FrancophonIA/ELRC3.0 huggingface dataset:
English: Victoza contains the active substance liraglutide.
Croatian: Victoza sadržava djelatnu tvar liraglutid.
English: In two ‘triple therapy' studies, Victoza with metformin and either glimepiride or rosiglitazone (a thiazolidinedione) were compared with treatments that included placebo or another anti-diabetes medicine instead of Victoza.
Croatian: U dvama ispitivanjima „trostruke terapije” terapija lijekom Victoza s metforminom i glimepiridom ili roziglitazonom (tiazolidinedion) uspoređivala se s terapijama koje su uključivale placebo ili drugi lijek protiv dijabetesa umjesto lijeka Victoza.
English: Victoza used on its own was more effective at controlling blood glucose than glimepiride.
Croatian: Lijek Victoza korišten kao monoterapija pokazao se djelotvornijim u kontroliranju glukoze u krvi od glimepirida.
English: Dual therapies containing Victoza and metformin or glimepiride led to reductions in HbA1c of around 1 percentage point compared with no reduction without Victoza.
Croatian: Dvojne terapije koje su sadržavale lijek Victoza i metformin ili glimepirid uzrokovale su smanjenje razine HbA1c od oko 1 postotnog boda u usporedbi s izostankom smanjenja kad se lijek Victoza nije primjenjivao.
English: How is Victoza used?
Croatian: Kako se lijek Victoza koristi?
English: In one ‘monotherapy' study, Victoza on its own was compared with glimepiride (a sulphonylurea).
Croatian: U jednom „monoterapijskom” ispitivanju lijek Victoza kao monoterapija uspoređen je s glimepiridom (sulfonilureja).
English: In two ‘dual therapy' studies, Victoza plus metformin or Victoza plus glimepiride were compared with metformin or glimepiride taken with a placebo (a dummy treatment).
Croatian: U dvama ispitivanjima „dvojnih terapija” uspoređen je lijek Victoza i metformin ili lijek Victoza i glimepirid s metforminom ili glimepiridom korištenim s placebom (prividno liječenje).
English: • on its own when use of metformin (another medicine for type 2 diabetes) is not recommended;
Croatian: Victoza se koristi: • kao monoterapija kada se ne prepoučuje uzimanje metformina (drugog lijeka protiv dijabetesa tipa
English: How does Victoza work?
Croatian: Kako djeluje Victoza?
English: This medicine is the same as Renagel, which is already authorised in the European Union (EU).
Croatian: Ovaj lijek isti je kao i Renagel, koji je već odobren u Europskoj uniji (EU).
English: This summary was last updated in 02-2015.
Croatian: Sažetak je posljednji put ažuriran u 02.2015.
English: The full EPAR for Tasermity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Tasermity nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This leads to phosphate accumulating in the body, which, in the long term, can cause complications affecting the heart and the bones.
Croatian: Ovo rezultira nakupljanjem fosfata u tijelu, što dugoročno gledano može uzrokovati komplikacije koje zahvaćaju srce i kosti.
English: Patients with severe kidney disease cannot eliminate phosphate from their bodies.
Croatian: Bolesnici s teškom bolesti bubrega ne mogu eliminirati fosfat iz svojeg tijela.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tasermity on 26 February 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Tasermity vrijedi na snazi u Europskoj uniji od 26. veljače 2015.
English: Tasermity is available as tablets (800 mg).
Croatian: Tasermity je dostupan u obliku tableta (800 mg).
English: What measures are being taken to ensure the safe and effective use of Tasermity?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tasermity?
English: This helps to reduce the phosphate levels in the blood.
Croatian: Ovo pomaže pri snižavanju koncentracije fosfata u krvi.
English: Other information about Tasermity
Croatian: Ostale informacije o lijeku Tasermity
English: The most common side effects with Tasermity (which may affect more than 1 in 10 people) are nausea (feeling sick) and vomiting.
Croatian: Najčešće nuspojave lijeka Tasermity (mogu se pojaviti u više od 1 na 10 osoba) su mučnina (osjećaj slabosti) i povraćanje).
English: Tasermity must be taken with meals and patients should keep to their prescribed diets.
Croatian: Tasermity se mora uzimati s obrocima, a bolesnici se trebaju pridržavati svoje propisane prehrane.
English: This is a summary of the European public assessment report (EPAR) for Tasermity.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Tasermity.
English: The dose of Tasermity should be adjusted every two to three weeks to reach an acceptable level of phosphate in the blood, which should then be monitored regularly.
