FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the second study showed that symptoms returned in 21% of the patients taking Thymanax over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Croatian: No, drugo je ispitivanje pokazalo da su se simptomi vratili u 21 % bolesnika (34 od 165) koji su uzimali lijek Thymanax tijekom 24 tjedna, u usporedbi s 41 % bolesnika (72 od 174) koji su uzimali placebo.
English: This is a summary of the European public assessment report (EPAR) for Thymanax.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Thymanax.
English: However, since the medicine has a different mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Thymanax could be a valuable treatment for some patients as long as their liver function is tested frequently.
Croatian: No, s obzirom na to da lijek ima drugačiji način djelovanja, malobrojne nuspojave i drugačijeg je sigurnosnog profila u odnosu na postojeće antidepresive, Odbor je zaključio da lijek Thymanax može biti vrijedna terapija za neke bolesnike sve dok se njihova funkcija jetre često kontrolira.
English: The company that markets Thymanax will supply educational material for doctors prescribing Thymanax.
Croatian: Tvrtka koja stavlja lijek Thymanax u promet dostavit će edukacijski materijal liječnicima koji propisuju lijek Thymanax.
English: In the first study, there was no difference between Thymanax and placebo in preventing symptoms from returning during 26 weeks of treatment.
Croatian: U prvom ispitivanju nije bilo razlike između lijeka Thymanax i placeba u sprječavanju vraćanja simptoma tijekom 26 tjedana liječenja.
English: The active comparator groups were included to check that the study was able to measure the effectiveness of medicines in treating depression.
Croatian: Skupine liječene aktivnim komparatorom uključene su kako bi se provjerilo je li ispitivanjem moguće utvrditi djelotvornost lijekova u liječenju depresije.
English: Therefore, the CHMP decided that Thymanax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Stoga je CHMP odlučio da koristi od lijeka Thymanax nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Thymanax has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Croatian: Thymanax je uspoređen s placebom (prividnim liječenjem) u pet glavnih kratkotrajnih ispitivanja kojima su bile obuhvaćene ukupno 1 893 odrasle osobe s teškom depresijom.
English: This material explains the safety of the medicine, its interactions with other medicines, and includes guidance on the monitoring of liver function and management of possible symptoms of liver problems.
Croatian: U tom se materijalu pojašnjava sigurnost lijeka, njegove interakcije s drugim lijekovima, a on obuhvaća i smjernice o praćenju funkcije jetre i kontroli simptoma bolesti jetre.
English: However, no effect of fluoxetine or paroxetine was seen in two of these studies, making the results difficult to interpret.
Croatian: No, u dvama od tih ispitivanja nije uočeno djelovanje fluoksetina ili paroksetina, čime je otežano tumačenje rezultata.
English: What measures are being taken to ensure the safe and effective use of Thymanax?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Thymanax?
English: Three of these studies included some patients treated with other antidepressants, either fluoxetine or paroxetine, as an ‘active comparator'.
Croatian: U trima su ispitivanjima sudjelovali neki bolesnici liječeni drugim antidepresivima, fluoksetinom ili paroksetinom, kao „aktivnim komparatorima”.
English: It must also not be used in patients who are taking medicines that slow down the breakdown of Thymanax in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Croatian: Ne smije se koristiti niti u bolesnika koji uzimaju lijekove koji usporavaju razgradnju lijeka Thymanax u tijelu, poput fluvoksamina (drugi antidepresiv) i ciprofloksacina (antibiotik).
English: The active substance in Thymanax, agomelatine, is an antidepressant.
Croatian: Djelatna tvar u lijeku Thymanax, agomelatin, je antidepresiv.
English: In the other three studies, which did include an active comparator, there were no differences in scores between the patients taking Thymanax and those taking placebo.
Croatian: U preostalim trima ispitivanjima, u kojima je korišten aktivni komparator, nije bilo razlika u rezultatima između bolesnika koji su uzimali Thymanax i onih koji su uzimali placebo.
English: The company also presented the results of a further study comparing Thymanax with sertraline (another antidepressant), which showed that Thymanax was more effective than sertraline, with a reduction in HAM D scores after six weeks.
