FrancophonIA/ELRC3.0 huggingface dataset:
English: Phenotypic switch to small cell lung cancer has also been reported in 5-10% of cases.
Croatian: Fenotipska promjena u rak malih stanica pluća također je zabilježena u 5-10% slučajeva.
English: Frequencies of occurrence of undesirable effects are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost nuspojava definirana je kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznata učestalost (ne može se procijeniti na temelju dostupnih podataka).
English: What IRESSA looks like and contents of the pack
Croatian: Kako IRESSA izgleda i sadržaj pakiranja
English: This may mean that you have an inflammation of the lungs called ‘interstitial lung disease'.
Croatian: To može značiti da imate upalu pluća koja se zove "intersticijska bolest pluća".
English: Gefitinib showed no genotoxic potential.
Croatian: Gefitinib nije pokazao genotoksični potencijal.
English: These data are consistent with the pre-planned exploratory Japanese subgroup analysis in IPASS (Goto 2012).
Croatian: Ovi su podaci u skladu s unaprijed planiranom eksploracijskom analizom podskupine japanskih bolesnika iz ispitivanja IPASS (Goto 2012.).
English: Children and adolescents IRESSA is not indicated in children and adolescents under 18 years.
Croatian: Djeca i adolescenti IRESSA nije namijenjena za primjenu u djece i adolescenata mlađih od 18 godina.
English: The safety and efficacy of IRESSA in children and adolescents aged less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka IRESSA u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Do not crush the tablet.
Croatian: Nemojte drobiti tabletu.
English: Talk to your doctor before taking this medicine if you are pregnant, may become pregnant or are breast-feeding.
Croatian: Obratite se svom liječniku prije nego uzmete ovaj lijek ako ste trudni, možete zatrudnjeti ili dojite.
English: The tablet may be taken orally with or without food, at about the same time each day.
Croatian: Tableta se može uzimati kroz usta s ili bez hrane, otprilike u isto vrijeme svakoga dana.
English: Tell your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:
Croatian: Odmah se javite liječniku ako primijetite neku od sljedećih nuspojava - možda će Vam biti potrebna hitna medicinska pomoć:
English: PVC/Aluminium perforated blister containing 10 tablets or PVC/Aluminium non-perforated blister containing 10 tablets.
Croatian: PVC/aluminijski perforirani blister koji sadrži 10 tableta ili PVC/aluminijski neperforirani blister koji sadrži 10 tableta.
English: This may affect about 1 in 100 patients taking IRESSA and can be life-threatening.
Croatian: Ona može nastupiti u približno 1 od 100 bolesnika koji uzimaju lijek IRESSA i može biti opasna po život.
English: Warfarin (a so-called oral anticoagulant, to prevent blood clots).
Croatian: Varfarin (takozvani oralni antikoagulans, za sprječavanje stvaranja ugrušaka krvi).
English: Do not take IRESSA if you are breast-feeding for the safety of your baby.
Croatian: Nemojte uzimati lijek IRESSA ako dojite zbog sigurnosti vašeg djeteta.
English: NC Not calculated for overall survival HR as the number of events is too few NR Not reached
Croatian: NI Nije izračunato za omjer rizika za ukupno preživljenje jer je premali broj događaja ND Nije dostignuto
English: Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking IRESSA.
Croatian: • Nemojte uzimati antacide (za smanjenje kiseline u želucu) 2 sata prije niti 1 sat poslije uzimanja lijeka IRESSA.
English: These symptoms should be managed as clinically indicated (see section 4.8).
Croatian: Ove simptome treba liječiti kako je klinički indicirano (vidjeti dio 4.8).
English: The tablet can be swallowed whole with some water or if dosing of whole tablets is not possible, tablets may be administered as a dispersion in water (non-carbonated).
Croatian: Tableta se može progutati cijela s malo vode ili, ako nije moguće uzeti cijelu tabletu, tablete se mogu primijeniti u obliku disperzije u (negaziranoj) vodi.
