FrancophonIA/ELRC3.0 huggingface dataset:
English: The second population PK model was applied to the multiple dose PK data from 22 paediatric aHUS patients receiving the recommended Soliris regimen in aHUS C10-003.
Croatian: Model druge populacijske farmakokinetičke analize primijenjen je na podatke farmakokinetičke analize za višestruke doze u 22 pedijatrijska bolesnika s aHUS-om koji su u ispitivanju aHUS-a
English: Time from current clinical TMA manifestation until first study dose (months), median ( min, max) Baseline platelet count (× 109/L), median (, min, max ) Baseline LDH (U/L), median (, min, max) Baseline eGFR (mL/min/1.73m2), median (min, max)
Croatian: LDH na početku (U/l), medijan (min, maks) eGFR na početku (ml/min/1,73 m2), medijan (min, maks)
English: Posology
Croatian: medijan
English: - If you have not been vaccinated against meningococcal infection unless you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated .
Croatian: najmanje 2 tjedna prije početka liječenja ili da ćete uzimati antibiotike koji smanjuju rizik od meningokokne infekcije do 2 tjedna nakon što ste bili cijepljeni.
English: Withdrawal of immunosuppressant and anticholinesterase therapies during Soliris treatment for refractory gMG was not assessed in the placebocontrolled studies.
Croatian: U placebom kontroliranim ispitivanjima nisu procjenjivane obustave terapija imunosupresivima i antikolinesteraznim lijekovima tijekom liječenja refraktornog gMG-a Solirisom.
English: No IST usage at baseline n (%)
Croatian: Bez primjene IST-a na početku ispitivanja n (%)
English: The primary analysis of the MG-ADL was a Worst-Rank ANCOVA with a mean rank of 56.6
Croatian: ANCOVA najgoreg ranga sa srednjom vrijednošću ranga od 56,6 u skupini koja je primala Soliris i
English: For adult aHUS, refractory gMG and NMOSD patients and paediatric aHUS patients supplemental dosing of Soliris is required in the setting of concomitant PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma infusion):
Croatian: PE/PI (plazmafereza ili zamjena plazme ili infuzija svježe zamrznute plazme): Vrsta intervencije koja uključuje plazmu
English: Additionally, all patients must be vaccinated against meningococcal infections at least 2 weeks prior to receiving Soliris unless the risk of delaying Soliris therapy outweighs the risks of developing a meningococcal infection.
Croatian: tjedna prije primanja lijeka Soliris, osim ako odgoda terapije Solirisom predstavlja veći rizik od rizika za razvoj meningokokne infekcije.
English: Excipients with known effect: Sodium (5 mmol per vial) For the full list of excipients, see section 6.1.
Croatian: Pomoćne tvari s poznatim učinkom: natrij (5 mmol po bočici)
English: Study ECU-NMO-301 was a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study of Soliris in patients with NMOSD.
Croatian: Ispitivanje ECU-NMO-301 bilo je dvostruko slijepo, randomizirano, placebom kontrolirano,
English: Change From Baseline QMG Total Score
Croatian: Početni rezultat QMG
English: 1/100 (1%) aHUS patients had low positive values for neutralizing antibodies.
Croatian: Niske pozitivne vrijednosti za neutralizirajuća protutijela ustanovljene su u 1/100 (1%) bolesnika s aHUS-om.
English: - polysorbate 80 (vegetable origin)
Croatian: Broj trombocita na početku (× 10
English: Hypertension
Croatian: Plodnost
English: At the last evaluation, 19 of 22 patients (86%) achieved eGFR
Croatian: U posljednjoj procjeni, 19 od 22 bolesnika (86%) postiglo je poboljšanje u vrijednosti eGFR od ≥15 ml/min/1,73 m2 u odnosu na početnu vrijednost.
English: SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Change in platelet count through week 26 (109/L)
Croatian: Promjena u broju trombocita do 26. tjedna (109/l) Hematološka normalizacija, n (%)
English: BATCH RELEASE
Croatian: Prijavljivanje nuspojava
English: - If you are allergic to eculizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na ekulizumab, proteine izvedene iz mišjih pripravaka, druga monoklonska protutijela ili neki drugi sastojak ovog lijeka (naveden u dijelu 6); - ako niste cijepljeni protiv meningokokne infekcije, osim ako uzimate antibiotike za smanjenje rizika od meningokokne infekcije do 2 tjedna nakon što ste bili cijepljeni; - ako imate meningokoknu infekciju.
