FrancophonIA/ELRC3.0 huggingface dataset:
English: Vancomycin is also given by mouth to treat infections caused by Clostridium difficile, which mostly develop in hospital patients treated with other antibiotics.
Croatian: Vankomicin se također uzima kroz usta u liječenju infekcija uzrokovanih bakterijom Clostridium difficile, koje se uglavnom razvijaju u hospitaliziranih bolesnika liječenih drugim antibioticima.
English: It is given by infusion (drip) into a vein to treat serious infections due to Gram-positive bacteria such as meticillin-resistant Staphylococcus aureus (MRSA) that are resistant to other antibiotics, or in patients in whom other antibiotics cannot be used.
Croatian: Primjenjuje se intravenskom infuzijom (drip) u liječenju ozbiljnih infekcija uzrokovanih gram-pozitivnim bakterijama, kao što su meticilin-rezistentni sojevi bakterije Staphylococcus aureus (MRSA) koji su otporni na druge antibiotike, ili u bolesnika u kojih se drugi antibiotici ne mogu primjenjivati.
English: The CHMP concluded that infusion of vancomycin can continue to be used for the treatment of serious infections caused by certain bacteria including MRSA (meticillin-resistant Staphylococcus aureus) in patients of all ages.
Croatian: CHMP je zaključio da se primjena vankomicina infuzijom može nastaviti u liječenju ozbiljnih infekcija uzrokovanih određenim bakterijama, uključujući MRSA (meticilin-rezistentni sojevi bakterije Staphylococcus aureus) u bolesnika svih dobi.
English: It can also be used for perioperative prophylaxis in patients at risk of developing bacterial endocarditis and for the treatment of peritoneal dialysis-associated peritonitis.
Croatian: Također se može primjenjivati za perioperativnu profilaksu u bolesnika s rizikom od razvoja bakterijskog endokarditisa te za liječenje peritonitisa povezanog s peritonejskom dijalizom.
English: • In patients with inflammatory intestinal disorders, the serum concentration of vancomycin after oral administration should be closely monitored.
Croatian: • U bolesnika s upalnim crijevnim poremećajima potrebno je pomno motriti koncentracije vankomicina u serumu nakon peroralne primjene.
English: • Any subsequent dose adjustments should be based on serum concentrations to achieve the target therapeutic concentrations.
Croatian: • Kako bi se postigle ciljane terapijske koncentracije, sve naknadne prilagodbe doza trebaju se temeljiti na koncentracijama u serumu.
English: Vancomycin can also be used to prevent bacterial endocarditis (an infection in the heart) in patients undergoing surgery and to treat infections in patients undergoing a procedure called peritoneal dialysis.
Croatian: Vankomicin se također može primjenjivati za sprječavanje bakterijskog endokarditisa (infekcija srca) u bolesnika koji se podvrgavaju operativnom zahvatu i za liječenje infekcija u bolesnika koji se podvrgavaju postupku koji se naziva peritonejska dijaliza.
English: • The available data do not adequately support the use of oral vancomycin in the treatment of staphylococcal enterocolitis and for the decontamination of the GI tract in immunocompromised patients.
Croatian: • Dostupni podatci ne podupiru na odgovarajući način peroralnu primjenu vankomicina u liječenju stafilokoknog enterokolitisa te za dekontaminaciju gastrointestinalnog trakta u imunokompromitiranih bolesnika.
English: Vancomycin has been used since the 1950s and to this day it remains an important therapeutic option for the treatment of serious infections.The Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the available data on vancomycin medicines given by infusion (drip) and injection and taken by mouth as part of its strategy to update the product information of old antibacterial agents in the context of the fight against antimicrobial resistance1.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji ocijenio je dostupne podatke o lijekovima koji sadržavaju vankomicin za primjenu intravenskom infuzijom (drip), injekcijom i kroz usta kao dio svoje strategije ažuriranja informacija o lijeku za stare antibakterijske agense u kontekstu borbe protiv antimikrobne otpornosti1.
English: • Vancomycin parenteral formulations authorised for oral use can be used by mouth in patients of all ages for the treatment of Clostridium difficile infection (CDI).
Croatian: • Parenteralne formulacije vankomicina odobrene za peroralnu primjenu mogu se uzimati kroz usta u liječenju infekcije bakterijom Clostridium difficile (CDI) u bolesnika svih dobi.
