FrancophonIA/ELRC3.0 huggingface dataset:
English: This is when you and your doctor agree that the symptoms are being controlled well enough and the side effects of the medicines are acceptable.
Croatian: To se događa kad zaključite sa svojim liječnikom da su simptomi dovoljno dobro kontrolirani i da su nuspojave lijekova prihvatljive.
English: If any of the above apply to you, do not use Leganto.
Croatian: Ako se bilo što od navedenoga odnosi na Vas, nemojte koristiti Leganto.
English: Date of first authorisation: 16 June 2011 Date of latest renewal: 14 January 2016
Croatian: Datum zadnje obnove odobrenja: 14. siječanj 2016.
English: Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body parts.
Croatian: Augmentacija se odnosi na raniju pojavu simptoma navečer (ili čak popodne), povećanje težine simptoma i širenje simptoma na druge dijelove tijela.
English: Periodic assessment of efficacy should be performed, along with evaluation of safety, including augmentation.
Croatian: Potrebno je provoditi periodičku procjenu djelotvornosti, kao i procjenu sigurnosti, uključujući augmentaciju.
English: The safety and efficacy of rotigotine in children and adolescents have not yet been established.
Croatian: Sigurnost i djelotvornost rotigotina u djece i adolescenata još uvijek nisu ustanovljene.
English: Treatment of overdose may require general supportive measures to maintain the vital signs.
Croatian: Liječenje predoziranja može zahtijevati opće potporne mjere za održavanje vitalnih funkcija.
English: The apparent volume of distribution in humans is approximately 84 l/kg.
Croatian: Prividni volumen distribucije u ljudi je oko 84 l/kg.
English: • Keep it pressed for about
Croatian: • Držite ga pritisnutim
English: Fibrotic complications
Croatian: Fibrotične komplikacije
English: However, there is no indication of a relevant impact on the clinical outcome.
Croatian: Međutim, nema naznaka da to bitno utječe na klinički ishod.
English: • if you have serious liver problems, your doctor may need to change the dose.
Croatian: • ako imate ozbiljnih jetrenih tegoba, liječnik će možda morati promijeniti dozu.
English: Additional studies to further evaluate the specific pathology have not been performed.
Croatian: Dodatna ispitivanja koja bi razjasnila specifičnu patologiju nisu provedena.
English: Leganto can cause loss of consciousness.
Croatian: Leganto može uzrokovati gubitak svijesti.
English: • you need ‘cardioversion' (specific treatment for abnormal heart beat).
Croatian: • ako Vam je potrebna „kardioverzija“ (posebno liječenje abnormalnih otkucaja srca).
English: Other medicines and Leganto
Croatian: Drugi lijekovi i Leganto
English: • abnormal thinking or behaviour - most of the symptoms occur more frequently in patients with
Croatian: • abnormalno razmišljanje ili ponašanje - većina simptoma češće se javlja u bolesnika s
English: The dose recommendations made are in nominal dose.
Croatian: Preporučene doze su u obliku nominalne doze.
English: The majority of erythema observed was mild and none severe.
Croatian: Većina opaženih eritema bila je vrlo blaga i nije bilo teških.
English: The safety profile was unchanged from that observed in previous studies.
Croatian: Sigurnosni profil bio je nepromijenjen u odnosu na onaj iz prijašnjih ispitivanja.
English: The patient should be monitored closely, including heart rate, heart rhythm and blood pressure.
Croatian: Bolesnika treba strogo nadzirati, uključujući srčanu frekvenciju, srčani ritam i krvni tlak.
English: • seeing or hearing things that are not real (hallucinations)
Croatian: • vidite ili čujete stvari koje nisu stvarne (halucinacije)
English: The information on metabolites is incomplete.
Croatian: Podaci o metabolitima su nepotpuni.
English: You can put a new patch on afterwards.
Croatian: Nakon toga možete staviti novi flaster.
English: • you are allergic to rotigotine or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na rotigotin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Comparable skin tolerability was reported for both formulations.
Croatian: Podnošljivost kože kod obje je formulacije bila podjednaka.
English: Open the sachet.
Croatian: Otvorite vrećicu.
English: Women of childbearing potential, contraception in females
Croatian: Žene reproduktivne dobi, kontracepcija u žena
English: • Slowly and carefully peel off the used patch.
Croatian: • Pažljivo i polako odlijepite iskorišteni flaster.
English: 30 seconds.
Croatian: 30 sekundi.