English: • Summary of product characteristics
Croatian: • sažetak opisa svojstava lijeka
English: Paraesthesia, Tremor Syncope
Croatian: Poremećaji živčanog sustava glavobolja omaglica, disgeuzija parestezija, tremor sinkopa
English: If PNH patients discontinue treatment with Soliris they should be closely monitored for signs and symptoms of serious intravascular haemolysis.
Croatian: Prekid liječenja kod paroksizmalne noćne hemoglobinurije Bolesnike s PNH-om koji prekinu liječenje lijekom Soliris treba pomno nadzirati zbog moguće pojave znakova i simptoma ozbiljne intravaskularne hemolize.
English: LDH levels at end of study (median, U/L)
Croatian: LDH na početku ispitivanja (U/l), srednja vrijednost (SD)
English: Efficacy Parameter aHUS Study C10-004 (N = 41)
Croatian: Ispitivanje aHUS-a C10-004 (N = 41) u 26. tjednu
English: Patients received meningococcal vaccination prior to initiating treatment with Soliris or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Croatian: Prije započinjanja liječenja Solirisom bolesnici su primili meningokokno cjepivo ili su primali profilaktičku terapiju odgovarajućim antibioticima do 2 tjedna poslije cijepljenja.
English: In patients with aHUS, their kidney and blood cells, including platelets, can be inflamed which can lead to low blood counts (thrombocytopenia and anaemia), reduced or lost kidney function, blood clots, tiredness and difficulty in functioning.
Croatian: U bolesnika s atipičnim hemolitičko-uremijskim sindromom može doći do upalom posredovanog oštećenja bubrega i krvnih stanica, uključujući krvne pločice, što može dovesti do sniženog broja krvnih stanica
English: Infrequent antibody responses have been detected in Soliris-treated patients across all clinical studies.
Croatian: U svim kliničkim ispitivanjima rijetko je bio izmjeren odgovor protutijela u bolesnika liječenih lijekom Soliris.
English: Baseline platelet count (x 109/L), median ( min, max)
Croatian: 9/l), medijan (min, maks)
English: Patients either received meningococcal vaccination at least 2 weeks prior to initiating treatment with Soliris or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Croatian: Najmanje 2 tjedna prije početka liječenja Solirisom bolesnici su cijepljeni protiv meningokoka ili su primali profilaktičku terapiju odgovarajućim antibioticima do 2 tjedna poslije cijepljenja.
English: In refractory gMG placebo-controlled studies, no antidrug antibodies were observed.
Croatian: Protutijela na lijek nisu opažena u placebom kontroliranim ispitivanjima refraktornog gMG-a.
English: *One patient achieved eGFR improvement after renal transplant A total of 22 paediatric and adolescents patients (aged 5 months to 17 years) received Soliris in aHUS Study C10-003.
Croatian: U ispitivanju aHUS-a C10-003, Soliris su primila ukupno 22 pedijatrijska i adolescentna bolesnika (u dobi od 5 mjeseci do 17 godina).
English: Table 17: Baseline Characteristics of Paediatric and Adolescents Patients Enrolled in aHUS Study
Croatian: Tablica 17: Karakteristike pedijatrijskih i adolescentnih bolesnika uključenih u ispitivanje aHUS-a C10-003 na početku ispitivanja
English: Patients with platelet count normalization, n (%) Complete TMA response, n (%)
Croatian: Bolesnici s normalizacijom broja trombocita, n (%)
English: Transfusion Avoidance during treatment (%)
Croatian: Izbjegnuta transfuzija tijekom liječenja (%) LDH razine na kraju ispitivanja (medijan, U/l)
English: Abnormal dreams, Sleep disorder
Croatian: poremećaj spavanja
English: Patients in aHUS C10-003 received Soliris for a minimum of 26 weeks.
Croatian: (min, maks) Bolesnici u ispitivanju aHUS-a C10-003 primali su Soliris najmanje 26 tjedana.
English: n (%) (95% CI) eGFR change mL/min/1.73 m2: median (range) eGFR improvement
Croatian: Promjena eGFR u ml/min/1,73 m2: medijan (raspon)
English: Number of PE/PI sessions in 7 days prior to first dose of eculizumab, median (min, max) Baseline platelet count (× 109/L), mean (SD) Baseline LDH (U/L), mean (SD) Patients without identified mutation, n (%)
Croatian: Broj PE/PI terapija zbog aktualne kliničke manifestacije TMA, medijan (min, maks) Broj PE/PI terapija u 7 dana prije prve doze ekulizumaba, medijan (min, maks)
English: RMP.
