FrancophonIA/ELRC3.0 huggingface dataset:
English: • in patients insufficiently controlled on their maximally tolerated dose of metformin alone
Croatian: • u bolesnika u kojih nije postignuta dostatna regulacija uz njihovu maksimalnu podnošljivu dozu metformina kao monoterapiju
English: Following administration of an oral [
Croatian: Nakon primjene oralne otopine [
English: For patients insufficiently controlled on metformin (either alone or in combination with other medicinal products for the treatment of diabetes)
Croatian: U bolesnika u kojih nije postignuta dostatna regulacija metforminom (bilo u monoterapiji ili u kombinaciji s drugim lijekovima za liječenje šećerne bolesti)
English: Initial increases in creatinine and initial decreases in estimated glomerular filtration rates in patients treated with empagliflozin as add-on to metformin therapy were generally transient during continuous treatment or reversible after drug discontinuation of treatment.
Croatian: Početna povišenja kreatinina i početna sniženja procijenjenih brzina glomerularne filtracije u bolesnika liječenih empagliflozinom kao dodatkom terapiji metforminom općenito su bila prolazna tijekom kontinuiranog liječenja ili reverzibilna nakon prekida liječenja.
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, or carcinogenic potential or reproductive toxicity.
Croatian: Neklinički podaci za metformin ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti ili reproduktivne toksičnosti.
English: When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Croatian: Kada je funkcija bubrega oštećena, bubrežni klirens se smanjuje proporcionalno klirensu kreatinina i stoga je poluvijek eliminacije produljen dovodeći do povišenih razina metformina u plazmi.
English: The glucosuria, natriuresis and osmotic diuresis observed with empagliflozin may contribute to the improvement in cardiovascular outcomes.
Croatian: Glukozurija, natriureza i osmotska diureza opažene uz empagliflozin mogu doprinijeti poboljšanju u kardiovaskularnim ishodima.
English: Furthermore, empagliflozin resulted in a reduction in FPG, body weight and blood pressure.
Croatian: Nadalje, terapija empagliflozinom rezultirala je sniženjem vrijednosti FPG-a, tjelesne težine i krvnog tlaka.
English: • Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2 (SGLT2).
Croatian: • Empagliflozin djeluje blokiranjem proteina u bubrezima koji se naziva suprijenosnik natrija i glukoze 2 (engl. sodium-glucose co-transporter 2, SGLT2).
English: In the EMPA-REG Outcome study, haematocrit values returned towards baseline values after a follow-up period of 30 days after treatment stop.
Croatian: Outcome vrijednosti hematokrita vratile su se prema početnim vrijednostima nakon razdoblja praćenja od 30 dana nakon prekida liječenja.
English: The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart diseases).
Croatian: Rizik od razvoja laktacidoze također je povećan uz nekontroliranu šećernu bolest, ozbiljne infekcije, dugotrajno gladovanje ili uzimanje alkohola, dehidraciju (dodatne informacije vidjeti niže), tegobe s jetrom i sva zdravstvena stanja u kojima dio tijela ima smanjenu opskrbu kisikom (kao što je akutna teška srčana bolest).
English: • rash or red skin- this this may be itchy and include raised bumps, oozing fluid or blisters
Croatian: • osip ili crvenilo kože - koji može svrbjeti i uključivati uzdignuta područja na koži, vlaženje ili mjehure
English: Empagliflozin exposure was similar with and without co-administration with verapamil, a P-gp inhibitor, indicating that inhibition of P-gp does not have any clinically relevant effect on empagliflozin.
Croatian: Izloženost empagliflozinu je bila slična sa i bez istodobne primjene s verapamilom, inhibitorom P-gpa, ukazujući da inhibicija P-gp-a nema klinički značajan učinak na empagliflozin.
English: In controlled clinical studies single doses of up to 800 mg empagliflozin (equivalent to 32-times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg empagliflozin (equivalent to 4-times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity.
Croatian: U kontroliranim kliničkim ispitivanjima jednokratnih doza do 800 mg empagliflozina (što odgovara dozi 32 puta višoj od najviše preporučene dnevne doze) u zdravih dobrovoljaca i višekratnih dnevnih doza do 100 mg empagliflozina (što odgovara dozi 4 puta višoj od najviše preporučene dnevne doze) u bolesnika sa šećernom bolešću tipa 2 nisu pokazale toksičnost.
English: Co-administration of multiple doses of empagliflozin and metformin does not meaningfully alter the pharmacokinetics of either empagliflozin or metformin in healthy subjects.