Croatian: Farmaceutska tvrtka također je dostavila rezultate još jednog ispitivanja u kojem je lijek Thymanax uspoređen sa sertralinom (drugim antidepresivom), a koje je pokazalo da je Thymanax djelotvorniji od sertralina, uz smanjenje vrijednosti na Hamiltonovoj ocjenskoj ljestvici za depresiju nakon šest tjedana.
English: Two other main studies compared the ability of Thymanax and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Thymanax.
Croatian: U dvama drugim glavnim ispitivanjima uspoređena je sposobnost lijeka Thymanax i placeba za sprječavanje vraćanja simptoma u 706 bolesnika u kojih je depresija već prethodno bila kontrolirana lijekom Thymanax.
English: In the two studies where no active comparator was used Thymanax was seen to be more effective than placebo.
Croatian: U dvama ispitivanjima u kojima nije korišten aktivni komparator, Thymanax se pokazao djelotvornijim od placeba.
English: What is Thymanax and what is it used for?
Croatian: Što je Thymanax i za što se koristi?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Thymanax's benefits in terms of treating depression might be lower than seen with other antidepressants.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji napomenuo je kako koristi lijeka Thymanax u kontekstu liječenja depresije mogu biti manje od koristi uočenih s drugim antidepresivima.
English: A patient booklet will also be distributed to all patients who are prescribed Thymanax so that they are aware of the risk to the liver, the importance of monitoring liver function and the signs of liver problems to look out for.
Croatian: Svim bolesnicima kojima je propisan lijek Thymanax bit će dostavljena i brošura za bolesnike kako bi bili upoznati s rizicima za jetru, važnosti praćenja funkcije jetre i znakovima problema s funkcijom jetre na koje trebaju obratiti pozornost.
English: Thymanax must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease, nor in patients whose level of transaminases (liver enzymes) in the blood is more than three times the normal level.
Croatian: Thymanax se ne smije primjenjivati u bolesnika koji imaju problema s jetrom, poput ciroze (ožiljkasta jetra) ili aktivne bolesti jetre, ni u bolesnika u kojih je razina transaminaze (enzima jetre) u krvi trostruko viša od normalne razine.
English: Other information about Thymanax
Croatian: Ostale informacije o lijeku Thymanax
English: It is not intended to provide practical advice on how to use Thymanax.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Thymanax.
English: Treatment should not be started or should be stopped in patients with abnormal liver enzyme levels in the blood (more than three times the normal level).
Croatian: Terapija se ne smije započinjati, odnosno mora se prekinuti, u bolesnika s abnormalnom razinom enzima jetre u krvi (većom od trostruke normalne razine).
English: For more information about treatment with Thymanax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Thymanax pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The most common side effects with Thymanax (seen in more than 1 patient in 100) are headache, nausea (feeling sick) and dizziness.
Croatian: Najčešće su nuspojave lijeka Thymanax (zabilježene u više od 1 na 100 osoba) glavobolja, mučnina i vrtoglavica.
English: This summary was last updated in 10-2016.
Croatian: Ovaj sažetak je posljednji put ažuriran: 10.
English: What are the risks associated with Thymanax?
Croatian: Koji su rizici povezani s lijekom Thymanax?
English: Thymanax contains the active substance agomelatine.
Croatian: Thymanax sadrži djelatnu tvar agomelatin.
English: Why is Thymanax approved?
Croatian: Zašto je lijek Thymanax odobren?
English: What benefits of Thymanax have been shown in studies?
Croatian: Koje su koristi lijeka Thymanax dokazane u ispitivanjima?
English: For practical information about using Thymanax, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Thymanax pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: For the full list of all side effects reported with Thymanax, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Thymanax potražite u uputi o lijeku.
English: How does Thymanax work?
Croatian: Kako djeluje Thymanax?
English: How is Thymanax used?
Croatian: Kako se Thymanax koristi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thymanax have also been included in the summary of product characteristics and the package leaflet.
Croatian: U sažetku opisa svojstava lijeka i uputi o lijeku također se nalaze preporuke i mjere opreza za sigurnu i učinkovitu primjenu lijeka Thymanax kojih se zdravstveni radnici i bolesnici trebaju pridržavati.
