natgillin/translations-raw huggingface dataset:
The way alemtuzumab acts in multiple sclerosis is not fully understood, but it is believed that its effect on lymphocytes reduces the immune system's damaging activity. 
Način djelovanja alemtuzumaba na multiplu sklerozu nije u potpunosti poznat, no smatra se da njegov učinak na limfocite smanjuje štetnu aktivnost imunosnog sustava.
Other information about Lemtrada 
Ostale informacije o lijeku Lemtrada
• disease that is highly active, even though they have been treated with a disease-modifying therapy; 
• kod kojih je bolest izrazito aktivna, iako su prošli terapiju koja modificira tijek bolesti;
Patients should receive certain medicines before or during treatment to reduce the side effects. 
Bolesnici trebaju primiti određene lijekove prije ili tijekom terapije za smanjenje nuspojava.
Lemtrada is used for patients with: 
Lemtrada se koristi u bolesnika:
The European Medicines Agency decided that Lemtrada's benefits are greater than its risks and it can be authorised for use in the EU. 
Europska agencija za lijekove zaključila je da koristi od lijeka Lemtrada nadmašuju s njim povezane rizike te da može biti odobren za primjenu u EU-u.
• rapidly worsening, severe disease, who have had 2 or more relapses in one year and whose brain scans show certain brain lesions. 
• s teškim oblikom bolesti koja brzo napreduje, koji su iskusili dva ili više relapsa u jednoj godini i kod kojih snimke mozga pokazuju određene lezije na mozgu.
As for all medicines, data on the use of Lemtrada are continuously monitored. 
Kao i za sve lijekove, podatci o primjeni lijeka Lemtrada kontinuirano se prate.
What are the risks associated with Lemtrada? 
Koji su rizici povezani s lijekom Lemtrada?
Lemtrada can only be obtained with a prescription. 
Lemtrada se izdaje samo na recept.
The company will ensure that doctors expected to prescribe the medicine receive educational materials containing important safety information, and a checklist covering the necessary screening, medicines to reduce side effects, monitoring before, during and after infusion, and long-term monitoring of patients. 
Tvrtka će osigurati da liječnici za koje se očekuje da će propisivati lijek dobe materijale za obuku sa važnim informacijama o sigurnosti lijeka te kontrolni popis koji obuhvaća nužna snimanja, lijekove za ublažavanje nuspojava, praćenje prije, tijekom i nakon infuzije te dugoročno praćenje bolesnika.
Over half of patients included in the extension study did not have disease progression and did not need additional Lemtrada infusions. 
U više od polovice bolesnika uključenih u produžetak ispitivanja nije došlo do progresije bolesti te nisu trebali dodatne infuzije lijeka Lemtrada.
For those patients who needed one or two additional infusions with Lemtrada, the number of relapses was lower, and disability progression was slower, compared with the previous year. 
U bolesnika koji su morali primiti jednu ili dvije dodatne infuzije lijeka Lemtrada, broj relapsa bio je manji, a progresija invaliditeta sporija u usporedbi s prethodnom godinom.
It is initially given in two courses of treatment: a first course of 12 mg daily for 5 days, followed 12 months later by a second course of 12 mg daily for 3 days. 
Inicijalno se daje u dva ciklusa liječenja: prvi ciklus iznosi 12 mg na dan tijekom pet dana, nakon čega 12 mjeseci kasnije slijedi drugi ciklus od 12 mg na dan tijekom tri dana.
Up to two additional courses, each of 12 mg daily for 3 days, can be given at 12-month intervals. 
Do dva dodatna ciklusa liječenja od 12 mg na dan tijekom tri dana mogu se primijeniti u intervalima od 12 mjeseci.
Side effects reported with Lemtrada are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Lemtrada pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
An overview of Lemtrada and why it is authorised in the EU 
Pregled informacija o lijeku Lemtrada i zašto je odobren u EU-u
Lemtrada has been studied in two main studies involving 1,421 patients with relapsing-remitting multiple sclerosis. 
Lijek Lemtrada ispitivan je u dvama glavnim ispitivanjima koja su obuhvatila 1 421 bolesnika s relapsno-remitirajućom multiplom sklerozom.
Why is Lemtrada authorised in the EU? 
Zašto je lijek Lemtrada odobren u EU-u?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lemtrada have also been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Lemtrada također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
For more information about using Lemtrada, see the package leaflet or contact your doctor or pharmacist. 
Više informacija o primjeni lijeka Lemtrada pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
Treatment should only be started and supervised by a neurologist experienced in treating MS. 
Liječenje mora započeti i nadzirati neurolog s iskustvom u liječenju multiple skleroze.
The company that markets Lemtrada will carry out studies on the safety of the medicine and to assess whether the medicine is used according to the latest recommendations. 
