenian: Na podlagi populacijske farmakokinetične analize starost ni vplivala na očistek benralizumaba.
English: In these trials, the asthma exacerbation rate in adolescent patients treated with Fasenra administered at the recommended dosing regimen was 0.70 (n=40, 95% CI: 0.42, 1.18) compared to 0.41 for placebo (n=46, 95% CI: 0.23, 0.73) [rate ratio 1.70, 95% CI: 0.78, 3.69].
Slovenian: V teh preskušanjih je bil delež poslabšanj astme pri bolnikih - mladostnikih, zdravljenih z zdravilom Fasenra v priporočeni odmerni shemi 0,70 (n = 40, 95 % IZ: 0,42; 1,18) in 0,41 pri tistih, ki so prejemali placebo (n = 46, 95 % IZ: 0,23; 0,73) [razmerje deležev 1,70, 95 % IZ: 0,78; 3,69].
English: Fasenra is given as an injection just under the skin (subcutaneously).
Slovenian: Zdravilo Fasenra se daje v obliki injekcije tik pod kožo (subkutano).
English: Description of selected adverse reaction
Slovenian: Opis izbranih neželenih učinkov