FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will make sure you have a blood test and will advise whether or not to continue with Cubicin.
Croatian: Vaš liječnik će se pobrinuti da obavite krvne pretrage i odrediti trebate li nastaviti primati Cubicin ili ne.
English: If unexplained abnormalities of PT/INR are observed in patients taking daptomycin, consideration should be given to a possible in vitro interaction with the laboratory test.
Croatian: Ako se u bolesnika koji primaju daptomicin uoče neobjašnjive nenormalnosti PV/INR, potrebno je razmotriti moguću in vitro interakciju u laboratorijskoj pretrazi.
English: Interaction studies for Cubicin were performed with aztreonam, tobramycin, warfarin and probenecid.
Croatian: Provedena su ispitivanja interakcije lijeka Cubicin s aztreonamom, tobramicinom, varfarinom i probenecidom.
English: These could interfere with the effects of Cubicin in the kidney.
Croatian: Oni mogu utjecati na djelovanje lijeka Cubicin na bubrege.
English: Uncommon: Vaginitis
Croatian: Manje često: Vaginitis
English: 12 mg/kg once every 24 hours infused over 60 minutes cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; (1) Minimum duration of Cubicin for paediatric SAB should be in accordance with the perceived risk of complications in the individual patient.
Croatian: 12 mg/kg jedanput svaka 24 sata infuzijom u trajanju od 60 minuta cSSTI = komplicirane infekcije kože i mekih tkiva; SAB = bakterijemija uzrokovana bakterijom S. aureus; (1) Minimalno trajanje liječenja lijekom Cubicin za SAB u pedijatrijskih bolesnika treba biti sukladno opaženom riziku od komplikacija u pojedinog bolesnika.
English: Secondary objectives included: Clinical outcome based on the blinded Evaluator's assessment of clinical response (success [cure, improved], failure, or nonevaluable) at the TOC Visit; and Microbiological response (success, failure, or non-evaluable) based on evaluation of Baseline infecting pathogen at TOC.
Croatian: Sekundarni ciljevi uključivali su: klinički ishod na temelju kliničkog odgovora prema slijepoj procjeni ocjenjivača (uspjeh [izlječenje, poboljšanje], neuspjeh ili neocjenjivo) prilikom dolaska zbog utvrđivanja izlječenja; i mikrobiološkog odgovora (uspjeh, neuspjeh, neocjenjivo) na temelju procjene zaraznog patogena s početka ispitivanja prilikom utvrđivanja izlječenja.
English: Cubicin is used in adults and in children and adolescents (age from 1 to 17 years) to treat infections of the skin and the tissues below the skin.
Croatian: Cubicin se u odraslih osoba te u djece i adolescenata (u dobi od 1 do 17 godina) koristi za liječenje infekcija kože i tkiva ispod kože.
English: Rare side effects (may affect up to 1 in 1,000 people) - Yellowing of the skin and eyes, - Prothrombin time prolonged.
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - žuta boja kože i očiju, - produljeno protrombinsko vrijeme.
English: Among these failures six patients treated with Cubicin and one patient treated with vancomycin were infected with Staphylococcus aureus that developed increasing MICs of daptomycin on or following therapy (see “Mechanisms of resistance” above).
Croatian: Od tih neuspjelih slučajeva, šest bolesnika liječenih lijekom Cubicin i jedan bolesnik liječen vankomicinom imali su infekcije izazvane Staphylococcus aureus kod kojih se tijekom ili nakon terapije povećao MIK za daptomicin (vidjeti “Mehanizmi rezistencije” iznad).
English: Reversal of both the microscopic and functional effects was complete within 6 months post-dose.
Croatian: I mikroskopski i funkcionalni učinci potpuno su nestali unutar 6 mjeseci nakon prestanka doziranja.
English: Pharmacokinetic parameter values estimated using a model-based approach with sparsely collected pharmacokinetic samples from individual patients in the study.