Tvrtka koja lijek Lemtrada stavlja u promet provest će ispitivanja o sigurnosti lijeka te o tome koristi li se lijek u skladu s najnovijim preporukama.
Patients will receive a patient alert card and a guide explaining the risks with the medicine and symptoms of Lemtrada's serious side effects. 
Bolesnici će dobiti karticu s upozorenjima i vodič s objašnjenjima rizika od lijeka te simptoma najozbiljnijih nuspojava lijeka Lemtrada.
With regards to safety, Lemtrada has rare but serious side effects, including disorders of the heart, blood vessels and immune system and measures have been put in place to minimise this risk.1 
U pogledu sigurnosti, lijek Lemtrada ima rijetke, ali vrlo ozbiljne nuspojave, uključujući poremećaje sa srcem, krvnim žilama i imunosnim sustavom te su uvedene mjere za minimizaciju rizika.1
In the first study, the average number of relapses per year in patients given Lemtrada was less than half the number in patients given interferon beta-1a (0.18 versus 0.39), but there was no meaningful effect in terms of progression of disability. 
U prvom ispitivanju prosječan broj relapsa godišnje u bolesnika koji su primali lijek Lemtrada bio je više od upola manji od broja relapsa u bolesnika koji su primali interferon beta-1a (0,18 nasuprot 0,39), no nije zabilježen značajan učinak u pogledu progresije invaliditeta.
When alemtuzumab attaches to the lymphocytes, it causes them to die, and they are replaced by new lymphocytes. 
Vezivanje alemtuzumaba na limfocite uzrokuje njihovo odumiranje, te se zamjenjuju novim limfocitima.
The most common side effects with Lemtrada (which may affect more than 1 in 5 people) are rash, headache, fever and respiratory tract infections (throat and chest infections). 
Najčešće nuspojave lijeka Lemtrada (koje se mogu javiti u više od 1 na 5 osoba) su osip, glavobolja, vrućica i infekcije dišnih putova (infekcije grla i prsišta).
The first study involved previously untreated patients, while the second study involved patients whose disease had relapsed despite treatment. 
Prvo je ispitivanje obuhvatilo prethodno neliječene bolesnike, a drugo bolesnike u kojih je unatoč liječenju došlo do relapsa bolesti.
In the second study, the average number of relapses per year in patients given Lemtrada was half the number in patients given interferon beta-1a (0.26 versus 0.52), and around 13% of patients given Lemtrada had a sustained progression of disability compared with around 21% of patients given interferon beta-1a. 
U drugom ispitivanju prosječan broj relapsa godišnje u bolesnika koji su primali lijek Lemtrada bio je otprilike upola manji od broja relapsa u bolesnika koji su primali interferon beta-1a (0,26 nasuprot 0,52), a otprilike 13 % bolesnika koji su primali lijek Lemtrada iskusilo je kontinuiranu progresiju invaliditeta u usporedbi s otprilike 21 % bolesnika koji su primali interferon beta-1a.
In both studies, Lemtrada was compared with another medicine for multiple sclerosis, interferon beta-1a. 
U obama ispitivanjima lijek Lemtrada uspoređen je s drugim lijekom za liječenje multiple skleroze, interferonom beta-1a.
It should be given in a hospital with access to intensive care, as well as equipment and specialist staff for managing serious reactions and side effects that can occur with Lemtrada. 
Lijek se primjenjuje u bolnici s pristupom intenzivnoj njezi, opremi i stručnom osoblju za suzbijanje ozbiljnih reakcija i nuspojava koje se mogu javiti s lijekom Lemtrada.
Lemtrada must not be used in patients with HIV and in patients with severe infections. 
Lemtrada se ne smije primjenjivati u bolesnika zaraženih HIV-om ni u bolesnika s teškim infekcijama.
It must not be used in patients with uncontrolled hypertension (high blood pressure), patients who have had arterial dissection (tears) of the cervicocephalic arteries (blood vessels in the head and neck), stroke, angina pectoris (pains to the chest, jaw and back, brought on by physical effort and due to problems with the blood flow to the heart) or myocardial infarction (heart attack). 
Ne smije se primjenjivati u bolesnika s nekontroliranom hipertenzijom (visokim krvnim tlakom), bolesnika s disekcijom (rascjepom) cervikocefalnih aorti (krvnih žila u glavi i vratu), s moždanim udarom, anginom pektoris (bolovima u prsištu, čeljusti i leđima prilikom fizičkog napora zbog problema dotoka krvi u srce) ili s infarktom miokarda (srčanim udarom).
In both studies, the main measure of effectiveness was based on the number of relapses the patients had each year and the progression of disability after two years of treatment. 
U obama ispitivanjima glavno mjerilo učinkovitosti temeljilo se na godišnjem broju relapsa u bolesnika i na progresiji invaliditeta nakon dvije godine liječenja.