Croatian: NP
English: • inflammation of the peritoneum (the tissue that lines most of the organs of the abdomen), constipation,
Croatian: • upala potrbušnice (tkiva koje oblaže većinu trbušnih organa), zatvor, nelagoda u trbuhu nakon obroka (dispepsija), nadimanje trbuha
English: Patients received meningococcal vaccination prior to receipt of Soliris or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Croatian: Prije lijeka Soliris bolesnici su primili meningokokno cjepivo ili su profilaktički liječeni odgovarajućim antibioticima tijekom 2 tjedna nakon cijepljenja.
English: Nine of the 11 patients who required dialysis at baseline no longer required dialysis after Study Day 15 of eculizumab treatment.
Croatian: više nije trebalo dijalizu nakon 15. dana liječenja ekulizumabom.
English: For 300 mg doses, use 30 ml of Soliris (10 mg/ml)
Croatian: 30 ml lijeka Soliris (10 mg/ml) i dodajte 30 ml otapala.
English: Other cases of Neisseria species have been reported including sepsis with Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp unspecified.
Croatian: Neisseria gonorrhoeae, Neisseria sicca/subflava te nespecificiranim bakterijama Neisseria spp.
English: 3- Administration
Croatian: 3 - Primjena
English: Urticaria, Erythema, Petechiae, Hyperhidrosis, Dry skin
Croatian: Poremećaji kože i potkožnog tkiva osip, pruritus, alopecija urtikarija, eritem, petehije, hiperhidroza,
English: 20g/L, n (%) (95% CI)
Croatian: Svi bolesnici, n (%) (95% CI)
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki spontana erekcija menstrualni poremećaj
English: Interrupting or stopping treatment with Soliris may cause your gMG symptoms to come back.
Croatian: Ako prestanete primati Soliris za liječenje atipičnog hemolitičko-uremijskog sindroma Prekid ili završetak liječenja lijekom Soliris može prouzročiti povratak simptoma atipičnog hemolitičko-uremijskog sindroma.
English: Cough, Oropharyngeal pain
Croatian: Tablični sažetak nuspojava
English: Change from baseline at 12 weeks in Plasma Free Haemoglobin (mg/dL) Change from baseline Type III RBC clone size (Percent of aberrant cells) Change from baseline at 12 weeks of PedsQLTM4.0 Generic Core scale (patients) 10.5 (6.66)
Croatian: Promjena broja eritrocitnih klonalnih stanica tipa III (postotak aberantnih stanica) od početne vrijednosti Promjena u rezultatima generičkog upitnika za mjerenje kvalitete života
English: Interrupting or ending treatment with Soliris may cause your PNH symptoms to come back more severely soon.
Croatian: Ako prestanete primati Soliris za liječenje paroksizmalne noćne hemoglobinurije Prekid ili prestanak liječenja lijekom Soliris može prouzročiti brz povratak još težih simptoma paroksizmalne noćne hemoglobinurije.
English: Diarrhoea, Vomiting, Nausea, Abdominal pain
Croatian: Poremećaji probavnog sustava proljev, povraćanje, mučnina, bol u trbuhu zatvor, dispepsija, distenzija abdomena gastroezofagealna refluksna bolest, bol u desnima
English: Patients were permitted to receive background immunosuppressant therapies at stable dose during the study, with the exclusion of rituximab and mitoxantrone.
Croatian: Tijekom ispitivanja bolesnici su smjeli primati osnovnu terapiju imunosupresivima u stabilnoj dozi,
English: Palpitation
Croatian: koagulopatija
English: Time from aHUS diagnosis to first study dose (months), median ( min, max)
Croatian: Vrijeme od prve dijagnoze do probira, u mjesecima, medijan (min, maks)
English: Supplemental Soliris Dose
Croatian: Drugi lijekovi i Soliris
English: Coombs test positive c
Croatian: Wilcoxonov test rangiranih predznaka
English: Adjusted adjudicated ARR
Croatian: Prilagođen ARR prema neovisnoj procjeni a
English: Change from baseline at 12 weeks of PedsQLTM4.0 Generic Core scale (parents) Change from baseline at 12 weeks of PedsQLTM Multidimensional Fatigue (patients)
Croatian: PedsQLTM 4.0 Generic Core Scale do
English: Daily TMA Intervention rate, median (range) Before eculizumab treatment, median On eculizumab treatment, median
Croatian: Stopa intervencija zbog TMA Dnevna stopa prije ekulizumaba, medijan (min, maks) Dnevna stopa tijekom ekulizumaba, medijan (min, maks) P-vrijednost
English: (range: 26 to 129 weeks).
Croatian: Poluvijek eliminacije iznosio je 297 sati (približno 12,4 dana).
