natgillin/translations-raw huggingface dataset:
• your symptoms of Restless Legs Syndrome may start earlier than usual, be more intense and involve other limbs.
• se lahko simptomi sindroma nemirnih nog pojavijo prej kot običajno, so bolj intenzivni in vključujejo druge okončine.
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.
Potekal je bolj ali manj vzporedno z zmanjšano relativno skupno rastjo celic, zato je lahko povezan s citotoksičnim učinkom te spojine.
Therefore, the relevance of the one positive in vitro mutagenicity test is not known.
Zato pomen tega pozitivnega preizkusa mutagenosti in vitro ni znan.
Changes in behaviour and abnormal thinking
Spremembe v vedenju in nenormalno mišljenje
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.
Prav tako ne uporabljajte orodja ali upravljajte strojev, če ste zelo zaspani- oziroma ne počnite ničesar, kar bi lahko v nevarnost za resne poškodbe spravilo vas ali druge.
• seeing or hearing things that are not real (hallucinations)
• videnje ali slišanje stvari, ki niso resnične (halucinacije)
• craving large doses of medicines like Leganto - more than needed for the illness.
• hrepenenje po velikih odmerkih zdravil, kot je zdravilo Leganto - več kot je potrebno za zdravljenje bolezni.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Če ste noseči ali dojite, mislite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden začnete uporabljati to zdravilo.
This is normally reached within 3 to 7 weeks.
Ta odmerek se navadno doseže v 3 do 7 tednih.
Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Razmisliti je treba o zmanjšanju odmerka/postopnem prenehanju, če se pojavijo takšni simptomi.
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.
Avgmentacija v tem primeru pomeni zgodnji pojav simptomov zvečer (ali celo popoldne), povečano resnost simptomov in razširitev simptomov po drugih delih telesa.
Rotigotine should not be used during pregnancy.
Rotigotina se med nosečnostjo ne sme uporabljati.
Do not use this medicine after the expiry date which is stated on the label and box.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
The percentage of subjects discontinuing was 25-38% over the first year, 10% in the second year, and 11% in the third year.
Prvo leto je prekinilo zdravljenje 25-38 % oseb, drugo leto 10 % in tretje leto 11 %.
• Each patch is packed in a separate sachet.
• Vsak obliž je pakiran v ločeno zaščitno vrečko.
• Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused by the patch.
• Izogibajte se izpostavljenosti direktni sončni svetlobi in solariju na predelih kože, ki kažejo kakršnekoli kožne reakcije, ki jih povzroča obliž.
This is normally reached within 3 to 4 weeks.
Ta odmerek se navadno doseže v 3 do 4 tednih.
Take off the old patch and use a new one.
Odstranite starega in namestite novega.
• Do not use creams, oils, lotions, powders or other skin products where you will put the patch.
• Ne uporabljajte krem, olj, losjonov, pudrov ali drugih izdelkov za kožo na mestu, kjer boste nalepili obliž.
Rotating the site of patch application may result in day-to-day differences in plasma levels.
Spreminjanje mesta namestitve obliža lahko povzroči dnevne razlike koncentracij v plazmi.
• you are allergic to rotigotine or any of the other ingredients of this medicine (listed in section 6)
• ste alergični na rotigotin ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
None of these patients discontinued therapy because of augmentation.
Nihče od bolnikov ni prekinil zdravljenja zaradi avgmentacije.
This mutagenic effect could be attributed to a clastogenic effect of rotigotine.
Ta mutageni učinek lahko pripišemo klastogenim učinkom rotigotina.
• Leave the patch on your skin for 24 hours, then take it off and put on a new one.
• Obliž pustite na koži 24 ur, nato ga odstranite in prilepite novega.
Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so navedeni v poglavju 5.2, vendar priporočil o odmerjanju ni mogoče dati.
Patients should be regularly monitored for the development of impulse control disorders.
Bolnike je treba redno nadzorovati glede razvoja motenj pri kontroli dražljajev.
BOX OF 28 PATCHES -TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
ŠKATLA Z 28 OBLIŽI - PAKIRANJE ZA ZAČETNO ZDRAVLJENJE - 4-TEDENSKI RAZPORED ZDRAVLJENJA
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).
