FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed instruction on how to take California poppy medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o načinu uzimanja lijekova koji sadrže zelen kalifornijskog maka i tko ih može koristiti dostupne su u uputi o lijeku koja je priložena uz lijek.
English: What are the risks associated with California poppy medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže zelen kalifornijskog maka?
English: What is California poppy?
Croatian: Što je zelen kalifornijskog maka?
English: For more information about treatment with California poppy medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže zelen kalifornijskog maka pročitajte u uputi o lijeku priloženoj uz lijek odnosno obratite se svom liječniku ili ljekarniku.
English: Other information about California poppy medicines
Croatian: Ostale informacije o lijekovima koji sadrže zelen kalifornijskog maka
English: For practical information about using California poppy medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže zelen kalifornijskog maka bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek odnosno obratiti se svom liječniku ili ljekarniku.
English: California poppy
Croatian: Zelen kalifornijskog maka
English: What evidence supports the use of California poppy medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže zelen kalifornijskog maka?
English: How are California poppy medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže zelen kalifornijskog maka?
English: The HMPC conclusions on the use of California poppy medicines are based on their long-standing use.
Croatian: Zaključci HMPC-a temelje se na dugotrajnoj uporabi lijekova koji sadrže zelen kalifornijskog maka.
English: It should be taken consistently either with or without food.
Croatian: Potrebno ga je uzimati dosljedno, uz obrok ili bez njega.
English: Further information on Epidyolex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/epidyolex.
Croatian: Više informacija o lijeku Epidyolex dostupno je na internetskim stranicama Agencijeema.europa.eu/medicines/human/EPAR/epidyolex.:
English: This risk can be managed with restrictions and regular liver monitoring and is considered acceptable given the seriousness of the conditions and the lack of treatments.
Croatian: Ovim se rizikom može upravljati uz pomoć ograničenja i redovitog praćenja funkcije jetre te se smatra prihvatljivim s obzirom na ozbiljnost stanja i nedostatak terapija.
English: Epidyolex (cannabidiol) EMA/428834/2019
Croatian: Epidyolex (kanabidiol) EMA/428834/2019
English: Depending on the individual response and how well the medicine is tolerated, the doctor may increase the dose gradually up to a maximum of 10 mg/kg twice a day.
Croatian: Ovisno o individualnom odgovoru bolesnika i o tome koliko se dobro podnosi lijek, liječnik može postupno povećavati dozu do najviše 10 mg/kg dvaput dnevno.
English: Further information on the orphan designations can be found on the European Medicines Agency's website: (Dravet syndrome: 15 October 2014; Lennox-Gastaut syndrome: 20 March 2017).
Croatian: Više informacija o statusu lijeka za rijetku bolest nalazi se na internetskim stranicama Europske agencije za lijekove: (Dravetov sindrom: 15. listopada 2014.; Lennox-Gastautov sindrom: 20. ožujka 2017.).
English: As this is important for the transmission of electrical signals in some nerve cells, and seizures are caused by excessive electrical activity in the brain, altering the movement of calcium is expected to reduce or prevent the
Croatian: Budući da je to bitno za prijenos električnih signala u pojedinim živčanim stanicama, a napadaje uzrokuje pretjerana električna aktivnost u mozgu, smatra se da promjena kretanja kalcija smanjuje ili sprječava napadaje
English: The recommended starting dose is 2.5 mg per kilogram body weight given twice a day.
Croatian: Preporučena početna doza iznosi 2,5 mg po kilogramu tjelesne težine dvaput dnevno.
English: Epidyolex (cannabidiol)
Croatian: Epidyolex (kanabidiol)
English: Symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Croatian: Simptomi obuhvaćaju nekoliko vrsta napadaja, abnormalnu električnu aktivnost u mozgu, poteškoće pri učenju i probleme u ponašanju.
English: After one week, the dose should be increased to a maintenance dose of 5 mg/kg twice a day.
Croatian: Nakon tjedan dana dozu treba povećati na dozu održavanja od 5 mg/kg dvaput dnevno.
English: What measures are being taken to ensure the safe and effective use of Epidyolex?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Epidyolex?
English: Cannabidiol is also thought to act on adenosine, a chemical messenger in the brain that plays an important role in suppressing seizures.
Croatian: Smatra se i da kanabidiol djeluje na adenozin, kemijski glasnik u mozgu koji je iznimno bitan u sprječavanju napadaja.
English: Regarding safety, treatment with Epidyolex is associated with an increased risk of liver problems.
Croatian: U pogledu sigurnosti primjene, liječenje lijekom Epidyolex povezuje se s povećanim rizikom od problema s jetrom.
English: Side effects reported with Epidyolex are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Epidyolex pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The most common reason for stopping treatment was increased blood levels of liver enzymes (a sign of liver problems).
Croatian: Najčešći razlog za prekid terapije bile su povećane razine jetrenih enzima (što upućuje na probleme s jetrom).
