FrancophonIA/ELRC3.0 huggingface dataset:
English: B/Colorado/06/2017 - like strain (B/Colorado/06/2017, MEDI 293454)
Croatian: B/Colorado/06/2017 - poput kojeg je korišten soj (B/Colorado/06/2017, MEDI 293454)
English: A/Kansas/14/2017 (H3N2) - like strain (A/Kansas/14/2017, MEDI 308763)
Croatian: A/Kansas/14/2017 (H3N2) - poput kojeg je korišten soj (A/Kansas/14/2017, MEDI 308763)
English: MA (EU) Number
Croatian: Broj (EU) odobrenja Ime
English: Some side effects, including infections, may be more common in children than in adults.
Croatian: Neke nuspojave, uključujući infekcije, mogu biti češće u djece nego u odraslih.
English: The full EPAR for Flixabi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Flixabi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Flixabi infliximab
Croatian: Flixabi infliksimab
English: It is used in adults, usually when other medicines or treatments have failed or cannot be used, for the treatment of the following diseases:
Croatian: Primjenjuje se u odraslih osoba, obično u slučaju kada su se drugi lijekovi pokazali neuspješnima ili se ne mogu primjenjivati u liječenju sljedećih bolesti:
English: The dose is 5 mg per kilogram for the other diseases.
Croatian: Za ostale se bolesti daje doza od 5 mg po kilogramu tjelesne težine.
English: This means that Flixabi is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: To znači da je Flixabi sličan biološkom lijeku (poznatom kao „referentni lijek”) koji je već odobren u Europskoj uniji (EU).
English: Flixabi is given as an infusion lasting one or two hours.
Croatian: Flixabi se daje infuzijom u trajanju od jedan ili dva sata.
English: In particular, information will be provided for doctors who intend to prescribe the medicine to children with Crohn's disease or ulcerative colitis, to explain that these patients may be at an increased risk of developing infections and to remind of the importance of keeping vaccinations up to date.
Croatian: Osobito će se takve informacije osiguravati za liječnike koji lijek namjeravaju propisivati djeci s Kronovom bolešću ili ulceroznim kolitisom kako bi se objasnilo da u takvih bolesnika postoji veći rizik od razvoja infekcija te kako bi se podsjetilo na važnost redovitog cijepljenja.
English: The main measure of effectiveness was the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 30 weeks of treatment.
Croatian: Glavno mjerilo djelotvornosti bio je udio bolesnika u kojih je zabilježeno smanjenje odgovora ACR od najmanje 20 % (mjera bolnih, natečenih zglobova i drugih simptoma) nakon 30 tjedana liječenja.
English: To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Flixabi or the infusion time may be slowed down.
Croatian: Kako bi se smanjio rizik od reakcija povezanih s infuzijom, bolesnicima se mogu davati drugi lijekovi prije ili nakon terapije lijekom Flixabi ili se davanje infuzije može usporiti.
English: This is a summary of the European public assessment report (EPAR) for Flixabi.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Flixabi.
English: The most common side effects with Flixabi (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper-respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Croatian: Najčešće nuspojave lijeka Flixabi (zabilježene u više od 1 na 10 bolesnika) su virusne infekcije (kao što su gripa i herpes), glavobolja, infekcije gornjeg respiratornog trakta (prehlade), sinusitis (infekcija sinusa), mučnina (osjećaj slabosti), abdominalna bol (bol u trbuhu), reakcije i bol povezani s infuzijom.
English: Flixabi is also used in patients aged between 6 and 17 years with severe Crohn's disease or ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Croatian: Lijek Flixabi također se primjenjuje u bolesnika u dobi od 6 do 17 godina s Kronovom bolesti ili ulceroznim kolitisom teškog stupnja ako ne mogu uzimati ili nisu pozitivno reagirali na druge lijekove ili terapije.
English: What measures are being taken to ensure the safe and effective use of Flixabi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Flixabi?
English: Flixabi is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Croatian: U slučaju reumatoidnog artritisa, Flixabi se obično daje u dozi od 3 mg po kilogramu tjelesne težine bolesnika, iako se po potrebi doza može povećati.
English: What is Flixabi and what is it used for?
Croatian: Što je Flixabi i za što se koristi?
