FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, men who are taking dabrafenib may have a reduced sperm count, and their sperm count may not return to normal levels after they stop taking this medicine.
Croatian: Dodatno, muškarci koji uzimaju dabrafenib mogu imati manji broj spermija i njihov spermiogram se možda ne vrati na normalne vrijednosti nakon što prestanu s uzimanjem ovog lijeka.
English: Read all the information in this leaflet for guidance.
Croatian: Pročitajte sve informacije u ovoj uputi kako biste dobili potrebne smjernice.
English: Liver events were detected in clinical trials with monitoring every four weeks.
Croatian: Jetreni događaji bili su uočeni u kliničkim ispitivanjima u kojima se kontrola provodila svaka četiri tjedna.
English: Because many medicinal products are excreted in human milk, a risk to the breast-feeding infant cannot be excluded.
Croatian: Budući da se mnogi lijekovi izlučuju u majčino mlijeko, ne može se isključiti rizik za dojenče.
English: Patients with LVEF lower than the institutional lower limit of normal were not included in clinical trials with trametinib.
Croatian: Bolesnici kojima je LVEF niži od institucionalne donje granice normale nisu bili uključeni u klinička ispitivanja s trametinibom.
English: Possible side effects in patients taking Mekinist alone
Croatian: Moguće nuspojave u bolesnika koji uzimaju samo Mekinist
English: For October 2011, 47% of subjects had crossed over, while for May 2013, 65% of subjects had crossed over.
Croatian: Do listopada 2011. u drugu je skupinu prešlo 47% ispitanika, a do svibnja 2013. to je učinilo njih 65%.
English: Don't take more Mekinist than your doctor has recommended, since this may increase the risk of side effects.
Croatian: Nemojte uzeti više lijeka Mekinist nego što Vam je preporučio liječnik, jer može doći do povećanog rizika od nuspojava.
English: Your doctor should check your heart function before and during treatment.
Croatian: Vaš liječnik bi trebao provjeriti Vašu funkciju srca prije i tijekom liječenja.
English: Table 11 Investigator-assessed efficacy results (ITT population)
Croatian: Tablica 11 Rezultati za djelotvornost prema ocjeni ispitivača (ITT populacija)
English: Dabrafenib is an inhibitor of RAF kinases.
Croatian: Dabrafenib je inhibitor RAF kinaza.
English: 3rd dose reduction (combination only)
Croatian: 3. smanjenje doze (samo u kombinaciji)
English: Some people taking Mekinist develop other conditions which can be serious.
Croatian: U nekih osoba koje uzimaju Mekinist mogu se razviti i druge bolesti, koje mogu biti ozbiljne.
English: If the missed dose is less than 12 hours late, take it as soon as you remember.
Croatian: Ako je od propuštene doze prošlo manje od 12 sati, uzmite je čim se sjetite.
English: One bottle contains either 7 or 30 tablets.
Croatian: Jedna bočica sadrži 7 ili 30 tableta.
English: Your doctor may decide to lower the dose if you get side effects.
Croatian: Vaš liječnik može odlučiti smanjiti dozu ako dobijete nuspojave.
English: An additional OS analysis was undertaken based upon the 20 May 2013 data cut, see Table 12.
Croatian: Provedena je dodatna analiza OS-a na temelju podataka prikupljenih zaključno s 20. svibnja 2013., vidjeti tablicu 12.
English: • have any liver problems.
Croatian: • imate bilo kakvih tegoba s jetrom.
English: Trametinib should be taken orally with a full glass of water.
Croatian: Trametinib treba uzeti peroralno s punom čašom vode.
English: These checks are to detect if any other cancer, including squamous cell carcinoma, develops inside your body.
Croatian: Svrha tih provjera je da se uoči je li se neki drugi rak, uključujući karcinom pločastih stanica, razvio u Vašem tijelu.
English: The majority of bleeding events were mild.
Croatian: Većina krvarenja bila je blaga.
English: Your doctor may take blood samples to monitor your liver function while you are taking this medicine.
Croatian: Liječnik će možda uzimati uzorke krvi kako bi nadzirao funkciju jetre dok uzimate ovaj lijek.