Croatian: Vrijednosti farmakokinetičkih parametara procijenjene pomoću modela s rijetko prikupljenim farmakokinetičkim uzorcima od pojedinih bolesnika u ispitivanju.
English: The following adverse reactions were reported during therapy and during follow-up with frequencies corresponding to 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: Sljedeće nuspojave su prijavljene tijekom terapije i u razdoblju praćenja s učestalošću koja je definirana kao vrlo često (1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko
English: When clinical information on the patients was available to make a judgement, approximately 50% of the cases occurred in patients with pre-existing renal impairment, or in those receiving concomitant medicinal products known to cause rhabdomyolysis.
Croatian: U bolesnika kod kojih su bili dostupni klinički podaci za prosudbu, u otprilike 50% slučajeva rabdomioliza se javila u bolesnika s ranije prisutnim oštećenjem funkcije bubrega, ili u onih koji su istodobno primali lijekove za koje je poznato da izazivaju rabdomiolizu.
English: Hypertension, hypotension Uncommon: Flushes
Croatian: Hipertenzija, hipotenzija Manje često: Navale vrućine
English: Of these 19 patients 11 were infected with methicillin-susceptible and 8 with methicillin-resistant Staphylococcus aureus.
Croatian: Od tih 19 bolesnika, 11 je imalo infekciju izazvanu Staphylococcus aureus osjetljivim na meticilin, a njih 8 imalo je infekciju izazvanu Staphylococcus aureus rezistentnim na meticilin.
English: Failures with daptomycin in the treatment of enterococcal infections that were mostly accompanied by bacteraemia have been reported.
Croatian: Prijavljeni su neuspjesi s daptomicinom u liječenju enterokoknih infekcija koje su većinom bile praćene bakterijemijom.
English: In most reported cases associated with Cubicin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
Croatian: U većini prijavljenih slučajeva povezanih s lijekom Cubicin, bolesnici su razvili vrućicu, dispneju s hipoksičnom respiratornom insuficijencijom te difuzne plućne infiltrate ili organiziranu pneumoniju.
English: The duration of Cubicin may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient.
Croatian: Možda će biti potrebno liječenje lijekom Cubicin u trajanju duljem od 14 dana u skladu s procijenjenim rizikom od komplikacija za svakog pojedinog bolesnika.
English: Whenever possible, Cubicin should be administered following the completion of dialysis on dialysis days (see section 5.2).
Croatian: Kad je god to moguće, Cubicin treba primjenjivati na sam dan dijalize, nakon završetka postupka dijalize (vidjeti dio 5.2).
English: In paediatric studies, 372 patients received Cubicin, of whom 61 received a single dose and 311 received a therapeutic regimen for cSSTI or SAB (daily doses ranged from 4 mg/kg to 12 mg/kg).
Croatian: U pedijatrijskim ispitivanjima, od 372 bolesnika koji su primali Cubicin, njih 61 primilo je jednu dozu, a 311 primalo je terapijski režim za kompliciranu infekciju kože i mekih tkiva ili bakterijemiju izazvanu bakterijom S. aureus (dnevne doze bile su u rasponu od 4 mg/kg do 12 mg/kg).
English: In a single human case study, Cubicin was intravenously administered daily for 28 days to a nursing mother at a dose of 500 mg/day, and samples of the patient's breast milk were collected over a 24hour period on day 27.
Croatian: Tijekom ispitivanja pojedinačnog slučaja, Cubicin je primijenjen intravenozno svaki dan tijekom 28 dana u dozi od 500 mg/dan majci koja je dojila, te su 27. dana prikupljeni uzorci izdojenog mlijeka bolesnice tijekom razdoblja od 24 sata.
English: Following intravenous administration, plasma clearance of daptomycin is approximately 7 to 9 ml/h/kg and its renal clearance is 4 to 7 ml/h/kg.
Croatian: Nakon intravenske primjene, klirens plazme za daptomicin iznosi otprilike 7 do 9 ml/h/kg, a bubrežni klirens iznosi 4 do 7 ml/h/kg.