English: Results of this study showed that Flixabi was as effective as Remicade in reducing symptoms of rheumatoid arthritis: 64% of those treated with Flixabi (148 of 231 patients) had at least a 20% reduction in ACR scores, compared with 66% of those given Remicade (163 out of 247).
Croatian: Rezultati ispitivanja pokazali su da je Flixabi jednako djelotvoran kao Remicade u ublažavanju simptoma reumatoidnog artritisa: u 64 % bolesnika (148 od 231) liječenih lijekom Flixabi zabilježeno je smanjenje odgovora ACR od najmanje 20 %, dok je u bolesnika liječenih lijekom Remicade isti rezultat zabilježen u 66 % bolesnika (163 od 247).
English: Why is Flixabi approved?
Croatian: Zašto je Flixabi odobren?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Flixabi has been shown to have a comparable quality, safety and effectiveness to Remicade.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da je dokazano da lijek Flixabi posjeduje usporedivu razinu kvalitete, sigurnosti i djelotvornosti kao i Remicade.
English: It is not intended to provide practical advice on how to use Flixabi.
Croatian: Svrha sažetka nije davati praktične savjete o načinu primjene lijeka Flixabi.
English: Flixabi is used with methotrexate (a medicine that acts on the immune system);
Croatian: Lijek Flixabi primjenjuje se s metotreksatom (lijekom koji djeluje na imunosni sustav);
English: Flixabi treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Flixabi is used to treat.
Croatian: Liječenje lijekom Flixabi potrebno je započeti i provoditi pod nadzorom liječnika specijalista s iskustvom u dijagnosticiranju i liječenju bolesti za koje se koristi Flixabi.
English: What are the risks associated with Flixabi?
Croatian: Koji su rizici povezani s lijekom Flixabi?
English: Flixabi must not be used in patients who are hypersensitive (allergic) to infliximab, mouse proteins or any of the other ingredients of Flixabi.
Croatian: Flixabi se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na infliksimab, mišje proteine ili bilo koji drugi sastojak lijeka.
English: By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of these diseases.
Croatian: Onemogućivanjem djelovanja proteina TNF-alfa infliksimab smanjuje upalu i druge simptome tih bolesti.
English: Flixabi was also compared with Remicade in one main study involving 584 patients with moderate to severe rheumatoid arthritis who had received previous treatment with methotrexate.
Croatian: Flixabi je također uspoređen s lijekom Remicade u glavnom ispitivanju na 584 bolesnika s reumatoidnim artritisom umjerenog do teškog stupnja koji su prethodno primali terapiju metotreksatom.
English: Other information about Flixabi
Croatian: Ostale informacije o lijeku Flixabi
English: The active substance in Flixabi, infliximab, is a monoclonal antibody (a type of protein) that has been designed to attach to a protein called tumour necrosis factor-alpha (TNF-alpha) and block its activity.
Croatian: Djelatna tvar u lijeku Flixabi, infliksimab, monoklonsko je protutijelo (vrsta proteina) i veže se na protein koji se naziva faktorom nekroze tumora alfa (TNF-alfa) te onemogućuje njegovo djelovanje.
English: A risk management plan has been developed to ensure that Flixabi is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Flixabi.
English: How often the treatment is repeated depends on which disease is being treated, and on the patient's response to the medicine.
Croatian: Učestalost terapije ovisi o bolesti koja se liječi i bolesnikovu odgovoru na lijek.
English: In addition, the company that markets Flixabi will provide an alert card for patients and educational material for prescribers, summarising the safety information about the medicine.
Croatian: Osim toga, tvrtka koja lijek Flixabi stavlja u promet osigurat će karticu s upozorenjima za bolesnike te edukativne materijale sa sažetim sigurnosnim informacijama o lijeku za liječnike koji propisuju lijek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Flixabi, 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 Flixabi, nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Flixabi is an anti-inflammatory medicine.
Croatian: Flixabi je protuupalni lijek.
English: • Crohn's disease (a disease causing inflammation of the gut), when the disease is moderate to severe or causes fistulae (abnormal passageways between the gut and other organs);
Croatian: • Kronove bolesti (bolesti koja uzrokuje upalu crijeva) u slučaju umjerenog do teškog stupnja bolesti ili kada bolest uzrokuje fistule (abnormalne prolaze između crijeva i drugih organa);
English: For more information about treatment with Flixabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Flixabi pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Flixabi contains the active substance infliximab and is a ‘biosimilar medicine'.