English: • Vancomycin parenteral formulations authorised for intraperitoneal use can be used in patients of all ages for the treatment of peritoneal dialysis-associated peritonitis.
Croatian: • Parenteralne formulacije vankomicina odobrene za intraperitonealnu primjenu mogu se primjenjivati u liječenju peritonitisa povezanog s peritonejskom dijalizom u bolesnika svih dobi.
English: The product information for vancomycin will be updated to reflect the following: Vancomycin solution for infusion
Croatian: Informacije o lijeku za vankomicin bit će ažurirane kako bi odražavale sljedeće:
English: • Vancomycin capsules can be used in patients aged 12 years and older for the treatment of CDI.
Croatian: • Vankomicin u obliku kapsula može se primjenjivati u bolesnika u dobi od 12 i više godina i u liječenju infekcije bakterijom Clostridium difficile.
English: To avoid the risk of developing kidney stones, patients should drink plenty of liquids (at least 1.5 litres every day for adults).
Croatian: Kako bi se izbjegao rizik od nastanka bubrežnih kamenaca, bolesnici bi trebali piti puno tekućine (barem 1,5 litru dnevno za odrasle osobe).
English: EPAR summary for the public indinavir
Croatian: EPAR, sažetak za javnost indinavir
English: The full EPAR for Crixivan 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 Crixivan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 11-2016.
Croatian: Ovaj je sažetak posljednji put ažuriran u svibnju 2012.
English: Other information about Crixivan
Croatian: Ostale informacije o lijeku Crixivan
English: This is a summary of the European public assessment report (EPAR) for Crixivan.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Crixivan.
English: The most common side effects with Crixivan (seen in more than 1 patient in 10) are increases in size of red blood cells, decreases in neutrophils (a type of white blood cell), headache, dizziness, nausea (feeling sick), vomiting, diarrhoea, heartburn, instances of high blood bilirubin levels that do not cause any symptoms, increased levels of liver enzymes (alanine and aspartate transaminases), rash, dry skin, blood in the urine, protein in the urine, crystals in the urine, weakness or tiredness, an altered sense of taste and abdominal pain (stomach ache).
Croatian: Najčešće nuspojave lijeka Crixivan (uočene u više od 1 na 10 bolesnika) jesu povećanje srednjeg staničnog volumena (velike crvene krvne stanice), smanjenje broja neutrofila (vrste bijelih krvnih stanica), glavobolja, omaglica, mučnina (osjećaj slabosti), povraćanje, proljev, dispepsija (žgaravica), izolirana asimptomatska hiperbilirubinemija (slučajevi visoke razine bilirubina u krvi koja ne uzrokuje nikakve simptome), povišene razine jetrenih enzima (alanin transaminaze i aspartat transaminaze), osip, suha koža, hematurija (krv u mokraći), proteinurija (proteini u mokraći), kristalurija (kristali u mokraći), astenija (slabost), iscrpljenost (umor), promjena osjeta okusa (izmijenjen osjećaj okusa) i abdominalna bol (bol u trbuhu).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Crixivan on 4 October 1996.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Crixivan u promet koje vrijedi na prostoru Europske unije od 4. listopada 1996.
English: It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Croatian: Djeluje tako da blokira enzim koji se naziva proteaza, a koji je uključen u reprodukciju HIV-a.
English: Crixivan does not cure HIV infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Lijekom Crixivan ne liječi se infekcija HIV-om ni AIDS, no njegovom primjenom može se odgoditi narušavanje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: In one study, 90% of those taking Crixivan in combination with zidovudine and lamivudine had viral loads below 500 copies/ml after 24 weeks of treatment, compared with 43% of those taking Crixivan alone and none (0%) of those taking zidovudine and lamivudine without Crixivan.
Croatian: U jednom ispitivanju 90 % bolesnika koji su uzimali lijek Crixivan u kombinaciji s zidovudinom i lamivudinom imali su virusna opterećenja manja od 500 kopija/ml nakon 24 tjedana, u usporedbi s 43 % u bolesnika koji su uzimali samo lijek Crixivan i nijednog bolesnika koji je uzimao zidovudin i lamivudin bez lijeka Crixivan.
