FrancophonIA/ELRC3.0 huggingface dataset:
English: Entacapone Teva is available in HDPE tablet containers with polypropylene screw caps with desiccant insert containing 30, 60, 100 or 175 film-coated tablets.
Croatian: Teva je dostupan u HDPE spremnicima za tablete s polipropilenskim zatvaračem s navojem te umetnutim sredstvom za sušenje koje sadrže 30, 60 100 ili 175 filmom obloženih tableta.
English: methyl transferase (COMT), e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine,dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
Croatian: rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopa i apomorfin
English: HDPE tablet containers with polypropylene screw caps with desiccant insert containing 30, 60, 100 or 175 film-coated tablets.
Croatian: HDPE spremnici za tablete s polipropilenskim zatvaračem s navojem te umetnutim sredstvom za sušenje koji sadrže 30, 60 100 ili 175 filmom obloženih tableta.
English: How to store Entacapone Teva
Croatian: Kako čuvati Entakapon Teva
English: It is characterised by stiffness, muscle twitching, shaking, agitation and confusion, coma, high body temperature, increased heart rate and unstable blood pressure; - a rare severe muscle disorder (rhabdomyolysis) which causes pain, tenderness and weakness of the muscles and may lead to kidney problems.
Croatian: Karakteriziran je ukočenošću, trzanjem mišića, drhtavicom, uznemirenošću, smetenošću, komom, visokom tjelesnom temperaturom, povećanom brzinom otkucaja srca i nestabilnim krvnim tlakom;
English: Uncommon (may affect up to 1 in 100 people): - Heart attack.
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba):
English: Entacapone Teva 200 mg film-coated tablets
Croatian: Entakapon Teva 200 mg filmom obložene tablete
English: Thus, entacapone should be administered cautiously to patients being treated with medicinal products metabolised by catechol-O
Croatian: Stoga entakapon treba primjenjivati s oprezom u bolesnika koji se liječe lijekovima metaboliziranim putem katehol-O-metil transferaze (COMT), npr.
English: • The active substance is entacapone.
Croatian: - Djelatna tvar je entakapon.
English: Suddenly stopping Entacapone Teva and other medicines to treat Parkinson´s disease may result in unwanted side effects.
Croatian: Teva i drugih lijekova za terapiju Parkinsonove bolesti može dovesti do nuspojava.
English: Erythematous or maculopapular rash
Croatian: Eritematozni ili makulopapulozni osip
English: Entacapone Teva is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Croatian: Teva se uzima zajedno s lijekovima koji sadrže levodopu (lijekovi koji sadrže ili kombinaciju levodope/karbidope ili kombinaciju levodope/benzerazida).
English: When stopping your doctor may need to re-adjust the dosage of your other medicines to treat Parkinson´s disease.
Croatian: Kada počnete uzimati Entakapon Teva, može biti potrebno prilagođavanje doze drugih lijekova u terapiji Parkinsonove bolesti.
English: Starch, pregelatinised Magnesium stearate
Croatian: Jezgra tablete celuloza, mikrokristalična povidon škrob, prethodno geliran magnezijev stearat
English: In doses of 1,400 to 2,000 mg per day, the following side effects are more common: - Uncontrollable movements; - nausea; - abdominal pain.
Croatian: U dozama od 1400 do 2000 mg po danu, sljedeće nuspojave su češće:
English: However, a longer dosing interval may be considered for patients who are receiving dialysis therapy.
Croatian: Međutim, u bolesnika na dijalizi dolazi u obzir produljenje intervala doziranja.
English: • if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure);
Croatian: • ako imate tumor nadbubrežne žlijezde (poznat pod nazivom feokromocitom; jer to može povećati rizik od izrazitog povišenja krvnog tlaka); • ako uzimate određene lijekove protiv depresije (upitajte svog liječnika ili ljekarnika može li se
English: Very common: Dyskinesia Common:
Croatian: Psihijatrijski poremećaji Često:
English: Your doctor may advise you to slowly discontinue the treatment with Entacapone Teva and other medicines to treat Parkinson's disease.
Croatian: Doktor Vam može savjetovati polagano prekidanje liječenja Entakaponom
English: Entacapone Teva 200 mg film-coated tablets entacapone
Croatian: Entakapon Teva 200 mg filmom obložene tablete entakapon
English: Some of the adverse reactions, such as dyskinesia, nausea, and abdominal pain, may be more common with the higher doses (1,400 to 2,000 mg per day) than with the lower doses of entacapone.
