FrancophonIA/ELRC3.0 huggingface dataset:
English: Oprymea tablets should be swallowed with water.
Croatian: Tablete lijeka Oprymea treba progutati s vodom.
English: The prolonged-release tablets must not be chewed, divided or crushed, and should be taken around the same time every day.
Croatian: Tablete s produljenim oslobađanjem ne smiju se žvakati, dijeliti ili drobiti te se trebaju uzimati u otprilike isto doba svakoga dana.
English: Oprymea (pramipexole)
Croatian: Oprymea (pramipeksol)
English: What is Oprymea and what is it used for?
Croatian: Što je Oprymea i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Oprymea?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Oprymea?
English: It is available as immediate-release tablets (0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg and 1.1 mg) and prolonged-release tablets (0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg).
Croatian: Dostupan je u obliku tableta s neposrednim oslobađanjem (0,088 mg, 0,18 mg, 0,35 mg, 0,7 mg i 1,1 mg) i tableta s produljenim oslobađanjem (0,26 mg, 0,52 mg, 1,05 mg, 1,57 mg, 2,1 mg, 2,62 mg i 3,15 mg).
English: Oprymea can be used either on its own or in combination with levodopa (another medicine for Parkinson's disease), at any stage of disease including the later stages when levodopa starts becoming less effective;
Croatian: Lijek Oprymea može se primjenjivati u monoterapiji ili u kombinaciji s levodopom (drugi lijek za Parkinsonovu bolest), u bilo kojem stadiju bolesti, uključujući kasnije stadije kad lijek levodopa počninje biti manje djelotvoran;
English: What are the benefits and risks of Oprymea?
Croatian: Koje su koristi i rizici lijeka Oprymea?
English: The recommended starting dose is one 0.088 mg tablet, but, if needed, this can be increased every four to seven days to reduce symptoms further, to a maximum of three 0.18 mg tablets.
Croatian: Preporučena početna doza je jedna tableta od 0,088 mg, no ako je potrebno ona se može povećavati svakih četiri do sedam dana kako bi se dodatno smanjili simptomi, najviše do tri tablete od 0,18 mg.
English: Oprymea received a marketing authorisation valid throughout the EU on 12 September 2008.
Croatian: Lijek Oprymea dobio je odobrenje za stavljanje lijeka u promet koje je na snazi na prostoru EU-a od 12. rujna 2008.
English: Oprymea is used when a specific cause for the disorder cannot be identified.
Croatian: Lijek Oprymea primjenjuje se u slučajevima kada se ne može utvrditi specifičan uzrok poremećaja.
English: • moderate to severe restless-legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Croatian: • umjerenog do teškog sindroma nemirnih nogu, poremećaja kod kojeg bolesnik ima nesavladiv poriv za pokretanjem ekstremiteta kako bi prekinuo neugodne, bolne ili neobične osjete u tijelu, uglavnom noću.
English: Other information about Oprymea
Croatian: Ostale informacije o lijeku Oprymea
English: As for every medicine, the company provided studies on the quality of Oprymea.
Croatian: Kao i za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kvalitete lijeka Oprymea.
English: For more information about using Oprymea, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Oprymea, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Why is Oprymea authorised in the EU?
Croatian: Zašto je lijek Oprymea odobren u EU-u?
English: Immediate-release tablets release the active substance into the body immediately, and prolonged-release tablets release it slowly over a few hours.
Croatian: Tablete s neposrednim oslobađanjem otpuštaju djelatnu tvar odmah, a tablete s produljenim oslobađanjem otpuštaju je polako tijekom nekoliko sati.
English: Side effects reported with Oprymea are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Oprymea pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Sifrol, and do not need to be repeated for Oprymea.
Croatian: Ispitivanja koristi i rizika djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Sifrol, i stoga ih nije potrebno ponavljati za lijek Oprymea.
English: • Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Croatian: • Parkinsonove bolesti, progresivne bolesti mozga koja uzrokuje tresavicu, usporene pokrete i ukočenost mišića.
