FrancophonIA/ELRC3.0 huggingface dataset:
English: It is only effective against certain types of bacteria (called Gram-positive bacteria) and should be used in combination with other antibiotics if necessary.
Croatian: Djelotvoran je samo u slučaju određenih tipova bakterija (naziva gram pozitivne bakterije) i mora se koristiti u kombinaciji s drugim antibioticima, ako je to potrebno.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Croatian: To je rezultiralo divergencijama u državama članicama na način da se lijek može koristiti kako je navedeno u različitim Sažetcima opisa svojstava lijeka (SmPC-ovi), etiketama i uputama o lijeku u državama u kojima je lijek stavljen u promet.
English: This includes initial doses as well as doses for maintenance treatment and doses to be used in patients with reduced kidney function.
Croatian: To uključuje početne doze kao i doze za održavanje liječenja i doze za primjenu u bolesnika sa smanjenom funkcijom bubrega.
English: • endocarditis (infection of the inner lining of the heart - most commonly the valves of the heart);
Croatian: • endokarditis (infekcije unutarnje prevlake srca - najčešće srčanih zalizaka);
English: • complicated infections of the skin and soft-tissues;
Croatian: • komplicirane infekcije kože i mekih tkiva;
English: The active substance, teicoplanin, is one of a group of antibiotics known as glycopeptides.
Croatian: Djelatna tvar, teikoplanin, jedan je iz grupe antibiotika poznatih pod nazivom glikopeptidi.
English: Prolonged use may encourage the growth of bacteria against which it is not active.
Croatian: Produljena primjena može potaknuti rast bakterija protiv kojih lijek nije djelotvoran.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Targocid in the European Union (EU).
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da postoji potreba za harmonizacijom informacija o propisivanju lijekova za Targocid u Europskoj uniji (EU).
English: Other possible effects for which treatment may need to be stopped or altered include infusion-related reactions called ‘red man syndrome', severe skin rashes, thrombocytopenia (low blood-levels of cells called platelets that are important for clotting), kidney damage, and effects on hearing.
Croatian: Druge moguće posljedice zbog kojih se liječenje možda mora zaustaviti ili promijeniti uključuju reakcije povezane s infuzijom poznate pod nazivom „sindrom crvenila”, teški osipi kože, trombocitopeniju (niske razine stanica naziva trombi u krvi koje su važne za zgrušavanje), oštećenje bubrega i posljedice po sluh.
English: The company that markets these medicines is Sanofi-Aventis.
Croatian: Sanofi-Aventis je tvrtka koja stavlja u promet ove lijekove.
English: • peritonitis (inflammation of the peritoneum, the membrane lining the abdominal cavity) in patients undergoing ‘continuous ambulatory peritoneal dialysis';
Croatian: • peritonitis (upala peritoneuma, membranske prevlake trbušne šupljine) u bolesnika koji se podvrgavaju „kontinuiranoj ambulantnoj peritonealnoj dijalizi”;
English: Targocid is an antibiotic that contains the active substance teicoplanin.
Croatian: Targocid je antibiotik koji sadrži djelatnu tvar teikoplanin.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Croatian: Na temelju dostavljenih podataka i znanstvenih rasprava unutar Povjerenstva, mišljenje CHMP-a je bilo da se SmPC-ovi, etikete i upute o lijeku moraju uskladiti na razini EU-a.
English: • complicated urinary tract infections (infections of the structures that carry urine);
Croatian: • komplicirane infekcije mokraćnih putova (upale struktura kojima se prenosi urin);
English: The CHMP agreed to harmonise the warnings and precautions for the medicine.
Croatian: CHMP usuglasio se oko usklađivanja upozorenja i mjera opreza pri uporabi za lijek.
English: For certain types of infections, a higher initial dose of 12 mg per kg body-weight twice daily (used in a few member states of the EU), was agreed by the CHMP.
Croatian: CHMP usuglasio je višu početnu dozu od 12 mg po kg tjelesne mase dva puta dnevno (primjenjuje se u nekoliko država članica u EU) u slučaju određenih tipova infekcija.
English: Regular blood and kidney function tests and monitoring of any effects on hearing are recommended during treatment.
Croatian: Tijekom liječenja preporučaju se redovite pretrage krvi i funkcije bubrega, kao i praćenje svih posljedica.
English: • bone and joint infections;
Croatian: • infekcije kosti i zglobova;
English: On 17 November 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Targocid in the EU.
