FrancophonIA/ELRC3.0 huggingface dataset:
English: 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever.
Croatian: BiResp Spiromax od 160/4.5 mikrograma (160 mikrograma budezonida i 4,5 mikrograma formoterola) može se primjenjivati u redovnom liječenju astme i ukoliko je u terapiji ublažavanja simptoma astme.
English: The Committee recommended that BiResp Spiromax be given marketing authorisation.
Croatian: Povjerenstvo je preporučilo izdavanje odobrenja za stavljanje u promet lijeka BiResp Spiromax u EU-u.
English: How is BiResp Spiromax used?
Croatian: Kako se BiResp Spiromax koristi?
English: How does BiResp Spiromax work?
Croatian: Kako djeluje BiResp Spiromax?
English: How has BiResp Spiromax been studied?
Croatian: Kako se BiResp Spiromax ispitivao?
English: What SIFROL is and what it is used for
Croatian: Što je SIFROL i za što se koristi
English: Other medicines and SIFROL
Croatian: Drugi lijekovi i SIFROL
English: If you take more SIFROL than you should
Croatian: Ako uzmete više SIFROLA nego što ste trebali
English: Date of latest renewal: 14 October 2007
Croatian: Datum posljednje obnove odobrenja: 14. listopada 2007.
English: The effect of SIFROL on the unborn child is not known.
Croatian: Učinak SIFROLA na nerođeno dijete nije poznat.
English: SIFROL can reduce the production of breast milk.
Croatian: SIFROL može smanjiti stvaranje majčinog mlijeka.
English: SIFROL can cause hallucinations (seeing, hearing or feeling things that are not there).
Croatian: SIFROL može izazvati halucinacije (možete vidjeti, čuti ili osjećati stvari koje nisu prisutne).
English: SIFROL should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Croatian: SIFROL se ne smije primjenjivati tijekom trudnoće osim ako je nužno potreban, tj. ako očekivana korist opravdava potencijalni rizik za fetus.
English: If you accidentally take too many tablets, - Contact your doctor or nearest hospital casualty department immediately for advice.
Croatian: Ako slučajno uzmete previše tableta, - Odmah se javite liječniku ili na odjel najbliže bolnice za savjet.
English: Do not take SIFROL: - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati SIFROL: - ako ste alergični na pramipeksol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: What SIFROL contains
Croatian: Što SIFROL sadrži
English: Then take your SIFROL prolonged-release tablets next morning and do not take any more SIFROL (immediate release) tablets.
Croatian: Zatim uzmite SIFROL tablete s produljenim oslobađanjem sljedeće jutro i ne uzimajte više SIFROL tablete (s trenutnim oslobađanjem).
English: You can take SIFROL with or without food.
Croatian: Možete uzimati SIFROL sa ili bez hrane.
English: Therefore, do not take SIFROL if you are pregnant unless your doctor tells you to do so.
Croatian: Stoga, ne uzimajte SIFROL tijekom trudnoće, osim ako Vam to ne preporuči liječnik.
English: What SIFROL is and what it is used for What you need to know before you take SIFROL How to take SIFROL
Croatian: Što je SIFROL i za što se koristi Što morate znati prije nego počnete uzimati SIFROL Kako uzimati SIFROL
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: 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: U klasifikaciji prema organskim sustavima, nuspojave su navedene prema učestalosti (broj bolesnika kod kojih se očekuje nuspojava), uz uporabu sljedećih kategorija: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Warnings and precautions Talk to your doctor before taking SIFROL.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete SIFROL.
English: Efficacy was maintained in 87 of 103 patients switched to SIFROL prolonged-release tablets.
Croatian: Djelotvornost je održana kod 87 od 103 bolesnika koji su prešli na SIFROL tablete s produljenim oslobađanjem.
English: Talk to your doctor before taking SIFROL.
Croatian: Obratite se svom liječniku prije nego uzmete SIFROL.
English: Do not stop taking SIFROL without first talking to your doctor.
Croatian: Ne prekidajte uzimanje SIFROLA bez prethodnog razgovora s liječnikom.
English: SIFROL can be taken with or without food.
Croatian: SIFROL se može uzimati sa ili bez hrane.