English: Doses are measured and given by mouth with a suitable syringe supplied with the medicine.
Croatian: Doze se mjere i daju se na usta uz pomoć odgovarajuće štrcaljke koja dolazi u pakiranju s lijekom.
English: Epidyolex can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of epilepsy.
Croatian: Epidyolex se izdaje samo na recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju epilepsije.
English: Four studies involving 715 patients with Lennox-Gastaut or Dravet syndrome looked at the effect of Epidyolex when added to treatment with other epilepsy medicines.
Croatian: U četirima ispitivanjima na 715 bolesnika s Lennox-Gastautovim ili Dravetovim sindromom proučavao je učinak lijeka Epidyolex kada se on dodaje liječenju drugim lijekovima protiv epilepsije.
English: The European Medicines Agency therefore decided that Epidyolex's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Epidyolex nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The most common side effects with Epidyolex (which may affect more than 1 in 10 people) are somnolence (sleepiness), decreased appetite, diarrhoea, fever, tiredness and vomiting.
Croatian: Najčešće nuspojave lijeka Epidyolex (mogu se javiti u više od 1 na 10 osoba) jesu somnolencija (pospanost), smanjeni apetit, proljev, vrućica, umor i povraćanje.
English: Although the way it works is not clearly understood, the active substance in Epidyolex, cannabidiol, is thought to act on targets that play a role in the movement of calcium in the cells.
Croatian: Premda nije potpuno jasan način na koji djeluje, smatra se da djelatna tvar u lijeku Epidyolex, kanabidiol, djeluje na ciljna mjesta koja utječu na kretanje kalcija u stanicama.
English: Epidyolex is available as a liquid containing 100 mg cannabidiol per ml.
Croatian: Lijek Epidyolex dostupan je u obliku tekućine koja sadrži 100 mg kanabidiola po jednom mililitru.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Epidyolex have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Epidyolex nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Other information about Epidyolex
Croatian: Ostale informacije o lijeku Epidyolex
English: Epidyolex must not be used in patients whose blood levels of liver enzymes are more than three times the normal limit and who also have levels of bilirubin (another marker of liver problems) more than twice the normal limit.
Croatian: Lijek Epidyolex ne smiju uzimati bolesnici čija je razina jetrenih enzima triput veća od uobičajenog ograničenja i čija je razina bilirubina (drugog pokazatelja problema s jetrom) dvaput veća od uobičajene.
English: What is Epidyolex and what is it used for?
Croatian: Što je Epidyolex i za što se koristi?
English: seizures in patients with Lennox-Gastaut syndrome or Dravet syndrome.
Croatian: u bolesnika s Lennox-Gastautovim ili Dravetovim sindromom.
English: Epidyolex is a medicine used in addition to clobazam, another epilepsy medicine, to treat patients from the age of two years who have Lennox-Gastaut syndrome or Dravet syndrome, rare types of epilepsy that begin in childhood and can continue into adulthood.
Croatian: Epidyolex je lijek koji se koristi uz klobazam, drugi lijek protiv epilepsije, za liječenje bolesnika u dobi od dvije godine i starijih koji boluju od Lennox-Gastautovog sindroma ili Dravetovog sindroma, rijetkih oblika epilepsije koji se javljaju u djetinjstvu i mogu se nastaviti do odrasle dobi.
English: As for all medicines, data on the use of Epidyolex are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Epidyolex kontinuirano se prate.
English: These conditions are rare, and Epidyolex was designated an ‘orphan medicine' (a medicine used in rare diseases).
Croatian: Te su bolesti rijetke, a Epidyolex je dobio status „lijeka za rijetku bolest”.
English: An overview of Epidyolex and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Epidyolex i zašto je odobren u EU-u
English: The main studies showed that Epidyolex is effective at lowering the number of seizures in patients with Lennox-Gastaut and Dravet syndromes who are taking clobazam.
Croatian: Glavna su ispitivanja pokazala da je Epidyolex učinkovit u smanjenju broja napadaja u bolesnika s Lennox-Gastautovim i Dravetovim sindromom koji uzimaju klobazam.
English: For more information about using Epidyolex, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Epidyolex pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: What are the risks associated with Epidyolex?
Croatian: Koji su rizici povezani s lijekom Epidyolex?
English: Why is Epidyolex authorised in the EU?
Croatian: Zašto je lijek Epidyolex odobren u EU-u?
English: In the first two studies, patients with Lennox-Gastaut syndrome taking Epidyolex in combination with clobazam had a reduction of up to 64% in the number of drop seizures (brief loss of muscle tone and reduced consciousness, causing abrupt falls), compared with a reduction of up to 31% for patients given placebo (a dummy treatment) with clobazam.
Croatian: U prva dva ispitivanja na bolesnicima s Lennox-Gastautovim sindromom koji su uzimali Epidyolex u kombinaciji s klobazamom astatski napadaji (kratki gubitak tonusa mišića i smanjena razina svijesti, što uzrokuje nagle padove) smanjili su se i do 64 %, u usporedbi s najviše 31 % za bolesnike koji su primali placebo (prividno liječenje) s klobazamom.