English: treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
Croatian: pakiranje za početak liječenja: 14 tableta + 14 tableta + 14 tableta + 14 tableta
English: 1 bottle + 1 measuring cup + 1 oral syringe
Croatian: 1 boca + 1 mjerna čaša + 1 štrcaljka za usta
English: Oral use bottle (glass)
Croatian: Sirup boca (staklo)
English: Syrup
Croatian: 200 ml
English: MA (EU) Number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/12/750/001 Esmya
Croatian: Farmaceutski oblik Put primjene
English: It is available as tablets (100 mg and 200 mg).
Croatian: Dostupan je kao tablete (100 mg i 200 mg).
English: This summary was last updated in 06-2014.
Croatian: Sažetak je posljednji put ažuriran u 06.2014.
English: The patients then lose their ability to control their movements reliably.
Croatian: Bolesnici zatim gube svoju sposobnost pouzdane kontrole pokreta.
English: The tablets should be swallowed whole.
Croatian: Tablete se moraju progutati cijele.
English: The recommended dose is 100 mg three times a day.
Croatian: Preporučena doza iznosi 100 mg tri puta na dan.
English: If after three weeks, no substantial benefit has been seen, treatment with Tasmar should be stopped.
Croatian: Ako nakon tri tjedna nije uočena nikakva značajna korist, treba prekinuti liječenje lijekom Tasmar.
English: The initial studies showed that Tasmar was more effective than placebo.
Croatian: Prvotna su ispitivanja pokazala da je Tasmar bio djelotvorniji od placeba.
English: Doctors should monitor patients very carefully during treatment.
Croatian: Liječnici trebaju pažljivo pratiti bolesnike tijekom liječenja.
English: In the switch study, more patients responded to Tasmar (53%; 40 out of 75) than to entacapone (43%; 32 out of 75).
Croatian: U ispitivanju prelaska više je bolesnika odgovorilo na liječenje lijekom Tasmar (53%; 40 od 75) nego na liječenje entakaponom (43%; 32 od 75).
English: As a result, levodopa remains active for longer.
Croatian: Rezultat levodopa ostaje aktivan tijekom duljeg razdoblja.
English: Tasmar can cause liver injury, which can be fatal in rare cases.
Croatian: Tasmar može uzrokovati oštećenja jetre, koja u rijetkim slučajevima mogu biti smrtonosna.
English: • severe dyskinesia.
Croatian: • ozbiljnom diskinezijom.
English: There was a reduction of about 20 to 30% in ‘off' time in patients taking Tasmar.
Croatian: Došlo je do smanjenja od otprilike 20 do 30% u stanju „isključenosti” u bolesnika koji su uzimali Tasmar.
English: The full EPAR for Tasmar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Tasmar nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tasmar is only used when patients do not respond, or cannot take other medicines of the same type.
Croatian: Tasmar se koristi samo u slučaju kada bolesnici ne odgovaraju na terapiju ili ne mogu uzimati druge lijekove istoga tipa.
English: The dose of Tasmar may be increased to 200 mg three times a day but only when the benefit expected outweighs the risk of liver injury.
Croatian: Doza lijeka Tasmar može se povećati na 200 mg tri puta na dan, no samo kada se očekuje da će koristi nadmašiti rizik od oštećenja jetre.
English: This helps to improve the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Croatian: Ovo pomaže pri poboljšavanju znakova i simptoma Parkinsonove bolesti poput ukočenosti i usporenosti pokreta.
English: • signs of liver disease or increased liver enzymes;
Croatian: • znakovima bolesti jetre ili povišenim jetrenim enzimima;
English: The first dose of the day of Tasmar should be taken together with the first daily dose of the levodopa preparation, and subsequent doses of Tasmar should be given approximately 6 and 12 hours later.
Croatian: Prvu dozu lijeka Tasmar u danu treba uzeti zajedno s prvom dnevnom dozom pripravka levodopa, a naredne doze lijeka Tasmar trebaju se primjenjivati otprilike 6 i 12 sati kasnije.
