FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that the improvement in survival with Dacogen in patients with AML was modest but relevant, as the benefits of current treatments are limited in patients who are not eligible for standard induction chemotherapy.
Croatian: CHMP je zaključio da je poboljšanje u pogledu preživljenja bolesnika s AML-om koji su se liječili Dacogenom bilo skromno, ali relevantno jer su koristi od postojećih terapija ograničene na bolesnike koji nisu kandidati za standardnu indukcijsku kemoterapiju.
English: In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA where it blocks the activity of enzymes called DNA methyltransferases (DNMTs).
Croatian: Decitabin se u tijelu pretvara u decitabin trifosfat te se potom ugrađuje u DNK blokirajući aktivnost enzima naziva DNK metiltransferaza (DNMT-ova).
English: Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Croatian: Dacogen se koristi za liječenje odraslih osoba s novodijagnosticiranom akutnom mijeloničnom leukemijom (ALM), vrstom raka koja zahvaća bijele krvne stanice.
English: This means that it is similar to cytidine deoxynucleoside, a fundamental component of the DNA (genetic material) of cells.
Croatian: To znači da je sličan citidin deoksinukleozidu, temeljnoj sastavnici DNK (genetskog materijala) stanica.
English: Because the number of patients with AML is low, the disease is considered ‘rare', and Dacogen was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2006.
Croatian: Budući da je broj bolesnika s akutnom mijeloničnom leukemijom (AML) nizak, dotična se bolest smatra „rijetkom” te se Dacogen označava kao lijek za liječenje rijetkih bolesti od 8. lipnja 2006.
English: As it is not known whether the active substance is excreted in breast milk, in the event that a patient is breastfeeding, they must discontinue breastfeeding if they require treatment with Dacogen.
Croatian: Budući da nije poznato izlučuje li se djelatna tvar u majčino mlijeko, bolesnice moraju prekinuti dojenje ako im je potrebno liječenje Dacogenom.
English: There were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine but some side effects such as infections and neutropenia were more common with Dacogen.
Croatian: Nisu ustanovljeni razlozi za ozbiljnu zabrinutost u pogledu sigurnosti Dacogena, čiji je ukupni sigurnosni profil sličan onom niske doze citarabina, iako se neke nuspojave kao što su infekcije i neutropenija češće javljaju pri primjeni Dacogena.
English: The most common serious side effects (seen in more than 20% of patients) include pneumonia (lung infection), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white blood cell count with fever) and anaemia.
Croatian: Najčešće ozbiljne nuspojave (utvrđene kod više od 20 % bolesnika) uključuju pneumoniju (upalu pluća), trombocitopeniju, neutropeniju (smanjenje broja neutrofila, vrste bijelih krvnih stanica), febrilnu neutropeniju (smanjenje broja neutrofila popraćeno vrućicom) i anemiju.
English: Dacogen has been studied in one main study involving 485 adults, who were newly diagnosed with AML but were not eligible for standard induction chemotherapy.
Croatian: Dacogen je ispitan u jednom glavnom ispitivanju koje je obuhvatilo 485 odraslih osoba s novodijagnosticiranim AML-om koji nisu bili kandidati za standardnu indukcijsku kemoterapiju.
English: The CHMP decided that Dacogen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Dacogen nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Dacogen is a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Dacogen je prašak od kojeg se priprema otopina za intravensku infuziju (drip).
English: What is the risk associated with Dacogen?
Croatian: Koji su rizici povezani s lijekom Dacogen?
English: What is Dacogen?
Croatian: Što je Dacogen?
English: The active substance in Dacogen, decitabine, is a cytidine deoxynucleoside analogue.
Croatian: Djelatna tvar lijeka Dacogen, decitabin, analog je citidin deoksinukleozida.
English: For the full list of all restrictions and side effects reported with Dacogen, see the package leaflet.
Croatian: Potpuni popis svih ograničenja i nuspojava zabilježenih pri primjeni lijeka Dacogen potražite u uputi o lijeku.
English: It contains the active substance decitabine.
Croatian: Sadrži djelatnu tvar decitabin.
