FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Vyxeos liposomal should be discontinued in patients with impaired cardiac function unless the benefit of initiating or continuing treatment outweighs the risk (see sections 4.5 and 4.8).
Croatian: Liječenje lijekom Vyxeos liposomalni treba obustaviti u bolesnika s oštećenom srčanom funkcijom osim ako je korist od započinjanja liječenja ili nastavka liječenja veća od rizika (vidjeti dijelove 4.5 i
English: Vyxeos liposomal treatment should be discountinued in patients who develop signs or symptoms of cardiomyopathy, unless the benefits outweigh the risks (see section
Croatian: Potrebno je prekinuti liječenje lijekom Vyxeos liposomalni u bolesnika koji razviju znakove ili simptome kardiomiopatije, osim ako je korist veća od rizika (vidjeti dio 4.4).
English: Immune systems disorders Very Common
Croatian: Poremećaji imunološkog sustava
English: Palmar-plantar erythrodysaesthesia syndrome
Croatian: Sindrom palmarno-plantarne eritrodizestezije (0,8)
English: Administration instructions
Croatian: Upute za primjenu
English: 30 seconds.
Croatian: do najviše 4 sata.
English: How to store Vyxeos liposomal
Croatian: Kako čuvati Vyxeos liposomalni
English: Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion daunorubicin/cytarabine
Croatian: Vyxeos liposomalni 44 mg/100 mg prašak za koncentrat za otopinu za infuziju daunorubicin/citarabin
English: Each vial contains 44 mg of daunorubicin and 100 mg of cytarabine.
Croatian: Jedna bočica sadrži 44 mg daunorubicina i 100 mg citarabina.
English: Severe myelosuppression
Croatian: Teška mijelosupresija
English: Vyxeos liposomal should be administered intravenously only.
Croatian: Vyxeos liposomalni se smije primjenjivati samo intravenski.
English: Cardiotoxic agents
Croatian: Kardiotoksični lijekovi
English: Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Vyxeos liposomalni 44 mg/100 mg prašak za koncentrat za otopinu za infuziju.
English: ADRs reported in clinical studies in patients treated with Vyxeos liposomal
Croatian: Tablica 2: Nuspojave prijavljene u kliničkim ispitivanjima u bolesnika liječenih lijekom Vyxeos liposomalni (n=375)
English: Cardiotoxicities were seen in Vyxeos liposomal clinical studies.
Croatian: U kliničkim ispitivanjima lijeka Vyxeos liposomalni zapažene su kardiotoksičnosti.
English: • kidney failure and abnormal blood tests due to massive death of cancer cells (Tumour lysis syndrome).
Croatian: • zatajenje bubrega i poremećene krvne pretrage zbog masivnog odumiranja stanica tumora
English: Second induction daunorubicin 44 mg/m and cytarabine 100 mg/m on days 1 and 3
Croatian: Druga indukcija daunorubicin 44 mg/m i citarabin 100 mg/m
English: Patients should be monitored for haematologic response and toxicities.
Croatian: Preporučene prilagodbe doze tijekom liječenja Bolesnike treba nadzirati da bi se uočili znakovi hematološkog odgovora i toksičnosti.
English: • After dilution, the solution in infusion bags should be stored in a refrigerator (2°C to 8°C) for up to 4 hours.
Croatian: • Nakon razrjeđivanja, otopinu u vrećicama za infuziju treba čuvati u hladnjaku (od 2°C do 8°C)
English: After reconstitution the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine encapsulated in liposomes
Croatian: Nakon rekonstitucije otopina sadrži 2,2 mg/ml daunorubicina i 5 mg/ml citarabina inkapsuliranih u liposomima
English: • If the reconstituted product is not diluted into an infusion bag immediately, store in a refrigerator (2ºC to 8ºC) for up to 4 hours.
Croatian: • Ako se rekonstituiran lijek ne razrijedi odmah u vrećici za infuziju, može se čuvati u hladnjaku (od 2ºC do 8ºC) do najviše 4 sata.
English: Pregnancy warning/women of childbearing potential Patients should be advised to avoid becoming pregnant while receiving Vyxeos liposomal.
Croatian: Bolesnice treba upozoriti da ne zatrudne dok dobivaju lijek Vyxeos liposomalni.
