FrancophonIA/ELRC3.0 huggingface dataset:
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Croatian: Zahtjev je povučen nakon što je CHMP procijenio inicijalnu dokumentaciju koju je tvrtka dostavila i sastavio popis pitanja.
English: Since Parkinson's disease usually occurs in people over 60 years, studies in older people would be required because the skin structure changes due to aging.
Croatian: Budući da Parkinsonova bolest uglavnom nastupa u osoba koje su starije od 60 godina, trebalo bi provesti ispitivanja na starijim osobama jer se struktura kože mijenja zbog starenja.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would be unable to provide the required additional data in the time available.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da ne može na vrijeme dostaviti tražene dodatne podatke.
English: EMEA/H/C/004286
Croatian: EMA/43037/2018 EMEA/H/C/004286
English: The CHMP was concerned that insufficient data had been provided on the quality of the medicine and its manufacturing process.
Croatian: CHMP je izrazio zabrinutost da nisu dostavljeni dostatni podatci o kvaliteti lijeka i njegovom postupku proizvodnje.
English: The Committee was also concerned that the studies on how the patch sticks to the skin had only been done in young adults.
Croatian: Odbor je također izrazio zabrinutost u pogledu provedbe ispitivanja prianjanja flastera na kožu samo na mladim punoljetnicima.
English: Dopamine is a messenger substance in the parts of the brain that control movement and coordination.
Croatian: Dopamin djeluje kao glasnik u dijelovima mozga koji kontroliraju kretanje i koordinaciju.
English: The company had not yet responded to the questions at the time of the withdrawal.
Croatian: U trenutku povlačenja tvrtka još nije bila dostavila svoje odgovore na pitanja.
English: The way rotigotine works in restless-legs syndrome is not fully understood.
Croatian: Način djelovanja rotigotina kod sindroma nemirnih nogu nije u potpunosti poznat.
English: Rotigotine Mylan was developed as a ‘generic medicine'.
Croatian: Rotigotine Mylan razvijen je kao „generički lijek”.
English: This means that Rotigotine Mylan contains the same active substance and was intended to work in the same way as a ‘reference medicine' already authorised in the European Union called Neupro.
Croatian: To znači da Rotigotine Mylan sadržava istu djelatnu tvar i da je trebao djelovati na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Neupro.
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.
Croatian: Smatra se da je sindrom prouzročen problemima u načinu djelovanja dopamina u mozgu, što se može poboljšati primjenom rotigotina.
English: Rotigotine Mylan was expected to be used to treat adults with Parkinson's disease and adults with restless-leg syndrome (a disorder where the patient has uncontrollable urges to move the legs to stop uncomfortable, painful or odd sensations in the body, usually at night).
Croatian: Rotigotine Mylan se trebao primjenjivati za liječenje odraslih osoba s Parkinsonovom bolešću i sindromom nemirnih nogu (poremećaj kod kojeg bolesnik ima nesavladiv poriv za pokretanjem ekstremiteta kako bi prekinuo neugodne, bolne ili neobične osjete u tijelu, uglavnom noću).
English: Rotigotine stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Croatian: Rotigotin stimulira mozak na isti način kao i dopamin tako da bolesnici mogu kontrolirati svoje pokrete te imaju manje znakova i simptoma Parkinsonove bolesti poput ukočenosti i usporavanja pokreta.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Neupro, and did not need to be repeated for Rotigotine Mylan.
Croatian: Ispitivanja o koristima i rizicima djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Neupro i ne treba ih ponavljati za lijek Rotigotine Mylan.
English: On 22 December 2017, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Rotigotine Mylan, for the treatment of Parkinson's disease and restless-leg syndrome.
Croatian: Dana 22. prosinca 2017. tvrtka Mylan SAS službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Rotigotine Mylan za liječenje Parkinsonove bolesti i sindroma nemirnih nogu.
English: In patients with Parkinson's disease, the cells that produce dopamine die and the amount of dopamine in the brain decreases.
Croatian: U bolesnika s Parkinsonovom bolešću stanice koje proizvode dopamin odumiru te se smanjuje količina dopamina u mozgu.
English: What is Rotigotine Mylan?
Croatian: Što je Rotigotine Mylan?
