FrancophonIA/ELRC3.0 huggingface dataset:
English: Lemtrada is a medicine that is used to treat adults with relapsing-remitting multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves as well as the nerves themselves.
Croatian: Lijek Lemtrada koristi se za liječenje relapsno-remitirajuće multiple skleroze (MS), bolesti kod koje upala oštećuje zaštitnu izolacijsku ovojnicu živaca kao i same živce. „Relapsno-remitirajuća” znači da u bolesnika dolazi do napada (relapsa) između razdoblja s malo simptoma ili bez njih (remisija).
English: Lemtrada contains the active substance alemtuzumab.
Croatian: Lemtrada sadrži djelatnu tvar alemtuzumab.
English: It should be given twice a week for 12 weeks, and then once a week for 24 weeks.
Croatian: Treba ga davati dva put tjedno tijekom 12 tjedana i potom jednom tjedno tijekom 24 tjedna.
English: The patients were followed up for up to 10 years.
Croatian: Bolesnici su bili praćeni do 10 godina.
English: The main measure of effectiveness was the number of patients who survived without the disease coming back.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika koji su preživjeli bez povratka bolesti.
English: Mepact mifamurtide
Croatian: Mepact mifamurtid
English: This summary was last updated in 09-2013.
Croatian: Sažetak je posljednji put obnovljen 9.2013.
English: Other information about Mepact:
Croatian: Druge informacije o lijeku Mepact:
English: The most common side effects with Mepact (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), loss of appetite, headache, dizziness, tachycardia (rapid heartbeat), hypertension (high blood pressure), hypotension (low blood pressure), dyspnoea (difficulty breathing), tachypnoea (rapid breathing), cough, vomiting, diarrhoea, constipation, abdominal pain (stomach ache), nausea, hyperhidrosis (excessive sweating), myalgia (muscle pain), arthralgia (joint pain), back pain, pain in extremity (the arms and legs), fever, chills, fatigue (tiredness), hypothermia (low body temperature), general pain, malaise (feeling unwell), asthenia (weakness) and chest pain.
Croatian: Najčešće nuspojave s lijekom Mepact (uočene u više od 1 na 10 bolesnika) su anemija (nizak broj eritrocita), gubitak apetita, glavobolja, vrtoglavica, tahikardija (ubrzani srčani otkucaji), hipertenzija (visoki krvni tlak), hipotenzija (niski krvni tlak), dispneja (poteškoće u disanju), tahipneja (ubrzano disanje), kašalj, povraćanje, proljev, konstipacija, bol u trbuhu, mučnina, hiperhidroza (prekomjerno znojenje), mijalgija (bol u mišićima), artralgija (bol u zglobovima), bol u leđima, bol u ekstremitetima (ruke i noge), vrućica, trnci, umor, hipotermija (niska tjelesna temperatura), opća bol, slabost (loše osjećanje), astenija (slabost) i bol u prsima.
English: The marketing authorisation is valid for five years, after which it can be renewed.
Croatian: Odobrenje za stavljanje lijeka u promet vrijedi pet godina nakon čega se može obnoviti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mepact on 6 March 2009.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Mepact vrijedi na prostoru Europske unije od 6. ožujka 2009.
English: It must not be given as a bolus injection (all at once).
Croatian: Ne smije se davati kao bolus injekcija (odjednom).
English: The dose of Mepact depends on the patient's height and weight.
Croatian: Doza lijeka Mepact ovisi o bolesnikovoj visini i težini.
English: Mepact is given as a slow infusion lasting an hour.
Croatian: Mepact se daje kao spora infuziju tijekom sat vremena.
English: Mepact treatment should be started and supervised by a specialised doctor who has experience in diagnosing and treating osteosarcoma.
Croatian: Liječenje lijekom Mepact treba započeti i nadzirati liječnik specijalist koji ima iskustva u dijagnosticiranju i liječenju osteosarkoma.
English: Mepact, used with other anticancer medicines, increased how long patients survived without their disease coming back: 68% of the patients receiving Mepact (231 out of 338) survived without the disease coming back, compared with 61% of the patients who did not receive it (207 out of 340).
