natgillin/translations-raw huggingface dataset:
- All patients treated with Corbilta should be monitored carefully for the development of mental changes, depression with suicidal tendencies, and other serious antisocial behaviour.
- Sve bolesnike liječene Corbiltom treba pažljivo pratiti glede razvoja mentalnih promjena, depresije sa suicidalnim tendencijama i drugog teškog antisocijalnog ponašanja.
Patients taking these medicinal products with Corbilta should be carefully observed for loss of therapeutic response.
Bolesnike koji uzimaju ove lijekove s Corbiltom mora se pažljivo pratiti radi gubitka terapijskog odgovora.
Talk to your doctor or pharmacist if you think the effect of Corbilta is too strong or too weak, or if you experience possible side effects.
Razgovarajte sa svojim liječnikom ili ljekarnikom ako mislite da je učinak Corbilte prejak ili preslab ili ako doživite moguće nuspojave.
If this happens, you should not drive or use any tools or machines (see also section 'Driving and using machines') - notice that uncontrolled movements begin or get worse after you started to take Corbilta.
Ako se to dogodi, ne smijete voziti niti rukovati alatima ili strojevima (vidjeti također dio "Upravljanje vozilima i strojevima"), - primijetite pojavu nekontroliranih pokreta ili se oni pogoršaju nakon što počnete uzimati Corbiltu.
The CHMP agrees with the scientific conclusions made by the PRAC.The CHMP agrees with the scientific conclusions made by the PRAC.
CHMP je suglasan sa znanstvenim zaključcima koje je donio PRAC.
The starting dose of Corbilta should provide either the same amount of levodopa or slightly (5-10%) more.
Potrebno je započeti s doziranjem Corbilte koje osigurava istu količinu levodope ili malo (5-10%) veću.
What Corbilta is and what it is used for What you need to know before you take Corbilta How to take Corbilta
Što je Corbilta i za što se koristi Što morate znati prije nego počnete uzimati Corbiltu
When used with Corbilta, the daily dose of selegiline should not exceed 10 mg.
Kada se primijenjuje s Corbiltom, dnevna doza selegilina ne smije prijeći 10 mg.
Corbilta may have a major influence on the ability to drive and use machines.
Corbilta može imati znatan utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
If you have accidentally taken more Corbilta tablets than you should, talk to your doctor or pharmacist immediately.
Ako ste slučajno uzeli više tableta Corbilte nego što ste trebali, odmah obavijestite svog liječnika ili ljekarnika.
If therapy has to be stopped temporarily, Corbilta may be restarted as soon as oral medicinal products can be taken at the same daily dose as before.
Ako terapiju treba privremeno obustaviti, primjena Corbilte može se ponovno započeti čim se mogu uzimati oralni lijekovi uz isto dnevno doziranje kao i prije.
Corbilta may lower your blood pressure, which may make you feel light-headed or dizzy.
Corbilta može sniziti krvni tlak, zbog čega možete osjetiti ošamućenost ili omaglicu.
However, caution should be exercised when these medicinal products are used concomitantly with Corbilta (see sections 4.3 and 4.4).
Međutim, kada se ovi lijekovi koriste istodobno s Corbiltom potreban je oprez (vidjeti dijelove 4.3 i 4.4).
At the initiation, Corbilta should be adjusted to correspond as closely as possible to the total daily dose of levodopa currently used.
Na početku se mora prilagoditi doza Corbilte da bi ona bila što je moguće bliža ukupnoj dnevnoj dozi levodope koja se trenutno koristi.
What you need to know before you take Corbilta
Što morate znati prije nego počnete uzimati Corbiltu
Corbilta is used for the treatment of Parkinson's disease.
Corbilta se koristi za liječenje Parkinsonove bolesti.
If this happens, a general medical evaluation including liver function should be considered - feel the need to stop using Corbilta, see section 'If you stop taking Corbilta'.
Ako se to dogodi, mora se razmotriti opća medicinska procjena uključujući procjenu jetrene funkcije. - osjetite potrebu da prestanete uzimati Corbiltu, vidjeti dio "Ako prestanete uzimati Corbiltu".
Always leave at least an hour between Corbilta tablets, to avoid possible side effects.
