FrancophonIA/ELRC3.0 huggingface dataset:
English: Hold the Fasenra Pen with 1 hand.
Slovenian: Držite peresnik Fasenra Pen z eno roko.
English: Median percent reductions in daily OCS over time (Trial 3 and 4)
Slovenian: Mediani odstotek zmanjšanja dnevnih OCS skozi čas (preskušanji 3 in 4)
English: Eosinophils may be involved in the immunological response to some helminth infections.
Slovenian: Eozinofilci so lahko vpleteni v imunski odziv na nekatere okužbe s helminti.
English: • 1 Fasenra Pen from the refrigerator • 1 alcohol wipe
Slovenian: • 1 peresnik Fasenra Pen iz hladilnika • 1 alkoholni listič
English: By attaching to the eosinophils, Fasenra helps to reduce their numbers.
Slovenian: Z vezavo na eozinofilce zdravilo Fasenra pomaga zmanjšati njihovo število.
English: The long-term efficacy and safety of Fasenra was evaluated in a phase 3, 56-week extension trial BORA (Trial 4).
Slovenian: Dolgoročno učinkovitost in varnost zdravila Fasenra so ovrednotili v podaljšanem 56-tedenskem preskušanju faze III BORA (preskušanje 4).
English: The estimated systemic clearance (CL) for benralizumab was at 0.29 L/d.
Slovenian: Ocenjeni sistemski očistek (CL) benralizumaba je bil 0,29 l/dan.
English: Patients with known helminth infections were excluded from participation in clinical trials.
Slovenian: Bolniki, ki so imeli znano okužbo s helminti, niso bili vključeni v klinična preskušanja.
English: Reduction in corticosteroid doses, if appropriate, should be gradual and performed under the supervision of a physician.
Slovenian: Če je primerno zmanjšanje odmerkov kortikosteroida, mora biti zmanjšanje postopno in mora potekati pod nadzorom zdravnika.
English: The trial enrolled 2123 patients, 2037 adults and 86 adolescent patients (aged 12 years and older) from Trials 1, 2 and 3.
Slovenian: Preskušanje je zajelo 2123 bolnikov, 2037 odraslih in 86 mladostnikov (starih 12 let ali več), iz preskušanj 1, 2 in 3.
English: Only patients with an optimised baseline OCS dose of 12.5 mg or less were eligible to achieve a 100% reduction in OCS dose during the study.
Slovenian: Le bolniki z optimiziranim izhodiščnim odmerkom OCS 12,5 mg ali manj so bili primerni za 100 % zmanjšanje odmerka OCS med študijo.
English: Do not press down on the plunger until the needle is completely inserted into the skin.
Slovenian: Ne potisnite bata navzdol, dokler ni igla povsem zabodena v kožo.
English: The absence of fucose in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors on immune effector cells such as natural killer (NK) cells.
Slovenian: Zaradi odsotnosti fukoze v odseku Fc ima benralizumab veliko afiniteto za receptorje FcɣRIII na imunskih efektorskih celicah, kot so naravne celice ubijalke (NK - natural killer).
English: • the expiry date (EXP) has passed
Slovenian: • če je datum izteka roka uporabnosti (EXP) že potekel.
English: For patients on maintenance oral corticosteroids, this was defined as a temporary increase in stable oral/systemic corticosteroids for at least 3 days or a single depo-injectable dose of corticosteroids.
Slovenian: Za bolnike na vzdrževalnem zdravljenju s peroralnimi kortikosteroidi, je bilo poslabšanje opredeljeno kot prehodno povečanje stabilnih peroralnih/sistemskih kortikosteroidov za vsaj 3 dni ali en odmerek depojske injekcije kortikosteroidov.
English: • if you have had an allergic reaction to an injection or medicine in the past (see section 4 for symptoms of an allergic reaction).
Slovenian: • če ste kdaj v preteklosti imeli alergijsko reakcijo na kakšno injekcijo ali zdravilo (za simptome alergijske reakcije glejte poglavje 4).
English: You or your caregiver should receive training on the right way to prepare and inject Fasenra.
