FrancophonIA/ELRC3.0 huggingface dataset:
English: Main metabolites are sulfates and glucuronide conjugates of the parent compound as well as N-desalkyl-metabolites, which are biologically inactive.
Croatian: Glavni su metaboliti izvorne tvari sulfati i konjugati glukuronida te N-dezalkilmetaboliti koji su biološki inaktivni.
English: The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application.
Croatian: Flaster treba ostaviti na koži 24 sata i zatim ga zamijeniti novim na drugom mjestu primjene.
English: • increased levels of creatine phosphokinase (CPK) in blood in Japanese patients (CPK is an enzyme found mainly in skeletal muscles), no information is available in other populations.
Croatian: • povišene razine kreatin fosfokinaze (CPK) u krvi japanskih bolesnika (CPK je enzim koji se uglavnom nalazi u koštanim mišićima); nema dostupnih informacija za druge populacije
English: Rotigotine is believed to elicit its beneficial effect on Parkinson's disease by activation of the D3, D2 and D1 receptors of the caudate-putamen in the brain.
Croatian: Pretpostavlja se da rotigotin svoje povoljno djelovanje na Parkinsonovu bolest postiže aktivacijom D3, D2 i D1 receptora nucleus caudatusa i putamena u mozgu.
English: Malignant tumours were noted predominantly in the uterus of mid- and high-dose females.
Croatian: Maligni tumori uglavnom su uočeni u maternici ženki koje su dobivale srednje i velike doze.
English: Rotigotine significantly reduced the periodic limb movement index (PLMI) from 50.9 to 7.7 versus 37.4 to 32.7 for placebo (p<0.0001).
Croatian: Rotigotin je značajno smanjio indeks povremenog gibanja ekstremiteta (PLMI) sa 50,9 na 7,7 naspram 37,4 na 32,7 za placebo (p<0,0001).
English: Switching to rotigotine was feasible, with minor dose adjustment (median 2 mg/24 h) being necessary in only 2 patients switching from ropinirole, 5 patients from pramipexole and 4 patients from cabergoline.
Croatian: Zamjena rotigotinom bila je moguća s manjom prilagodbom doze (medijan 2 mg/24 h) potrebnom samo u 2 bolesnika prebačenih s ropinirola, 5 bolesnika prebačenih s pramipeksola i 4 bolesnika prebačenih s kabergolina.
English: The most likely adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, confusion, convulsions and other signs of central dopaminergic stimulation.
Croatian: Najvjerojatnije nuspojave bi bile one koje su povezane s farmakodinamičkim svojstvima agonista dopamina, uključujući mučninu, povraćanje, hipotenziju, nevoljne pokrete, halucinacije, konfuziju, konvulzije i ostale znakove središnje dopaminergičke stimulacije.
English: If the patch falls off, put on a new patch for the rest of the day - then replace the patch at the usual time.
Croatian: Ako se flaster odlijepi, stavite novi flaster za ostatak dana, a zatim ga promijenite u uobičajeno vrijeme.
English: There is no relevant use of Leganto in the paediatric population in Parkinson's disease.
Croatian: Nema relevantne primjene lijeka Leganto u pedijatrijskoj populaciji u indikaciji Parkinsonove bolesti.
English: The primary outcome assessment was the score for the Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part III) of the Unified Parkinson's Disease Rating Scale (UPDRS).
Croatian: Ocjena primarnog ishoda ispitivanja bila je rezultat komponente dnevnih aktivnosti (Activities of Daily Living-ADL) (dio II) plus komponenta motoričkog pregleda (dio III) prema ujedinjenoj ljestvici za ocjenu Parkinsonove bolesti (Unified Parkinson's Disease Rating Scale - UPDRS).
English: Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/day, had no effect on the pharmacokinetics and metabolism of rotigotine in healthy volunteers.
Croatian: Istodobna primjena omeprazola (inhibitor CYP2C19) u dozi od 40 mg/dan u zdravih dobrovoljaca nije imala utjecaja na farmakokinetiku ni metabolizam rotigotina.
English: Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Croatian: Preporučuju se redoviti oftalmološki pregledi ili ako se pojave poremećaji vida.
English: • you may get skin problems caused by the patch - see ‘Skin problems caused by the patch' in section 4.
Croatian: • flaster može uzrokovati kožne tegobe - pogledajte odlomak 'Promjene na koži uzrokovane flasterom' u dijelu 4.