Croatian: Europska komisija uputila je slučaj CHMP-u s ciljem usklađivanja odobrenja za stavljanje lijeka u promet za lijek Targocid u EU.
English: Targocid was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Croatian: Koordinacijska skupina za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) identificirala je potrebu za usklađivanjem za Targocid.
English: It can also be given by mouth to treat diarrhoea and colitis (inflammation of the bowel) caused by infection with a bacterium called Clostridum difficile.
Croatian: Može se davati i peroralno za liječenje proljeva i kolitisa (upale crijeva) uzrokovane infekcijom bakterijom naziva Clostridum difficile.
English: The Committee also agreed that Targocid could be taken by mouth to treat diarrhoea and colitis (inflammation of the bowel) associated with infection by bacteria called Clostridium difficile.
Croatian: Povjerenstvo je također suglasno da se Targocid može uzimati peroralno za liječenje proljeva i kolitisa (upale crijeva) povezanih s infekcijom uzrokovanom bakterijom Clostridium difficile.
English: • hospital- or community-acquired pneumonia (infection of the lung caught in or outside hospital);
Croatian: • hospitalne upale pluća kao i one kojima se bolesnici zaraze drugdje;
English: Results in children aged below 12 years are not yet available.
Croatian: Rezultati u djece mlađe od 12 godina još nisu dostupni.
English: Further information on Sovaldi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Sovaldi možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is one tablet taken once a day with food, normally for 12 or 24 weeks.
Croatian: Preporučena je doza jedna tableta jedanput na dan uz obrok, uglavnom tijekom 12 ili 24 tjedna.
English: • rifampicin and rifabutin (antibiotics);
Croatian: • rifampicin i rifabutin (antibiotici);
English: Sovaldi received a marketing authorisation valid throughout the EU on 16 January 2014.
Croatian: Lijek Sovaldi dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 16. siječnja 2014.
English: Sovaldi must not be used together with certain types of medicines which can reduce the effects of Sovaldi.
Croatian: Sovaldi se ne smije koristiti zajedno s određenim vrstama lijekova koji mogu smanjiti učinak lijeka Sovaldi.
English: Sovaldi is available as 400 mg tablets.
Croatian: Lijek Sovaldi dostupan je u obliku tableta od 400 mg.
English: • carbamazepine, phenobarbital and phenytoin (medicines for epilepsy).
Croatian: • karbamazepin, fenobarbital i fenitoin (lijekovi za liječenje epilepsije).
English: Other information about Sovaldi
Croatian: Ostale informacije o lijeku Sovaldi
English: The Agency considered that adding Sovaldi to standard treatment is of benefit to patients.
Croatian: Agencija smatra da je dodavanje lijeka Sovaldi standardnom liječenju korisno za bolesnike.
English: What measures are being taken to ensure the safe and effective use of Sovaldi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Sovaldi?
English: What is Sovaldi and what is it used for?
Croatian: Što je Sovaldi i za što se koristi?
English: Why is Sovaldi authorised in the EU?
Croatian: Zašto je Sovaldi odobren u EU-u?
English: Regarding safety, the Agency noted that, although there is limited information in some groups of patients such as those with decompensated liver disease (where the liver is damaged and no longer works properly), no side effects specific to Sovaldi have been identified, and those that occur are mainly due to combined treatment with ribavirin or interferons.
Croatian: U pogledu sigurnosti Agencija je napomenula da, iako postoje ograničene informacije za neke skupine bolesnika, kao što su bolesnici s dekompenziranom bolešću jetre (kada je jetra oštećena i više ne radi ispravno), nisu utvrđene specifične nuspojave lijeka Sovaldi, a one koje se javljaju uglavnom su uzrokovane kombiniranim liječenjem ribavirinom ili interferonima.
English: The 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 liječenje tim lijekovima moglo izložiti osobe koje su imale rak jetre opasnosti od ranog povratka raka.
English: Side effects reported with Sovaldi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Sovaldi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Sovaldi allows the virus to be cleared without the patient having to take peginterferon alfa or with only short courses of this medicine (which can cause serious side effects, including reduced growth in adolescents).
Croatian: Sovaldi omogućuje uklanjanje virusa, pri čemu bolesnik ne mora uzeti peginterferon alfa ili može uzeti samo kratke kure toga lijeka (koji može uzrokovati ozbiljne nuspojave, uključujući usporavanje rasta u adolescenata).