English: What you need to know before you take SIFROL
Croatian: Što morate znati prije nego počnete uzimati SIFROL
English: The use of SIFROL tablets should be considered.
Croatian: Potrebno je razmotriti primjenu SIFROL tableta.
English: Nausea and fatigue were more often reported in female patients treated with SIFROL (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Croatian: Mučnina i umor češće su prijavljeni kod žena liječenih SIFROLOM (20,8% i 10,5%, po istom redoslijedu) u usporedbi s muškarcima (6,7% i 7,3%, po istom redoslijedu).
English: SIFROL contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain.
Croatian: SIFROL sadrži djelatnu tvar pramipeksol i pripada skupini lijekova poznatih kao agonisti dopamina koji stimuliraju dopaminergičke receptore u mozgu.
English: In a placebo-controlled polysomnography study over 3 weeks SIFROL significantly reduced the number of periodic limb movements during time in bed.
Croatian: U placebom kontroliranom polisomnografskom ispitivanju, u trajanju preko 3 tjedna, SIFROL je znatno smanjio broj periodičnih pokreta udovima tijekom vremena provedenog u krevetu.
English: However, in Phase III trials in Parkinson's disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of SIFROL prolonged-release tablets was detected.
Croatian: Međutim, u fazi III kliničkog ispitivanja na bolesnicima s Parkinsonovom bolešću nije pronađen klinički značajan utjecaj tjelesne težine na terapijski učinak i podnošljivost SIFROL tableta s produljenim oslobađanjem.
English: If you forget to take a dose of SIFROL, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Croatian: Ako ste zaboravili uzeti dozu SIFROLA te se sjetite u roku 12 sati od uobičajenog vremena doziranja, uzmite tabletu odmah, a zatim uzmite sljedeću tabletu u uobičajeno vrijeme.
English: If renal function declines during maintenance therapy the SIFROL daily dose should be reduced by the same percentage as the decline in creatinine clearance, i.e. if creatinine clearance declines by 30%, then the SIFROL daily dose should be reduced by 30%.
Croatian: Ukoliko dođe do pogoršanja funkcije bubrega za vrijeme terapije održavanja, dnevnu dozu SIFROLA je potrebno sniziti u istom postotku za koji se smanjio klirens kreatinina, tj. ako se klirens smanjio za 30%, tada je potrebno sniziti ukupnu dnevnu dozu SIFROLA za 30%.
English: However, the potential influence of hepatic insufficiency on SIFROL pharmacokinetics has not been investigated.
Croatian: Međutim, potrebno je znati da potencijalni utjecaj insuficijencije jetre na farmakokinetiku SIFROLA nije istraživan.
English: In a clinical trial with healthy volunteers, where SIFROL prolonged-release tablets were titrated faster (every 3 days) than recommended up to 3.15 mg pramipexole base (4.5 mg of salt) per day, an increase in blood pressure and heart rate was observed.
Croatian: U kliničkom ispitivanju na zdravim dobrovoljcima, gdje su SIFROL tablete s produljenim oslobađanjem brže titrirane (svaka 3 dana) nego što je preporučeno do 3,15 mg baze pramipeksola (4,5 mg soli) dnevno, primijećeni su porast krvnog tlaka i srčane frekvencije.
English: If you suffer from Parkinson's disease you should not stop treatment with SIFROL abruptly.
Croatian: Ako patite od Parkinsonove bolesti, ne smijete naglo prekidati liječenje SIFROLOM.
English: In the absence of human data, SIFROL should not be used during breast-feeding.
Croatian: U nedostatku podataka za ljude, SIFROL se ne bi trebao primjenjivati tijekom dojenja.
English: In the Phase III studies that established safety and efficacy of SIFROL prolonged-release tablets, patients were instructed to take study medication without regard to food intake.
Croatian: U ispitivanjima faze III, koja su utvrđivala sigurnost i djelotvornost SIFROL tableta s produljenim oslobađanjem, bolesnici su bili upućeni na uzimanje lijeka iz ispitivanja, bez obzira na unos hrane.