English: Pack sizes: One bottle contains either 7 or 30 tablets.
Croatian: Veličine pakiranja: Jedna bočica sadrži 7 ili 30 tableta.
English: Grade 2-3 RPED
Croatian: RPED 2. ili 3. stupnja
English: Most patients (66%) received no prior chemotherapy for advanced or metastatic disease.
Croatian: Većina bolesnika (66%) prethodno nije primala kemoterapiju za uznapredovalu ili metastatsku bolest.
English: • after taking Mekinist, you must wait at least 1 hour before eating, or
Croatian: • nakon uzimanja lijeka Mekinist morate pričekati najmanje 1 sat prije jela, ili
English: • If you do become pregnant while you are taking Mekinist, tell your doctor immediately.
Croatian: • Ako zatrudnite dok uzimate Mekinist, odmah o tome obavijestite svog liječnika.
English: What Mekinist contains
Croatian: Što Mekinist sadrži
English: • have or have ever had lung or breathing problems.
Croatian: • imate ili ste ikad imali tegobe s plućima ili disanjem.
English: The efficacy results in the primary efficacy population were consistent with those in the ITT population; therefore, only the efficacy data for the ITT population are presented in Table 11.
Croatian: Rezultati za djelotvornost u primarnoj populaciji za ispitivanje djelotvornosti bili su u skladu s onima u ITT populaciji; stoga su u tablici 11 prikazani samo rezultati za djelotvornost u ITT populaciji.
English: CYP3A4 oxidation is considered a minor pathway of metabolism.
Croatian: Oksidacija putem CYP3A4 smatra se sporednim metaboličkim putom.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor, ATC code: L01XE25
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein-kinaze, ATK oznaka: L01XE25
English: The median time to first presentation of ILD or pneumonitis was 160 days (range: 60 to 172 days).
Croatian: Medijan vremena do prvog nastupa IBP-a ili pneumonitisa iznosio je 160 dana (raspon: od 60 do 172 dana).
English: Mekinist can cause serious bleeding problems, especially in your brain or stomach.
Croatian: Mekinist može uzrokovati ozbiljne probleme s krvarenjem, osobito u mozgu ili želucu.
English: In the previously-treated population, 38 patients (67%) had one line of systemic anti-cancer therapy for metastatic disease.
Croatian: U prethodno liječenoj populaciji, 38 bolesnika (67%) imalo je jednu liniju antitumorske sistemske terapije za metastatsku bolest.
English: Physicians should be alert to the possibility of myocarditis in patients who develop new or worsening cardiac signs or symptoms.
Croatian: Liječnici trebaju obratiti pažnju na mogućnost miokarditisa u bolesnika koji su razvili nove ili im se pogoršavaju postojeći srčani znakovi ili simptomi.
English: Check with your doctor if you think this applies to you.
Croatian: Provjerite se svojim liječnikom ako mislite da bi se to moglo odnositi na Vas.
English: No initial dose adjustment is required in patients >65 years of age.
Croatian: Nije potrebno prilagođavati početnu dozu u bolesnika starijih od 65 godina.
English: The film-coated tablets are supplied in opaque white plastic bottles with threaded plastic closures.
Croatian: Filmom obložene tablete dolaze u bijelim neprozirnim plastičnim bočicama s plastičnim zatvaračima s navojem.
English: Based on the population pharmacokinetic analysis (range 19 to 92 years), age had no relevant clinical effect on trametinib pharmacokinetics.
Croatian: Na temelju populacijske farmakokinetičke analize (u rasponu od 19 do 92 godine), dob nije imala klinički značajnog utjecaja na farmakokinetiku trametiniba.
English: Grade 2-3 RPED that does not improve to at least Grade 1 within 3 weeks
Croatian: RPED 2. ili 3. stupnja koji se ne poboljša barem na 1. stupanj unutar 3 tjedna
English: Contains desiccant, do not remove or eat.
Croatian: Sadrži sredstvo za sušenje, koje se ne smije ukloniti niti pojesti.
English: The tablets should not be chewed or crushed and they should be taken without food, at least 1 hour before or 2 hours after a meal.