Croatian: Neke od nuspojava, kao diskinezija, mučnina i bol u trbuhu, mogu biti češće s višim dozama (1400
English: Daily ON time (Mean ±SD) Study I: Daily On time (h)
Croatian: Tablica 2: Dnevno trajanje „ON“ faze (srednja vrijednost ± SD) Ispitivanje I: dnevno trajanje „ON“ faze (sati) Entakapon (n=85)
English: Each film-coated tablet contains 200 mg entacapone.
Croatian: Jedna filmom obložena tableta sadrži 200 mg entakapona.
English: The recommended dose of Entacapone Teva is one 200 mg tablet with each levodopa dose.
Croatian: Teva je jedna tableta od 200 mg, uz svaku dozu levodope.
English: If you experience such effects at the start of treatment with Entacapone Teva you should contact your doctor who may decide to adjust your dosage of levodopa.
Croatian: Teva, trebate se obratiti svom liječniku koji može odlučiti o prilagođavanju doziranja levodope.
English: Hence, to reduce levodopa-related dopaminergic adverse reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment.
Croatian: Zato je tijekom prvih dana ili prvih tjedana od početka liječenja entakaponom često potrebno prilagoditi doziranje levodope kako bi se smanjile dopaminergičke nuspojave povezane s levodopom, npr. diskinezije, mučnina, povraćanje i halucinacije.
English: Each tablet contains 200 mg of entacapone
Croatian: Jedna tableta sadrži 200 mg entakapona
English: In particular please tell your doctor if you are taking any of the following: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine; antidepressants including desipramine, maprotiline, venlafaxine, paroxetine; warfarin used to thin the blood; iron supplements.
Croatian: • rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopa apomorfin; • antidepresivi: desipramin, maprotilin, venlafaksin, paroksetin;
English: prolonged muscle cramps (dystonia); - being sick (vomiting), diarrhoea, abdominal pain, constipation, dry mouth; - dizziness, tiredness, increased sweating, fall; - hallucinations (seeing/hearing/feeling/smelling things that are not really there), sleeplessness,
Croatian: Često (mogu se javiti u do 1 na 10 osoba): - pretjerani pokreti (hiperkinezije), pogoršanje simptoma Parkinsonove bolesti, produženo trajanje grčeva mišića (distonija); - osjećaj da vam je loše (povraćanje), proljev, bol u trbuhu, zatvor, suhoća usta; - omaglica, umor, pojačano znojenje, padanje;
English: Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment from controlled trials in which entacapone was discontinued abruptly.
Croatian: NMS niti rabdomioliza u vezi s liječenjem entakaponom.
English: Read the package leaflet before use
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku
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 (eating more food than normal and more than is needed to satisfy your hunger).
Croatian: - nekontrolirano prejedanje (jedenje velikih količina hrane u kratkom razdoblju) ili kompulzivno jedenje (jedenje više hrane nego što je normalno i potrebno za utaživanje gladi).
English: Urine discoloration
Croatian: Diskinezija
English: If you take more Entacapone Teva than you should
Croatian: Ako uzmete više Entakapona
English: Therefore, the use of Entacapone Teva in children cannot be recommended.
Croatian: Stoga se ne preporučuje primjena Entakapona
English: Very common (may affect more than 1 in 10 people): - Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias); - feeling sick (nausea); - harmless reddish-brown discoloration of urine.
Croatian: - nekontrolirani pokreti sa teškoćama u izvođenju voljnih pokreta (diskinezije); - mučnina;
English: Isolated cases of NMS have been reported following abrupt reduction or discontinuation of entacapone and other dopaminergic treatments.
Croatian: Pri naglom smanjenju doze ili prekidu uzimanja entakapona i drugih dopaminergičkih terapija, zabilježeni su izolirani slučajevi NMS-a.
English: Name and address of the manufacturers responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Entacapone Teva and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Croatian: Neuroleptički maligni sindrom (NMS) je ozbiljna, ali rijetka reakcija na neke lijekove.
English: The dose of other medicines to treat Parkinson's disease may need to be adjusted when you start taking Entacapone Teva.
Croatian: U početku liječenja entakaponom može biti potrebno prilagođavanje doze drugih lijekova za Parkinsonovu bolest.