English: Vyxeos liposomal should only be used in patients with severe renal impairment if the benefits outweigh the risks (see sections 4.4 and 5.2).
Croatian: Vyxeos liposomalni se smije koristiti u bolesnika s teškim oštećenjem funkcije bubrega samo ako je korist veća od rizika (vidjeti dijelove 4.4 i 5.2).
English: Oedema (52.3) Fatigue (46.4) Chills (31.2) Pyrexia (29.6)
Croatian: Vrlo često Edem (52,3) Umor (46,4) Zimica (31,2)
English: Any unused product should be disposed of in accordance with local requirements for cytotoxic agents.
Croatian: Sav neiskorišteni lijek potrebno je zbrinuti sukladno nacionalnim propisima za citotoksične lijekove.
English: Dizziness (0.8)
Croatian: Manje često Omaglica (0,8)
English: Visual impairment (0.3)
Croatian: Manje često Oštećenje vida (0,3)
English: Fatigue and dizziness have been reported with the use of Vyxeos liposomal.
Croatian: Umor i omaglica prijavljene su uz primjenu lijeka Vyxeos liposomalni.
English: Distearoylphosphatidylcholine Distearoylphosphatidylglycerol Cholesterol
Croatian: Distearoilfosfatidilkolin Distearoilfosfatidilglicerol Kolesterol
English: First induction daunorubicin 44 mg/m and cytarabine 100 mg/m on days 1, 3, and 5
Croatian: Prva indukcija daunorubicin 44 mg/m i citarabin 100 mg/m
English: CR, n (%) Odds ratio (95% CI) p-value (2-sided)
Croatian: Omjer izgleda (95%-tni CI) p-vrijednost (2-strana)
English: Vyxeos liposomal should only be used in patients with severe hepatic and/or renal impairment if the benefits outweigh the risks (see section 4.2).
Croatian: Vyxeos liposomalni se smije koristiti u bolesnika s teškim oštećenjem funkcije jetre i/ili bubrega samo ako je korist veća od rizika (vidjeti dio 4.2).
English: How you are given Vyxeos liposomal
Croatian: Kako ćete primati Vyxeos liposomalni
English: Vyxeos liposomal should only be used in patients with severe hepatic impairment if the benefits outweigh the risks (see section 4.4).
Croatian: Vyxeos liposomalni se smije koristiti u bolesnika s teškim oštećenjem funkcije jetre samo ako je korist veća od rizika (vidjeti dio 4.4).
English: The incidence of haemorrhage events is 69.1%; the incidence of non-serious events of haemorrhage was 67.2 %; the incidence of serious events of haemorrhage is 5.6%; the incidence of haemorrhage which led to discontinuation is 0.
Croatian: Incidencija krvarenja bila je 69,1%; incidencija slučajeva krvarenja koji nisu bili ozbiljni bila je 67,2 %; incidencija ozbiljnih krvarenja bila je 5,6%; incidencija krvarenja koja je dovela do prekida primjene lijeka bila je 0.
English: What Vyxeos liposomal looks like and contents of the pack
Croatian: Kako čuvati Vyxeos liposomalni Sadržaj pakiranja i druge informacije
English: Haemorrhage (13.1)
Croatian: Vrlo često Dispneja (13,1)
English: The pharmacokinetics of daunorubicin and cytarabine administered as Vyxeos liposomal were investigated in adult patients who received a dose of daunorubicin 44 mg/m and cytarabine 100
Croatian: Farmakokinetika daunorubicina i citarabina primijenjenih kao Vyxeos liposomalni ispitivana je u odraslih bolesnika koji su primali dozu daunorubicina 44 mg/m i citarabina 100 mg/m u obliku intravenske infuzije u trajanju od 90 minuta 1., 3. i 5. dana.
English: Haemorrhage
Croatian: • svrbež
English: Complete response rate
Croatian: Način primjene
English: For moderate hypersensitivity symptoms (e.g., moderate rash, flushing, mild dyspnoea, chest discomfort) the treatment should be stopped.
Croatian: Potrebno je prekinuti liječenje ako se pojave umjereni simptomi preosjetljivosti (npr. umjeren osip, navale crvenila, blaga dispneja, nelagoda u prsištu).
English: Renal insufficiency (10.4)
Croatian: Vrlo često Umor (10,4)
English: Dosing schedule
Croatian: Režim doziranja
English: You may feel sleepy or dizzy after having Vyxeos liposomal.