Croatian: Mepact u kombinaciji s drugim lijekovima protiv karcinoma povećao je preživljavanje bolesnika bez povratka bolesti: 68 % bolesnika koji su primali Mepact (231 od 338) preživjelo je bez povratka bolesti u usporedbi sa 61 % bolesnika koji ga nisu primali (207 od 340).
English: The precise way that mifamurtide works in osteosarcoma is not fully understood, but it is thought to cause the white blood cells to release chemicals that kill the cancerous cells.
Croatian: Točan način djelovanja mifamurtida kod osteosarkoma nije do kraja razjašnjen, ali smatra se da potiče leukocite na oslobađanje kemikalija koje ubijaju stanice karcinoma.
English: After surgery to remove the cancer, all of the patients were given various combinations of anticancer medicines.
Croatian: Nakon kirurškog uklanjanja karcinoma, svi su bolesnici dobili različite kombinacije lijekova protiv karcinoma.
English: It must not be used at the same time as ciclosporin or other calcineurin inhibitors (medicines that reduce the activity of the immune system), or high doses of non-steroidal anti-inflammatory drugs (NSAIDs; used to treat pain and inflammation).
Croatian: Ne smije se koristiti u isto vrijeme kao i ciklosporin ili drugi inhibitori kalcineurina (lijekovi koji smanjuju aktivnost imunološkog sustava) ili visoke doze nesteroidnih protuupalnih lijekova (NSAIDs; koriste se za liječenje boli i upale).
English: Mepact should not be used in people who may be hypersensitive (allergic) to mifamurtide or any of the other ingredients.
Croatian: Mepact se ne smije koristiti u osoba koje bi mogle biti preosjetljive (alergične) na mifamurtid ili na bilo koje druge sastojke lijeka.
English: Mepact is a powder that is made up into a suspension for infusion (drip into a vein).
Croatian: Mepact je prašak koji se pretvara u suspenziju za infuziju (drip u venu).
English: The risk of dying was also reduced by 28% in patients receiving Mepact.
Croatian: Rizik od smrti smanjen je za 28 % u bolesnika koji su primali Mepact.
English: Half of the patients were also given Mepact.
Croatian: Polovica bolesnika također je primila Mepact.
English: For more information about treatment with Mepact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Mecapt pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
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 Mepact.
Croatian: Objašnjava kako je Povjerenstvo za humane lijekove (CHMP) ocijenilo lijek Mecapt da bi izdalo mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i preporučilo uvjete za njegovu primjenu.
English: Mepact has been studied in one main study involving 678 patients aged between one and 31 years with high-grade non-metastatic osteosarcoma.
Croatian: Mepact se ispitivao u jednom glavnom ispitivanju koje je uključivalo 678 bolesnika u dobi između jedne i 31 godine s nemetastatskim osteosarkomom visokog stupnja.
English: The active substance in Mepact, mifamurtide, is an immunomodulator.
Croatian: Djelatna tvar u lijeku Mepact, mifamurtid, je imunomodulator.
English: Mepact is used with other anticancer medicines after the cancer has been removed by surgery.
Croatian: Mepact se koristi s drugim lijekovima protiv karcinoma nakon kirurškog uklanjanja karcinoma.
English: Because the number of patients with osteosarcoma is low, the disease is considered ‘rare', and Mepact was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 June 2004.
Croatian: Budući da je broj bolesnika s osteosarkomom mali, dotična se bolest smatra „rijetkom” te se Mepact označava kao lijek za liječenje rijetkih i teških bolesti od 21. lipnja 2004.
English: It works by activating macrophages and monocytes (types of white blood cell that form part of the immune system).
Croatian: Djeluje aktivacijom makrofaga i monocita (vrsta leukocita koji su dio imunološkog sustava).
English: This document is a summary of the European public assessment report (EPAR) for Mepact.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Mepact.
English: Why has Mepact been approved?
Croatian: Zašto je Mepact odobren?
English: The study compared patients who were given Mepact with those who were not.
Croatian: Ispitivanje je usporedilo bolesnike koji su primali Mepact s onima koji nisu primali Mepact.
English: What is the risk associated with Mepact?
Croatian: Koji su rizici povezani s lijekom Mepact?
English: What is Mepact?
Croatian: Što je Mepact?
English: It contains the active substance mifamurtide.
Croatian: Sadrži djelatnu tvar mifamurtid.