English: Patients being treated with SIFROL and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Croatian: Bolesnike koji su tijekom liječenja SIFROLOM imali somnolenciju i/ili epizode iznenadnog usnivanja potrebno je upozoriti da ne upravljaju motornim vozilima ili obavljaju nekakve druge aktivnosti gdje bi njihova smanjena mogućnost reagiranja ponekad mogla ugroziti vlastitu ili tuđu sigurnost te dovesti do rizika za tešku ozljedu ili smrt (npr. upravljanje strojevima), sve dok takve opetovane epizode i somnolencija ne prestanu (vidjeti također dijelove 4.4, 4.5 i 4.8).
English: If you stop taking SIFROL
Croatian: Ako prestanete uzimati SIFROL
English: The treatment of patients with a creatinine clearance below 30 ml/min with SIFROL prolonged-release tablets is not recommended as no data are available for this patient population.
Croatian: Kod bolesnika s klirensom kreatinina manjim od 30 ml/min, ne preporučuje se liječenje SIFROL tabletama s produljenim oslobađanjem, s obzirom da nisu dostupni podaci za ovu skupinu bolesnika.
English: - Altered or increased sexual interest and behaviour of significant concern to you or to others,
Croatian: - Promijenjen ili povećan interes za seksom i ponašanje koje zabrinjava Vas ili druge, na primjer, povećani spolni nagon.
English: Take SIFROL prolonged-release tablets only once a day and each day at about the same time.
Croatian: Uzimajte SIFROL tablete s produljenim oslobađanjem jedanput dnevno i to svaki dan u otprilike isto vrijeme.
English: Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your SIFROL treatment.
Croatian: Obavijestite svog liječnika ako osjetite simptome poput depresije, apatije, tjeskobe, umora, znojenja ili boli nakon prestanka liječenja ili sniženja doze SIFROLA.
English: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including SIFROL (see section 4.4).
Croatian: Patološka želja za kockanjem, pojačani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje se mogu pojaviti kod bolesnika koji se liječe agonistom dopamina, uključujući SIFROL (vidjeti dio 4.4).
English: Patients already taking SIFROL tablets may be switched to SIFROL prolonged-release tablets overnight, at the same daily dose.
Croatian: Bolesnici koji već uzimaju SIFROL tablete mogu se prebaciti na SIFROL tablete s produljenim oslobađanjem tijekom noći, u jednakoj dnevnoj dozi.
English: The maximum plasma concentrations occur at about 6 hours after administration of SIFROL prolonged-release tablets once daily.
Croatian: Maksimalne koncentracije u plazmi se javljaju oko 6 sati nakon primjene SIFROL tableta s produljenim oslobađanjem jedanput dnevno.
English: SIFROL is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
Croatian: SIFROL je indiciran za liječenje znakova i simptoma idiopatske Parkinsonove bolesti u odraslih, u obliku monoterapije (bez levodope) ili u kombinaciji s levodopom, tj. tijekom trajanja bolesti, pa sve do uznapredovale faze, kada učinak levodope jenjava ili postane nestalan te dolazi do fluktuacija u terapijskom učinku (učinak "kraja doze” ili “on-off” fluktuacije).
English: When the intake of a dose is missed, SIFROL prolonged-release tablets should be taken within 12 hours after the regularly scheduled time.
Croatian: Kada se propusti doziranje, SIFROL tablete s produljenim oslobađanjem se uzimaju u roku 12 sati nakon redovnog vremena doziranja.
English: You should have regular eye examinations during treatment with SIFROL.
Croatian: Potreban je redovit pregled očiju tijekom liječenja SIFROLOM.
English: If you forget to take SIFROL
Croatian: Ako ste zaboravili uzeti SIFROL
English: The safety and efficacy of SIFROL prolonged-release tablets in the treatment of Parkinson's disease was evaluated in a multinational drug development program consisting of three randomised, controlled trials.
Croatian: Sigurnost i djelotvornost SIFROL tableta s produljenim oslobađanjem u liječenju Parkinsonove bolesti ocjenjivane su u multinacionalnom razvojnom programu lijeka, koji se sastojao od tri randomizirana kontrolirana ispitivanja.
English: You should avoid taking SIFROL together with antipsychotic medicines.
Croatian: Potrebno je izbjegavati istovremenu primjenu SIFROLA i antipsihotičnih lijekova.
English: Ascending dose schedule of SIFROL Week
Croatian: Postupak povećanja doze SIFROLA Tjedan
English: SIFROL can have a major influence on the ability to drive and use machines.
