FrancophonIA/ELRC3.0 huggingface dataset:
English: If an infusion-related reaction develops later during the infusion or at a subsequent infusion further management will depend on its severity:
Slovenian: Če se kasneje med infundiranjem ali pri naslednjih infuzijah pojavi reakcija, povezana z infundiranjem, je nadaljnja obravnava odvisna od resnosti:
English: Side effects of which the frequency is not known (cannot be estimated from the available data) • inflammation of the lining of the brain (aseptic meningitis)
Slovenian: Neželeni učinki z neznano pogostnostjo (ni mogoče oceniti iz razpoložljivih podatkov) • vnetje možganske ovojnice (aseptični meningitis)
English: A cytokine release syndrome (CRS) typically occurs within one hour after infusion and is less commonly associated with bronchospasm and urticaria.
Slovenian: Sindrom sproščanja citokinov se običajno pojavi v eni uri od infundiranja in je manj pogosto povezan z bronhospazmom in urtikarijo.
English: The use of cetuximab in combination with chemo-radiotherapy has so far not been adequately investigated.
Slovenian: Uporaba cetuksimaba v kombinaciji s kemoterapijo in radioterapijo doslej še ni bila primerno raziskana.
English: Pharmacokinetics in special populations
Slovenian: Farmakokinetika v posebnih skupinah bolnikov
English: Pulmonary embolism; interstitial lung disease, which may be fatal (see section 4.4).
Slovenian: pljučna embolija; intersticijska pljučna bolezen, ki ima lahko za posledico smrt (glejte poglavje 4.4).
English: Current data on the development of HACAs is limited.
Slovenian: Podatkov o nastanku HAHP je malo.
English: In uncommon cases (may affect up to 1 in 100 people) patients may experience an inflammation of the lungs (called interstitial lung disease), which may have serious consequences including lifethreatening conditions.
Slovenian: V občasnih primerih (pojavijo se lahko pri do 1 od 100 bolnikov) se lahko pri bolnikih pojavi vnetje pljuč (ki se imenuje intersticijska pljučna bolezen), ki ima lahko resne posledice, vključno s smrtno nevarnimi stanji.
English: Before initiation of combination treatment, contraindications for concomitantly used chemotherapeutic agents or radiation therapy must be considered.
Slovenian: Pred začetkom kombiniranega zdravljenja morate upoštevati kontraindikacije za sočasno uporabljene kemoterapevtike ali radioterapijo.
English: The third experimental arm used an intermittent OxMdG or XELOX regimen without cetuximab.
Slovenian: Tretja eksperimentalna skupina je občasno uporabljala režim OxMdG ali XELOX brez cetuksimaba.
English: Cardiovascular disorders
Slovenian: Kardiovaskularne bolezni
English: Squamous cell cancer of the head and neck
Slovenian: Rak skvamoznih celic glave in vratu
English: An embryo-foetal toxicity study in Cynomolgus monkeys revealed no signs of teratogenicity.
Slovenian: Študija toksičnosti za zarodek/plod pri opicah vrste Cynomolgus ni pokazala znakov teratogenosti.
English: If you experience these symptoms, please speak to a doctor immediately, because these signs may have serious consequences including life-threatening conditions.
Slovenian: Če se pri vas pojavijo ti simptomi, se nemudoma pogovorite z zdravnikom, saj imajo lahko ti znaki resne posledice, vključno s smrtno nevarnimi stanji.
English: In the randomised trial, the improvement in overall survival time did not reach statistical significance; however, in the follow-up treatment, nearly 50% of the patients of the cetuximab alone arm received a combination of cetuximab and irinotecan after progression of disease, which may have influenced overall survival time.
Slovenian: V randomiziranem preskušanju izboljšanje skupnega časa preživetja ni doseglo statistične pomembnosti, vendar pa je med sledenjem skoraj 50 % bolnikov, ki so prejemali samo cetuksimab, prejelo kombinacijo cetuksimaba in iritonekana po napredovanju bolezni, kar je morda vplivalo na rezultate skupnega časa preživetja.
English: If severe skin reactions occur a fourth time or do not resolve to grade 2 during interruption of treatment, permanent discontinuation of cetuximab treatment is required.