Croatian: Nakon primanja lijeka Vyxeos liposomalni mogu se pojaviti pospanost ili omaglica.
English: In clinical studies only, Vyxeos liposomal 100 units/m2/day (equivalent to 44 mg/100 mg/m2) was administered intravenously over 90 minutes on days 1, 3, and 5 for the first induction and on days 1 and 3 for patients requiring a second induction.
Croatian: Samo u kliničkim ispitivanjima, Vyxeos liposomalni 100 jedinica/m2/dan (jednako 44 mg/100 mg/m2) primijenjen je intravenski tijekom
English: The pharmacokinetics of Vyxeos liposomal in patients aged > 85 years has not yet been evaluated.
Croatian: > 85 godina nije još procijenjena.
English: Package leaflet: Information for the patient Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion daunorubicin and cytarabine
Croatian: Vyxeos liposomalni 44 mg/100 mg prašak za koncentrat za otopinu za infuziju daunorubicin i citarabin
English: Headache (32.3)
Croatian: Pireksija (29,6)
English: What Vyxeos liposomal is used for
Croatian: Za što se Vyxeos liposomalni koristi
English: Renal impairment
Croatian: Mjeseci od randomizacije
English: The Decentralised procedure LT/H/0112/001/DC started on 24 September 2014.
Croatian: Decentralizirani postupak LT/H/0112/001/DC započeo je 24. rujna 2014.
English: Annex II
Croatian: Dodatak II.
English: The EAGER study
Croatian: Ispitivanje EAGER
English: Difference in the incidence of adverse events
Croatian: Razlika u odnosu na pojavu neželjenih događaja
English: Scientific conclusions and grounds for positive opinion
Croatian: Znanstveni zaključci i razlozi za pozitivno mišljenje
English: The CMDh 60 day procedure was initiated on 03 August 2015.
Croatian: CMDh-ov 60-dnevni postupak započeo je 3. kolovoza 2015.
English: Greater safety in a substantial portion of the target population
Croatian: Veća sigurnost u znatnom udjelu ciljne populacije
English: The application was submitted to the reference Member State (RMS): Lithuania, and the concerned Member States (CMS): Bulgaria, Estonia, Hungary, Latvia, Poland and Romania.
Croatian: Zahtjev je dostavljen referentnoj državi članici (RDČ): Litvi te predmetnim državama članicama (PDČ): Bugarskoj, Estoniji, Mađarskoj, Latviji, Poljskoj i Rumunjskoj.
English: Safety was the primary endpoint of this study, nevertheless it was powered for efficacy (secondary endpoint) and therefore demonstrated non-inferiority in terms of efficacy only.
Croatian: Sigurnost je bila primarna krajnja točka navedenog ispitivanja, no bez obzira na to temeljila se na učinkovitosti (sekundarna krajnja točka) te je stoga dokazana neinferiornost jedino u smislu učinkovitosti.
English: Tobramycin is an aminoglycoside antibiotic.
Croatian: Tobramycin je antibiotik aminoglikozoid.
English: These observations were replicated in post-hoc analyses of different age groups.
Croatian: Ta su razmatranja ponovljena u analizama post hoc različitih dobnih skupina.
English: Although fewer children receiving TIP discontinued the treatment, the overall number of children in EAGER study was small, and thus no definite conclusion about this subpopulation can be drawn.
Croatian: Iako je manji broj djece koja su primala TIP prekinuo liječenje, ukupan broj djece u ispitivanju EAGER bio je mali, stoga nije moguće izvesti konačan zaključak o navedenoj podpopulaciji.
English: Day 60 of the CMDh procedure was on 01 October 2015 and since the Member States failed to reach an agreement, the procedure was referred to the CHMP in accordance with Article 29(4) of Directive 2001/83/EC.
Croatian: Šezdeseti dan postupka CMDh-a bio je 1. listopada 2015., a s obzirom na to da države članice nisu postigle dogovor, postupak je upućen CHMP-u, a u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
English: It is therefore established that there is a portion of the target population who cannot use powder inhalator due to the development of intolerance.
Croatian: Stoga se utvrđuje da postoji udio ciljne populacije koji ne može upotrebljavati nebulizator s praškom zbog razvoja netolerancije.