English: Soliris is indicated in adults for the treatment of: - Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor
Croatian: U programu kliničkog razvoja ekulizumaba za liječenje NMOSD-a, doza Solirisa u odraslih bolesnika s
English: In Study ECU-MG-301, a clinical responder in the MG-ADL total score was defined as having at least a 3-point improvement.
Croatian: MG-ADL-a definiran je onaj bolesnik koji ima poboljšanje za najmanje 3 boda.
English: C08-003, C09-001r and C10-003, the safety profile appeared similar to that observed in adult aHUS patients.
Croatian: U pedijatrijskih bolesnika s aHUS-om (u dobi od 2 mjeseca do manje od 18 godina) uključenih u ispitivanja aHUS-a C08-002, C08-003, C09-001r i C10-003, sigurnosni profil činio se sličan onome u odraslih bolesnika s aHUS-om.
English: In study C04-001 (TRIUMPH) PNH patients with at least 4 transfusions in the prior 12 months, flow cytometric confirmation of at least 10% PNH cells and platelet counts of at least 100,000/microliter were randomized to either Soliris (n = 43) or placebo (n = 44).
Croatian: 100 000/mikrolitar bili su randomizirani u skupinu koja je primala Soliris (N = 43) ili u skupinu koja je primala placebo (N = 44).
English: A reduction in terminal complement activity and an increase in platelet count relative to baseline were observed after commencement of Soliris.
Croatian: Nakon početka liječenja lijekom Soliris, opaženo je smanjenje aktivnosti terminalnih komponenti komplementa i povećanje broja trombocita u odnosu na početnu vrijednost.
English: Double Blind
Croatian: Omjer stope
English: Solvent: water for injections
Croatian: Otapalo: voda za injekcije Kako Soliris izgleda i sadržaj pakiranja
English: Total
Croatian: Nakon
English: In the eculizumab NMOSD clinical development program, the dose of Soliris in adult patients with NMOSD was 900 mg every 7 ± 2 days for 4 weeks, followed by 1200 mg at Week 5 ± 2 days, then 1200 mg every 14 ± 2 days for the study duration.
Croatian: NMOSD-om iznosila je 900 mg svakih 7 ± 2 dana tijekom 4 tjedna, nakon toga je slijedila doza od 1200 mg u 5. tjednu ± 2 dana, a zatim su tijekom trajanja ispitivanja primali 1200 mg svakih
English: Tinnitus, Vertigo
Croatian: kongestija nosa, rinoreja
English: Age at MG Diagnosis (years),
Croatian: Dob u vrijeme dijagnoze MG-a (godine), srednja vrijednost (min, maks)
English: 4.7 Effects on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Soliris ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Children and adolescents Onbrez Breezhaler should not be given to children or adolescents below the age of 18 years.
Croatian: Djeca i adolescenti Onbrez Breezhaler se ne smije davati djeci ili adolescentima mlađim od 18 godina.
English: These may be signs of a condition called bronchospasm.
Croatian: To mogu biti znaci stanja koje se naziva bronhospazam.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Onbrez Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Croatian: Onbrez Breezhaler se može koristiti tijekom trudnoće samo ako je očekivana korist veća od mogućih rizika.
English: In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Croatian: U ovom pakiranju naći ćete inhalator i kapsule (u blisteru) koje sadrže lijek kao prašak inhalata.
English: Onbrez Breezhaler should be administered at the same time of the day each day.
Croatian: Onbrez Breezhaler treba primjenjivati svakog dana u isto vrijeme.
English: Do not use Onbrez Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Onbrez Breezhaler - ako ste alergični na indakaterol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Onbrez Breezhaler (i.e. medicines such as salmeterol and formoterol).
Croatian: Posebno Vas molimo da obavijestite svog liječnika ako uzimate: lijekove za probleme s disanjem koji su slični Onbrez Breezhaleru (tj. lijekovi kao što su salmeterol i formoterol).
English: If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Onbrez Breezhaler should be discontinued immediately and alternative therapy instituted.
Croatian: Ako znakovi koji se pojave ukazuju na alergijsku reakciju (osobito poteškoće u disanju ili gutanju, oticanje jezika, usana i lica, urtikarija, osip na koži), primjenu Onbrez Breezhaler treba odmah prekinuti i uvesti alternativnu terapiju.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Onbrez Breezhaler therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Onbrez Breezhaler uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: COPD is a long-term disease and you should use Onbrez Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Croatian: KOPB je dugotrajna bolest i trebate primijeniti Onbrez Breezhaler svaki dan, a ne samo kada imate poteškoće s disanjem ili druge simptome KOPB-a.