English: Blood tests 12 weeks after the end of treatment showed no sign of the virus in 96% of patients (48 out of 50) aged 12 to 18 years.
Croatian: Rezultati krvnih pretraga 12 tjedana nakon završetka liječenja nisu pokazivali znakove virusa u 96 % bolesnika (48 od 50) u dobi od 12 do 18 godina.
English: • St. John's wort (a herbal preparation used to treat depression and anxiety);
Croatian: • gospinu travu (biljni pripravak za liječenje depresije i tjeskobe);
English: What are the risks associated with Sovaldi?
Croatian: Koji su rizici povezani s lijekom Sovaldi?
English: The company that markets Sovaldi will carry out a study in patients who have had liver cancer to evaluate the risk of the cancer returning after treatment with direct-acting antivirals such as Sovaldi.
Croatian: Tvrtka koja stavlja na tržište lijek Sovaldi provest će ispitivanje na bolesnicima koji su bolovali od raka jetre kako bi se procijenio rizik od povratka raka nakon liječenja protuvirusnim lijekovima s izravnim djelovanjem kao što je Sovaldi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sovaldi have also 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 Sovaldi nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: As for all medicines, data on the use of Sovaldi are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Sovaldi kontinuirano se prate.
English: The duration of treatment will depend on the genotype of the virus the patient is infected with and on which medicines are used with Sovaldi.
Croatian: Trajanje liječenja ovisi o genotipu virusa kojim je bolesnik zaražen i o lijekovima koji se primjenjuju uz lijek Sovaldi.
English: The Agency also considered that, if given before a liver transplant, Sovaldi in combination with ribavirin can prevent re-infection of the liver, which in the absence of treatment occurs nearly always and results in a poor prognosis.
Croatian: Agencija također smatra da primjena lijeka Sovaldi u kombinaciji s ribavirinom prije transplantacije jetre može spriječiti ponovnu infekciju jetre, koja u slučaju izostanka liječenja nastupa gotovo uvijek i rezultira slabom prognozom.
English: In this study, 91% (296 out of 327) of patients had no sign of the virus 12 weeks after the end of treatment.
Croatian: U tom ispitivanju 91 % bolesnika (296 od 327) nije imalo znakova virusa 12 tjedana nakon završetka liječenja.
English: Treatment with Sovaldi was as effective (67% patients - 171 out of 256 - had no sign of the virus) as peginterferon-based treatment (67% of patients - 162 out of 243).
Croatian: Liječenje lijekom Sovaldi bilo je jednako učinkovito (67 % bolesnika, 171 od 256, nisu imali znakova virusa) kao liječenje peginterferonom (67 % bolesnika, 162 od 243).
English: Sovaldi is being investigated in one main study in children and adolescents aged between 3 and 18 years infected with hepatitis C virus genotypes 2 or 3.
Croatian: Lijek Sovaldi ispituje se u jednom glavnom ispitivanju na djeci i adolescentima u dobi između tri i 18 godina zaraženima virusom hepatitisa C genotipa 2 ili 3.
English: An overview of Sovaldi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Sovaldi i zašto je odobren u EU-u
English: Sovaldi must be used in combination with other medicines used to treat chronic hepatitis C, such as ribavirin or peginterferon alfa and ribavirin.
Croatian: Lijek Sovaldi mora se primjenjivati u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa C, kao što su ribavirin ili peginterferon alfa i ribavirin.
English: The European Medicines Agency decided that Sovaldi's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Sovaldi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The most common side effects with Sovaldi in combination with ribavirin and peginterferon alfa were similar to those commonly reported with ribavirin or peginterferon alfa and included fatigue (tiredness), headache, nausea (feeling sick) and insomnia (difficulty sleeping).
Croatian: Najčešće nuspojave lijeka Sovaldi u kombinaciji s ribavirinom i peginterferonom alfa slične su zabilježenim čestim nuspojavama ribavirina ili peginterferona alfa, a uključuju iscrpljenost (umor), glavobolju, mučninu (osjećaj slabosti) i nesanicu (poteškoće sa spavanjem).
English: Sovaldi can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Croatian: Sovaldi se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju osoba oboljelih od kroničnog hepatitisa C.
English: For further information about using Sovaldi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Sovaldi pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: In this study, 50% (51 out of 103) of patients taking Sovaldi and ribavirin for 12 weeks had no sign of the hepatitis C virus, compared with 71% (70 out of 98) of patients treated for 16 weeks.