Croatian: Istodobna primjena višekratnih doza empagliflozina i metformina ne mijenja značajno farmakokinetiku, niti empagliflozina ni metformina u zdravih ispitanika.
English: In addition, urinary glucose excretion triggers calorie loss, associated with body fat loss and body weight reduction.
Croatian: Nadalje, izlučivanje glukoze mokraćom pokreće gubitak kalorija koji je povezan s gubitkom tjelesne masti i smanjenjem tjelesne težine.
English: Administration of empagliflozin 25 mg after intake of a high-fat and high calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16% and Cmax by approximately 37% compared to fasted condition.
Croatian: Primjena empagliflozina 25 mg nakon unosa obroka s visokim sadržajem masti i kalorija rezultirala je neznatno nižom izloženošću; AUC se smanjio za približno 16 %, a Cmax za približno 37 % u usporedbi sa stanjem natašte.
English: General toxicity studies in rats of up to 13 weeks were performed with the combination of empagliflozin and metformin and did not reveal any additional target organs when compared to empagliflozin or metformin alone.
Croatian: Ispitivanja opće toksičnosti u štakora u trajanju do 13 tjedana provedena su s kombinacijom empagliflozina i metformina te nisu pokazala dodatne ciljne organe u usporedbi s empagliflozinom ili metforminom kao monoterapijama.
English: At week 18, empagliflozin provided statistically significant improvement in HbA1c.
Croatian: U 18. tjednu empagliflozin je postigao statistički značajno poboljšanje vrijednosti HbA1c.
English: • if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see ‘Risk of lactic acidosis' below) or ketoacidosis.
Croatian: • ako imate nekontroliranu šećernu bolest uz, primjerice, tešku hiperglikemiju (visoka razina glukoze u krvi), mučninu, povraćanje, proljev, brz gubitak tjelesne težine, laktacidozu (vidjeti „Rizik od laktacidoze“ niže) ili ketoacidozu.
English: Increased urinary glucose excretion was maintained at the end of the 4-week treatment period, averaging approximately 78 g/day with empagliflozin 25 mg.
Croatian: Povećano izlučivanje glukoze mokraćom održalo se pri kraju 4-tjednog razdoblja liječenja iznoseći u prosjeku približno 78 g/dan uz empagliflozin 25 mg.
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness;
Croatian: Rizik od razvoja dijabetičke ketoacidoze može biti povećan kod produljenog gladovanja, prekomjerne konzumacije alkohola, dehidracije, iznenadnog smanjenja doze inzulina ili povećane potrebe za inzulinom zbog velikog kirurškog zahvata ili ozbiljne bolesti.
English: In patients tolerating a total daily dose of empagliflozin 10 mg and who need tighter glycaemic control, the dose can be increased to a total daily dose of empagliflozin 25 mg.
Croatian: U bolesnika koji podnose ukupnu dnevnu dozu empagliflozina od 10 mg i koji trebaju bolju regulaciju glikemije, doza se može povećati na ukupnu dnevnu dozu empagliflozina od 25 mg.
English: Blood creatinine increased/ Glomerular filtration rate decreased Haematocrit increased
Croatian: Povišena razina kreatinina u krvi/snižena brzina glomerularne filtracije
English: Following administration of a dose of 850 mg metformin hydrochloride, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 minute prolongation of the time to peak plasma concentration were observed.
Croatian: Nakon primjene doze od 850 mg metforminklorida uočena je 40 % niža vršna koncentracija u plazmi, 25 %-tno smanjenje vrijednosti AUC i 35-minutno produljenje vremena do postizanja vršne koncentracije u plazmi.
English: The efficacy and safety of empagliflozin was evaluated in a double-blind, placebo controlled study of 12 weeks duration in patients with type 2 diabetes and high blood pressure on different antidiabetic and up to 2 antihypertensive therapies.
Croatian: Djelotvornost i sigurnost empagliflozina ocjenjivane su u dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 12 tjedana u bolesnika sa šećernom bolešću tipa 2 i visokim krvnim tlakom na različitim antidijabetičkim lijekovima i do dvije antihipertenzivne terapije.
English: The efficacy for preventing cardiovascular mortality has not been conclusively established in patients using empagliflozin concomitantly with DPP-4 inhibitors or in Black patients because the representation of these groups in the EMPA-REG OUTCOME study was limited.
Croatian: Djelotvornost u sprječavanju kardiovaskularnog mortaliteta nije bila uvjerljivo ustanovljena u bolesnika koji su istodobno primjenjivali empagliflozin i DPP-4 inhibitore niti u bolesnika crne rase, jer je zastupljenost ovih skupina u ispitivanju EMPA-REG
English: It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.