English: Please read the following instructions carefully to learn how to use and care for your Onbrez Breezhaler inhaler.
Croatian: Molimo Vas da pažljivo pročitate upute u nastavku kako biste naučili primjenjivati i brinuti se o svom Onbrez Breezhaler inhalatoru.
English: The 24-hour bronchodilator effect of Onbrez Breezhaler was maintained from the first dose throughout a one-year treatment period with no evidence of loss in efficacy (tachyphylaxis).
Croatian: Bronhodilatacijski 24-satni učinak Onbrez Breezhalera bio je zadržan od prve doze kroz jednogodišnje razdoblje liječenja bez dokaza gubitka djelotvornosti (tahifilaksija).
English: Tell your doctor immediately if your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse.
Croatian: odmah se obratite svom liječniku ako Vam se simptomi KOPB-a (nedostatak daha prilikom udisanja, piskanje pri disanju, kašalj) nisu popravili ili ako su se pogoršali.
English: The mean of the maximum changes in blood glucose were similar between Onbrez Breezhaler and placebo.
Croatian: Srednja vrijednost najvećih promjena glukoze u krvi bila je slična za Onbrez Breezhaler i placebo.
English: As with other inhalation therapy, administration of Onbrez Breezhaler may result in paradoxical bronchospasm that may be life-threatening.
Croatian: Kao i kod drugih inhalacijskih terapija, primjena Onbrez Breezhalera može dovesti do paradoksalnog bronhospazma koji može ugroziti život.
English: You should not use Onbrez Breezhaler unless your doctor tells you so.
Croatian: Nemojte koristiti Onbrez Breezhaler osim ako Vam to nije rekao liječnik.
English: As demonstrated in 605 patients with COPD in a 26-week, double-blind, placebo-controlled Phase III study, there was no clinically relevant difference in the development of arrhythmic events monitored over 24 hours, at baseline and up to 3 times during the 26-week treatment period, between patients receiving recommended doses of Onbrez Breezhaler treatment and those patients who received placebo or treatment with tiotropium.
Croatian: Kao što je pokazano u 605 bolesnika s KOPB-om u dvostruko slijepom, placebo kontroliranom ispitivanju faze III u trajanju od 26 tjedana, nije bilo klinički značajne razlike u razvoju aritmičkih događaja praćenih tijekom 24 sata, na početku i do 3 puta tijekom razdoblja liječenja od 26 tjedana, između bolesnika koji bili liječeni preporučenim dozama Onbrez Breezhalera i onih koji su primali placebo ili bili liječeni tiotropijem.
English: If you have questions about how long to continue your treatment with Onbrez Breezhaler, talk to your doctor or pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo trebate provoditi liječenje Onbrez Breezhalerom, obratite se svom liječniku ili ljekarniku.
English: Onbrez Breezhaler was shown to reduce lung hyperinflation, resulting in increased inspiratory capacity during exercise and at rest, compared to placebo.
Croatian: Dokazano je da Onbrez Breezhaler smanjuje plućnu hiperinflaciju, što dovodi do povećanog kapaciteta udisanja tijekom vježbe i u mirovanju, u usporedbi s placebom.
English: If you use more Onbrez Breezhaler than you should If you have inhaled too much Onbrez Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit.
Croatian: Ako ste udahnuli previše Onbrez Breezhalera ili ako je netko drugi koristio Vaše kapsule, morate odmah obavijestiti svog liječniku ili otići u najbližu jedinicu hitne pomoći.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Onbrez Breezhaler at the recommended doses than on placebo.
Croatian: Tijekom ispitivanja, klinički značajne promjene glukoze u krvi u pravilu su bile češće za 1-2% pri primjeni Onbrez Breezhalera u preporučenim dozama nego pri primjeni placeba.
English: Therefore, long-acting beta2-adrenergic agonists such as Onbrez Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval.
Croatian: Stoga, dugodjelujuće beta2adrenergičke agoniste kao što je Onbrez Breezhaler treba oprezno koristiti u bolesnika s poznatim ili suspektnim produljenjem QT intervala ili u onih koji se liječe lijekom koji utječe na QT interval.
English: At 600 microgram once-daily, the safety profile of Onbrez Breezhaler was overall similar to that of recommended doses.
Croatian: Pri dozi od 600 mikrograma jedanput na dan, sigurnosni profil Onbrez Breezhalera u cjelini je bio sličan onom pri preporučenim dozama.
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Onbrez Breezhaler.
Croatian: Istodobna primjena drugih simpatomimetičkih lijekova (samih ili u kombiniranom liječenju) može potencirati nuspojave Onbrez Breezhalera.