FrancophonIA/ELRC3.0 huggingface dataset:
English: Further to the evaluation of a Worksharing PSUR of ambroxol-containing medicinal products started in January 2012 and of follow-up submissions as well as signal detection activities, the Belgian national competent authority (FAMHP) identified an increase in reporting of hypersensitivity reactions over the years 2012-2014, reports of severe cutaneous adverse reactions (SCARs) and a benefit-risk evaluation in children below 6 years of age concluded that while there was no indication of a different safety profile, insufficient evidence of efficacy was available in secretolytic therapy in this age group, leading to a negative benefit-risk balance.
Slovenian: Na podlagi poročil o hudih kožnih neželenih učinkih ter ocene razmerja med tveganji in koristmi pri otrocih, mlajših od šest let, so sklenili, da so dokazi glede učinkovitosti sekretolitične terapije pri tej starostni skupini nezadostni (čeprav ne kažejo na drugačen varnostni profil), kar posledično kaže na negativno razmerje med tveganji in koristmi.
English: If this happens, do not drive.
Slovenian: Če pride do tega, ne vozite.
English: Contains E223.
Slovenian: Vsebuje E223.
English: Allée de la Recherche 60 B-1070 Bruxelles Belgium
Slovenian: Allée de la Recherche 60 B-1070 Bruxelles Belgija
English: The right dose for you will depend on your needs.
Slovenian: Ustrezni odmerek za vas je odvisen od vaših potreb.
English: The effect was maintained over a 6 months period.
Slovenian: Učinek so vzdrževali v obdobju 6 mesecev.
English: It is also likely to lower the amount of milk you produce.
Slovenian: Prav tako lahko zmanjša količino mleka.
English: This is because it may change the colour of the skin.
Slovenian: To je zato, ker lahko spremeni obarvanost kože.
English: Interactions with other forms of hormonal contraception have not been investigated.
Slovenian: Interakcije z drugimi oblikami hormonske kontracepcije niso bile raziskane.
English: Additional studies to further evaluate the specific pathology have not been performed.
Slovenian: Dodatnih študij za nadaljnjo oceno specifične patologije niso opravili.
English: All differences between the active treatments and placebo were statistically significant.
Slovenian: Vse razlike med aktivnimi zdravljenji in placebom so bile statistično pomembne.
English: The safety profile was comparable, with the exception of application site reactions.
Slovenian: Varnostni profil je bil primerljiv, z izjemo reakcij na mestu apliciranja.
English: Treatment of overdose may require general supportive measures to maintain the vital signs.
Slovenian: Pri zdravljenju prevelikega odmerjanja bodo morda potrebni splošni podporni ukrepi za vzdrževanje vitalnih znakov.
English: Periodic assessment of efficacy should be performed, along with evaluation of safety, including augmentation.
Slovenian: Voditi bi bilo treba periodično oceno učinkovitosti, skupaj z oceno varnosti, vključujoč avgmentacijo.
English: This is when you and your doctor agree that the symptoms are being controlled well enough and the side effects of the medicines are acceptable.
Slovenian: To je takrat, ko se vi in vaš zdravnik strinjata, da so simptomi ustrezno nadzorovani in neželeni učinki zdravil sprejemljivi.
English: Do not give this medicine to children below 18 years of age because it is not known if it is safe or effective in this age group.
Slovenian: Ne dajajte zdravila otrokom, mlajšim od 18 let, ker njegova varnost in učinkovitost za to starostno skupino nista znani.
English: The primary outcome assessment was the reduction in “off” time (hours).
Slovenian: Primarna ocena izida je bilo zmanjšanje časa »izklop« (v urah).
English: Also do not use them on or near a patch you are already wearing.
Slovenian: Prav tako jih ne uporabljajte v bližini obliža, ki ga že nosite.
English: 30 months.
Slovenian: 30 mesecev.
English: The relevance of these findings to humans is not known.
Slovenian: Pomen teh ugotovitev za človeka ni znan.
English: Efficacy/safety data is insufficient to establish a relation between exposure and response (see also paediatric information in section 4.2).
Slovenian: Podatki o učinkovitosti/varnosti ne zadoščajo za vzpostavitev povezave med izpostavljenostjo in odzivom (glejte tudi pediatrične informacije v poglavju 4.2).
English: The safety profile was unchanged from that observed in previous studies.
Slovenian: Varnostni profil je ostal nespremenjen v primerjavi s prejšnjimi študijami.
English: High Level Term b
Slovenian: Izraz visoke stopnje b
English: This should be considered when prescribing rotigotine.
Slovenian: To je treba upoštevati pri predpisovanju rotigotina.
English: They will discuss ways of managing or reducing symptoms.
Slovenian: Poiskal bo način obvladovanja ali zmanjšanja simptomov.
English: It is thin and has three layers.
Slovenian: Je tanek in ima tri plasti.
English: Observed in open-label studies c
Slovenian: Opaženo pri odprtih študijah c
English: This is because the medicine may be released faster.
Slovenian: To velja zato, ker se lahko v teh primerih zdravilo sprosti hitreje.
English: Both indications:
Slovenian: Obe indikaciji:
English: For information on fertility studies, please see section 5.3.
Slovenian: Za informacije o študijah plodnosti glejte poglavje 5.3.
English: What to do with the used and unused patches
Slovenian: Kaj storiti z rabljenimi in nerabljenimi obliži
English: However, there is no indication of a relevant impact on the clinical outcome.
Slovenian: Vendar to nima pomembnega vpliva na klinični izid.
English: • abnormal thoughts about reality
Slovenian: • nenormalne misli o resničnosti
English: The safety and efficacy of rotigotine in children and adolescents have not yet been established.
Slovenian: Varnost in učinkovitost rotigotina pri otrocih in mladostnikih še nista bili dokazani.
English: Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs, has been reported.
Slovenian: Poročali so o nenadnem spancu med dnevnimi aktivnostmi, v nekaterih primerih brez zavedanja kakršnihkoli opozorilnih znakov.
English: The majority of erythema observed was mild and none severe.
Slovenian: Večina eritemov, ki so jih opazili, je bilo blagih, noben ni bil hud.
English: It is recommended that the application site should be rotated on a daily basis (e.g. from the right side to the left side and from the upper body to the lower body).
Slovenian: Mesto aplikacije je priporočljivo vsak dan zamenjati (npr. z desne strani na levo in z zgornjega dela telesa na spodnjega).
English: Efficacy was demonstrated in controlled trials in patients treated for up to 29 weeks.
Slovenian: Učinkovitost je bila dokazana v kontrolnih študijah na bolnikih, zdravljenih do 29 tednov.
English: Women of childbearing potential, contraception in females
Slovenian: Ženske v rodni dobi, kontracepcija pri ženskah
English: • The reactions normally go away after a few hours - once you remove the patch.
Slovenian: • Te reakcije navadno izginejo nekaj ur po odstranitvi obliža.
English: • Please follow the instructions of the prescriber carefully.
Slovenian: • Pozorno sledite navodilom zdravnika.
English: (see Special populations)
Slovenian: (glejte Posebne populacije)
English: Observed during post-marketing d
Slovenian: Opaženo v postmarketinškem obdobju d
English: Any used or unused patches should be disposed of in accordance with local requirements or returned to the pharmacy.
Slovenian: Vse uporabljene in neuporabljene obliže zavrzite v skladu z lokalnimi predpisi ali jih vrnite v lekarno.
English: DL-α-tocopherol (E307).
Slovenian: DL-α-tokoferol (E307).
English: Rotigotine may have major influence on the ability to drive and use machines.
Slovenian: Rotigotin ima lahko pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
English: • abnormal thinking or behaviour - most of the symptoms occur more frequently in patients with
Slovenian: • nenormalno mišljenje ali vedenje - večina simptomov se pogosteje pojavi pri bolnikih s
English: CPK levels have not been routinely measured in other populations.
Slovenian: CPK vrednosti niso rutinsko merili pri drugih populacijah.
English: • Keep it pressed for about 30 seconds.
Slovenian: • Pritiskajte približno 30 sekund.
English: The dose recommendations made are in nominal dose.
Slovenian: Priporočila za odmerjanje so v nominalnih odmerkih.
English: Both treatments showed improvements in early morning motor function and sleep.
Slovenian: Pri obeh skupinah se je pokazalo izboljšanje motoričnih funkcij zgodaj zjutraj in spanja.
English: The absolute bioavailability after transdermal application is approximately 37%.
Slovenian: Absolutna biološka uporabnost po transdermalni uporabi je približno 37 %.
English: Date of first authorisation: 16 June 2011 Date of latest renewal: 14 January 2016
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 14. januar 2016
English: • unable to achieve or maintain an erection
Slovenian: • nezmožnost doseganja ali ohranjanja erekcije
English: The patient should be monitored closely, including heart rate, heart rhythm and blood pressure.
Slovenian: Bolnika je treba skrbno nadzorovati, vključno s frekvenco bitja srca, srčnim ritmom in krvnim tlakom.
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.
Slovenian: Ker so bili bolniki s klinično pomembno srčnožilno boleznijo izključeni iz teh študij, je treba bolnike s hudo srčnožilno boleznijo vprašati o simptomih sinkope in predsinkope.
English: Therefore, it is recommended to taper treatment (see section 4.2).
Slovenian: Zato se priporoča, da se zdravljenje opušča počasi (glejte poglavje 4.2).
English: This is so that your family or carer can tell you, or your doctor, if they are worried about any changes in your behaviour.
Slovenian: To pa zato, da lahko družinski član ali negovalec obvesti vas ali vašega zdravnika, če je zaskrbljen zaradi sprememb v vašem vedenju.
English: Loss of consciousness can occur
Slovenian: Pojavi se lahko izguba zavesti
English: If any of the above apply to you, do not use Leganto.
Slovenian: Če kaj od zgoraj navedenega velja za vas, ne uporabljajte zdravila Leganto.
English: • Used patches still contain the active substance ‘rotigotine', which may be harmful to others.
Slovenian: • Obliž po uporabi še vedno vsebuje učinkovino ‘rotigotin', ki je lahko škodljiva za druge.
English: The apparent volume of distribution in humans is approximately 84 l/kg.
Slovenian: Navidezni volumen porazdelitve pri človeku je 84 l/kg.
English: • medicines that lower blood pressure.
Slovenian: • zdravila, ki znižujejo krvni tlak.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja)
English: • Parkinson's disease - Leganto can be used on its own or with another medicine called levodopa.
Slovenian: • Parkinsonove bolezni - zdravilo Leganto se lahko uporablja samostojno ali z drugim zdravilom, imenovanim levodopa.
English: Sulphite sensitivity
Slovenian: Občutljivost na sulfit
English: The same site should not be used within 14 days.
Slovenian: Istega mesta se v 14 dneh ne sme uporabiti znova.
English: These are usually mild or moderate in intensity and transient even if treatment is continued.
Slovenian: Ponavadi so blagi ali zmerni ter prehodni, tudi če se zdravljenje nadaljuje.
English: • uncontrolled shopping or spending too much
Slovenian: • nenadzorovano pretirano nakupovanje ali zapravljanje
English: These packages are usually needed for the first four weeks of therapy, but depending on your response to Leganto, you may not need to use all of the dose packages included or you may need additional higher doses after week 4, which are not covered by this package.
Slovenian: Ta pakiranja se ponavadi potrebujejo za prve štiri tedne zdravljenja, vendar odvisno od vašega odziva na zdravilo Leganto morda ne boste uporabili vseh priloženih pakiranj ali pa boste potrebovali dodatne večje odmerke po 4. tednu, ki jih v tem pakiranju ni.
English: The effects were more pronounced in female rats.
Slovenian: Učinki so bili izrazitejši pri podganjih samicah.
English: • Gently wash the area with warm water and mild soap.
Slovenian: • Mesto nežno umijte s toplo vodo in blagim milom.
English: • altered or increased sexual interest and behaviour which causes significant concern to you or others - for example, an increased sex drive
Slovenian: • spremenjena ali povečana želja po spolnosti in vedenje, ki je zaskrbljujoče za vas ali druge, na primer - povečan spolni nagon
English: For example, put it on the right side of your body one day, then on the left side of your body the next day.
Slovenian: Na primer, dajte ga na desno stran telesa en dan, nato na levo stran naslednji dan. Ali pa na zgornji del telesa en dan, nato naslednji dan na spodnji del telesa.
English: • your symptoms of Restless Legs Syndrome may start earlier than usual, be more intense and involve other limbs.
Slovenian: • se lahko simptomi sindroma nemirnih nog pojavijo prej kot običajno, so bolj intenzivni in vključujejo druge okončine.
English: Since it ran more or less parallel with a decreased relative total growth of the cells, it may be related to a cytotoxic effect of the compound.
Slovenian: Potekal je bolj ali manj vzporedno z zmanjšano relativno skupno rastjo celic, zato je lahko povezan s citotoksičnim učinkom te spojine.
English: Therefore, the relevance of the one positive in vitro mutagenicity test is not known.
Slovenian: Zato pomen tega pozitivnega preizkusa mutagenosti in vitro ni znan.
English: Changes in behaviour and abnormal thinking
Slovenian: Spremembe v vedenju in nenormalno mišljenje
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.
Slovenian: 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.
English: • seeing or hearing things that are not real (hallucinations)
Slovenian: • videnje ali slišanje stvari, ki niso resnične (halucinacije)
English: • craving large doses of medicines like Leganto - more than needed for the illness.
Slovenian: • hrepenenje po velikih odmerkih zdravil, kot je zdravilo Leganto - več kot je potrebno za zdravljenje bolezni.
English: 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.
Slovenian: 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.
English: This is normally reached within 3 to 7 weeks.
Slovenian: Ta odmerek se navadno doseže v 3 do 7 tednih.
English: Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Slovenian: Razmisliti je treba o zmanjšanju odmerka/postopnem prenehanju, če se pojavijo takšni simptomi.
English: Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body parts.
Slovenian: Avgmentacija v tem primeru pomeni zgodnji pojav simptomov zvečer (ali celo popoldne), povečano resnost simptomov in razširitev simptomov po drugih delih telesa.
English: Rotigotine should not be used during pregnancy.
Slovenian: Rotigotina se med nosečnostjo ne sme uporabljati.
English: Do not use this medicine after the expiry date which is stated on the label and box.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
English: The percentage of subjects discontinuing was 25-38% over the first year, 10% in the second year, and 11% in the third year.
Slovenian: Prvo leto je prekinilo zdravljenje 25-38 % oseb, drugo leto 10 % in tretje leto 11 %.
English: • Each patch is packed in a separate sachet.
Slovenian: • Vsak obliž je pakiran v ločeno zaščitno vrečko.
English: • Avoid sunlight and solarium exposure on areas of skin showing any kind of skin reaction caused by the patch.
Slovenian: • Izogibajte se izpostavljenosti direktni sončni svetlobi in solariju na predelih kože, ki kažejo kakršnekoli kožne reakcije, ki jih povzroča obliž.
English: This is normally reached within 3 to 4 weeks.
Slovenian: Ta odmerek se navadno doseže v 3 do 4 tednih.
English: Take off the old patch and use a new one.
Slovenian: Odstranite starega in namestite novega.
English: • Do not use creams, oils, lotions, powders or other skin products where you will put the patch.
Slovenian: • Ne uporabljajte krem, olj, losjonov, pudrov ali drugih izdelkov za kožo na mestu, kjer boste nalepili obliž.
English: Rotating the site of patch application may result in day-to-day differences in plasma levels.
Slovenian: Spreminjanje mesta namestitve obliža lahko povzroči dnevne razlike koncentracij v plazmi.
English: • you are allergic to rotigotine or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • ste alergični na rotigotin ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: None of these patients discontinued therapy because of augmentation.
Slovenian: Nihče od bolnikov ni prekinil zdravljenja zaradi avgmentacije.
English: This mutagenic effect could be attributed to a clastogenic effect of rotigotine.
Slovenian: Ta mutageni učinek lahko pripišemo klastogenim učinkom rotigotina.
English: • Leave the patch on your skin for 24 hours, then take it off and put on a new one.
Slovenian: • Obliž pustite na koži 24 ur, nato ga odstranite in prilepite novega.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so navedeni v poglavju 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: Patients should be regularly monitored for the development of impulse control disorders.
Slovenian: Bolnike je treba redno nadzorovati glede razvoja motenj pri kontroli dražljajev.
English: BOX OF 28 PATCHES -TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
Slovenian: ŠKATLA Z 28 OBLIŽI - PAKIRANJE ZA ZAČETNO ZDRAVLJENJE - 4-TEDENSKI RAZPORED ZDRAVLJENJA
English: Doses higher than the approved dose range for RLS should be avoided as this may lead to higher rates of augmentation (see section 5.1).
Slovenian: 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).
English: The information on metabolites is incomplete.
Slovenian: Podatki o presnovkih so nepopolni.