English: The company also carried out studies to investigate whether Rotigotine Mylan is ‘bioequivalent' to the reference medicine.
Croatian: Tvrtka je također provela ispitivanja kako bi istražila je li Rotigotine Mylan „bioekvivalentan” referentnom lijeku.
English: As for every medicine, the company provided studies on the quality of Rotigotine Mylan, including studies on how the patch sticks to the skin.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Rotigotine Mylan, uključujući ispitivanja prianjanja flastera za kožu.
English: The active substance in Rotigotine Mylan, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Croatian: Djelatna je tvar u lijeku Rotigotine Mylan rotigotin, agonist dopamina, što znači da imitira djelovanje dopamina.
English: Withdrawal of the marketing authorisation application for Rotigotine Mylan (rotigotine)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Rotigotine Mylan (rotigotin)
English: The company informed the CHMP that there are no ongoing clinical trials with Rotigotine Mylan.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja lijeka Rotigotine Mylan koja su u tijeku.
English: EMA/43037/2018
Croatian: Mylan (rotigotin) EMA/43037/2018
English: It was to be available as transdermal patches (patches that deliver a medicine across the skin).
Croatian: Trebao je biti dostupan u obliku transdermalnih flastera (flasteri koji otpuštaju lijek preko kože).
English: Rotigotine Mylan is a medicine that contains the active substance rotigotine.
Croatian: Rotigotine Mylan je lijek koji sadržava djelatnu tvar rotigotin.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Rotigotine Mylan could not have been approved for the treatment Parkinson's disease and restless-leg syndrome.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za Rotigotine Mylan za liječenje Parkinsonove bolesti i sindroma nemirnih nogu.
English: What was Rotigotine Mylan expected to be used for?
Croatian: Za što se Rotigotine Mylan trebao koristiti?
English: How does Rotigotine Mylan work?
Croatian: Kako djeluje Rotigotine Mylan?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Rotigotine Mylan did not outweigh its risks.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Rotigotine Mylan ne nadmašuju s njim povezane rizike.
English: This is particularly important for the following medicines:
Croatian: To je osobito važno za sljedeće lijekove:
English: 26 May 2016
Croatian: 26. svibnja 2016.
English: It is advisable to take your medicine at the same time each day.
Croatian: Preporučljivo je da uzimate svoj lijek u isto vrijeme svakog dana.
English: Do not take Neparvis:
Croatian: Nemojte uzimati Neparvis:
English: No significant interaction
Croatian: Bez značajne interakcije
English: Therefore, this combination is not recommended.
Croatian: Stoga se ova kombinacija ne preporučuje.
English: Both components contributed to the risk reduction.
Croatian: Obje su komponente doprinijele smanjenju rizika.
English: Some side effects may be serious.
Croatian: Neke nuspojave mogu biti ozbiljne.
English: What Neparvis is and what it is used for
Croatian: Što je Neparvis i za što se koristi
English: What Neparvis contains
Croatian: Što Neparvis sadrži
English: KM estimate of cumulative failure rate (%)
Croatian: KM procjena kumulativne stope neuspjeha (%)
English: This period coincides with 36 weeks of gestation in humans, which could occasionally extend up to 44 weeks after conception in humans.
Croatian: Ovo se razdoblje podudara s 36 tjedana gestacije u ljudi, koje bi se povremeno moglo produžiti do 44 tjedna nakon začeća u ljudi.
English: Within 2 years after Commission Decision.
Croatian: U roku od dvije godine od Odluke Komisije
English: PVC/PVDC/Aluminium blisters.
Croatian: PVC/PVDC/aluminij blisteri.
English: In these patients, exposure may be increased and safety is not established.
Croatian: U tih bolesnika, izloženost može biti povećana i sigurnost nije utvrđena.
English: The safety and efficacy of Neparvis in children and adolescents aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Neparvisa u djece i adolescenata u dobi ispod 18 godina nisu ustanovljene.
English: It may be necessary to change the dose, to take other precautions, or even to stop taking one of the medicines.
Croatian: Možda će trebati promijeniti dozu, poduzeti druge mjere opreza, ili čak prestati uzimati jedan od lijekova.
English: Effect of gender
Croatian: Učinak spola
English: This is because it has not been studied in this age group.
