FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Učinak benralizumaba na eozinofile u sluznici dišnih putova bolesnika s astmom koji imaju povišen broj eozinofila u sputumu (najmanje 2,5%) ocjenjivao se u 12-tjednom randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju faze 1, u kojem se benralizumab primjenjivao u supkutanoj dozi od 100 mg ili 200 mg.
English: Peel off the entire lid from the plastic tray.
Croatian: Odlijepite cijelu zaštitnu foliju s plastičnog podloška.
English: Effect on blood eosinophils
Croatian: Učinak na eozinofile u krvi
English: Fasenra can potentially cause serious allergic reactions.
Croatian: Pripazite na znakove ozbiljnih alergijskih reakcija Fasenra bi mogla uzrokovati ozbiljne alergijske reakcije.
English: Put the cap aside to throw away later.
Croatian: Odložite zatvarač sa strane da biste ga kasnije bacili.
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.
Croatian: U tim se ispitivanjima lijek Fasenra primjenjivao kao dodatak osnovnoj terapiji u dozi od 30 mg jedanput svaka 4 tjedna za prve 3 doze, a zatim svakih 4 ili 8 tjedana, a ocjenjivao se u odnosu na placebo.
English: Effect on eosinophils in the airway mucosa
Croatian: Učinak na eozinofile u sluznici dišnih putova
English: Pre-bronchodilator FEV1 (L)
Croatian: FEV1 prije primjene bronhodilatatora (l)
English: Fasenra solution for injection is supplied in a sterile single-use pre-filled syringe or pre-filled pen for individual use.
Croatian: Fasenra otopina za injekciju dolazi u sterilnoj napunjenoj štrcaljki ili napunjenoj brizgalici za jednokratnu uporabu namijenjenoj za samo jednu osobu.
English: Allergic reactions have occurred in patients receiving this medicine.
Croatian: Kod bolesnika koji su primali ovaj lijek zabilježene su alergijske reakcije.
English: Fasenra is clear to opalescent, colourless to yellow, and may contain translucent or white to off-white particles.
Croatian: Fasenra je bistra do opalescentna, bezbojna do žuta otopina koja može sadržavati prozirne ili bijele do bjelkaste čestice.
English: An effect of benralizumab on the pharmacokinetics of co-administered medicinal products is not expected.
Croatian: Ne očekuje se da će benralizumab utjecati na farmakokinetiku istodobno primijenjenih lijekova.
English: Benralizumab is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa).
Croatian: Benralizumab je humanizirano, afukozilirano monoklonsko protutijelo koje djeluje protiv eozinofila (IgG1, kapa).
English: • 1 Fasenra Pen from the refrigerator • 1 alcohol wipe
Croatian: • 1 Fasenra Pen iz hladnjaka
English: Read this ‘Instructions for Use' before you start using your Fasenra Pen and each time you get a refill.
Croatian: Pročitajte ove 'Upute za uporabu' prije nego što počnete koristiti svoj Fasenra Pen, ali i svaki put kad preuzmete novo pakiranje.
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).
Croatian: Stopa egzacerbacija koje su zahtijevale hospitalizaciju i/ili posjet hitnoj službi među bolesnicima liječenima lijekom Fasenra u odnosu na one koji su primali placebo u Ispitivanju 1 iznosila je 0,09 naspram 0,25 (omjer stopa: 0,37; 95% CI: 0,20; 0,67, p < 0,001), dok je u Ispitivanju 2 iznosila 0,12 naspram 0,10 (omjer stopa: 1,23; 95% CI: 0,64; 2,35, p = 0,538).
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.
Croatian: U Ispitivanju 4 ocjenjivali su se dugoročni učinci lijeka Fasenra na godišnju stopu egzacerbacija, plućnu funkciju, rezultate upitnika ACQ-6 i AQLA(S)+12 te održavanje smanjenja doze OKS-a uz 2 režima doziranja koja su se ispitivala u prethodnim ispitivanjima.