Slovenian: Vi ali vaš skrbnik morate opraviti usposabljanje za pravilno pripravo in injiciranje zdravila Fasenra.
English: Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Slovenian: Bolnikom je treba naročiti, naj se posvetujejo z zdravnikom, če jim astma po uvedbi zdravljenja ostaja neurejena ali se poslabša.
English: Do not touch the needle guard activation clips to keep from activating the safety device (needle guard) too soon.
Slovenian: Ne dotikajte se zaponk za aktivacijo ščitnika igle, da ne boste prezgodaj aktivirali varnostnega pripomočka (ščitnika igle).
English: Trial 3 evaluated the effect of Fasenra on reducing the use of maintenance oral corticosteroids.
Slovenian: Preskušanje 3 je ovrednotilo vpliv zdravila Fasenra na zmanjšanje uporabe vzdrževalnih peroralnih kortikosteroidov.
English: Maintenance of the reduction in daily OCS dose was also observed over the extension trial in patients enrolled from Trial 3 (Figure 1).
Slovenian: Ohranjeno zmanjšanje dnevnega odmerka OCS so opažali tudi v podaljšanem preskušanju pri bolnikih, vključenih iz preskušanja 3 (slika 1).
English: Effect of Fasenra on OCS dose reduction, Trial 3
Slovenian: Vpliv zdravila Fasenra na zmanjšanje odmerka OCS, preskušanje 3
English: Parasitic (Helminth) Infection
Slovenian: Parazitske okužbe (okužbe s helminti)
English: Inject Fasenra by following the steps in figures a, b and c.
Slovenian: Injicirajte zdravilo Fasenra tako, da sledite korakom na slikah a, b in c.
English: Name and address of the manufacturer of the biological active substance AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court
Slovenian: AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court
English: The target of benralizumab is a protein called interleukin-5 receptor, which is found particularly on a type of white blood cell called an eosinophil.
Slovenian: Ciljna snov benralizumaba je beljakovina, imenovana receptor interlevkina-5, ki se nahaja zlasti na posebni vrsti belih krvnih celic, imenovanih eozinofilci.
English: Insert the needle at an angle of 45 degrees.
Slovenian: Iglo zabodite pod kotom 45 stopinj.
English: In addition, change from baseline in mean FEV1 showed benefit as early as 4 weeks, which was maintained through to end of treatment (Table 2).
Slovenian: Poleg tega je sprememba povprečnega FEV1 v primerjavi z izhodiščem pokazala korist že po 4 tednih in korist se je ohranila do konca zdravljenja (preglednica 2).
English: Fasenra has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Fasenra nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of benralizumab in pregnant women.
Slovenian: Podatkov o uporabi benralizumaba pri nosečnicah je malo (manj kot 300 izidov nosečnosti).
English: If you or your caregiver have any questions, talk to your healthcare provider.
Slovenian: Če imate vi ali vaš skrbnik kakšna vprašanja, se pogovorite z zdravnikom.
English: Eosinophil depletion does not produce chronic systemic alterations of proinflammatory cytokines.
Slovenian: Izguba eozinofilcev ne povzroči kroničnih sistemskih sprememb vnetnih citokinov.
English: It is unknown whether benralizumab or its metabolites are excreted in human or animal milk.
Slovenian: Ni znano, ali se benralizumab ali njegovi presnovki pri človeku ali živalih izločajo v materino mleko.
English: Eosinophils are white blood cells involved in asthma inflammation.
Slovenian: Eozinofilci so bele krvne celice, vpletene v vnetje pri astmi.
English: * Pharyngitis was defined by the following grouped preferred terms: ‘Pharyngitis', ‘Pharyngitis bacterial', ‘Viral pharyngitis', ‘Pharyngitis streptococcal'.
Slovenian: * Faringitis je bil opredeljen z naslednjimi združenimi prednostnimi izrazi: "faringitis", "bakterijski faringitis", "virusni faringitis", "streptokokni faringitis".
English: After this, injections are 30 mg every 8 weeks.
Slovenian: Potem se daje injekcije s 30 mg na vsakih 8 tednov.
