natgillin/translations-raw huggingface dataset:
Fold the used patch with the sticky side inwards.
Iskorišteni flaster presavijte napola s ljepljivim stranama prema unutra.
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.
Obavezno morate skinuti Leganto flaster neposredno prije snimanja magnetskom rezonancijom (MRI) ili kardioverzije kako biste izbjegli opekline na koži jer flaster sadrži aluminij.
The effects of rotigotine on reproduction have been investigated in rats, rabbits and mice.
Učinak rotigotina na reprodukciju ispitivan je u štakora, kunića i miševa.
Leganto is used in adults to treat the signs and symptoms of:
Leganto se primjenjuje u odraslih za liječenje znakova i simptoma:
In studies SP824 and SP825 conducted since the initial comparative trial, rotigotine and ropinirole at equivalent doses were shown to have comparable efficacy.
U ispitivanjima SP824 i SP825 provedenim nakon početnog komparativnog istraživanja pokazalo se da rotigotin i ropinirol u jednakim dozama imaju usporedivu djelotvornost.
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned.
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.
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.
Većina nuspojava povišenog CPK opaženih u svim dvostruko slijepim i otvorenim studijama se povukla te se smatrala blagima po težini.
In isolated cases people have fallen asleep while driving and this has caused accidents.
Bilo je pojedinačnih slučajeva kad su ljudi zaspali tijekom upravljanja vozilom i uzrokovali prometne nesreće.
• If the edges of the patch lift, the patch may be taped down with adhesive medical tape.
• Ako se rubovi flastera podižu, flaster se može pričvrstiti ljepljivom medicinskom trakom.
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.
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.
What Leganto contains
Što Leganto sadrži
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).
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).
Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in postural/orthostatic hypotension.
Za agoniste dopamina poznato je da utječu na sistemsku regulaciju krvnog tlaka, što može izazvati posturalnu/ortostatsku hipotenziju.
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.
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.
Rotigotine is metabolised by N-dealkylation as well as direct and secondary conjugation.
Rotigotin se metabolizira N-dealkilacijom, kao i direktnom i sekundarnom konjugacijom.
The discontinuation rate was studied in 3 clinical trials ranging up to 3 years in duration.
Stopa prekida liječenja ispitivana je u tri klinička ispitivanja u vremenskom trajanju do 3 godine.
A reduction of dosage or termination of therapy should be carefully considered.
Pažljivo treba razmotriti potrebu smanjivanja doze ili prekida terapije.
• Flank (your side, between the ribs and hips).
• slabinsko područje (bočna strana tijela, između rebara i kukova)
Each patch is packed in a sachet and should be applied directly after the sachet has been opened.
Svaki flaster pakiran je u zasebnu zaštitnu vrećicu i treba ga primijeniti odmah po otvaranju zaštitne vrećice.
What to do with the used and unused patches
Kako odlagati iskorištene i neiskorištene flastere
The patch should be pressed down firmly with the palm of the hand for about 30 seconds, so that it sticks well.
Kako bi se dobro zalijepio, flaster treba čvrsto pritisnuti dlanom i tako držati oko 30 sekundi.
The efficacy of rotigotine was evaluated in 5 placebo-controlled trials with more than 1,400 patients with idiopathic Restless Legs Syndrome (RLS).
Djelotvornost rotigotina ocijenjena je u 5 placebom kontroliranih ispitivanja s više od 1400 bolesnika s idiopatskim oblikom sindroma nemirnih nogu (engl.
There is no known antidote for overdose of dopamine agonists.
Ne postoji poznati antidot u slučaju predoziranja agonistima dopamina.
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.
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.
• 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)
• ako trebate obaviti snimanje magnetskom rezonancijom (MR) (dijagnostičke snimke unutrašnjosti tijela koje se ne stvaraju pomoću rendgenskog već magnetskog zračenja)
• abnormal thinking or behaviour.
• abnormalno razmišljanje ili ponašanje
Take off the old patch and use a new one.
Skinite stari flaster i zalijepite novi.
These changes are well-known effects of dopamine agonists in rats after life-long therapy and assessed as not relevant to man.
Te su promjene dobro poznate u štakora nakon doživotne primjene agonista dopamina i nisu ocijenjene značajnim za čovjeka.
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.
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.
