FrancophonIA/ELRC3.0 huggingface dataset:
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Croatian: „Želučanootporno” znači da sadržaji tablete prolaze kroz želudac bez razgradnje sve dok ne dosegnu crijeva.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Croatian: Neurotransmiteri su kemikalije u živčanom sustavu koje omogućuju međusobnu komunikaciju živčanih stanica.
English: Since these neurotransmitters are involved in maintaining high mood and reducing the sensation of pain, blocking their re-uptake into nerve cells can improve the symptoms of depression, anxiety and neuropathic pain.
Croatian: Budući da su neurotransmiteri uključeni u održavanje dobrog raspoloženja i smanjivanje osjećaja boli, inhibirajući njihov ponovni unos u živčane stanice poboljšavaju se simptomi depresije, anksioznosti i neuropatske boli.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Croatian: • boli uslijed dijabetske periferne neuropatije (oštećenje živaca u ekstremitetima koje može nastupiti u bolesnika s dijabetesom);
English: Duloxetine Mylan is used to treat adults with the following diseases:
Croatian: Duloxetine Mylan se koristi za liječenje odraslih osoba sa sljedećim bolestima:
English: This prevents the active substance being destroyed by the acid in the stomach.
Croatian: Na ovaj se način sprječava razgradnja djelatne tvari kiselinom u želucu.
English: It works by preventing the neurotransmitters serotonin (5-hydroxytryptamine) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Croatian: Djeluje sprečavajući neurotransmitere serotonin (5-hidroksitriptamin) i noradrenalin od ponovne apsorpcije u živčane stanice u mozgu i leđnoj moždini.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Croatian: Inhibirajući ponovni unos, duloksetin povećava količinu ovih neurotransmitora u prostoru između živčanih stanica, povećavajući razinu komunikacije između stanica.
English: The dose of Duloxetine Mylan should be reduced gradually when stopping treatment.
Croatian: Dozu lijeka Duloxetine Mylan treba postepeno smanjivati prilikom prekida terapije.
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Duloxetine Mylan.
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Croatian: U slučaju generaliziranih anksioznih poremećaja, preporučena početna doza iznosi 30 mg jednom na dan. no doza se može povećati na 60, 90 ili 120 mg ovisno o odgovoru bolesnika.
English: In patients who respond to Duloxetine Mylan, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Croatian: U bolesnika koji su odgovorili na Duloxetine Mylan, terapiju treba nastaviti tijekom nekoliko mjeseci da bi se spriječio povratak bolesti ili dulje u bolesnika koji imaju ponovljena razdoblja depresije u prošlosti.
English: The Committee recommended that Duloxetine Mylan be approved for use in the EU.
Croatian: Odbor je preporučio odobrenje lijeka Duloxetine Mylan za korištenje u EU-u.
English: Duloxetine Mylan duloxetine
Croatian: Duloxetine Mylan duloksetine
English: Patients who also have major depression should start with 60 mg once a day.
Croatian: Bolesnici koji imaju veće depresije trebaju započeti s dozom od 60 mg jednom na dan.
English: For major depression, the recommended dose of Duloxetine Mylan is 60 mg once a day.
Croatian: U slučaju velikih depresija, preporučena doza lijeka Duloxetine Mylan iznosi 60 mg jednom na dan.
English: This means that Duloxetine Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Croatian: To znači da je Duloxetine Mylan sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Cymbalta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duloxetine Mylan on 19 June 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Duloxetine Mylan na snazi u Europskoj uniji od 19. lipnja 2015.
English: Duloxetine Mylan is available as gastroresistant capsules (30 and 60 mg).
Croatian: Dostupan je kao želučanootporne kapsule (30 i 60 mg).
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day.