Između uzimanja Corbilta tableta uvijek mora proći najmanje jedan sat, kako bi se izbjegle moguće nuspojave.
Do not take Corbilta if you are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
Ne uzimajte Corbiltu ako uzimate određene lijekove za liječenje depresije (kombinaciju selektivnih MAO-A i MAO-B inhibitora, ili neselektivne MAO inhibitore).
What Corbilta is and what it is used for
Što je CORBILTA i za što se koristi
Corbilta contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet.
Corbilta sadrži tri djelatne tvari (levodopu, karbidopu i entakapon) u jednoj filmom obloženoj tableti.
However, a direct switch from levodopa/DDC inhibitor to Corbilta is not recommended for patients who have dyskinesias or whose daily levodopa dose is above 800 mg.
Međutim, izravni prijelaz s levodope/DDC-inhibitora na Corbiltu ne preporučuje se za bolesnike koji imaju diskinezije ili čija je dnevna doza levodope iznad 800 mg.
Detailed information on this medicinal product is available on the website of European Medicines Agency http://www.ema.europa.eu
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
What Corbilta looks like and contents of the pack
Kako Corbilta izgleda i sadržaj pakiranja
What Corbilta contains
Što Corbilta sadrži
Therefore Corbilta should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
Stoga Corbiltu treba oprezno davati bolesnicima koji uzimaju druge lijekove koji mogu prouzročiti ortostatsku hipotenziju.
Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Corbilta and other medicines used to treat Parkinson's disease.
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 Corbilta i drugih lijekova koji se koriste za liječenje Parkinsonove bolesti.
When more levodopa is required, an increase in the frequency of doses and/or the use of an alternative strength of Corbilta should be considered, within the dose recommendations.
Kada je potrebno više levodope, treba razmotriti češće uzimanje doza i/ili korištenje alternativne jačine Corbilte, u okviru preporuka za doziranje.
Corbilta may make it harder for you to digest iron.
Corbilta može otežati probavu željeza.
Corbilta may increase the effects and side effects of certain medicines.
Corbilta može pojačati učinke i nuspojave nekih lijekova.
- Corbilta is not recommended for the treatment of drug-induced extrapyramidal reactions.
- Corbilta se ne preporučuje za liječenje ekstrapiramidnih reakcija izazvanih lijekovima.
Other antiparkinsonian medicinal products: To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Corbilta therapy.
Drugi antiparkinsonici: do sada nema naznaka interakcija koje bi isključivale istodobnu primjenu standardnih antiparkinsonika uz liječenje Corbiltom.
- Patients with chronic wide-angle glaucoma may be treated with Corbilta with caution, provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure.
- Bolesnici s kroničnim glaukomom otvorenog kuta mogu se uz oprez liječiti Corbiltom pod uvjetom da je intraokularni tlak dobro kontroliran i da se bolesnike pažljivo prati zbog promjena intraokularnog tlaka.
Thus, a control of INR is recommended when Corbilta is initiated for patients receiving warfarin.
Zbog toga se preporučuje kontroliranje INR-a kada se Corbilta počinje primjenjivati bolesnicima koji primaju varfarin.
In the pharmacokinetic studies with Corbilta 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.
U farmakokinetičkim ispitivanjima Corbilte, 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.
Corbilta 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.
Corbilta se ne preporučuje koristiti za liječenje ekstrapiramidnih simptoma (npr. nevoljnih pokreta, tresenja, mišićne ukočenosti i mišićnih kontrakcija) uzrokovanih drugim lijekovima.
5 How to store Corbilta Contents of the pack and other information
Kako čuvati Corbiltu Sadržaj pakiranja i druge informacije
- Corbilta may induce orthostatic hypotension.
- Corbilta može izazvati ortostatsku hipotenziju.
- Corbilta contains sucrose, and therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
- Corbilta sadržava saharozu te stoga bolesnici s rijetkim nasljednim problemima nepodnošenja fruktoze, malapsorpcije glukoze-galaktoze ili nedostatka saharaza-izomaltaze ne bi smjeli uzimati ovaj lijek.
Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Corbilta may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin.