Croatian: Važno je nastaviti sa svojim režimom prehrane i tjelovježbom prema preporukama koje ste dobili od svog liječnika, ljekarnika ili medicinske sestre.
English: • blood tests may show increases in the amount of red blood cells in your blood (haematocrit)
Croatian: • krvne pretrage mogu pokazati povećanje u količini crvenih krvnih stanica u Vašoj krvi
English: Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects.
Croatian: Apsolutna bioraspoloživost tablete metformina od 500 mg ili 850 mg iznosila je približno 50-60 % u zdravih ispitanika.
English: High overdose of metformin or concomitant risks may lead to lactic acidosis.
Croatian: Visoko predoziranje metforminom ili istodobni rizici mogu dovesti do laktacidoze.
English: Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin.
Croatian: • induktorima OCT1 (kao što je rifampicin) može povećati gastrointestinalnu apsorpciju i djelotvornost metformina.
English: Empagliflozin is not recommended.
Croatian: Empagliflozin se ne preporučuje.
English: Of these, 266 or 264 patients were treated with empagliflozin 10 mg or 25 mg as add-on to metformin plus insulin, respectively.
Croatian: Od toga je 266 ili 264 bolesnika bilo liječeno empagliflozinom 10 mg odnosno 25 mg kao dodatkom metforminu plus inzulin.
English: Empagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is 5000-times more selective for SGLT2 versus SGLT1, the major transporter responsible for glucose absorption in the gut.
Croatian: Empagliflozin ne inhibira druge prijenosnike glukoze važne za prijenos glukoze u periferna tkiva te je 5000 puta selektivniji za SGLT2 naspram SGLT1, glavnog prijenosnika odgovornog za apsorpciju glukoze u crijevu.
English: • abnormalities in liver function tests, inflammation of the liver (hepatitis)
Croatian: • abnormalne vrijednosti pretraga jetrenih funkcija, upala jetre (hepatitis)
English: At 78 weeks, the decrease in HbA1c and insulin sparing effect of empagliflozin was maintained.
Croatian: U 78. tjednu održano je smanjenje vrijednosti HbA1c kao i učinak empagliflozina na uštedu inzulina.
English: Synjardy is added to diet and exercise to treat type 2 diabetes in adult patients (aged 18 years and older) whose diabetes cannot be controlled by adding metformin alone or metformin with other medicines for diabetes.
Croatian: Synjardy se primjenjuje uz dijetu i tjelovježbu kako bi se liječila šećerna bolest tipa 2 u odraslih bolesnika (u dobi od 18 ili više godina) čija se šećerna bolest ne može kontrolirati primjenom metformina kao monoterapije ili kombinacije metformina s drugim lijekovima za liječenje šećerne bolesti.
English: In addition, initiation of empagliflozin increases excretion of sodium resulting in osmotic diuresis and reduced intravascular volume.
Croatian: Povrh toga, započinjanje terapije empagliflozinom povećava izlučivanje natrija što rezultira osmotskom diurezom i smanjenim intravaskularnim volumenom.
English: As Synjardy contains empagliflozin it may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Croatian: S obzirom da Synjardy sadrži empagliflozin, može pridonijeti diuretskom učinku tiazida i diuretika Henleove petlje te može povećati rizik od dehidracije i hipotenzije (vidjeti dio 4.4).
English: For patients switching from separate tablets of empagliflozin and metformin Patients switching from separate tablets of empagliflozin (10 mg or 25 mg total daily dose) and metformin to Synjardy should receive the same daily dose of empagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Croatian: Za bolesnike koji prelaze s odvojenih tableta empagliflozina i metformina Bolesnici koji prelaze s odvojenih tableta empagliflozina (10 mg ili 25 mg ukupne dnevne doze) i metformina na Synjardy, moraju primiti jednaku dnevnu dozu empagliflozina i metformina koju su već uzimali ili najbližu terapijski odgovarajuću dozu metformina.
English: Urinary tract infection, seen commonly (may affect up to 1 in 10 people) The signs of urinary tract infection are:
Croatian: Infekcija mokraćnog sustava, često (može se javiti u do 1 na 10 osoba) Znakovi infekcije mokraćnog sustava su:
English: Increased urinary glucose excretion resulted in an immediate reduction in plasma glucose levels in patients with type 2 diabetes.