English: The lips, nose, eyes and genitals may also be affected.
Croatian: Usne, nos, oči i spolovilo također mogu biti zahvaćeni.
English: Survival outcomes differed by smoking status and ethnicity (see Table 6).
Croatian: Ishodi preživljenja razlikovali su se prema pušačkom statusu i etničkoj pripadnosti (vidjeti Tablicu 6).
English: Gefitinib is extensively metabolised in humans.
Croatian: Gefitinib se opsežno metabolizira u ljudi.
English: The signs include very severe pain in the upper part of the stomach area and severe nausea and vomiting.
Croatian: Znakovi uključuju vrlo snažnu bol u gornjem dijelu trbuha te tešku mučninu i povraćanje.
English: Tell your doctor as soon as possible if you notice any of the following side effects:
Croatian: Javite se liječniku što prije ako opazite neku od sljedećih nuspojava:
English: This side effect is uncommon; however, some patients have died from this.
Croatian: Ova nuspojava javlja se manje često; ipak neki su bolesnici umrli od nje.
English: It is therefore considered unlikely that it contributes to the clinical activity of gefitinib.
Croatian: Stoga se ne smatra vjerojatnim da on doprinosi kliničkom djelovanju gefitiniba.
English: Do not take IRESSA if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section6, ‘What IRESSAcontains').
Croatian: Nemojte uzimati lijek IRESSA ako ste alergični na gefitinib ili neki drugi sastojak ovog lijeka (navedeni su u dijelu 6 ‘Što IRESSA sadrži').
English: Therefore, patients who experience this symptom should be cautious when driving or using machines.
Croatian: Stoga, bolesnici kod kojih se javi taj simptom trebaju biti oprezni ako upravljaju vozilom ili rade sa strojevima.
English: The glass should be rinsed with half a glass of water, which should also be drunk.
Croatian: Stijenke čaše treba isprati s pola čaše vode, koju također treba popiti.
English: Five metabolites have been fully identified in excreta and 8 metabolites in plasma.
Croatian: U potpunosti je utvrđeno 5 metabolita u izlučevinama i 8 metabolita u plazmi.
English: There are no data from the use of gefitinib in pregnant women.
Croatian: Nema podataka o primjeni gefitiniba u trudnica.
English: 40/235 (17%) of females are M+ 35/551 (6%) of males are M+
Croatian: 40/235 (17%) žena su M+ 35/551 (6%) muškaraca su M+
English: AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA United Kingdom
Croatian: AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA Ujedinjeno Kraljevstvo
English: Therefore, periodic liver function testing is recommended.
Croatian: Stoga se preporučuje periodički kontrolirati jetrenu funkciju.
English: Itraconazole (for fungal infections).
Croatian: Itrakonazol (za liječenje gljivičnih infekcija).
English: Mean absolute bioavailability is 59% in cancer patients.
Croatian: Sredanja apsolutna bioraspoloživost iznosi 59% u bolesnika s rakom.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, potpunog nedostatka laktaze ili malapsorpcije glukoze-galaktoze ne bi trebali uzimati ovaj lijek.
English: At no-effect levels in both mice and rats there was no margin in clinical exposure.
Croatian: Pri razinama bez učinka i u miševa i u štakora nije bilo granica kliničke izloženosti.
English: Interstitial lung disease (ILD)
Croatian: Intersticijska bolest pluća (ILD)
English: IRESSA comes in blister packs of 30 tablets.
Croatian: IRESSA je dostupna u blister pakiranju s 30 tableta.
English: These medicines may affect the way IRESSA works.
Croatian: Ovi lijekovi mogu utjecati na djelovanje lijeka IRESSA.