English: • 1 cotton ball or gauze
Croatian: • 1 komad pamučne vate ili gaze
English: Comprehensive instructions for administration using the pre-filled syringe/pre-filled pen (Fasenra Pen) are provided in the ‘Instructions for Use'.
Croatian: Sveobuhvatne upute za primjenu lijeka uz pomoć napunjene štrcaljke/napunjene brizgalice (Fasenra Pen) navedene su u 'Uputama za uporabu'.
English: • Each pre-filled syringe contains a single dose of Fasenra and cannot be re-used.
Croatian: • Svaka napunjena štrcaljka sadrži jednu dozu lijeka Fasenra i ne može se ponovno upotrijebiti.
English: Wilcoxon rank sum test (primary analysis method) Median % reduction in daily OCS dose from baseline (95% CI) 75 (60, 88) Wilcoxon rank sum test p-value
Croatian: Wilcoxonov test sume rangova (metoda za primarnu analizu) Medijan % smanjenja dnevne doze OKS-a od početne vrijednosti (95% CI) p-vrijednost za Wilcoxonov test sume rangova Model proporcionalnih izgleda (analiza osjetljivosti) Postotno smanjenje doze OKS-a od početka ispitivanja do 28. tjedna Smanjenje za ≥ 90%
English: Do not hold the plunger or plunger head while removing the needle cover.
Croatian: Nemojte držati štrcaljku za klip ili vrh klipa dok skidate zatvarač igle.
English: The other ingredients are histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20 and water for injections.
Croatian: Drugi sastojci su histidin, histidinklorid hidrat, trehaloza dihidrat, polisorbat 20 i voda za injekcije.
English: Step 2 - Prepare to use your pre-filled syringe
Croatian: 2. korak - Pripremite se za uporabu napunjene štrcaljke
English: You may see a drop of liquid at the end of the needle.
Croatian: Na vrhu igle možda ćete vidjeti kapljicu tekućine.
English: Each pack contains 1 Fasenra Pen
Croatian: Jedno pakiranje sadrži 1 brizgalicu Fasenra Pen
English: Animal studies showed no adverse effects of benralizumab treatment on fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala neželjene učinke benralizumaba na plodnost (vidjeti dio 5.3).
English: • Each Fasenra Pen contains a single dose of Fasenra and cannot be re-used.
Croatian: • Svaki Fasenra Pen sadrži jednu dozu lijeka Fasenra i ne može se ponovno upotrijebiti.
English: What Fasenra looks like and contents of the pack Fasenra is a solution in a clear glass syringe.
Croatian: Kako lijek Fasenra izgleda i sadržaj pakiranja Lijek Fasenra je otopina u prozirnoj staklenoj štrcaljki.
English: Step 4 - Choose the injection site
Croatian: 4. korak - Odaberite mjesto za injiciranje
English: Clean the injection site with an alcohol wipe in a circular motion.
Croatian: Kružnim pokretima očistite mjesto za injiciranje tupferom natopljenim alkoholom.
English: Step 3 - Check the liquid
Croatian: 3. korak - Pregledajte tekućinu
English: Store in the original package to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Step 8 - Check the viewing window
Croatian: 8. korak - Pregledajte prozorčić za provjeru
English: Based on population pharmacokinetic analysis, baseline hepatic function biomarkers (ALT, AST, and bilirubin) had no clinically relevant effect on benralizumab clearance.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, početne vrijednosti bioloških biljega jetrene funkcije (ALT, AST i bilirubin) nisu imale klinički značajnog učinka na klirens benralizumaba.
English: United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836
Croatian: United Kingdom AstraZeneca UK Limited Tel: +44 1582 836 836
English: Hold the Fasenra Pen in place for the entire injection.
Croatian: Držite Fasenra Pen na istom mjestu tijekom cijele injekcije.
English: Not powered to detect a treatment difference in patients with blood eosinophils <300 cells/μl.
Croatian: Nema statističku snagu za otkrivanje razlike između liječenja kod bolesnika kojima je broj eozinofila < 300 stanica/μl.