Croatian: Povećano izlučivanje glukoze u mokraći rezultiralo je trenutnim sniženjem razina glukoze u plazmi u bolesnika sa šećernom bolešću tipa 2.
English: Boehringer Ingelheim Ellas A.E. 5th km Paiania - Markopoulo Koropi Attiki, 19400
Croatian: 5th km Paiania - Markopoulo Koropi Attiki, 19400
English: Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and
Croatian: Oštećenje jetrene funkcije Ovaj lijek se ne smije primjenjivati u bolesnika s oštećenjem jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
English: The treatment effect was driven by a significant reduction in cardiovascular death with no significant change in non-fatal myocardial infarction, or non-fatal stroke.
Croatian: Učinak liječenja predvodilo je značajno smanjenje kardiovaskularne smrti bez značajne promjene kod infarkta miokarda bez smrtnog ishoda ili kod moždanog udara bez smrtnog ishoda.
English: Only at maternally toxic doses, empagliflozin also caused bent limb bones in the rat and increased embryofetal loss in the rabbit.
Croatian: Samo je pri dozama toksičnim za majku empagliflozin prouzročio savijene kosti udova u potomaka štakora i povećanu embriofetalnu smrtnost u kunića.
English: Treatment with empagliflozin in combination with metformin (5 mg and 500 mg; 5 mg and 1000 mg; 12.5 mg and 500 mg, and 12.5 mg and 1000 mg given twice daily) provided statistically significant improvements in HbA1c (Table 4) and led to greater reductions in FPG (compared to the individual components) and body weight (compared to metformin).
Croatian: Liječenje empagliflozinom u kombinaciji s metforminom (5 mg i 500 mg; 5 mg i 1000 mg; 12,5 mg i 500 mg; te 12,5 mg i 1000 mg davani dvaput dnevno) pružilo je statistički značajna poboljšanja vrijednosti HbA1c (Tablica 4) i dovelo je do većih smanjenja vrijednosti FPG (u usporedbi s pojedinačnim komponentama) i tjelesne težine (u usporedbi s metforminom).
English: In patients ≥75 years of age volume depletion events have been reported in a single patient treated with empagliflozin 25 mg as add-on to metformin therapy.
Croatian: U bolesnika u dobi od ≥ 75 godina događaji deplecije volumena prijavljeni su u jednog bolesnika liječenog empagliflozinom 25 mg kao dodatkom terapiji metforminom.
English: Liver function tests abnormalities Hepatitis
Croatian: Abnormalni nalazi pretrage jetrene funkcije Hepatitis
English: Synjardy combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: empagliflozin, an inhibitor of sodium-glucose co-transporter 2 (SGLT2), and metformin hydrochloride, a member of the biguanide class.
Croatian: Synjardy kombinira dva antihiperglikemijska lijeka s komplementarnim mehanizmima djelovanja kako bi se poboljšala regulacija glikemije u bolesnika s šećernom bolešću tipa 2: empagliflozin, inhibitor suprijenosnika natrija i glukoze 2 (engl. sodium-glucose co-transporter 2, SGLT2) i metforminklorid, član skupine bigvanidna.
English: Treatment with empagliflozin in combination with metformin with or without other antidiabetic medicinal products (pioglitazone, sulfonylurea, DPP-4 inhibitors, and insulin) led to clinically relevant improvements in HbA1c, fasting plasma glucose (FPG), body weight, systolic and diastolic blood pressure.
Croatian: Liječenje empagliflozinom u kombinaciji s metforminom sa ili bez drugih antidijabetika (pioglitazona, sulfonilureje, inhibitora enzima DPP-4 i inzulina) dovelo je do klinički značajnih poboljšanja vrijednosti HbA1c, glukoze u plazmi natašte (engl. fasting plasma glucose, FPG), tjelesne težine, te sistoličkog i dijastoličkog krvnog tlaka.
English: • straining or pain when emptying the bladder
Croatian: • naprezanje ili bol kod pražnjenja mjehura
English: If this happens you must stop taking Synjardy and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Croatian: Ako Vam se to dogodi, morate prestati uzimati lijek Synjardy i odmah se obratiti liječniku ili otići u najbližu bolnicu, jer laktacidoza može dovesti do kome.
English: The safety and efficacy of empagliflozin in patients with type 1 diabetes have not been established and empagliflozin should not be used for treatment of patients with type 1 diabetes.