Approximately 45% of the active substance within the patch is released to the skin in 24 hours.
Tijekom 24 h oko 45% djelatne tvari iz flastera otpušta se u kožu.
Magnetic resonance imaging and cardioversion
Snimanje magnetskom rezonancijom i kardioverzija
The in vitro binding of rotigotine to plasma proteins is approximately 92%.
In vitro je oko 92% rotigotina vezano za proteine plazme.
• 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
• 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
Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) has not been observed.
Kod poštivanja navedenog postupka nije bio primjećen rebound (pogoršanje simptoma nakon prekida liječenja koje je gore od početnog intenziteta.
What you need to know before you use Leganto
Što morate znati prije nego počnete primjenjivati Leganto
• loss of consciousness, involuntary movements (dyskinesia)
• gubitak svijesti, nevoljni pokreti (diskinezija)
having unusual dreams
neobični snovi
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.
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.
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.
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.
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.
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.
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.
Ako bolesnik zaboravi primijeniti flaster u uobičajeno vrijeme u danu ili ako se flaster odlijepi, za ostatak dana treba primijeniti novi flaster.
This study failed to demonstrate non-inferiority of rotigotine to ropinirole.
Ispitivanje nije uspjelo dokazati neinferiornost rotigotina u odnosu na ropinirol.
To avoid skin irritation
Da biste izbjegli nadražaj kože
If you stop using Leganto
Ako prestanete primjenjivati Leganto
This leaflet was last revised in {MM/YYYY}
Ova uputa je zadnji put revidirana u {MM/GGGG} Ostali izvori informacija
In long-term clinical studies with rotigotine, the majority of augmentation episodes were seen in the first and second years of treatment.
U dugoročnim kliničkim ispitivanjima s rotigotinom, većina epizoda augmentacije primjećena je u prvoj i drugoj godini liječenja.
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.
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.
It is square-shaped with rounded edges.
Četvrtastog je oblika sa zaobljenim rubovima.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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.
Special populations)
Posebne populacije)
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).
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).
Thin, matrix-type, square-shaped with rounded edges, consisting of three layers.
Tanak, matriksnog tipa, četvrtast sa zaobljenim rubovima, sastoji se od tri sloja.
Skin adhesion
Prianjanje na kožu
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.
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.
• If you have forgotten to stick on a new patch after removing the old one, use a new patch as soon as you remember.
• Ako ste zaboravili staviti novi flaster nakon odstranjenja starog flastera, čim se sjetite, zalijepite novi.
Retinal degeneration was not observed during the routine histopathological evaluation of the eyes in any of the toxicology studies in any species used.
Degeneracija retine nije uočena tijekom rutinskih histopatoloških pregleda očiju u drugim toksikološkim studijama, neovisno o životinjskim vrstama.
With nondopaminergic receptors, rotigotine showed antagonism at alpha2B and agonism at 5HT1A receptors, but no activity on the 5HT2B receptor.
Što se tiče nedopaminergičkih receptora, rotigotin pokazuje antagonističko djelovanje na alfa2B te agonističko djelovanje na 5HT1A receptore, ali nema djelovanja na 5HT2B receptor.
• Restless Legs Syndrome (RLS) - this can be associated with discomfort in your legs or arms,
• sindroma nemirnih nogu - ovaj sindrom može biti povezan s nelagodom u nogama ili rukama,
• Change the patches at about the same time every day.
• Flastere mijenjajte svaki dan u približno isto vrijeme.
• Make sure that you take the old patch off before putting on a new one.
• Obavezno skinite stari flaster prije nego što stavite novi.
Put the patch in the original sachet and then throw it away safely, out of the reach of children.
Stavite ga u originalnu vrećicu i sigurno ga uklonite, izvan dohvata djece.
To prevent the patch becoming loose or falling off
Kako biste spriječili da se flaster olabavi ili odlijepi:
• 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.
• 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.
Main metabolites are sulfates and glucuronide conjugates of the parent compound as well as N-desalkyl-metabolites, which are biologically inactive.
Glavni su metaboliti izvorne tvari sulfati i konjugati glukuronida te N-dezalkilmetaboliti koji su biološki inaktivni.
The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application.
Flaster treba ostaviti na koži 24 sata i zatim ga zamijeniti novim na drugom mjestu primjene.