English: Experience with the concomitant administration of Cubicin and warfarin is limited.
Croatian: Ograničena su iskustva s istodobnom primjenom lijeka Cubicin i varfarina.
English: If not used immediately, in-use storage times are the responsibility of the user and would not normally be longer than 24 hours at 2C - 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja odgovornost je korisnika i normalno ne smije biti dulje od 24 sata pri 2C - 8°C, osim ako se rekonstitucija/razrjeđivanje ne obavlja u kontroliranim i validiranim aseptičkim uvjetima.
English: In the paediatric SAB study, the mean duration of IV Cubicin was 12 days, with a range of 1 to 44 days.
Croatian: U pedijatrijskom SAB ispitivanju, srednja vrijednost trajanja liječenja lijekom Cubicin primjenjenog intravenski, iznosila je 12 dana, s rasponom od 1 do 44 dana.
English: No data are available in patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: Nisu dostupni podaci za bolesnike s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
English: The possibility of erroneous results may be minimised by drawing samples for PT or INR testing near the time of trough plasma concentrations of daptomycin (see section 4.4).
Croatian: Mogućnost dobivanja pogrešnih rezultata može se smanjiti tako da se uzorci za određivanje PV ili INR uzmu u vrijeme kada su koncentracije daptomicina u plazmi najniže (vidjeti dio 4.4).
English: Your doctor will check the condition of your lungs and decide whether or not you should continue Cubicin treatment.
Croatian: Liječnik će Vam pregledati pluća te će odlučiti da li trebate nastaviti liječenje lijekom Cubicin ili ne.
English: A rare but potentially serious lung disorder called eosinophilic pneumonia has been reported in patients given Cubicin, mostly after more than 2 weeks of treatment.
Croatian: U bolesnika koji su primili Cubicin zabilježen je rijetki, ali potencijalno ozbiljni plućni poremećaj koji se zove eozinofilna upala pluća, do koje je došlo najčešće nakon više od 2 tjedna liječenja.
English: Creatine phosphokinase and myopathy Increases in plasma creatine phosphokinase (CPK; MM isoenzyme) levels associated with muscular pains and/or weakness and cases of myositis, myoglobinaemia and rhabdomyolysis have been reported during therapy with Cubicin (see also sections 4.5, 4.8 and 5.3).
Croatian: Tijekom terapije lijekom Cubicin prijavljeni su porasti razina kreatin fosfokinaze (CPK; MM izoenzim) u plazmi, povezani s bolovima i/ili slabošću mišića, kao i slučajevi miozitisa, mioglobinemije i rabdomiolize (vidjeti također dijelove 4.5, 4.8 i 5.3).
English: In a mass balance study using radiolabelled material, 78% of the administered dose was recovered from the urine based on total radioactivity, whilst urinary recovery of unchanged daptomycin was approximately 50% of the dose.
Croatian: U ispitivanju masene bilance pomoću radioaktivno označenog materijala, temeljeno na ukupnoj radioaktivnosti, 78% primijenjene doze nađeno je u mokraći, dok je otprilike 50% doze nađeno u mokraći u obliku nepromijenjenog daptomicina.
English: Read the package leaflet before use for directions on reconstitution.
Croatian: Prije uporabe pročitajte uputu o lijeku radi uputa za rekonstituciju.
English: If not used immediately, in-use storage times are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C unless reconstitution /dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja odgovornost je korisnika i normalno ne smije biti dulje od 24 sata pri 2°C - 8°C, osim ako se rekonstitucija/razrjeđivanje ne obavlja u kontroliranim i validiranim aseptičkim uvjetima.