Croatian: U slučaju dijabetske neuropatske boli, preporučena doza iznosi 60 mg na dan, no za pojedine bolesnike može biti potrebna veća doza od 120 mg na dan.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Mylan has been shown to have comparable quality and to be bioequivalent to Cymbalta.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Duloxetine Mylan posjeduje usporedivu kakvoću te je bioekvivalentan s lijekom Cymbalta.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Duloxetine Mylan nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What measures are being taken to ensure the safe and effective use of Duloxetine Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Duloxetine Mylan?
English: In patients who respond to Duloxetine Mylan, treatment should continue for several months, to prevent the disorder coming back.
Croatian: U bolesnika koji su odgovorili na lijek Duloxetine Mylan, terapiju treba nastaviti tijekom nekoliko mjeseci kako bi se spriječio povratak poremećaja.
English: What is Duloxetine Mylan and what is it used for?
Croatian: Što je Duloxetine Mylan i za što se koristi?
English: It is not intended to provide practical advice on how to use Duloxetine Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Duloxetine Mylan.
English: The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Croatian: Djelatna tvar lijeka Duloxetine Mylan , duloksetin, je inhibitor ponovnog unosa serotonin noradrenalina.
English: The full EPAR and risk management plan summary for Duloxetine Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Duloxetine Mylan nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Duloxetine Mylan pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: For practical information about using Duloxetine Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Duloxetine Mylan bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Because Duloxetine Mylan is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Duloxetine Mylan generički lijek, smatra se da su njegovi koristi i rizici isti kao i kod referentnog lijeka.
English: What are the benefits and risks of Duloxetine Mylan?
Croatian: Koje su koristi i rizici od lijeka Duloxetine Mylan?
English: A risk management plan has been developed to ensure that Duloxetine Mylan is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Duloxetine Mylan.
English: Because Duloxetine Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cymbalta.
Croatian: Budući da je Duloxetine Mylan generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje da je lijek bioekvivalentan referentnom lijeku Cymbalta.
English: Duloxetine Mylan contains the active substance duloxetine and is a ‘generic medicine'.
Croatian: Duloxetine Mylan sadrži djelatnu tvar duloksetin te je „generički lijek”.
English: Other information about Duloxetine Mylan
Croatian: Ostale informacije o lijeku Duloxetine Mylan
English: Why is Duloxetine Mylan approved?
Croatian: Zašto je Duloxetine Mylan odobren?
English: Therefore, the CHMP's view was that, as for Cymbalta, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da u pogledu lijeka Duloxetine Mylan koristi nadmašuju utvrđene rizike.
English: How is Duloxetine Mylan used?
Croatian: Kako se koristi Duloxetine Mylan?
English: How does Duloxetine Mylan work?
Croatian: Kako djeluje Duloxetine Mylan?
English: How has Duloxetine Mylan been studied?
Croatian: Kako je Duloxetine Mylan ispitivan?
English: It is used in the following ways:
Croatian: Primjenjuje se na sljedeće načine:
English: Further information on Kigabeq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Kigabeq možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The company provided information from the published literature on the benefits and risks of vigabatrin in the approved uses.
Croatian: Tvrtka je dostavila informacije iz objavljene literature o koristima i rizicima vigabatrina u odobrenim primjenama.
English: Other common side effects include psychiatric disorders such as agitation, excitedness, aggression, nervousness, depression and paranoid reactions, as well as reduced consciousness and confusion.
Croatian: Druge učestale nuspojave obuhvaćaju psihijatrijske poremećaje kao što su uznemirenost, ekscitacija, agresija, nervoza, depresija i paranoične reakcije, kao i smanjena razina svijesti te zbunjenost.
English: The medicine is available as soluble tablets of 100 or 500 mg, with a score-line so they can be halved.
Croatian: Lijek je dostupan u obliku topivih tableta od 100 ili 500 mg s razdjelnom crtom kako bi se mogle prepoloviti.
English: This helps suppress the abnormal electrical activity that leads to infantile spasms and partial epilepsy, and so controls the symptoms of these conditions.