Croatian: U okviru tog ispitivanja 50 % bolesnika (51 od 103) koji su 12 tjedana primali lijek Sovaldi i ribavirin nisu imali znakova virusa hepatitisa C, u usporedbi sa 71% bolesnika (70 od 98) liječenih 16 tjedana.
English: Sovaldi contains the active substance sofosbuvir.
Croatian: Lijek Sovaldi sadržava djelatnu tvar sofosbuvir.
English: Sovaldi can be used in all 6 varieties (genotypes) of hepatitis C virus.
Croatian: Lijek Sovaldi može se primjenjivati u liječenju svih šest varijanti (genotipova) virusa hepatitisa C.
English: Sovaldi has been investigated in four main studies involving a total of 1,305 adult patients infected with hepatitis C. In all four studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end of treatment.
Croatian: Lijek Sovaldi ispitivan je u okviru četiriju glavnih ispitivanja na ukupno 1 305 odraslih bolesnika zaraženih hepatitisom C. Glavno mjerilo učinkovitosti u svim četirima ispitivanjima bio je broj bolesnika čiji rezultati krvnih pretraga 12 tjedana nakon završetka liječenja nisu pokazivali nikakve znakove prisutnosti virusa hepatitisa C.
English: The active substance in Sovaldi, sofosbuvir, blocks the action of a protein called ‘NS5B RNA-dependent RNA polymerase' in the hepatitis C virus, which is essential for the virus to multiply.
Croatian: Djelatna tvar lijeka Sovaldi, sofosbuvir, u virusu hepatitisa C inhibira djelovanje proteina naziva „NS5B RNK-ovisna RNK polimeraza”, neophodnog za umnožavanje virusa.
English: This study investigated 12 weeks of treatment with Sovaldi and ribavirin compared with placebo (a dummy treatment) and found that 78% (161 out of 207) of patients taking Sovaldi and ribavirin had no sign of the hepatitis C virus 12 weeks after the end of treatment, whereas none of 71 patients taking placebo were free of the virus.
Croatian: U tom ispitivanju istraživalo se 12 tjedana liječenja lijekom Sovaldi i ribavirinom u usporedbi s placebom (prividno liječenje) te je utvrđeno da 78 % bolesnika (161 od 207) koji su primali lijek Sovaldi i ribavirin nije imalo znakova virusa hepatitisa C 12 tjedana nakon završetka liječenja, dok virus nije uklonjen ni u jednog od 71 bolesnika koji su primali placebo.
English: Sovaldi is an antiviral medicine used in combination with other medicines to treat adults and children from 12 years of age with chronic (long-term) hepatitis C, an infection caused by the hepatitis C virus that affects the liver.
Croatian: Sovaldi je protuvirusni lijek koji se primjenjuje u kombinaciji s drugim lijekovima za liječenje kroničnog (dugotrajnog) hepatitisa C u odraslih osoba i djece starije od 12 godina, infekcije uzrokovane virusom hepatitisa C koja zahvaća jetru.
English: In addition, virus resistance to Sovaldi is very uncommon and Sovaldi works against all types of hepatitis C virus.
Croatian: Osim toga, vrlo je rijetka otpornost virusa na lijek Sovaldi, koji je djelotvoran protiv svih tipova virusa hepatitisa C.
English: Additional studies showed that Sovaldi in combination with ribavirin decreased the risk of infection of the new liver with hepatitis C virus in adult patients undergoing transplantation, that Sovaldi is also effective in patients infected with both hepatitis C and HIV, and that the outcome of patients with genotype 3 infection could be improved by extending treatment to 24 weeks.
Croatian: Dodatnim ispitivanjima pokazalo se da kombinacija lijeka Sovaldi i ribavirina smanjuje rizik od infekcije nove jetre virusom hepatitisa C u odraslih bolesnika podvrgnutih transplantaciji, da je lijek Sovaldi učinkovit i u bolesnika zaraženih hepatitisom C i HIV-om, te da se produljenjem liječenja na 24 tjedna može poboljšati ishod u bolesnika zaraženih genotipom
English: Patients infected with hepatitis C virus of genotype 2 received Sovaldi with ribavirin for 12 weeks and those infected with genotype 3 received the combination for 24 weeks.