English: 28/70 (40%) of never smokers are M+ 47/716 (7%) of ever smokers are M+
Croatian: 28/70 (40%) osoba koje nikada nisu pušile su M+ 47/716 (7%) osoba koje su ikada pušile su M+
English: Definition
Croatian: Definicija
English: Figures 1 and 2 Efficacy outcomes in subgroups of non-Asian patients in the INTEREST study (N patients = Number of patients randomised)
Croatian: Slike 1 i 2 Ishodi djelotvornosti u podskupinama bolesnika koji nisu Azijati u INTEREST ispitivanju (N bolesnika = broj randomiziranih bolesnika)
English: What IRESSA is and what it is used for What you need to know before you take IRESSA How to take IRESSA
Croatian: Što je IRESSA i za što se koristi Što morate znati prije nego počnete uzimati lijek IRESSA
English: Quality of life outcomes differed according to EGFR mutation status.
Croatian: Ishodi kvalitete života razlikovali su se s obzirom na status mutacije EGFR-a.
English: If you forget to take IRESSA What to do if you forget to take a tablet depends on how long it is until your next dose.
Croatian: Što ćete učiniti ako ste zaboravili uzeti tabletu, ovisi o tome koliko je vremena preostalo do Vaše sljedeće doze.
English: Women of childbearing potential must be advised not to get pregnant during therapy.
Croatian: Ženama u generativnoj dobi mora se savjetovati da tijekom liječenja ne smiju zatrudnijeti.
English: These data are similar to those reported in the IPASS study.
Croatian: Ovi su podaci jednaki rezultatima prijavljenima u IPASS ispitivanju.
English: In about 60% of cases, resistance is associated with a secondary T790M mutation for which T790M targeted EGFR TKIs may be considered as a next line treatment option.
Croatian: U otprilike 60% slučajeva, rezistencija je povezana sa sekundarnom T790M mutacijom za koju bi se T790M ciljani inhibitori tirozin kinaze EGFR-a mogli razmotriti kao opcija sljedeće linije liječenja.
English: This may mean that you have an ulcer on the surface of the eye (cornea).
Croatian: To može značiti da imate vrijed na površini oka (rožnici).
English: Histology <0.0001 4.4 times higher in adenocarcinoma than in non-adenocarcinoma
Croatian: <0,0001 4,4 puta veći kod adenokarcinoma u odnosu na ne-adenokarcinome
English: In one study a limited number of patients were treated weekly with doses from 1500 mg to 3500 mg.
Croatian: U jednom kliničkom ispitivanju ograničen broj bolesnika liječen je tjedno dozama od 1500 mg do 3500 mg.
English: The blister foil may be perforated or non-perforated.
Croatian: Folija blistera može biti perforirana ili neperforirana.
English: When gefitinib was administered to rats during organogenesis, there were no effects on embryofoetal development at the highest dose (30 mg/kg/day).
Croatian: Kad je gefitinib primijenjen štakorima tijekom organogeneze, nije bilo učinaka na razvoj embrija i fetusa pri najvišim dozama (30mg/kg/dan).
English: Treatment with IRESSA should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.
Croatian: Liječenje lijekom IRESSA mora započeti i nadzirati liječnik s iskustvom u liječenju raka.
English: 63/396 (16%) of patients with adenocarcinoma histology are M+ 12/390 (3%) of patients with non-adenocarcinoma histology are M+
Croatian: 63/396 (16%) osoba s histologijom adenokarcinoma su M+ 12/390 (3%) osoba s histologijom neadenokarcinoma su M+
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows:
Croatian: Nuspojave koje nisu uočene u kliničkim ispitivanjima, no koje su zapažene u životinja pri razinama izloženosti sličnim kliničkim, i s mogućim značajem za kliničku primjenu, bile su sljedeće:
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE02
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein-kinaze; ATK oznaka: L01XE02
English: Never smoker
Croatian: Nikad nisu pušili
English: Asymptomatic laboratory elevations in blood creatinine Proteinuria
Croatian: Asimptomatsko povišenje laboratorijskih vrijednosti kreatinina u krvi Proteinurija
English: Then take the next dose as usual.
Croatian: Zatim uzmite sljedeću dozuu uobičajeno vrijeme.
English: Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever.