English: Results of annual exacerbation rate and lung function at end of treatment of Trial 1 and 2 by eosinophil count.
Croatian: Rezultati za godišnju stopu egzacerbacija i plućnu funkciju na kraju liječenja u Ispitivanjima 1 i 2 prema broju eozinofila
English: Do not try to inject yourself in the arm.
Croatian: Nemojte si pokušavati sami injicirati lijek u nadlakticu.
English: Hypersensitivity reactions** Anaphylactic reaction
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti** anafilaktička reakcija često nepoznato
English: A caregiver may inject you in the upper-arm, thigh, or abdomen.
Croatian: Njegovatelj Vam može injicirati lijek u nadlakticu, bedro ili trbuh.
English: Doses of up to 200 mg were administered subcutaneously in clinical trials to patients with eosinophilic asthma without evidence of dose-related toxicities.
Croatian: U kliničkim su se ispitivanjima bolesnicima s eozinofilnom astmom davale supkutane doze do 200 mg bez znakova toksičnosti povezane s dozom.
English: Intravenous and subcutaneous administration to cynomolgus monkeys was associated with reductions in peripheral blood and bone marrow eosinophil counts, with no toxicological findings.
Croatian: Intravenska i supkutana primjena kod makaki majmuna bila je povezana s padom broja eozinofila u perifernoj krvi i koštanoj srži, ali nisu pronađeni znakovi toksičnosti.
English: It should be injected into the thigh or abdomen.
Croatian: Lijek Fasenra treba injicirati u bedro ili abdomen.
English: A population pharmacokinetics analysis, indicated that there was no significant effect of gender and race on benralizumab clearance.
Croatian: Populacijska farmakokinetička analiza pokazala je da spol i rasa ne utječu značajno na klirens benralizumaba.
English: If you are breast-feeding or plan to breast-feed, talk to your doctor.
Croatian: Ako dojite ili planirate dojiti, obratite se svome liječniku.
English: Excipients: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20, water for injections.
Croatian: Pomoćne tvari: histidin, histidinklorid hidrat, trehaloza dihidrat, polisorbat 20, voda za injekcije.
English: Driving and using machines It is unlikely that Fasenra will affect your ability to drive and use machines.
Croatian: Nije vjerojatno da će Fasenra utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: In patients who received Fasenra in predecessor Trials 1 and 2, 73% were exacerbation-free in the extension Trial 4.
Croatian: Među bolesnicima koji su primali lijek Fasenra u prethodnim Ispitivanjima 1 i 2, njih 73% nije doživjelo egzacerbaciju u Ispitivanju
English: Based on population pharmacokinetic analysis, age did not affect benralizumab clearance.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, dob ne utječe na klirens benralizumaba.
English: Finger flange
Croatian: Rubnik za prste
English: Do not inject Fasenra if the liquid is cloudy, discoloured, or contains large particles.
Croatian: Nemojte injicirati lijek Fasenra ako je tekućina mutna, ako je promijenila boju ili sadrži velike čestice.
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).
Croatian: Uz preporučeni se režim doziranja smanjenje godišnje stope egzacerbacija opaženo u prethodnim placebom kontroliranim Ispitivanjima 1 i 2 (provedenima kod bolesnika s početnim brojem eozinofila u krvi ≥ 300 stanica/μl koji su uzimali visoke doze IKS-a) održalo i tijekom druge godine liječenja (Tablica 6).
English: Keep pushing until it is down as far as it will go.
Croatian: Nastavite pritiskati klip sve do kraja.
English: Intent to treat population (patients on high-dose ICS and blood eosinophils ≥300 cells/μl).
Croatian: Populacija predviđena za liječenje (bolesnici liječeni visokim dozama IKS-a kojima je broj eozinofila u krvi iznosio ≥ 300 stanica/μl).
English: Do not pull back on the plunger at any time.
Croatian: Ni u jednom trenutku nemojte povlačiti klip.
English: Predecessor Trial 3 patients who continued Fasenra treatment into Trial 4.