Croatian: To je zato što nije bio ispitivan u ovoj dobnoj skupini.
English: PDE5 inhibitors including sildenafil
Croatian: PDE5 inhibitori uključujući sildenafil
English: Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Neparvis affects you.
Croatian: Prije nego što upravljate vozilom, upotrebljavate alate ili upravljate strojevima, ili provodite druge aktivnosti koje zahtijevaju koncentraciju, provjerite kako Neparvis utječe na Vas.
English: The clinical relevance of these findings is unknown.
Croatian: Klinička relevantnost tih nalaza nije poznata.
English: This medicine is not for use in children (aged below 18 years).
Croatian: Ovaj lijek nije za primjenu u djece (mlađe od 18 godina).
English: Amyloid content was not, however, measured quantitatively in this study.
Croatian: Amiloidni sadržaj nije, međutim, bio kvantitativno mjeren u ovom ispitivanju.
English: However, if you forget to take a dose, you should simply take the next one at the scheduled time.
Croatian: Međutim, ako zaboravite uzeti dozu, jednostavno uzmite sljedeću u planirano vrijeme.
English: If you feel dizzy or very tired while taking this medicine, do not drive a vehicle, cycle or use any tools or machines.
Croatian: Ako osjećate omaglicu ili ste vrlo umorni dok uzimate ovaj lijek, nemojte upravljati vozilom, voziti bicikl ili upotrebljavati bilo koje alate ili strojeve.
English: This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body.
Croatian: Ova vrsta zatajenja srca nastaje kada je srce slabo i ne može pumpati dovoljno krvi u pluća i ostatak tijela.
English: Symptomatic treatment should be provided.
Croatian: Potrebno je osigurati simptomatsko liječenje.
English: Relative risk reduction p-value ***
Croatian: Relativno smanjenje rizika p-vrijednost ***
English: ***One-sided p-value
Croatian: ***Jednostrana p-vrijednost
English: The tablets must be swallowed with a glass of water.
Croatian: Tablete se moraju progutati uz čašu vode.
English: This effect was observed early and was sustained throughout the duration of the study (see Figure 1).
Croatian: Ovaj je učinak bio uočen rano i održao se za vrijeme trajanja ispitivanja (vidjeti Sliku 1).
English: Do not stop taking your medicine unless your doctor tells you to.
Croatian: Nemojte prestati uzimati lijek ako Vam to ne kaže liječnik.
English: NT-proBNP is not a neprilysin substrate and is therefore a more suitable biomarker.
Croatian: NT-proBNP nije supstrat neprilizina i stoga je prikladniji biomarker.
English: Whilst there is no controlled epidemiological data on the risk with ARBs, similar risks may exist for this class of medicinal product.
Croatian: Dok nema kontroliranih epidemioloških podataka o riziku s ARB-ovima, slični rizici mogu postojati i za ovu skupinu lijekova.
English: • medicines that increase the amount of potassium in the blood.
Croatian: • lijekovi koji povećavaju količinu kalija u krvi.
English: This medicine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Croatian: Ovaj lijek se ne preporučuje u ranoj trudnoći te se ne smije uzimati kada ste trudni više od 3 mjeseca, jer može ozbiljno naštetiti Vašem djetetu ako se uzima nakon trećeg mjeseca trudnoće.
English: Your doctor will then adjust the dose depending on how you respond to the treatment until the best dose for you is found.
Croatian: Liječnik će Vam zatim prilagoditi dozu ovisno o tome kako odgovarate na liječenje dok se ne pronađe najbolja doza za Vas.
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • na zahtjev Europske agencije za lijekove; • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Fertility, reproduction and development
Croatian: Plodnost, razmnožavanje i razvoj
English: Hazard ratio (95% CI)
Croatian: Omjer rizika (95% CI)
English: It must not be re-administered.
Croatian: Ne smije se ponovno primijeniti.
English: What Neparvis is and what it is used for What you need to know before you take Neparvis How to take Neparvis
Croatian: Što je Neparvis i za što se koristi Što morate znati prije nego počnete uzimati Neparvis Kako uzimati Neparvis
English: Appropriate care should be exercised when initiating or ending concomitant treatment with such medicinal products.