English: • delusions and hallucinations (seeing or hearing things that are not real)
Croatian: • deluzije, halucinacije (vidite ili čujete stvari koje nisu stvarne)
English: DL-α-tocopherol (E307).
Croatian: DL--tokoferol (E307).
English: • Do not stick Leganto on the same area of skin twice within 14 days.
Croatian: • Nemojte staviti Leganto na isto mjesto na koži dvaput unutar 14 dana.
English: It belongs to a group of medicines called ‘dopamine agonists'.
Croatian: Pripada skupini lijekova pod nazivom „agonisti dopamina“.
English: • abnormal thoughts about reality
Croatian: • abnormalne misli o stvarnosti
English: This is because the medicine may be released faster.
Croatian: Zbog grijanja se lijek može brže osloboditi.
English: If you are treated with Leganto and levodopa at the same time, some side effects may get more serious.
Croatian: Ako istodobno uzimate Leganto i levodopu, neke nuspojave mogu postati ozbiljnije.
English: Neuroleptics
Croatian: Neuroleptici
English: Dopamine is a messenger in the brain which is important for movement.
Croatian: Dopamin je prijenosnik u mozgu koji je važan za pokrete.
English: Do not stop using Leganto without talking to your doctor.
Croatian: Nemojte prestati koristiti Leganto bez prethodnog razgovora sa svojim liječnikom.
English: The primary outcome assessment was the reduction in “off” time (hours).
Croatian: Ocjena primarnog ishoda bila je skraćivanje trajanja off razdoblja (u satima).
English: Leganto is available in the following pack-sizes:
Croatian: Leganto je dostupan u sljedećim veličinama pakiranja:
English: (see Special populations)
Croatian: (vidjeti Posebne populacije)
English: Loss of consciousness can occur
Croatian: Može doći do gubitka svijesti
English: • sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression.
Croatian: • sedative kao što su benzodiazepini ili lijekove koji se koriste za liječenje psihičkih bolesti ili depresije
English: • unable to resist the impulse to perform an action that is harmful involving excessive gambling,
Croatian: • nemogućnost odupiranja porivima za obavljanje štetnih radnji, kao što su pretjerano kockanje,
English: The absolute bioavailability after transdermal application is approximately 37%.
Croatian: Apsolutna bioraspoloživost nakon transdermalne primjene jest oko 37%.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: • prilikom svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika)
English: • falling asleep suddenly without warning
Croatian: • iznenadno usnivanje bez upozorenja
English: Both indications:
Croatian: Obje indikacije:
English: Rotigotine has not been investigated in this patient group.
Croatian: Rotigotin nije ispitivan u toj skupini bolesnika.
English: The sticky side of the patch should not be touched.
Croatian: Ljepljivu stranu flastera se ne smije dirati.
English: • uncontrolled shopping or spending too much
Croatian: • nekontrolirano prekomjerno kupovanje ili trošenje
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenim na europskom internetskom portalu za lijekove.
English: Because rotigotine enters your bloodstream through your skin, food or drink does not affect the way this medicine is absorbed by the body.
Croatian: Budući da rotigotin ulazi u krvotok kroz Vašu kožu, hrana i piće ne utječu na način na koji ga tijelo apsorbira.
English: However, a contribution of these metabolites to clinical effects is unlikely.
Croatian: No nije vjerojatan doprinos tih metabolita na kliničke učinke.
English: In both cases, use a new patch at the usual time on the following day.
Croatian: U oba slučaja sljedeći dan nalijepite novi flaster u uobičajeno vrijeme.
English: If you use more Leganto than you should
Croatian: Ako primijenite više Leganto flastera nego što ste trebali
English: • craving large doses of medicines like Leganto - more than needed for the illness.
Croatian: • žudnja za velikim dozama lijekova kao što je Leganto - većima od onih potrebnih za liječenje bolesti.
English: Magnetic resonance imaging or cardioversion (see section 4.4).
Croatian: Snimanje magnetskom rezonancijom ili kardioverzija (vidjeti dio 4.4).
English: Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is excreted in faeces.
Croatian: Oko 71% doze rotigotina izlučuje se urinom, a manji dio od oko 23% izlučuje se fecesom.
English: Women of childbearing potential should use effective contraception to prevent pregnancy during treatment with rotigotine.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju kako bi spriječile trudnoću tijekom liječenja rotigotinom.
English: Leganto should not be placed on skin that is red, irritated or damaged (see section 4.4).
Croatian: Leganto se ne smije primijeniti na kožu koja je crvena, nadražena ili oštećena (vidjeti dio 4.4).
English: The safety profile was comparable, with the exception of application site reactions.