Croatian: Dozu lijeka Tasermity treba prilagoditi svaka dva do tri tjedna kako bi se postigla prihvatljiva razina fosfata u krvi, koju je potrebno redovito pratiti.
English: The company that makes Renagel has agreed that its scientific data can be used for Tasermity (‘informed consent').
Croatian: Proizvođač lijeka Renagel je pristao da se njegovi znanstveni podaci koriste za lijek Tasermity (tzv. „informirani pristanak”).
English: What is Tasermity and what is it used for?
Croatian: Što je Tasermity i za što se koristi?
English: The recommended starting dose of Tasermity is 1 or 2 tablets three times a day, depending on clinical need and the level of phosphate in the blood.
Croatian: Preporučena početna doza za lijek Tasermity je 1 do 2 tablete tri puta dnevno, ovisno o kliničkoj potrebi i koncentraciji fosfata u krvi.
English: Similar results with Tasermity were seen in another 8-week study involving 172 haemodialysis patients, while in a third longer-term study (over 44 weeks) Tasermity led to an average fall of 0.71 mmol/l.
Croatian: Slični rezultati kao s lijekom Tasermity uočeni su u drugom ispitivanju u trajanju od 8 tjedana koje je obuhvatilo 172 bolesnika na hemodijalizi, dok je u trećem dugoročnom ispitivanju (tijekom 44 tjedana) Tasermity rezultirao prosječnim padom od 0,71 mmol/l.
English: Why is Tasermity approved?
Croatian: Zašto je Tasermity odobren?
English: Tasermity sevelamer hydrochloride
Croatian: Tasermity sevelamerhidroklorid
English: A risk management plan has been developed to ensure that Tasermity is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Tasermity.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tasermity's benefits are greater than its risks for the treatment of hyperphosphataemia and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Tasermity nadmašuju s njim povezane rizike za terapiju hiperfosfatemije te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: What are the risks associated with Tasermity?
Croatian: Koji su rizici povezani s lijekom Tasermity?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tasermity, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Tasermity nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For more information about treatment with Tasermity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Tasermity pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: In a study of 84 patients undergoing haemodialysis, there was an average fall in phosphate levels of 0.65 mmol/l in patients taking Tasermity for 8 weeks, compared with a fall of 0.68 mmol/l in patients taking calcium acetate, another phosphate-lowering medicine.
Croatian: U ispitivanju provedenom na 84 bolesnika koji se podvrgavaju hemodijalizi, prisutan je prosječan pad u koncentraciji fosfata od 0,65 mmol/l u bolesnika koji su uzimali Tasermity tijekom 8 tjedana, u usporedbi s padom od 0,68 mmol/l u bolesnika koji su uzimali kalcij acetat, drugi lijek za snižavanje fosfata.
English: It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Croatian: Može se koristiti u bolesnika koji se podvrgavaju hemodijalizi (uz primjenu uređaja za filtraciju krvi) ili peritonealnoj dijalizi (u slučaju kada se tekućina pumpa u trbuh, a interna membrana tijela filtrira krv).
English: When taken with meals, the sevelamer molecules in Tasermity attach in the gut to phosphate from food, preventing it from being absorbed into the body.
Croatian: Ako se uzima s obrocima, molekule sevelamera u lijeku Tasermity vezuju se u crijevima na fosfat iz hrane, sprječavajući ga da se apsorbira u tijelu.
English: The benefit of Tasermity has also been shown in a study of 143 patients undergoing peritoneal dialysis: patients receiving Tasermity in this study had similar falls in phosphate levels over 12 weeks as the patients receiving calcium acetate (0.52 and 0.58 mmol/l, respectively).
Croatian: Korist lijeka Tasermity utvrđena je također u ispitivanju provedenom na 143 bolesnika koji su podvrgnuti peritonealnoj dijalizi: bolesnici koji su primali Tasermity u ovom ispitivanju imali su sličan pad u koncentracijama fosfata tijekom 12 tjedana kao bolesnici koji su primali kalcij acetat (0,52 odnosno 0,58 mmol/l)
English: Tasermity is a medicine used to control hyperphosphataemia (high blood phosphate levels) in adult patients on dialysis (a blood clearance technique).
Croatian: Tasermity je lijek koji se koristi za kontrolu hiperfosfatemije (visoke koncentracije fosfata u krvi) u odraslih bolesnika koji su na dijalizi (tehnika čišćenja krvi).
English: Tasermity must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).
Croatian: Tasermity se ne smije koristi u osoba s hipofosfatemijom (niskim razinama fosfata u krvi) ili s opstrukcijom crijeva (blokadom u crijevima).