English: • The Committee considered the notification of the referral initiated by the Reference Member State Lithuania under Article 29(4) of Directive 2001/83/EC where the Concerned Member State Poland raised objections to the granting of the marketing authorisation;
Croatian: • Odbor je razmotrio obavijest o upućivanju koje je inicirala referentna država članica Litva u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ u kojem je predmetna država članica Poljska izrazila prigovore na davanje odobrenja za stavljanje u promet;
English: The CHMP issued a positive opinion by consensus recommending the granting of the marketing authorisation and of the summary of product characteristics, labelling and package leaflet as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion.
Croatian: CHMP je izdao pozitivno mišljenje na temelju konsenzusa te preporučio davanje odobrenja za stavljanje u promet, uz sažetak svojstava proizvoda, označivanje i upute o lijeku koji ostaju kao kod zadnje verzije utvrđene tijekom postupka Skupine za koordinaciju, kao što je spomenuto u Prilogu III. mišljenja CHMP-a.
English: When taken together, these elements allow to estimate that at least 10% of the target population may not be able to use TOBI Podhaler due to intolerance.
Croatian: Uzimajući navedene elemente zajedno, možemo procijeniti da najmanje 10 % ciljne populacije možda neće biti u mogućnosti uzimati lijek TOBI Podhaler zbog netolerancije.
English: For these patients, the nebuliser solution is a safer alternative (in terms of tolerability) and 10% is considered by CHMP to be a substantial portion of the target population.
Croatian: Kad je riječ o tim bolesnicima, otopina za nebulizator sigurnija je alternativa (u smislu podnošljivosti), a CHMP smatra da je 10 % znatan udio ciljne populacije.
English: Overall summary of the scientific evaluation of Tobramycin VVB and associated names (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene lijeka Tobramycin VVB i povezanih imena (vidi Prilog I.)
English: The overall discontinuation rates for TIP were 3.6% in the children (≥6 to <13 years), 18.2% in the adolescents (≥13 to <20 years), and 32.7% in the adults (≥ 20 years), while the discontinuation rates with TIS were 16.7% in the children and adolescents, and 18.9% in the adults.
Croatian: Cjelokupne stope prekida primjene lijeka TIP iznosile su 3,6 % u djece (≥ 6 do < 13 godina), 18,2 % u adolescenata (≥ 13 do < 20 godina) te 32,7 % u odraslih (≥ 20 godina), dok su stope prekida primjene lijeka TIS iznosile 16,7 % u djece i adolescenata te 18,9 % u odraslih.
English: Results of audiology performed in a subpopulation of patients (TIP: 78 [25.3%]; TIS: 45 [21.5%]) revealed that a higher proportion of TIP-treated patients (25.6%; 20/78) than TIS-treated patients (15.6%; 7/45) experienced a decrease from baseline in any audiology test frequency at any visit.
Croatian: Rezultati audiološkog ispitivanja izvedenog u podpopulaciji bolesnika (TIP: 78 [25,3 %]; TIS: 45 [21,5%]) otkrili su da je veći udio bolesnika liječenih TIP-om (25,6 %; 20/78) u odnosu na bolesnike liječene TIS-om (15,6 %; 7/45) doživio smanjenje u odnosu na početno stanje u bilo kojoj učestalosti audiološkog ispitivanja u bilo kojem posjetu.
English: With regards to the claim of clinical superiority on the ground of greater safety in a substantial portion of the target population, the applicant was requested by CHMP during the procedure:
Croatian: U pogledu tvrdnje o kliničkoj nadmoći na temelju veće sigurnosti u velikom udjelu ciljne populacije CHMP je tijekom postupka od podnositelja zahtjeva zatražio sljedeće:
English: In addition, 3.9% (12/308) of TIP-treated patients discontinued due to cough vs 1% (2/209) of TIS-treated patients.
Croatian: Nadalje, 3,9 % (12/308) bolesnika liječenih TIP-om prekinulo je primjenu lijeka zbog kašlja u odnosu na 1 % (2/209) bolesnika liječenih TIS-om.
English: The proposed medicinal product contains the same qualitative and quantitative composition and the same pharmaceutical form as TOBI 300mg/5 ml nebuliser solution, therefore clinical studies for demonstrating therapeutic equivalence can be waived in accordance with the scientific guidelines (EMEA/CHMP/QWP/49313/2005 Corr. and CPMP/EWP/4151/00 Rev.1).