Croatian: Tablete se ne smiju žvakati niti drobiti i treba ih uzimati bez hrane, najmanje 1 sat prije ili 2 sata nakon obroka.
English: The deacetylated metabolite was further metabolised by glucuronidation.
Croatian: Deacetilirani metabolit je dalje metaboliziran glukuronidacijom.
English: Your doctor may ask you to stop taking Mekinist or refer you to a specialist, if you develop signs and symptoms in your vision that include:
Croatian: Liječnik će možda zatražiti da prestanete uzimati Mekinist ili će Vas uputiti specijalistu ako se pojave znakovi i simptomi tegoba s vidom, koji uključuju:
English: Therefore other treatment options should be considered before treatment with the combination in this prior BRAF inhibitor treated population.
Croatian: Stoga je potrebno razmotriti druge mogućnosti liječenja prije liječenja s kombinacijom u ovoj populaciji prethodno liječenoj BRAF inhibitorom.
English: The median DoR and PFS were not yet estimable (Table 14).
Croatian: Medijan DoR-a i PFS-a nije se još mogao procijeniti (Tablica 14).
English: • Take Mekinist once daily and take dabrafenib twice daily.
Croatian: • Uzimajte Mekinist jedanput na dan i uzimajte dabrafenib dvaput na dan.
English: and a type of white blood cells (leukopenia)
Croatian: • i vrste bijelih krvnih stanica (leukopenija)
English: Table 2 Dose modification schedule based on the grade of any adverse reactions
Croatian: Tablica 2 Raspored prilagodbe doze prema stupnju bilo koje nuspojave
English: Extremadura, 3, 09400, Aranda De Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Croatian: Glaxo Wellcome, S.A., Avd. Extremadura, 3, 09400, Aranda De Duero, Burgos, Španjolska Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ujedinjeno Kraljevstvo
English: Date of first authorisation: 30 June 2014 Date of latest renewal: 14 February 2019
Croatian: Datum posljednje obnove odobrenja: 14. veljače 2019.
English: Safety data in patients ≥75 years is limited (see section 4.8).
Croatian: ≥ 75 godina su ograničeni (vidjeti dio 4.8).
English: • If you get side effects your doctor may decide that you should take lower doses of Mekinist and dabrafenib.
Croatian: • Ako dođe do nuspojava liječnik će možda odlučiti da trebate uzimati niže doze Mekinista i dabrafeniba.
English: It is recommended that patients continue treatment with trametinib until patients no longer derive benefit or the development of unacceptable toxicity (see Table 2).
Croatian: Preporučuje se da bolesnici nastave liječenje trametinibom sve dok od njega imaju koristi ili do razvoja neprihvatljive toksičnosti (vidjeti tablicu 2).
English: Keep a list of the medicines you take, so you can show it to your doctor, nurse or pharmacist when you get a new medicine.
Croatian: Vodite popis svih lijekova koje uzimate kako biste ga mogli pokazati svom liječniku, medicinskoj sestri ili ljekarniku kad dobijete novi lijek.
English: All of these effects were reversible following an off-treatment period and attributable to pharmacology.
Croatian: Svi ovi učinci su bili reverzibilni nakon razdoblja bez liječenja i mogli su se pripisati farmakološkom učinku lijeka.
English: Mekinist can cause new or worsening high blood pressure (hypertension).
Croatian: Mekinist može uzrokovati povišenje krvnog tlaka ili pogoršati postojeći visok krvni tlak (hipertenziju).
English: Check with your doctor if you think any of these may apply to you.
Croatian: Provjerite sa svojim liječnikom ako mislite da bi se bilo što od toga moglo odnositi na Vas.
English: If you take more Mekinist than you should
Croatian: Ako uzmete više lijeka Mekinist nego što ste trebali
English: Thus, trametinib and dabrafenib inhibit two kinases in this pathway, MEK and RAF, and therefore the combination provides concomitant inhibition of the pathway.
Croatian: Tako trametinib i dabrafenib inhibiraju dvije kinaze u ovom putu, MEK i RAF, te stoga kombinacija omogućuje istodobnu inhibiciju puta.