Lemtrada must not be used in patients with coagulopathy (problems with blood clotting) or in patients who are taking anti-platelet or anti coagulant therapy. 
Lemtrada se ne smije primjenjivati u bolesnika s koagulopatijom (problemima sa zgrušavanjem krvi) ni u bolesnika koji primaju antitrombocitnu terapiju ili onu protiv zgrušavanja krvi.
What benefits of Lemtrada have been shown in studies? 
Koje su koristi od lijeka Lemtrada utvrđene u ispitivanjima?
The most important side effects with Lemtrada are autoimmune conditions (where the body's defence system attacks normal tissue), including thyroid gland disorders, immune thrombocytopenic purpura (a bleeding disorder caused by low blood platelet counts) and kidney damage, as well as low blood cell counts, reactions to the infusion and infections. 
Najvažnije nuspojave lijeka Lemtrada su autoimune bolesti (kada obrambeni sustav tijela napada zdravo tkivo), uključujući poremećaje štitnjače, imuna trombocitopenična purpura (poremećaj krvarenja uzrokovan niskim brojem trombocita u krvi), oštećenja bubrega, nizak broj krvnih stanica, reakcije na infuziju i infekcije.
Patients involved in the two main studies were followed-up for at least four years in an extension study, during which they were given up to two additional doses of Lemtrada, at one-year intervals, if their disease progressed. 
U okviru produžetka ispitivanja provedeno je kontrolno praćenje bolesnika uključenih u dva glavna ispitivanja u trajanju od najmanje četiri godine, tijekom kojeg su bolesnici u kojih je došlo do progresije bolesti primili dvije dodatne doze lijeka Lemtrada u intervalu od jedne godine.
The active substance in Lemtrada, alemtuzumab, is a type of protein called a monoclonal antibody that has been designed to attach to another protein called CD52. 
Djelatna tvar lijeka Lemtrada, alemtuzumab, vrsta je bjelančevine naziva monoklonsko protutijelo, namijenjeno za vezanje na drugu bjelančevinu naziva CD52.
How does Lemtrada work? 
Kako djeluje Lemtrada?
How is Lemtrada used? 
Kako se Lemtrada primjenjuje?
For the full list of side effects of Lemtrada, see the package leaflet. 
Potpuni popis nuspojava povezanih s lijekom Lemtrada potražite u uputi o lijeku.
The medicine must not be used in patients with autoimmune diseases besides MS. For the full list of restrictions, see the package leaflet. 
Lijek se ne smije primjenjivati u bolesnika s drugim autoimunim bolestima uz multiplu sklerozu.
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. 
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).
Lemtrada contains the active substance alemtuzumab. 
Lemtrada sadrži djelatnu tvar alemtuzumab.
It should be given twice a week for 12 weeks, and then once a week for 24 weeks. 
Treba ga davati dva put tjedno tijekom 12 tjedana i potom jednom tjedno tijekom 24 tjedna.
The patients were followed up for up to 10 years. 
Bolesnici su bili praćeni do 10 godina.
The main measure of effectiveness was the number of patients who survived without the disease coming back. 
Glavna mjera djelotvornosti bio je broj bolesnika koji su preživjeli bez povratka bolesti.
Mepact mifamurtide 
Mepact mifamurtid
This summary was last updated in 09-2013. 
Sažetak je posljednji put obnovljen 9.2013.
Other information about Mepact: 
Druge informacije o lijeku Mepact:
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. 
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.
The marketing authorisation is valid for five years, after which it can be renewed. 
Odobrenje za stavljanje lijeka u promet vrijedi pet godina nakon čega se može obnoviti.
The European Commission granted a marketing authorisation valid throughout the European Union for Mepact on 6 March 2009. 
Europska komisija izdaje odobrenje za stavljanje u promet koje za Mepact vrijedi na prostoru Europske unije od 6. ožujka 2009.
It must not be given as a bolus injection (all at once). 
Ne smije se davati kao bolus injekcija (odjednom).
The dose of Mepact depends on the patient's height and weight. 
Doza lijeka Mepact ovisi o bolesnikovoj visini i težini.
Mepact is given as a slow infusion lasting an hour. 
Mepact se daje kao spora infuziju tijekom sat vremena.
Mepact treatment should be started and supervised by a specialised doctor who has experience in diagnosing and treating osteosarcoma. 
Liječenje lijekom Mepact treba započeti i nadzirati liječnik specijalist koji ima iskustva u dijagnosticiranju i liječenju osteosarkoma.
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). 
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).
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. 
Točan način djelovanja mifamurtida kod osteosarkoma nije do kraja razjašnjen, ali smatra se da potiče leukocite na oslobađanje kemikalija koje ubijaju stanice karcinoma.