English: Studies have shown that Tasermity significantly reduces blood phosphate levels in patients with kidney disease undergoing dialysis.
Croatian: Ispitivanjima je utvrđeno da lijek Tasermity značajno snižava koncentracije fosfata u krvi u bolesnika s bolešću bubrega koji se podvrgavaju dijalizi.
English: What benefits of Tasermity have been shown in studies?
Croatian: Koje su koristi lijeka Tasermity dokazane u ispitivanjima?
English: The active substance in Tasermity, sevelamer hydrochloride, is a phosphate binder.
Croatian: Djelatna tvar u lijeku Tasermity, sevelamerhidroklorid, je sredstvo za vezanje fosfata.
English: How does Tasermity work?
Croatian: Kako djeluje Tasermity?
English: Tasermity contains the active substance sevelamer hydrochloride.
Croatian: Tasermity sadrži djelatnu tvar sevelamerhidroklorid.
English: For the full list of all side effects and restrictions with Tasermity, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Tasermity potražite u uputi o lijeku.
English: Tasermity should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Croatian: Tasermity se smije koristiti s drugim terapijama poput dodataka kalcija i vitamina
English: How is Tasermity used?
Croatian: Kako se Tasermity koristi?
English: For practical information about using Tasermity, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Tasermity Praktične informacije o korištenju lijeka Tasermity pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: 1.5 - 3.1 ml 1 vial
Croatian: 1,5 - 3,1 ml
English: Vial (glass)
Croatian: Bočica (staklena)
English: 2 to 4 GBq per vial at calibration date
Croatian: 2 do 4 GBq po bočici na referentni datum (1,3 GBq/ml na referentni datum)
English: EU Number Invented name Strength
Croatian: Broj (EU) odobrenja Zaštićeno ime
English: Intravenous use
Croatian: Intravenski
English: Pharmaceutical form Route of administration Packaging Content
Croatian: Put primjene Unutarnje pakovanje
English: Before you start Read these messages first
Croatian: Prije nego počnete Prvo pročitajte ove poruke
English: • progressive, or
Croatian: • progresivan, ili
English: Your doctor will discuss this with you.
Croatian: Vaš liječnik će o tome porazgovarati s Vama.
English: You will need regular tests
Croatian: Trebat ćete redovite pretrage
English: But there will still be some left in the bottle, even though you may not be able to see it.
Croatian: Međutim još će nešto lijeka ostati u boci čak i ako ga možda ne budete vidjeli.
English: If you do, the medicine will not be properly absorbed into your body.
Croatian: Ako to učinite, lijek se neće pravilno apsorbirati u tijelo.
English: Revolade with food and drink
Croatian: Revolade s hranom i pićem
English: Now you need to complete steps 11 to 13 to make sure the child receives all of the medicine.
Croatian: Sada trebate proći korake 11. do 13. kako biste bili sigurni da je dijete dobilo sav lijek.
English: Avoid direct contact with the medicine.
Croatian: Izbjegavajte izravan kontakt s lijekom.
English: • and the 2 hours after you take Revolade you don't consume any of the following:
Croatian: • i 2 sata nakon što uzmete Revolade ne konzumirate ništa od navedenoga:
English: • Try not to let the medicine touch your skin.
Croatian: • Nastojte da lijek ne dodirne Vašu kožu.
English: Do not take more than one dose of Revolade in one day.
Croatian: Nemojte uzeti više od jedne doze lijeka Revolade u jednome danu.
English: % patients achieving virologic response
Croatian: % bolesnika koji su postigli virološki odgovor
English: • Prepare the suspension with water only.
Croatian: • Pripremajte suspenziju samo s vodom.
English: Make sure the child has time to swallow.
Croatian: Pazite da dijete ima vremena da ga proguta.
English: Interference with laboratory tests
Croatian: Interferencija s laboratorijskim testovima
English: You have now given the child nearly all of their dose of medicine.
Croatian: Upravo ste djetetu dali gotovo cijelu dozu lijeka.
English: For hepatitis C
Croatian: Za hepatitis C
English: • IMPORTANT: Because some medicine will remain in the mixing bottle, complete the following steps.
Croatian: • VAŽNO: Budući da će nešto lijeka ostati u boci za miješanje, poduzmite sljedeće korake.
English: Effects were less severe at lower doses and were characterised by a spectrum of regenerative changes.
Croatian: Učinci su bili manje teški pri nižim dozama i bili su karakterizirani nizom regenerativnih promjena.
English: Component of a multipack, can't be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati pojedinačno.
English: Read and follow these instructions to prepare a dose of Revolade and give it to the child.