English: Table 14 Summary of efficacy in the combination treatment cohorts based on investigator and independent radiology review
Croatian: Tablica 14 Sažetak djelotvornosti u kohortama na kombiniranom načinu liječenja na temelju ispitivačeve i neovisne radiološke procjene
English: If possible, show them the Mekinist pack and this leaflet.
Croatian: Ako je moguće, pokažite im pakiranje lijeka Mekinist i ovu uputu.
English: Primary tumour or tumour from a metastatic site was tested with a validated polymerase chain reaction (PCR) assay developed by Response Genetics Inc.
Croatian: Primarni tumor ili tumor s mjesta metastaze testiran je uz pomoć validiranog testa lančane reakcije polimerazom (engl. polymerase chain reaction, PCR) koji je razvila tvrtka Response Genetics Inc.
English: It is currently unknown if hormonal contraceptives are affected by trametinib.
Croatian: Trenutačno nije poznato utječe li trametinib na hormonske kontraceptive.
English: However, in rat and dog toxicity studies up to 13 weeks in duration, there were no treatment effects observed in male reproductive tissues.
Croatian: Međutim, u ispitivanjima toksičnosti na štakorima i psima u trajanju do 13 tjedana nisu primijećeni učinci liječenja na reproduktivna tkiva mužjaka.
English: Before you take Mekinist in combination with dabrafenib your doctor needs to know if you:
Croatian: Prije nego što uzmete Mekinist u kombinaciji s dabrafenibom Vaš liječnik mora znati ako:
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Croatian: Dođe li do predoziranja, bolesnika treba liječiti suportivno te po potrebi uvesti odgovarajući nadzor.
English: Take Mekinist once a day, on an empty stomach (at least 1 hour before a meal or 2 hours after a meal).
Croatian: Mekinist uzmite jedanput na dan, na prazan želudac (najmanje 1 sat prije obroka ili 2 sata nakon obroka).
English: Keep the bottle tightly closed with the dessicant inside (small cylinder shaped container).
Croatian: Bočicu držati čvrsto zatvorenom sa sredstvom za sušenje unutar bočice (maleni cilindrični spremnik).
English: Mekinist can cause eye problems.
Croatian: Mekinist može uzrokovati očne tegobe.
English: You and your doctor will decide whether you will take Mekinist or breast-feed.
Croatian: Vi i Vaš liječnik morate donijeti odluko o tome hoćete li uzimati Mekinist ili dojiti.
English: Survival estimates at 1 and 2 years from randomisation were 97% and 91% in the combination arm and 94% and 83% in the placebo arm, respectively.
Croatian: Procjene preživljavanja u 1. i 2. godini od randomizacije bile su 97% i 91% u skupini koja je primala kombinaciju, odnosno 94% i 83% u skupini koja je primala placebo.
English: Table 1 Recommended dose level reductions
Croatian: Tablica 1 Preporučeno smanjivanje doze
English: Treatment for all patients continued until disease progression, death or withdrawal.
Croatian: Svi bolesnici su liječeni do progresije bolesti, smrti ili povlačenja iz ispitivanja.
English: In some cases, patients were able to continue trametinib.
Croatian: U nekim slučajevima bolesnici su mogli nastaviti liječenje trametinibom.
English: Fertility - both men and women Mekinist may impair fertility in both men and women.
Croatian: Plodnost muškaraca i žena Mekinist može štetno utjecati na plodnost muškaraca i žena.
English: Swallow the tablet whole, with a full glass of water.
Croatian: Tabletu progutajte cijelu, s punom čašom vode.
English: Inter-subject variability at steady state was low (<28%).
Croatian: Varijabilnost među ispitanicima u stanju dinamičke ravnoteže bila je mala (< 28%).
English: Mean terminal half-life is 127 hours (5.3 days) after single dose administration.
Croatian: Srednja vrijednost terminalnog poluvijeka nakon primjene jedne doze iznosi 127 sati (5,3 dana).
English: Median OS and estimated 1-year, 2-year, 3-year, 4-year and 5-year survival rates are presented in Table 8.
Croatian: Medijan OS-a i procijenjene 1-godišnje, 2-godišnje, 3-godišnje, 4-godišnje i 5-godišnje stope preživljenja prikazane su u tablici 8.