After surgery to remove the cancer, all of the patients were given various combinations of anticancer medicines. 
Nakon kirurškog uklanjanja karcinoma, svi su bolesnici dobili različite kombinacije lijekova protiv karcinoma.
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). 
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).
Mepact should not be used in people who may be hypersensitive (allergic) to mifamurtide or any of the other ingredients. 
Mepact se ne smije koristiti u osoba koje bi mogle biti preosjetljive (alergične) na mifamurtid ili na bilo koje druge sastojke lijeka.
Mepact is a powder that is made up into a suspension for infusion (drip into a vein). 
Mepact je prašak koji se pretvara u suspenziju za infuziju (drip u venu).
The risk of dying was also reduced by 28% in patients receiving Mepact. 
Rizik od smrti smanjen je za 28 % u bolesnika koji su primali Mepact.
Half of the patients were also given Mepact. 
Polovica bolesnika također je primila Mepact.
For more information about treatment with Mepact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o liječenju lijekom Mecapt pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
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. 
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.
Mepact has been studied in one main study involving 678 patients aged between one and 31 years with high-grade non-metastatic osteosarcoma. 
Mepact se ispitivao u jednom glavnom ispitivanju koje je uključivalo 678 bolesnika u dobi između jedne i 31 godine s nemetastatskim osteosarkomom visokog stupnja.
The active substance in Mepact, mifamurtide, is an immunomodulator. 
Djelatna tvar u lijeku Mepact, mifamurtid, je imunomodulator.
Mepact is used with other anticancer medicines after the cancer has been removed by surgery. 
Mepact se koristi s drugim lijekovima protiv karcinoma nakon kirurškog uklanjanja karcinoma.
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. 
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.
It works by activating macrophages and monocytes (types of white blood cell that form part of the immune system). 
Djeluje aktivacijom makrofaga i monocita (vrsta leukocita koji su dio imunološkog sustava).
This document is a summary of the European public assessment report (EPAR) for Mepact. 
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Mepact.
Why has Mepact been approved? 
Zašto je Mepact odobren?
The study compared patients who were given Mepact with those who were not. 
Ispitivanje je usporedilo bolesnike koji su primali Mepact s onima koji nisu primali Mepact.
What is the risk associated with Mepact? 
Koji su rizici povezani s lijekom Mepact?
What is Mepact? 
Što je Mepact?
It contains the active substance mifamurtide. 
Sadrži djelatnu tvar mifamurtid.
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. 
Mepacta veće od njegovih rizika kad se koristi s drugim lijekovima protiv karcinoma i preporučio izdavanje odobrenja za stavljanje u promet lijeka Mepact.
‘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. 
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.
The summary of the opinion of the Committee for Orphan Medicinal Products for Mepact is available here. 
Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Mepact možete naći ovdje.
What benefit has Mepact shown during the studies? 
Mepacta su dokazane tijekom ispitivanja?
What is Mepact used for? 
Za što se Mepact koristi?
For the full list of all side effects reported with Mepact, see the package leaflet. 
Potpuni popis nuspojava koje su zabilježene s lijekom Mecapt potražite u uputi o lijeku.
How does Mepact work? 
Kako djeluje Mepact?
The full EPAR for Mepact can be found here. 
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) može se naći ovdje.
How is Mepact used? 
Kako se Mepact koristi?
How has Mepact been studied? 
Kako se Mepact ispitivao?
74.2 mg Implant 
74,2 mg Implantat
4 implants + 1 applicator 
4 implantata + 1 aplikator
Subcutaneous use sachet (PET/LDPE/alu) 
Vrećica (PET/LDPE/Alu)
The correct dose is determined individually for each patient. 
Točna doza određuje se pojedinačno za svakog bolesnika.
Studies lasted for six months or one year. 
Ispitivanja su trajala od 6 mjeseci do godine dana.
After 26 weeks of treatment, patients had the option to either stop treatment or continue with it for up to a year. 
Nakon 26 tjedana liječenja, bolesnici su imali mogućnost prekinuti terapiju ili je nastaviti sljedećih godinu dana.
The full EPAR for Tresiba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR za lijek Tresiba nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Tresiba is injected once a day, preferably at the same time every day. 
Tresiba se injektira jednom na dan, po mogućnosti u isto vrijeme svaki dan.
The European Commission granted a marketing authorisation valid throughout the European Union for Tresiba on 21 January 2013. 
Europska komisija izdaje odobrenje za stavljanje u promet koje za Tresibu vrijedi na prostoru Europske unije od 21. siječnja 2013.
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. 
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.
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). 
Dostupan je kao otopina za injekciju u ulošku (100 jedinica/ml) i u napunjenoj brizgalici (100 jedinica/ml i 200 jedinica/ml).