English: Fungal infections, urinary tract infection, candida infection Uncommon: Fungaemia Not known*: Clostridium difficile-associated diarrhoea**
Croatian: Gljivične infekcije, infekcija mokraćnog sustava, infekcija Candidom Manje često: Fungemija Nepoznato*: Proljev povezan s Clostridium difficile**
English: It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Croatian: Nije vjerojatno da će daptomicin inhibirati ili inducirati metabolizam lijekova koji se metaboliziraju putem sustava P450.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe/use Cubicin are provided with: - Summary of Product Characteristics - Dosage card
Croatian: Nositelj odobrenja će osigurati da svi liječnici za koje se očekuje da će propisivati/primjenjivati Cubicin dobiju sljedeće: - sažetak opisa svojstava lijeka - karticu za doziranje
English: Therefore, until more experience is gained, breastfeeding should be discontinued when Cubicin is administered to nursing women.
Croatian: Stoga, dok se ne bude raspolagalo većim brojem podataka, treba prekinuti dojenje ukoliko se Cubicin primjenjuje u dojilja.
English: 1 to 6 years (N=19)*
Croatian: 1 do 6 godina (N=19)*
English: The interaction between daptomycin and tobramycin with an approved dose of Cubicin is unknown.
Croatian: Nisu poznate interakcije daptomicina i tobramicina tijekom primjene lijeka Cubicin u odobrenoj dozi.
English: Less frequently reported, but more serious, adverse reactions include hypersensitivity reactions, eosinophilic pneumonia (occasionally presenting as organising pneumonia), drug rash with eosinophilia and systemic symptoms (DRESS), angioedema and rhabdomyolysis.
Croatian: Manje učestale, ali ozbiljnije nuspojave, uključuju reakcije preosjetljivosti, eozinofilnu pneumoniju (koja se povremeno manifestira kao organizirana pneumonija), osip uzrokovan lijekom uz eozinofiliju i sustavne simptome (DRESS), angioedem i rabdomiolizu.
English: The recommended dosage regimens for paediatric patients based on age and indication are shown below.
Croatian: U nastavku je prikazan preporučeni režim doziranja u pedijatrijskih bolesnika na temelju dobi i indikacije.
English: In addition, regular monitoring of renal function is advised during concomitant administration of potentially nephrotoxic agents, regardless of the patient's pre-existing renal function (see also section 4.5).
Croatian: Osim toga, tijekom istodobne primjene potencijalno nefrotoksičnih lijekova savjetuje se redovito praćenje bubrežne funkcije, bez obzira na prethodnu bubrežnu funkciju bolesnika (vidjeti također dio
English: The safety and efficacy of Cubicin in children and adolescents aged below 18 years with right-sided infective endocarditis (RIE) due to Staphylococcus aureus have not been established.
Croatian: Sigurnost i djelotvornost lijeka Cubicin u djece i adolescenata mlađih od 18 godina s desnostranim infektivnim endokarditisom izazvanim bakterijom Staphylococcus aureus nisu ustanovljene.
English: Simulation using a population pharmacokinetic model demonstrated that the AUCss (area under the concentrationtime curve at steady state) of daptomycin in paediatric patients 1 to <2 years of age receiving 12 mg/kg once daily would be comparable to that in adult patients receiving 6 mg/kg once daily.
Croatian: Simulacija korištenjem modela populacijske farmakokinetike pokazala je da bi AUCss (površina ispod krivulje u stanju mirovanja) daptomicina u pedijatrijskih bolesnika u dobi od 1 do <2 godine koji su primali 12 mg/kg na dan bio usporediv s onim primijećenim u odraslih bolesnika koja su primali 6 mg/kg na dan.
English: Recurrence of eosinophilic pneumonia upon reexposure has been reported.
Croatian: Nakon ponovnog uvođenja lijeka prijavljena je ponovna pojava eozinofilne pneumonije.
English: Obesity In obese subjects with Body Mass Index (BMI) > 40 kg/m2 but with creatinine clearance > 70 ml/min, the AUC0-∞ daptomycin was significantly increased (mean 42% higher) compared with non-obese matched controls.
Croatian: Body Mass Index, BMI) >40 kg/m2 i klirensom kreatinina >70 ml/min, AUC0-∞ daptomicina bio je značajno povećan (u prosjeku za 42% veći) u usporedbi s kontrolnom skupinom ispitanika koji nisu bili pretili.