English: - Entacapone Teva taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
Croatian: Teva i levodope, može se dogoditi da tijekom dana osjetite prekomjernu pospanost ili da naglo utonete u san;
English: Baseline
Croatian: Urtikarija
English: ul.
Croatian: U
English: Hepatobiliary disorders
Croatian: inhibitora dopa dekarboksilaze.
English: • if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Entacapone Teva);
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Entakapon Teva:
English: Usually side effects caused by Entacapone Teva are mild to moderate.
Croatian: Teva obično su blage do umjerene.
English: Commission decision date: 22/03/2017.
Croatian: Datum odluke Komisije: 22/03/2017
English: • If you have any questions or concerns, speak with your doctor, pharmacist or nurse.
Croatian: • Ako imate pitanja ili nedoumice, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: The prescribing information for these medicines will be updated in line with the above recommendations.
Croatian: Informacije za propisivanje tih lijekova ažurirat će se u skladu s prethodno navedenim preporukama.
English: If you develop any of these signs and symptoms you should seek medical advice immediately.
Croatian: Ako se u vas pojave bilo koji od tih znakova i simptoma, smjesta potražite liječničku pomoć.
English: They have been authorised for up to 20 years as Valette and other trade names via national procedures in the following EU Member States: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania, Luxembourg, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Croatian: Austriji, Belgiji, Bugarskoj, Češkoj Republici, Estoniji, Njemačkoj, Mađarskoj, Latviji, Litvi, Luksemburgu, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Sloveniji i Španjolskoj.
English: This alters the production of oils in the skin and also suppresses ovulation.
Croatian: Time se mijenja stvaranje masnoća u koži i također potiskuje ovulacija.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji koja je izdala konačnu zakonski obvezujuću odluku primjenjivu u svim državama članicama EU-a.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Croatian: Ocjenjivanje je proveo Odbor za lijekove za humanu uporabu (CHMP), odgovoran za pitanja koja se odnose na lijekove za humanu uporabu, koji je usvojio mišljenje Agencije.
English: • The currently available safety data do not raise any new safety concerns.
Croatian: • Trenutačno dostupni sigurnosni podatci ne ukazuju na postojanje novih sigurnosnih rizika.
English: They work by blocking the effects of a class of hormones called androgens.
Croatian: Djeluju blokiranjem učinka hormona koji se nazivaju androgeni.
English: Dienogest and ethinylestradiol are two types of hormones, a progestogen and an oestrogen.
Croatian: Dienogest i etinilestradiol dvije su vrste hormona, progestogen i estrogen.
English: • When taking dienogest/ethinylestradiol, you should be alert to the signs and symptoms of blood clots in veins, which may include severe pain or swelling in the legs, sudden unexplained breathlessness, rapid breathing or cough, chest pain, and weakness or numbness of the face, arms or legs.
Croatian: • Pri uzimanju dienogesta/etinilestradiola morate budno paziti na znakove i simptome krvnih ugrušaka u venama, koji mogu uključivati jaku bol ili oticanje nogu, iznenadan neobjašnjiv nedostatak zraka, brzo disanje ili kašalj, bol u prsima, te slabost ili utrnulost lica, ruku ili nogu.
English: The known risk of venous thromboembolism (VTE or blood clots in veins), which can occur with all combined hormonal contraceptives, is considered low.
Croatian: Poznati rizik od venske tromboembolije (VTE ili krvni ugrušci u venama), koja se može pojaviti kod svih kombiniranih hormonskih kontraceptiva, smatra se niskim.
English: However, these medicines, which are also approved as hormonal contraceptives, should only be used in women who choose oral contraception.
Croatian: Međutim, ti lijekovi, koji su također odobreni kao hormonska kontracepcijska sredstva, trebaju se primjenjivati samo u žena koje odaberu uzimanje oralne kontracepcije.
English: • Your acne will usually improve after 3 to 6 months of treatment with dienogest/ethinylestradiol.
Croatian: • Akne se obično poboljšaju nakon tri do šest mjeseci liječenja dienogestom/etinilestradiolom.
English: They should only be used when treatments applied to the skin or an antibiotic taken by mouth have not worked.
Croatian: Treba ih primjenjivati samo ako liječenje primjenom na kožu ili peroralnim antibioticima nije djelovalo.
