FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking this enzyme, Intelence, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Blokirajući ovaj enzim, lijek Intelence, ako se uzima u kombinaciji s drugim lijekovima protiv HIV-a, smanjuje razinu HIV-a u krvi i održava je na niskoj razini.
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Croatian: On inhibira djelovanje povratne transkriptaze, enzima koji HIV stvara i koji virusu omogućuje da zarazi tjelesne stanice i stvori veći broj virusa.
English: For further information about using Intelence, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Intelence pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.
Croatian: Ovaj se lijek izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: How is Intelence used?
Croatian: Kako se Intelence koristi?
English: It contains the active substance etravirine.
Croatian: Lijek sadržava djelatnu tvar etravirin.
English: Intelence must not be used together with elbasvir/grazoprevir, a medicine to treat hepatitis C infection.
Croatian: Intelence se ne smije primjenjivati u kombinaciji s elbasvirom/grazoprevirom, lijekom za liječenje infekcije hepatitisom C. Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Intelence potražite u uputi o lijeku.
English: What benefits of Intelence have been shown in studies?
Croatian: Koje su koristi lijeka od Intelence utvrđene u ispitivanjima?
English: This summary was last updated in 09-2014.
Croatian: Ovaj sažetak je posljednji put ažuriran u 09.2014.
English: Noxafil posaconazole
Croatian: Noxafil posakonazol
English: In both studies, the main measure of effectiveness was the number of patients with a complete or partial response to treatment.
Croatian: U oba ispitivanja, glavna mjera djelotvornosti bio je broj bolesnika s potpunim ili djelomičnim odgovorom na liječenje.
English: After 14 days of treatment, both medicines had been successful in curing or improving about 92% of patients.
Croatian: Nakon 14 dana liječenja, oba su lijeka bila uspješna u liječenju ili poboljšavanju stanja u otprilike 92 % bolesnika.
English: Noxafil must not be used in patients who are taking any of the following medicines:
Croatian: Noxafil se ne smije koristiti u bolesnika koji uzimaju bilo koji od sljedećih lijekova:
English: The full EPAR for Noxafil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Noxafil nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Gastroresistant means that the tablets pass through the stomach without being broken down until they reach the intestine.
Croatian: Gastrorezistentno znači da tablete prolaze kroz želudac bez razgradnje sve dok ne dosegnu crijeva.
English: Without ergosterol, the fungus dies or is prevented from spreading.
Croatian: Bez ergosterola, gljivica umire ili je spriječeno njezino širenje.
English: • Noxafil tablets can be taken with or without food and should be swallowed whole with water; the tablets should not be crushed, chewed, broken or dissolved.
Croatian: • Tablete Noxafil mogu se uzimati s hranom ili bez nje te se trebaju gutati cijele s vodom; tablete se ne smiju drobiti, žvakati, lomiti ili otapati.
English: Caution is also needed when Noxafil is taken at the same time as other medicines.
Croatian: Oprez je potreban prilikom uzimanja lijeka Noxafil istovremeno s drugim lijekovima.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Noxafil on 25 October 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Noxafil vrijedi na prostoru Europske unije od 25. listopada 2005.
English: The studies looked at the number of patients who developed an invasive fungal infection.
Croatian: Ispitivanja su istražila broj bolesnika u kojih se razvila invazivna gljivična infekcija.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Croatian: Djeluje sprječavajući formiranje ergosterola, koji je važan sastavni dio stjenke stanice gljivica.
English: • Noxafil oral suspension is taken with a meal or nutritional supplement; the suspension must be shaken well before use.
Croatian: • Oralna suspenzija Noxafil uzima se zajedno s obrokom ili dodacima prehrani; suspenziju treba dobro promućkati prije primjene.
English: What measures are being taken to ensure the safe and effective use of Noxafil?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Noxafil?
English: This document is a summary of the European public assessment report (EPAR) for Noxafil.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Noxafil.