Croatian: Potrebno je primijeniti odgovarajući oprez kod započinjanja ili završavanja istodobnog liječenja s takvim lijekovima.
English: If this happens, your doctor may reduce the dose of any other medicine you are taking, temporarily reduce your Neparvis dose, or stop your Neparvis treatment completely.
Croatian: Ako se to dogodi, Vaš liječnik može smanjiti dozu bilo kojeg drugog lijeka kojeg uzimate, privremeno smanjiti Vašu dozu Neparvisa ili u potpunosti prekinuti liječenje Neparvisom.
English: If you have accidentally taken too many Neparvis tablets, or if someone else has taken your tablets, contact your doctor immediately.
Croatian: Ako ste slučajno uzeli previše Neparvis tableta, ili ako je netko drugi uzeo Vaše tablete, odmah se obratite svom liječniku.
English: This finding is not considered adverse.
Croatian: Taj nalaz se ne smatra štetnim.
English: CYP 450 interactions
Croatian: Interakcije s CYP 450
English: Do not use any Neparvis pack that is damaged or shows signs of tampering.
Croatian: Nemojte koristiti niti jedno pakiranje Neparvisa koje je oštećeno ili na kojem su vidljivi znakovi otvaranja.
English: Elderly population The dose should be in line with the renal function of the elderly patient.
Croatian: Starija populacija Doza treba biti u skladu s bubrežnom funkcijom starijeg bolesnika.
English: Valsartan is minimally metabolised, as only about 20% of the dose is recovered as metabolites.
Croatian: Valsartan se minimalno metabolizira, budući da se samo oko 20% doze vraća u obliku metabolita.
English: Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Neparvis.
Croatian: Liječnik će Vas u pravilu savjetovati da prekinete uzimati ovaj lijek prije trudnoće ili čim saznate da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto Neparvisa.
English: In general no dose adjustment is required.
Croatian: U principu, nije potrebno prilagođavanje doze.
English: Limited data are available with regard to overdose in humans.
Croatian: Dostupni su ograničeni podaci o predoziranju u ljudi.
English: If you take more Neparvis than you should
Croatian: Ako uzmete više Neparvisa nego što ste trebali
English: *See description of selected adverse reactions.
Croatian: *Vidjeti opis odabranih nuspojava.
English: While there was no relevant change in urine volume, the urinary excretion of sodium was reduced within 4 hours and 24 hours after co-administration.
Croatian: Iako nije bilo relevantne promjene u volumenu urina, izlučivanje natrija putem urina smanjilo se u roku od 4 sata i 24 sata nakon istodobne primjene.
English: As they may be at higher risk for angioedema, caution is recommended if Neparvis is used in these patients.
Croatian: Budući da oni mogu biti izloženi povećanom riziku od angioedema, preporučuje se oprez ako se Neparvis koristi u tih bolesnika.
English: What you need to know before you take Neparvis
Croatian: Što morate znati prije nego počnete uzimati Neparvis
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded.
Croatian: Epidemiološki dokaz rizika teratogenosti nakon izlaganja ACE inhibitorima tijekom prvog tromjesečja trudnoće nije zaključan; međutim, mali porast rizika se ne može isključiti.
English: These may be signs of angioedema (an uncommon side effect which may affect up to 1 in 100 people).
Croatian: To bi mogli biti znakovi angioedema (manje česta nuspojava koja se može javiti u do 1 na 100 osoba).
English: • Second and third trimester of pregnancy (see section 4.6).
Croatian: • Drugo i treće tromjesečje trudnoće (vidjeti dio 4.6).
English: A decision should be made whether to abstain from breast-feeding or to discontinue Neparvis while breast-feeding, taking into account the importance of Neparvis to the mother.
Croatian: Potrebno je odlučiti treba li se suzdržati od dojenja ili prekinuti primjenu Neparvisa tijekom dojenja, uzimajući u obzir važnost Neparvisa za majku.
English: The median follow-up duration was 27 months and patients were treated for up to 4.3 years.
Croatian: Medijan trajanja praćenja bio je 27 mjeseci, a bolesnici su se liječili do 4,3 godine.
English: Swallow the tablets with a glass of water.
