FrancophonIA/ELRC3.0 huggingface dataset:
English: Alkindi is available as capsules containing granules.
Croatian: Lijek Alkindi dostupan je u obliku kapsula koje sadrže granule.
English: Other information about Alkindi
Croatian: Ostale informacije o lijeku Alkindi
English: What are the risks associated with Alkindi?
Croatian: Koji su rizici povezani s lijekom Alkindi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alkindi 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 Alkindi nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Studies on the benefits and risks of the active substance have already been carried out with the reference medicine and do not need to be repeated for Alkindi.
Croatian: Ispitivanja omjera koristi i rizika djelatnih tvari već su provedena s referentnim lijekom i ne treba ih ponavljati za lijek Alkindi.
English: Why is Alkindi approved?
Croatian: Zašto je lijek Alkindi odobren?
English: It is not intended to provide practical advice on how to use Alkindi.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Alkindi.
English: For more information about treatment with Alkindi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Alkindi pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Alkindi contains the active substance hydrocortisone.
Croatian: Alkindi sadrži djelatnu tvar hidrokortizon.
English: No side effects were reported in studies with Alkindi, but some side effects have been reported with other hydrocortisone medicines.
Croatian: Nisu zabilježene nuspojave za lijek Alkindi, ali su prijavljene određene nuspojave kod drugih lijekova s hidrokortizonom.
English: The active substance in Alkindi, hydrocortisone, is the same as cortisol, the main steroid hormone released by the body's adrenal gland.
Croatian: Hidrokortizon, djelatna tvar u lijeku Alkindi, ista je kao kortizol, glavni steroidni hormon koji izlučuje nadbubrežna žlijezda.
English: Alkindi must not be used in patients with hypersensitivity (allergy) to the active substance or to any of the ingredients of Alkindi.
Croatian: Lijek Alkindi ne smije se primjenjivati u bolesnika koji su preosjetljivi (alergični) na djelatnu tvar ili na bilo koji sastojak lijeka.
English: For practical information about using Alkindi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Alkindi bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: What benefits of Alkindi have been shown in studies?
Croatian: Koje su koristi lijeka Alkindi utvrđene u ispitivanjima?
English: How is Alkindi used?
Croatian: Kako se Alkindi koristi?
English: How does Alkindi work?
Croatian: Kako djeluje Alkindi?
English: For the full list of side effects see the package leaflet.
Croatian: Potpuni popis nuspojava potražite u uputi o lijeku.
English: The full EPAR for Pritor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Pritor nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pritor on 11 December 1998.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Pritor na snazi u Europskoj uniji od 11. prosinca 1998.
English: What measures are being taken to ensure the safe and effective use of Pritor?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pritor?
English: Pritor must not be used in women who are more than three months pregnant.
Croatian: Pritor ne smiju uzimati žene koje su trudne dulje od tri mjeseca.
English: Other information about Pritor
Croatian: Ostale informacije o lijeku Pritor
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment
Croatian: No, sljedeće su nuspojave zabilježene kod 1 do 10 bolesnika na 1000: infekcija gornjeg dišnog sustava (prehlade), uključujući upalu grla i sinusa, infekcija mokraćnog sustava (infekcija organa koje prenose mokraću), uključujući infekciju mjehura, anemija (mali broj crvenih krvnih stanica), hiperkalijemija (visoke koncentracije kalija u krvi), depresija, nesanica (poteškoće sa spavanjem), sinkopa (nesvjestica), vertigo (vrtoglavica), bradikardija (usporena frekvencija srca), hipotenzija (niski krvni tlak), dispneja (otežano disanje), kašalj, abdominalna bol (bol u trbuhu), proljev, dispepsija (žgaravica), flatulencija (plinovi), povraćanje, hiperhidroza (prekomjerno znojenje), pruritus (svrbež), osip, mijalgija (mišićna bol), bol u leđima,
English: Pritor is a medicine that contains the active substance telmisartan.
Croatian: Pritor je lijek koji sadrži djelatnu tvar telmisartan.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pritor.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Pritor.
English: A risk management plan has been developed to ensure that Pritor is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Pritor.
English: Pritor was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines.
Croatian: Pritor je uspoređen s ramiprilom (još jednim lijekom za prevenciju kardiovaskularnih problema) te s kombinacijom obaju lijekova.
English: This is a summary of the European public assessment report (EPAR) for Pritor.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Pritor.