English: Other common side effects include vomiting, diarrhoea, pyrexia (fever) and increased bilirubin (a sign of liver problems) in the blood.
Croatian: Ostale uobičajene nuspojave uključuju povraćanje, proljev, pireksiju (groznicu) i povišenu razinu bilirubina (znak problema s jetrom) u krvi.
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 Noxafil.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek kako bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i preporuke o uvjetima uporabe lijeka Noxafil.
English: The duration of treatment depends on the patient's condition.
Croatian: Trajanje liječenja ovisi o stanju bolesnika.
English: The CHMP concluded that, although the first study compared Noxafil with records of patients who were actually enrolled in that study, the effectiveness of Noxafil was shown.
Croatian: CHMP je zaključio da je, iako je prvo ispitivanje usporedilo lijek Noxafil s prijavama bolesnika koji su uistinu bili upisani u to ispitivanje, dokazana djelotvornost lijeka Noxafil.
English: • simvastatin, lovastatin or atorvastatin (used to lower cholesterol).
Croatian: • simvastatin, lovastatin ili atorvastatin (koriste se za liječenje kolesterola).
English: Other information about Noxafil
Croatian: Ostale informacije o lijeku Noxafil
English: Noxafil treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections.
Croatian: Liječenje lijekom Noxafil treba započeti liječnik s iskustvom u liječenju gljivičnih infekcija ili u liječenju bolesnika izloženih visokom riziku od invazivnih gljivičnih infekcija.
English: Noxafil is used to treat adults (aged 18 years or over) with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed:
Croatian: Noxafil se koristi za liječenje odraslih osoba (u dobi od 18 godina ili starijih) sa sljedećim gljivičnim bolestima u slučaju kada bolesnici ne podnose druge terapije antifungicidima (amfotericinom B, itrakonazolom ili flukonazolom) ili kada iste nisu uspješne:
English: A risk management plan has been developed to ensure that Noxafil is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Noxafil.
English: • chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters),
Croatian: • kromoblastomikoza i micetom (dugotrajne gljivične infekcije kože ili tkiva neposredno ispod kože, koje najčešće uzrokuju gljivične spore koje inficiraju rane nastale trnovima ili špranjama),
English: For more information about treatment with Noxafil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Noxafil pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: • pimozide (used for treating mental illness),
Croatian: • pimozid (koristi se za liječenje mentalnih bolesti),
English: The results obtained with Noxafil were compared with the records of 218 patients who were treated with other antifungal medicines.
Croatian: Rezultati dobiveni s lijekom Noxafil uspoređeni su s prijavama 218 bolesnika koji su liječeni drugim antifungicidima.
English: Noxafil is an antifungal medicine that contains the active substance posaconazole; it is available as an oral suspension (40 mg/ml), a concentrate (300 mg) for solution for infusion (drip) into a vein and as gastroresistant tablets (100 mg).
Croatian: Noxafil je antifungicid koji sadrži djelatnu tvar posakonazol; dostupan je kao oralna suspenzija (40 mg/ml), koncentrat (300 mg) otopine za infuziju (drip) u venu te kao gastrorezistentne tablete (100 mg).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Noxafil, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Noxafil uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Patients given the solution for infusion should be switched to Noxafil tablets or oral suspension as soon as the patient's condition allows it.
Croatian: Bolesnici koji primaju otopinu za infuziju trebaju je zamijeniti tabletama ili oralnom suspenzijom Noxafil čim njihovo stanje to dopusti.
English: The duration of treatment depends on the severity of the disease and the patient's response.
Croatian: Trajanje liječenja ovisi o težini bolesti i odgovoru bolesnika.
English: The active substance in Noxafil, posaconazole, is an antifungal medicine that belongs to the triazole group.
Croatian: Djelatna tvar lijeka Noxafil, posakonazol, je antifungicid koji se ubraja u grupu triazola.
English: What is the risk associated with Noxafil?
Croatian: Koji su rizici povezani s lijekom Noxafil?