Croatian: Sigurnosni profil je bio usporediv s iznimkom reakcija na mjestu primjene.
English: Sulphite sensitivity
Croatian: Osjetljivost na sulfite
English: These packages are usually needed for the first four weeks of therapy, but depending on your response to Leganto, you may not need to use all of the dose packages included or you may need additional higher doses after week 4, which are not covered by this package.
Croatian: Ta pakiranja su obično potrebna za prva četiri tjedna liječenja, no ovisno o Vašem odgovoru na Leganto, možda nećete trebati primijeniti pakiranja svih doza ili ćete nakon 4 tjedna trebati dodatne, veće doze koje nisu uključene u ovo pakiranje.
English: It is thought that rotigotine may exert its activity mainly via dopamine receptors.
Croatian: Pretpostavlja se da rotigotin može ostvariti svoj učinak uglavnom preko dopaminskih receptora.
English: The pharmacokinetic profile shows a biphasic elimination with an initial half-life of about 2 to 3 hours.
Croatian: Farmakokinetički profil pokazuje bifazičnu eliminaciju s početnim poluvremenom eliminacije od oko 2 do 3 sata.
English: Talk to your doctor if they last for a long time or if you are worried about them.
Croatian: Obratite se svom liječniku ako potraju duže ili ako Vas zabrinjavaju.
English: It is recommended that the application site should be rotated on a daily basis (e.g. from the right side to the left side and from the upper body to the lower body).
Croatian: Preporučuje se svaki dan mijenjati mjesto primjene na koži (npr. s desne strane tijela na lijevu, odnosno s gornjeg na donji dio tijela).
English: 4 mg of Leganto every day may be an effective dose for some patients.
Croatian: 4 mg Leganta svaki dan može biti djelotvorna doza za neke bolesnike.
English: If it is necessary to discontinue rotigotine, this should be done gradually to prevent neuroleptic malignant syndrome.
Croatian: Ako je potrebno prekinuti primjenu rotigotina, to treba učiniti postupno kako bi se spriječila pojava neuroleptičkog malignog sindroma.
English: The backing layer of Leganto contains aluminium.
Croatian: Potporni sloj Leganta sadrži aluminij.
English: This mutagenic effect could be attributed to a clastogenic effect of rotigotine.
Croatian: Taj mutageni učinak može se pripisati klastogenom učinku rotigotina.
English: Rotigotine should not be used during pregnancy.
Croatian: Rotigotin se ne smije primjenjivati tijekom trudnoće.
English: Leganto is a patch that is put on the skin.
Croatian: Leganto je flaster koji se stavlja na kožu.
English: If you have to stop taking this medicine, see ‘If you stop using Leganto' in section 3.
Croatian: Ako morate prestati primjenjivati ovaj lijek, pročitajte odlomak 'Ako prestanete primjenjivati Leganto' u dijelu 3.
English: • movements you cannot control related to Parkinson's disease (dyskinesia)
Croatian: • pokreti koje ne možete kontrolirati povezani s Parkinsonovom bolešću (diskinezija)
English: • Each patch is packed in a separate sachet.
Croatian: • Svaki flaster pakiran je u zasebnu vrećicu.
English: Efficacy/safety data is insufficient to establish a relation between exposure and response (see also paediatric information in section 4.2).
Croatian: Podaci o djelotvornosti/sigurnosti nisu dostatni da bi se utvrdio odnos između izloženosti lijeku i odgovora na lijek (vidjeti i informacije o pedijatrijskoj primjeni u dijelu 4.2).
English: repetitive meaningless actions, uncontrolled shopping or spending too much
Croatian: ponavljajuće besmislene radnje, nekontrolirano kupovanje ili prekomjerno trošenje
English: To open the sachet, hold the sachet in both hands.
Croatian: Da biste otvorili vrećicu, uhvatite je objema rukama.
English: • Do not put the patch in an area where it can be rubbed by tight clothing.
Croatian: • Nemojte stavljati flaster na mjesta gdje ga tijesna odjeća može otrgnuti.
English: Since it ran more or less parallel with a decreased relative total growth of the cells, it may be related to a cytotoxic effect of the compound.
Croatian: Budući da se pojavio više ili manje usporedno sa smanjenim relativnim ukupnim rastom stanica, može biti povezan s citotoksičnim učinkom tvari.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.2, no nije moguće dati preporuku o doziranju.
English: Neuroleptic malignant syndrome
Croatian: Neuroleptični maligni sindrom
English: A sudden stop could lead to a medical condition called ‘neuroleptic malignant syndrome' which could be life-threatening.