English: Clinically significant asthma exacerbation was defined as worsening of asthma requiring use of oral/systemic corticosteroids for at least 3 days, and/or emergency department visits requiring use of oral/systemic corticosteroids and/or hospitalisation.
Slovenian: Klinično pomembno poslabšanje astme je bilo opredeljeno kot poslabšanje astme, ki je zahtevalo uporabo peroralnih/sistemskih kortikosteroidov vsaj 3 dni in/ali obisk v ambulanti za nujno pomoč s potrebo po peroralnih/sistemskih kortikosteroidih in/ali sprejem v bolnišnico.
English: In Trial 2, there were too few events in the placebo treatment arm to draw conclusions for exacerbations requiring hospitalisation or emergency room visits.
Slovenian: V preskušanju 2 je bilo dogodkov v terapevtski skupini s placebom premalo, da bi lahko sklepali o poslabšanjih, ki so zahtevala sprejem v bolnišnico ali obisk v ambulanti za nujno pomoč.
English: Benralizumab has not been studied in children (5 to 11 years old) (see section 4.2).
Slovenian: Benralizumab ni raziskan pri otrocih (od 5. do 11. leta) (glejte poglavje 4.2).
English: Do not remove the cap until you have reached Step 6.
Slovenian: Ne odstranite pokrovčka, dokler ne pridete do 6. koraka.
English: There may be a small amount of blood or liquid where you injected.
Slovenian: Na mestu, kamor ste injicirali, se lahko pojavi malenkost krvi ali tekočine.
English: No evidence of an association of anti-drug antibodies with efficacy or safety was observed.
Slovenian: Dokazov o povezanosti protiteles proti zdravilu z učinkovitostjo ali varnostjo niso našli.
English: Do not expose to heat.
Slovenian: Ne izpostavljajte vročini.
English: You should not inject Fasenra yourself if you have not received Fasenra previously and if you had previous allergic reaction with Fasenra.
Slovenian: Zdravila Fasenra si ne smete injicirati sami, če v preteklosti še niste prejeli zdravila Fasenra, ali če ste imeli v preteklosti alergijsko reakcijo na zdravilo Fasenra.
English: Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of benralizumab.
Slovenian: Encimi citokroma P450, mehanizmi iztočne črpalke in mehanizmi vezave na beljakovine niso vključeni v očistek benralizumaba.
English: Fasenra is intended for long-term treatment.
Slovenian: Zdravilo Fasenra je namenjeno za dolgotrajno zdravljenje.
English: Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma.
Slovenian: Zdravljenje z zdravilom Fasenra mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem hude astme.
English: EU/1/17/1252/001 1 pre-filled syringe EU/1/17/1252/002 1 pre-filled pen
Slovenian: EU/1/17/1252/001 1 napolnjena injekcijska brizga EU/1/17/1252/002 1 napolnjen injekcijski peresnik
English: Patients had blood eosinophil counts ≥150 cells/μL and a history of at least one exacerbation in the past 12 months.
Slovenian: Bolniki so imeli število eozinofilcev v krvi ≥ 150 celic/μl in anamnezo vsaj enega poslabšanja v preteklih 12 mesecih.
English: The recommended injection site is the front of your thigh.
Slovenian: Priporočeno mesto injiciranja je na sprednji strani stegna.
English: • anaphylaxis symptoms usually include: o swelling of your face, tongue, or mouth o breathing problems o fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)
Slovenian: • anafilaksija med simptomi so običajno: o oteklost obraza, jezika ali ust o težave z dihanjem o omedlevica, omotica, vrtoglavica (zaradi padca krvnega tlaka)
English: ** Hypersensitivity reactions were defined by the following grouped preferred terms: ‘Urticaria', ‘Papular urticaria', and ‘Rash'.
Slovenian: ** Preobčutljivostne reakcije so bile opredeljene z naslednjimi združenimi prednostnimi izrazi: "urtikarija", "papularna urtikarija" in "izpuščaj".
English: Benra 30 mg q. 8 weeks n =
Slovenian: Tedni benralizumab 30 mg na 8 tednov n =
English: If patients become infected, while receiving treatment with Fasenra and do not respond to anti-helminth treatment, treatment with Fasenra should be discontinued until infection resolves.