Croatian: • ozbiljni nedostatak daha ili nedostatak daha koji se iznenada pogoršava, uz moguć kašalj ili vrućicu.
English: Red or sore mouth
Croatian: • crvena ili bolna usta
English: High doses of short-acting antacids may have a similar effect if taken regularly close in time to administration of gefitinib.
Croatian: Visoke doze kratkodjelujućih antacida mogu imati sličan učinak ako se uzimaju redovito u kratkom vremenskom razmaku u odnosu na primjenu gefitiniba.
English: Only robust, reliable and sensitive test(s) with demonstrated utility for the determination of EGFR mutation status of tumours or ctDNA should be used to avoid false negative or false positive determinations (see section 5.1).
Croatian: Smiju se koristiti samo robusni, pouzdani i osjetljivi testovi koji su dokazano korisni za određivanje statusa mutacije EGFR-a u tumorima ili ctDNK, kako bi se izbjegli lažno negativni ili lažno pozitivni rezultati (vidjeti dio 5.1).
English: Corneal erosion, reversible and sometimes in association with aberrant eyelash growth Keratitis (0.12%)
Croatian: Erozija rožnice, reverzibilna i ponekad udružena s aberantnim rastom trepavica Keratitis (0,12%)
English: Do not take a double dose (two tablets at the same time) to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu (dvije tablete u isto vrijeme), kako biste nadoknadili propuštenu dozu.
English: N Number of patients evaluable for quality of life analyses QoL Quality of life
Croatian: N Broj bolesnika pogodnih za analizu kvalitete života QoL kvaliteta života (Quality of life)
English: EGFR activating mutation within a cancer cell is an important factor in promotion of tumour cell growth, blocking of apoptosis, increasing the production of angiogenic factors and facilitating the processes of metastasis.
Croatian: Aktivirajuća mutacija EGFR-a unutar stanice raka je važan čimbenik u promociji rasta tumorske stanice, blokiranju apoptoze, povećanju stvaranja angiogenih faktora i omogućavanju procesa metastaziranja.
English: Approximately 3% of patients stopped therapy due to an ADR.
Croatian: Približno 3% bolesnika je zbog nuspojava prekinulo liječenje.
English: The safety profile presented in Table 1 is based on the gefitinib clinical development programme and postmarketed experience.
Croatian: Sigurnosni profil prikazan u Tablici 1 temelji se na programu kliničkog razvoja gefitiniba i iskustvu nakon puštanja lijeka u promet.
English: Available data do not suggest any clinical consequences to this in vitro finding.
Croatian: Dostupni podaci ne ukazuju na kliničke posljedice ovog in vitro nalaza.
English: If it is less than 12 hours to the next dose, the patient should not take the missed dose.
Croatian: Ako je do sljedeće doze preostalo manje od 12 sati, bolesnik ne treba uzeti propuštenu dozu.
English: *This adverse reaction can occur in association with other dry conditions (mainly skin reactions) seen with gefitinib.
Croatian: *Ova nuspojava može biti udružena s drugim stanjima u kojima je prisutna suhoća (uglavnom kožnim reakcijama) opaženima uz primjenu gefitiniba.
English: FACT-LFunctional assessment of cancer therapy-lung LCS Lung cancer subscale
Croatian: FACT-L Funkcionalna procjena terapije raka pluća (Functional assessment of cancer therapy-lung) LCS Podljestvica za rak pluća (Lung cancer subscale)
English: Following oral administration of C-14 labelled gefitinib to lactating rats 14 days post-partum, concentrations of radioactivity in milk were 11-19 fold higher than in blood.
Croatian: Nakon peroralne primjene C-14 obilježenog gefitiniba u štakorica u laktaciji 14 dana po okotu, koncentracije radioaktivnosti u mlijeku bile su 11-19 puta više nego u krvi.
English: If a dose is missed, it should be taken as soon as the patient remembers.
Croatian: Propusti li bolesnik dozu, treba je uzeti čim se sjeti.
English: <2D barcode carrying the unique identifier included.>
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom.