Slovenian: Če se huda kožna reakcija pojavi še četrtič ali če se v času prekinitve zdravljenja ne izboljša do 2. stopnje, je potrebna stalna ukinitev terapije s cetuksimabom.
English: More than 10 out of 100 patients are likely to experience infusion-related side effects; in more than 1 out of 100 patients these side effects are likely to be severe.
Slovenian: Pri več kot 10 od 100 bolnikov obstaja verjetnost, da se bodo pojavili neželeni učinki, povezani z infundiranjem; pri več kot 1 od 100 bolnikov je verjetno, da bodo ti neželeni učinki hudi.
English: EGFR signalling pathways are involved in the control of cell survival, cell cycle progression, angiogenesis, cell migration and cellular invasion/metastasis.
Slovenian: Poti za prenos signalov prek EGFR sodelujejo pri nadzoru preživetja celice, napredovanju celičnega ciklusa, angiogenezi, celični migraciji in celični invaziji oz. metastaziranju.
English: In the event of symptoms (such as dyspnoea, cough, fever) or radiographic findings suggestive of ILD, prompt diagnostic investigation should occur.
Slovenian: V primeru simptomov (kot so dispneja, kašelj, zvišana telesna temperatura) ali radiografskih ugotovitev, ki kažejo na IPB, je potrebna takojšnja diagnostična preiskava.
English: However, dependent on the dose, an increased incidence of abortion was observed.
Slovenian: Vendar pa so opazili povečano incidenco abortusov, odvisno od odmerka.
English: Neutropenia and related infectious complications
Slovenian: Nevtropenija in drugi zapleti zaradi okužb
English: Confounding or contributing factors, such as concomitant chemotherapy known to be associated with ILD, and pre-existing pulmonary diseases were frequent in fatal cases.
Slovenian: Sočasni ali sodelujoči dejavniki, kot so sočasna kemoterapija, ki je znano povezana z IPB, in obstoječe pljučne bolezni so bili pri smrtnih primerih pogosti.
English: If a patient experiences an intolerable or severe skin reaction ( grade 3; Common Terminology Criteria for Adverse Events, CTCAE), cetuximab therapy must be interrupted.
Slovenian: Če se pri bolniku pojavi kožna reakcija, ki je ne more prenašati, ali huda kožna reakcija (≥ 3. stopnje po kriterijih Common Terminology Criteria for Adverse Events; CTCAE), morate prekiniti terapijo s cetuksimabom.
English: Do not drive or use any tools or machines if you experience treatment-related symptoms that affect your ability to concentrate and react.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne vozite avtomobila in ne upravljajte orodij ali strojev, če imate z zdravljenjem povezane simptome, ki vplivajo na vašo zbranost in reakcijsko sposobnost.
English: The development of human anti-chimeric antibodies (HACA) is a class effect of monoclonal chimeric antibodies.
Slovenian: Nastanek humanih antihimernih protiteles (HAHP) je razredni učinek monoklonskih himernih protiteles.
English: Mutations of RAS genes at certain hot-spots on exons 2, 3 and 4 result in constitutive activation of RAS proteins independently of EGFR signalling.
Slovenian: Mutacije genov RAS na nekaterih točkah na eksonih 2, 3 in 4 povzročijo osnovno aktivacijo beljakovin RAS, ne glede na pošiljanje signalov faktorja EGFR.
English: Dose-dependent skin alterations, starting at dose levels equivalent to those used in humans, were the major findings observed in toxicity studies with Cynomolgus monkeys (a chronic repeat-dose toxicity study and an embryo-foetal development study).
Slovenian: Kožne spremembe, odvisne od odmerka, ki se pojavijo pri stopnjah odmerjanja, ki so enake kot pri človeku, so glavne ugotovitve, ki so jih opazili v študijah toksičnosti pri opicah vrste Cynomolgus (študiji kronične toksičnosti ponavljajočih se odmerkov in študiji razvoja zarodka/ploda).
English: Remove the needle and put the syringe into the syringe pump.
Slovenian: Snemite iglo in postavite brizgo v črpalko za brizgo.
English: Cetuximab does not bind to other receptors belonging to the HER family.
Slovenian: Cetuksimab se ne veže na druge receptorje iz skupine HER.