Croatian: Flixabi sadrži djelatnu tvar infliksimab te je „biosličan lijek”.
English: TNF-alpha is involved in causing inflammation and is found at high levels in patients with the diseases that Flixabi is used to treat.
Croatian: TNF-alfa pridonosi uzrokovanju upale te se u bolesnika s bolestima koje se liječe lijekom Flixabi nalazi u visokim razinama.
English: The reference medicine for Flixabi is Remicade.
Croatian: Referentni lijek za Flixabi je Remicade.
English: Studies were carried out to show that Flixabi is comparable to Remicade, including a study to show that it produces similar levels of the active substance in the body to Remicade.
Croatian: Provedena su ispitivanja u cilju dokazivanja da je Flixabi usporediv s lijekom Remicade, a jedno od njih provedeno je u cilju dokazivanja da Flixabi proizvodi slične razine djelatne tvari kao Remicade.
English: The Committee recommended that Flixabi be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Flixabi.
English: • rheumatoid arthritis (an immune-system disease causing inflammation of the joints).
Croatian: • reumatoidnog artritisa (bolesti imunosnog sustava koja uzrokuje upalu zglobova).
English: Flixabi must also not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Croatian: drugim teškim infekcijama ili umjerenim ili teškim zatajenjem srca (nemogućnost srca da pumpa dovoljne količine krvi u tijelu).
English: For further information see the summary of product characteristics (also part of the EPAR).
Croatian: Dodatne informacije pročitajte u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: Therefore, the CHMP's view was that, as for Remicade, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđeni rizik, kao i za lijek Remicade.
English: How does Flixabi work?
Croatian: Kako djeluje Flixabi?
English: • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
Croatian: • ankilozantnog spondilitisa (bolesti koja uzrokuje upalu i bol u zglobovima kralježnice);
English: For practical information about using Flixabi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Flixabi pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Flixabi used?
Croatian: Kako se Flixabi koristi?
English: What benefits of Flixabi have been shown in studies?
Croatian: Koje su koristi lijeka Flixabi utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Flixabi, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Flixabi potražite u uputi o lijeku.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
Croatian: • psorijatičnog artritisa (bolesti koja uzrokuje crvene ljuskave mrlje na koži i upalu zglobova);
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Croatian: • ulceroznog kolitisa (bolesti koja uzrokuje upalu i čireve na stjenci želuca);
English: This may take about 10 minutes.
Croatian: To može potrajati oko 10 minuta.
English: • Then drink it straight away.
Croatian: • Zatim odmah popijte.
English: • Every 3 months thereafter
Croatian: • svaka 3 mjeseca nakon toga
English: Then take the next dose at the normal time.
Croatian: Zatim uzmite sljedeću dozu u uobičajeno vrijeme.
English: Some cases have been fatal.
Croatian: Neki su slučajevi imali smrtni ishod.
English: 7 day schedule:
Croatian: Sedmodnevni raspored:
English: Only use water, do not use any other liquids.
Croatian: Koristite samo vodu, ne koristite nikakve druge tekućine.
English: The objective response rate observed was 43.8%, all of which were partial responses.
Croatian: Opažena stopa objektivnog odgovora bila je 43,8%, od kojih su svi bili djelomični odgovori.
English: These do not usually cause symptoms but your doctor may want to monitor them.
Croatian: Obično ne uzrokuju simptome, ali će ih liječnik možda htjeti pratiti.
English: N=Number of events/number of randomised patients
Croatian: N = broj događaja/broj randomiziranih bolesnika;
English: This is because Caprelsa may harm an unborn child.
Croatian: To je zato što Caprelsa može naškoditi nerođenom djetetu.
English: • If you start taking medicines that affect your heart
Croatian: • ako počnete uzimati lijekove koji djeluju na srce
English: What to do if you forget to take a tablet depends on how long it is until your next dose.
Croatian: Što ćete učiniti ako ste zaboravili uzeti tabletu, ovisi o tome koliko je vremena preostalo do Vaše sljedeće doze.
English: Monitoring of your blood and your heart:
Croatian: Kontrole krvi i srca:
English: You should have these tests:
Croatian: Te pretrage trebate obaviti:
English: • Stroke or other conditions where the brain may not get enough blood.
Croatian: • moždani udar ili druga stanja u kojima mozak ne dobiva dovoljno krvi.