English: • Data from two phase III trials (study no. A07062 and A28501) in a total of around 2,400 women (mostly with moderate acne) showed that dienogest/ethinylestradiol was more effective than placebo and at least as effective as ethinylestradiol/norgestimate and ethinylestradiol/cyproterone at treating acne in terms of changes in inflammatory lesion count, total lesion count and improvement of facial acne according to IGA (Investigator's Global Assessment).
Croatian: • Podatci iz dvaju ispitivanja III. faze (ispitivanja br. A07062 i A28501) na ukupnom broju od otprilike 2400 žena (uglavnom s aknama umjerenog stupnja) pokazali su da je u liječenju akni dienogest/etinilestradiol bio djelotvorniji od placeba te barem jednako djelotvoran kao etinilestradiol/norgestimat i etinilestradiol/ciproteron s obzirom na promjene broja upaljenih lezija, ukupan broj lezija i poboljšanje akni na licu prema sveukupnoj procjeni ispitivača (IGAInvestigator's Global Assessment).
English: Use should be limited to women who choose oral contraception
Croatian: Primjenu treba ograničiti na žene koje odaberu uzimanje oralne kontracepcije
English: The review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne was initiated on 25 February 2016 at the request of the UK's medicines agency (the Medicines and Healthcare products Regulatory Agency, MHRA), under Article 31 of Directive 2001/83/EC.
Croatian: Ocjenjivanje lijekova koji sadržavaju dienogest (2 mg) i etinilestradiol (0,03 mg) za liječenje akni započeto je 25. veljače 2016. na zahtjev Agencije za lijekove Ujedinjene Kraljevine (Regulatorne agencije za lijekove i zdravstvene proizvode, MHRA), sukladno članku 31. Direktive 2001/83/EZ.
English: • You should be aware that, as with other hormonal contraceptives, there is a risk of blood clots associated with the use of dienogest/ethinylestradiol.
Croatian: • Imajte u vidu da, kao i kod ostalih hormonskih kontraceptiva, postoji rizik od krvnih ugrušaka koji je povezan s primjenom dienogesta/etinilestradiola.
English: Having evaluated the existing data on the effectiveness of the combination in the treatment of acne, EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that there is sufficient evidence to support its use in moderate acne.
Croatian: Nakon ocjene postojećih podataka o učinkovitosti te kombinacije u liječenju akni, Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da postoje dostatni dokazi u korist njezine primjene u liječenju akni umjerenog stupnja.
English: Regarding the risk of side effects, the CHMP considered that the available data do not raise any new safety concern.
Croatian: U pogledu rizika od nuspojava, zaključak je CHMP-a da dostupni podatci ne ukazuju na postojanje novih sigurnosnih rizika.
English: Your doctor will assess whether you should continue treatment with this medicine 3 to 6 months after you have started treatment and regularly after that.
Croatian: Vaš će liječnik donijeti procjenu o nastavku liječenja tri do šest mjeseci nakon što ste započeli s liječenjem i redovito nakon toga.
English: • It is not known how the efficacy of dienogest/ethinylestradiol compares with other acne treatments, i.e. topical treatments and systemic antibiotics.
Croatian: • Nije poznata djelotvornost dienogesta/etinilestradiola u usporedbi s drugim vrstama liječenja akni, tj. topikalnih terapija i sistemskih antibiotika.
English: However, to date, there are insufficient data to accurately determine the relative risk of venous thromboembolism (VTE) with respect to other combined hormonal contraceptives containing other progestogens.
Croatian: Međutim, zasad ne postoje dostatni podatci na osnovi kojih bi se točno utvrdio relativan rizik od venske tromboembolije (VTE) u odnosu na druge kombinirane hormonske kontraceptive koji sadržavaju druge progestogene.
English: Considering the observed benefits of dienogest/ethinylestradiol in the treatment of acne, the potential risk of VTE and the nature of the disease, the CHMP concluded that this combination should only be used after certain other treatments have failed, and only when oral contraception is chosen.
Croatian: S obzirom na uočene koristi u primjeni dienogesta/etinilestradiola u liječenju akni, mogući rizik od VTEa i prirodu bolesti, zaključak CHMP-a je da bi ovu kombinaciju trebalo primjenjivati samo nakon što se ostale vrste liječenja pokažu neuspješnima, te samo u slučaju uzimanja oralne kontracepcije.