Croatian: Predloženi lijek sadržava isti kvalitativni i kvantitativni sastav te isti farmaceutski oblik kao i otopina za nebulizator TOBI 300mg/5 ml, stoga klinička ispitivanja radi dokazivanja terapijske ekvivalencije mogu biti povučena u skladu sa znanstvenim smjernicama (EMEA/CHMP/QWP/49313/2005 Corr. i CPMP/EWP/4151/00 Rev.1).
English: Cough (not including productive cough) was the most frequently reported AE throughout the entire study period (TIP: 48.4%; TIS: 31.1%) despite being present in the same proportion of patients (42%) in both groups as a baseline symptom.
Croatian: Kašalj (ne uključujući produktivni kašalj) bio je najčešće naveden nepovoljni događaj tijekom cijelog trajanja ispitivanja (TIP: 48,4 %; TIS: 31,1 %) unatoč prisutnosti kao osnovni simptom u istom udjelu bolesnika (42 %) u objema skupinama.
English: This is in line with fact that cough is described as a ‘very common' adverse reaction in association with TOBI Podhaler, which means that it occurs with a frequency of at least 10%.
Croatian: To je u skladu s činjenicom da je kašalj opisan kao „vrlo česta” nepovoljna reakcija u vezi s lijekom TOBI Podhaler, što znači da se javlja u najmanje 10 % slučajeva.
English: Notification of a referral for arbitration, under Article 29(4) of Directive 2001/83/EC, to the CHMP was made by the Reference Member State Lithuania on 14 October 2015 based on concerns raised by the Concerned Member State Poland.
Croatian: Obavijest o upućivanju na arbitražu u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ uputila je referentna država članica Litva 14. listopada 2015. na temelju zabrinutosti koje je izrazila predmetna država članica Poljska.
English: Post hoc subgroup analyses of EAGER data compared the safety profiles of TIP and TIS in children, adolescents, and adults.
Croatian: Analizama post hoc podataka za skupinu u ispitivanju EAGER uspoređeni su sigurnosni profili lijekova TIP i TIS u djece, adolescenata i odraslih.
English: Local respiratory intolerability to the dry powder inhalation can manifest itself through symptoms such as cough, and result in discontinuation of treatment.
Croatian: Lokalna netolerancija udisanja suhog praška povezana s respiratornim razlozima može se manifestirati pojavom simptoma kao što je kašalj te dovesti do prekida liječenja.
English: According to the European Cystic Fibrosis Society Patient Registry, 48.0% of cystic fibrosis patients in the 20 European countries presenting data are over 18 years of age3.
Croatian: Prema registru pacijenata Europske udruge oboljelih od cistične fibroze, a na temelju podataka iz 20 europskih zemalja, 48 % bolesnika s cističnom fibrozom starije je od 18 godina3.
English: During the discussion, CHMP also noted the differences in terms of inhalation time between Tobramycin VVB and Tobi Podhaler.
Croatian: Tijekom rasprave CHMP je također primijetio razliku u smislu vremena udisanja između lijekova Tobramycin VVB i TOBI Podhaler.
English: The smallest difference was observed in the adult population (45% powder inhalation vs 34% nebuliser solution).
Croatian: Najmanja razlika primijećena je u populaciji odraslih (45 % prašak za udisanje u odnosu na 34 % otopina za nebulizator).
English: Having established that there is a portion of the target population who cannot use powder inhalator due to the development of intolerance and that for these patients the tobramycin nebuliser solution is a safer alternative, in order for a conclusion on clinical superiority to be drawn CHMP needed to assess whether these patients correspond to a substantial portion of the target population.
Croatian: Utvrdivši da postoji udio ciljne populacije koji ne može upotrebljavati inhalator za prah zbog razvoja netolerancije te da je za te bolesnike otopina tobramicina za nebulizator sigurnija alternativa, a kako bi se donio zaključak o kliničkoj nadmoći, CHMP je morao procijeniti odgovaraju li navedeni bolesnici znatnom udjelu ciljne populacije.
English: However, CHMP concluded that these differences are not relevant in the context of the claim of clinical superiority based on greater safety as the patients constituting a substantial portion of the target population are intolerant to Tobi Podhaler and cannot use therefore Tobi Podhaler.