English: Dacogen can only be obtained with a prescription.
Croatian: Dacogen se izdaje samo na liječnički recept.
English: Why has Dacogen been approved?
Croatian: Zašto je lijek Dacogen odobren?
English: The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count).
Croatian: Najčešće nuspojave Dacogena (mogu se javiti utvrđene kod više od 35 % bolesnika) su vrućica, anemija (smanjenje broja crvenih krvnih stanica) i trombocitopenija (smanjenje broja krvnih pločica).
English: What benefit has Dacogen shown during the studies?
Croatian: Koje su koristi lijeka Dacogen dokazane u ispitivanjima?
English: Dacogen must not be used in people who are breastfeeding.
Croatian: Dacogen ne smiju uzimati dojilje.
English: What is Dacogen used for?
Croatian: Za što se Dacogen koristi?
English: How is Dacogen used?
Croatian: Kako se Dacogen koristi?
English: By blocking DNMTs, decitabine will prevent the increase of tumour cells and lead to their death.
Croatian: Decitabin sprječava rast stanica tumora i dovodi do njihova odumiranja blokiranjem DNMT-ova.
English: How does Dacogen work?
Croatian: Kako djeluje Dacogen?
English: How has Dacogen been studied?
Croatian: Kako je Dacogen ispitivan?
English: Previously known as Zenas.
Croatian: Prethodno poznat pod nazivom Zenas.
English: Firdapse amifampridine
Croatian: Firdapse amifampridin
English: Firdapse has been authorised under ‘exceptional circumstances'.
Croatian: Firdapse je odobren u „iznimnim okolnostima”.
English: It is available as tablets (10 mg).
Croatian: Dostupan je u obliku tableta (10 mg).
English: The name of the medicine was changed to Firdapse on 28 January 2010.
Croatian: Naziv lijeka promijenjen je u Firdapse dana 28. siječnja 2010.
English: The recommended starting dose of Firdapse is 15 mg per day, which can be increased by 5 mg every four to five days up to a maximum of 60 mg per day.
Croatian: Preporučena početna doza lijeka Firdapse je 15 mg na dan, što se može povećati za 5 mg svaka četiri do pet dana do maksimalno 60 mg na dan.
English: This summary was last updated in 04-2014.
Croatian: Sažetak je posljednji put ažuriran: 04.2014.
English: CMAP is a measure of electrical activity in muscles.
Croatian: CMAP je mjera električne aktivnosti u mišićima.
English: It must also not be used with medicines that have a narrow therapeutic window.
Croatian: Ne smije se koristiti s lijekovima koji imaju uzak terapijski prozor.
English: Acetylcholine is released from the nerve endings during a period of ‘depolarisation'.
Croatian: Acetilkolin se otpušta iz završetaka živaca tijekom razdoblja „depolarizacije”.
English: A medicine with a narrow therapeutic window can easily cause side effects if given at a dose a little higher than the recommended dose.
Croatian: Lijek s uskim terapijskim prozorom može vrlo lako prouzročiti nuspojave ako se primjenjuje u dozi koja je malo veća od preporučene doze.
English: What measures are being taken to ensure the safe and effective use of Firdapse?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Firdapse?
English: The European Commission granted a marketing authorisation valid throughout the EU for Zenas on 23 December 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Zenas vrijedi na prostoru Europske unije od 23. prosinca 2009.
English: Because amifampridine-containing medicines have been used in the European Union (EU) for over 20 years, the company presented the results of studies from the scientific literature on amifampridine to support the use of Firdapse.
Croatian: Budući da se lijekovi koji sadrže amifampridin primjenjuju u Europskoj uniji (EU) dulje od 20 godina, tvrtka je dostavila rezultate ispitivanja iz znanstvene literature o amifampridina, kako bi se potkrijepila primjena lijeka Firdapse.
English: What is Firdapse?
Croatian: Što je Firdapse?
English: What is the risk associated with Firdapse?
Croatian: Koji su rizici povezani s lijekom Firdapse?
English: Firdapse is taken in divided doses, three or four times a day, and a single dose should not be more than 20 mg. Firdapse should be taken with food.