English: The standard dose is 800 mg every eight hours, but Crixivan can also be taken at a dose of 400 mg twice a day if each dose is taken with 100 mg ritonavir (another antiviral medicine).
Croatian: Lijek Crixivan također se može primjenjivati u dozi od 400 mg dvaput dnevno ako se svaka doza uzima sa 100 mg ritonavira (drugi antivirusni lijek).
English: It slows down the rate at which indinavir is broken down, helping to increase levels of indinavir in the blood.
Croatian: On usporava brzinu razgradnje indinavira i tako povećava razine indinavira u krvi.
English: By blocking this enzyme, indinavir stops the virus from reproducing normally and thereby slows down the spread of infection.
Croatian: Kad je taj enzim blokiran, virus se ne može normalno razmnožavati, što usporava širenje infekcije.
English: The CHMP decided that Crixivan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Crixivan nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: For more information about treatment with Crixivan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Crixivan pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: What are the risks associated with Crixivan?
Croatian: Koji su rizici povezani s lijekom Crixivan?
English: The active substance in Crixivan, indinavir, is a protease inhibitor.
Croatian: Djelatna tvar u lijeku Crixivan, indinavir, inhibitor je proteaze.
English: Crixivan is an antiviral medicine for treating adults infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Lijek Crixivan primjenjuje se u kombinaciji s drugim lijekovima za liječenje HIV-a u liječenju odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Why is Crixivan been approved?
Croatian: Zašto je lijek Crixivan odobren?
English: Ritonavir, another protease inhibitor, is sometimes used with Crixivan as a ‘booster'.
Croatian: Ritonavir je drugi inhibitor proteaze koji se upotrebljava kao „pojačivač”.
English: What benefits of Crixivan have been shown in studies?
Croatian: Koje su koristi lijeka Crixivan dokazane u ispitivanjima?
English: How is Crixivan used?
Croatian: Kako se Crixivan koristi?
English: Crixivan is available as capsules (200 and 400 mg) and is taken by mouth one hour before or two hours after a meal with water or a light low-fat meal.
Croatian: Kapsule treba progutati cijele, bez hrane, ali s vodom jedan sat prije ili dva sata nakon obroka.
English: Crixivan should only be prescribed by doctors with experience in treating HIV and can only be obtained by prescription.
Croatian: Liječenje lijekom Crixivan trebaju provoditi liječnici s iskustvom u liječenju infekcije HIV-om.
English: For the full list of side effects reported with Crixivan, see the package leaflet.
Croatian: Potpuniji popis nuspojava zabilježenih pri primjeni lijeka Crixivan potražite u uputi o lijeku.
English: How does Crixivan work?
Croatian: Kako djeluje Crixivan?
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Crixivan.
English: Studies have shown that Crixivan in combination with other antiviral medicines is effective at reducing the level of HIV in the blood (viral load).
Croatian: Lijek Crixivan, kad se primjenjuje u kombinaciji s drugim antivirusnim lijekovima, smanjuje količinu HIV-a u krvi i održava je na niskoj razini.
English: What is Crixivan and what is it used for?
Croatian: Za što se Crixivan koristi?
English: Crixivan is used in combination with other antiviral medicines and contains the active substance indinavir.
Croatian: Lijek Crixivan mora se primjenjivati u kombinaciji s drugim antivirusnim lijekovima.
English: Crixivan must not be taken with certain other medicines because of the possibility of harmful interactions.
Croatian: Lijek Crixivan ne smije se primjenjivati u bolesnika koji uzimaju bilo koji od sljedećih lijekova:
English: At the start of treatment, Waylivra is given once a week.
Croatian: Na početku se terapije Waylivra daje jednom tjedno.
English: The frequency of injections is adjusted again after 6 and 9 months depending on how well the medicine is working.
Croatian: Učestalost injekcija prilagođava se ponovo nakon šest i devet mjeseci, ovisno o djelovanju lijeka na bolesnika.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3141249.
Croatian: Više informacija o statusu lijeka za rijetku bolest nalazi se ovdje: ema.europa.eu/medicines/human/orphandesignations/eu3141249.
English: Further information on Waylivra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/waylivra.
Croatian: Više informacija o lijeku Waylivra nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/waylivra.
English: Waylivra has been given ‘conditional authorisation'.