Slovenian: Če se bolnik okuži med zdravljenjem z zdravilom Fasenra in se ne odzove na zdravljenje z antihelmintiki, je treba zdravljenje z zdravilom Fasenra prekiniti, dokler okužba ne mine.
English: Clinically significant exacerbations Rate
Slovenian: Klinično pomembna poslabšanja Delež
English: Do not use Fasenra if you are pregnant unless your doctor tells you otherwise.
Slovenian: Če ste noseči, ne uporabite zdravila Fasenra, razen če vam zdravnik naroči drugače.
English: Long-term extension trial
Slovenian: Dolgoročno podaljšano preskušanje
English: • 1 alcohol wipe
Slovenian: • 1 alkoholni listič
English: The green plunger will fill the viewing window.
Slovenian: Zeleni bat bo napolnil okence za ogled.
English: It is not known whether the ingredients of Fasenra can pass into breast milk.
Slovenian: Prav tako ni znano, ali lahko sestavine zdravila Fasenra preidejo v materino mleko.
English: You may see a small air bubble in the liquid.
Slovenian: V tekočini boste morda opazili majhen zračni mehurček.
English: Fasenra is used together with other medicines to treat asthma (high doses of ‘corticosteroid inhalers' plus other asthma medicines) when the disease is not well controlled by those other medicines alone.
Slovenian: Zdravilo Fasenra se uporablja skupaj z drugimi zdravili za zdravljenje astme (veliki odmerki kortikosteroidov z inhalatorjem (vdihovalnikom) in še drugimi zdravili za astmo), če bolezen ni dobro urejena samo s temi drugimi zdravili.
English: Step 1 - Gather Supplies
Slovenian: 1. korak - Zberite pribor
English: A decision to continue the therapy should be made at least annually based on disease severity, level of exacerbation control and blood eosinophil counts.
Slovenian: Odločitev za nadaljevanje zdravljenja je treba pretehtati vsaj enkrat na leto na podlagi tega, kako resna je bolezen, v kolikšni meri so poslabšanja obvladana in števila eozinofilcev v krvi.
English: This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), which reduces eosinophilic inflammation.
Slovenian: To povzroči apoptozo eozinofilcev in bazofilcev z ojačeno, od protiteles odvisno, celično posredovano citotoksičnostjo (ADCC - Antibody-Dependent Cell-mediated Cytotoxicity), ki zmanjša eozinofilno vnetje.
English: Hold the syringe body with 1 hand, and carefully pull the needle cover straight off with your other hand.
Slovenian: Držite telo brizge z eno roko, z drugo roko pa previdno potegnite pokrovček igle naravnost z igle.
English: Abrupt discontinuation of corticosteroids after initiation of Fasenra therapy is not recommended.
Slovenian: Hitro prenehanje uporabe kortikosteroidov po uvedbi zdravila Fasenra ni priporočljivo.
English: In a 56-week extension trial in patients with asthma from Trials 1, 2 and 3, 842 patients were treated with Fasenra at the recommended dose and remained in the trial.
Slovenian: V 56-tedenskem podaljšanem preskušanju bolnikov z astmo iz preskušanj 1, 2 in 3 so 842 bolnikov zdravili z zdravilom Fasenra v priporočenem odmerku in so ostali v preskušanju.
English: Exacerbation rate requiring hospitalisation/emergency room visit
Slovenian: Delež poslabšanj, ki so zahtevala sprejem v bolnišnico oz. obisk v ambulanti za nujno pomoč
English: You and your doctor or nurse should decide if you should inject Fasenra yourself.
Slovenian: Skupaj z zdravnikom ali medicinsko sestro se morate odločiti, ali si boste zdravilo Fasenra injicirali sami.
English: It is not known whether Fasenra could harm your unborn baby.
Slovenian: Ni namreč znano, ali lahko zdravilo Fasenra škoduje nerojenemu otroku.
English: There are limited data in paediatric patients (see section 5.1).
Slovenian: Podatkov o pediatričnih bolnikih je malo (glejte poglavje 5.1).