Croatian: Time se pomaže u suzbijanju abnormalne električne aktivnosti koja dovodi do infantilnih spazama i parcijalne epilepsije, čime se kontroliraju simptomi navedenih stanja.
English: Because the effects on vision can lead to blindness, vigabatrin should only be used after careful assessment of possible alternatives, and patients' vision must be regularly tested during treatment.
Croatian: Budući da učinci na vid mogu dovesti do sljepoće, vigabatrin se treba koristiti isključivo nakon pažljive procjene mogućih alternativa, a bolesnikov vid mora se redovito ispitivati tijekom liječenja.
English: • together with other medicines to treat partial epilepsy (seizures affecting one part of the brain), including when the seizures spread to other parts of the brain and become more generalised.
Croatian: • zajedno s drugim lijekovima za liječenje parcijalne epilepsije (napadaji koji utječu na jedan dio mozga), uključujući kada se napadaji šire na druge dijelove mozga i postaju općenitiji.
English: In patients who cannot drink it can be given by a tube into the stomach.
Croatian: U bolesnika koji ne mogu popiti otopinu može se davati s pomoću cjevčice u želudac.
English: Vigabatrin should not be used in patients who already have visual field defects.
Croatian: Vigabatrin se ne smije koristiti u bolesnika koji već imaju oštećenja vidnog polja.
English: Blocking the enzyme that breaks it down increases the amount of GABA present in the brain, and so increases its effect.
Croatian: Blokiranjem enzima koji ga razgrađuje povećava količinu tvari GABA koja je prisutna u mozgu, čime povećava njezin učinak.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Kigabeq is available in a different form and strengths.
Croatian: To znači da je sličan „referentnom lijeku” koji sadrži istu djelatnu tvar, ali je lijek Kigabeq dostupan u drugim oblicima i jačinama.
English: Kigabeq is a medicine for treating epilepsy in children between 1 month and 7 years of age.
Croatian: Kigabeq je indiciran za liječenje epilepsije u djece u dobi od jednog mjeseca do sedam godina.
English: The dose depends on the condition being treated and the patient's body weight, and is adjusted according to the patient's response to treatment.
Croatian: Doza ovisi o stanju koje se liječi i tjelesnoj masi bolesnika i prilagođava se u skladu s reakcijom bolesnika na liječenje.
English: • on its own to treat infantile spasms (West syndrome), a rare epilepsy disorder that starts at a very young age, usually in the first few months of life;
Croatian: • kao monoterapija za liječenje infantilnih spazama (Westov sindrom), rijetkog epileptičkog poremećaja koji započinje u vrlo ranoj dobi, najčešće tijekom prvih nekoliko mjeseci života;
English: Kigabeq is only used in partial epilepsy when patients have already tried all other appropriate treatments or cannot use them because of side effects.
Croatian: Kigabeq se koristi isključivo za liječenje parcijalne epilepsije nakon što su bolesnici već pokušali sa svim ostalim prikladnim terapijama ili ih ne mogu primjenjivati zbog nuspojava.
English: The most common side effects with vigabatrin (which may affect more than 1 in 10 people) are visual field defects (effects on vision), tiredness, sleepiness and joint pains.
Croatian: Najčešće nuspojave vigabatrina (mogu se pojaviti u više od 1 na 10 osoba) jesu oštećenja vidnog polja (učinci na vid), umor, pospanost i bol u zglobovima.
English: The reference medicine for Kigabeq is Sabril (500 mg granules).
Croatian: Referentni lijek za Kigabeq je Sabril (granule od 500 mg).
English: What measures are being taken to ensure the safe and effective use of Kigabeq?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kigabeq?
English: The tablets are dissolved in water to make a solution for the patient to drink.
Croatian: Tablete se otapaju u vodi kako bi se dobila otopina koji bolesnik može popiti.
English: GABA reduces the electrical activity of the brain.
Croatian: električnu aktivnost mozga.
English: Rarely there may be effects on the retina (the light-sensing layer at the back of the eye), encephalopathy (brain damage) or attempts at suicide.