English: • terfenadine, astemizole (used for allergy),
Croatian: • terfenadin, astemizol (koristi se za alergije),
English: In oropharyngeal candidiasis, Noxafil oral suspension was as effective as fluconazole.
Croatian: U slučaju orofaringalne kandidijaze, oralna suspenzija Noxafil bila je podjednako djelotvorna kao flukonazol.
English: • quinidine (used for irregular heart beat),
Croatian: • kinidin (koristi se za nepravilne otkucaje srca),
English: In invasive aspergillosis, a successful response at the end of treatment was seen in 42% of the patients taking Noxafil oral suspension, compared with 26% of the patients in the comparator group.
Croatian: U slučaju invazivne aspergiloze, uspješan odgovor po završetku terapije uočen je u 42 % bolesnika koji su uzimali oralnu suspenziju lijeka Noxafil u usporedbi s 26 % bolesnika u usporednoj grupi.
English: The Committee decided that Noxafil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi od lijeka Noxafil nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Noxafil oral suspension and tablets have different dosages and should not be used interchangeably.
Croatian: Oralna suspenzija i tablete Noxafil imaju različito doziranje te se ne smiju koristiti kao zamjena jedno za drugo.
English: The most common side effect with Noxafil, seen in more than one patient in 10, is nausea (feeling sick).
Croatian: Najčešća je nuspojava lijeka Noxafil, kod više od jednog bolesnika na 10, mučnina (osjećaj slabosti).
English: Noxafil also successfully treated 11 of the 18 patients who had proven or probable fusariosis, 9 of the 11 patients with chromoblastomycosis or mycetoma, and 11 of the 16 patients with coccidioidomycosis.
Croatian: Noxafil je također uspješno liječio 11 od 18 bolesnika koji su imali dokazanu ili izglednu fusariozu, 9 od 11 bolesnika s kromoblastomikozom ili micetomom te 11 od 16 bolesnika s kokidioidomikozom.
English: • ergotamine or dihydroergotamine (used to treat migraine),
Croatian: • ergotamin ili dihidroergotamin (koristi se za liječenje migrene),
English: The ability to prevent infections was investigated in two additional main studies, where Noxafil oral suspension was compared with fluconazole in 600 stem cell transplant patients and with fluconazole or itraconazole in 602 patients with blood or bone marrow cancer.
Croatian: Sposobnost sprječavanja infekcija istražena je u dva dodatna glavna ispitivanja, u kojima je oralna suspenzija lijeka Noxafil uspoređena s flukonazolom u 600 bolesnika s transplantiranim matičnim stanicama te s flukonazolom ili itrakonazolom u 602 bolesnika s rakom krvi ili koštane srži.
English: Noxafil oral suspension is also used as a first-line treatment for ‘thrush', a fungal infection of the mouth and throat due to Candida.
Croatian: Oralna suspenzija Noxafil koristi se kao terapija prve linije za „mliječac”, gljivičnu infekciju usta i grla prouzročenu gljivicom Candida.
English: In one main study, Noxafil oral suspension was studied in 238 patients with invasive fungal infections that did not respond to standard antifungal treatment.
Croatian: U jednom glavnom ispitivanju, oralna suspenzija Noxafil ispitivala se u 238 bolesnika s invazivnim gljivičnim infekcijama koji nisu odgovorili na standardno liječenje protiv gljivica.
English: • halofantrine (used to treat malaria),
Croatian: • halofantrin (koristi se za liječenje malarije),
English: The study included 107 patients with aspergillosis, 18 patients with fusariosis, 11 with chromoblastomycosis or mycetoma, and 16 with coccidioidomycosis.
Croatian: Ispitivanje je obuhvatilo 107 bolesnika oboljelih od aspergiloze, 18 bolesnika oboljelih od fusarioze, 11 s kromoblastomikozom ili micetomom, te 16 s kokidioidomikozom.
English: The list of fungi against which Noxafil is active can be found in the summary of product characteristics (also part of the EPAR).
