FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on population pharmacokinetic analysis, benralizumab clearance was comparable in subjects with creatinine clearance values between 30 and 80 mL/min and patients with normal renal function.
Slovenian: Glede na populacijsko farmakokinetično analizo je bil očistek benralizumaba pri osebah z očistkom kreatinina med 30 in 80 ml/min podoben kot pri bolnikih z normalnim delovanjem ledvic.
English: Exacerbation rate and pulmonary function (FEV1) at end of treatment by number of exacerbations in the previous year - Patients on high-dose ICS and blood eosinophils ≥300 cells/μL
Slovenian: Delež poslabšanj in pljučna funkcija (FEV1) na koncu zdravljenja glede na število poslabšanj v preteklem letu - bolniki na velikem odmerku ICS in s številom eozinofilcev v krvi ≥ 300 celic/μl
English: There is no evidence of IL-5Rα expression on hepatocytes.
Slovenian: O izraženosti IL-5Rα na jetrnih celicah ni dokazov.
English: Step 3 - Check the liquid
Slovenian: 3. korak - Preverite tekočino
English: Following subcutaneous administration to patients with asthma, the absorption half-life was 3.5 days.
Slovenian: Razpolovni čas absorpcije je bil po subkutani uporabi pri bolnikih z astmo 3,5 dneva.
English: An effect of benralizumab on the pharmacokinetics of co-administered medicinal products is not expected (see section 5.2).
Slovenian: Vpliva benralizumaba na farmakokinetiko sočasno uporabljenih zdravil ni pričakovati (glejte poglavje 5.2).
English: The effect of benralizumab on eosinophils in the airway mucosa in asthmatic patients with elevated sputum eosinophil counts (at least 2.5%) was evaluated in a 12-week, phase 1, randomised, doubleblind, placebo-controlled clinical study with benralizumab 100 or 200 mg SC.
Slovenian: Vpliva benralizumaba na eozinofilce v sluznici dihal so pri astmatičnih bolnikih s povečanim številom eozinofilcev v sputumu (vsaj 2,5 %) ocenili v 12 - tedenski randomizirani, dvojno slepi, s placebom kontrolirani klinični študiji faze I s 100 ali 200 mg benralizumaba subkutano.
English: You can either gently pinch at the injection site or give the injection without pinching the skin.
Slovenian: Kožo na mestu injiciranja lahko nežno stisnete v gubo, lahko pa injicirate, ne da bi naredili takšno gubo.
English: Peel off the entire lid from the plastic tray.
Slovenian: Odlepite celotno folijo s plastične podloge.
English: Predecessor Trial 3 patients who continued Fasenra treatment into Trial 4.
Slovenian: a. Bolniki iz predhodnega preskušanja 3, ki so nadaljevali zdravljenje z zdravilom Fasenra v preskušanju 4.
English: Animal studies showed no adverse effects of benralizumab treatment on fertility (see section 5.3).
Slovenian: Študije na živalih niso pokazale neželenih učinkov zdravljenja z benralizumabom na plodnost (glejte poglavje 5.3).
English: You must look out for signs of these reactions (such as hives, rash, breathing problems, fainting, dizziness, feeling lightheaded and/or swelling of your face, tongue or mouth) while you are taking Fasenra.
Slovenian: Med uporabo zdravila Fasenra bodite pozorni na znake takšnih reakcij (npr. na koprivnico, izpuščaj, težave z dihanjem, omedlevico, omotico, vrtoglavico in/ali oteklost obraza, jezika ali ust).
English: Tell your doctor if you are taking, have recently taken or might take any other medicines before using Fasenra.
Slovenian: Preden prejmete zdravilo Fasenra obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Do not inject Fasenra if the liquid is cloudy, discoloured, or contains large particles.
Slovenian: Ne injicirajte zdravila Fasenra, če je tekočina motna, spremenjene barve ali vsebuje velike delce.
English: A caregiver may inject you in the upper-arm, thigh, or abdomen.
Slovenian: Vaš skrbnik vam lahko zdravilo injicira v nadlaket, stegno ali trebuh.
English: Results of annual exacerbation rate and lung function at end of treatment of Trial 1 and 2 by eosinophil count.
Slovenian: Rezultati letnega deleža poslabšanj in pljučne funkcije na koncu zdravljenja v preskušanjih 1 in 2 glede na število eozinofilcev.
