FrancophonIA/ELRC3.0 huggingface dataset:
English: If your liver problems get worse during treatment, talk to your doctor straight away.
Croatian: Ako Vam se jetrene tegobe pogoršaju tijekom liječenja, odmah se obratite svom liječniku.
English: These are usually mild or moderate in intensity and transient even if treatment is continued.
Croatian: One su obično blagog ili umjerenog intenziteta i prolazne, čak i pri nastavku liječenja.
English: Do not use Leganto if:
Croatian: Nemojte primjenjivati Leganto:
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: Unutar klasifikacije organskih sustava nuspojave su poredane prema učestalosti (broj bolesnika kod kojih se očekuje pojava nuspojava), koristeći sljedeće kategorije: 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: To avoid skin burns, Leganto should be removed if the patient has to undergo magnetic resonance imaging (MRI) or cardioversion.
Croatian: Kako bi se spriječila pojava opeklina na koži, Leganto treba odstraniti prije snimanja magnetskom rezonancijom (MRI) ili kardioverzije.
English: Irritability, oedema peripheral
Croatian: iritabilnost, periferni edem
English: Two additional pivotal trials (SP650DB and SP515) were conducted in patients who were receiving concomitant levodopa therapy.
Croatian: Provedena su još dva dodatna pivotalna istraživanja (SP650DB i SP515) u bolesnika koji su istovremeno primali terapiju levodopom.
English: In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion.
Croatian: U ispitivanjima ponavljanih doza i dugotrajne toksičnosti, glavni učinci bili su povezani s farmakodinamičkim učincima agonista dopamina i posljedično smanjenom sekrecijom prolaktina.
English: One half of the release liner should be removed and the sticky side should be applied and pressed firmly to the skin.
Croatian: Polovica zaštitnog sloja treba se odstraniti, a ljepljiva strana treba se zalijepiti i čvrsto pritisnuti na kožu.
English: You should take Leganto 2 mg for 7 days (e.g. if you start on a Sunday, switch to the next dose on the following Sunday.).
Croatian: Leganto 2 mg morate primijenjivati 7 dana (npr. ako započnete u nedjelju, na sljedeću dozu prijeđite sljedeću nedjelju).
English: Abnormal thinking and behaviour
Croatian: Abnormalno razmišljanje i ponašanje
English: • difficulty falling asleep, sleep disorder, difficulty sleeping, nightmare, unusual dreams
Croatian: • teškoće s usnivanjem, poremećaji spavanja, teškoće sa spavanjem, noćne more, neobični snovi
English: The percentage of subjects discontinuing was 25-38% over the first year, 10% in the second year, and 11% in the third year.
Croatian: Postotak ispitanika koji su prekinuli liječenje bio je 25-38% tijekom prve godine, 10 % u drugoj godini i 11% u trećoj godini.
English: Any used or unused patches should be disposed of in accordance with local requirements or returned to the pharmacy.
Croatian: Iskorištene ili neiskorištene flastere potrebno je zbrinuti sukladno nacionalnim propisima ili vratiti u ljekarnu.
English: Co-administration of rotigotine (3 mg/24 h) did not affect the pharmacodynamics and pharmacokinetics of oral contraceptives (0.03 mg ethinylestradiol, 0.15 mg levonorgestrel).
Croatian: Istodobna primjena rotigotina (3 mg/24 h) nije utjecala na farmakodinamiku ni farmakokinetiku oralnih kontraceptiva (0,03 mg etinilestradiola, 0,15 mg levonorgestrela).
English: • binge eating (eating large amount of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)
Croatian: • prejedanje (uzimanje velikih količina hrane u kratkom vremenskom razdoblju) ili kompulzivno uzimanje hrane (uzimanje više hrane nego obično i više nego što je potrebno da bi se utažila glad)
English: This can happen especially when you start using Leganto or when your dose is increased.
Croatian: To se može dogoditi osobito kad ga počinjete primjenjivati ili kad Vam se poveća doza.
English: Regarding the functional activity at the various receptor subtypes and their distribution in the brain, rotigotine is a D2 and D3 receptor agonist acting also on D1, D4 and D5 receptors.
Croatian: S obzirom na funkcionalnu aktivnost na različitim podtipovima receptora i njihovu raspodjelu u mozgu, rotigotin je agonist D2 i D3 receptora koji djeluje i na D1, D4 i D5 receptore.