• 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.
• 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
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.
Pretpostavlja se da rotigotin svoje povoljno djelovanje na Parkinsonovu bolest postiže aktivacijom D3, D2 i D1 receptora nucleus caudatusa i putamena u mozgu.
Malignant tumours were noted predominantly in the uterus of mid- and high-dose females.
Maligni tumori uglavnom su uočeni u maternici ženki koje su dobivale srednje i velike doze.
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).
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).
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.
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.
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.
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.
If the patch falls off, put on a new patch for the rest of the day - then replace the patch at the usual time.
Ako se flaster odlijepi, stavite novi flaster za ostatak dana, a zatim ga promijenite u uobičajeno vrijeme.
There is no relevant use of Leganto in the paediatric population in Parkinson's disease.
Nema relevantne primjene lijeka Leganto u pedijatrijskoj populaciji u indikaciji Parkinsonove bolesti.
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).
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).
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.
Istodobna primjena omeprazola (inhibitor CYP2C19) u dozi od 40 mg/dan u zdravih dobrovoljaca nije imala utjecaja na farmakokinetiku ni metabolizam rotigotina.
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Preporučuju se redoviti oftalmološki pregledi ili ako se pojave poremećaji vida.
• you may get skin problems caused by the patch - see ‘Skin problems caused by the patch' in section 4.
• flaster može uzrokovati kožne tegobe - pogledajte odlomak 'Promjene na koži uzrokovane flasterom' u dijelu 4.
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)
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).
Which strength patches to use
Koju jačinu flastera upotrijebiti
The adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p <0.0001).
Prilagođena srednja razlika bila je -6,5 bodova (CI95% -8,7; -4,4, p<0,0001).
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
Simptomi koji upućuju na neuroleptični maligni sindrom zabilježeni su kod naglog prekida dopaminergične terapije.
Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
Rotigotin je povezan sa somnolencijom uključujući pojačanu dnevnu somnolenciju i iznenadne nastupe epizoda spavanja.
These may include:
Oni mogu uključivati:
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.
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.
The patch should not be cut into pieces.
Flaster se ne smije rezati u komadiće.
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).
Natrijev metabisulfit (E223) rijetko može uzrokovati teške reakcije preosjetljivosti (alergijske reakcije) i bronhospazam (otežano disanje uzrokovano suženjem dišnih putova).
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.
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.
• rash over larger parts of the body
• osip koji prekriva velike dijelove tijela
While these complications may resolve when treatment is discontinued, complete resolution does not always occur.
Po prestanku liječenja te komplikacije mogu nestati, ali se nastale promjene ne povlače uvijek u potpunosti.
Sudden onset of sleep and somnolence
Iznenadni nastup spavanja i somnolencija
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.
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.
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.
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.
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.
Slučajevi retroperitonealne fibroze, plućnih infiltrata, pleuralnog izljeva, zadebljanja pleure, perikarditisa i kardijalne valvulopatije zabilježeni su u nekih bolesnika liječenih dopaminergičkim agensima dobivenim iz ergota.
• increased levels of creatine phosphokinase (CPK) in blood in Japanese patients (CPK is an enzyme found mainly in skeletal muscles)
• povišene razine kreatin fosfokinaze (CPK) u krvi japanskih bolesnika (CPK je enzim koji se uglavnom nalazi u koštanim mišićima)
• Do not let the area of the patch get hot - for example too much sunlight, saunas, hot baths, heating pads or hot-water bottles.
• Nemojte dopustiti da se područje flastera previše ugrije - npr. prekomjerno sunčanje, sauna, vruće kupke topli oblozi ili termofori.
• Stick the Leganto patch onto your skin as soon as you have opened the sachet and removed the release liner.
• Nalijepite Leganto flaster na kožu odmah po otvaranju vrećice i odstranjivanju zaštitnog sloja.
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).
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).
• Restless Legs Syndrome - lowered by 1 mg every other day.
• sindrom nemirnih nogu - smanjivati za 1 mg svaki drugi dan
The patches of 2 mg/24 h are used for the treatment of Parkinson´s disease and Restless Leg Syndrome.
Flasteri od 2 mg/24 h primjenjuju se za liječenje Parkinsonove bolesti i sindroma nemirnih nogu.