English: If a Parkinson's disease patient is insufficiently controlled while on treatment with rotigotine switching to another dopamine agonist might provide additional benefit (see section 5.1)
Croatian: Ako se u bolesnika koji boluje od Parkinsonove bolesti tijekom liječenja rotigotinom ne uspije postići zadovoljavajuća kontrola bolesti zamjena drugim lijekom iz skupine agonista dopamina može pružiti dodatnu korist (vidjeti dio 5.1).
English: Which strength patches to use
Croatian: Koju jačinu flastera upotrijebiti
English: The adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p <0.0001).
Croatian: Prilagođena srednja razlika bila je -6,5 bodova (CI95% -8,7; -4,4, p<0,0001).
English: Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
Croatian: Simptomi koji upućuju na neuroleptični maligni sindrom zabilježeni su kod naglog prekida dopaminergične terapije.
English: Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
Croatian: Rotigotin je povezan sa somnolencijom uključujući pojačanu dnevnu somnolenciju i iznenadne nastupe epizoda spavanja.
English: These may include:
Croatian: Oni mogu uključivati:
English: Furthermore, in this study a higher dose of 4 mg/24 h that is unapproved in RLS was also used and led to higher rates of augmentation.
Croatian: Nadalje, u tom je ispitivanju također korištena veća doza od 4 mg/24 h, koja nije odobrena za sindrom nemirnih nogu, te su s njom zabilježene veće stope augmentacije.
English: The patch should not be cut into pieces.
Croatian: Flaster se ne smije rezati u komadiće.
English: Leganto contains sodium metabisulphite (E223) Sodium metabisulphite (E223) may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing distress caused by narrowing of the airways).
Croatian: Natrijev metabisulfit (E223) rijetko može uzrokovati teške reakcije preosjetljivosti (alergijske reakcije) i bronhospazam (otežano disanje uzrokovano suženjem dišnih putova).
English: Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of Leganto, and co-administration should be avoided.
Croatian: Budući da je rotigotin agonist dopamina, može se pretpostaviti da antagonisti dopamina kao što su neuroleptici (npr. fenotiazini, butirofenoni, tioksanteni) ili metoklopramid, mogu smanjiti učinkovitost Leganta te bi takve kombinacije trebalo izbjegavati.
English: • rash over larger parts of the body
Croatian: • osip koji prekriva velike dijelove tijela
English: While these complications may resolve when treatment is discontinued, complete resolution does not always occur.
Croatian: Po prestanku liječenja te komplikacije mogu nestati, ali se nastale promjene ne povlače uvijek u potpunosti.
English: Sudden onset of sleep and somnolence
Croatian: Iznenadni nastup spavanja i somnolencija
English: Leganto contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.
Croatian: Leganto sadrži natrijev metabisulfit, sulfit koji u osjetljivih osoba može uzrokovati alergijske reakcije, uključujući simptome anafilaksije, te za život ugrožavajuće ili manje teške napadaje astme.
English: Also do not use tools or machines if you feel very sleepy - or do anything else which may put others or yourself at risk of serious injury.
Croatian: Isto tako, ako se osjećate jako pospano, nemojte rukovati alatima, raditi sa strojevima niti raditi išta drugo što bi Vas ili druge moglo dovesti u opasnost od ozbiljne ozljede.
English: Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents.
Croatian: Slučajevi retroperitonealne fibroze, plućnih infiltrata, pleuralnog izljeva, zadebljanja pleure, perikarditisa i kardijalne valvulopatije zabilježeni su u nekih bolesnika liječenih dopaminergičkim agensima dobivenim iz ergota.
English: • increased levels of creatine phosphokinase (CPK) in blood in Japanese patients (CPK is an enzyme found mainly in skeletal muscles)
Croatian: • povišene razine kreatin fosfokinaze (CPK) u krvi japanskih bolesnika (CPK je enzim koji se uglavnom nalazi u koštanim mišićima)
English: • Do not let the area of the patch get hot - for example too much sunlight, saunas, hot baths, heating pads or hot-water bottles.
Croatian: • Nemojte dopustiti da se područje flastera previše ugrije - npr. prekomjerno sunčanje, sauna, vruće kupke topli oblozi ili termofori.
English: • Stick the Leganto patch onto your skin as soon as you have opened the sachet and removed the release liner.
Croatian: • Nalijepite Leganto flaster na kožu odmah po otvaranju vrećice i odstranjivanju zaštitnog sloja.
English: Patients being treated with rotigotine and presenting with somnolence and/or sudden sleep episodes must be informed not to drive or engage in activities (e.g. operating machines) where impaired alertness may put themselves or others at risk of serious injury or death until such recurrent episodes and somnolence have resolved (see also sections 4.4 and 4.5).