Croatian: Firdapse se uzima u raspodijeljenim dozama, tri ili četiri puta na dan, a jedna doza ne smije biti više od 20 mg.
English: In the QT study, amifampridine was observed to have no effects on the activity of the heart, as shown by the electrocardiograms of healthy volunteers taking part in this study.
Croatian: U QT ispitivanju je uočeno da amifampridin nije imao učinka na aktivnost srca kako je dokazano elektrokardiogramima zdravih dobrovoljaca koji su sudjelovali u ovom ispitivanju.
English: The company will ensure that all healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.
Croatian: Tvrtka će osigurati da se svim zdravstvenim djelatnicima za koje se očekuje da će koristiti lijek dostave informacije o načinu upisa bolesnika u registar.
English: Patients with lower NDS or QMG scores have better muscle function.
Croatian: Bolesnici s manjim rezultatom NDS-a ili QMG-a imaju bolju mišićnu funkciju.
English: Firdapse is used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Croatian: Firdapse se koristi za liječenje simptoma Lambert-Eatonovog mijasteničnog sindroma (LEMS) u odraslih.
English: Other information about Firdapse
Croatian: Ostale informacije o lijeku Firdapse
English: Another study combined data from the two published studies and looked at compound muscle action potential (CMAP).
Croatian: Drugo je ispitivanje objedinilo podatke iz dva objavljenja ispitivanja i istražilo složeni mišićni akcijski potencijal (CMAP).
English: The most common side effects reported with Firdapse are paraesthesia (unusual sensations like pins and needles) and gastro-intestinal disorders such as epigastralgia (pain around the upper part of the stomach), diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Croatian: Najčešće nuspojave prijavljene s lijekom Firdapse su parestezija (neobični osjećaji poput trnaca ili uboda iglica) i gastrointestinalni poremećaji poput epigastralgije (boli oko gornjeg dijela želuca), proljev, mučnina (osjećaj slabosti) i abdominalna bol (bol u želucu).
English: Because the number of patients with LEMS is low, the disease is considered ‘rare', and Firdapse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2002.
Croatian: Budući da je broj bolesnika s LEMS-om nizak, dotična se bolest smatra „rijetkom” te se Firdapse označava kao lijek za liječenje rijetkih bolesti od 18. prosinca 2002.
English: The main measures of effectiveness were based on the rating of how well the muscles worked using a scoring system, either the neurological disability score (NDS) or the quantitative myasthenia gravis (QMG) score.
Croatian: Glavna mjera djelotvornosti temeljila se na ocijeni rada mišića pomoću sustava ocjenjivanja, bilo ocjenom neurološke invalidnosti (NDS) ili kao rezultat kvantitativne mijastenije gravis (QMG).
English: Firdapse is a medicine that contains the active substance amifampridine.
Croatian: Firdapse je lijek koji sadrži djelatnu tvar amifampridin.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Firdapse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke bolesti o lijeku Firdapse možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: A risk management plan has been developed to ensure that Firdapse is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Firdapse.
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 Firdapse.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i preporuke o uvjetima korištenja lijeka Firdapse.
English: It must not be used with sultopride (an antipsychotic medicine), or medicines known to cause QTc prolongation (an alteration of the electrical activity of the heart).
Croatian: Ne smije se primjenjivati zajedno sa sultopridom (antipsihotikom) niti s lijekovima za koje je poznato da uzrokuju prolongaciju QTc-a (izmjenu električne aktivnosti srca).
English: Additionally, the effect of Firdapse on the QT interval (the electrical activity of the heart) was investigated.
Croatian: Nadalje, istraženo je djelovanje lijeka Firdapse na QT interval (električnu aktivnost srca).
English: This document is a summary of the European public assessment report (EPAR) for Firdapse.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Firdapse.
English: In two published studies involving a total of 38 adults with LEMS, amifampridine was compared with placebo (a dummy treatment).
Croatian: U dva objavljena ispitivanja koja su obuhvatila ukupno 38 odraslih osoba oboljelih od LEMS-a, amifampridin je uspoređen s placebom (liječenjem bez djelatne tvari).