Croatian: SIFROL može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: After switching to SIFROL prolonged-release tablets, the dose may be adjusted depending on the patient's therapeutic response (see section 5.1).
Croatian: Nakon prijelaza na SIFROL tablete s produljenim oslobađanjem, doza se može podesiti prema terapijskom odgovoru bolesnika (vidjeti dio 5.1).
English: SIFROL prolonged-release tablets is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested.
Croatian: SIFROL tablete s produljenim oslobađanjem posebno su oblikovane tablete iz kojih se djelatna tvar postupno oslobađa nakon što se tableta proguta.
English: SIFROL prolonged-release tablets were non-inferior to pramipexole immediate release tablets as assessed on the UPDRS Parts II+III score at week 33.
Croatian: SIFROL tablete s produljenim oslobađanjem nisu bile inferiorne pramipeksol tabletama s trenutnim oslobađanjem, ocjenjivano prema rezultatu UPDRS-ljestvice-dijelovima II+III nakon 33 tjedna.
English: SIFROL should not be used during breast-feeding.
Croatian: SIFROL se ne bi trebao primjenjivati tijekom dojenja.
English: SIFROL is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Croatian: SIFROL je indiciran za simptomatsko liječenje umjerenog do teškog idiopatskog sindroma nemirnih nogu u odraslih pri dozama do 0,54 mg baze (0,75 mg soli) (vidjeti dio 4.2).
English: Children and adolescents SIFROL is not recommended for use in children or adolescents under 18 years.
Croatian: Djeca i adolescenti SIFROL se ne preporučuje za primjenu kod djece i adolescenata mlađih od 18 godina.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 1997
Croatian: Datum prvog odobrenja: 14. listopada 1997.
English: The safety and efficacy of SIFROL in children below 18 years has not been established.
Croatian: Sigurnost i djelotvornost SIFROLA u djece u dobi do 18 godina nisu ustanovljene.
English: SIFROL is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Croatian: Primjena SIFROLA se ne preporučuje u djece i adolescenata u dobi do 18 godina zbog nedostatnih podataka o sigurnosti i djelotvornosti.
English: The European Medicines Agency has waived the obligation to submit the results of studies with SIFROL in all subsets of the paediatric population in Parkinson's Disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka SIFROL u svim podskupinama pedijatrijske populacije s Parkinsonovom bolešću (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: SIFROL prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Croatian: SIFROL tablete s produljenim oslobađanjem su jednokratna dnevna oralna formulacija pramipeksola.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with SIFROL in one or more subsets of the paediatric population in Restless Legs Syndrome (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka SIFROL u jednoj ili više podskupina pedijatrijske populacije sa sindromom nemirnih nogu (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with SIFROL.
Croatian: Ako uzimate levodopu, preporučuje se snižavanje doze levodope pri započinjanju liječenja SIFROLOM.
English: Your doctor will then discuss with you if you should continue to take SIFROL.
Croatian: Liječnik će s Vama razmotriti je li potreban nastavak liječenja SIFROLOM.
English: The efficacy and tolerability of an overnight switch from SIFROL tablets to SIFROL prolongedrelease tablets at the same daily dose were evaluated in a double-blind clinical study in patients with early Parkinson's disease.
Croatian: Djelotvornost i podnošljivost prijelaza „preko noći“ sa SIFROL tableta na SIFROL tablete s produljenim oslobađanjem u jednakoj dnevnoj dozi ocjenjivane su u dvostruko-slijepom kliničkom ispitivanju na bolesnicima u ranom stadiju Parkinsonove bolesti.
English: If use of SIFROL is unavoidable, breast-feeding should be stopped.
Croatian: Ako je primjena SIFROLA neizbježna, potrebno je prekinuti dojenje.
English: Superiority of SIFROL prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (CGI-I and PGI-I responder rates) efficacy endpoints in a double-blind placebo-controlled trial including a total of 539 patients with early Parkinson's disease.
Croatian: Veća djelotvornost SIFROL tableta s produljenim oslobađanjem u odnosu na placebo pokazana je nakon 18 tjedana liječenja i u primarnim (rezultat prema UPDRS - dijelovima II+III) i ključnim sekundarnim (stopa odgovora prema CGI-I i PGI-I) mjerama ishoda za djelotvornost u dvostrukoslijepom, placebom kontroliranom ispitivanju koje je uključivalo ukupno 539 bolesnika s ranim stadijem Parkinsonove bolesti.