Croatian: Bolesnike koji se liječe rotigotinom i pokazuju znakove somnolencije i/ili iznenadne pojave spavanja mora se upozoriti da ne voze i da izbjegavaju druge aktivnosti (npr. upravljanje strojevima) pri kojima zbog narušene budnosti mogu sebe ili druge osobe izložiti povećanom riziku od ozbiljnih ozljeda ili smrti sve dok takve opetovane epizode i somnolencija ne prestanu(vidjeti također dijelove 4.4 i 4.5).
English: • Restless Legs Syndrome - lowered by 1 mg every other day.
Croatian: • sindrom nemirnih nogu - smanjivati za 1 mg svaki drugi dan
English: The patches of 2 mg/24 h are used for the treatment of Parkinson´s disease and Restless Leg Syndrome.
Croatian: Flasteri od 2 mg/24 h primjenjuju se za liječenje Parkinsonove bolesti i sindroma nemirnih nogu.
English: Leganto treatment initiation pack contains 4 different packages (one for each strength) with 7 patches each, for the first four weeks of therapy.
Croatian: Leganto pakiranje za započinjanje liječenja sadrži 4 različita pakiranja (jedno od svake jačine), svako s po 7 flastera, za prva četiri tjedna liječenja.
English: • Do not touch the sticky side of the patch with your fingers.
Croatian: • Nemojte prstima dodirivati ljepljivu stranu.
English: Rotigotine did not induce gene mutations in the Ames test, but did show effects in the in vitro Mouse Lymphoma Assay with metabolic activation and weaker effects without metabolic activation.
Croatian: Rotigotin u Amesovu testu nije inducirao mutaciju gena, ali je utjecao na test mišjeg limfoma in vitro s metaboličkom aktivacijom te slabljenjem učinka bez metaboličke aktivacije.
English: • Hold the patch in both hands with the release liner facing you.
Croatian: • Primite flaster objema rukama tako da je zaštitni sloj okrenut prema Vama.
English: Because therapy with Leganto is initiated at a low dose and gradually titrated according to clinical tolerability to obtain the optimum therapeutic effect, adjustment of the dose based on gender, weight, or age is not necessary.
Croatian: Budući da se liječenje Legantom započinje manjom dozom i da se doza postupno titrira ovisno o kliničkoj toleranciji do odgovarajućeg terapijskog učinka, nije potrebna prilagodba doze ovisno o spolu, tjelesnoj težini ili dobi.
English: Currently available data are described in section 5.2 but no recommendation on a posology in children with RLS can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.2, no nije moguće dati preporuku o doziranju rotigotina u djece sa sindromom nemirnih nogu.
English: Contact your doctor if you notice signs of an allergic reaction - these can include swelling of the face, tongue or lips.
Croatian: Obratite se svom liječniku ako primijetite znakove alergijske reakcije, koje mogu uključivati oticanje lica, jezika ili usana.
English: In subjects with moderate hepatic impairment or mild to severe renal impairment, no relevant increases of rotigotine plasma levels were observed.
Croatian: U osoba s umjerenim oštećenjem jetre ili blagim do teškim oštećenjem bubrega nisu zabilježena značajna povećanja koncentracije rotigotina u plazmi.
English: • feeling sleepy, falling asleep suddenly without warning, difficulty in sleeping, sleep problems,
Croatian: • pospanost, iznenadno usnivanje bez upozorenja, teškoće s usnivanjem, poremećaji spavanja,
English: In the absence of human data, breast-feeding should be discontinued.
Croatian: Zbog odsustva podataka o primjeni u ljudi, dojenje treba prekinuti.
English: Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance.
Croatian: Preporučuje se oprez prilikom liječenja bolesnika s teškim oštećenjem jetre jer može doći do smanjenog klirensa rotigotina.
English: This is known as ‘dopamine dysregulation syndrome' and can lead to use of too much Leganto.
Croatian: To je poznato kao 'sindrom dopaminergičke disregulacije' i može dovesti do prekomjerne primjene Leganta.
English: Plasma levels of conjugates of rotigotine and its desalkyl metabolites increase with impaired renal function.
Croatian: Razine konjugata rotigotina i njegovih dezalkil-metabolita u plazmi se povećavaju kod oštećenja funkcije bubrega.
English: The improved room temperature patch formulation showed better skin adhesion than the cold storage formulation with >90% of patches showing sufficient adhesion (i.e. >70% of the patch area adhering) compared to <83%.