English: For more information about treatment with Pritor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Pritor pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Various doses of Pritor were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Croatian: Različite doze lijeka Pritor uspoređene su s placebom (prividnim liječenjem) te s drugim lijekovima za liječenje hipertenzije (atenololom, lizinoprilom, enalaprilom i amlodipinom).
English: Pritor must not be used in people who have severe liver problems or bile problems.
Croatian: Pritor ne smije koristiti u osoba koje imaju ozbiljne probleme s jetrom ili žuči.
English: Side effects with Pritor are not common.
Croatian: Nuspojave lijeka Pritor nisu uobičajene.
English: The active substance in Pritor, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Telmisartan, djelatna tvar u lijeku Pritor, „antagonist je receptora angiotenzina II”, što znači da u tijelu blokira djelovanje hormona naziva angiotenzin II.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pritor, 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 o lijeku za lijek Pritor nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Croatian: Blokiranjem receptora na koje se angiotenzin II obično veže, telmisartan sprječava učinak hormona i na taj način omogućuje snižavanje krvnog tlaka, čime se smanjuju rizici povezani s visokim krvnim tlakom, kao što su nastanak srčanog ili moždanog udara.
English: Hypotension may be more common in patients receiving Pritor to prevent cardiovascular problems.
Croatian: Hipotenzija se može pojaviti češće u bolesnika koji primaju lijek Pritor radi prevencije kardiovaskularnih problema.
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Pritor must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Croatian: U bolesnika s dijabetesom tipa 2 ili u bolesnika s umjerenim ili ozbiljnim oštećenjem bubrežne funkcije, Pritor se također ne smije primjenjivati u kombinaciji s lijekovima koji sadrže aliskiren (također se primjenjuje u liječenju esencijalne hipertenzije).
English: In the treatment of essential hypertension, Pritor was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Croatian: U liječenju esencijalne hipertenzije, Pritor je bio djelotvorniji od placeba u snižavanju dijastoličkog krvnog tlaka i imao je slično djelovanje kao drugi antihipertenzivi.
English: What is Pritor?
Croatian: Što je Pritor?
English: Pritor is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Croatian: Pritor se također koristi radi sprječavanja kardiovaskularnih problema (problema sa srcem i krvnim žilama), primjerice srčanih ili moždanih udara.
English: For the prevention of cardiovascular problems, 80 mg Pritor once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems.
Croatian: Za potrebe prevencije kardiovaskularnih problema, doza od 80 mg lijeka Pritor jednom na dan ispitivana je u jednom glavnom ispitivanju kojim je obuhvaćeno gotovo 26 000 bolesnika u dobi od 55 godina ili starijih koji su bolovali od bolesti srca ili arterijske bolesti, pretrpjeli moždani udar ili koji su bolovali od dijabetesa i bili izloženi visokom riziku od kardiovaskularnih problema.
English: What is the risk associated with Pritor?
Croatian: Koji su rizici povezani s lijekom Pritor?
English: Why has Pritor been approved?
Croatian: Zašto je Pritor odobren?
English: The CHMP decided that Pritor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Pritor nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: In the prevention of cardiovascular problems, Pritor had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke.
Croatian: U prevenciji kardiovaskularnih problema, Pritor je imao slično djelovanje kao ramipril, pri čemu je otprilike 17 % bolesnika preminulo, hospitalizirano zbog kardiovaskularnih problema ili pretrpjelo srčani ili moždani udar.
English: For the treatment of essential hypertension, the usual recommended dose of Pritor is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Croatian: Za potrebe liječenja esencijalne hipertenzije, uobičajena preporučena doza lijeka Pritor iznosi 40 mg jednom na dan, no u nekih se bolesnika može zabilježiti pozitivan učinak već pri dozi od 20 mg jednom na dan.
English: The doctor should monitor the patient's blood pressure closely when starting Pritor, and may decide to adjust the patient's blood pressure-lowering medication.
Croatian: Pri započinjanju terapije lijekom Pritor liječnik treba pomno pratiti krvni tlak bolesnika i može donijeti odluku o prilagodbi terapije za snižavanje krvnoga tlaka bolesnika.
English: For the treatment of essential hypertension, Pritor has been studied in 2,647 patients who took Pritor either alone or in combination with hydrochlorothiazide.
Croatian: Za potrebe liječenja esencijalne hipertenzije, Pritor je ispitivan na 2647 bolesnika koji su uzimali lijek Pritor kao monoterapiju ili u kombinaciji s hidroklorotiazidom.
English: (reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown).
Croatian: grčevi mišića, oštećenja funkcije bubrega (smanjena funkcija bubrega), uključujući iznenadno zatajenje bubrega, bol u prsima, astenija (slabost) i povišene koncentracije kreatinina u krvi (markera razgradnje mišića).