English: If application site reactions occur which last for more than a few days or are persistent, if there is an increase in severity, or if the skin reaction spreads outside the application site, an assessment of the risk/benefit balance for the individual patient should be conducted.
Croatian: Ako se na mjestu primjene pojave reakcije koje traju po nekoliko dana ili su postojane, ako se pogoršavaju ili ako se reakcije na koži šire van mjesta primjene, treba procijeniti odnos koristi i rizika za tog bolesnika.
English: Also do this if it spreads outside the area of skin that was covered by the patch.
Croatian: Obratite mu se i ako se kožna reakcija širi izvan područja koje je bilo prekriveno flasterom.
English: Following application, rotigotine is continuously released from the transdermal patch and absorbed through the skin.
Croatian: Nakon primjene rotigotin se kontinuirano otpušta iz transdermalnog flastera i apsorbira kroz kožu.
English: In such cases, contact your doctor or hospital straight away.
Croatian: U takvim se slučajevima odmah obratite svom liječniku ili otiđite u bolnicu.
English: • unusual urges or cravings which you cannot resist and that could harm yourself or others
Croatian: • neuobičajene nagone ili žudnje kojima se ne možete oduprijeti i koje bi mogle naškoditi Vama ili drugima
English: These effects are usually mild or moderate and only last for a short time.
Croatian: Te su nuspojave obično blage ili umjerene i kratko traju.
English: Studies in rats have shown that rotigotine and/or its metabolite(s) are excreted in breast milk.
Croatian: Ispitivanja na štakorima pokazala su da se rotigotin i/ili njegov(i) metabolit(i) izlučuju u majčino mlijeko.
English: Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see section 5.2).
Croatian: Neočekivano nakupljanje rotigotina može također nastati kod akutnog pogoršanja bubrežne funkcije (vidjeti dio 5.2).
English: Leganto is available in different strength patches which release the medicine over 24 hours.
Croatian: Leganto je dostupan u različitim jačinama flastera koji oslobađaju lijek tijekom 24 sata.
English: Which strength patches to use The dose of Leganto will depend on your illness - see below.
Croatian: Koju jačinu flastera upotrijebiti Doza lijeka Leganto ovisi o Vašoj bolesti - vidjeti dolje.
English: Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder versus thigh).
Croatian: Razlike u bioraspoloživosti rotigotina variraju od 2% (nadlaktica naprama slabinski dio leđa) do 46% (rame naspram bedra).
English: Leganto was not investigated in patients with severe hepatic impairment.
Croatian: Leganto nije ispitivan u bolesnika s teškim oštećenjem jetre.
English: • Used patches still contain the active substance ‘rotigotine', which may be harmful to others.
Croatian: • Flaster nakon primjene još uvijek sadrži djelatnu tvar 'rotigotin', koja može biti štetna za druge.
English: Leganto may make you feel very sleepy and you may fall asleep very suddenly.
Croatian: Tijekom primjene Leganta možete se osjećati jako pospano i čak posve iznenada zaspati.
English: Do not take the following medicines while using Leganto - because they may decrease its effect:
Croatian: Nemojte uzimati sljedeće lijekove dok uzimate Leganto - jer mogu smanjiti njegov učinak:
English: • Leave the patch on your skin for 24 hours, then take it off and put on a new one.
Croatian: • Ostavite flaster na koži 24 sata, a zatim ga skinite i stavite novi.
English: Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs, has been reported.
Croatian: U nekim slučajevima zabilježena je pojava iznenadnih epizoda spavanja tijekom dnevnih aktivnosti, bez prethodnih upozoravajućih znakova.
English: Fold the used patch with the sticky side inwards.
Croatian: Iskorišteni flaster presavijte napola s ljepljivim stranama prema unutra.
English: You must take your Leganto patch off just before undergoing magnetic resonance imaging (MRI) or cardioversion to avoid skin burns because the patch contains aluminium.
Croatian: Obavezno morate skinuti Leganto flaster neposredno prije snimanja magnetskom rezonancijom (MRI) ili kardioverzije kako biste izbjegli opekline na koži jer flaster sadrži aluminij.
English: The effects of rotigotine on reproduction have been investigated in rats, rabbits and mice.
Croatian: Učinak rotigotina na reprodukciju ispitivan je u štakora, kunića i miševa.
English: Leganto is used in adults to treat the signs and symptoms of:
Croatian: Leganto se primjenjuje u odraslih za liječenje znakova i simptoma:
English: In studies SP824 and SP825 conducted since the initial comparative trial, rotigotine and ropinirole at equivalent doses were shown to have comparable efficacy.