Croatian: Popis gljivica protiv kojih je Noxafil aktivan dostupan je u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: • cisapride (used for stomach problems),
Croatian: • cisaprid (koristi se za želučane probleme),
English: What is Noxafil?
Croatian: Što je Noxafil?
English: Noxafil tablets and solution for infusion must not be used for the treatment of thrush.
Croatian: Tablete i otopina za infuziju Noxafil ne smiju se koristiti za liječenje „mliječca”.
English: Noxafil oral suspension, solution for infusion and gastro-resistant tablets are also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a transplant of cells that make blood cells).
Croatian: Noxafil također se koriste za sprječavanje invazivnih gljivičnih infekcija u bolesnika s oslabljenim imunosnim sustavom uslijed terapija koje primaju za liječenje rakova krvi ili koštane srži ili lijekova koji se koriste u transplantaciji hematopoetskih matičnih stanica (transplantaciji stanica koje stvaraju krvne stanice).
English: For additional information, see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: In another main study involving 350 HIV-infected patients with oropharyngeal candidiasis, Noxafil oral suspension was compared with fluconazole.
Croatian: U drugom glavnom ispitivanju koje je obuhvatilo 350 bolesnika zaraženih HIV-om s orofaringealnom kandidijazom, oralna suspenzija lijeka Noxafil uspoređena je s flukonazolom.
English: The medicine was more effective than fluconazole or itraconazole in cancer patients, with 2% of patients developing an infection in the Noxafil group, and 8% in the comparator groups.
Croatian: Lijek je bio djelotvorniji od flukonazola ili itrakonazola u bolesnika s rakom, pri čemu se infekcija razvila u 2 % bolesnika u grupi koja je uzimala Noxafil, te u 8 % bolesnika u usporednim grupama.
English: • invasive aspergillosis (fungal infection caused by Aspergillus),
Croatian: • invazivna aspergiloza (gljivična infekcija prouzročena gljivicama iz obitelji Aspergillus),
English: Why has Noxafil been approved?
Croatian: Zašto je lijek Noxafil odobren?
English: For oral candidiasis, Noxafil oral suspension is taken as 200 mg (5 ml) on the first day followed by 100 mg (2.5 ml) once a day for the following 13 days.
Croatian: U slučaju oralne kandidijaze, oralna suspenzija uzima se u dozi od 200 mg (5 ml) prvog dana nakon čega slijedi 100 mg (2,5 ml) jednom dnevno tijekom sljedećih 13 dana.
English: For the prevention of invasive fungal infections, Noxafil oral suspension is given at a dose of 200 mg (5 ml) three times a day.
Croatian: Radi prevencije invazivne gljivične infekcije, oralna suspenzija Noxafil primjenjuje se u dozi od 200 mg (5 ml) tri puta dnevno.
English: In the prevention studies, Noxafil oral suspension was as effective as fluconazole in stem cell transplant patients, with 5% of patients developing an infection in the Noxafil group, and 9% in the comparator group.
Croatian: U ispitivanjima prevencije, oralna suspenzija lijeka Noxafil bila je podjednako učinkovita kao flukonazol u bolesnika s transplantiranim matičnim stanicama, pri čemu se infekcija razvila u 5 % bolesnika u grupi koja je uzimala Noxafil, te u 9 % bolesnika u usporednoj grupi.
English: • fusariosis (fungal infection caused by Fusarium),
Croatian: • fusarioza (gljivična infekcija prouzročena gljivicama iz obitelji Fusarium),
English: For the treatment of fungal infections, with the exception of oral candidiasis, Noxafil oral suspension is taken at a dose of 400 mg (10 ml) twice a day, or 200 mg (5 ml) four times a day in patients who cannot tolerate a meal.
Croatian: Za liječenje gljivičnih infekcija, uz iznimku oralne kandidijaze, oralna suspenzija Noxafil primjenjuje se u jednoj dozi od 400 mg (10 ml) dva put na dan ili 200 mg (5 ml) četiri puta na dan u bolesnika koji ne podnose obroke.