Croatian: Međutim, CHMP je zaključio da navedene razlike nisu važne u kontekstu tvrdnje o kliničkoj nadmoći na temeljuveće sigurnosti jer bolesnici koji čine znatan udio ciljne populacije ne podnose lijek Tobi Podhaler, stoga ga ne mogu upotrebljavati.
English: A Marketing Authorisation for Tobramycin VVB can therefore only be granted with the currently proposed indication if at least one of the derogation grounds set out in Article 8(3) of Regulation (EC) No 141/2000 is fulfilled.
Croatian: Odobrenje za stavljanje u promet lijeka Tobramycin VVB moguće je stoga dati uz trenutačno predloženu indikaciju pod uvjetom da se ispuni najmanje jedan razlog za odstupanje naveden u članku 8. stavku 3. Uredbe (EZ) br. 141/2000.
English: • The Committee reviewed the responses submitted by the applicant to address the issues raised with regard to the claim for clinical superiority of Tobramycin VVB vs. TOBI Podhaler;
Croatian: • Odbor je pregledao odgovore koje je dostavio podnositelj zahtjeva kako bi riješio pitanja spomenuta u odnosu na tvrdnju o kliničkoj nadmoći lijeka Tobramycin VVB u odnosu na TOBI Podhaler;
English: Post hoc analysis of AEs profile in different age groups confirmed the results that were originally observed in EAGER study, i.e., any AE and cough, dysphonia and dysgeusia were more frequent among TIP-treated patients across all age groups.
Croatian: Analizom post hoc profila nepovoljnih događaja u različitim dobnim skupinama potvrđeni su rezultati koji su izvorno primijećeni u ispitivanju EAGER, tj. bilo koji nepovoljni događaj, i kašalj, disfonija i disgeuzija bili su češći među bolesnicima koji su primali TIP u svim dobnim skupinama.
English: In the EAGER trial, the overall discontinuation rate was higher with TIP (26.9%) than TIS (18.2%).
Croatian: U ispitivanju EAGER ukupna stopa prekida primjene lijeka bila je veća u slučaju TIP-a (26,9 %) nego TIS-a (18,2 %).
English: Considering the data from EAGER study and its post-hoc analyses, the difference in overall discontinuations is nearly 9% and difference in discontinuations due AEs is ~5% in favour of Tobramycin nebuliser solution.
Croatian: Uzimajući u obzir podatke iz ispitivanja EAGER te provedenih analiza post hoc, razlika u cjelokupnim prekidima primjene iznosi oko 9 %, a razlika u prekidu primjene zbog nepovoljnih događaja iznosi ~5 % u korist otopine za nebulizator Tobramycin.
English: During the assessment of the marketing authorisation application for Tobramycin VVB and in the context of the abovementioned Article, a similarity assessment was performed concluding that Tobramycin VVB was similar to Tobi Podhaler.
Croatian: Tijekom procjene zahtjeva za stavljanje u promet lijeka Tobramycin VVB te u kontekstu spomenutog članka, provedena je procjena sličnosti u kojoj je zaključeno da je lijek Tobramycin sličan lijeku Tobi Podhaler.
English: This is particularly illustrated by the differences in the discontinuation rates due to AEs (13% for the inhalation powder vs. 8% for the nebuliser solution), development of cough as an adverse drug related event (25% for the inhalation powder vs. 4% for the nebuliser solution) and dysphonia rates (13% for the inhalation powder vs. 4% for the nebuliser solution).
Croatian: To se osobito prikazuje razlikama u stopama prekida primjene zbog nepovoljnih događaja (13 % za prašak za udisanje u odnosu na 8 % za otopinu za nebulizator), razvoja kašlja kao nepovoljnog događaja povezanog s lijekom (25 % za prašak za udisanje u odnosu na 4 % za otopinu za nebulizator) te stopama disfonije (13 % za prašak u odnosu na 4 % za otopinu za nebulizator).
English: This study evaluated the safety, efficacy and convenience of TIP vs TIS in CF patients aged 6 years and above with chronic P. aeruginosa infection.
Croatian: U navedenom ispitivanju ocijenjene su sigurnost, učinkovitost i praktičnost TIP-a u odnosu na TIS u bolesnika s cističnom fibrozom u dobi od šest godina naviše s kroničnom upalom prouzročenom bakterijom P. aeruginosa.