English: Very rare serious side effects (may affect up to 1 in 10,000 people) A hypersensitivity reaction (serious allergic reaction including anaphylaxis, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS)) has been reported, in some cases during administration of Cubicin.
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba) Zabilježena je reakcija preosjetljivosti (ozbiljna alergijska reakcija, uključujući anafilaksiju, angioedem, osip uzrokovan lijekom uz eozinofiliju i sustavne simptome (DRESS)), u nekim slučajevima tijekom primjene lijeka Cubicin.
English: The Marketing Authorisation Holder shall ensure that all laboratories expected to perform Cubicin susceptibility testing are provided with: - Summary of Product Characteristics - Laboratory susceptibility testing leaflet
Croatian: Nositelj odobrenja će osigurati da svi laboratoriji za koje se očekuje da će izvoditi testove osjetljivosti na Cubicin dobiju sljedeće: - sažetak opisa svojstava lijeka. - letak za laboratorije vezano uz testiranje osjetljivosti.
English: Gastrointestinal and abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence, bloating and distension Uncommon: Dyspepsia, glossitis
Croatian: Gastrointestinalni i abdominalni bolovi, mučnina, povraćanje, konstipacija, proljev, flatulencija, napuhnutost i distenzija trbuha Manje često: Dispepsija, glositis
English: Studies of Cubicin with anticoagulants other than warfarin have not been conducted.
Croatian: Nisu provedena ispitivanja istodobne primjene lijeka Cubicin i drugih antikoagulansa osim varfarina.
English: Concomitant administration of probenecid and daptomycin has no effect on daptomycin pharmacokinetics in humans suggesting minimal to no active tubular secretion of daptomycin.
Croatian: Istodobna primjena probenecida i daptomicina ne utječe na farmakokinetiku daptomicina u ljudi, što ukazuje da je aktivna tubularna sekrecija daptomicina minimalna, ili je uopće nema.
English: Following administration of a single 4 mg/kg intravenous dose of Cubicin over a 30-minute period, the mean total clearance of daptomycin was approximately 35% lower and the mean AUC0-∞ was approximately 58% higher in elderly subjects (≥ 75 years of age) compared with those in healthy young subjects (18 to 30 years of age).
Croatian: Nakon jednokratne primjene lijeka Cubicin u dozi od 4 mg/kg intravenski tijekom 30 minuta, prosječni ukupni klirens daptomicina bio je otprilike 35% manji, a prosječni AUC0-∞ bio je otprilike 58% veći u starijih ispitanika (≥75 godina starosti) u usporedbi sa skupinom mladih zdravih ispitanika (18 do 30 godina starosti).
English: The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes as directed in section 4.2.
Croatian: Rekonstituirana i razrijeđena otopina se zatim treba primijeniti putem intravenske infuzije tijekom 30 ili 60 minuta, kao što je navedeno u dijelu 4.2.
English: Other side effects which may occur following Cubicin treatment are described below:
Croatian: Niže su navedene druge nuspojave koje se mogu javiti tijekom primjene lijeka Cubicin:
English: The pharmacokinetics of daptomycin in patients with severe hepatic impairment (Child-Pugh C classification) have not been evaluated.
Croatian: Farmakokinetika daptomicina u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) nije ispitivana.
English: In all populations the clinical success rates were comparable between the daptomycin and SOC treatment arms, supporting the primary efficacy analysis in the ITT population.
Croatian: U svim populacijama stope kliničkog uspjeha bile su usporedive između skupina liječenih daptomicinom i skupina liječenih SOC-om, što podupire primarnu analizu djelotvornosti u populaciji planiranoj za liječenje.
English: Not known*: Eosinophilic pneumonia
Croatian: Nepoznato*: Eozinofilna pneumonija
English: Cubicin given as 2 -minute intravenous injection (adult patients only)
Croatian: Cubicin za primjenu 2-minutnom intravenskom injekcijom (samo odrasli bolesnici)
English: Paediatric patients below the age of one year should not be given Cubicin due to the risk of potential effects on muscular, neuromuscular and/or nervous systems (either peripheral and/or central) that were observed in neonatal dogs (see section 5.3).