Croatian: Bolesnici zaraženi virusom hepatitisa C genotipa 2 primali su lijek Sovaldi s ribavirinom tijekom 12 tjedana, a bolesnici zaraženi genotipom 3 primali su istu kombinaciju lijekova tijekom 24 tjedna.
English: • The fourth study involved 201 patients with hepatitis C virus (genotypes 2 or 3) whose infection did not improve on previous treatment with interferon or whose infections came back.
Croatian: • Četvrtim je ispitivanjem obuhvaćen 201 bolesnik s virusom hepatitisa C (genotipovi 2 ili 3) u kojeg prethodno liječenje interferonom nije dovelo do ublažavanja infekcije ili čija se infekcija ponovno pojavila.
English: • The second study involved 499 previously untreated patients who had hepatitis C of genotypes 2 or 3.
Croatian: • Drugim je ispitivanjem bilo obuhvaćeno 499 prethodno neliječenih bolesnika koji su bolovali od hepatitisa C genotipova 2 ili 3.
English: How does Sovaldi work?
Croatian: Kako djeluje Sovaldi?
English: How is Sovaldi used?
Croatian: Kako se Sovaldi koristi?
English: • The third study involved 278 patients with genotypes 2 or 3 hepatitis C virus who could not take or did not want to have treatment with interferon.
Croatian: • Trećim je ispitivanjem bilo obuhvaćeno 278 bolesnika s genotipovima 2 ili 3 virusa hepatitisa C koji nisu mogli primiti terapiju interferonom ili to nisu željeli.
English: In this study, patients given Sovaldi together with ribavirin for 12 weeks were compared with patients given peginterferon alfa and ribavirin for 24 weeks.
Croatian: U tom ispitivanju bolesnici koji su primali lijek Sovaldi i ribavirin tijekom 12 tjedana uspoređeni su s bolesnicima koji su primali peginterferon alfa i ribavirin tijekom 24 tjedna.
English: What benefits of Sovaldi have been shown in studies?
Croatian: Koje su koristi od lijeka Sovaldi utvrđene u ispitivanjima?
English: This study compared Sovaldi and ribavirin taken for 12 weeks with Sovaldi and ribavirin taken for 16 weeks.
Croatian: U tom je ispitivanju uspoređeno 12 tjedana liječenja lijekom Sovaldi i ribavirinom sa 16 tjedana liječenja lijekom Sovaldi i ribavirinom.
English: • The first study involved 327 previously untreated patients who were infected with hepatitis C virus of genotypes 1, 4, 5 or 6, and who were given Sovaldi together with two other antiviral medicines,
Croatian: • Prvo je ispitivanje obuhvatilo 327 prethodno neliječenih bolesnika koji su bili zaraženi virusom hepatitisa C genotipova 1, 4, 5 ili 6 te su primali lijek Sovaldi zajedno s dvama drugim protuvirusnim lijekovima, peginterferonom alfa i ribavirinom, tijekom 12 tjedana.
English: For the full list of side effects of Sovaldi, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Sovaldi potražite u uputi o lijeku.
English: The medicine is available as tablets (1, 2, 3 and 4 mg).
Croatian: Dostupan je u obliku tableta (1, 2, 3 i 4 mg).
English: The recommended starting dose for all patients is 1 mg taken by mouth once a day.
Croatian: Preporučena početna doza za sve bolesnike iznosi 1 mg koji se uzima kroz usta jednom na dan.
English: Sleepiness usually begins at the start of treatment and lasts for 2 to 3 weeks.
Croatian: Pospanost najčešće započinje na početku terapije i traje 2 do 3 tjedna.
English: Weekly monitoring is required at the start of treatment and the patient should continue to be monitored at least every 3 months for the first year.
Croatian: Tjedno praćenje treba započeti odmah na početku terapije, a bolesnika treba nastaviti pratiti najmanje svaka 3 mjeseca tijekom prve godine.
English: The full EPAR and risk management plan summary for Intuniv 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 Intuniv nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The CHMP has recommended several measures, including regular monitoring to manage these risks.
Croatian: CHMP je preporučio nekoliko mjera koje uključuju redovite kontrole kako bi se upravljalo rizicima.
English: Intuniv guanfacine
Croatian: Intuniv gvanfacin
English: Intuniv is used as part of a comprehensive treatment programme that typically involves psychological, educational and other interventions.
Croatian: Intuniv se koristi kao dio složenog programa liječenja koji najčešće obuhvaća psihološke, edukacijske i druge intervencije.