English: In particular, in these patients negative effects on progression-free survival (PFS) and overall survival (OS) were seen as add-on to FOLFOX4 (see section 5.1).
Slovenian: Zlasti pri teh bolnikih so opazili negativen vpliv na čas preživetja brez napredovanja bolezni (PFS, progression-free survival time) in na celokupno preživetje (OS, overall survival) pri dodajanju zdravila k FOLFOX4 (glejte poglavje 5.1).
English: Infusion-related, including anaphylactic, reactions
Slovenian: Reakcije, povezane z infundiranjem, vključno z anafilaktičnimi
English: • in combination with radiation therapy for locally advanced disease,
Slovenian: • v kombinaciji z radioterapijo za lokalno napredovalo bolezen;
English: The 5 randomised studies investigated a total of 3734 patients with metastatic colorectal cancer, in whom EGFR expression was detectable and who had an ECOG performance status of ≤ 2.
Slovenian: Pet randomiziranih študij je preučilo skupno število 3734 bolnikov z metastatskim kolorektalnim rakom, pri katerih je bila ugotovljena ekspresija EGFR in pri katerih je bil indeks zmogljivosti ECOG ≤ 2.
English: • acne-like skin alterations
Slovenian: • aknam podobne kožne spremembe
English: What Erbitux is and what it is used for What you need to know before you use Erbitux How to use Erbitux
Slovenian: Kaj je zdravilo Erbitux in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Erbitux Kako uporabljati zdravilo Erbitux Možni neželeni učinki
English: Of these, 342 patients had RAS wild-type tumours while RAS mutations were identified in 65 patients.
Slovenian: 342 od teh bolnikov je imelo tumorje z nemutiranim tipom RAS, pri 65 bolnikih pa so ugotovili mutacije RAS.
English: If necessary, repeat this procedure until the calculated volume has been infused.
Slovenian: Po potrebi ponovite ta postopek, dokler ne bo infundiran ves izračunani volumen.
English: Some of these reactions may be anaphylactic or anaphylactoid in nature or represent a cytokine release syndrome (CRS).
Slovenian: Nekatere od teh reakcij imajo lahko anafilaktični ali anafilaktoidni značaj ali predstavljajo sindrom sproščanja citokinov (CRS, cytokine release syndrome).
English: With the second and third occurrences of severe skin reactions, cetuximab therapy must again be interrupted.
Slovenian: Ob drugem ali tretjem pojavu hude kožne reakcije morate spet prekiniti terapijo s cetuksimabom.
English: Other medicines and Erbitux
Slovenian: Druga zdravila in zdravilo Erbitux
English: More than 80 out of 100 patients are likely to experience side effects involving the skin.
Slovenian: Pri več kot 80 od 100 bolnikov obstaja verjetnost, da bodo imeli neželene učinke, povezane s kožo.
English: Cetuximab has not been studied in patients with pre-existing haematological disorders (see section 4.4).
Slovenian: Cetuksimaba niso raziskovali pri bolnikih z obstoječimi hematološkimi motnjami (glejte poglavje 4.4).
English: A formal interaction study showed that the pharmacokinetic characteristics of cetuximab remain unaltered after co-administration of a single dose of irinotecan (350 mg/m2 body surface area).
Slovenian: Formalna študija medsebojnega delovanja z drugimi zdravili je pokazala, da ostanejo farmakokinetične značilnosti cetuksimaba nespremenjene po sočasni uporabi enkratnega odmerka irinotekana (350 mg/m² telesne površine).
English: Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck
Slovenian: Zdravilo Erbitux je indicirano za zdravljenje bolnikov z rakom skvamoznih celic glave in vratu
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Slovenian: Bolnike z znaki in simptomi, ki bi vzbujali sum na keratitis, kot je akutni pojav ali poslabšanje: vnetja očesa, solzenja, občutljivosti na svetlobo, zamegljenega vida, bolečine v očesu in/ali pordelosti očesa, je treba takoj napotiti k specialistu oftalmologu.
English: In particular a negative effect of cetuximab add-on in the RAS mutant population was observed.
Slovenian: Opazili so zlasti negativni učinek dodajanja cetuksimaba pri populaciji z mutacijo RAS.