English: • 1 Fasenra pre-filled syringe from the refrigerator
Slovenian: • 1 napolnjen injekcijski peresnik z zdravilom Fasenra iz hladilnika
English: If any of the above happens, throw away the Fasenra Pen in a puncture-resistant sharps container and use a new Fasenra Pen.
Slovenian: Če se zgodi kar koli od naštetega, peresnik Fasenra Pen zavrzite v vsebnik za ostre odpadke, varen proti prebadanju, in uporabite nov peresnik.
English: Treatment difference in mean change from baseline in total asthma symptom score, ACQ-6 and AQLQ(s)+12 at end of treatment - Patients on high-dose ICS and blood eosinophils ≥300 cells/μL
Slovenian: Razlika med zdravljenjema v povprečni spremembi celotnih ocen simptomov astme, ACQ-6 in AQLQ(s)+12 ob koncu zdravljenja v primerjavi z izhodiščem - bolniki na velikem odmerku ICS in s številom eozinofilcev v krvi ≥ 300 celic/μl
English: An effect of benralizumab on the pharmacokinetics of co-administered medicinal products is not expected.
Slovenian: Vpliva benralizumaba na farmakokinetiko sočasno uporabljenih zdravil ni pričakovati.
English: Acute systemic reactions including anaphylactic reactions and hypersensitivity reactions (e.g. urticaria, papular urticaria, rash) have occurred following administration of benralizumab (see section 4.8).
Slovenian: Po uporabi benralizumaba so se pojavile akutne sistemske reakcije, vključno z anafilaktičnimi reakcijami in preobčutljivostnimi reakcijami (npr. urtikarija, papularna urtikarija, izpuščaj) (glejte poglavje 4.8).
English: Before using your Fasenra pre-filled syringe, your healthcare provider should show you or your caregiver how to use it correctly.
Slovenian: Preden uporabite napolnjeno injekcijsko brizgo zdravila Fasenra, mora zdravnik vam ali vašemu skrbniku pokazati, kako jo pravilno uporabite.
English: If any of the above happens, throw away the syringe in a puncture-resistant sharps container and use a new pre-filled syringe.
Slovenian: Če se zgodi kar koli od naštetega, brizgo zavrzite v vsebnik za ostre odpadke, varen proti prebadanju, in uporabite novo napolnjeno injekcijsko brizgo.
English: Difference (95% CI) AQLQ(S)+12
Slovenian: Izboljšanje od izhodišča Razlika (95 % IZ) AQLQ(S)+12
English: Hypersensitivity reactions** Anaphylactic reaction
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije** anafilaktične reakcije pogosti neznana
English: Use your thumb to push down on the plunger head.
Slovenian: S palcem potisnite glavo bata navzdol.
English: Intent to treat population (patients on high-dose ICS and blood eosinophils ≥300 cells/μl).
Slovenian: Populacija, z namenom zdravljenja (bolniki na velikem odmerku ICS in s številom eozinofilcev v krvi ≥ 300 celic/μl).
English: Fasenra Pen is for single-use only.
Slovenian: Peresnik Fasenra Pen je samo za enkratno uporabo.
English: Store the pre-filled syringe/pre-filled pen (Fasenra Pen) in the original package in order to protect from light.
Slovenian: Napolnjeno injekcijsko brizgo/napolnjen injekcijski peresnik (Fasenra Pen) shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeated dose toxicity studies in monkeys.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih pri opicah ne kažejo posebnega tveganja za človeka.
English: The rate of exacerbations requiring hospitalisation and/or emergency room visits for patients receiving Fasenra compared to placebo for Trial 1 were 0.09 versus 0.25 (rate ratio 0.37, 95% CI: 0.20, 0.67, p=<0.001) and for Trial 2 were 0.12 versus 0.10 (rate ratio 1.23, 95% CI: 0.64, 2.35, p=0.538).
Slovenian: Delež poslabšanj, ki so zahtevala sprejem v bolnišnico in/ali obisk v ambulanti za nujno pomoč je bil v preskušanju 1 med prejemniki zdravila Fasenra 0,09 in med prejemniki placeba 0,25 (razmerje deležev 0,37, 95 % IZ: 0,20; 0,67, p =< 0,001), v preskušanju 2 pa med prvimi 0,12 in med drugimi 0,10 (razmerje deležev 1,23, 95 % IZ: 0,64; 2,35, p = 0,538).