Croatian: Lijek Waylivra dobio je „uvjetno odobrenje”.
English: What measures are being taken to ensure the safe and effective use of Waylivra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Waylivra?
English: After 3 months, patients who have had a sufficient reduction in the level of triglycerides can continue to receive the medicine once every 2 weeks.
Croatian: Nakon tri mjeseca bolesnici u kojih je došlo do dovoljnog smanjenja razine triglicerida mogu nastaviti primati lijek jednom svaka dva tjedna.
English: Depending on the results, frequency of injections may be adjusted, or treatment paused or discontinued.
Croatian: Ovisno o rezultatima, učestalost injekcija može se prilagoditi ili se terapiju može privremeno ili trajno obustaviti.
English: Side effects reported with Waylivra are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Waylivra pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Why is Waylivra authorised in the EU?
Croatian: Zašto je Waylivra odobren u EU-u?
English: What is Waylivra and what is it used for?
Croatian: Što je Waylivra i za što se primjenjuje?
English: The most common side effects with Waylivra are reduced platelet levels (which may affect 4 in 10 people) and reactions at the site of the injection such as pain, swelling, itching, or bruising (which may affect 8 in 10 people).
Croatian: Najčešće nuspojave lijeka Waylivra su smanjenje razina trombocita (koje se može javiti u 4 na 10 osoba) i reakcije na mjestu injiciranja poput boli, oticanja, svrbeži ili modrica (koje se mogu javiti u 8 na 10 osoba).
English: After 3 months, patients given Waylivra had an average 77% reduction in the level of triglycerides compared with an average 18% reduction in patients given placebo (a dummy treatment).
Croatian: Nakon tri mjeseca, u bolesnika koji su primili lijek Waylivra u prosjeku je došlo do smanjenja razine triglicerida od 77 % u usporedbi s prosječnim smanjenjem od 18 % u bolesnika koji su primili placebo (prividno liječenje).
English: An overview of Waylivra and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Waylivra i zašto je odobren u EU-u
English: The European Medicines Agency decided that, for patients at high risk of pancreatitis and for whom other medicines and a low-fat diet have not worked well enough, Waylivra's benefits are greater than its risks and that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove odlučila je da za bolesnike u kojih postoji visok rizik od pankreatitisa i kod kojih drugi lijekovi u kombinaciji s dijetom siromašnom mastima nisu djelovali, koristi od lijeka Waylivra nadmašuju njegove rizike te da može biti odobren za primjenu u EU-u.
English: As for all medicines, data on the use of Waylivra are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Waylivra kontinuirano se prate.
English: It is only given to patients in whom other medicines to reduce triglycerides have not worked and who are at high risk of developing pancreatitis.
Croatian: Daje se samo bolesnicima u kojih drugi lijekovi za smanjenje triglicerida nisu djelovali te kod kojih postoji visok rizik od razvoja pankreatitisa.
English: The active substance in Waylivra, volanesorsen, is an ‘antisense oligonucleotide,' a very short piece of synthetic RNA (a type of genetic material).
Croatian: Djelatna tvar lijeka Waylivra, volanesorsen, je „antisense oligonukleotid”, vrlo kratak dio sintetskog RNK-a (vrste genetskog materijala).
English: Excess fat builds up in various parts of the body and leads to symptoms including abdominal pain (belly ache), deposits of fat under the skin and pancreatitis (inflammation of the pancreas).
Croatian: Prekomjerne količine masti nakupljaju se u različitim dijelovima tijela te uzrokuju simptome koji uključuju abdominalnu bol (bol u trbuhu), naslage masti ispod kože i pankreatitis (upalu gušterače).
English: FCS is rare, and Waylivra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 February 2014.
Croatian: FCS je rijetka bolest, a lijek Waylivra je dobio status „lijeka za rijetku bolest” 19. veljače 2014.
English: Waylivra is available as a solution for injection under the skin, which patients or their carers can inject themselves once they have been trained.
Croatian: Lijek Waylivra dostupan je kao otopina za injekciju koja se daje pod kožu, koju bolesnici ili njihovi njegovatelji mogu sami primijeniti nakon što prođu odgovarajuću obuku.
English: Other information about Waylivra
Croatian: Ostale informacije o lijeku Waylivra
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Waylivra 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 Waylivra također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: Waylivra contains the active substance volanesorsen.