Croatian: Nagli prestanak može dovesti do medicinskog stanja zvanog 'neuroleptički maligni sindrom', koji može biti opasan po život.
English: Leganto may affect your blood pressure.
Croatian: Leganto može utjecati na krvni tlak.
English: • medicines that lower blood pressure.
Croatian: • lijekove koji snižavaju krvni tlak.
English: This should be considered when prescribing rotigotine.
Croatian: To treba imati na umu prilikom propisivanja rotigotina.
English: Therefore, the relevance of the one positive in vitro mutagenicity test is not known.
Croatian: Stoga, važnost jednog pozitivnog testa mutagenosti in vitro nije poznata.
English: In two openlabel, follow-up studies over a subsequent 12 months, the rate of clinically relevant augmentation was 2.9%.
Croatian: U dvije otvorene studije praćenja koje su trajale sljedećih 12 mjeseci, stopa klinički značajne augmentacije bila je 2,9%.
English: • Before opening the sachet decide where you are going to stick this new patch and check you have removed any old patch.
Croatian: • Prije nego što otvorite vrećicu, odlučite gdje ćete staviti novi flaster i provjerite jeste li skinuli stari flaster.
English: • The reactions normally go away after a few hours - once you remove the patch.
Croatian: • Te reakcije obično nestanu nekoliko sati nakon odstranjivanja flastera.
English: • ‘anti-psychotic' medicines - used to treat certain mental illnesses
Croatian: • antipsihotike - koriste se za liječenje određenih psihičkih bolesti
English: It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of orthostatic hypotension associated with dopaminergic therapy.
Croatian: Preporučuje se redovito mjerenje krvnog tlaka, posebno na početku liječenja, zbog općeg rizika od ortostatske hipotenzije povezane s dopaminergičkom terapijom.
English: The relevance of these findings to humans is not known.
Croatian: Značaj tih nalaza za ljude za sada nije poznat.
English: Patients should be regularly monitored for the development of impulse control disorders.
Croatian: Bolesnike se mora redovito nadzirati glede mogućeg razvoja poremećaja kontrole nagona.
English: They will discuss ways of managing or reducing symptoms.
Croatian: On će razgovarati s Vama o načinima na koje možete ukloniti ili ublažiti simptome.
English: Talk to your doctor before using Leganto if you are taking:
Croatian: Razgovarajte sa svojim liječnikom prije nego što uzmete Leganto ako uzimate:
English: In isolated cases “sudden onset of sleep” occurred while driving and resulted in motor vehicle accidents (see also sections 4.4 and 4.7).
Croatian: U izoliranim slučajevima iznenadni nastup spavanja javio se tijekom upravljanja vozilom što je uzrokovalo prometne nesreće (vidjeti također dijelove 4.4 i 4.7).
English: What Leganto is and what it is used for
Croatian: Što je Leganto i za što se koristi
English: Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09
Croatian: Farmakoterapijska skupina: antiparkinsonici, agonisti dopamina; ATK oznaka: N04BC09
English: Therefore, it is recommended to taper treatment (see section 4.2).
Croatian: Stoga se preporučuje postupno smanjivanje doze (vidjeti dio 4.2).
English: The same site should not be used within 14 days.
Croatian: Isto mjesto primjene na koži ne smije se koristiti unutar 14 dana.
English: If you have any unpleasant reactions, contact your doctor.
Croatian: Ako imate bilo kakve neugodne reakcije, javite se svom liječniku.
English: If you have used a different patch (e.g. Leganto 4 mg/24 h instead of Leganto 2 mg/24 h) than your doctor told you to, contact your doctor or hospital for advice immediately, and follow their advice on changes of patches.
Croatian: Ako ste primjenili različiti flaster (npr. Leganto 4 mg/24 h umjesto Leganto 2 mg/24 h) od onog što Vam je liječnik rekao, odmah se javite svom liječniku ili bolnici za savjet te slijedite njihov savjet o tome kako promijeniti flastere.
English: • your symptoms of Restless Legs Syndrome may start earlier than usual, be more intense and involve other limbs.
Croatian: • simptomi sindroma nemirnih nogu mogu se pojaviti ranije nego inače, biti intenzivniji i uključivati druge udove.
English: • Parkinson's disease - lowered by 2 mg every other day.
Croatian: • Parkinsonova bolest - smanjivati za 2 mg svaki drugi dan
English: • feeling of heartbeat (palpitation)
Croatian: • osjećaj lupanja srca (palpitacije)
English: Efficacy was demonstrated in controlled trials in patients treated for up to 29 weeks.