English: Tasmar was originally studied in a total of 594 patients, in two 13-week studies and one six-week study.
Croatian: Tasmar je izvorno ispitan na ukupno 594 bolesnika u 13-tjednim ispitivanjima i jednom šestotjednom ispitivanju.
English: Tasmar must also not be used in patients who are being treated with medicines known as nonselective monoamine oxidase (MAO) inhibitors.
Croatian: Tasmar se također ne smije koristiti u bolesnika koji su liječeni lijekovima poznatima kao inhibitorima neselektivne monoamino oksidaze (MAO).
English: Doctors should check the patient's liver before starting treatment with Tasmar and then regularly during treatment.
Croatian: Liječnici moraju pregledati jetru bolesnika prije početka liječenja lijekom Tasmar te zatim redovito tijekom liječenja.
English: The medicine can only be obtained with a prescription.
Croatian: Ovaj se lijek izdaje samo na liječnički recept.
English: The main measure of effectiveness was the number of patients with an increase in ‘on' time of one hour or more, during the three weeks following the switch.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika s povišem vremenom u stanju „uključenosti” jedan sat ili više tijekom tri tjedna nakon prijelaza.
English: What measures are being taken to ensure the safe and effective use of Tasmar?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tasmar?
English: Other information about Tasmar
Croatian: Ostale informacije o lijeku Tasmar
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tasmar on 27 August 1997.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Tasmar vrijedi na prostoru Europske unije od 27. kolovoza 1997.
English: Treatment should be stopped in patients who develop liver problems.
Croatian: Liječenje treba zaustaviti u bolesnika kod kojih dođe do razvoja problema s jetrom.
English: This is a summary of the European public assessment report (EPAR) for Tasmar.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Tasmar.
English: The study compared continuing to take entacapone with switching to Tasmar.
Croatian: Ispitivanje je usporedilo kontinuitet uzimanja entakapona s prijelazom na Tasmar.
English: Tasmar must not be used in patients with:
Croatian: Tasmar se ne smije koristiti u bolesnika s:
English: The most common side effects with Tasmar (seen in more than 1 patient in 10) are nausea (feeling sick), loss of appetite, diarrhoea, dyskinesia (uncontrollable movements), dystonia (muscle spasms), headache, dizziness, sleep disorders, excessive dreaming, somnolence (sleepiness), confusion, hallucination (seeing things that are not there) and orthostatic complaints (dizziness on standing).
Croatian: Najčešće nuspojave lijeka Tasmar (kod više od 1 na 10 osoba bolesnika) su mučnina (osjećaj slabosti), gubitak apetita, proljev, diskinezija (nekontrolirani pokreti), distonija (mišićni spazmi), glavobolja, vrtoglavica, poremećaji spavanja, prekomjerno sanjanje, somnolencija (nesanica), konfuznost, halucinacije (pričinjavanje stvari koje ne postoje) i ortostatički problemi (vrtoglavica prilikom stajanja).
English: Tasmar treatment should only be prescribed and supervised by a doctor who has experience in the management of advanced Parkinson's disease.
Croatian: Liječenje lijekom Tasmar treba propisati i nadzirati samo liječnik iskusan u zbrinjavanju i upravljanju uznapredovalom Parkinsonovom bolesti.
English: When patients add Tasmar to their existing anti Parkinson's disease medication, they need to be made aware that they may experience some of the side effects of levodopa, although these can often be reduced by lowering the dose of levodopa.
Croatian: Nakon što bolesnici dodaju Tasmar u svoje postojeće lijekove za liječenje Parkinsonove bolesti, moraju biti upoznati sa činjenicom da mogu osjetiti određene nuspojave lijeka levodopa, iako se iste mogu često smanjiti snižavanjem doze levodopa.
English: A risk management plan has been developed to ensure that Tasmar is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Tasmar.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tasmar.
Croatian: Pojašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima primjene lijeka Tasmar.
English: Tasmar is used to treat patients with Parkinson's disease.
Croatian: Tasmar se koristi za liječenje bolesnika oboljelih od Parkinsonove bolesti.