Croatian: U ispitivanjima SP824 i SP825 provedenim nakon početnog komparativnog istraživanja pokazalo se da rotigotin i ropinirol u jednakim dozama imaju usporedivu djelotvornost.
English: Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned.
Croatian: Liječnici koji propisuju ovaj lijek trebaju kontinuirano ispitivati bolesnike o omamljenosti ili pospanosti jer bolesnici možda nisu svjesni omamljenosti ili pospanosti dok ih se direktno ne upita.
English: The majority of the adverse reactions of increased CPK observed in all double-blind and open-label studies resolved and were considered mild in severity.
Croatian: Većina nuspojava povišenog CPK opaženih u svim dvostruko slijepim i otvorenim studijama se povukla te se smatrala blagima po težini.
English: In isolated cases people have fallen asleep while driving and this has caused accidents.
Croatian: Bilo je pojedinačnih slučajeva kad su ljudi zaspali tijekom upravljanja vozilom i uzrokovali prometne nesreće.
English: • If the edges of the patch lift, the patch may be taped down with adhesive medical tape.
Croatian: • Ako se rubovi flastera podižu, flaster se može pričvrstiti ljepljivom medicinskom trakom.
English: After removal, the used patch should be folded in half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet and then discarded.
Croatian: Nakon odstranjivanja iskorišteni flaster treba presaviti na pola s ljepljivim stranama iznutra tako da je matriksna strana okrenuta prema unutra te ga staviti u originalnu vrećicu i ukloniti.
English: What Leganto contains
Croatian: Što Leganto sadrži
English: Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. 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: Leganto je indiciran za liječenje znakova i simptoma ranog stadija idiopatske Parkinsonove bolesti kao monoterapija (tj. bez levodope) ili u kombinaciji s levodopom, tj. tijekom trajanja bolesti i u njenoj završnoj fazi kada učinak levodope slabi ili postaje nestalan te se pojavljuju fluktuacije terapijskog učinka levodope (tzv. učinak kraja doze ili on-off fluktuacije).
English: Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in postural/orthostatic hypotension.
Croatian: Za agoniste dopamina poznato je da utječu na sistemsku regulaciju krvnog tlaka, što može izazvati posturalnu/ortostatsku hipotenziju.
English: Leganto can cause unusual urges or cravings which you cannot resist such as the impulse, drive or temptation to do things that could harm yourself or others.
Croatian: Leganto može uzrokovati neuobičajene nagone ili žudnje kojima se ne možete oduprijeti, kao što su poriv, nagon ili iskušenje da činite stvari koje bi mogle naškoditi Vama ili drugima.
English: Rotigotine is metabolised by N-dealkylation as well as direct and secondary conjugation.
Croatian: Rotigotin se metabolizira N-dealkilacijom, kao i direktnom i sekundarnom konjugacijom.
English: The discontinuation rate was studied in 3 clinical trials ranging up to 3 years in duration.
Croatian: Stopa prekida liječenja ispitivana je u tri klinička ispitivanja u vremenskom trajanju do 3 godine.
English: A reduction of dosage or termination of therapy should be carefully considered.
Croatian: Pažljivo treba razmotriti potrebu smanjivanja doze ili prekida terapije.
English: • Flank (your side, between the ribs and hips).
Croatian: • slabinsko područje (bočna strana tijela, između rebara i kukova)
English: Each patch is packed in a sachet and should be applied directly after the sachet has been opened.
Croatian: Svaki flaster pakiran je u zasebnu zaštitnu vrećicu i treba ga primijeniti odmah po otvaranju zaštitne vrećice.
English: What to do with the used and unused patches
Croatian: Kako odlagati iskorištene i neiskorištene flastere
English: The patch should be pressed down firmly with the palm of the hand for about 30 seconds, so that it sticks well.
Croatian: Kako bi se dobro zalijepio, flaster treba čvrsto pritisnuti dlanom i tako držati oko 30 sekundi.
English: The efficacy of rotigotine was evaluated in 5 placebo-controlled trials with more than 1,400 patients with idiopathic Restless Legs Syndrome (RLS).
Croatian: Djelotvornost rotigotina ocijenjena je u 5 placebom kontroliranih ispitivanja s više od 1400 bolesnika s idiopatskim oblikom sindroma nemirnih nogu (engl.
English: There is no known antidote for overdose of dopamine agonists.
Croatian: Ne postoji poznati antidot u slučaju predoziranja agonistima dopamina.