English: Based on current patient follow-up, no evidence of an association of anti-drug antibodies with efficacy or safety was observed.
Slovenian: Na podlagi trenutnega spremljanja bolnikov niso ugotovili povezave med protitelesi proti zdravilu ter učinkovitostjo in varnostjo zdravila.
English: Step 2 - Prepare to use your pre-filled syringe
Slovenian: 2. korak - Pripravite se za uporabo napolnjene injekcijske brizge
English: Keep Fasenra and all medicines out of the sight and reach of children.
Slovenian: Zdravilo Fasenra in tudi vsa druga zdravila shranjujte nedosegljiva otrokom!
English: Do not throw away the Fasenra Pen in your household waste.
Slovenian: Peresnik Fasenra Pen ne smete odvreči med gospodinjske odpadke.
English: Fasenra solution for injection is supplied in a sterile single-use pre-filled syringe or pre-filled pen for individual use.
Slovenian: Zdravilo Fasenra raztopina za injiciranje je na voljo v sterilni napolnjeni injekcijski brizgi ali v sterilnem napolnjenem injekcijskem peresniku za enkratno, individualno uporabo.
English: Not powered to detect a treatment difference in patients with blood eosinophils <300 cells/μl.
Slovenian: Preskušanje ni omogočilo odkrivanja terapevtske razlike pri bolnikih s številom eozinofilcev < 300 celic/μl.
English: Do not use Fasenra:
Slovenian: Ne uporabljajte zdravila Fasenra:
English: The primary endpoint was the annual rate of clinically significant asthma exacerbations in patients with baseline blood eosinophil counts ≥300 cells/μL who were taking high-dose ICS and LABA.
Slovenian: Primarni opazovani dogodek je bil letni delež klinično pomembnih poslabšanj astme pri bolnikih, ki so imeli izhodiščno število eozinofilcev v krvi ≥ 300 celic/μl in so jemali velik odmerek ICS in LABA.
English: Efficacy in Trial 4 was also evaluated in patients with baseline blood eosinophil counts <300 cells/µl and was consistent with Trials 1 and 2.
Slovenian: Učinkovitost v preskušanju 4 so ovrednotili tudi pri bolnikih, ki so imeli izhodiščno število eozinofilcev v krvi < 300 celic/µl, in se je skladala z ugotovitvami v preskušanjih 1 in 2.
English: Step 4 - Choose the injection site
Slovenian: 4. korak - Izberite mesto injiciranja
English: Fasenra is clear to opalescent, colourless to yellow, and may contain translucent or white to off-white particles.
Slovenian: Zdravilo Fasenra je bistro do opalescentno, brezbarvno do rumeno in lahko vsebuje prosojne oziroma bele ali skoraj bele delce.
English: Step 7 - Inject Fasenra
Slovenian: 7. korak - Injicirajte zdravilo Fasenra
English: Comprehensive instructions for administration using the pre-filled syringe/pre-filled pen (Fasenra Pen) are provided in the ‘Instructions for Use'.
Slovenian: Izčrpna navodila za injiciranje z napolnjeno injekcijsko brizgo/napolnjenim injekcijskim peresnikom (Fasenra Pen) so navedena v "Navodilih za uporabo zdravila".
English: • 1 cotton ball or gauze
Slovenian: • 1 kosem vate ali zloženec gaze
English: Doses of up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic asthma without evidence of dose-related toxicities.
Slovenian: V kliničnih preskušanjih so bolnikom z eozinofilno astmo dajali odmerke do 200 mg subkutano brez znakov z odmerkom povezanih toksičnih učinkov.
English: The pharmacokinetics of benralizumab were dose-proportional in patients with asthma following subcutaneous administration over a dose range of 2 to 200 mg. Absorption
Slovenian: Pri bolnikih z astmo je bila farmakokinetika benralizumaba po subkutani uporabi v razponu odmerkov od 2 do 200 mg sorazmerna odmerku.
English: A population pharmacokinetics analysis, indicated that there was no significant effect of gender and race on benralizumab clearance.
Slovenian: Populacijska farmakokinetična analiza ni pokazala, da bi spol in rasa pomembno vplivala na očistek benralizumaba.
English: Similar improvement in favour of Fasenra was observed for the Asthma Control Questionnaire-6 (ACQ-6) and Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) (Table 3).