English: The CHMP decided that Mepact's benefits are greater than its risks when used with other anticancer medicines and recommended that it be given marketing authorisation.
Croatian: Mepacta veće od njegovih rizika kad se koristi s drugim lijekovima protiv karcinoma i preporučio izdavanje odobrenja za stavljanje u promet lijeka Mepact.
English: ‘High grade' means that the cancer is of a severe type, and ‘non-metastatic' means that it is at an early stage and has not spread far within the body.
Croatian: Mepact se koristi za liječenje nemetastatskog osteosarkoma visokog stupnja (vrste raka kostiju) u bolesnika u dobi između dvije i 30 godina. „Visokog stupnja” znači da je karcinoma teškog oblika, a „nemetastatski” znači da je u ranom stadiju i da se nije proširio po tijelu.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Mepact is available here.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Mepact možete naći ovdje.
English: What benefit has Mepact shown during the studies?
Croatian: Mepacta su dokazane tijekom ispitivanja?
English: What is Mepact used for?
Croatian: Za što se Mepact koristi?
English: For the full list of all side effects reported with Mepact, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Mecapt potražite u uputi o lijeku.
English: How does Mepact work?
Croatian: Kako djeluje Mepact?
English: The full EPAR for Mepact can be found here.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) može se naći ovdje.
English: How is Mepact used?
Croatian: Kako se Mepact koristi?
English: How has Mepact been studied?
Croatian: Kako se Mepact ispitivao?
English: 74.2 mg Implant
Croatian: 74,2 mg Implantat
English: 4 implants + 1 applicator
Croatian: 4 implantata + 1 aplikator
English: Subcutaneous use sachet (PET/LDPE/alu)
Croatian: Vrećica (PET/LDPE/Alu)
English: The correct dose is determined individually for each patient.
Croatian: Točna doza određuje se pojedinačno za svakog bolesnika.
English: Studies lasted for six months or one year.
Croatian: Ispitivanja su trajala od 6 mjeseci do godine dana.
English: After 26 weeks of treatment, patients had the option to either stop treatment or continue with it for up to a year.
Croatian: Nakon 26 tjedana liječenja, bolesnici su imali mogućnost prekinuti terapiju ili je nastaviti sljedećih godinu dana.
English: The full EPAR for Tresiba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Tresiba nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tresiba is injected once a day, preferably at the same time every day.
Croatian: Tresiba se injektira jednom na dan, po mogućnosti u isto vrijeme svaki dan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tresiba on 21 January 2013.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Tresibu vrijedi na prostoru Europske unije od 21. siječnja 2013.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively.
Croatian: Dijabetes je bolest kod koje tijelo ne proizvodi dovoljno inzulina kako bi kontroliralo razinu šećera u krvi ili kada tijelo nije u stanju učinkovito koristiti inzulin.
English: It is available as a solution for injection in a cartridge (100 units/ml) and in a pre-filled pen (100 units/ml and 200 units/ml).
Croatian: Dostupan je kao otopina za injekciju u ulošku (100 jedinica/ml) i u napunjenoj brizgalici (100 jedinica/ml i 200 jedinica/ml).
English: By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Croatian: Kontrolirajući razinu glukoze u krvi, smanjuju se simptomi i komplikacije dijabetesa.
English: This is a summary of the European public assessment report (EPAR) for Tresiba.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Tresiba.
English: The place within the chosen area should be changed with each injection to reduce the risk of lipodystrophy (changes in the distribution of body fat) under the skin that can affect the amount of insulin absorbed.
Croatian: Mjesta injektiranja unutar odabranog područja treba mijenjati sa svakom injekcijom kako bi se smanjio rizik od lipodistrofije (promjena u distribuciji masnog tkiva) ispod kože koja može utjecati na količinu apsorpcije inzulina.
English: Other information about Tresiba
Croatian: Ostale informacije o lijeku Tresiba
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 Tresiba.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Tresiba.
English: After 26 weeks of treatment with Tresiba, the average reduction in HbA1c was 0.2 percentage points (HbA1c decreased from 8.2% to 8.0%) compared with a reduction of 0.3 percentage points with insulin detemir (HbA1c decreased from 8.0% to 7.7%).