English: A further case of CNS haemorrhage has been reported in a child with an ependymoma from a trial with gefitinib alone.
Croatian: Još jedan slučaj krvarenja u SŽS-u prijavljen je u djeteta s ependimomom u ispitivanju u kojem se primjenjivao samo gefitinib.
English: What you need to know before you take IRESSA
Croatian: Što morate znati prije nego počnete uzimati lijek IRESSA
English: If a diagnosis of ulcerative keratitis is confirmed, treatment with gefitinib should be interrupted, and if symptoms do not resolve, or if symptoms recur on reintroduction of gefitinib, permanent discontinuation should be considered.
Croatian: Ako je potvrđena dijagnoza ulceroznog keratitisa, liječenje gefitinibom treba prekinuti, a ako se simptomi ne povuku, ili se vrate nakon ponovnog uvođenjagefitiniba, treba razmotriti trajni prestanak uzimanja gefitiniba.
English: IFUM rate % (CI)
Croatian: Stopa u ispitivanju IFUM % (CI)
English: Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes).
Croatian: Simptomi mogu obuhvaćati opće loše osjećanje s ili bez prisutne žutice (žutilo kože i očiju).
English: First line treatment The randomised phase III first line IPASS study was conducted in patients in Asia
Croatian: Randomizirano kliničko ispitivanje faze III prve linije liječenja (IPASS) provedeno je u bolesnika u Aziji
English: Circulating Tumour DNA (ctDNA)
Croatian: Cirkulirajuća tumorska DNK (ctDNK)
English: Gefitinib total plasma clearance is approximately 500 ml/min and the mean terminal half-life is 41 hours in cancer patients.
Croatian: Ukupan klirens gefitiniba iz plazme iznosi približno 500 ml/min, a srednja vrijednost poluvijeka je 41 sat u bolesnika s rakom.
English: There is no specific treatment in the event of overdose of gefitinib.
Croatian: Nema specifične terapije u slučaju predoziranja gefitinibom.
English: The epidermal growth factor (EGF) and its receptor (EGFR [HER1; ErbB1]) have been identified as key drivers in the process of cell growth and proliferation for normal and cancer cells.
Croatian: Utvrđeno je da su epidermalni faktor rasta (EGF) i njegov receptor (EGFR [HER1; ErbB1]) ključni čimbenici u procesu rasta i proliferacije normalnih stanica i stanica raka.
English: N Objective response rates and 95% CI for difference between treatments
Croatian: Stope objektivnog odgovora i 95% CI za razliku između liječenja
English: Adverse reactions associated with overdose should be treated symptomatically; in particular severe diarrhoea should be managed as clinically indicated.
Croatian: Nuspojave povezane s predoziranjem treba liječiti simptomatski; osobito se teški proljev mora liječiti kako je klinički indicirano.
English: Published studies have shown that genetically modified mice, lacking expression of EGFR, exhibit developmental defects, related to epithelial immaturity in a variety of organs including the skin, gastrointestinal tract and lung.
Croatian: Objavljene studije su pokazale su da genetski modificirani miševi, kojima manjka ekspresija EGFR-a, pokazuju razvojne poremećaje povezane s nezrelošću epitela u nizu organa, uključujući kožu, gastrointestinalni trakt i pluća.
English: An increased risk of ILD on gefitinib relative to chemotherapy was seen predominantly during the first 4 weeks of treatment (adjusted OR 3.8; 95% CI 1.9 to 7.7); thereafter the relative risk was lower (adjusted OR 2.5; 95% CI 1.1 to 5.8).
Croatian: Povećani rizik za ILD uz primjenu gefitiniba u odnosu na kemoterapiju uočen je uglavnom tijekom prva 4 tjedna liječenja (prilagođeni omjer izgleda (odds ratio, OR) 3,8; 95% CI 1,9 do 7,7); nakon toga je relativni rizik bio manji (prilagođeni OR 2,5; 95% CI 1,1 do 5,8).