English: For more information about treatment with Firdapse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Firdapse pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Firdapse, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Firdapse uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: LEMS is a disease in which patients have muscle weakness because of a failure of the nerves to transmit electrical impulses to the muscles.
Croatian: LEMS je bolest pri kojoj bolesnici osjećaju slabost mišića uslijed nemogućnosti živaca da prenose električne impulse u mišiće.
English: Additionally, the company that markets Firdapse has been required to set up a patient registry for patients with LEMS.
Croatian: Nadalje, od tvrtke koja stavlja lijek Firdapse na tržište zatraženo je da uspostavi registar bolesnika za osobe oboljele od LEMS-a.
English: For muscles to contract, nerves have to transmit electrical impulses to the muscles through a chemical messenger called acetylcholine.
Croatian: Kako bi se mišići kontrahirali, živci moraju odašiljati električne impulse u mišiće kroz kemijskog glasnika naziva acetilkolin.
English: What information is still awaited for Firdapse?
Croatian: Koje se još informacije očekuju o lijeku Firdapse?
English: Why has Firdapse been approved?
Croatian: Zašto je lijek Firdapse odobren?
English: This prolongs the period of depolarisation, allowing more time for the nerves to release acetylcholine and so stimulate the muscles to contract.
Croatian: Time se produljuje razdoblje depolarizacije, što dozvoljava više vremena živcima da otpuste acetilkolin te tako stimuliraju kontrakciju mišića.
English: The full EPAR for Firdapse can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Firdapse nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Firdapse was more effective than placebo at treating patients with LEMS.
Croatian: Firdapse je bio djelotvorniji od placeba u liječenju bolesnika oboljelih od LEMS-a.
English: In the third combined study, patients taking Firdapse had better improvements in CMAP than patients taking placebo.
Croatian: U trećem kombiniranom ispitivanju, bolesnici koji su uzimali lijek Firdapse imali su bolja poboljšanja u CMAP-u od bolesnika koji su uzimali placebo.
English: Firdapse must not be used in patients who have epilepsy or in patients with uncontrolled asthma or congenital QT syndromes (disruption of the heartbeat).
Croatian: Firdapse se ne smije primjenjivati u bolesnika koji boluju od epilepsije ili u bolesnika s nekontroliranom astmom, odnosno s kongenitalnim QT sindromima (poremećaji u frekvenciji srca).
English: The company that makes Firdapse will provide further data from studies on cancer in experimental models.
Croatian: Proizvođač lijeka Firdapse dostavit će daljnje informacije iz ispitivanja o raku provedenima u eksperimentalnih modela.
English: Treatment with Firdapse should only be started under the supervision of a doctor experienced in treating LEMS.
Croatian: Liječenje lijekom Firdapse treba započeti pod nadzorom liječnika s iskustvom u liječenju bolesti LEMS.
English: What benefit has Firdapse shown during the studies?
Croatian: Koje su koristi lijeka Firdapse dokazane u ispitivanjima?
English: This means that because the disease is rare, it has not been possible to obtain complete information about Firdapse.
Croatian: Tome je razlog nemogućnost dobivanja potpunih informacija o lijeku Firdapse zbog rijetkosti bolesti.
English: The CHMP decided that Firdapse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Firdapse nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The other study showed a reduction in the QMG score of 2 points in patients taking Firdapse compared with a rise of 0.25 points in patients taking placebo.
Croatian: Drugo je ispitivanje pokazalo smanjenje u QMG rezultatu od 2 boda u bolesnika koji su uzimali Firdapse u usporedbi s povećanjem od 0,25 bodova u bolesnika koji su uzimali placebo.
English: In one study, the NDS was reduced from 40 to 22 points in patients taking Firdapse compared with a drop to 35 points in patients taking placebo.
Croatian: U jednom ispitivanju, NDS je smanjen sa 40 na 22 boda u bolesnika koji su uzimali lijek Firdapse u usporedbi sa sniženjem na 35 boda u bolesnika koji su uzimali placebo.
English: The active substance in Firdapse, amifampridine, is a potassium channel blocker, which prevents charged potassium particles from leaving the nerve cells.