Croatian: Nakon 26 tjedana liječenja s lijekom Tresiba, prosječno smanjenje HbA1c iznosilo je 0,2 postotna boda (HbA1c se smanjio s 8,2% na 8,0%) u usporedbi sa smanjenjem od 0,3 postotna boda s inzulinom detemir (HbA1c se smanjio s 8,0% na 7,7%).
English: What measures are being taken to ensure the safe and effective use of Tresiba?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tresiba?
English: The most frequently reported side effect during treatment with Tresiba (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels).
Croatian: Najčešće prijavljene nuspojave tijekom liječenja lijekom Tresiba (koje mogu zahvatiti više od 1 na 10 osoba) su hipoglikemija (niske razine glukoze u krvi).
English: It will also produce educational materials for patients on how to use Tresiba correctly, which they should receive through their doctor together with suitable training.
Croatian: Također će osigurati edukacijske materijale za bolesnike o tome kako ispravno koristiti lijek Tresiba, koje bi trebali dobiti od svog liječnika skupa s odgovarajućom obukom.
English: All of the studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose.
Croatian: Sva su ispitivanja mjerila razinu tvari u krvi zvanu glikolizirani hemoglobin (HbA1c) koji predstavlja postotak hemoglobina u krvi na kojeg je vezana glukoza.
English: A risk management plan has been developed to ensure that Tresiba is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Tresiba.
English: For more information about treatment with Tresiba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Tresiba pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The CHMP noted that the higher strength formulation of Tresiba met a medical need for patients requiring higher dose insulin (such as overweight patients), which would allow these patients to take their daily dose in a single injection rather than two injections.
Croatian: CHMP je zabilježio da formulacije veće jačine lijeka Tresiba ispunjavaju medicinsku potrebu bolesnika kojima je potrebna viša doza inzulina (poput pretilih bolesnika), čime bi se tim bolesnicima omogućilo uzimanje dnevne doze u jednoj injekciji umjesto u dvije.
English: Regarding its safety, the Committee concluded that Tresiba is generally safe and its side effects are comparable to those of other insulin analogues with no unexpected side effects reported.
Croatian: U pogledu sigurnosti lijeka, Odbor je zaključio da je lijek Tresiba općenito siguran i da su njegove nuspojave usporedive s nuspojavama drugih analoga inzulina bez prijavljenih neočekivanih nuspojava.
English: What is Tresiba?
Croatian: Što je Tresiba?
English: Tresiba acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Croatian: Tresiba djeluje na isti način kao prirodno proizveden inzulin, te pomaže glukozi da iz krvi uđe u stanice.
English: What is the risk associated with Tresiba?
Croatian: Koji su rizici povezani s lijekom Tresiba?
English: In addition Tresiba was compared with insulin detemir in one main study involving 350 children aged 1 to 18 years of age with type 1 diabetes.
Croatian: Osim toga, Tresiba je uspoređena s inzulinom detemir u jednom glavnom ispitivanju koje je uključivalo 350 djece u dobi od 1 do 18 godina s dijabetesom tipa 1.
English: Tresiba is a medicine that contains the active substance insulin degludec.
Croatian: Tresiba je lijek koji sadrži djelatnu tvar inzulin degludek.
English: The company that markets Tresiba will provide educational materials to healthcare professionals expected to treat or dispense medicines to patients with diabetes, aimed particularly at raising awareness of the higher strength formulation of Tresiba in order to ensure that the patient is prescribed the correct strength.
Croatian: Tvrtka koja prodaje lijek Tresiba također će osigurati edukacijske materijale za zdravstvene djelatnike za koje se očekuje da će liječiti bolesnike s dijabetesom ili im izdavati lijekove za liječenje dijabetesa s posebnim ciljem podizanja svijesti o prisutnosti jačih formulacija lijeka Tresiba na tržištu kako bi se osiguralo propisivanje točne doze bolesniku.
English: Tresiba is used to treat type 1 and type 2 diabetes in adults and children aged 1 to 18 years of age.
Croatian: Tresiba se koristi za liječenje dijabetesa tipa 1 i 2 u odraslih, te u djece u dobi od 1 do 18 godina.
English: Patients in these studies could also be given other diabetes medicines or rapid-acting insulin at mealtimes if needed.