Slovenian: Control Questionnaire-6) in AQLQ(S)+12 (Standardised Asthma Quality of Life Questionnaire for 12 Years and Older) (preglednica 3).
English: Reduction in the daily OCS dose to 0 mg/day* Odds ratio (95% CI)
Slovenian: Zmanjšanje dnevnega odmerka OCS na 0 mg na dan* Razmerje obetov (95 % IZ)
English: Step 6 - Pull off the needle cover
Slovenian: 6. korak - Snemite pokrovček igle
English: After proper training in the subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4), patients with no known history of anaphylaxis or their caregivers may administer Fasenra if their physician determines that it is appropriate, with medical follow-up as necessary.
Slovenian: Bolniki, ki v anamnezi nimajo anafilaksije, oz. njihovi skrbniki lahko injicirajo zdravilo Fasenra, potem ko opravijo ustrezno usposabljanje o tehniki subkutanega injiciranja ter izobraževanje o znakih in simptomih preobčutljivostnih reakcij (glejte poglavje 4.4), če zdravnik presodi, da je to primerno, in ob zdravniškem spremljanju, kot je potrebno.
English: Do not shake.
Slovenian: Ne pretresajte.
English: The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20 and water for injections.
Slovenian: Druge sestavine zdravila so histidin, histidinijev klorid monohidrat, trehaloza dihidrat, polisorbat 20 in voda za injekcije.
English: Oral corticosteroid dose reduction trial
Slovenian: Preskušanje zmanjšanja odmerka peroralnih kortikosteroidov
English: If the healthcare professional or caregiver administers the injection, the upper arm can also be used.
Slovenian: Če injekcijo da zdravnik ali skrbnik, lahko uporabi tudi nadlaket.
English: Carefully pull the cap straight off with your other hand.
Slovenian: Z drugo roko previdno snemite pokrovček naravnost dol.
English: Put the cap aside to throw away later.
Slovenian: Pokrovček odložite, da ga boste pozneje zavrgli.
English: At the recommended dosing regimen, the reduction in annual rate of exacerbations observed in the placebo-controlled predecessor Trials 1 and 2 (in patients with baseline blood eosinophil counts ≥300 cells/μL who were taking high-dose ICS) was maintained over the second year of treatment (Table 6).
Slovenian: Ob priporočeni odmerni shemi se je zmanjšan letni delež poslabšanj, opažen v predhodnih, s placebom nadzorovanih preskušanjih 1 in 2 (pri bolnikih z izhodiščnim številom eozinofilcev v krvi ≥ 300 celic/µl, ki so uporabljali velike odmerke ICS), ohranil med drugim letom zdravljenja (preglednica 6).
English: Position the Fasenra Pen at the injection site.
Slovenian: Namestite peresnik Fasenra Pen na mesto injiciranja.
English: Do not use your Fasenra Pen if:
Slovenian: Ne uporabljajte peresnika Fasenra Pen:
English: Pack containing 1 single-use pre-filled pen (Fasenra Pen).
Slovenian: Pakiranje vsebuje 1 napolnjen injekcijski peresnik za enkratno uporabo (Fasenra Pen).
English: How to store Fasenra Pen Contents of the pack and other information
Slovenian: Shranjevanje zdravila Fasenra Vsebina pakiranja in dodatne informacije
English: It should be injected into the thigh or abdomen.
Slovenian: Zdravilo je treba injicirati v stegno ali trebuh.
English: Reduction in the daily OCS dose to ≤5 mg/day Odds ratio (95% CI)
Slovenian: Zmanjšanje dnevnega odmerka OCS ≤ 5 mg na dan Razmerje obetov (95 % IZ)
English: Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20, water for injections.
Slovenian: Pomožne snovi: histidin, histidinijev klorid monohidrat, trehaloza dihidrat, polisorbat 20, voda za injekcije.
English: Do not shake, freeze or expose to heat.
Slovenian: Ne pretresajte, ne zamrzujte in ne izpostavljajte vročini.
English: Do not use Fasenra if liquid is cloudy, discoloured, or if it contains large particles or foreign particulate matter.
Slovenian: Ne uporabite ga, če je tekočina motna, spremenjene barve, vsebuje velike delce ali delce tuje snovi.
English: Based on population pharmacokinetic analysis, baseline hepatic function biomarkers (ALT, AST, and bilirubin) had no clinically relevant effect on benralizumab clearance.