English: Limited pharmacokinetic data obtained in adolescent patients with RLS (13-17 years, n=24) following treatment with multiple doses of 0.5 to 3mg/24h showed that systemic exposure to rotigotine was similar to that observed in adults.
Croatian: Ograničeni farmakokinetički podaci prikupljeni u adolescentnih bolesnika sa sindromom nemirnih nogu (13-17 godina, n=24) nakon liječenja višestrukim dozama od 0,5 do 3 mg/24 sata pokazali su da je sistemska izloženost rotigotinu bila slična onoj opaženoj u odraslih.
English: • you need to have a magnetic resonance imaging (MRI) scan (diagnostic pictures of the inside of the body, created using magnetic rather than x-ray energy)
Croatian: • ako trebate obaviti snimanje magnetskom rezonancijom (MR) (dijagnostičke snimke unutrašnjosti tijela koje se ne stvaraju pomoću rendgenskog već magnetskog zračenja)
English: • abnormal thinking or behaviour.
Croatian: • abnormalno razmišljanje ili ponašanje
English: Take off the old patch and use a new one.
Croatian: Skinite stari flaster i zalijepite novi.
English: These changes are well-known effects of dopamine agonists in rats after life-long therapy and assessed as not relevant to man.
Croatian: Te su promjene dobro poznate u štakora nakon doživotne primjene agonista dopamina i nisu ocijenjene značajnim za čovjeka.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), a koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim ažuriranim verzijama RMP-a.
English: Approximately 45% of the active substance within the patch is released to the skin in 24 hours.
Croatian: Tijekom 24 h oko 45% djelatne tvari iz flastera otpušta se u kožu.
English: Magnetic resonance imaging and cardioversion
Croatian: Snimanje magnetskom rezonancijom i kardioverzija
English: The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Croatian: In vitro je oko 92% rotigotina vezano za proteine plazme.
English: • unusual urges or cravings which you cannot resist and that could harm yourself or others - the symptoms are mainly seen in patients with Parkinson's disease
Croatian: • neuobičajene nagone ili žudnje kojima se ne možete oduprijeti i koje bi mogle naškoditi Vama ili drugima - simptomi se uglavnom javljaju u bolesnika s Parkinsonovom bolešću
English: Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) has not been observed.
Croatian: Kod poštivanja navedenog postupka nije bio primjećen rebound (pogoršanje simptoma nakon prekida liječenja koje je gore od početnog intenziteta.
English: What you need to know before you use Leganto
Croatian: Što morate znati prije nego počnete primjenjivati Leganto
English: • loss of consciousness, involuntary movements (dyskinesia)
Croatian: • gubitak svijesti, nevoljni pokreti (diskinezija)
English: having unusual dreams
Croatian: neobični snovi
English: Rotigotine did not influence male fertility in rats, but clearly reduced female fertility in rats and mice, because of the effects on prolactin levels which are particularly significant in rodents.
Croatian: Rotigotin nije utjecao na plodnost mužjaka štakora, ali je jasno smanjio plodnost ženki štakora i miševa zbog svog utjecaja na razine prolaktina koje su posebno značajne u glodavaca.
English: A further multinational double-blind study (SP889) was conducted in 287 patients with early or advanced stages of Parkinson's disease who had unsatisfactory early morning motor symptom control.
Croatian: Sljedeće multinacionalno, dvostruko-slijepo ispitivanje (SP889) uključilo je 287 bolesnika u ranom ili uznapredovalom stadiju Parkinsonove bolesti koji nisu imali odgovarajuću kontrolu ranojutarnjih motoričkih simptoma bolesti.
English: Depending on the patient's response, not all of the following dose steps may be required or additional higher doses may be needed after week 4, which are not covered by this package.
Croatian: Ovisno o terapijskom odgovoru bolesnika, možda neće biti potrebne sve doze ili će nakon 4 tjedna biti potrebne dodatne, veće doze koje nisu uključene u ovo pakiranje.
English: If the patient forgets to apply the patch at the usual time of the day or if the patch becomes detached, another patch should be applied for the remainder of the day.
Croatian: Ako bolesnik zaboravi primijeniti flaster u uobičajeno vrijeme u danu ili ako se flaster odlijepi, za ostatak dana treba primijeniti novi flaster.
English: This study failed to demonstrate non-inferiority of rotigotine to ropinirole.
Croatian: Ispitivanje nije uspjelo dokazati neinferiornost rotigotina u odnosu na ropinirol.