Croatian: Djelatna tvar lijeka Firdapse, amifampridin, je blokator kanala natrija, što sprječava napunjene čestice natrija da napuste živčane stanice.
English: What is Firdapse used for?
Croatian: Za što se Firdapse koristi?
English: For the full list of all side effects and restrictions with Firdapse, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja potražite u uputi o lijeku.
English: How is Firdapse used?
Croatian: Kako se Firdapse koristi?
English: How has Firdapse been studied?
Croatian: Kako se Firdapse ispitivao?
English: How does Firdapse work?
Croatian: Kako djeluje Firdapse?
English: In such cases, the Western Blot method is negative.
Croatian: U takvim slučajevima rezultati Western Blot metode su negativni.
English: 1105BJ Amsterdam Netherlands
Croatian: 1105BJ Amsterdam Nizozemska
English: • if you have a severe infection with a high temperature (over 38°C).
Croatian: • ako imate tešku infekciju uz visoku temperaturu (iznad 38°C).
English: • Generalised skin reactions including
Croatian: • Generalizirane kožne reakcije uključujući:
English: AFLUNOV should be used in accordance with official recommendations.
Croatian: AFLUNOV se mora koristiti u skladu sa službenim preporukama.
English: Fever ≥ 38°C (≥ 40°C)
Croatian: Vrućica ≥38°C (≥40°C)
English: Human infections are primarily caused by contact with infected animals, but do not spread easily between people.
Croatian: Infekcija se u ljudi prvenstveno prenosi kontaktom sa zaraženim životinjama, ali se ne širi lako kontaktom između ljudi.
English: Other rare side effects observed after routine use:
Croatian: Druge rijetke nuspojave primijećene nakon rutinske primjene:
English: Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Croatian: Takva situacija zahtijeva brzo objavljivanje informacija o sigurnosti koje mogu imati najveće implikacije za ravnotežu između rizika i koristi u pandemiji.
English: Immunocompromised
Croatian: Imunokompromitirani
English: Long term booster immune memory:
Croatian: Dugoročna imunološka memorija booster cjepiva:
English: Packs of 1 or 10 pre-filled syringes.
Croatian: Pakiranja od 1 ili 10 napunjenih štrcaljki.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Croatian: Kada osoba primi cjepivo, imunološki sustav (prirodni obrambeni sustav tijela) stvara vlastitu zaštitu (protutijela) protiv bolesti.
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Croatian: • ako ste podvrgnuti krvnim pretragama radi traženja dokaza o infekciji određenim virusima.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Croatian: Vaš će liječnik ili medicinska sestra primijeniti cjepivo u skladu sa službenim preporukama.
English: Do not throw any medicines via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Croatian: Promptna analiza skupnih informacija o sigurnosti, s obzirom na razmjer izloženosti, bit će ključna za regulatorne odluke i zaštitu populacije cijepljenjem.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be taken by a state laboratory or a laboratory designated for that purpose.
Croatian: Direktive 2001/83/EC, službeno puštanje serije lijeka u promet preuzet će državni laboratorij ili laboratorij određen za tu svrhu.
English: A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with AFLUNOV;
Croatian: Manja infekcija kao što je prehlada ne bi trebala biti problem, no Vaš bi Vas liječnik ili medicinska sestra trebali savjetovati možete li biti cijepljeni cjepivom AFLUNOV;
English: - Other ingredients:
Croatian: Drugi sastojci:
English: For the adjuvant, see section 2
Croatian: Za adjuvans, vidjeti dio 2.
English: Available data in paediatric population
Croatian: Dostupni podaci u pedijatrijskoj populaciji
English: There is limited experience in elderly over 70 years of age (see section 5.1).
Croatian: Postoji ograničeno iskustvo u osoba starijih od 70 godina (vidjeti dio 5.1).
English: HI results for the two clinical studies revealed lower values than those reported in previous studies.
Croatian: Rezultati za HI u dva klinička ispitivanja pokazali su niže vrijednosti od onih zabilježenih u prethodnim ispitivanjima.