English: If you receive Erbitux in combination with other anticancer medicines, these medicines must be administered at least 1 hour after the end of the Erbitux infusion.
Slovenian: Če zdravilo Erbitux prejemate v kombinaciji z drugimi zdravili proti raku, je treba ta zdravila vzeti vsaj eno uro po koncu infuzije zdravila Erbitux.
English: Not all vial sizes may be marketed.
Slovenian: Na trgu morda ni vseh navedenih pakiranj vial.
English: A diagnostic assay (EGFR pharmDx) was used for immunohistochemical detection of EGFR expression in tumour material.
Slovenian: Diagnostični test za EGFR (EGFR pharmDx) je bil uporabljen za imunohistokemično ugotavljanje ekspresije EGFR v tumorskem tkivu.
English: • reduction in the number of white blood cells
Slovenian: • zmanjšanje števila belih krvnih telesc
English: Since Erbitux is only compatible with sterile sodium chloride 9 mg/mL (0.9%) solution for injection, it must not be mixed with other intravenously applied medicinal products.
Slovenian: Ker je zdravilo Erbitux združljivo samo s sterilno raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje, ga ne smete mešati z drugimi zdravili za intravensko uporabo.
English: Severe infusion-related reactions, in some cases with fatal outcome (see section 4.4); fatigue.
Slovenian: hude reakcije, povezane z infundiranjem, v nekaterih primerih s smrtnim izidom (glejte poglavje 4.4); utrujenost.
English: Approximately 75% of the patients with metastatic colorectal cancer screened for clinical studies had an EGFR-expressing tumour and were therefore considered eligible for cetuximab treatment.
Slovenian: Približno 75% bolnikov z metastatskim kolorektalnim rakom, pri katerih so opravili presejalni test za klinično študijo, je imelo tumor z ekspresijo EGFR, in so bili torej primerni za zdravljenje s cetuksimabom.
English: • drying out which may be due to diarrhoea or reduced fluid intake
Slovenian: • izguba tekočine, ki je lahko posledica driske ali zmanjšanega vnosa tekočine
English: Erbitux 5 mg/mL must be prepared as follows:
Slovenian: Zdravilo Erbitux 5 mg/ml mora biti pripravljeno, kot sledi:
English: Only patients with adequate renal and hepatic function have been investigated to date (serum creatinine  1.5fold, transaminases  5fold and bilirubin  1.5fold the upper limit of normal).
Slovenian: Doslej so bili v študije vključeni le bolniki s primernim delovanjem jeter in ledvic (vrednost serumskega kreatinina ≤ 1,5-kratna zgornja meja normalnih vrednosti, transaminaze ≤ 5-kratna zgornja meja normalnih vrednosti in bilirubin ≤ 1,5-kratna zgornja meja normalnih vrednosti).
English: If the patient experiences a mild or moderate infusion-related reaction, the infusion rate may be decreased.
Slovenian: Če pri bolniku nastopi blaga ali zmerna reakcija, povezana z infundiranjem, lahko zmanjšate hitrost infundiranja.
English: • metastatic cancer of the large intestine.
Slovenian: • Metastatskega raka debelega črevesa.
English: Erbitux 5 mg/mL is chemically and physically stable for up to 48 hours at 25°C, if the solution is prepared as described hereafter.
Slovenian: Zdravilo Erbitux 5 mg/ml je kemično in fizikalno stabilno do 48 ur pri temperaturi 25 °C, če je raztopina pripravljena, kot je opisano v nadaljevanju.
English: Skin reactions may develop in more than 80% of patients and mainly present as acne-like rash and/or, less frequently, as pruritus, dry skin, desquamation, hypertrichosis, or nail disorders (e.g. paronychia).
Slovenian: Kožne reakcije se lahko pojavijo pri več kot 80% bolnikov, nastopijo pa v obliki aknam podobnega izpuščaja in/ali (manj pogosto) v obliki pruritusa, suhe kože, deskvamacije, hipertrihoze ali bolezni nohtov (npr. paronihija).
English: Transfer the Erbitux into the prepared infusion bag.
Slovenian: Prenesite zdravilo Erbitux v pripravljeno vrečko za infundiranje.
English: If you notice symptoms such as occurrence or worsening of breathing difficulties, speak to a doctor immediately, especially if you also experience cough or fever.