Croatian: U kontroliranim ispitivanjima djelotvornost je dokazana u bolesnika liječenih do 29 tjedana.
English: If you forget to change the patch at your usual time
Croatian: Ako ste zaboravili promijeniti flaster u uobičajeno vrijeme
English: • If you have forgotten to change the patch at your usual time, change it as soon as you remember.
Croatian: • Ako ste zaboravili promijeniti flaster u uobičajeno vrijeme, promijenite ga čim se sjetite.
English: Because rotigotine decreases prolactin secretion in humans, inhibition of lactation is expected.
Croatian: Budući da rotigotin smanjuje sekreciju prolaktina u ljudi, očekuje se inhibicija laktacije.
English: Rotigotine may have major influence on the ability to drive and use machines.
Croatian: Rotigotin može značajno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour.
Croatian: Tada će oni moći reći Vama ili Vašem liječniku ako su zabrinuti zbog bilo kakvih promjena u Vašem ponašanju.
English: This includes seeing or hearing things that are not real (hallucinations), movements you cannot control related to Parkinson's disease (‘dyskinesia'), and swelling of legs and feet.
Croatian: One uključuju situacije u kojima vidite ili čujete stvari koje nisu stvarne (halucinacije), pokrete koje ne možete kontrolirati povezane s Parkinsonovom bolešću (diskinezija) te oticanje nogu i stopala.
English: • aggressive behaviour
Croatian: • agresivno ponašanje
English: Improvements were seen in UPDRS Parts I - IV scores.
Croatian: Poboljšanja su opažena u dijelovima I - IV UPDRS ljestvice.
English: Your doctor will let you know if it is safe to keep taking these medicines while using Leganto.
Croatian: Liječnik će Vam reći je li sigurno nastaviti uzimati te lijekove dok uzimate Leganto.
English: The patch should be applied at approximately the same time every day.
Croatian: Flaster treba primjeniti svaki dan u približno isto vrijeme.
English: 81.5% of these patients were on concomitant levodopa therapy.
Croatian: 81,5% tih bolesnika istodobno je liječeno levodopom.
English: The effects were more pronounced in female rats.
Croatian: Promjene su bile izraženije u ženki štakora.
English: For example, put it on the right side of your body one day, then on the left side of your body the next day.
Croatian: Na primjer, jedan ga dan stavite na desnu stranu tijela, a drugi dan na lijevu, ili ga jedan dan stavite na gornji dio tijela, a dan nakon toga na donji dio tijela
English: • Do not use creams, oils, lotions, powders or other skin products where you will put the patch.
Croatian: • Nemojte nanositi kreme, ulja, losione, pudere ili druge proizvode za kožu na mjesto gdje ćete staviti flaster niti blizu mjesta na kojem se flaster već nalazi.
English: Doses higher than the approved dose range for RLS should be avoided as this may lead to higher rates of augmentation (see section 5.1).
Croatian: Potrebno je izbjegavati doze veće od odobrenog raspona doza za sindrom nemirnih nogu jer to može dovesti do većih stopa augmentacije (vidjeti dio 5.1).
English: • increased or abnormal liver function test results
Croatian: • povišene ili abnormalne vrijednosti nalaza testova jetrene funkcije
English: Do not use this medicine after the expiry date which is stated on the label and box.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji.
English: Rotigotine is metabolised to a great extent.
Croatian: Rotigotin se značajno metabolizira.
English: If you experience such symptoms either before or after beginning treatment with Leganto, contact your doctor as your treatment may need to be adjusted.
Croatian: Ako takve simptome osjetite prije ili nakon početka liječenja Legantom, obratite se svom liječniku jer će možda trebati prilagoditi liječenje.
English: What Leganto is and what it is used for What you need to know before you use Leganto How to use Leganto
Croatian: Što je Leganto i za što se koristi Što morate znati prije nego počnete primjenjivati Leganto Kako primjenjivati Leganto
English: The clearance of rotigotine after transdermal administration is approximately 10 l/min and its overall elimination half-life is 5 to 7 hours.
Croatian: Klirens rotigotina nakon transdermalne primjene iznosi oko 10 l/min, a ukupno poluvrijeme eliminacije je 5 do 7 sati.
English: • paranoia
Croatian: • paranoja
English: In this study, the majority of augmentation episodes occurred in the first and second years of treatment.
Croatian: U tom ispitivanju većina epizoda augmentacije javljala se tijekom prve i druge godine liječenja.