English: What is Pritor used for?
Croatian: Za što se Pritor koristi?
English: What benefit has Pritor shown during the studies?
Croatian: Koje su koristi lijeka Pritor utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Pritor, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Pritor potražite u uputi o lijeku.
English: How is Pritor used?
Croatian: Kako se Pritor koristi?
English: Pritor is used to treat essential hypertension (high blood pressure) in adults.
Croatian: Pritor se primjenjuje u liječenju esencijalne hipertenzije (visokog krvnog tlaka) u odraslih. „Esencijalne” znači da visok krvni tlak nije izazvan nijednim očitim uzrokom.
English: How has Pritor been studied?
Croatian: Kako je Pritor ispitivan?
English: How does Pritor work?
Croatian: Kako djeluje Pritor?
English: 24 January 2014
Croatian: 24. siječnja 2014.
English: For more information, see here.
Croatian: Više informacija dostupno je ovdje.
English: What is Winfuran?
Croatian: Što je Winfuran?
English: The main measure of effectiveness was the change in symptoms such as itching intensity and sleep disturbance after 4 weeks of treatment based on a standard scoring system.
Croatian: Glavna mjera djelotvornosti bila je promjena u simptomima, poput intenziteta svrbeži i poremećaja spavanja, nakon 4 tjedna liječenja na temelju standardnog sustava ocjenjivanja.
English: The evaluation had finished and the CHMP had given a negative opinion.
Croatian: Ocjenjivanje je završeno i CHMP je dao negativno mišljenje.
English: The effects of Winfuran were first tested in experimental models before being studied in humans.
Croatian: Djelovanje lijeka Winfuran prvi put je testirano na eksperimentalnim modelima, prije nego što se ispitalo na ljudima.
English: It was to be available as a concentrate for solution for infusion into a vein.
Croatian: Trebao je biti dostupan kao koncentrat za otopinu za infuziju u venu.
English: Although an additional analysis showed a modest benefit in a subpopulation of patients with a severe form of uraemic pruritus, the CHMP considered that the clinical relevance had not been shown.
Croatian: Iako je dodatna analiza pokazala skromnu korist u podpopulaciji bolesnika s ozbiljnim oblikom uremičkog pruritusa, CHMP je smatrao da nije dokazana klinička relevantnost.
English: Although the exact cause of uraemic pruritus is not known it is thought that the itching is linked to an excessive activity of certain receptors called mu-opioid receptors in the brain and skin.
Croatian: Iako točan uzrok uremičkog pruritusa nije poznat, smatra se da je svrbež povezan s prekomjernom aktivnošću određenih receptora naziva mu-opioidni receptori u mozgu i na koži.
English: Winfuran activates different opioid receptors, called kappa receptors, which block the activity of the mu-opioid receptors and therefore relieve the itching in patients with uraemic pruritus.
Croatian: Winfuran aktivira različite opioidne receptore, naziva kapa receptori, koji blokira djelovanje mu-opioidnog receptora i stoga ublažava svrbež u bolesnika s uremičkim pruritusom.
English: What was Winfuran expected to be used for?
Croatian: Za što se Winfuran trebao koristiti?
English: The effects of Winfuran were compared with placebo (a dummy treatment) in one main study involving 339 patients with uraemic pruritus who were on regular dialysis.
Croatian: Djelovanje lijeka Winfuran uspoređeno je s placebom (lažnim liječenjem) u jednom glavnom ispitivanju koje je obuhvatilo 339 bolesnika s uremičkim pruritusom, koji su bili na redovitoj dijalizi.
English: Withdrawal of the marketing authorisation application for Winfuran (nalfurafine)
Croatian: Povlačenje zahtjeva za davanje odobrenja za stavljanje u promet lijeka Winfuran (nalfurafin)
English: The main study failed to show that Winfuran was more effective than placebo at relieving itching.
Croatian: Glavnim ispitivanjem nije dokazano da je lijek Winfuran djelotvorniji od placeba u ublažavanju svrbeži.
English: Winfuran is a medicine that contains the active substance nalfurafine.
Croatian: Winfuran je lijek koji sadrži djelatnu tvar nalfurafin.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Winfuran did not outweigh its risks and it concluded that the medicine could not have been approved on the basis of the data presented by the company.
Croatian: Stoga, u trenutku povlačenja, CHMP-a je bio mišljenja da koristi lijeka Winfuran ne nadmašuju s njim povezane rizike, te je zaključio da se lijek ne može odobriti na temelju podataka koje je dostavila tvrtka.