English: Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Croatian: Parkinsonova bolest je progresivan poremećaj mozga koji uzrokuje drhtanje, usporene kretnje i ukočenost mišića.
English: It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Croatian: Djeluje samo kada se unosi s levodopom, kopijom neurotransmitera dopamina koji se uzima peroralno.
English: • a history of neuroleptic malignant syndrome (a dangerous nervous disorder usually caused by antipsychotic medicines), rhabdomyolysis (breakdown of muscle fibres) or hyperthermia (heat stroke);
Croatian: • anamnezom neuroleptičkog malignog sindroma (opasnog nervoznog poremećaja koji je najčešće uzrokovan antipsihoticima), rabdomiolizom (razgradnjom mišićnih vlakana) ili hipertermijom (toplinskim udarom);
English: Tasmar has also been studied in a ‘switch' study in 150 patients.
Croatian: Tasmar je također ispitan u ispitivanju „prijelaza s jednog lijeka na drugi” u 150 bolesnika.
English: The main measure of effectiveness was how long the patients spent in the ‘off' or in the ‘on' state.
Croatian: Glavna mjera djelotvornosti je bila koliko su dugo bolesnici bili u stanju „isključenosti” ili u stanju „uključenosti”.
English: The active substance in Tasmar, tolcapone, works to restore the levels of dopamine in the parts of the brain that control movement and coordination.
Croatian: Djelatna tvar lijeka Tasmar, tolkapon, djeluje na ponovno uspostavljanje dopamina u dijelovima mozga koji kontroliraju pokrete i koordinaciju.
English: In patients with Parkinson's disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Croatian: U bolesnika oboljelih od Parkinsonove bolesti, stanice u mozgu koje stvaraju neurotransmiter dopamin počinju umirati te se smanjuje količina dopamina u mozgu.
English: Tasmar is a medicine that contains the active substance tolcapone.
Croatian: Tasmar je lijek koji sadrži djelatnu tvar tolkapon.
English: • phaeochromocytoma (a tumour of the adrenal gland);
Croatian: • feokromocitomom (tumorom adrenalne žlijezde);
English: Tasmar is always given with levodopa and benserazide or with levodopa and carbidopa.
Croatian: Tasmar se uvijek primjenjuje zajedno s levodopom i benserazidom ili s levodopom i karbidopom.
English: Tasmar is used together with other standard treatments for Parkinson's disease (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patients have ‘fluctuations' towards the end of the period between two doses of their standard combination.
Croatian: Tasmar se koristi zajedno s drugim standardnim liječenjima za Parkinsonovu bolest (bilo kombinacijom levodopa i benserazida ili kombinacijom levodopa i karbidopa) u slučajevima kada bolesnici imaju „fluktuacije” prema kraju razdoblja između dvije doze svoje standardne kombinacije.
English: Fluctuations are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and immobile.
Croatian: Fluktuacije su povezane sa smanjenjem učinkovitosti levodopa, kada bolesnik osjeća iznenadne promjene između razdoblja „uključenog” i mobilnog, te „isključenog” i nemobilnog.
English: These patients were already receiving a combination of levodopa and entacapone (another medicine that blocks COMT).
Croatian: Ovi su bolesnici već primali kombinaciju levodopa i entakapona (drugog lijeka koji inhibira COMT).
English: What is the risk associated with Tasmar?
Croatian: Koji su rizici povezani s lijekom Tasmar?
English: Tolcapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catecholO-methyl transferase (COMT).
Croatian: Tolkapon inhibira enzim koji je uključen u razgradnju levodopa u tijelu naziva katekol-O-metil transferaze (COMT).
English: For more information about treatment with Tasmar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Tasmar pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: What is Tasmar?
Croatian: Što je Tasmar?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tasmar, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Tasmar uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: All of the studies compared Tasmar with placebo (a dummy treatment) when they were added to the patient's existing medication (levodopa and either carbidopa or benserazide).
Croatian: Sva su ispitivanja usporedila Tasmar s placebom (lažnim liječenjem) nakon što su dodana postojećem liječenju bolesnika (levodop te ili karbidop ili benserazid).