English: To avoid skin irritation
Croatian: Da biste izbjegli nadražaj kože
English: If you stop using Leganto
Croatian: Ako prestanete primjenjivati Leganto
English: This leaflet was last revised in {MM/YYYY}
Croatian: Ova uputa je zadnji put revidirana u {MM/GGGG} Ostali izvori informacija
English: In long-term clinical studies with rotigotine, the majority of augmentation episodes were seen in the first and second years of treatment.
Croatian: U dugoročnim kliničkim ispitivanjima s rotigotinom, većina epizoda augmentacije primjećena je u prvoj i drugoj godini liječenja.
English: In case of suspected overdose, removal of the patch(es) should be considered because after removal of the patch(es) the active substance input is stopped and the plasma concentration of rotigotine decreases rapidly.
Croatian: Ako se sumnja u predoziranje, treba razmotriti odstranjenje flastera jer nakon odstranjenja flastera prestaje unos djelatne tvari te se koncentracija rotigotina u plazmi vrlo brzo smanjuje.
English: It is square-shaped with rounded edges.
Croatian: Četvrtastog je oblika sa zaobljenim rubovima.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koje ste dobili bez recepta i biljne lijekove.
English: Special populations)
Croatian: Posebne populacije)
English: Animal studies do not indicate any teratogenic effects in rats and rabbits, but embryo-toxicity was observed in rats and mice at materno-toxic doses (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na teratogene učinke u štakora i kunića, ali je opažena embriotoksičnost u štakora i miševa u maternotoksičnim dozama (vidjeti dio 5.3).
English: Thin, matrix-type, square-shaped with rounded edges, consisting of three layers.
Croatian: Tanak, matriksnog tipa, četvrtast sa zaobljenim rubovima, sastoji se od tri sloja.
English: Skin adhesion
Croatian: Prianjanje na kožu
English: In a 5-year open-label treatment study, augmentation occurred in 11.9% of patients treated with the approved dosages for RLS (1-3 mg/24 h), and 5.1% were considered clinically significant.
Croatian: U otvorenom ispitivanju liječenja, u trajanju od 5 godina, augmentacija se pojavila u 11,9% bolesnika koji su uzimali odobrene doze za liječenje sindroma nemirnih nogu (1-3 mg/24 h), a 5,1% smatralo se klinički značajnim.
English: • If you have forgotten to stick on a new patch after removing the old one, use a new patch as soon as you remember.
Croatian: • Ako ste zaboravili staviti novi flaster nakon odstranjenja starog flastera, čim se sjetite, zalijepite novi.
English: Retinal degeneration was not observed during the routine histopathological evaluation of the eyes in any of the toxicology studies in any species used.
Croatian: Degeneracija retine nije uočena tijekom rutinskih histopatoloških pregleda očiju u drugim toksikološkim studijama, neovisno o životinjskim vrstama.
English: With nondopaminergic receptors, rotigotine showed antagonism at alpha2B and agonism at 5HT1A receptors, but no activity on the 5HT2B receptor.
Croatian: Što se tiče nedopaminergičkih receptora, rotigotin pokazuje antagonističko djelovanje na alfa2B te agonističko djelovanje na 5HT1A receptore, ali nema djelovanja na 5HT2B receptor.
English: • Restless Legs Syndrome (RLS) - this can be associated with discomfort in your legs or arms,
Croatian: • sindroma nemirnih nogu - ovaj sindrom može biti povezan s nelagodom u nogama ili rukama,
English: • Change the patches at about the same time every day.
Croatian: • Flastere mijenjajte svaki dan u približno isto vrijeme.
English: • Make sure that you take the old patch off before putting on a new one.
Croatian: • Obavezno skinite stari flaster prije nego što stavite novi.
English: Put the patch in the original sachet and then throw it away safely, out of the reach of children.
Croatian: Stavite ga u originalnu vrećicu i sigurno ga uklonite, izvan dohvata djece.
English: To prevent the patch becoming loose or falling off
Croatian: Kako biste spriječili da se flaster olabavi ili odlijepi:
English: • Restless Legs Syndrome (RLS) - this can be associated with discomfort in your legs or arms, urge to move around, sleep disturbance and feeling tired or sleepy during the day.
Croatian: • sindroma nemirnih nogu - ovaj sindrom može biti povezan s nelagodom u nogama ili rukama, neodoljivom potrebom za kretanjem, poremećajem spavanja te umorom ili pospanošću tijekom dana.