English: Deep vein thrombosis (DVT)/Pulmonary embolism (PE)
Croatian: Duboka venska tromboza (DVT)/plućna embolija (PE)
English: There are insufficient data to evaluate the potential effect of race on trametinib pharmacokinetics as clinical experience is limited to Caucasians.
Croatian: Nema dovoljno podataka da bi se procijenio mogući učinak rase na farmakokinetiku trametiniba jer je kliničko iskustvo ograničeno na bijelu rasu.
English: It is used either on its own or in combination with another medicine containing dabrafenib to treat a type of skin cancer called melanoma that has spread to other parts of the body, or cannot be removed by surgery.
Croatian: Koristi se sam ili u kombinaciji s drugim lijekom koji sadrži dabrafenib, za liječenje vrste raka kože koji se zove melanom, a koji se proširio u druge dijelove tijela ili ne može biti odstranjen operacijom.
English: • Bleeding, at various sites in the body, which may be mild or serious
Croatian: • krvarenje u različitim dijelovima tijela, koje može biti blago ili ozbiljno
English: 35 (16) NR
Croatian: 35 (16) ND
English: Based on its mechanism of action, dabrafenib may increase the risk of non-cutaneous malignancies when RAS mutations are present.
Croatian: Na temelju svog mehanizma djelovanja, dabrafenib može povećati rizik od zloćudnih bolesti koje ne zahvaćaju kožu kada su prisutne RAS mutacije.
English: • Take Mekinist and dabrafenib on an empty stomach, at least one hour before or two hours after a meal.
Croatian: • Uzimajte Mekinist i dabrafeniba na prazan želudac, najmanje jedan sat prije ili dva sata nakon obroka.
English: Of the specimens from the non-clinical and clinical trials (n=876) that were mutation positive by the THxID BRAF assay and subsequently were sequenced using the reference method, the specificity of the assay was 94%.
Croatian: Iz uzoraka iz nekliničkih i kliničkih ispitivanja (N=876) koji su bili pozitivni na mutaciju prema THxID BRAF testu i kasnije su sekvencionirani primjenom referentne metode, specifičnost testa iznosila je 94%.
English: Mekinist is a medicine that contains the active substance trametinib.
Croatian: Mekinist je lijek koji sadrži djelatnu tvar trametinib.
English: Taking Mekinist with dabrafenib: Dabrafenib may permanently reduce male fertility.
Croatian: Uzimanje Mekinista s dabrafenibom: Dabrafenib može trajno smanjiti plodnost muškaraca.
English: Take Mekinist tablets and dabrafenib capsules with you when possible.
Croatian: Ponesite sa sobom tablete Mekinista i kapsule dabrafeniba kad možete.
English: Mekinist can cause heart problems, or make existing heart problems worse (see also “Heart conditions” in section 4) in people taking Mekinist in combination with dabrafenib.
Croatian: Mekinist može uzrokovati srčane tegobe ili pogoršati postojeće srčane tegobe (pogledajte i odlomak „Srčane bolesti“ u dijelu 4) u osoba koje uzimaju Mekinist u kombinaciji s dabrafenibom.
English: LVEF should be evaluated in all patients prior to initiation of treatment with trametinib, one month after initiation of therapy, and then at approximately 3-monthly intervals while on treatment (see section 4.2 regarding dose modification).
Croatian: LVEF je potrebno procijeniti u svih bolesnika prije početka liječenja trametinibom, jedan mjesec nakon početka liječenja, a zatim u intervalima od približno 3 mjeseca tijekom liječenja (vidjeti odlomak o prilagodbi doze u dijelu 4.2).
English: Effects on spermatogenesis have been observed in animals given dabrafenib.
Croatian: Učinci na spermatogenezu uočeni su u životinja koje su dobivale dabrafenib.
English: • Decrease in number of red blood cells (anaemia), blood platelets (cells that help blood to clot),
Croatian: • smanjenje broja crvenih krvnih stanica (anemija), trombocita u krvi (stanice koje pomažu u zgrušavanju krvi),
English: • Infection of the skin (cellulitis)
Croatian: • infekcija kože (celulitis)
English: If you forget to take Mekinist
Croatian: Ako ste zaboravili uzeti Mekinist
English: In the ITT population, 54% of patients were male and all were Caucasian.