Croatian: Sigurnost i djelotvornost empagliflozina u bolesnika sa šećernom bolešću tipa 1 nisi ustanovljene te se empagliflozin ne smije primjenjivati u liječenju bolesnika sa šećernom bolešću tipa
English: In patients with mild, moderate or severe renal impairment (creatinine clearance <30 - <90 ml/min) and patients with kidney failure/end stage renal disease (ESRD), AUC of empagliflozin increased by approximately 18%, 20%, 66%, and 48%, respectively compared to subjects with normal renal function.
Croatian: U bolesnika s blagim, umjerenim ili teškim oštećenjem bubrega (klirens kreatinina < 30< 90 ml/min.) i bolesnika sa zatajenjem bubrega/terminalnim stadijem bolesti bubrega, AUC empagliflozina se povećao za približno 18 %, 20 %, 66 % odnosno 48 % u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: It is not known whether empagliflozin passes into human breast milk.
Croatian: Nije poznato prolazi li empagliflozin u majčino mlijeko.
English: In patients with type 2 diabetes, urinary glucose excretion increased immediately following the first dose of empagliflozin and is continuous over the 24 hour dosing interval.
Croatian: U bolesnika sa šećernom bolešću tipa 2 izlučivanje glukoze mokraćom povećalo se odmah nakon prve doze empagliflozina te je bilo stabilno tijekom 24-satnog intervala doziranja.
English: Driving and using machines Synjardy has minor influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Synjardy malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: 10 x 1 film-coated tablets 14 x 1 film-coated tablets 30 x 1 film-coated tablets 56 x 1 film-coated tablets 60 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
Croatian: 10 x 1 filmom obložena tableta 14 x 1 filmom obložena tableta 30 x 1 filmom obložena tableta 56 x 1 filmom obložena tableta 60 x 1 filmom obložena tableta 90 x 1 filmom obložena tableta 100 x 1 filmom obložena tableta
English: • a general feeling of not being well with severe tiredness
Croatian: • opće loše osjećanje uz jaki umor
English: In subjects with mild, moderate, and severe hepatic impairment according to the Child-Pugh classification, AUC of empagliflozin increased approximately by 23%, 47%, and 75% and Cmax by approximately 4%, 23%, and 48%, respectively, compared to subjects with normal hepatic function.
Croatian: U ispitanika s blagim, umjerenim i teškim oštećenjem jetre, prema klasifikaciji Child-Pugh, AUC empagliflozina se povećao za približno 23 %, 47 % odnosno 75 %, a Cmax za približno 4 %, 23 % odnosno 48 % u usporedbi s ispitanicima s normalnom funkcijom jetre.
English: All treatments with empagliflozin resulted in significant reductions in HbA1c from baseline (total mean 7.8%) after 16 weeks of treatment compared with placebo.
Croatian: Sva liječenja empagliflozinom rezultirala su značajnim sniženjima vrijednosti HbA1c u odnosu na početnu vrijednost (ukupna srednja vrijednost 7,8 %) nakon 16 tjedana liječenja u usporedbi s placebom.
English: Table 2: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studies and from post-marketing experience
Croatian: Tablični popis nuspojava (MedDRA) u placebom kontroliranim ispitivanjima i iz iskustva nakon stavljanja lijeka u promet
English: Consistent with the half-life, up to 22% accumulation, with respect to plasma AUC, was observed at steady-state.
Croatian: U skladu s poluvijekom, u stanju dinamičke ravnoteže opažena je akumulacija do 22 % u odnosu na plazmatski AUC.
English: Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Croatian: Ispitivanja interakcija provedena na zdravim dobrovoljcima sugeriraju da empagliflozin nije imao klinički značajan učinak na farmakokinetiku metformina, glimepirida, pioglitazona, sitagliptina, linagliptina, simvastatina, varfarina, ramiprila, digoksina, diuretika i oralnih kontraceptiva.
English: • if you have a serious infection of the kidney or the urinary tract with fever.
Croatian: • ako imate ozbiljnu infekciju bubrega ili mokraćnog sustava popraćenu vrućicom.
English: Serum lipids increased
Croatian: Povišene razine lipida u serumu
English: Avoid excessive alcohol intake while taking Synjardy since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions').
Croatian: Izbjegavajte prekomjerni unos alkohola dok uzimate lijek Synjardy jer to može povećati rizik od laktacidoze (vidjeti dio “Upozorenja i mjere opreza”).
English: No additional adverse reactions were identified in clinical trials with empagliflozin as add-on to metformin compared to the side effects of the single components.
Croatian: Nisu identificirane dodatne nuspojave u kliničkim ispitivanjima empagliflozina kao dodatka metforminu u usporedbi s nuspojavama pojedinačnih komponenata.