Zbog afiniteta entakapona prema citokromu P450 2C9 in vitro (vidjeti dio 5.2), Corbilta može potencijalno interferirati s djelatnim tvarima čiji metabolizam ovisi o ovom izoenzimu, kao što je Svarfarin.
For some patients, Corbilta 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).
U nekih bolesnika se Corbilta možda neće dobro apsorbirati ako se uzme tijekom ili kratko nakon obroka bogatog bjelančevinama (npr. meso, riba, mliječni proizvodi, sjemenke i orašasti plodovi).
- If general anaesthesia is required, therapy with Corbilta may be continued for as long as the patient is permitted to take fluids and medicinal products by mouth.
- Ako je potrebna opća anestezija, terapija Corbiltom može se nastaviti tako dugo dok bolesnik smije uzimati tekućinu i lijekove na usta.
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 Corbilta.
Kod takvih bolesnika je preporučljivo uvesti entakapon kao odvojeni lijek (entakapon tablete) i po potrebi prilagoditi dozu levodope, prije prelaska na Corbiltu.
Serious hepatitis with mainly cholestatic features, rhabdomyolysis and neuroleptic malignant syndrome may occur with Corbilta although no cases have been identified from the clinical trial data.
Ozbiljni hepatitis s uglavnom kolestatskim obilježjima, rabdomioliza i neuroleptički maligni sindrom mogu se javiti uz Corbiltu, iako takvi slučajevi nisu bili otkriveni u podacima iz kliničkih ispitivanja.
If other levodopa products are used concomitantly with a Corbilta tablet, the maximum dose recommendations should be followed.
Ako se istodobno s Corbilta tabletom koriste drugi preparati levodope, moraju se pratiti preporuke o maksimalnoj dozi.
Not known (cannot be estimated from the available data) Craving for large doses of Corbilta in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome.
Nepoznato (ne može se procijeniti na temelju dostupnih podataka) Žudnja za velikim dozama lijeka Corbilta, koje su veće od onih potrebnih za kontrolu motoričkih simptoma, što je poznato kao sindrom poremećene regulacije dopamina.
In the first study, entacapone increased the mean daily ON time by 1 h 20 min (CI 95% 45 min, 1 h 56 min) from baseline.
U prvom ispitivanju entakapon je povisio srednje trajanje "ON" faze za 1 h 20 min (CI95% 45 min, 1 h 56 min) u odnosu na početnu vrijednost.
The most frequently reported adverse reactions with Corbilta 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.
Najčešće prijavljivane nuspojave Corbilte 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.
Other forms of interactions: Since levodopa competes with certain amino acids, the absorption of Corbilta may be impaired in some patients on high protein diet.
Ostali oblici interakcija: budući da se levodopa natječe s određenim aminokiselinama, apsorpcija Corbilte može biti narušena u nekih bolesnika na dijeti bogatoj bjelančevinama.
If you stop taking Corbilta
Ako prestanete uzimati Corbiltu
Patients being treated with Corbilta 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).
Bolesnike, koji su liječeni Corbiltom 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).
If you forget to take Corbilta
Ako ste zaboravili uzeti Corbiltu
Elderly: No dose adjustment of Corbilta is required for elderly.
Starije osobe: starijim osobama nije potrebno prilagođavati dozu Corbilte.
Because the effects of Corbilta 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 Corbilta as well.
Budući da su učinci Corbilta 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 Corbilte.
When considered necessary, the replacement of Corbilta with levodopa and DDC inhibitor without entacapone or other dopaminergic treatment should proceed slowly and an increase in levodopa dose may be necessary.
Kada se pokaže potrebnim, nadomještanje Corbilte levodopom i DDC-inhibitorom bez entakapona ili drugim dopaminergičkim liječenjem treba se odvijati polako te može biti potrebno povećanje doziranja levodope.
Management of acute overdose with Corbilta therapy is similar to acute overdose with levodopa.
Zbrinjavanje akutnog predoziranja tijekom terapije Corbiltom slično je kao u slučaju akutnog predoziranja levodopom.
Discontinuation of Corbilta therapy: If Corbilta 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.
Prekid liječenja Corbiltom: ako se liječenje Corbiltom (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 pakinsonizma.