English: Only one patient switched to SIFROL prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
Croatian: Samo je jedan bolesnik koji je prešao na SIFROL tablete s produljenim oslobađanjem imao nuspojavu povezanu s lijekom koja je dovela do prekida terapije.
English: SIFROL should not be used in children or adolescents with Tourette Disorder because of a negative benefit-risk balance for this disorder (see section 5.1).
Croatian: SIFROL se ne smije primjenjivati u djece i adolescenata s Touretteovim sindromom zbog negativnog omjera koristi i rizika za ovaj poremećaj (vidjeti dio 5.1).
English: SIFROL is used to: - treat the symptoms of primary Parkinson's disease in adults.
Croatian: SIFROL se primjenjuje u: - liječenju simptoma primarne Parkinsonove bolesti kod odraslih.
English: In a double-blind placebo-controlled trial including a total of 517 patients with advanced Parkinson's disease who were on concomitant levodopa therapy superiority of SIFROL prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (off-time) efficacy endpoints.
Croatian: U dvostruko-slijepom, placebom kontroliranom ispitivanju, koje je uključivalo ukupno 517 bolesnika s uznapredovalom Parkinsonovom bolešću koji su bili na istovremenoj terapiji levodopom, pokazana je superiornost SIFROL tableta s produljenim oslobađanjem u odnosu na placebo nakon 18 tjedana liječenja i za primarne (rezultat prema UPDRS dijelovima II+III) i ključne sekundarne (off-time) mjere ishoda za djelotvornost.
English: In patients with a creatinine clearance between 30 and 50 ml/min, treatment should be started with 0.26 mg SIFROL prolonged-release tablets every other day.
Croatian: Kod bolesnika s klirensom kreatinina između 30 i 50 ml/min, liječenje treba započeti sa SIFROL 0,26 mg tabletom s produljenim oslobađanjem svaki drugi dan.
English: Some patients have reported the occurrence of remnants in faeces which may resemble intact SIFROL prolonged-release tablets.
Croatian: Neki su bolesnici prijavili pojavu ostataka u stolici koji bi mogli nalikovati čitavim SIFROL tabletama s produljenim oslobađanjem.
English: - You may experience vomiting, restlessness, or any of the side effects as described in section 4
Croatian: - Mogu se javiti povraćanje, nemir, ili neka od nuspojava koje su opisane u dijelu 4.„Moguće nuspojave“.
English: SIFROL has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
Croatian: SIFROL je povezan s pospanošću i epizodama iznenadnog usnivanja, osobito kod bolesnika s Parkinsonovom bolešću.
English: BATCH NUMBER Lot {number} OTHER
Croatian: BROJ SERIJE Lot {broj} DRUGO
English: It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with SIFROL, depending on reactions in individual patients (see section 4.5).
Croatian: Preporučuje se smanjiti dozu levodope za vrijeme postupnog povećavanja doze, kao i za vrijeme terapije održavanja SIFROLOM, ovisno o reakcijama pojedinog bolesnika (vidjeti dio 4.5).
English: SIFROL is used to treat the symptoms of primary Parkinson's disease in adults.
Croatian: SIFROL se primjenjuje u liječenju simptoma primarne Parkinsonove bolesti kod odraslih.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including SIFROL.
Croatian: Bolesnici i njihovi njegovatelji moraju biti svjesni simptoma poremećaja kontrole nagona uključujući patološku želju za kockanjem, pojačani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje koji se mogu javiti kod bolesnika liječenih dopaminskim agonistima, uključujući SIFROL.
English: When prescribing SIFROL in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Croatian: Kada se SIFROL propisuje bolesnicima s Parkinsonovom bolešću koji imaju oštećenje bubrega, preporučuje se snižena doza u skladu s dijelom 4.2.
English: How to take SIFROL
Croatian: Kako uzimati SIFROL
English: In these cases SIFROL may affect your ability to drive and operate machinery.
Croatian: U spomenutim slučajevima, SIFROL može utjecati na sposobnost upravljanja vozilima i rada na strojevima.