English: c. Integrated analysis at End of Treatment (EOT) of Trial 1(Week 48) and Trial 2 (Week 56).
Slovenian: c. Združena analiza ob koncu zdravljenja v preskušanju 1 (48. teden) in preskušanju 2 (56. teden).
English: As benralizumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted.
Slovenian: Ker je benralizumab monoklonsko protitelo, študij genotoksičnosti in kancerogenosti niso izvedli.
English: If this happens or if you have any other concerns, call your healthcare provider.
Slovenian: Če se to zgodi ali če imate kakšne druge pomisleke, se posvetujte z zdravnikom.
English: In line with clinical practice, patients should be monitored for an appropriate time after administration of Fasenra.
Slovenian: V skladu s klinično prakso je treba bolnike po uporabi zdravila Fasenra ustrezen čas spremljati.
English: Subgroup analyses from Trials 1 and 2 identified patients with higher prior exacerbation history as a potential predictor of improved treatment response.
Slovenian: Analize podskupin v preskušanju 1 in preskušanju 2 so pokazale, da je anamneza več predhodnih poslabšanj možen napovednik boljšega odziva na zdravljenje.
English: What you need to know before you use Fasenra
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Fasenra
English: The needle guard will slide down and lock into place over the needle.
Slovenian: Ščitnik igle bo zdrsnil dol in se bo zaskočil nad iglo.
English: The efficacy of Fasenra was evaluated in 3 randomised, double-blind, parallel-group, placebo-controlled clinical trials between 28 to 56 weeks duration, in patients aged 12 to 75 years.
Slovenian: Učinkovitost zdravila Fasenra so ocenili v 3 randomiziranih, dvojno slepih, s placebom kontroliranih kliničnih preskušanjih z vzporednimi skupinami; preskušanja so trajala od 28 do 56 tednov in so zajela bolnike, stare od 12 do 75 let.
English: Use Fasenra within 14 days of removing from the refrigerator.
Slovenian: Zdravilo Fasenra uporabite v 14 dneh po tem, ko ste ga vzeli iz hladilnika.
English: Use your other hand to gently pinch and hold the area of skin where you want to inject.
Slovenian: Z drugo roko nežno stisnite predel kože, kamor želite injicirati, in ga držite.
English: Place the needle guard of the Fasenra Pen flat against your skin (90-degree angle).
Slovenian: Položite ščitnik igle peresnika Fasenra plosko na kožo (pod kotom 90 stopinj).
English: Fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and decrease your asthma symptoms.
Slovenian: Zdravilo Fasenra vam lahko zmanjša število napadov astme, olajša dihanje in zmanjša simptome astme.
English: When considered alone or in combination with baseline blood eosinophils count, these factors may further identify patients who may achieve greater response from benralizumab treatment (Table 4).
Slovenian: Če te dejavnike upoštevamo same ali v kombinaciji z izhodiščnim številom eozinofilcev, lahko dodatno pomagajo odkriti bolnike, ki bi lahko dosegli večji odziv na zdravljenje z benralizumabom (preglednica 4).
English: Lift the Fasenra Pen straight up.
Slovenian: Dvignite peresnik Fasenra Pen naravnost navzgor.
English: In a randomized, double-blind parallel-group study of 103 patients aged between 12 and 21 years with severe asthma, the humoral antibody responses induced by seasonal influenza virus vaccination do not appear to be affected by benralizumab treatment.
Slovenian: Randomizirana, dvojno slepa študija vzporednih skupin, ki je zajela 103 bolnike s hudo astmo, stare od 12 do 21 let, ni pokazala, da bi zdravljenje z benralizumabom neugodno vplivalo na odzive humoralnih protiteles, ki jih povzroči cepljenje proti sezonskim virusom influence.
English: It is unknown if Fasenra may influence a patient's response against helminth infections.
Slovenian: Ni znano, ali lahko zdravilo Fasenra vpliva na bolnikov odziv na okužbe s helminti.
English: Of these, 46 received placebo, 40 received Fasenra every 4 weeks for 3 doses, followed by every 8 weeks thereafter, and 22 received Fasenra every 4 weeks.