English: An overview of Oprymea and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Oprymea i zašto je odobren u EU-u
English: Because Oprymea is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Oprymea generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: The prolonged-release tablets are not suitable for restless-legs syndrome.
Croatian: Tablete s produljenim oslobađanjem nisu prikladne za sindrom nemirnih nogu.
English: Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination.
Croatian: Dopamin djeluje kao glasnik u dijelovima mozga koji kontroliraju kretanje i koordinaciju.
English: Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the symptoms of Parkinson's disease, such as shaking, stiffness and slowness of movement.
Croatian: Pramipeksol stimulira mozak na isti način kao i dopamin tako da bolesnici mogu kontrolirati svoje pokrete te imaju manje simptoma Parkinsonove bolesti poput tresavice, ukočenosti i usporavanja pokreta.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oprymea have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Oprymea nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: For restless-legs syndrome, Oprymea immediate-release tablets should be taken once a day, two to three hours before going to bed.
Croatian: Kod sindroma nemirnih nogu, lijek Oprymea u obliku tableta s neposrednim oslobađanjem treba uzimati jedanput na dan, dva do tri sata prije odlaska na počinak.
English: Oprymea must be given less frequently in patients who have problems with their kidneys.
Croatian: Lijek Oprymea treba rjeđe davati bolesnicima koji imaju problema s bubrezima.
English: The maximum daily dose for the immediate-release tablets is 1.1 mg three times a day and in case of the prolonged release tablets is 3.15 mg once a day.
Croatian: Maksimalna dnevna doza za tablete s neposrednim oslobađanjem je 1,1 mg tri puta na dan te u slučaju tableta s produljenim oslobađanjem 3,15 mg jedanput na dan.
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which can be corrected by pramipexole.
Croatian: Smatra se da je sindrom prouzročen problemima u načinu djelovanja dopamina u mozgu, što se može ispraviti primjenom pramipeksola.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Oprymea has been shown to have comparable quality and to be bioequivalent to Sifrol.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, lijek Oprymea dokazao usporedivu kakvoću te da je bioekvivalentan lijeku Sifrol.
English: Oprymea can only be obtained with a prescription.
Croatian: Oprymea se izdaje samo na recept.
English: The way pramipexole works in restless-legs syndrome is not fully understood.
Croatian: Način djelovanja pramipeksola kod sindroma nemirnih nogu nije u potpunosti poznat.
English: The active substance in Oprymea, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Croatian: Djelatna je tvar u lijeku Oprymea je pramipeksol, agonist dopamina koji imitira djelovanje dopamina.
English: Therefore, the Agency's view was that, as for Sifrol, the benefit of Oprymea outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist kod lijeka Oprymea, kao i kod lijeka Sifrol, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: In patients with Parkinson's disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases.
Croatian: U bolesnika s Parkinsonovom bolešću stanice koje proizvode dopamin počinju odumirati te se smanjuje količina dopamina u mozgu.
English: For Parkinson's disease, the starting dose is either one 0.088 mg immediate-release tablet three times a day or one 0.26 mg prolonged-release tablet once a day.
Croatian: Kod Parkinsonove bolesti, početna je doza tableta s neposrednim oslobađanjem od 0,088 mg tri puta na dan ili tableta s produljenim oslobađanjem od 0,26 mg jedanput na dan.
English: As for all medicines, data on the use of Oprymea are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Oprymea kontinuirano se prate.
English: How does Oprymea work?
Croatian: Kako djeluje Oprymea?
English: This means that Oprymea contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Sifrol (also known as Mirapexin).
Croatian: To znači da Oprymea sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Sifrol (također poznat i kao Mirapexin) Više informacija o generičkim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje.
English: Oprymea contains the active substance pramipexole.
Croatian: Oprymea sadrži djelatnu tvar pramipeksol.
English: How is Oprymea used?
Croatian: Kako se Oprymea koristi?
English: How has Oprymea been studied?
Croatian: Kako je lijek Oprymea ispitivan?
English: It was to be available as tablets (125 mg and 250 mg).