Women should not breast-feed during treatment with Corbilta.
Žene ne smiju dojiti tijekom liječenja Corbiltom.
The evidence of the therapeutic effects of Corbilta 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.
Dokaz o terapijskim učincima Corbilte 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.
c. When initiating Corbilta 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 Corbilta should be started in the next morning.
Kada se Corbilta uvodi bolesnicima koji su trenutno liječeni entakaponom i formulacijom sa standardnim oslobađanjem levodope/benzerazida, potrebno je prekinuti doziranje levodope/benzerazida noć prije i započeti s Corbiltom sljedeće jutro.
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 Corbilta 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.
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 Corbiltom 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.
No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Corbilta therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Nisu objavljena posebna ispitivanja farmakokinetike levodope i karbidope kod bolesnika s bubrežnom insuficijencijom, pa se stoga terapija Corbiltom mora oprezno primjenjivati kod bolesnika s teškim bubrežnim oštećenjem, uključujući bolesnike na dijalizi (vidjeti dio 5.2).
- Corbilta 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.
- Liječenje Corbiltom 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.
How to take Corbilta
Kako uzimati Corbiltu
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 Corbilta.
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 Corbiltu.
The possibility that the patient has taken other active substances in addition to Corbilta should be taken into consideration.
Mora se uzeti u obzir mogućnost da je bolesnik uz Corbiltu uzeo i druge djelatne tvari.
How to transfer patients not currently treated with entacapone to Corbilta
Kako na Corbiltu prebaciti bolesnike koji trenutno nisu liječeni entakaponom
Depression, hallucination, confusional state*, abnormal dreams*, anxiety, insomnia
Depresija, halucinacija, konfuzno stanje*, poremećeni snovi*, anksioznost, nesanica Manje često: Psihoza, agitacija*
MAO-B inhibitors, or non-selective MAO-inhibitors) - have ever had neuroleptic malignant syndrome (NMS - this is a rare reaction to medicines used to treat severe mental disorders) - have ever had non-traumatic rhabdomyolysis (a rare muscle disorder) - have a severe liver disease.
inhibitora, ili neselektivne MAO-inhibitore), - ako ste ikada imali neuroleptički maligni sindrom (NMS - to je rijetka reakcija na lijekove koji se koriste za liječenje teških duševnih poremećaja), - ako ste bilo kada imali netraumatsku rabdomiolizu (rijetki mišićni poremećaj), - ako imate tešku bolest jetre.
If you suddenly stop taking Corbilta and other antiparkinsonian medicines it may result in unwanted side effects.
Naglo ukidanje Corbilte i drugih antiparkinsonika može rezultirati neželjenim nuspojavama.
When less levodopa is required, the total daily dose of Corbilta should be reduced either by decreasing the frequency of administration by extending the time between doses, or by decreasing the strength of Corbilta at an administration.
Kada je potrebno manje levodope, ukupna dnevna doza Corbilte mora se smanjiti ili smanjenjem učestalosti primjene povećanjem vremenskog razmaka između doza ili primjenom manje jačine Corbilte.
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 Corbilta (see section
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 Corbiltu (vidjeti dio 4.4).
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 Corbilta tablet four times daily in place of their usual levodopa/carbidopa and entacapone doses.
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 Corbilta 50 mg/12,5 mg/200 mg tabletu četiri puta dnevno umjesto svojih uobičajenih doza levodope/karbidope i entakapona.
Corbilta is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Corbilta je indicirana za liječenje odraslih bolesnika s Parkinsonovom bolešću, kao i za liječenje motoričkih fluktuacija na kraju intervala doziranja koje nisu stabilizirane primjenom levodope/inhibitora dopa dekarboksilaze (DDC).
Patients should be instructed to take only one Corbilta tablet per dose administration.
Bolesnike se mora upozoriti da prilikom svake primjene lijeka uzmu samo jednu tabletu Corbilte.
Corbilta comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Corbilta dolazi u šest različitih veličina pakiranja (10, 30, 100, 130, 175 ili 250 tableta).
The effects of Corbilta may be weakened by certain medicines.
Neki lijekovi mogu oslabiti učinke Corbilte.