Croatian: Waylivra sadrži djelatnu tvar volanesorsen.
English: What are the risks associated with Waylivra?
Croatian: Koji su rizici povezani s lijekom Waylivra?
English: It has been designed to block the production of a protein that slows down the breakdown of fats called apolipoprotein C-III.
Croatian: Osmišljen je za blokiranje proizvodnje bjelančevine koja usporava razgradnju masti, naziva apoC-III.
English: The main risk with this medicine is thrombocytopenia which, when severe, can lead to bleeding.
Croatian: Glavni je rizik od ovog lijeka trombocitopenija koja u ozbiljnom stadiju može dovesti do krvarenja.
English: Waylivra is a medicine used to treat familial chylomicronaemia syndrome (FCS), a genetic condition that gives rise to high levels of fats called triglycerides in the blood.
Croatian: Waylivra je lijek za liječenje sindroma obiteljske hilomikronemije (FCS), genetskog poremećaja koji uzrokuje visoke razine masti naziva trigliceridi u krvi.
English: Patients must therefore be monitored closely and the frequency of injections adjusted if needed.
Croatian: Stoga je bolesnike potrebno pažljivo pratiti te prema potrebi prilagođavati učestalost injekcija.
English: Waylivra can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in treating FCS.
Croatian: Waylivra se izdaje samo na liječnički recept, a liječenje mora nadzirati liječnik s iskustvom u liječenju FCS-a.
English: By blocking the production of this protein, the medicine reduces the level of triglycerides in the blood and, as a result, fat accumulation in the body, which is expected to reduce the risk of pancreatitis.
Croatian: Blokiranjem proizvodnje te bjelančevine lijek smanjuje razinu triglicerida u krvi i posljedično nakupljanje masti u organizmu, te se očekuje da stoga smanji i rizik od pankreatitisa.
English: For more information about using Waylivra, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Waylivra pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Waylivra must not be used in patients who have long-term or unexplained thrombocytopenia (low blood platelet levels).
Croatian: Waylivra se ne smije primjenjivati u bolesnika s dugoročnom ili neobjašnjivom trombocitopenijom (niskom razinom trombocita).
English: Waylivra effectively reduces triglyceride levels and is expected to reduce the risk of pancreatitis in patients with FCS.
Croatian: Waylivra učinkovito smanjuje razine triglicerida te se očekuje da smanji rizik od pankreatitisa u bolesnika s FCS-om.
English: The company that markets Waylivra will provide educational materials for patients and healthcare professionals with information on the risk of thrombocytopenia and bleeding with treatment and the importance of regularly checking platelet levels in patients.
Croatian: Tvrtka koja lijek Waylivra stavlja u promet osigurat će materijale za obuku bolesnika i zdravstvenih radnika s informacijama o rizicima od trombocitopenije i krvarenja te o terapiji i važnosti redovne kontrole razina trombocita u bolesnika.
English: What information is still awaited for Waylivra?
Croatian: Koje se još informacije očekuju o lijeku Waylivra?
English: How does Waylivra work?
Croatian: Kako djeluje Waylivra?
English: Since Waylivra has been given conditional authorisation, the company that markets Waylivra will provide results of a study based on a registry of patients to investigate how blood checks and adjustments to frequency of injections are carried out in practice and how well they work to prevent thrombocytopenia and bleeding.
Croatian: Kako je lijek Waylivra dobio uvjetno odobrenje, tvrtka koja ga stavlja u promet dostavit će rezultate ispitivanja na temelju registra bolesnika u kojem će se istražiti kako se u praksi provode kontrole krvne slike i prilagodbe učestalosti injekcija te koliko uspješno sprječavaju trombocitopeniju i krvarenje.
English: Because Waylivra can reduce blood levels of platelets (components that help the blood to clot), patients' blood platelet levels should be checked regularly, in addition to regular checks of triglycerides to see how well the medicine is working.
Croatian: S obzirom na to da Waylivra može smanjiti razine trombocita u krvi (tvari koje pomažu pri zgrušavanju krvi), potrebno je, uz redovnu kontrolu razina triglicerida, redovito kontrolirati i razine trombocita u krvi bolesnika da se vidi kako djeluje lijek.