Croatian: Trebao je biti dostupan u obliku tableta (od 125 mg i 250 mg).
English: The main measure of effectiveness is the number of patients who respond to treatment.
Croatian: Glavno mjerilo učinkovitosti jest broj pacijenata s pozitivnim odgovorom na liječenje.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27. svibnja 2016.
English: In addition, QT prolongation (a change in the heart's electrical activity) and cases of serious heart problems presented a safety concern.
Croatian: Osim toga, QT-prolongacija (promjena u električnoj aktivnosti srca) i slučajevi ozbiljnih problema sa srcem predstavljali su razloge za zabrinutost.
English: What is Xegafri?
Croatian: Što je Xegafri?
English: In lung cancer cells, EGFR is often overactive, causing uncontrolled division of cancer cells.
Croatian: U stanicama raka pluća EGFR je često pretjerano aktivan što uzrokuje nekontrolirano dijeljenje stanica raka.
English: EGFR controls growth and division of cells.
Croatian: EGFR upravlja rastom i dijeljenjem stanica.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing its application because of a revised business strategy for the product.
Croatian: U dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev zbog izmjene poslovne strategije za taj proizvod.
English: The company informed the CHMP that they will stop enrolling patients in the ongoing clinical trials.
Croatian: Tvrtka je obavijestila CHMP da će prestati s uključivanjem pacijenata u klinička ispitivanja koja su u tijeku.
English: In addition, patients currently receiving Xegafri through a compassionate use programme can continue to receive this medicine.
Croatian: Osim toga, pacijenti koji trenutačno primaju lijek Xegafri u programu milosrdnog davanja lijekova mogu i dalje dobivati ovaj lijek.
English: The data provided were too limited to enable evaluation of the effectiveness of Xegafri at this time.
Croatian: Dostavljeni podaci bili su preoskudni da bi se u tom trenutku omogućila ocjena učinkovitosti lijeka Xegafri.
English: The company will continue to provide Xegafri to patients whose doctor recommend they should continue to take this medicine.
Croatian: Tvrtka će osigurati lijek Xegafri za pacijente kojima su liječnici preporučili da nastave uzimati taj lijek.
English: In these studies, Xegafri is not compared with any other treatment.
Croatian: U tim ispitivanjima, lijek Xegafri nije uspoređen niti s jednom drugom terapijom.
English: How is Xegafri expected to work?
Croatian: Kako je Xegafri trebao djelovati?
English: Withdrawal of the marketing authorisation application for Xegafri (rociletinib)
Croatian: Povlačenje zahtjeva za odobrenje za stavljanje u promet lijeka Xegafri (rociletinib)
English: This means that it blocks the activity of enzymes known as tyrosine kinases, particularly tyrosine kinases that are present in EGFRs.
Croatian: To znači da onemogućuje djelovanje enzima poznatih pod nazivom tirozin kinaze, osobito tirozin kinaza koje se nalaze u EGFR-ovima.
English: Xegafri is a medicine that contains the active substance rociletinib.
Croatian: Xegafri je lijek koji sadrži djelatnu tvar rociletinib.
English: Xegafri was to be used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults who have the T790M mutation (a particular change in the gene for a protein called epidermal growth factor receptor or EGFR) and who had already been treated with EGFR-targeted therapy.
Croatian: Lijek Xegafri trebao se koristiti za liječenje vrste raka pluća koji se naziva rak pluća nemalih stanica (NSCLC) u odraslih pacijenata s mutacijom T790M (određenom promjenom u genu za protein koji se naziva receptor epidermalnog faktora rasta ili EGFR) koji su prethodno već liječeni EGFR-ciljanom terapijom.
English: What was Xegafri expected to be used for?
Croatian: Za što se Xegafri trebao koristiti?
English: By blocking the tyrosine kinase in EGFR, rociletinib is expected to help reduce the growth and spread of the cancer.
Croatian: Onemogućivanjem djelovanja tirozin kinaze u EGFR-u rociletinib bi trebao pomoći u smanjenju rasta i širenja raka.