Croatian: Pokazalo se da poboljšana formulacija flastera koja se čuva na sobnoj temperaturi bolje prianja na kožu od formulacije flastera čuvanih na hladnom mjestu, s time da je ˃ 90 % flastera čuvanih na sobnoj temperaturi pokazalo dovoljno prianjanje (to znači da je ˃ 70 % površine flastera bilo nalijepljeno na kožu) u usporedbi s < 83 % kod flastera čuvanih na hladnom mjestu.
English: Motor symptoms (UPDRS Part III) improved by 6.3 ± 1.3 points in rotigotine-treated patients, and by 5.9 ± 1.3 points in the ropinirolegroup after 4 weeks of maintenance.
Croatian: Motorički simptomi (UPDRS dio III) poboljšali su se za 6,3 ± 1,3 bodova u bolesnika liječenih rotigotinom i za 5,9 ± 1,3 bodova u ropinirol skupini nakon 4 tjedna održavanja.
English: • Do not cut the Leganto patches into pieces.
Croatian: • Nemojte rezati Leganto flaster na manje dijelove.
English: • The patches should not be cut into pieces.
Croatian: • Flasteri se ne smiju rezati na manje dijelove.
English: • You may get redness and itching on the skin where the patch has been - these reactions are usually mild or moderate.
Croatian: • Na mjestu gdje je flaster bio nalijepljen mogu se javiti crvenilo i svrbež - te su reakcije obično blage ili umjerene.
English: In a carcinogenicity study, male rats developed Leydig cell tumours and hyperplasia.
Croatian: U ispitivanju karcinogeneze u mužjaka štakora pojavili su se tumori Leydigovih stanica i hiperplazija.
English: • feeling agitated, disorientated, confused or paranoid
Croatian: • uznemirenost, dezorijentacija, smetenost ili paranoja
English: Wash your hands with soap and water straight after handling the patch.
Croatian: Odmah nakon rukovanja flasterom operite ruke sapunom i vodom.
English: Leganto should be discontinued gradually.
Croatian: Prekid primjene Leganta treba biti postupan.
English: Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson's disease and Restless Legs Syndrome.
Croatian: Rotigotin je neergolinski agonist dopamina namijenjen liječenju znakova i simptoma Parkinsonove bolesti i sindroma nemirnih nogu.
English: • your blood pressure needs checking regularly while using Leganto, especially at the start of the treatment.
Croatian: • tijekom liječenja Legantom potrebno je redovito kontrolirati krvni tlak, osobito na početku liječenja.
English: If you experience these symptoms after beginning treatment with Leganto, contact your doctor.
Croatian: Ako te simptome osjetite nakon početka liječenja Legantom, obratite se svom liječniku.
English: If you notice any problems with your eyesight between checks, talk to your doctor straight away.
Croatian: Ako primijetite bilo kakve vidne tegobe između dviju kontrola, odmah se obratite svom liječniku.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Leganto.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Leganto.
English: The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies and three studies investigating specific aspects of Parkinson's disease.
Croatian: Učinkovitost rotigotina u liječenju znakova i simptoma idiopatske Parkinsonove bolesti ocijenjena je u multinacionalnom programu za razvoj lijeka koji se sastojao od četiri ključna, usporedna, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja i tri studije koje su ispitivale specifične aspekte Parkinsonove bolesti.
English: There are no adequate data from the use of rotigotine in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni rotigotina u trudnica.
English: Rotating the site of patch application may result in day-to-day differences in plasma levels.
Croatian: Izmjena mjesta primjene flastera može uzrokovati dnevne oscilacije razine rotigotina u plazmi.
English: • involuntary muscle spasms (convulsion)
Croatian: • nevoljni mišićni grčevi (konvulzija)
English: In a randomized, open-label study (SP825) in patients with early-stage Parkinson's disease, 25 patients were randomized to rotigotine treatment and 26 to ropinirole.
Croatian: U randomiziranom, otvorenom ispitivanju (SP825) u bolesnika u ranom stadiju Parkinsonove bolesti 25 bolesnika randomizirano je za liječenje rotigotinom, a njih 26 za liječenje ropinirolom.
English: Because patients with clinically relevant cardiovascular disease were excluded in these studies, patients with severe cardiovascular disease should be asked about symptoms of syncope and pre-syncope.
Croatian: Budući da su bolesnici s klinički značajnom kardiovaskularnom bolesti bili isključeni iz tih ispitivanja, bolesnike s teškom kardiovaskularnom bolesti potrebno je pitati o simptomima sinkope i presinkope.
English: You should discuss with your doctor if it is safe for you to drink alcohol while using Leganto.