Slovenian: Glede na populacijsko farmakokinetično analizo, izhodiščne vrednosti bioloških označevalcev delovanja jeter (ALT, AST in bilirubin) niso imele klinično pomembnega učinka na očistek benralizumaba.
English: Hold the Fasenra Pen in place for the entire injection.
Slovenian: Peresnik Fasenra Pen držite na mestu med celotnim injiciranjem.
English: If your response to the treatment allows it, your doctor may try to reduce the dose of some of these medicines, especially ones called ‘corticosteroids'.
Slovenian: Zdravnik vam lahko poskusi zmanjšati odmerek nekaterih od teh zdravil, zlasti zdravila imenovana kortikosteroidi, če vaš odziv na zdravljenje to dopušča.
English: Step 10 - Dispose of the used Fasenra Pen safely
Slovenian: 10. korak - Kako varno zavreči uporabljeni peresnik Fasenra Pen
English: • Each pre-filled syringe contains a single dose of Fasenra and cannot be re-used.
Slovenian: • Vsaka napolnjena injekcijska brizga vsebuje en sam odmerek zdravila Fasenra in je ni mogoče ponovno uporabiti.
English: • Put your used pre-filled syringe in a puncture-resistant sharps container right away after use.
Slovenian: • Uporabljeno napolnjeno injekcijsko brizgo takoj po uporabi dajte v vsebnik za ostre odpadke, odporen proti prebadanju.
English: From population pharmacokinetic analysis, benralizumab exhibited linear pharmacokinetics and no evidence of target receptor-mediated clearance pathway.
Slovenian: V populacijski farmakokinetični analizi je imel benralizumab linearno farmakokinetiko in ni bilo znakov, da bi odstranjevanje potekalo preko ciljnega receptorja.
English: Subcutaneous use Read the instructions for use and the package leaflet before use
Slovenian: subkutana uporaba Pred uporabo preberite navodila za uporabo zdravila in priloženo navodilo.
English: The syringe may be kept at room temperature up to 25°C for a maximum of 14 days.
Slovenian: Brizga je lahko shranjena na sobni temperaturi do 25 °C največ 14 dni.
English: • Each Fasenra Pen contains a single dose of Fasenra and cannot be re-used.
Slovenian: • Vsak peresnik Fasenra Pen vsebuje en sam odmerek zdravila Fasenra in ga ni mogoče ponovno uporabiti.
English: Patients that entered Trial 4 from predecessor Trials 1 and 2 with baseline blood eosinophil counts ≥300 cells/μL who were taking high-dose ICS.
Slovenian: Bolniki, ki so vstopili v preskušanje 4 iz predhodnih preskušanj 1 in 2 z izhodiščnim številom eozinofilcev v krvi ≥ 300 celic/µl in so jemali velike odmerke ICS.
English: Stopping treatment with Fasenra
Slovenian: Končanje zdravljenja z zdravilom Fasenra
English: Step 9 - Dispose the used pre-filled syringe
Slovenian: 9. korak - Zavrzite uporabljeno napolnjeno injekcijsko brizgo
English: Trial 1
Slovenian: Preskušanje 1
English: Do not freeze, shake or expose to heat.
Slovenian: Ne zamrzujte, ne pretresajte in ne izpostavljajte vročini.
English: Before Injection
Slovenian: pred injiciranjem po injiciranju
English: • Put your used Fasenra Pen in a puncture-resistant sharps container right away after use.
Slovenian: • Uporabljeni peresnik Fasenra Pen takoj po uporabi dajte v vsebnik za ostre odpadke, odporen proti prebadanju.
English: No formal clinical studies have been conducted to investigate the effect of hepatic impairment on benralizumab.
Slovenian: Formalnih kliničnih študij za proučitev vpliva okvare jeter na benralizumab niso izvedli.
English: Change from baseline for lung function, ACQ-6, and AQLQ(S)+12
Slovenian: Sprememba pljučne funkcije, ACQ-6 in AQLQ(S)+12
English: Renal and hepatic impairment No dose adjustment is required for patients with renal or hepatic impairment (see section 5.2).
Slovenian: Okvara ledvic ali jeter Bolnikom z okvaro ledvic ali jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Fasenra is available in a pack containing 1 pre-filled syringe.