English: Unlike most other tyrosine kinase inhibitors, rociletinib targets cancer cells with the T790M mutation in the EGFR gene.
Croatian: Za razliku od ostalih inhibitora tirozin kinaza, rociletinib djeluje na stanice raka s mutacijom T790M u genu EGFR-a.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Xegafri could not have been approved for the treatment of NSCLC patients who have the T790M mutation.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja, CHMP je smatrao da postoje problemi te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Xegafri za liječenje pacijenata s NSCLC-om s mutacijom T790M.
English: Xegafri is being investigated in two studies in 457 NSCLC patients who have the T790M mutation and had already been treated with EGFR-targeted therapy.
Croatian: Lijek Xegafri ispituje se u dvama ispitivanjima koja uključuju 457 pacijenata s NSCLC-om s mutacijom T790M koji su prethodno već liječeni EGFR-ciljanom terapijom.
English: On 3 May 2016, Clovis Oncology UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Xegafri, for the treatment of non-small cell lung cancer.
Croatian: Ltd službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoju prijavu za odobrenje za stavljanje u promet lijeka Xegafri, za liječenje raka pluća nemalih stanica.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Xegafri did not outweigh its risks.
Croatian: Sukladno navedenome, u vrijeme povlačenja, CHMP je smatrao kako koristi od lijeka Xegafri ne nadmašuju s njim povezane rizike.
English: The active substance in Xegafri, rociletinib, is a tyrosine kinase inhibitor.
Croatian: Djelatna tvar u lijeku Xegafri, rociletinib, inhibitor je tirozin kinaza.
English: 1 ml (100 mg/ml) 2 (2 x 1) pre-filled syringes (multipack)
Croatian: 1 ml (100 mg/ml) 2 (2 x 1) napunjene štrcaljke (višestruko pakiranje)
English: 1 ml (100 mg/ml) 2 (2 x 1) pre-filled pens (multipack)
Croatian: 1 ml (100 mg/ml) 2 (2 x 1) napunjene brizgalice (višestruko pakiranje)
English: 2 pre-filled syringes + 2 safety needles
Croatian: 2 napunjene štrcaljke + 2 sigurnosne igle
English: 1 pre-filled syringe + 1 safety needle
Croatian: 1 napunjena štrcaljka + 1 sigurnosna igla
English: Invented name Strength Pharmaceutical Form
Croatian: Farmaceutski oblik
English: Packaging Content Package size
Croatian: Ciljne vrste Put primjene Pakiranje Sadržaj Veličina pakiranja
English: (EU) MA number Invented name
Croatian: Broj EU odobrenja Zaštićeno ime
English: Raxone has been authorised under ‘exceptional circumstances'.
Croatian: Raxone je odobren u „iznimnim okolnostima”.
English: Raxone is available as 150 mg tablets, and the recommended dose is two tablets taken three times a day with food.
Croatian: Raxone je dostupan kao tablete od 150 mg, a preporučena doza je dvije tablete koje se uzimaju tri puta na dan sa hranom.
English: Raxone idebenone
Croatian: Raxone idebenon
English: Raxone is a ‘hybrid medicine'.
Croatian: Raxone je „hibridni lijek”.
English: Patients affected by LHON have mutations (defects) in the genetic material of mitochondria.
Croatian: Bolesnici koji boluju od LHON-a imaju mutacije (nedostatke) u genetskom materijalu mitohondrija.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Raxone contains idebenone at a different strength.
Croatian: To znači da je sličan „referentom lijeku” koji sadrži iste djelatne tvari, no Raxone sadrži idebenon druge jačine.
English: This is because it has not been possible to obtain complete information about Raxone due to the rarity of the disease.
Croatian: Tome je razlog nemogućnost dobivanja potpunih informacija o lijeku Raxone zbog rijetkosti bolesti.
English: This is a summary of the European public assessment report (EPAR) for Raxone.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Raxone.
English: The main measure of effectiveness was improvement in vision, mostly based on the numbers of letters patients were able to read on a standard eye test chart.