Slovenian: Če opazite simptome kot je pojav ali poslabšanje težav pri dihanju, se nemudoma pogovorite z zdravnikom, zlasti, če ob tem tudi kašljate ali imate povišano telesno temperaturo.
English: In a phase-I study in paediatric patients (1-18 years) with refractory solid tumours, cetuximab was administered in combination with irinotecan.
Slovenian: V študiji faze I pri pediatričnih bolnikih (1-18 let) z refraktornimi solidnimi tumorji so cetuksimab dajali v kombinaciji z irinotekanom.
English: If you notice that already affected areas of your skin get worse, speak to a doctor immediately, especially if you also experience general signs of infection such as fever and tiredness.
Slovenian: Če opazite, da se stanje prizadetih mest na koži poslabša, se nemudoma pogovorite z zdravnikom, zlasti če imate tudi splošne znake okužbe, kot sta zvišana telesna temperatura in utrujenost.
English: Further post-hoc analyses were performed for studies EMR 62 202-013 and EMR 62 202-047, where also mutations on RAS genes (NRAS and KRAS) other than KRAS exon 2 have been determined.
Slovenian: Opravljene so bile nadaljnje post-hoc analize v študijah EMR 62 202-013 in EMR 62 202-047, s katerimi so bile poleg mutacij na eksonu 2 gena KRAS določene tudi druge mutacije na genih RAS (NRAS in KRAS).
English: Calculate the required volume of Erbitux.
Slovenian: Izračunajte potreben volumen zdravila Erbitux.
English: 20 mL or 100 mL of solution in a vial (Type I glass) with a stopper (halobutyl rubber) and a seal (aluminium/polypropylen).
Slovenian: 20 ml ali 100 ml raztopine v viali (iz stekla tipa I) z zamaškom (halobutilna guma) in zaporko (iz aluminija/polipropilena).
English: Diarrhoea; nausea; vomiting.
Slovenian: driska; navzea; bruhanje.
English: Combination treatment
Slovenian: Kombinirano zdravljenje
English: Skin reactions are very common and treatment interruption or discontinuation may be required.
Slovenian: Zaradi kožnih reakcij, ki so zelo pogoste, bo morda treba prekiniti ali ukiniti zdravljenje.
English: These side effects may have serious consequences, in rare cases including life-threatening conditions, and require immediate attention.
Slovenian: Taki neželeni učinki imajo lahko resne posledice, v redkih primerih so lahko smrtno nevarni in zahtevajo takojšnjo pomoč.
English: Cetuximab is a chimeric monoclonal IgG1 antibody that is specifically directed against the epidermal growth factor receptor (EGFR).
Slovenian: Cetuksimab je himerno monoklonsko IgG1 protitelo, ki je specifično usmerjeno proti receptorju za epidermalni rastni faktor (EGFR).
English: In combination with local radiation therapy of the head and neck area, additional undesirable effects were those typical of radiation therapy (such as mucositis, radiation dermatitis, dysphagia or leukopenia, mainly presenting as lymphocytopenia).
Slovenian: V kombinaciji z lokalno radioterapijo glave in vratu so se pojavili dodatni neželeni učinki, značilni za radioterapijo (na primer mukozitis, radiacijski dermatitis, disfagija ali levkopenija, ki se pretežno kaže kot limfocitopenija).
English: In patients with locally advanced squamous cell cancer of the head and neck, cetuximab is used concomitantly with radiation therapy.
Slovenian: Pri bolnikih z lokalno napredovalim rakom skvamoznih celic glave in vratu se cetuksimab uporablja sočasno z radioterapijo.
English: Erbitux is usually infused once a week.
Slovenian: Zdravilo Erbitux se navadno infundira enkrat na teden.
English: What you need to know before you use Erbitux
Slovenian: Kaj moratevedeti, preden boste uporabili zdravilo Erbitux
English: Anaphylactic reactions may occur as early as within a few minutes of the first infusion e.g. due to preformed IgE antibodies cross-reacting with cetuximab.
Slovenian: Anafilaktične reakcije se lahko pojavijo že nekaj minut po prvem infundiranju, npr. zaradi navzkrižne reakcije obstoječih protiteles IgE s cetuksimabom.