Odmerkom, ki so večji od odobrenega razpona odmerkov za RLS se je treba izogibati, saj lahko to privede do višjih stopenj avgmentacije (glejte poglavje 5.1).
The information on metabolites is incomplete.
Podatki o presnovkih so nepopolni.
Magnetic resonance imaging or cardioversion (see section 4.4).
Magnetnoresonančno slikanje ali kardioverzija (glejte poglavje 4.4).
• Do not put the patch in an area where it can be rubbed by tight clothing.
• Obliža ne namestite na mesto, kjer bi se ob njega drgnila tesna oblačila.
• your blood pressure needs checking regularly while using Leganto, especially at the start of the treatment.
• potrebujete redne meritve krvnega tlaka med uporabo zdravila Leganto, zlasti na začetku zdravljenja.
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.
V kliničnih študijah pri bolnikih s Parkinsonovo boleznijo je bila po šestih mesecih specifična pogostnost perifernih edemov približno 4-odstotna in je taka ostala ves čas opazovanja do 36 mesecev.
Which strength patches to use
Katero jakost obližev uporabiti
In two openlabel, follow-up studies over a subsequent 12 months, the rate of clinically relevant augmentation was 2.9%.
V dveh odprtih, nadaljevalnih študijah, ki sta potekali naslednjih 12 mesecev, je bil delež klinično pomembne avgmentacije 2,9 %.
Tell your doctor if you lose consciousness or feel dizzy.
Povejte zdravniku, če ste izgubili zavest ali ste omotični.
Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09
Farmakoterapevtska skupina: Antiparkinsoniki, agonisti dopamina; oznaka ATC: N04BC09
These effects are usually mild or moderate and only last for a short time.
Ta neželena učinka sta ponavadi blaga ali zmerna in trajata le kratek čas.
The sticky side of the patch should not be touched.
Lepljive strani obliža se ne smemo dotakniti.
The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Vezava rotigotina na beljakovine v plazmi in vitro je približno 92 %.
• falling asleep suddenly without warning
• nenaden spanec brez opozorila
Leganto should not be placed on skin that is red, irritated or damaged (see section 4.4).
Zdravila Leganto ne smemo namestiti na rdečo, razdraženo ali poškodovano kožo (glejte poglavje 4.4).
• sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression.
• sedative, kot so benzodiazepini ali zdravila za zdravljenje duševnih bolezni ali depresije.
Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is excreted in faeces.
Približno 71 % odmerka rotigotina se izloči z urinom, manjši delež, približno 23 %, pa z blatom.
Leganto can cause loss of consciousness.
Zdravilo Leganto lahko povzroči izgubo zavesti.
While these complications may resolve when treatment is discontinued, complete resolution does not always occur.
Ti zapleti lahko po prekinitvi zdravljenja izginejo, vendar pa ne vedno popolnoma.
Leganto may affect your blood pressure.
Zdravilo Leganto lahko vpliva na vaš krvni tlak.
After a single dose of rotigotine, binding to melanin-containing tissues (i.e., eyes) in the pigmented rat and monkey was evident, but was slowly cleared over the 14-day observation period.
Po enkratnem odmerku rotigotina je bila njegova vezava na tkiva, ki vsebujejo melanin (tj. oči), pri pigmentiranih podganah in opicah očitna, vendar se je v 14-dnevnem opazovalnem obdobju postopno sprostila.
Dopamine is a messenger in the brain which is important for movement.
Dopamin je prenašalec v možganih, ki je pomemben za gibanje.
There are no adequate data from the use of rotigotine in pregnant women.
Ni zadostnih podatkov o uporabi rotigotina pri nosečnicah.
• Slowly and carefully peel off the used patch.
• Počasi in previdno odstranite stari obliž.
This is because the effects of rotigotine on pregnancy and the unborn baby are not known.
saj učinki rotigotina na nosečnost in nerojenega otroka niso znani.
The pharmacokinetic profile shows a biphasic elimination with an initial half-life of about 2 to 3 hours.
Farmakokinetični profil nakazuje na dvofazno izločanje z začetnim razpolovnim časom 2 do 3 ure.