English: What benefit has Noxafil shown during the studies?
Croatian: Koje su koristi lijeka Noxafil dokazane u ispitivanjima?
English: What is Noxafil used for?
Croatian: Za što se Noxafil koristi?
English: • coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).
Croatian: • kokidioidomikoza (gljivična infekcija pluća uzrokovana udisanjem pora).
English: For the treatment and prevention of fungal infections, the recommended dose of Noxafil tablets or Noxafil solution for infusion is 300 mg twice a day on the first day followed by 300 mg once a day thereafter; the duration of treatment depends on the severity of the disease and the patient's response.
Croatian: Za potrebe liječenja i prevencije gljivičnih infekcija, preporučena je doza tableta Noxafil ili otopine za infuziju Nofaxil 300 mg dva puta na dan tijekom prvog dana nakon čega slijedi 300 mg jednom na dan.
English: How is Noxafil used?
Croatian: Kako se Noxafil koristi?
English: It is used in patients whose infection is severe or patients with weakened immune systems, when medicines applied topically (directly on the thrush) are unlikely to work.
Croatian: Koristi se u bolesnika čija je infekcija ozbiljna ili u bolesnika s oslabljenim imunosnim sustavom.
English: How does Noxafil work?
Croatian: Kako djeluje Noxafil?
English: For the full list of all side effects reported with Noxafil, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Noxafil potražite u uputi o lijeku.
English: How has Noxafil been studied?
Croatian: Kako se Noxafil ispitivao?
English: When this happens in the joints and causes pain, it is known as ‘gout'.
Croatian: Kada se to dogodi u zglobovima i uzrokuje bol, to je stanje poznato pod nazivom „giht”.
English: The full EPAR for Febuxostat Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Febuxostat Mylan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This usually reduces blood uric acid levels within two weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after two to four weeks.
Croatian: Time se razine mokraćne kiseline u krvi snižavaju najčešće u roku od dva tjedna, ali doza se može povećati na 120 mg jedanput na dan ako nakon dva do četiri tjedna razine mokraćne kiseline i dalje ostanu visoke (više od 6 mg po decilitru).
English: Febuxostat Mylan should be started 2 days before chemotherapy and continued for at least 7 days.
Croatian: Liječenje lijekom Febuxostat Mylan treba započeti dva dana prije kemoterapije i nastaviti najmanje 7 dana.
English: This means that Febuxostat Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Adenuric.
Croatian: To znači da Febuxostat Mylan sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Adenuric.
English: As for every medicine, the company provided studies on the quality of Febuxostat Mylan.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Febuxostat Mylan.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Febuxostat Mylan has been shown to have comparable quality and to be bioequivalent to Adenuric.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Febuxostat Mylan posjeduje usporedivu razinu kvalitete i da je bioekvivalentatn lijeku Adenuric.
English: This can reduce the symptoms of gout.
Croatian: Primjenom može doći do smanjenja simptoma gihta.
English: For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, the recommended dose is 120 mg once a day.
Croatian: Za potrebe prevencije i liječenja hiperuricemije u bolesnika koji primaju kemoterapiju, preporučena doza iznosi 120 mg jedanput na dan.
English: Because Febuxostat Mylan 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 Febuxostat Mylan generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Febuxostat Mylan is available as tablets (80 and 120 mg) and can only be obtained with a prescription.
Croatian: Febuxostat Mylan dostupan je u obliku tableta (80 i 120 mg) te se izdaje samo na liječnički recept.
English: This is a summary of the European public assessment report (EPAR) for Febuxostat Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Febuxostat Mylan.
English: Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Febuxostat Mylan.
Croatian: Tijekom prvih nekoliko mjeseci liječenja još može doći do napada gihta te se preporučuje uzimanje drugih lijekova za sprječavanje napada gihta tijekom najmanje prvih šest mjeseci liječenja lijekom Febuxostat Mylan.