Croatian: Bolesnici u tim ispitivanjima također su prema potrebi mogli primiti druge lijekove za dijabetes ili inzulin brzog djelovanja u vrijeme obroka.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tresiba, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Tresiba nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Why has Tresiba been approved?
Croatian: Zašto je lijek Tresiba odobren?
English: It is given as an injection under the skin in the thigh, upper arm or abdominal wall (at the front of the waist).
Croatian: Daje se u obliku potkožne injekcije u bedro, nadlakticu ili trbušnu stjenku (u prednji dio struka).
English: In children, the effects of Tresiba on blood glucose control were similar to those of insulin detemir.
Croatian: Kod djece je učinak lijeka Tresiba na kontrolu glukoze u krvi bio sličan onom inzulina detemir.
English: In type 1 diabetes, Tresiba must always be used in combination with rapid acting insulin, which is injected at mealtimes.
Croatian: Kod dijabetesa tipa 1 lijek Tresiba treba uvijek koristiti u kombinaciji s inzulinom brzog djelovanja koji se injektira u vrijeme obroka.
English: Another main study involving 177 adults with type 2 diabetes investigated the effectiveness of combining Tresiba and liraglutide (a GLP-1 receptor agonist).
Croatian: Drugo glavno ispitivanje koje je uključivalo je 177 odraslih bolesnika s dijabetesom mellitusom tipa 2 ispitivalo je djelotvornost kombinacije lijeka Tresiba i liraglutida (agonist receptora GLP1).
English: Tresiba has been studied in three main studies involving 1,578 adults with type 1 diabetes, where Tresiba (in combination with rapid acting mealtime insulin) was compared with insulin glargine or insulin detemir (other long acting insulins).
Croatian: Tresiba je proučavana u tri glavna ispitivanja koja su uključivala 1578 odraslih bolesnika s dijabetesom tipa 1 kod kojih je Tresiba (u kombinaciju s inzulinom brzog djelovanja uzetog u vrijeme obroka) uspoređivana s inzulinom glarginom ili inzulinom detemirom (drugim inzulinom dugog djelovanja).
English: For the full list of side effects and restrictions with Tresiba, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja koje su zabilježene s lijekom Tresiba potražite u uputi o lijeku.
English: The studies showed that Tresiba was at least as effective as other long acting insulins in controlling blood glucose levels in adults with type 1 and type 2 diabetes, and more effective than sitagliptin in adults with type 2 diabetes.
Croatian: Ispitivanja su pokazala da je Tresiba bila barem jednako djelotvorna kao i drugi inzulini dugog djelovanja u kontroli razina glukoze u krvi odraslih bolesnika s dijabetesom tipa 1 i dijabetesom tipa 2, te djelotvornija od sitagliptina u odraslih bolesnika s dijabetesom tipa 2.
English: It also noted that Tresiba reduces the risk of hypoglycaemia during the night in patients with type 1 and type 2 diabetes.
Croatian: Također je zabilježeno da Tresiba smanjuje rizik od noćne hipoglikemije u bolesnika s dijabetesom tipa 1 i 2.
English: Across the studies, the average reduction in HbA1c levels with Tresiba treatment was 0.6 percentage points in adults with type 1 diabetes and 1.2 points in adults with type 2 diabetes.
Croatian: U drugim ispitivanjima, prosječno smanjenje razina HbA1c s lijekom Tresiba iznosila je 0,6 postotnih bodova u odraslih bolesnika s dijabetesom tipa 1 i 1,2 postotna boda u odraslih bolesnika s dijabetesom tipa 2.
English: In type 2 diabetes, Tresiba can be used alone or in combination with diabetes medicines given by mouth, GLP-1 receptor agonist medicines and rapid acting mealtime insulin.
Croatian: Kod dijabetesa tipa 2 Tresiba se može koristiti sama ili u kombinaciji s peroralnim lijekovima protiv dijabetesa, lijekovima koji djeluju kao agonisti receptora GLP1 i inzulinom brzog djelovanja u vrijeme obroka.
English: The CHMP concluded that Tresiba is effective in controlling blood glucose levels in patients with type 1 and type 2 diabetes.
Croatian: CHMP je zaključio da je lijek Tresiba djelotvoran u kontroli razina glukoze u krvi kod bolesnika s dijabetesom tipa 1 i tipa