Croatian: Rijetko se mogu pojaviti učinci na mrežnicu (sloj stražnjeg dijela oka osjetljiv na svjetlost), encefalopatija (oštećenje mozga) ili pokušaji samoubojstva.
English: The active substance in Kigabeq, vigabatrin, blocks the action of an enzyme called GABA transaminase, which breaks down a substance in the brain called GABA (gamma aminobutyric acid).
Croatian: Djelatna tvar u lijeku Kigabeq, vigabatrin, blokira djelovanje enzima koji se naziva GABA transaminaza, a koji razgrađuje tvar u mozgu koja se naziva GABA (gama-aminomaslačna kiselina).
English: Side effects reported with Kigabeq are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Kigabeq pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What is Kigabeq and what is it used for?
Croatian: Što je Kigabeq i za što se primjenjuje?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kigabeq 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 Kigabeq nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: As for every medicine, the company provided studies on the quality of Kigabeq.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Kigabeq.
English: Kigabeq can only be obtained with a prescription and treatment must started and supervised by a doctor specialising in the treatment of epilepsy or nervous system disorders.
Croatian: Kigabeq se izdaje samo na liječnički recept, a terapiju mora započeti i pratiti liječnik s iskustvom u liječenju epilepsije ili poremećaja živčanog sustava.
English: An overview of Kigabeq and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Kigabeq i zašto je odobren u EU-u
English: Other information about Kigabeq
Croatian: Ostale informacije o lijeku Kigabeq
English: What are the risks associated with Kigabeq?
Croatian: Koji su rizici povezani s lijekom Kigabeq?
English: Why is Kigabeq authorised in the EU?
Croatian: Zašto je lijek Kigabeq odobren u EU-u?
English: As for all medicines, data on the use of Kigabeq are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Kigabeq kontinuirano se prate.
English: For more information about using Kigabeq, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Kigabeq pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Kigabeq contains the active substance vigabatrin and is a ‘hybrid medicine'.
Croatian: Kigabeq sadrži djelatnu tvar vigabatrin te je „hibridni lijek”.
English: It also carried out a study that showed that Kigabeq is bioequivalent to the reference medicine, Sabril.
Croatian: Tvrtka je također provela ispitivanje koje je pokazalo da je lijek Kigabeq „bioekvivalentan” referentnom lijeku Sabril.
English: The European Medicines Agency decided that in accordance with EU requirements, Kigabeq has been shown to have comparable quality and to be bioequivalent to Sabril.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Kigabeq dokazao kakvoću, sigurnost i učinkovitost usporedivu s lijekom Sabril.
English: What benefits of Kigabeq have been shown in studies?
Croatian: Koje su koristi od lijeka Kigabeq utvrđene u ispitivanjima?
English: Therefore, the Agency's view was that, as for Sabril, Kigabeq's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist lijeka Kigabeq, kao i od lijeka Sabril, nadmašuje identificirani rizik te da lijek može biti odobren.
English: How is Kigabeq used?
Croatian: Kako se Kigabeq primjenjuje?
English: How does Kigabeq work?
Croatian: Kako djeluje Kigabeq?
English: For the full list of side effects and restrictions with Kigabeq, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Kigabeq potražite u uputi o lijeku.
English: Note: P values in the table are nominal.
Croatian: Napomena: P vrijednosti u tablici su nominalne.
English: Check with the doctor if you are not sure.
Croatian: Provjerite s liječnikom ako niste sigurni.
English: Respiratory events
Croatian: Respiratorni događaji
English: (See the end of section 2 - Important information about the contents of Orkambi.)
Croatian: (Pogledajte na kraju dijela 2 - Važne informacije o sadržaju lijeka Orkambi.)
English: Changes in FEV1
Croatian: Promjene u FEV1
English: No data are available (see section 5.1).
Croatian: Nema dostupnih podataka (vidjeti dio 5.1).