Croatian: Bolesnici iz prethodnog Ispitivanja 3 koji su nastavili liječenje lijekom Fasenra i u Ispitivanju
English: Fasenra is for single use only.
Croatian: Lijek Fasenra je namijenjen isključivo za jednokratnu uporabu.
English: • Put your used pre-filled syringe in a puncture-resistant sharps container right away after use.
Croatian: • Odložite upotrijebljenu štrcaljku u neprobojan spremnik za oštre predmete odmah nakon uporabe.
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
Croatian: Farmakokinetika benralizumaba kod bolesnika s astmom nakon supkutane primjene doza u rasponu od 2 do 200 mg bila je proporcionalna dozi.
English: Infections & infestations
Croatian: Infekcije i infestacije faringitis*
English: Read the ‘Instructions for Use' for the Fasenra Pen carefully before using Fasenra.
Croatian: Pažljivo pročitajte 'Upute za uporabu' brizgalice Fasenra Pen prije nego što primijenite lijek Fasenra.
English: e. Baseline is prior to Fasenra treatment in Trial 1 and 2.
Croatian: e. Početna vrijednost odnosi se na vrijednost prije liječenja lijekom Fasenra u Ispitivanjima 1 i 2.
English: Clear to opalescent, colourless to yellow solution and may contain translucent or white to off-white particles.
Croatian: Bistra do opalescentna, bezbojna do žuta otopina, koja može sadržavati prozirne ili bijele do bjelkaste čestice.
English: Do not throw away the pre-filled syringe in your household waste.
Croatian: Nemojte baciti štrcaljku u kućni otpad.
English: Similar maintenance of effect was observed throughout Trial 4 in lung function, ACQ-6 and AQLQ(S)+12 (Table 7).
Croatian: Slično održanje učinka tijekom cijelog Ispitivanja 4 opaženo je i za plućnu funkciju te rezultate upitnika ACQ-6 i AQLQ(S)+12 (Tablica 7).
English: Use your thumb to push down on the plunger head.
Croatian: Palcem pritisnite vrh klipa prema dolje.
English: Follow your healthcare provider's instructions on how to inject.
Croatian: Slijedite upute za injiciranje koje Vam je dao zdravstveni radnik.
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.
Croatian: Jedan ml otopine u napunjenoj štrcaljki za jednokratnu uporabu izrađenoj od stakla tipa I, s pričvršćenom iglom od nehrđajućeg čelika veličine 29G i 12,7 mm, čvrstim štitnikom igle i čepom klipa obloženim FluoroTec filmom u pasivnoj sigurnosnoj napravi.
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
Croatian: Tablica 3. Razlika između liječenja s obzirom na srednju vrijednost promjene ukupnih rezultata za simptome astme (ACQ-6 i AQLQ(s)+12) od početka ispitivanja do kraja liječenja - Bolesnici liječeni visokim dozama IKS-a kojima je broj eozinofila u krvi iznosio ≥ 300 stanica/μl
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
Croatian: Tablica 4. Stopa egzacerbacija i plućna funkcija (FEV1) na kraju liječenja prema broju egzacerbacija u prethodnih godinu dana - Bolesnici liječeni visokim dozama IKS-a kojima je broj eozinofila u krvi iznosio ≥ 300 stanica/μl
English: What Fasenra looks like and contents of the pack Fasenra is a solution which is colourless to yellow.
Croatian: Kako lijek Fasenra izgleda i sadržaj pakiranja Lijek Fasenra je bezbojna do žuta otopina.
English: Subgroup analyses by prior exacerbation history
Croatian: Analize podskupina prema egzacerbacijama u anamnezi
English: Position the Fasenra Pen at the injection site.
Croatian: Namjestite Fasenra Pen na mjesto za injiciranje.
English: No formal clinical studies have been conducted to investigate the effect of hepatic impairment on benralizumab.
Croatian: Nisu provedena formalna klinička ispitivanja koja bi ocijenila učinak oštećenja jetrene funkcije na benralizumab.