Irritability, oedema peripheral
razdražljivost, periferni edem
This includes medicines obtained without a prescription and herbal medicines.
To velja tudi za zdravila brez recepta in zdravila rastlinskega izvora.
Currently available data are described in section 5.2 but no recommendation on a posology in children with RLS can be made.
Trenutno razpoložljivi podatki so opisani v poglavju 5.2, vendar priporočil o odmerjanju rotigotina pri otrocih z RLS ni mogoče dati.
• If you need to stick the patch to a hairy area of skin, you must shave the area at least 3 days before sticking the patch there.
• Če morate obliž nalepiti na poraščeno mesto na koži, morate to mesto obriti vsaj tri dni pred namestitvijo obliža.
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.
Odvisno od bolnikovega odziva morda ne bodo potrebni vsi koraki povečevanja odmerjanja ali pa bodo po 4. tednu potrebni dodatni večji odmerki, ki jih komplet ne vsebuje.
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).
V organskih sistemih so neželeni učinki razvrščeni po pogostnosti (število bolnikov, pri katerih se pričakuje, da bodo imeli reakcijo) takole: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
• abnormal thinking or behaviour.
• nenormalno mišljenje ali vedenje.
Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) has not been observed.
Ob upoštevanju navedenega postopka ni bilo opaziti poslabšanja stanja (poslabšanje simptomov z intenziteto, višjo od začetne, po prekinitvi zdravljenja).
• Always check that the patch has not fallen off after activities such as bathing, showering or exercising.
• Vedno preverite ali se je obliž odlepil po aktivnostih kot so kopanje, prhanje ali telovadba.
BOX OF 7 [28] [30] PATCHES
ŠKATLA S 7 [28] [30] [OBLIŽI
• delusions and hallucinations (seeing or hearing things that are not real)
• blodnje in halucinacije (videnje ali slišanje stvari, ki niso resnične)
If it is necessary to discontinue rotigotine, this should be done gradually to prevent neuroleptic malignant syndrome.
Če je prekinitev zdravljenja z rotigotinom nujna, jo je treba izvesti postopoma, da se prepreči nevroleptični maligni sindrom.
• aggressive behaviour
• agresivno vedenje
In long-term clinical studies with rotigotine, the majority of augmentation episodes were seen in the first and second years of treatment.
V dolgoročnih kliničnih študijah z rotigotinom, so večino epizod avgmentacije opazili v prvem in drugem letu zdravljenja.
If you experience such symptoms either before or after beginning treatment with Leganto, contact your doctor as your treatment may need to be adjusted.
Če se pri vas pojavijo takšni simptomi pred ali po začetku zdravljenja z zdravilom Leganto, se posvetujte z zdravnikom, saj bo vaše zdravljenje morda treba prilagoditi.
• feeling agitated, disorientated, confused or paranoid
• občutek vznemirjenosti, dezorientiranosti, zmedenosti ali paranoje
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned.
Zdravniki morajo redno ocenjevati dremavost ali zaspanost bolnikov, kajti bolniki dremavosti ali zaspanosti morda ne bodo omenili, dokler ne bodo neposredno vprašani.
Leganto is available in the following pack-sizes:
Zdravilo Leganto je na voljo v naslednjih velikostih pakiranja:
You may have to use more than one patch to reach your dose, as prescribed by your doctor.
Morda boste morali uporabiti več kot en obliž, da dosežete svoj odmerek, ki vam ga je predpisal zdravnik.
• If you have forgotten to change the patch at your usual time, change it as soon as you remember.
• Če ste pozabili zamenjati obliž ob vašem običajnem času, ga zamenjajte takoj, ko se spomnite.
In this study, the majority of augmentation episodes occurred in the first and second years of treatment.
Večina epizod avgmentacije v tej študiji se je pojavila v prvem in drugem letu zdravljenja.
Comparable skin tolerability was reported for both formulations.
Za obe formulaciji so poročali o primerljivem prenašanju.
Rotigotine is metabolised to a great extent.
Rotigotin se presnavlja v veliki meri.
Contact your doctor if you notice signs of an allergic reaction - these can include swelling of the face, tongue or lips.