English: • Since improvement of acne usually requires at least 3 months of treatment with dienogest/ethinylestradiol and further improvement has been seen after 6 months, women should be assessed 3 to 6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
Croatian: • Budući da je za poboljšanje akni uglavnom potrebno barem tri mjeseca liječenja s dienogestom/etinilestradiolom te da je daljnje poboljšanje uočeno nakon šest mjeseci, stanje u žena trebalo bi procijeniti tri do šest mjeseci nakon početka liječenja, a potom periodički, kako bi se ocijenilo je li terapiju potrebno nastaviti.
English: Medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg are used as oral contraceptives and for the treatment of moderate acne.
Croatian: Lijekovi koji sadržavaju dienogest (2 mg) i etinilestradiol (0,03 mg) primjenjuju se kao oralni kontraceptivi i za liječenje akni umjerenog stupnja.
English: • Taking into account the available evidence, and in order not to unnecessarily expose women to a potentially higher risk of VTE, use of dienogest/ethinylestradiol should be restricted to second line and to women who also choose oral contraception.
Croatian: • Uzimajući u obzir dostupne dokaze, te kako bi se izbjeglo nepotrebno izlaganje žena terapiji s potencijalno većim rizikom od venske tromboembolije, primjenu dienogesta/etinilestradiola trebalo bi ograničiti na drugu liniju liječenja te na žene koje također odaberu uzimanje oralne kontracepcije.
English: The CHMP also recommended that women should be assessed by their doctor 3 to 6 months after starting treatment and periodically thereafter to review the need for continuation of treatment.
Croatian: CHMP je također preporučio da tri do šest mjeseci nakon početka liječenja, a potom periodički, žene treba pregledati njihov liječnik kako bi ocijenio treba li nastaviti terapiju.
English: While this risk is low, the data on the risk with dienogest/ethinylestradiol are still insufficient to accurately estimate how it compares with other contraceptives.
Croatian: Iako je rizik nizak, podatci o riziku kod primjene dienogesta/etinilestradiola još uvijek su nedostatni za točnu procjenu u pogledu usporedbe s drugim kontraceptivima.
English: However, the data on the risk with dienogest/ethinylestradiol are not sufficient to accurately estimate how it compares with other contraceptives and further data are still awaited.
Croatian: Međutim, podatci o riziku pri primjeni dienogesta/etinilestradiola nisu dostatni za točnu procjenu u pogledu usporedbe s drugim kontraceptivima, te se očekuju novi podatci.
English: On 26 January 2016, the European Medicines Agency (EMA) recommended that medicines containing a combination of dienogest 2 mg and ethinylestradiol 0.03 mg can continue to be used to treat moderate acne when suitable treatments applied to the skin or antibiotics taken by mouth have not worked.
Croatian: Europska agencija za lijekove (EMA) preporučila je da se lijekovi koji sadržavaju kombinaciju dienogesta od 2 mg i etinilestradiola od 0,03 mg mogu i dalje upotrebljavati u liječenju umjerenih akni ako odgovarajuća liječenja primjenom na kožu ili liječenja peroralnim antibioticima nisu djelovala.
English: • Medicines containing dienogest and ethinylestradiol should only be used to treat moderate acne in women who also choose oral contraception.
Croatian: • Lijekovi koji sadržavaju dienogest i etinilestradiol trebaju se primjenjivati samo za liječenje akni umjerenog stupnja u žena koje odaberu uzimanje oralne kontracepcije.
English: • The combination dienogest/ethinylestradiol should be used for the treatment of moderate acne only after failure of suitable local therapies or oral antibiotic treatment in women who elect to use an oral contraceptive.
Croatian: • Kombinaciju dienogesta/etinilestradiola treba primjenjivati za liječenje akni umjerenog stupnja u žena koje odaberu primjenjivati oralnu kontracepciju tek nakon što su se odgovarajuće lokalne terapije ili terapije peroralnim antibioticima pokazale neuspješnima.
English: It is available as tablets (20 mg).
Croatian: Dostupan je u obliku tableta (20 mg).
English: The full EPAR for Conbriza can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Conbriza nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 06-2015.
Croatian: Sažetak je posljednji put ažuriran: 06.2015.
English: The recommended dose of Conbriza is one tablet once a day.
Croatian: Preporučena doza lijeka Conbriza je jedna tableta jedanput na dan.
English: Conbriza bazedoxifene
Croatian: Conbriza bazedoksifen