English: Step 8 - Check the injection site
Croatian: 8. korak - Pregledajte mjesto injiciranja
English: Reduction in the daily OCS dose to ≤5 mg/day Odds ratio (95% CI)
Croatian: Smanjenje dnevne doze OKS-a na ≤ 5 mg na dan Omjer izgleda (95% CI)
English: Step 9 - Check the injection site
Croatian: 9. korak - Pregledajte mjesto injiciranja
English: Step 6 - Pull off the needle cover
Croatian: 6. korak - Skinite zatvarač igle
English: If a dose of Fasenra is missed
Croatian: Ako ste propustili primiti dozu lijeka Fasenra
English: What Fasenra is and what it is used for What you need to know before you use Fasenra How to use Fasenra
Croatian: Što je Fasenra i za što se koristi Što morate znati prije nego počnete primati lijek Fasenra Kako primjenjivati lijek Fasenra Moguće nuspojave
English: Clinically significant exacerbations Rate
Croatian: Klinički značajne egzacerbacije Stopa
English: The estimated systemic clearance (CL) for benralizumab was at 0.29 L/d.
Croatian: Procijenjeni sistemski klirens benralizumaba iznosio je 0,29 l na dan.
English: Read this 'Instructions for Use' before you start using your Fasenra pre-filled syringe and each time you get a refill.
Croatian: Pročitajte ove 'Upute za uporabu' prije nego što počnete koristiti napunjenu štrcaljku s lijekom Fasenra, ali i svaki put kad preuzmete novo pakiranje.
English: Your Fasenra Pen
Croatian: Vaš Fasenra Pen
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
Croatian: Lijek Fasenra čuvajte u njegovoj kutiji u hladnjaku, na temperaturi između 2°C i 8°C, dok ga ne budete spremni primijeniti.
English: Solution for injection 1 pre-filled syringe
Croatian: Otopina za injekciju 1 napunjena štrcaljka
English: Let Fasenra warm up at room temperature 20°C to 25°C for about 30 minutes before giving the injection.
Croatian: Prije injiciranja ostavite lijek Fasenra da se ugrije na sobnoj temperaturi (20 - 25°C) približno 30 minuta.
English: Prior to administration, warm Fasenra by leaving carton at room temperature.
Croatian: Prije primjene, ostavite kutiju na sobnoj temperaturi i pričekajte da se lijek Fasenra ugrije.
English: Needle guard activation clips
Croatian: Kvačice za aktivaciju štitnika igle
English: Liquid medicine
Croatian: Tekući lijek
English: Syringe body
Croatian: Tijelo štrcaljke
English: Read the ‘Instructions for Use' for the pre-filled syringe carefully before using Fasenra.
Croatian: Pažljivo pročitajte 'Upute za uporabu' napunjene štrcaljke prije nego što primijenite lijek Fasenra.
English: Step 9 - Dispose the used pre-filled syringe
Croatian: 9. korak - Bacite upotrijebljenu štrcaljku
English: In a prenatal and postnatal development study in pregnant cynomolgus monkeys, there were no benralizumab-related maternal, embryo-foetal, or postnatal effects observed.
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja provedenom na skotnim ženkama makaki majmuna nisu opaženi štetni učinci benralizumaba na majku, zametak i plod ni postnatalni razvoj.
English: *Benralizumab is a humanised monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Croatian: *Benralizumab je humanizirano monoklonsko protutijelo koje se proizvodi u stanicama jajnika kineskog hrčka (engl.
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.
Croatian: Djelotvornost se u Ispitivanju 4 ocjenjivala i kod bolesnika s početnim brojem eozinofila u krvi < 300 stanica/µl i odgovarala je onoj opaženoj u Ispitivanjima 1 i 2.
English: Fasenra may be kept at room temperature up to 25°C for a maximum of 14 days.
Croatian: Fasenra se može čuvati na sobnoj temperaturi do 25°C tijekom najviše 14 dana.
English: Complete the following steps right away after removing the cap.