Posvetujte se z zdravnikom, če opazite znake alergijske reakcije - kot so otekanje obraza, jezika ali ustnic.
• you need ‘cardioversion' (specific treatment for abnormal heart beat).
• potrebujete ‘kardioverzijo' (specifično zdravljenje nenormalnega srčnega ritma)
4 mg of Leganto every day may be an effective dose for some patients.
4 mg zdravila Leganto vsak dan je lahko učinkovit odmerek za nekatere bolnike.
• Do not touch the sticky side of the patch with your fingers.
• Lepljive strani obliža se ne dotikajte s prsti.
It belongs to a group of medicines called ‘dopamine agonists'.
Spada v skupino zdravil, imenovanih ‘dopaminski agonisti'.
Two additional pivotal trials (SP650DB and SP515) were conducted in patients who were receiving concomitant levodopa therapy.
Dve dodatni ključni preskušanji (SP650DB in SP515) so opravili pri bolnikih, ki so prejemali sočasno zdravljenje z L-dopo.
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.
Naslednja večnacionalna dvojno slepa študija (SP889) je bila opravljena z 287 bolniki v zgodnji ali napredovali fazi Parkinsonove bolezni, ki so imeli zgodaj zjutraj nezadovoljivo kontrolo nad motoriko.
The effects of rotigotine on reproduction have been investigated in rats, rabbits and mice.
Učinke rotigotina na razmnoževanje so raziskovali pri podganah, kuncih in miših.
Differences in bioavailability of rotigotine ranged from 2% (upper arm versus flank) to 46% (shoulder versus thigh).
Razlike biološke uporabnosti rotigotina so se spreminjale od 2 % (nadlaht v primerjavi z bokom) do 46 % (rama v primerjavi s stegnom).
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.).
Zdravilo Leganto 2 mg jemljite 7 dni (npr. če začnete v nedeljo, preidite na naslednji odmerek naslednjo nedeljo).
Following application, rotigotine is continuously released from the transdermal patch and absorbed through the skin.
Po aplikaciji se rotigotin neprekinjeno sprošča iz transdermalnega obliža in absorbira skozi kožo.
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.
• Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
The patch should be pressed down firmly with the palm of the hand for about 30 seconds, so that it sticks well.
Obliž približno 30 sekund trdno pritiskamo z dlanjo, da se dobro prilepi.
• you may feel very sleepy or fall asleep suddenly - see ‘Driving and using machines' in section 2.
• lahko postanete zelo zaspani ali nenadno zaspite - glejte 'Vpliv na sposobnost upravljanja vozil in strojev' v poglavju 2.
Other medicines and Leganto
Druga zdravila in zdravilo Leganto
Each patch is packed in a sachet and should be applied directly after the sachet has been opened.
Vsak obliž je pakiran v zaščitno vrečko, uporabiti pa ga je treba takoj po odprtju zaščitne vrečke.
The adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p <0.0001).
Prilagojena srednja razlika je bila -6,5 točk (CI95% -8,7 - -4,4, p<0,0001).
In isolated cases “sudden onset of sleep” occurred while driving and resulted in motor vehicle accidents (see also sections 4.4 and 4.7).
V posameznih primerih je nastopil "nenaden spanec" med vožnjo, zaradi katerega so se zgodile prometne nesreče(glejte tudi poglavji 4.4 in 4.7).
The efficacy of rotigotine was evaluated in 5 placebo-controlled trials with more than 1,400 patients with idiopathic Restless Legs Syndrome (RLS).
Učinkovitost rotigotina so ocenili v petih s placebom kontroliranih študijah z več kot 1.400 bolniki z idiopatičnim sindromom nemirnih nog (RLS - Restless Legs Syndrome).
If you have to stop taking this medicine, see ‘If you stop using Leganto' in section 3.
Če morate prekiniti uporabo zdravila, glejte, 'Če ste prenehali uporabljati zdravilo Leganto' v poglavju 3.
Leganto may potentiate the dopaminergic adverse reaction of L-dopa and may cause and/or exacerbate pre-existing dyskinesia, as described with other dopamine agonists.
Zdravilo Leganto lahko okrepi dopaminergične neželene učinke L-dope ter povzroči in/ali poslabša obstoječo diskinezijo, kot je opisano pri drugih agonistih dopamina.