Slovenian: Zdravilo Fasenra je na voljo v pakiranju, ki vsebuje 1 napolnjeno injekcijsko brizgo.
English: Let Fasenra warm up at room temperature 20°C to 25°C for about 30 minutes before giving the injection.
Slovenian: Preden zdravilo Fasenra injicirate, ga približno 30 minut pustite na sobni temperaturi (od 20 do 25 °C), da se ogreje.
English: One mL solution in a single-use pre-filled syringe made from type I glass with a staked 29-gauge ½-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated plunger stopper in a passive safety device.
Slovenian: En mililiter raztopine v napolnjeni injekcijski brizgi za enkratno uporabo iz stekla tipa I, z nameščeno 1/2-colsko iglo (12,7 mm) debeline 29 G iz nerjavnega jekla, s togim ščitnikom igle in s Fluorotecom prekritim čepom bata v pasivni varnostni napravi.
English: Step 9 - Check the injection site
Slovenian: 9. korak - Preverite mesto injiciranja
English: Step 8 - Check the viewing window
Slovenian: 8. korak - Preverite okence za ogled
English: Do not re-cap the pre-filled syringe.
Slovenian: Ne nameščajte pokrovčka nazaj na napolnjeno injekcijsko brizgo.
English: Lung function, asthma symptom score, ACQ-6 and AQLQ(S)+12 were also assessed in Trial 3 and showed results similar to those in Trials 1 and 2.
Slovenian: V preskušanju 3 so ocenili tudi pljučno funkcijo, oceno simptomov astme, vprašalnika ACQ-6 in AQLQ(S)+12; rezultati so bili podobni kot v preskušanjih 1 in 2.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX10
Slovenian: Farmakoterapevtska skupina: zdravila za obstruktivne pljučne bolezni, druga sistemska zdravila za obstruktivne pljučne bolezni.
English: Store Fasenra in a refrigerator between 2°C to 8°C in its carton until you are ready to use it. Fasenra may be kept at room temperature up to 25
Slovenian: Zdravilo Fasenra shranjujte v hladilniku na temperaturi od 2 do 8 °C in v škatli zdravila, dokler niste pripravljeni, da ga uporabite.
English: Fasenra can potentially cause serious allergic reactions.
Slovenian: Bodite pozorni na znake resnih alergijskih reakcij Zdravilo Fasenra lahko povzroči resne alergijske reakcije.
English: Baseline of 2 exacerbations
Slovenian: Izhodiščno 2 poslabšanji
English: Read the instructions for use and the package leaflet before use.
Slovenian: Pred uporabo preberite navodila za uporabo zdravila in priloženo navodilo.
English: • it has been dropped or damaged
Slovenian: • če vam je brizga kam padla ali je poškodovana,
English: Similar maintenance of effect was observed throughout Trial 4 in lung function, ACQ-6 and AQLQ(S)+12 (Table 7).
Slovenian: Podobno ohranitev učinka so med celotnim preskušanjem 4 opažali za pljučno funkcijo, ACQ-6 in AQLQ(S)+12 (preglednica 7).
English: Do not:
Slovenian: NE:
English: If a dose of Fasenra is missed
Slovenian: Če ste izpustili odmerek zdravila Fasenra
English: Do not touch the needle, or let it touch any surface.
Slovenian: Ne dotikajte se igle in pazite, da se z njo česa ne dotaknete.
English: Fasenra is for single use only.
Slovenian: Zdravilo Fasenra je samo za enkratno uporabo.
English: Step 8 - Check the injection site
Slovenian: 8. korak - Preverite mesto injiciranja
English: Read the ‘Instructions for Use' for the Fasenra Pen carefully before using Fasenra.
Slovenian: Pred uporabo zdravila Fasenra skrbno preberite "Navodila za uporabo zdravila" peresnika Fasenra Pen.
English: Fasenra (N=318)
Slovenian: Zdravilo Fasenra (N=318)
English: Solution for injection 1 pre-filled syringe
Slovenian: raztopina za injiciranje 1 napolnjena injekcijska brizga
English: Clear to opalescent, colourless to yellow solution and may contain translucent or white to off-white particles.
Slovenian: Bistra do opalescentna, brezbarvna do rumena raztopina, ki lahko vsebuje prosojne oziroma bele ali skoraj bele delce.
English: Fasenra (N=73)
Slovenian: Zdravilo Fasenra (N=73)