English: • Caprelsa may be taken with or without food.
Croatian: • Caprelsa se može uzimati s hranom ili bez nje.
English: These may be signs of a change in the electrical activitiy of your heart.
Croatian: To mogu biti znakovi promjene u električnoj aktivnosti srca.
English: Use caution before driving or using machines.
Croatian: Budite oprezni prije vožnje ili rukovanja strojevima.
English: The recommended dose is 300 mg once a day, taken with or without food at about the same time each day.
Croatian: Preporučena doza je 300 mg jednom na dan, uzeta s ili bez hrane, otprilike u isto vrijeme svakoga dana.
English: Date of latest renewal: 15 January 2019
Croatian: Datum posljednje obnove odobrenja: 15. siječnja 2019.
English: Some people who are taking Caprelsa become more sensitive to the sun.
Croatian: Neke osobe koje uzimaju lijek Caprelsa postaju osjetljivije na sunce.
English: 19.3 months
Croatian: 19,3 mjeseca
English: If you have trouble swallowing the tablet, you can mix it with water as follows:
Croatian: Ako imate teškoća s gutanjem tablete, možete je pomiješati s vodom na sljedeći način:
English: Dose increase (mg)b when tolerated well after 8 weeks at starting dose
Croatian: Povećanje doze (mg)b kad se dobro podnosi nakon 8 tjedana na početnoj dozi
English: Disease Control Rate including best response or Stable Disease >24 weeks was 75.0%.
Croatian: Stopa kontrolirane bolesti, uključujući najbolji odgovor ili stabilnu bolest >24 tjedana, bila je 75,0%.
English: • Take Caprelsa about the same time each day.
Croatian: • Uzimajte lijek Caprelsa svakoga dana približno u isto vrijeme.
English: • The recommended dose is 300 mg each day.
Croatian: • Preporučena doza je 300 mg svakoga dana.
English: This cuts off the supply of food and oxygen to the tumour.
Croatian: Time se prekida opskrba tumora hranom i kisikom.
English: • Put the tablet into the water.
Croatian: • Stavite tabletu u vodu.
English: • Toxins in the blood as a complication of infection.
Croatian: • toksini u krvi kao komplikacija infekcije.
English: Most (95% of the patients) had metastatic disease.
Croatian: Većina (95%) bolesnika imala je metastatsku bolest.
English: The treatment may either be given to your child as a once-daily dose, an every other day dosing or a repeating 7-day schedule as indicated in the dosing guide that has been given to you by your doctor.
Croatian: Liječenje vašeg djeteta može biti propisano kao doziranje jednom dnevno, kao doziranje svaki drugi dan ili kao ponavljajući sedmodnevni raspored kako je naznačeno u vodiču za doziranje koji Vam je dao liječnik.
English: The amount of Caprelsa given will depend on your child's body weight and height.
Croatian: Dana količina lijeka Caprelsa ovisit će o visini i težini Vašega djeteta.
English: • Sensitivity of the skin to sunlight.
Croatian: • osjetljivost kože na sunčevu svjetlost.
English: • How to use the daily tracker table (including examples of a completed daily tracker);
Croatian: • kako koristiti dnevnu tablicu za praćenje (uključujući primjere ispunjene dnevne tablice za praćenje);
English: Patients with documented RET mutation (n=187)
Croatian: Bolesnici s dokumentiranom RET mutacijom (n=187)
English: This section includes only data derived from completed studies where patient exposure is known.
Croatian: U ovom dijelu obuhvaćeni su samo podaci iz završenih ispitivanja kod kojih je izloženost bolesnika poznata.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines that you buy without a prescription and herbal medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ukoliko uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta i biljne lijekove.
English: What Caprelsa is and what it is used for
Croatian: Što je Caprelsa i za što se koristi
English: If you are not sure, talk to your doctor.
Croatian: Ako niste sigurni, obratite se svom liječniku.
English: 31.3% of patients had stable disease for at least 8 weeks.
Croatian: 31,3% bolesnika imalo je stabilnu bolest barem
English: The doctor will tell you how many tablets of Caprelsa to give to your child.
Croatian: Liječnik će Vam reći koliko tableta lijeka Caprelsa trebate dati svom djetetu.
English: • Severe skin reactions affecting large areas of your body.
Croatian: • teške kožne reakcije koje zahvaćaju velike površine tijela.