Croatian: Pedijatrijskim bolesnicima mlađima od jedne godine ne smije se davati Cubicin zbog rizika od potencijalnih učinaka na mišićni, neuromišićni i/ili živčani sustav (periferni i/ili središnji) koji su zamijećeni u neonatalne štenadi (vidjeti dio 5.3).
English: In adults, Cubicin is given by intravenous infusion (see section 6.6) and administered over a 30minute period or by intravenous injection (see section 6.6) and administered over a 2-minute period.
Croatian: U odraslih, Cubicin se daje intravenskom infuzijom (vidjeti dio 6.6) koja se primjenjuje u trajanju od 30 minuta ili intravenskom injekcijom (vidjeti dio 6.6) koja se primjenjuje u trajanju od 2 minute.
English: The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use.
Croatian: Rekonstituiranu otopinu treba prije primjene pažljivo pregledati da se osigura da je lijek u otopini te vizualno provjeriti da ne sadrži vidljive čestice.
English: The lyophilised product takes approximately 15 minutes to dissolve.
Croatian: Liofilizirani lijek se otapa otprilike 15 minuta.
English: The dosage regimen for Cubicin in paediatric patients with renal impairment has not been established.
Croatian: Režim doziranja lijeka Cubicin u pedijatrijskih bolesnika s oštećenjem funkcije bubrega nije ustanovljen.
English: Tell a doctor or a nurse straight away if you experience symptoms suggestive of allergic reaction, such as wheezing, difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever (see section 4 of this leaflet for more information).
Croatian: Vam se pojave simptomi koji upućuju na alergijsku reakciju, poput piskanja, otežanog disanja, oticanja lica, vrata ili grla, osipa i koprivnjače, vrućice (za više podataka vidjeti dio 4 ove upute).
English: Tell your doctor or nurse straight away if you experience any of the following symptoms: - Chest pain or tightness, - Rash with blistering, sometimes affecting the mouth and genitals, - Swelling around throat, - Rapid or weak pulse, - Wheezing, - Fever, - Shivering or trembling, - Hot flushes, - Dizziness, - Fainting, - Metallic taste.
Croatian: Liječniku ili medicinskoj sestri odmah kažite ako osjetite bilo koji od sljedećih simptoma: - bol ili stezanje u prsnom košu, - osip s pojavom mjehura, koji ponekada zahvaća usta i spolne organe, - oticanje oko grla, - ubrzan ili slab puls, - piskanje, - vrućicu, - groznicu ili drhtavicu, - navale vrućine, - omaglicu, - nesvjesticu, - metalni okus u ustima.
English: The active substance in Cubicin powder for solution for injection or infusion is daptomycin.
Croatian: Djelatna tvar u Cubicin prašku za otopinu za injekciju ili infuziju je daptomicin.
English: Pharmacokinetic parameter values estimated by noncompartmental analysis Individual values reported as only two patients in this age group provided pharmacokinetic samples to enable pharmacokinetic analysis; AUC, apparent t1/2 and CL/wt could be determined for only one of the two patients Pharmacokinetic analysis conducted on the pooled pharmacokinetic profile with mean concentrations across subjects at each time point
Croatian: Prijavljene pojedinačne vrijednosti jer su se farmakokinetički uzorci dobili od samo dva bolesnika u ovoj dobnoj skupini da bi se omogućila farmakokinetička analiza; AUC, prividni t1/2 i CL/wt mogli su se odrediti samo u jednog od ta dva bolesnika.
English: On the basis of reported adverse drug reactions, Cubicin is presumed to be unlikely to produce an effect on the ability to drive or use machinery.
Croatian: Na temelju prijavljenih nuspojava, nije vjerojatno da bi Cubicin utjecao na sposobnost upravljanja vozilima ili rada sa strojevima.