Croatian: Nakon što skinete zatvarač odmah dovršite preostale korake.
English: Trial 2
Croatian: Ispitivanje 2
English: Viewing window
Croatian: Prozorčić za provjeru
English: One mL solution in a sterile, single use pre-filled pen made from type I glass with staked 29-gauge ½-inch (12.7 mm) stainless steel needle, rigid needle shield, and Fluorotec-coated stopper in a pre-filled pen.
Croatian: Jedan ml otopine u sterilnoj napunjenoj brizgalici za jednokratnu uporabu izrađenoj od stakla tipa I, s pričvršćenom iglom od nehrđajućeg čelika veličine 29G i 12,7 mm, čvrstim štitnikom igle i čepom klipa obloženim FluoroTec filmom u napunjenoj brizgalici.
English: Subcutaneous use Read the instructions for use and the package leaflet before use
Croatian: Supkutana primjena Prije uporabe pročitajte upute za uporabu i uputu o lijeku
English: Reduction in the daily OCS dose to 0 mg/day* Odds ratio (95% CI)
Croatian: Smanjenje dnevne doze OKS-a na 0 mg na dan* Omjer izgleda (95% CI)
English: Disposal guidelines
Croatian: Smjernice za odlaganje
English: • 1 puncture-resistant sharps container.
Croatian: • 1 neprobojan spremnik za oštre predmete
English: Trial 1
Croatian: Ispitivanje 1
English: Exacerbation rate Difference Rate ratio (95% CI) Pre-bronchodilator FEV1 mean change Difference (95% CI)
Croatian: Omjer stopa (95% CI) FEV1 prije primjene bronhodilatatora (l) Srednja vrijednost promjene Razlika (95% CI)
English: The syringe may be kept at room temperature up to 25°C for a maximum of 14 days.
Croatian: Štrcaljka se može čuvati na sobnoj temperaturi do 25°C tijekom najviše 14 dana.
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.
Croatian: Primarna mjera ishoda bila je godišnja stopa klinički značajnih egzacerbacija astme kod bolesnika kojima je broj eozinofila u krvi na početku ispitivanja iznosio ≥ 300 stanica/μl i koji su uzimali visoke doze IKS-a te LABA lijek.
English: Renal and hepatic impairment No dose adjustment is required for patients with renal or hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu kod bolesnika s oštećenjem bubrežne ili jetrene funkcije (vidjeti dio 5.2).
English: Τηλ: +357 22490305
Croatian: Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305
English: Alcohol wipe
Croatian: Tupfer natopljen alkoholom
English: Fasenra is available in a pack containing 1 pre-filled syringe.
Croatian: Lijek Fasenra dolazi u pakiranju koje sadrži 1 napunjenu brizgalicu.
English: Fasenra 30 mg solution for injection in pre-filled syringe Fasenra 30 mg solution for injection in pre-filled pen
Croatian: Fasenra 30 mg otopina za injekciju u napunjenoj štrcaljki Fasenra 30 mg otopina za injekciju u napunjenoj brizgalici
English: Trial 3
Croatian: Ispitivanje 3
English: SD = standard deviation a. Baseline blood eosinophil counts ≥300 cells/μL and taking high-dose ICS: Fasenra administered at the recommended dosage regimen.
Croatian: Početni broj eozinofila u krvi ≥ 300 stanica/μl i primjena visokih doza IKS-a: Fasenra primijenjena prema preporučenom režimu doziranja.
English: Do not use your Fasenra pre-filled syringe if:
Croatian: Nemojte upotrijebiti napunjenu štrcaljku s lijekom Fasenra:
English: Each Fasenra Pen contains 1 dose of Fasenra that is for one-time use only.
Croatian: Jedan Fasenra Pen sadrži 1 dozu lijeka Fasenra namijenjenu samo za jednokratnu primjenu.
English: For Subcutaneous Injection Single-use Pre-filled Syringe
Croatian: Za supkutanu injekciju Napunjena štrcaljka za jednokratnu uporabu