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.
Učinkovitost rotigotina pri zdravljenju znakov in simptomov idiopatične Parkinsonove bolezni so ocenili v večnacionalnem programu za razvoj zdravila, sestavljenem iz štirih ključnih, vzporednih, randomiziranih, dvojno slepih s placebom nadzorovanih kliničnih študij in treh študij, kjer so ocenjevali specifične vidike Parkinsonove bolezni.
• Do not stick Leganto on the same area of skin twice within 14 days.
• Ne lepite obliža zdravila Leganto ponovno na isto mesto prej kot v 14 dneh.
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.
Če ste uporabili drugačen obliž (npr. Leganto 4 mg/24 h, namesto Leganto 2 mg/24 h), kot vam je predpisal zdravnik, takoj obvestite svojega zdravnika ali bolnišnico in sledite njihovemu navodilu za odstranitev obližev.
A sudden stop could lead to a medical condition called ‘neuroleptic malignant syndrome' which could be life-threatening.
Nenadna prekinitev lahko vodi v razvoj ‘malignega nevroleptičnega sindroma', ki je lahko življensko nevaren.
The clearance of rotigotine after transdermal administration is approximately 10 l/min and its overall elimination half-life is 5 to 7 hours.
Po transdermalni uporabi je očistek rotigotina približno 10 l/min, celokupni razpolovni čas izločanja pa 5 do 7 ur.
• difficulty falling asleep, sleep disorder, difficulty sleeping, nightmare, unusual dreams
• težava zaspati, motnje spanja, težave s spanjem, nočne more, nenavadne sanje
If you have any unpleasant reactions, contact your doctor.
Če imate kakršne koli neprijetne reakcije, se posvetujte s svojim zdravnikom.
• Before opening the sachet decide where you are going to stick this new patch and check you have removed any old patch.
• Pred odprtjem zaščitne vrečke se odločite kam boste nalepili nov obliž in preverite, če ste odstranili stari obliž.
Although these adverse reactions are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.
Čeprav naj bi bile te neželene reakcije povezane z ergolinsko strukturo teh spojin, ni znano, ali jih povzročajo tudi drugi agonisti dopamina, ki niso pridelani iz ergota.
Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Okulistični nadzor se priporoča v rednih časovnih presledkih ali če se pojavijo motnje vida.
If you forget to change the patch at your usual time
Če pozabite zamenjati obliž ob običajnem času
• unusual urges or cravings which you cannot resist and that could harm yourself or others
• nenavadne težnje ali želje, ki se jim ne morete upreti in bi lahko škodovale vam ali drugim
In isolated cases, people have fallen asleep while driving and this has caused accidents.
V posameznih primerih so vozniki med vožnjo zaspali, kar je povzročilo nesreče.
• You may have to use more than one patch to reach your dose, as prescribed by your doctor.
• Morda boste morali uporabiti več kot en obliž, da dosežete svoj odmerek, ki vam ga je predpisal zdravnik.
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).
Študije na živalih ne kažejo kakršnihkoli teratogenih učinkov pri podganah in kuncih, vendar so pri podganah in miših opazili toksične učinke na zarodek pri odmerkih, ki so bili toksični za mater (glejte poglavje 5.3).
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.
Če bolnik pozabi namestiti obliž ob običajnem času ali če se obliž odlepi, mora za preostanek tega dneva namestiti nov obliž.
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)
Če je odziv bolnika s Parkinsonovo boleznijo na zdravljenje z rotigotinom nezadosten, lahko prehod na drugi agonist dopamina ponuja dodaten uspeh zdravljenja (glejte poglavje 5.1).
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.
Če se pojavijo reakcije na mestu aplikacije, ki trajajo več kot nekaj dni ali ne izginejo, če se slabšajo ali če se razširijo zunaj mesta uporabe, je treba oceniti razmerje koristi in tveganja zdravljenja za tega bolnika.
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.
Pri študijah ponavljajočih se odmerkov in dolgotrajne toksičnosti je bila večina učinkov povezana s farmakodinamiko agonistov dopamina in posledičnim zmanjšanjem izločanja prolaktina.