English: How is Winfuran expected to work?
Croatian: Kako je Winfuran trebao djelovati?
English: In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's view that the data provided do not allow the Committee to conclude on a positive benefit-risk balance.
Croatian: U svom službenom dopisu, tvrtka je navela da svoju odluku za povlačenje zahtjeva temelji na mišljenju CHMP-a da dostavljeni podaci ne dozvoljavaju Povjerenstvu donošenje zaključka o pozitivnom omjeru koristi i rizika.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Winfuran for the treatment of severe uraemic pruritus.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja, CHMP je dao negativno mišljenje preporučujući odbijanje davanja odobrenja za stavljanje u promet za Winfuran za liječenje uremičkog pruritusa.
English: Winfuran was to be used in patients with end-stage renal disease (when the kidneys have stopped working completely) and who are on dialysis (a technique for removing waste products from the blood).
Croatian: Winfuran se koristio u bolesnika s posljednjim stadijem bolesti bubrega (nakon što su bubrezi prestali ispravno raditi) i onih na dijalizi (tehnika za uklanjanje otpadnih tvari iz krvi).
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes for Winfuran.
Croatian: Tvrtka je obavijestila CHMP da za Winfuran nema kliničkih ispitivanja u tijeku ili programa milosrdnog davanja lijekova.
English: Uraemic pruritus is a persisting form of itching that occurs in some patients whose kidneys are not functioning properly.
Croatian: Uremički pruritus je perzistirajući oblik svrbeža koji se pojavljuje u pojedinih bolesnika čiji bubrezi ne rade ispravno.
English: On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis.
Croatian: Limited službeno je obavijestio Povjerenstvo za humane lijekove (CHMP) kako želi povući svoju prijavu za odobrenje za stavljanje u promet za Winfuran, predviđen za liječenje ozbiljnog uremičkog pruritusa (oblika svrbeži) u bolesnika s posljednjim stadijem bolesti bubrega na dijalizi.
English: Winfuran was expected to be used for the treatment of patients with severe uraemic pruritus.
Croatian: Winfuran se trebao koristiti za liječenje bolesnika s ozbiljnim uremičkim pruritusom.
English: Winfuran was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 September 2002 for uraemic pruritus.
Croatian: Winfuran je bio označen kao lijek za liječenje rijetkih i teških bolesti dana 11. rujna 2002. godine za uremijskog pruritusa.
English: Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EMA/33514/2014
Croatian: (nalfurafin) EMA/33514/2014
English: The CHMP's main concern was that the benefits of Winfuran in the treatment of uraemic pruritus had not been sufficiently shown.
Croatian: Glavni razlog za zabrinutost CHMP-a bio je da koristi od lijeka Winfuran za liječenje uremičkog pruritusa nisu dokazane u dostatnoj mjeri.
English: The recommended dose is one capsule taken once a day with food for 12 or 24 weeks.
Croatian: Preporučena doza je jedna kapsula koja se uzima jednom na dan uz obrok tijekom 12 tjedana ili 24 tjedna.
English: The full EPAR and risk management plan summary for Olysio 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 Olysio nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Olysio and what is it used for?
Croatian: Što je Olysio i za što se koristi?
English: Olysio is available as 150 mg capsules.
Croatian: Lijek Olysio dostupan je u obliku kapsula od 150 mg.
English: This is a summary of the European public assessment report (EPAR) for Olysio.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Olysio.
English: Prolonging treatment to 24 weeks resulted in a clearance rate of above 90%.
Croatian: Produljivanje liječenja na 24 tjedna rezultiralo je stopom čišćenja od 90 %.
English: What measures are being taken to ensure the safe and effective use of Olysio?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Olysio?
English: Olysio is used in combination with other medicines.
Croatian: Lijek Olysio primjenjuje se samo u kombinaciji s drugim lijekovima.
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Croatian: To ispitivanje provodi se s obzirom na podatke koji upućuju na to da bi bolesnici koji su liječeni tim lijekovima i koji su imali rak jetre mogli biti u opasnosti od ranog povratka raka.
English: Regarding its safety, Olysio was well tolerated and the side effects were manageable.
Croatian: Što se tiče sigurnosti, Olysio se dobro podnosi, a nuspojave se mogu kontrolirati.
English: Olysio is an antiviral medicine that contains the active substance simeprevir.
Croatian: Olysio je antivirusni lijek koji sadrži djelatnu tvar simeprevir.