Croatian: Glavni pokazatelj učinkovitosti bilo je poboljšanje vida, većinom na temelju na broju slova koje su bolesnici bili sposobni pročitati na standardnoj ploči za testiranje vida.
English: The reference medicine for Raxone is Mnesis (45 mg tablets).
Croatian: Referentni lijek za lijek Raxone je Mnesis (tablete od 45 mg).
English: Furthermore, some patients who were classified as ‘off chart' (unable to read any letters on the chart) at the beginning of the study were able to read at least one line during the eye test after treatment, and this was also considered clinically important.
Croatian: Nadalje, pojedini bolesnici koji su klasificirani kao „najlošiji” (nisu mogli pročitati nijedno slovo s ploče) na početku ispitivanja, nakon terapije mogli su pročitati najmanje jedan red tijekom testiranja oka, što je također ocijenjeno klinički važnim.
English: European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Croatian: Svake godine Europska agencija za lijekove procjenjuje sve nove dostupne informacije te se ovaj sažetak po potrebi ažurira.
English: Additionally, 30% of patients treated with Raxone (16 out of 53) had a clinically relevant recovery of vision in at least one eye, compared with 10% of patients (3 out of 29) in the placebo group.
Croatian: Osim toga, 30 % bolesnika liječenih lijekom Raxone (16 od 53) doživjelo je klinički značajan oporavak vida u najmanje jednom oku, u usporedbi s 10 % bolesnika (3 od 29) u placebo skupini.
English: It is not intended to provide practical advice on how to use Raxone.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Raxone.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Raxone are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Raxone nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: What is Raxone and what is it used for?
Croatian: Što je Raxone i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Raxone?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Raxone?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Raxone can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Raxone dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: The Committee noted the lack of treatments for preventing or reversing the vision loss in patients with LHON.
Croatian: Odbor je zaključio da postoji nedostatak terapija za sprječavanje ili poništavanje gubitka vida u bolesnika s LHON-om.
English: This means that mitochondria do not work properly to generate energy, and produce toxic forms of oxygen (free radicals) that damage nerve cells in the eye that are needed for vision.
Croatian: To znači da mitohondriji ne funkcioniraju ispravno i stvaraju energiju te da proizvode toksične oblike kisika (slobodne radikale) koji oštećuju živčane stanice u oku koje su potrebne za vid.
English: By the end of the study, patients treated with Raxone were able to read on average 3 to 6 letters more compared with patients receiving placebo.
Croatian: Do završetka ispitivanja bolesnici liječeni lijekom Raxone mogli su pročitati prosječno 3 do 6 slova više u odnosu na bolesnike koji su primali placebo.
English: Because the number of patients with Leber's hereditary optic neuropathy is low, the disease is considered ‘rare', and Raxone was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 February 2007.
Croatian: Budući da je broj bolesnika s Leberovom nasljednom optičkom neuropatijom nizak, ta se bolest smatra „rijetkom” te je lijek Raxone uvršten u skupinu lijekova za rijetke bolesti 15. veljače 2007.
English: Other information about Raxone
Croatian: Ostale informacije o lijeku Raxone
English: A risk management plan has been developed to ensure that Raxone is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Raxone.
English: Idebenone is thought to help improve production of energy by restoring mitochondrial function, thereby preventing the cellular damage and the loss of sight seen in LHON.
Croatian: Smatra se da idebenon pomaže u proizvodnji energije tako što ponovno uspostavlja mitohondrijsko djelovanje te stoga sprječava stanično oštećenje i gubitak vida uočen kod LHON-a.
English: The most common side effects with Raxone (which may affect more than 1 in 10 people) are nasopharyngitis and cough; mild to moderate diarrhoea and back pain are also common (affecting up to 1 in 10 people).
Croatian: Najčešće nuspojave lijeka Raxone (koje su uočene u više od 1 na 10 bolesnika) su nazofaringitis i kašalj; blagi do umjereni proljev i bol u leđima najčešće su nuspojave (zahvaćaju do 1 na 10 osoba).