English: The following side effects may be shown in tests that may be carried out by your doctor:
Croatian: Sljedeće se nuspojave mogu pokazati u nalazima pretraga koje će obavljati liječnik:
English: Caprelsa may also act directly on cancer cells to kill them or slow down their growth.
Croatian: Caprelsa također može djelovati izravno na stanice raka, da ih uništi ili uspori njihov rast.
English: Recommended dosing regimens and dose modifications are presented in Table 1.
Croatian: Preporučeni režimi doziranja i promjene doze prikazani su u Tablici 1.
English: • Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or a high temperature (fever).
Croatian: • ozbiljni nedostatak zraka ili nedostatak zraka koji se iznenada pogoršava, uz moguć kašalj ili visoku temperaturu (vrućicu).
English: • Take half a glass of still (non-carbonated) water.
Croatian: • Uzmite pola čaše obične (negazirane) vode.
English: ** including two deaths in patients with QTc > 550 ms (one due to sepsis and one due to heart failure)
Croatian: ** uključujući dva smrtna slučaja u bolesnika s QTc-intervalom > 550 ms (jedan zbog sepse, a drugi zbog zatajenja srca)
English: PVC/ PVDC/Alu blisters, sealed with aluminium foil, each containing 30 film-coated tablets.
Croatian: PVC/PVDC/Al blisteri, zatvoreni aluminijskom folijom, od kojih svaki sadrži 30 filmom obloženih tableta.
English: What you need to know before you take Caprelsa
Croatian: Što morate znati prije nego počnete uzimati Caprelsu
English: • If your doctor or pharmacist changes your dose of Caprelsa
Croatian: • ako Vam liječnik ili ljekarnik promijene dozu lijeka Caprelsa
English: You must not breast-feed during treatment with Caprelsa for the safety of your baby.
Croatian: Ne smijete dojiti tijekom liječenja lijekom Caprelsa radi sigurnosti Vašeg djeteta.
English: Tell your doctor or pharmacist if you are taking any of the following medicines:
Croatian: Obavijestite svog liječnika ili ljekarnika ukoliko uzimate neki od sljedećih lijekova:
English: After having well tolerated the first 1 or 2 cycles of therapy (1 cycle = 28 days), the remaining patients continued on 100 mg/m2 of treatment.
Croatian: Nakon što su dobro podnijeli prvih 1 ili 2 ciklusa terapije (1 ciklus = 28 dana), preostali su bolesnici nastavili s liječenjem pri dozi od 100 mg/m2.
English: • Stir the tablet until it has dispersed into the water.
Croatian: • Miješajte tabletu dok se ne otopi u vodi.
English: • A type of rash that affects the hands and feet (hand foot syndrome).
Croatian: • vrsta osipa koji zahvaća šake i stopala (sindrom šake i stopala).
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Croatian: Odmah obavijestite svog liječnika ako se pojavi neka od sljedećih nuspojava - možda će Vam biti potrebna hitna medicinska pomoć:
English: Table 3: Summary of other efficacy findings in study 58 ORRa
Croatian: Tablica 3: Sažetak ostalih nalaza djelotvornosti u Ispitivanju 58 ORRa
English: Other medicines and Caprelsa
Croatian: Drugi lijekovi i Caprelsa
English: Clinical efficacy in adults
Croatian: Klinička djelotvornost u odraslih
English: First QTc prolongations occurred most often in the first 3 months of treatment, but continued to first occur after this time.
Croatian: Prvo produljenje QTc-intervala najčešće je nastupilo u prva 3 mjeseca liječenja, ali je prva pojava zabilježena i nakon tog razdoblja.
English: The remaining 158 patients (68%) were censored in the analysis of PFS.
Croatian: Podaci za preostalih 158 bolesnika (68%) su u analizi PFS-a bili cenzurirani.
English: The analysis was performed using a logistic regression model with treatment as the only factor.
Croatian: Analiza je provedena korištenjem modela logističke regresije u kojemu je liječenje bilo jedini faktor.
English: If you take more Caprelsa than you should
Croatian: Ako uzmete više lijeka Caprelsa nego što ste trebali
English: • Trouble sleeping (insomnia).
Croatian: • poteškoće sa spavanjem (nesanica).
English: This medicine has been given ‘conditional approval'.
Croatian: Ovom lijeku izdano je "uvjetno odobrenje".