English: **This includes isolated reports of hepatic failure which in some cases led to fatal outcomes.
Croatian: **Ovo uključuje izolirana izvješća o zatajenju jetre koje je u nekim slučajevima imalo smrtni ishod.
English: N Number of patients randomised.
Croatian: N Broj randomiziranih bolesnika.
English: Gefitinib shows no enzyme induction effects in animal studies and no significant inhibition (in vitro) of any other cytochrome P450 enzyme.
Croatian: Gefitinib ne pokazuje učinke indukcije enzima u ispitivanjima na životinjama, kao ni značajnu inhibiciju (in vitro) bilo kojeg drugog enzima citokroma P450.
English: If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember.
Croatian: •Ako je do sljedeće doze ostalo 12sati ili više:uzmite propuštenu tabletu čim se sjetite.
English: Gefitinib should be used cautiously in the presence of mild to moderate changes in liver function.
Croatian: Gefitinib se mora primjenjivati uz oprez u slučaju blagih do umjerenih promjena jetrene funkcije.
English: Bullous conditions including toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme Cutaneous vasculitis
Croatian: Bulozna stanja uključujući toksičnu epidermalnu nekrolizu, StevensJohnsonov sindrom i eritema multiforme Kožni vaskulitis
English: Other potential mechanisms of resistance that have been reported following treatment with EGFR signal blocking agents include: bypass signalling such as HER2 and MET gene amplification and PIK3CA mutations.
Croatian: Drugi potencijalni mehanizmi rezistencije koji su zabilježeni nakon liječenja blokatorima signala EGFR-a uključuju: zaobilaznu signalizaciju kao što je amplifikacija HER2 i MET gena i PIK3CA mutacija.
English: Gefitinib response data is more sparse in patients whose tumours contain the less common mutations; the available data indicates that G719X, L861Q and S7681 are sensitising mutations; and T790M alone or exon 20 insertions alone are resistance mechanisms.
Croatian: Podaci o odgovoru na gefitinib su malobrojniji kod bolesnika s tumorima koji imaju manje česte mutacije; dostupni podaci upućuju na to da su mutacije G719X, L861Q i S7681 senzibilizirajuće, dok samo mutacija T790M ili samo insercije u eksonu 20 predstavljaju mehanizme rezistencije.
English: In the overall population, no statistically significant difference between gefitinib and docetaxel (75 mg/m2) was observed for overall survival, progression free survival and objective response rates (see Table 5).
Croatian: U ukupnoj populaciji nije zabilježena statistički značajna razlika između gefitiniba i docetaksela (75 mg/m2) u ukupnom preživljenju, preživljenju bez progresije bolesti i stopi objektivnog odgovora (vidjeti Tablicu 5).
English: Asian patients also have a higher incidence of EGFR mutation-positive tumours.
Croatian: Bolesnici azijskog podrijetla također imaju veću incidenciju tumora pozitivnih na mutaciju EGFR.
English: To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.
Croatian: Kako biste bili sigurni da ste popili sav lijek, isperite stijenke čaše s pola čaše vode pa i to popijte.
English: IRESSA is used to treat adults with non-small cell lung cancer.
Croatian: IRESSA se koristi za liječenje odraslih bolesnika s rakom pluća ne-malih stanica.
English: Data from non-clinical (in vitro) studies indicate that gefitinib has the potential to inhibit the cardiac action potential repolarisation process (e.g. QT interval).
Croatian: Podaci iz nekliničkih (in vitro) ispitivanja ukazuju da gefitinib ima potencijal za inhibiciju procesa repolarizacije srčanog akcijskog potencijala (npr. QT-intervala).
English: Gefitinib plus best supportive care was compared to placebo plus best supportive care.
Croatian: Gefitinib uz najbolju suportivnu skrb uspoređen je s placebom uz najbolju suportivnu skrb.
English: Contains lactose and sodium, see package leaflet for further information.
Croatian: Sadrži laktozu i natrij, za dodatne informacije pročitati uputu o lijeku.