Croatian: Posavjetujte se s liječnikom je li sigurno piti alkoholna pića dok primjenjujete Leganto.
English: See ‘Changes to your behaviour and abnormal thinking' in section 4 for more information.
Croatian: Za više informacija pogledajte odlomak 'Promjene u ponašanju i abnormalno razmišljanje' u dijelu 4.
English: Efficacy was determined by the subject's response to therapy in terms of responder and absolute improvement in the time spent “off”.
Croatian: Djelotvornost je određena prema odgovoru ispitanika na terapiju i apsolutnom poboljšanju trajanja off razdoblja.
English: Take the patch out of the sachet.
Croatian: Izvadite flaster iz vrećice.
English: In two 6-month, double-blind, placebo-controlled studies, clinically relevant augmentation was observed in 1.5% of rotigotine-treated patients versus 0.5% of placebo treated patients.
Croatian: U dva 6-mjesečna, dvostruko slijepa, placebom kontrolirana ispitivanja, primjećena je klinički značajna augmentacija kod 1,5% bolesnika koji su liječeni rotigotinom naspram 0,5% bolesnika koji su primali placebo.
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 - the symptoms are mainly seen in patients with Parkinson's disease.
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 - simptomi se uglavnom javljaju u bolesnika s Parkinsonovom bolešću.
English: If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals, as exposure could lead to changes in the skin color.
Croatian: Ako se javi osip na koži ili nadraženost kože od transdermalnog sustava, treba izbjegavati direktno izlaganje tog područja sunčevoj svjetlosti dok se koža u potpunosti ne oporavi budući da izlaganje može uzrokovati promjene u boji kože.
English: For both primary endpoints statistically significant differences have been observed for the doses 1 mg/24 h, 2 mg/24 h and 3 mg/24 h in comparison to placebo.
Croatian: Za oba primarna ishoda bile su vidljive statistički značajne razlike pri dozama 1 mg/24 h, 2 mg/24 h i 3 mg/24 h u usporedbi s placebom.
English: Where to stick the patch
Croatian: Gdje trebate nalijepiti flaster
English: 190 patients received rotigotine, and 97 placebo.
Croatian: Rotigotin je primalo 190 bolesnika, a 97 placebo.
English: In vitro results indicate that different CYP isoforms are able to catalyse the N-dealkylation of rotigotine.
Croatian: In vitro rezultati ukazuju da različite CYP izoforme mogu katalizirati Ndealkilaciju rotigotina.
English: How to take off a used patch
Croatian: Kako skinuti iskorišteni flaster
English: Efficacy was determined by the subject's response to therapy in terms of responder and absolute points improvement in the scores of ADL and Motor Examination combined (UPDRS part II+III).
Croatian: Djelotvornost je određena prema terapijskom odgovoru u ispitanika i apsolutnom povećanju broja bodova u zbirnom rezultatu ADL ljestvice i motoričkog pregleda (UPDRS dijelovi II + III).
English: Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults.
Croatian: Leganto je indiciran za simptomatsko liječenje umjerenog do teškog idiopatskog oblika sindroma nemirnih nogu u odraslih.
English: The maximum dose is 8 mg/24 h.
Croatian: Maksimalna doza je 8 mg/24 h.
English: In clinical studies in Parkinson's patients, the 6 month-specific rates of peripheral oedema remained at about 4% through the entire observation period up to 36 months.
Croatian: U kliničkim ispitivanjima u bolesnika s Parkinsonovom bolešću, kroz cijelo razdoblje praćenja u trajanju od 36 mjeseci incidencija pojave perifernog edema u 6-mjesečnim razmacima bila je oko 4%.
English: Sleep (PDSS) improved by 4.1 ± 13.8 points for rotigotinetreated patients, and by 2.5 ± 13.5 points for ropinirole-treated patients.
Croatian: San (PDSS) se poboljšao za 4,1 ± 13,8 bodova u bolesnika liječenih rotigotinom i za 2,5 ± 13,5 bodova u bolesnika liječenih ropinirolom.
English: Application site reactions
Croatian: Reakcije na mjestu primjene
English: Rotigotine has been associated with somnolence and episodes of sudden sleep onset.
Croatian: Rotigotin se povezuje s pojavom somnolencije i iznenadnim epizodama spavanja.
English: • psychotic disorders
Croatian: • psihotični poremećaji
English: Put the sticky side of the patch onto clean, dry, healthy skin on the following areas as shown in grey on the pictures opposite:
Croatian: Postavite ljepljivu stranu flastera na čistu, suhu i zdravu kožu na sljedeća područja, označena sivom bojom na slici: