FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore Stalevo should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
Croatian: Stoga Stalevo treba oprezno davati bolesnicima koji uzimaju druge lijekove koji mogu prouzročiti ortostatsku hipotenziju.
English: Stalevo may have a major influence on the ability to drive and use machines.
Croatian: Stalevo može imati znatan utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist immediately.
Croatian: Ako ste slučajno uzeli više tableta Staleva nego što ste trebali, odmah obavijestite svog liječnika ili ljekarnika.
English: If this happens, a general medical evaluation including liver function should be considered - feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'.
Croatian: Ako se to dogodi, mora se razmotriti opća medicinska procjena uključujući procjenu jetrene funkcije. - osjetite potrebu da prestanete uzimati Stalevo, vidjeti dio "Ako prestanete uzimati Stalevo".
English: However, a direct switch from levodopa/DDC inhibitor to Stalevo is not recommended for patients who have dyskinesias or whose daily levodopa dose is above 800 mg.
Croatian: Međutim, izravni prijelaz sa levodope/DDC-inhibitora na Stalevo ne preporučuje se za bolesnike koji imaju diskinezije ili čija je dnevna doza levodope iznad 800 mg.
English: If you stop taking Stalevo
Croatian: Ako prestanete uzimati Stalevo
English: Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet.
Croatian: Stalevo sadrži tri djelatne tvari (levodopu, karbidopu i entakapon) u jednoj filmom obloženoj tableti.
English: What Stalevo contains
Croatian: Što Stalevo sadrži
English: If you must undergo surgery, please tell your doctor that you are using Stalevo.
Croatian: Ako morate na kirurški zahvat, obavijestite svog liječnika da uzimate Stalevo.
English: Stalevo may increase the effects and side effects of certain medicines.
Croatian: Stalevo može pojačati učinke i nuspojave nekih lijekova.
English: Always leave at least an hour between Stalevo tablets, to avoid possible side effects.
Croatian: Između uzimanja Stalevo tableta uvijek mora proći najmanje jedan sat, kako bi se izbjegle moguće nuspojave.
English: - Patients with chronic wide-angle glaucoma may be treated with Stalevo with caution, provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure.
Croatian: - Bolesnici s kroničnim glaukomom otvorenog kuta mogu se uz oprez liječiti Stalevom pod uvjetom da je intraokularni tlak dobro kontroliran i da se bolesnike pažljivo prati zbog promjena intraokularnog tlaka.
English: Thus, a control of INR is recommended when Stalevo is initiated for patients receiving warfarin.
Croatian: Zbog toga se preporučuje kontroliranje INR-a kada se Stalevo počinje primjenjivati bolesnicima koji primaju varfarin.
English: Detailed information on this medicinal product is available on the website of European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: - Stalevo contains sucrose, and therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Croatian: - Stalevo sadržava saharozu te stoga bolesnici s rijetkim nasljednim problemima nepodnošenja fruktoze, malapsorpcije glukoze-galaktoze ili nedostatka saharaza-izomaltaze ne bi smjeli uzimati ovaj lijek.
English: 5 How to store Stalevo Contents of the pack and other information
Croatian: Kako čuvati Stalevo Sadržaj pakiranja i druge informacije
English: What Stalevo looks like and contents of the pack
Croatian: Kako Stalevo izgleda i sadržaj pakiranja
English: When more levodopa is required, an increase in the frequency of doses and/or the use of an alternative strength of Stalevo should be considered, within the dose recommendations.
Croatian: Kada je potrebno više levodope, treba razmotriti češće uzimanje doza i/ili korištenje alternativne jačine Staleva, u okviru preporuka za doziranje.
English: Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Stalevo and other medicines used to treat Parkinson's disease.
Croatian: Obavijestite svog liječnika ako Vi ili Vaša obitelj/njegovatelj primijetite da se kod Vas razvijaju simptomi nalik na ovisnost, zbog kojih žudite za velikim dozama lijeka Stalevo i drugih lijekova koji se koriste za liječenje Parkinsonove bolesti.
English: - If general anaesthesia is required, therapy with Stalevo may be continued for as long as the patient is permitted to take fluids and medicinal products by mouth.
Croatian: - Ako je potrebna opća anestezija, terapija Stalevom može se nastaviti tako dugo dok bolesnik smije uzimati tekućinu i lijekove na usta.
English: In the pharmacokinetic studies with Stalevo the bioavailability of levodopa is higher in women than in men, primarily due to the difference in body weight, while there is no gender difference with carbidopa and entacapone.
Croatian: U farmakokinetičkim ispitivanjima Staleva, bioraspoloživost levodope je viša u žena nego u muškaraca, u prvom redu zbog razlike u tjelesnoj težini, dok kod karbidope i entakapona ne postoje razlike među spolovima.
English: Other antiparkinsonian medicinal products: To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Stalevo therapy.
Croatian: Drugi antiparkinsonici: do sada nema naznaka interakcija koje bi isključivale istodobnu primjenu standardnih antiparkinsonika uz liječenje Stalevom.
English: For some patients, Stalevo may not be well absorbed if it is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and nuts).
Croatian: U nekih bolesnika se Stalevo možda neće dobro apsorbirati ako se uzme tijekom ili kratko nakon obroka bogatog bjelančevinama (npr. meso, riba, mliječni proizvodi, sjemenke i orašasti plodovi).
English: In such patients it is advisable to introduce entacapone treatment as a separate treatment (entacapone tablets) and adjust the levodopa dose if necessary, before switching to Stalevo.
Croatian: Kod takvih bolesnika je preporučljivo uvesti entakapon kao odvojeni lijek (entakapon tablete) i po potrebi prilagoditi dozu levodope, prije prelaska na Stalevo.
English: If other levodopa products are used concomitantly with a Stalevo tablet, the maximum dose recommendations should be followed.
Croatian: Ako se istodobno sa Stalevo tabletom koriste drugi preparati levodope, moraju se pratiti preporuke o maksimalnoj dozi.
English: - Stalevo is not recommended for the treatment of drug-induced extrapyramidal reactions.
Croatian: - Stalevo se ne preporučuje za liječenje ekstrapiramidnih reakcija izazvanih lijekovima.
English: Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Stalevo may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin.
Croatian: Zbog afiniteta entakapona prema citokromu P450 2C9 in vitro (vidjeti dio 5.2), Stalevo može potencijalno interferirati s djelatnim tvarima čiji metabolizam ovisi o ovom izoenzimu, kao što je Svarfarin.
English: Not known (cannot be estimated from the available data) Craving for large doses of Stalevo in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome.
Croatian: Nepoznato (ne može se procijeniti na temelju dostupnih podataka) Žudnja za velikim dozama lijeka Stalevo, koje su veće od onih potrebnih za kontrolu motoričkih simptoma, što je poznato kao sindrom poremećene regulacije dopamina.
English: Stalevo may make it harder for you to digest iron.
Croatian: Stalevo može otežati probavu željeza.
English: How to take Stalevo
Croatian: Kako uzimati Stalevo
English: Serious hepatitis with mainly cholestatic features, rhabdomyolysis and neuroleptic malignant syndrome may occur with Stalevo although no cases have been identified from the clinical trial data.
Croatian: Ozbiljni hepatitis s uglavnom kolestatskim obilježjima, rabdomioliza i neuroleptički maligni sindrom mogu se javiti uz Stalevo, iako takvi slučajevi nisu bili otkriveni u podacima iz kliničkih ispitivanja.
English: Stalevo is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.
Croatian: Stalevo se ne preporučuje koristiti za liječenje ekstrapiramidnih simptoma (npr. nevoljnih pokreta, tresenja, mišićne ukočenosti i mišićnih kontrakcija) uzrokovanih drugim lijekovima.
English: Taking into account the PRAC Assessment Report on the PSURs for carbidopa/entacapone/levodopa, the scientific conclusions of the CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog izvješća o neškodljivosti lijeka (PSUR) za karbidopu/entakapon/levodopu, znanstveni zaključci CHMP-a su sljedeći:
English: The following side effects have also been reported: - hepatitis (inflammation of the liver) - itching
Croatian: Sljedeće nuspojave su također zabilježene: - hepatitis (upala jetre)
English: Patients being treated with Stalevo and presenting with somnolence and/or sudden sleep onset episodes must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes have resolved (see section 4.4).
Croatian: Bolesnike, koji su liječeni Stalevom i u kojih se javlja somnolencija i/ili imaju epizode iznenadnog nastupa sna, mora se uputiti da se suzdrže od upravljanja vozilima ili od aktivnosti u kojima zbog poremećene budnosti oni ili druge osobe mogu biti pod rizikom od ozbiljne ozljede ili smrti (npr. rad sa strojevima), sve dok takve ponavljajuće epizode ne prestanu (vidjeti dio 4.4).
English: The most frequently reported adverse reactions with Stalevo are dyskinesias occurring in approximately 19% of patients; gastrointestinal symptoms including nausea and diarrhoea occurring in approximately 15% and 12% of patients, respectively; muscle, musculoskeletal and connective tissue pain occurring in approximately 12% of patients; and harmless reddish-brown discolouration of urine (chromaturia) occurring in approximately 10% of patients.
Croatian: Najčešće prijavljivane nuspojave Staleva su diskinezije koje se javljaju u otprilike 19% bolesnika; gastrointestinalni simptomi uključujući mučninu i proljev javljaju se u otprilike 15%, odnosno 12% bolesnika; bol u mišićima, mišićnokoštana bol i bol vezivnog tkiva javlja se u otprilike 12% bolesnika; te bezopasna crvenkasto-smeđa diskoloracija mokraće (kromaturija) javlja se u otprilike 10% bolesnika.
English: Other forms of interactions: Since levodopa competes with certain amino acids, the absorption of Stalevo may be impaired in some patients on high protein diet.
Croatian: Ostali oblici interakcija: budući da se levodopa natječe s određenim aminokiselinama, apsorpcija Staleva može biti narušena u nekih bolesnika na dijeti bogatoj bjelančevinama.
English: Management of acute overdose with Stalevo therapy is similar to acute overdose with levodopa.
Croatian: Zbrinjavanje akutnog predoziranja tijekom terapije Stalevom slično je kao u slučaju akutnog predoziranja levodopom.
English: If you forget to take Stalevo
Croatian: Ako ste zaboravili uzeti Stalevo
English: Elderly: No dose adjustment of Stalevo is required for elderly.
Croatian: Starije osobe: starijim osobama nije potrebno prilagođavati dozu Staleva.
English: When considered necessary, the replacement of Stalevo with levodopa and DDC inhibitor without entacapone or other dopaminergic treatment should proceed slowly and an increase in levodopa dose may be necessary.
Croatian: Kada se pokaže potrebnim, nadomještanje Staleva levodopom i DDC-inhibitorom bez entakapona ili drugim dopaminergičkim liječenjem treba se odvijati polako te može biti potrebno povećanje doziranja levodope.
English: The possibility that the patient has taken other active substances in addition to Stalevo should be taken into consideration.
Croatian: Mora se uzeti u obzir mogućnost da je bolesnik uz Stalevo uzeo i druge djelatne tvari.
English: Because the effects of Stalevo tablets are equivalent with entacapone 200 mg tablet administered concomitantly with the commercially available standard release carbidopa/levodopa preparations in corresponding doses these results are applicable to describe the effects of Stalevo as well.
Croatian: Budući da su učinci Stalevo tableta ekvivalentni s entakapon 200 mg tabletom primijenjenom istodobno s komercijalno dostupnim preparatima karbidope/levodope sa standardnim oslobađanjem u odgovarajućim dozama, ovi su rezultati isto tako primjenjivi za opis učinaka Staleva.
English: How to transfer patients not currently treated with entacapone to Stalevo
Croatian: Kako na Stalevo prebaciti bolesnike koji trenutno nisu liječeni entakaponom
English: Discontinuation of Stalevo therapy: If Stalevo treatment (levodopa/carbidopa/entacapone) is discontinued and the patient is transferred to levodopa/DDC inhibitor therapy without entacapone, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Croatian: Prekid liječenja Stalevom: ako se liječenje Stalevom (levodopa/karbidopa/entakapon) prekida i bolesnici prelaze na terapiju levodopom/DDC-inhibitorom bez entakapona, potrebno je prilagoditi doziranje drugog antiparkinsonika, osobito levodope, da bi se postigla dovoljna razina kontrole simptoma parkinsonizma.
English: - Stalevo therapy should be administered cautiously to patients with ischemic heart disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal or endocrine disease, history of peptic ulcer disease or history of convulsions.
Croatian: - Liječenje Stalevom treba provoditi uz oprez u bolesnika s ishemijskom bolešću srca, teškom kardiovaskularnom ili plućnom bolešću, bronhijalnom astmom, bubrežnom ili endokrinom bolešću, kao i u bolesnika s peptičkim ulkusom ili konvulzijama u anamnezi.
English: maprotiline, venlafaxine and paroxetine - rimiterole and isoprenaline, used to treat respiratory diseases - adrenaline, used for severe allergic reactions - noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure - alpha-methyldopa, used to treat high blood pressure - apomorphine, which is used to treat Parkinson's disease.
Croatian: maprotilin, venlafaksin i paroksetin, - rimiterol i izoprenalin, koji se koriste za liječenje respiratornih bolesti, - adrenalin, koji se koristi za teške alergijske reakcije, - noradrenalin, dopamin i dobutamin, koji se koriste za liječenje srčanih bolesti i niskog krvnog tlaka, - alfa-metildopu, koja se koristi za liječenje visokog krvnog tlaka, - apomorfin, koji se koristi za liječenje Parkinsonove bolesti.
English: c. When initiating Stalevo in patients currently treated with entacapone and levodopa/benserazide in a standard release formulation, the dosing of levodopa/benserazide should be discontinued in the previous night, and Stalevo should be started in the next morning.
Croatian: Kada se Stalevo uvodi bolesnicima koji su trenutno liječeni entakaponom i formulacijom sa standardnim oslobađanjem levodope/benzerazida, potrebno je prekinuti doziranje levodope/benzerazida noć prije i započeti sa Stalevom sljedeće jutro.
English: No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Stalevo therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Croatian: Nisu objavljena posebna ispitivanja farmakokinetike levodope i karbidope kod bolesnika s bubrežnom insuficijencijom, pa se stoga terapija Stalevom mora oprezno primjenjivati kod bolesnika s teškim bubrežnim oštećenjem, uključujući bolesnike na dijalizi (vidjeti dio 5.2).
English: Women should not breast-feed during treatment with Stalevo.
Croatian: Žene ne smiju dojiti tijekom liječenja Stalevom.
English: The evidence of the therapeutic effects of Stalevo is based on two phase III double-blind studies, in which 376 Parkinson's disease patients with end-of-dose motor fluctuations received either entacapone or placebo with each levodopa/DDC inhibitor dose.
Croatian: Dokaz o terapijskim učincima Staleva temelji se na dva dvostruko slijepa klinička ispitivanja faze III, u kojima je 376 bolesnika s Parkinsonovom bolešću i motoričkim fluktuacijama na kraju intervala doziranja, uz svaku dozu levodope/DDC-inhibitora primalo ili entakapon ili placebo.
English: The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Stalevo or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the postmarketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
Croatian: Sljedeće nuspojave, navedene u Tablici 1, prikupljene su i iz objedinjenih podataka jedanaest dvostruko slijepih kliničkih ispitivanja u kojima su bila uključena 3230 bolesnika (1810 liječenih Stalevom ili entakaponom u kombinaciji s levodopom/DDC-inhibitorom, i 1420 liječenih placebom u kombinaciji s levodopom/DDC-inhibitorom ili kabergolinom u kombinaciji s levodopom/DDCinhibitorom) i iz podataka dobivenih nakon stavljanja entakapona na tržište za njegovu kombiniranu primjenu s levodopom/DDC-inhibitorom.
English: Daily ON time with and without entacapone was recorded in home-diaries by patients.
Croatian: Dnevno trajanje "ON" faze sa ili bez entakapona bolesnici su bilježili u dnevnik.
English: - Coadministration of Stalevo with non-selective monoamine oxidase (MAO-A and MAO-B)
Croatian: - Istodobna primjena Staleva s neselektivnim inhibitorima monoaminooksidaze (MAO-A i MAO
English: If you suddenly stop taking Stalevo and other antiparkinsonian medicines it may result in unwanted side effects.
Croatian: Naglo ukidanje Staleva i drugih antiparkinsonika može rezultirati neželjenim nuspojavama.
English: - are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6) - have narrow-angle glaucoma (an eye disorder) - have a tumour of the adrenal gland - are taking certain medicines for treating depression (combinations of selective MAO-A and
Croatian: - ako ste alergični na levodopu, karbidopu ili entakapon, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.), - ako imate glaukom zatvorenog kuta (očni poremećaj), - ako imate tumor nadbubrežne žlijezde, - ako uzimate određene lijekove za liječenje depresije (kombinaciju selektivnih MAO-A i MAO
English: - In clinical studies, dopaminergic adverse reactions, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
Croatian: U kliničkim su studijama neželjeni dopaminergički učinci, npr. diskinezija, bili češći u bolesnika koji su primali entakapon i agoniste dopamina (kao što je bromokriptin), selegilin ili amantadin, u usporedbi s onima koji su primali placebo s tom kombinacijom.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Stalevo.
Croatian: Bolesnici i skrbnici trebaju znati da se simptomi u ponašanju kod poremećaja kontrole impulsa uključujući patološko kockanje, pojačani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje mogu javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima koji sadrže levodopu, uključujući Stalevo.
English: inhibitors (e.g. phenelzine, tranylcypromine).
Croatian: B) (npr. fenelzin, tranilcipromin).
English: When less levodopa is required, the total daily dose of Stalevo should be reduced either by decreasing the frequency of administration by extending the time between doses, or by decreasing the strength of Stalevo at an administration.
Croatian: Kada je potrebno manje levodope, ukupna dnevna doza Staleva mora se smanjiti ili smanjenjem učestalosti primjene povećanjem vremenskog razmaka između doza ili primjenom manje jačine Staleva.
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Stalevo (see section
Croatian: Poremećaji kontrole impulsa: Patološko kockanje, pojačani libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje mogu se javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima koji sadrže levodopu, uključujući Stalevo (vidjeti dio 4.4).
English: You may experience the following side effects: - Inability to resist the impulse to perform an action that could be harmful, which may include: - strong impulse to gamble excessively despite serious personal or family consequences - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive - uncontrollable excessive shopping or spending - binge eating (eating large amounts of food in a short time period) or compulsive eating
Croatian: Možda ćete osjetiti slijedeće nuspojave: - Nemogućnost odupiranja impulsu za neki postupak koji može biti štetan, što može uključivati: - snažan impuls za prekomjerno kockanje usprkos teškim osobnim ili obiteljskim posljedicama - promijenjeno ili povećano zanimanje za seks i ponašanje koje značajno zabrinjava Vas i druge, na primjer, pojačani seksualni nagon - nekontrolirano prekomjerno kupovanje ili trošenje - prejedanje (jedenje velikih količina hrane u kratkom vremenskom razdoblju) ili kompulzivno jedenje (jedenje više hrane nego obično i više nego je potrebno za utoliti glad).
English: - stomach ulcers or convulsions - if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon - any form of severe mental disorder like psychosis - chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.
Croatian: - čireve želuca ili konvulzije, - ako dobijete dugotrajan proljev posavjetujte se sa svojim liječnikom, jer to može biti znak upale debelog crijeva, - bilo kakav oblik teškog duševnog poremećaja poput psihoze, - kronični glaukom otvorenog kuta, jer tada Vašu dozu možda treba prilagoditi i pratiti očni tlak.
English: Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Croatian: Stalevo dolazi u šest različitih veličina pakiranja (10, 30, 100, 130, 175 ili 250 tableta).
English: For example, a patient taking one tablet of 50 mg/12.5 mg of levodopa/carbidopa with one tablet of entacapone 200 mg four times daily can take one 50 mg/12.5 mg/200 mg Stalevo tablet four times daily in place of their usual levodopa/carbidopa and entacapone doses.
Croatian: Na primjer, bolesnik koji uzima jednu tabletu od 50 mg/12,5 mg levodope/karbidope s jednom tabletom entakapona 200 mg četiri puta dnevno može uzeti jednu Stalevo 50 mg/12,5 mg/200 mg tabletu četiri puta dnevno umjesto svojih uobičajenih doza levodope/karbidope i entakapona.