Croatian: Pročitajte i slijedite ove upute da biste pripremili dozu lijeka Revolade i dali ga djetetu.
English: For more advice about suitable foods and drinks, talk to your doctor.
Croatian: Za dodatne savjete o prikladnoj prehrani i piću obratite se svom liječniku.
English: Always start with a complete new kit for each 30 sachets.
Croatian: Uvijek započnite s potpunim novim kompletom za svakih 30 vrećica.
English: Table 4 Secondary efficacy results from RAISE
Croatian: Tablica 4 Rezultati sekundarne djelotvornosti iz RAISE studije
English: • Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Croatian: • Recite svom liječniku ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: Tell your doctor immediately if you have any of these symptoms.
Croatian: Recite odmah svom liječniku ako imate bilo koji od ovih simptoma.
English: Warnings and precautions Talk to your doctor before taking Revolade:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Revolade:
English: To prepare and give a dose of Revolade, you need:
Croatian: Da biste pripremili i dali dozu lijeka Revolade, treba Vam:
English: The majority of TEEs were non-serious and resolved by the end of the study.
Croatian: Većina TED-a nije bila ozbiljna i riješena je do kraja ispitivanja.
English: Other medicines and Revolade
Croatian: Drugi lijekovi i Revolade
English: This includes medicines obtained without prescription and vitamins.
Croatian: To uključuje i lijekove koje ste nabavili bez recepta i vitamine.
English: Do not open the foil sachets until ready for use.
Croatian: Ne otvarajte vrećice od folije dok niste spremni za primjenu.
English: If you have either of these signs of liver problems:
Croatian: Ako imate bilo koji od ovih znakova jetrenih tegoba:
English: After you have used all 30 sachets in the kit, dispose of the bottle.
Croatian: Nakon što ste upotrijebili svih 30 vrećica u kompletu, odložite bočicu.
English: • Revolade powder must be mixed only with water at room temperature.
Croatian: • Revolade prašak smije se miješati samo s vodom na sobnoj temperaturi.
English: Stop eltrombopag; for at least one week.
Croatian: Prekinuti primjenu eltrombopaga; najmanje na 1 tjedan.
English: The majority of patients (84%) had received at least 2 prior immunosuppressive therapies.
Croatian: Većina bolesnika (84%) primila je najmanje 2 prethodne imunosupresivne terapije.
English: Check with your doctor if you think this applies to you.
Croatian: Provjerite kod svog liječnika ako mislite da se to odnosi na Vas.
English: • Take care that the child does not play with the bottle, cap, lid or syringes - there is a risk of choking if the child puts them in their mouth.
Croatian: • Pazite da se dijete ne igra s bočicom, zatvaračem, poklopcem ili štrcaljkama - postoji rizik od gušenja ako ih dijete stavi u usta.
English: The powder for oral suspension is in sachets, the contents of which will need to mixed before you can take the medicine.
Croatian: Prašak za oralnu suspenziju je u vrećicama čiji će sadržaj trebati promiješati prije nego ćete moći uzeti lijek.
English: <50,000/µl following at least 2 weeks of therapy
Croatian: <50 000/µl nakon barem 2 tjedna liječenja
English: IMPORTANT:
Croatian: VAŽNO:
English: In non-splenectomised patients this should include evaluation relative to splenectomy.
Croatian: U nesplenektomiranih bolesnika to treba uključivati evaluaciju povezanu sa splenektomijom.
English: • unusually dark-coloured urine tell your doctor immediately.
Croatian: • neuobičajeno taman urin recite odmah svom liječniku.
English: Symptoms needing attention: see a doctor
Croatian: Simptomi koje treba liječiti: posjetite liječnika
English: Date of first authorisation: 11 March 2010 Date of latest renewal: 15 January 2015
Croatian: Datum posljednje obnove odobrenja: 15. siječnja 2015.
English: What Revolade is and what it is used for
Croatian: Što je Revolade i za što se koristi
English: • if you have another blood condition, such as myelodysplastic syndrome (MDS).
Croatian: • ako imate drugu bolest krvi, poput mijelodisplastičnog sindroma (MDS).
English: • Let all the equipment dry in the air.
Croatian: • Pustite svu opremu da se osuši na zraku.
English: Revolade is not recommended for use in children under the age of one year with ITP due to insufficient data on safety and efficacy.
Croatian: Revolade se ne preporučuje za primjenu u djece mlađe od godinu dana s ITP-om zbog nedostatnih podataka o sigurnosti i djelotvornosti.