Slovenian: Od teh jih je 46 prejemalo placebo, 40 zdravilo Fasenra na 4 tedne za 3 odmerke in pozneje na 8 tednov ter 22 zdravilo Fasenra na 4 tedne.
English: Fasenra should not be used to treat acute asthma exacerbations.
Slovenian: Zdravila Fasenra se ne sme uporabljati za zdravljenje akutnih poslabšanj astme.
English: Reductions in exacerbation rates were observed irrespective of baseline eosinophil count; however, increasing baseline eosinophil counts was identified as a potential predictor of improved treatment response particularly for FEV1.
Slovenian: Zmanjšanje deleža poslabšanj so opažali ne glede na izhodiščno število eozinofilcev, toda naraščajoče izhodiščno število eozinofilcev se je izkazalo kot možen napovednik boljšega odziva na zdravljenje, še zlasti glede FEV1.
English: Hold the pre-filled syringe in 1 hand as shown.
Slovenian: Napolnjeno iglo držite z eno roko, kot je prikazano.
English: In the event of a hypersensitivity reaction, Fasenra should be discontinued permanently and appropriate therapy initiated.
Slovenian: V primeru preobčutljivostne reakcije je treba zdravilo Fasenra trajno prenehati uporabljati in uvesti ustrezno zdravljenje.
English: Gently hold pressure over your skin with a cotton ball or gauze until the bleeding stops.
Slovenian: S kosmom vate ali zložencem gaze nežno pritiskajte na kožo, dokler se krvavitev ne ustavi.
English: Do not use the syringe if it is dropped without the needle cover in place or if the needle is damaged or dirty.
Slovenian: Ne uporabite brizge, če vam kam pade, ko pokrovček igle ni več nameščen, ali če je igla poškodovana ali umazana.
English: Do not try to put the cap back on the Fasenra Pen.
Slovenian: Ne poskušajte namestiti pokrovčka nazaj na peresnik Fasenra Pen.
English: Its colour may vary from colourless to yellow.
Slovenian: Lahko je brezbarvno do rumeno.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: The recommended dose of benralizumab is 30 mg by subcutaneous injection every 4 weeks for the first 3 doses, and then every 8 weeks thereafter.
Slovenian: Priporočeni odmerek benralizumaba je 30 mg v subkutani injekciji na 4 tedne prve 3 odmerke, pozneje pa na 8 tednov.
English: Patients with pre-existing helminth infections should be treated before initiating therapy with Fasenra.
Slovenian: Bolnike z obstoječimi okužbami s helminti je treba zdraviti pred uvedbo zdravljenja z zdravilom Fasenra.
English: Treatment with benralizumab results in near complete depletion of blood eosinophils within 24 hours following the first dose which is maintained throughout treatment.
Slovenian: Zdravljenje z benralizumabom povzroči skoraj popolno izgubo eozinofilcev v krvi, ki se pojavi v 24 urah po prvem odmerku in se ohrani med celotnim zdravljenjem.
English: There are limited data available in subjects with creatinine clearance values less than 30 mL/min; however, benralizumab is not cleared renally.
Slovenian: Podatkov za bolnike z očistkom kreatinina manj kot 30 ml/min je malo, vendar se benralizumab ne odstranjuje skozi ledvica.
English: Fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists (see section 5.1).
Slovenian: Zdravilo Fasenra je indicirano kot dodatno vzdrževalno zdravljenje za odrasle bolnike s hudo eozinofilno astmo, ki ni ustrezno urejena kljub velikim odmerkom inhalacijskih kortikosteroidov in dolgodelujočih agonistov β (glejte poglavje 5.1).
English: Slowly ease up on the plunger until the needle guard covers the needle.
Slovenian: Počasi sprostite bat, dokler ščitnik igle ne prekrije igle.
English: Placebo patients in Trials 1 and 2 are included up to the end of the predecessor trial (Week 48 in Trial 1, Week 56 in Trial 2).
Slovenian: Bolniki, ki so v preskušanjih 1 in 2 prejemali placebo, so vključeni do konca predhodnega preskušanja (48. teden v preskušanju 1, 56. teden v preskušanju 2).