Croatian: U ITT populaciji je 54% bolesnika bilo muškoga spola i svi su bili bijelci.
English: • have had a different type of cancer other than melanoma or NSCLC, as you may be at greater risk of developing non-skin cancers when taking Mekinist.
Croatian: • ste imali neku drugu vrstu raka osim melanoma ili raka pluća nemalih stanica, budući da biste mogli biti izloženi većem riziku od razvoja raka koji ne zahvaća kožu dok uzimate Mekinist.
English: If trametinib is used during pregnancy, or if the patient becomes pregnant while taking trametinib, the patient should be informed of the potential hazard to the foetus.
Croatian: Ako se trametinib primjenjuje u trudnoći ili ako bolesnica zatrudni tijekom uzimanja trametiniba, bolesnicu se mora upozoriti na moguću opasnost za plod.
English: The majority of these cases were Grade 1 or 2 and did not require any dose interruptions or dose reductions (see sections 4.2 and 4.4).
Croatian: Većina tih slučajeva bila je 1. ili 2. stupnja i nije zahtijevala privremeni prekid primjene niti smanjenje doze (vidjeti dijelove 4.2 i 4.4).
English: Trametinib should not be administered to pregnant women.
Croatian: Trametinib se ne smije primjenjivati u trudnica.
English: Drug-related material was excreted predominantly in the faeces (>80% of recovered radioactivity) and to a minor extent in urine (≤19%).
Croatian: Spojevi koji potječu od lijeka su pretežno izlučeni u stolicu (> 80% pronađene radioaktivnosti) i manjim dijelom u mokraću (< 19%).
English: Follow your doctor's instructions for what to do to help prevent rash.
Croatian: Slijedite liječničke upute o tome kako spriječiti pojavu osipa.
English: The risk of haemorrhage may be increased with concomitant use of antiplatelet or anticoagulant therapy.
Croatian: Rizik od krvarenja može biti povećan uz istodobnu primjenu antitrombocitne ili antikoagulacijske terapije.
English: Taking Mekinist or the combination of Mekinist and dabrafenib may cause fever, although it is more likely if you are taking the combination treatment (see also section 4).
Croatian: Uzimanje Mekinista ili kombinacije Mekinista i dabrafeniba može uzrokovati vrućicu, iako je ona vjerojatnija ako uzimate kombiniranu terapiju (također pogledajte dio 4).
English: Most of the findings are reversible after drug-free recovery.
Croatian: Većina ovih nalaza bila je reverzibilna nakon oporavka bez primjene lijeka.
English: 29 (27) NR
Croatian: 29 (27) ND
English: Carcinogenicity studies with trametinib have not been conducted.
Croatian: Nisu provedena ispitivanja kancerogenosti trametiniba.
English: Your disease symptoms and treatment situation may also affect your ability to drive or use machines.
Croatian: Simptomi Vaše bolesti, kao i njezino liječenje, također mogu utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with trametinib in all subsets of the paediatric population in melanoma and malignant neoplasms (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja trametiniba u svim podskupinama pedijatrijske populacije za melanom i zloćudne novotvorine (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If RPED worsens follow instructions below and withhold trametinib for up to 3 weeks.
Croatian: Ako se RPED pogorša, slijediti upute u nastavku i odgoditi primjenu trametiniba do 3 tjedna.
English: Up to 3 in 100 people taking Mekinist in combination with dabrafenib may develop a different type of skin cancer called cutaneous squamous cell carcinoma (cuSCC).
Croatian: U do 3 na 100 osoba koje uzimaju Mekinist u kombinaciji s dabrafenibom može se razviti drugačija vrsta raka kože koji se naziva planocelularni karcinom kože (engl. cutaneous squamous cell carcinoma, cuSCC).
English: Mild and moderate renal impairment had no effect on trametinib exposure (<6% for either group).
Croatian: Blago i umjereno oštećenje bubrežne funkcije nije utjecalo na izloženost trametinibu (< 6% u svakoj skupini).