English: The apparent terminal half-life is approximately 26 hours.
Croatian: Prividni terminalni poluvijek iznosi približno 26 sati.
English: All other drug interactions shown are predicted.
Croatian: Sve su druge prikazane interakcije lijekova predviđene.
English: Component of a multipack, cannot be sold separately
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati zasebno.
English: Most of these reactions were mild or moderate in severity and non-serious.
Croatian: Većina tih reakcija bile su blage ili umjerene težine i nisu bile ozbiljne.
English: • Nutritional bars or drinks
Croatian: • hranjive pločice ili pića.
English: As such, risks to the suckling child cannot be excluded.
Croatian: Zbog toga se rizici za dojenče ne mogu isključiti.
English: These results are presented in Table 7 below:
Croatian: Ti su rezultati prikazani u tablici 7 niže:
English: Your child's doctor will determine the correct dose for your child.
Croatian: Djetetov liječnik odredit će odgovarajuću dozu za Vaše dijete.
English: Like all medicines, this medicine can cause side effects although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Based on exposure and indicated doses, the interaction profile is considered to be the same for all strengths and pharmaceutical forms.
Croatian: Na temelju izloženosti i indiciranih doza, smatra se da je profil interakcija isti za sve jačine i farmaceutske oblike.
English: Side effects seen in children are similar to those seen in adults and adolescents.
Croatian: Nuspojave opažene u djece slične su onima koje se opažaju u odraslih i adolescenata.
English: Following this period, the recommended daily dose should be continued.
Croatian: Poslije tog razdoblja treba nastaviti s preporučenom dnevnom dozom.
English: † Indicates statistical significance confirmed in the hierarchical testing procedure.
Croatian: †Pokazuje statističku značajnost potvrđenu postupkom hijerarhijskog testiranja.
English: • Usual dose: Take one sachet of ORKAMBI granules every 12 hours.
Croatian: • Uobičajena doza: Uzmite jednu vrećicu ORKAMBI granula svakih 12 sati.
English: (morning and evening), one sachet the next (morning only).
Croatian: (ujutro i navečer), a jedna vrećica sljedeći dan (samo ujutro).
English: Once mixed, the mixture has been shown to be stable for one hour.
Croatian: Nakon miješanja, pokazalo se da je mješavina stabilna jedan sat.
English: No dose adjustments are necessary based on gender.
Croatian: Nisu potrebne prilagodbe doze na temelju spola.
English: Treatment of overdose consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Croatian: Liječenje predoziranja sastoji se od općih potpornih mjera uključujući praćenje vitalnih znakova i promatranje kliničkog stanja bolesnika.
English: Improvements in ppFEV1 were observed regardless of age, disease severity, sex and geographic region.
Croatian: Poboljšanja vrijednosti ppFEV1 opažena su bez obzira na dob, težinu bolesti, spol i zemljopisnu regiju.
English: See section 4.5 for interactions with immunosuppressants.
Croatian: Vidjeti dio 4.5 za interakcije s imunosupresivima.
English: Patients aged 12 to 17 years were included in Trials 1 and 2.
Croatian: Bolesnici u dobi od 12 do 17 godina bili su uključeni u ispitivanja 1 i 2.
English: Drug interactions that have the most clinical relevance are listed first.
Croatian: Interakcije lijekova koje imaju najveći klinički značaj navedene su prve.
English: After Day 15, heart rate was not monitored in the period after dosing in these studies.
Croatian: Nakon 15. dana, frekvencija srca nije bila praćena u razdoblju nakon doziranja u tim ispitivanjima.
English: That is a total of four tablets per day, to be taken with food containing fat.
Croatian: To je ukupno četiri tablete na dan, koje se uzimaju s hranom koja sadrži masti.
English: † 1 patient out of 738 ‡ 2 patients out of 738
Croatian: † 1 bolesnik od 738 ‡ 2 bolesnika od 738