English: Only patients with adequate renal and hepatic function have been investigated to date (see section 4.4).
Slovenian: Doslej so bili v študije vključeni le bolniki s primernim delovanjem jeter in ledvic (glejte poglavje 4.4).
English: • increase in blood levels of certain liver enzymes
Slovenian: • zvišanje ravni nekaterih jetrnih encimov v krvi
English: In tumours, activation of RAS by EGFR contributes to EGFR-mediated increased proliferation, survival and the production of pro-angiogenic factors.
Slovenian: Pri tumorjih aktivacija RAS, ki jo sproži faktor EGFR, povzroči povečano proliferacijo, ki jo povzroča faktor EGFR, preživetje in tvorbo proangiogenetskih faktorjev.
English: The risk for anaphylactic reactions is much increased in patients with a history of allergy to red meat or tick bites or positive results of tests for IgE antibodies against cetuximab (α-1-3-galactose).
Slovenian: Tveganje za anafilaktične reakcije se močno poveča pri bolnikih z anamnezo alergij na rdeče meso ali ugrize klopa ali s pozitivnimi rezultati testov za protitelesa za IgE proti cetuksimabu (α-1-3-galaktoza).
English: Careful monitoring is recommended in such patients, in particular in those who experience skin lesions, mucositis or diarrhoea that may facilitate the occurrence of infections (see section 4.8).
Slovenian: Takšne bolnike je treba skrbno nadzorovati, zlasti tiste, pri katerih se pojavijo kožne lezije, mukozitis ali driska, ki lahko omogočijo pojav okužb (glejte poglavje 4.8).
English: The protein product of the proto-oncogene RAS (rat sarcoma) is a central down-stream signaltransducer of EGFR.
Slovenian: Beljakovinski produkt protoonkogenega RAS (podganji sarkom) je osrednji prevodnik signala faktorja EGFR po signalni poti navzdol.
English: Cetuximab as a single agent or in combination with chemotherapy was investigated in 5 randomised controlled clinical studies and several supportive studies.
Slovenian: Cetuksimab kot samostojno zdravilo ali v kombinaciji s kemoterapijo so preučevali v petih randomiziranih, nadzorovanih kliničnih študijah in več podpornih študijah.
English: The risk for secondary infections (mainly bacterial) is increased and cases of staphylococcal scalded skin syndrome, necrotising fasciitis and sepsis, in some cases with fatal outcome, have been reported (see section 4.8).
Slovenian: Tveganje za sekundarne okužbe (v glavnem bakterijske) je večje in poročali so o primerih stafilokoknega sindroma luščenja kože, nekrotizirajočega fasciitisa in sepse, ki so bili v nekaterih primerih smrtni (glejte poglavje 4.8).
English: • with polypropylene (PP) syringes for syringe pump.
Slovenian: • s polipropilenskimi (PP) brizgami za črpalko za brizgo.
English: The RAS mutant population comprises these 65 patients together with 113 patients with KRAS exon 2 mutant tumours treated before study enrolment was restricted to patients with KRAS exon 2 wild-type mCRC.
Slovenian: Populacijo z mutacijo RAS je sestavljalo teh 65 bolnikov skupaj s 113 bolniki s tumorji z mutiranim tipom KRAS (eksona 2), ki so se zdravili, preden je bila vključitev v študijo omejena na bolnike z mCRC z nemutiranim tipom KRAS (eksona 2).
English: No formal animal studies have been performed to establish the carcinogenic potential of cetuximab or to determine its effects on male and female fertility.
Slovenian: Formalne študije pri živalih za ugotavljanje kancerogenosti cetuksimaba, določanje njegovih učinkov na plodnost pri moških ali ženskah, niso bile opravljene.
English: Each subsequent dose (250 mg/m² body surface area) is infused in approximately 1 hour with an infusion rate not faster than 10 mg/min.
Slovenian: Vsak naslednji odmerek (250 mg/m² telesne površine) se infundira približno 1 uro s hitrostjo infundiranja, ki ni hitrejša kot 10 mg/min.
English: The majority of patients included had an ECOG performance status of ≤ 1.
Slovenian: Pri večini vključenih bolnikov je bil indeks zmogljivosti ≤ 1.