English: Magnetic resonance imaging or cardioversion (see section 4.4).
Slovenian: Magnetnoresonančno slikanje ali kardioverzija (glejte poglavje 4.4).
English: • Do not put the patch in an area where it can be rubbed by tight clothing.
Slovenian: • Obliža ne namestite na mesto, kjer bi se ob njega drgnila tesna oblačila.
English: • your blood pressure needs checking regularly while using Leganto, especially at the start of the treatment.
Slovenian: • potrebujete redne meritve krvnega tlaka med uporabo zdravila Leganto, zlasti na začetku zdravljenja.
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.
Slovenian: 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.
English: Which strength patches to use
Slovenian: Katero jakost obližev uporabiti
English: In two openlabel, follow-up studies over a subsequent 12 months, the rate of clinically relevant augmentation was 2.9%.
Slovenian: V dveh odprtih, nadaljevalnih študijah, ki sta potekali naslednjih 12 mesecev, je bil delež klinično pomembne avgmentacije 2,9 %.
English: Tell your doctor if you lose consciousness or feel dizzy.
Slovenian: Povejte zdravniku, če ste izgubili zavest ali ste omotični.
English: Vistor hf.
Slovenian: Ísland Vistor hf.
English: Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists; ATC code: N04BC09
Slovenian: Farmakoterapevtska skupina: Antiparkinsoniki, agonisti dopamina; oznaka ATC: N04BC09
English: These effects are usually mild or moderate and only last for a short time.
Slovenian: Ta neželena učinka sta ponavadi blaga ali zmerna in trajata le kratek čas.
English: The sticky side of the patch should not be touched.
Slovenian: Lepljive strani obliža se ne smemo dotakniti.
English: The in vitro binding of rotigotine to plasma proteins is approximately 92%.
Slovenian: Vezava rotigotina na beljakovine v plazmi in vitro je približno 92 %.
English: • falling asleep suddenly without warning
Slovenian: • nenaden spanec brez opozorila
English: Leganto should not be placed on skin that is red, irritated or damaged (see section 4.4).
Slovenian: Zdravila Leganto ne smemo namestiti na rdečo, razdraženo ali poškodovano kožo (glejte poglavje 4.4).
English: • sedating medicines such as benzodiazepines or medicines used to treat mental illness or depression.
Slovenian: • sedative, kot so benzodiazepini ali zdravila za zdravljenje duševnih bolezni ali depresije.
English: Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is excreted in faeces.
Slovenian: Približno 71 % odmerka rotigotina se izloči z urinom, manjši delež, približno 23 %, pa z blatom.
English: Leganto can cause loss of consciousness.
Slovenian: Zdravilo Leganto lahko povzroči izgubo zavesti.
English: While these complications may resolve when treatment is discontinued, complete resolution does not always occur.
Slovenian: Ti zapleti lahko po prekinitvi zdravljenja izginejo, vendar pa ne vedno popolnoma.
English: Leganto may affect your blood pressure.
Slovenian: Zdravilo Leganto lahko vpliva na vaš krvni tlak.
English: 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.
Slovenian: 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.
English: Dopamine is a messenger in the brain which is important for movement.
Slovenian: Dopamin je prenašalec v možganih, ki je pomemben za gibanje.
English: There are no adequate data from the use of rotigotine in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi rotigotina pri nosečnicah.
English: • Slowly and carefully peel off the used patch.
Slovenian: • Počasi in previdno odstranite stari obliž.
English: This is because the effects of rotigotine on pregnancy and the unborn baby are not known.
Slovenian: saj učinki rotigotina na nosečnost in nerojenega otroka niso znani.
English: The pharmacokinetic profile shows a biphasic elimination with an initial half-life of about 2 to 3 hours.
Slovenian: Farmakokinetični profil nakazuje na dvofazno izločanje z začetnim razpolovnim časom 2 do 3 ure.
English: Irritability, oedema peripheral
Slovenian: razdražljivost, periferni edem
English: This includes medicines obtained without a prescription and herbal medicines.
Slovenian: To velja tudi za zdravila brez recepta in zdravila rastlinskega izvora.
English: Currently available data are described in section 5.2 but no recommendation on a posology in children with RLS can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 5.2, vendar priporočil o odmerjanju rotigotina pri otrocih z RLS ni mogoče dati.