English: Eltrombopag is highly coloured and so has the potential to interfere with some laboratory tests.
Croatian: Eltrombopag je jako obojen i stoga ima potencijal za interferenciju s nekim laboratorijskim testovima.
English: However a risk for humans cannot be ruled out (see section 5.3).
Croatian: Međutim, ne može se isključiti rizik za ljude (vidjeti dio 5.3).
English: Method of administration (see section 6.6)
Croatian: Način primjene (vidjeti dio 6.6)
English: If the laboratory results and clinical observations are inconsistent, re-testing using another method may help in determining the validity of the result.
Croatian: Ako su rezultati laboratorijskih testova nekonzistentni s kliničkim opažanjima, ponovno provođenje testova primjenom druge metode može pomoći u određivanju valjanosti rezultata.
English: This was measured by delayed phototoxic index.
Croatian: Isto je mjereno odgođenim fototoksičnim indeksom.
English: Care should be taken when using Revolade if you are aged 65 years or above.
Croatian: Treba paziti za vrijeme uzimanja lijeka Revolade ako imate 65 ili više godina.
English: Eltrombopag is highly bound to human plasma proteins (>99.9%), predominantly to albumin.
Croatian: Eltrombopag se izrazito veže za proteine ljudske plazme (>99,9%), prvenstveno za albumin.
English: p-value a
Croatian: p-vrijednost a
English: Older people (65 years and above)
Croatian: Stariji ljudi (u dobi od 65 godina i stariji)
English: If you have MDS and take Revolade, your MDS may get worse.
Croatian: Ako imate MDS i uzimate Revolade, MDS bi se mogao pogoršati.
English: • Tap the top of each sachet to make sure the contents fall to the bottom
Croatian: • Kucnite po vrhu svake vrećice kako biste bili sigurni da je sadržaj pao na dno
English: The plasma elimination half-life of eltrombopag is approximately 21-32 hours.
Croatian: Poluvrijeme eliminacije eltrombopaga iz plazme iznosi otprilike 21-32 sata.
English: • feeling cold
Croatian: • osjećaj hladnoće
English: Gently and slowly shake the mixing bottle backwards and forwards for at least 20 seconds to mix the water with the powder.
Croatian: Lagano i polako mućkajte bočicu za miješanje naprijed-nazad najmanje 20 sekundi da biste pomiješali vodu s praškom.
English: Juvenile animal studies
Croatian: Ispitivanja juvenilnih životinja
English: Cleaning of the mixing equipment:
Croatian: Čišćenje opreme za miješanje:
English: • accumulation of iron in the body (iron overload)
Croatian: • nakupljanje željeza u tijelu (preopterećenje željezom)
English: • vomiting blood or something that looks like coffee grounds
Croatian: • povraćanje krvi ili sadržaja koji izgleda kao talog kave
English: Patients received study medication for up to 8 years (in EXTEND).
Croatian: Bolesnici su primali ispitivani lijek do 8 godina (u ispitivanju EXTEND).
English: At tolerated doses, no ocular opacities were observed (see above subsection ‘Safety pharmacology and repeat-dose toxicity').
Croatian: Pri podnošljivim dozama nisu uočeni opaciteti oka (vidjeti podnaslov „Sigurnosna farmakologija i toksičnost ponovljenih doza“).
English: The remaining 5 patients discontinued treatment, three due to relapse at the month 3 extension visit.
Croatian: Preostalih 5 bolesnika prekinulo je liječenje, troje zbog relapsa prilikom posjete u 3. mjesecu produžene faze.
English: • medicines such as methotrexate and topotecan, to treat cancer Talk to your doctor if you take any of these.
Croatian: • lijekovi poput metotreksata i topotekana, za liječenje raka Recite svom liječniku ako uzimate neki od navedenih preparata.
English: • some medicines to treat HIV infection, such as lopinavir and/or ritonavir
Croatian: • neki lijekovi za liječenje HIV infekcije, poput lopinavira i/ili ritonavira
English: You should not take Revolade unless your doctor considers that the expected benefits outweigh the risk of blood clots.
Croatian: Revolade ne bi trebali uzimati osim ako Vaš liječnik ne smatra da očekivana korist nadmašuje rizik od zgrušavanja krvi.
English: • increased levels of some proteins
Croatian: • povećana razina nekih proteina
English: For more information, see ‘When to take it' in section 3.
Croatian: Za više informacija pogledajte „Kada uzeti lijek“ u dijelu 3.
English: Progression of existing myelodysplastic syndrome (MDS)
Croatian: Progresija postojećeg mijelodisplastičkog sindroma (MDS)