Croatian: Progutajte tablete uz čašu vode.
English: • Stop taking Neparvis and seek immediate medical attention if you notice any swelling of the face, lips, tongue and/or throat, which may cause difficulties in breathing or swallowing.
Croatian: • Prestanite uzimati Neparvis i odmah zatražite liječničku pozornost ako primijetite bilo što od navedenoga u nastavku: oticanje lica, usana, jezika i/ili grla, što može uzrokovati poteškoće s disanjem ili gutanjem.
English: Your doctor will decide your exact starting dose based on which medicines you have been taking previously.
Croatian: Vaš liječnik će odlučiti koja je početna doza prikladna za Vas na temelju toga koje ste lijekove uzimali prethodno.
English: • if you have ever had angioedema (see “Do not take Neparvis” and section 4 “Possible side effects”).
Croatian: • ako ste ikada imali angioedem (vidjeti „Nemojte uzimati Neparvis“ i dio 4 „Moguće nuspojave“).
English: Your doctor may check the amount of potassium in your blood at regular intervals during Neparvis treatment.
Croatian: Vaš liječnik Vam može provjeriti količinu kalija u krvi u redovitim intervalima tijekom liječenja Neparvisom.
English: The mean age of the population studied was 64 years of age and 19% were 75 years of age or older.
Croatian: Srednja dob ispitivane populacije bila je 64 godine, a 19% imalo je 75 godina ili više.
English: This medicine does not require any special temperature storage conditions.
Croatian: Ovaj lijek ne zahtijeva posebne temperaturne uvjete čuvanja.
English: Adverse reactions are ranked by System organ class and then by frequency with the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Croatian: Nuspojave su poredane po klasifikaciji organskih sustava i zatim po učestalosti, pri čemu su najučestalije navedene prve, prema sljedećoj konvenciji: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000).
English: If you are taking one of these, your doctor may want to check your kidney function when starting or adjusting treatment (see “Warnings and precautions”).
Croatian: Ako uzimate neki od njih, liječnik će Vam možda htjeti provjeriti bubrežnu funkciju kada se započinje ili prilagođava liječenje (vidjeti „Upozorenja i mjere opreza“).
English: At randomisation, 70% of patients were NYHA class II, 24% were class III and 0.7% were class IV.
Croatian: Kod randomizacije je 70% bolesnika bilo NYHA klase II, 24% je bilo klase III, a 0,7% je bilo klase IV.
English: One blister contains either 10 or 14 film-coated tablets.
Croatian: Jedan blister sadrži 10 ili 14 filmom obloženih tableta.
English: Interactions requiring precautions
Croatian: Interakcije koje zahtijevaju mjere opreza
English: ACE inhibitors are used to treat high blood pressure or heart failure.
Croatian: ACE inhibitori se koriste za liječenje visokog krvnog tlaka ili zatajenja srca.
English: OATP and MRP2 transporters
Croatian: OATP i MRP2 prijenosnici
English: These reach peak plasma concentrations in 2 hours, 1 hour, and 2 hours, respectively.
Croatian: Oni postižu vršne koncentracije u plazmi za 2 sata, 1 sat, odnosno 2 sata.
English: Other medicines and Neparvis Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Neparvis Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms.
Croatian: U slučajevima potvrđenog angioedema kada je oticanje ograničeno na lice i usta, stanje se općenito riješilo bez liječenja, iako su antihistaminici korisni u ublažavanju simptoma.
English: Table 2 Treatment effect for the primary composite endpoint, its components and all-cause mortality over a median follow-up of 27 months
Croatian: Tablica 2 Učinak liječenja za primarni kompozitni ishod, njegove komponente i smrtnost od svih uzroka tijekom medijana praćenja od 27 mjeseci
English: B-type natriuretic peptide (BNP)
Croatian: B-tip natriuretskog peptida (BNP)
English: • some medicines known as statins that are used to lower high cholesterol levels (for example atorvastatin).
Croatian: • neki lijekovi poznati kao statini koji se koriste za snižavanje visokih razina kolesterola (na primjer atorvastatin).
English: The clinical relevance of this finding is not known (see section 5.3).
Croatian: Klinička relevantnost ovog nalaza nije poznata (vidjeti dio 5.3).