English: They showed that Epidyolex lowered the number of seizures after 14 weeks in patients who were also taking clobazam.
Croatian: Ispitivanja su pokazala da je lijek Epidyolex smanjio broj napadaja nakon 14 tjedana u bolesnika koji su uz njega uzimali i klobazam.
English: In the two other studies in patients with Dravet syndrome, the reduction in the number of convulsive seizures (major fits with loss of consciousness) was up to 61% for patients taking Epidyolex and clobazam, and up to 38% for patients on placebo and clobazam.
Croatian: U druga dva ispitivanja u bolesnika s Dravetovim sindromom smanjenje konvulzivnih napadaja (velikih napadaja s gubitkom svijesti) iznosilo je najviše 61 % za bolesnike koji su primali Epidyolex i klobazam, a najviše 38 % za bolesnike koji su primali placebo i klobazam.
English: Epidyolex contains the active substance cannabidiol.
Croatian: Lijek Epidyolex sadrži djelatnu tvar kanabidiol.
English: What benefits of Epidyolex have been shown in studies?
Croatian: Koje su koristi od lijeka Epidyolex utvrđene u ispitivanjima?
English: How does Epidyolex work?
Croatian: Kako djeluje Epidyolex?
English: How is Epidyolex used?
Croatian: Kako se Epidyolex primjenjuje?
English: For the full list of side effects of Epidyolex, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Epidyolex potražite u uputi o lijeku.
English: bottle (HDPE) (without outer carton)
Croatian: bočica (HDPE) (bez vanjskog pakiranja)
English: 180 (6 x 30) tablets (multipack)
Croatian: 180 (6 x 30) tableta (višestruko pakiranje)
English: 90 sachets (with dosing spoon)
Croatian: 90 vrećica (sa dozirnom žličicom)
English: Route of Administration
Croatian: Icandra
English: This summary was last updated in 10/2017.
Croatian: Sažetak je posljednji put ažuriran u 10.2017.
English: However, there is uncertainty regarding the size of the improvement because further analysis of the data showed a reduced effect.
Croatian: Međutim, postoje dvojbe u pogledu razine poboljšanja jer je dodatna analiza podataka pokazala smanjeni učinak.
English: The recommended dose is 4 mg taken once a week (on the same day of the week) for 3 consecutive weeks, followed by a week with no Ninlaro treatment.
Croatian: Preporučena doza jest 4 mg jedanput tjedno (istoga dana u tjednu) tri tjedna uzastopno, a nakon toga treba uslijediti tjedan bez liječenja lijekom Ninlaro.
English: Ninlaro is available as capsules (2.3, 3 and 4 mg) to be taken at least one hour before or two hours after food.
Croatian: Lijek Ninlaro dostupan je u obliku kapsula (od 2,3 mg, 3 mg i 4 mg) koje se uzimaju najmanje jedan sat prije ili dva sata nakon obroka.
English: When the proteins in the cancer cells are not broken down, including the proteins that control cell growth, the cancer cells are damaged and they eventually die.
Croatian: Ako se proteini u stanicama raka ne razgrađuju, uključujući proteine koji kontroliraju rast stanica, dolazi do oštećenja stanica raka koje naposljetku odumiru.
English: This means that it blocks the proteasome, which is a system within cells that breaks down proteins when they are no longer needed.
Croatian: To znači da djeluje blokiranjem proteazoma, odnosno sustava unutar stanice koji razgrađuje bjelančevine kada više nisu potrebne.
English: What is Ninlaro and what is it used for?
Croatian: Što je Ninlaro i za što se koristi?
English: Treatment may need to be stopped temporarily or the dose reduced if the patient has certain side effects.
Croatian: Liječenje će se možda trebati privremeno prekinuti ili će se doza morati smanjiti ako bolesnik ima određene nuspojave.
English: Ninlaro ixazomib
Croatian: Ninlaro iksazomib
English: Why is Ninlaro approved?
Croatian: Zašto je Ninlaro odobren?
English: This is a summary of the European public assessment report (EPAR) for Ninlaro.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Ninlaro.
English: The most common side effects with Ninlaro taken together with lenalidomide and dexamethasone (seen in more than 1 in 5 people) were diarrhoea, constipation, thrombocytopenia (low blood platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell), peripheral neuropathy (nerve damage in the hands and feet causing tingling or numbness), nausea (feeling sick), peripheral oedema (swelling, especially of the ankles and feet), vomiting and nose and throat infection.
Croatian: Najčešće nuspojave lijeka Ninlaro kada se uzima zajedno s lenalidomidom i deksametazonom (uočene u više od 1 na 5 osoba) bile su proljev, zatvor, trombocitopenija (nizak broj trombocita u krvi), neutropenija (niske razine neutrofila, vrste bijelih krvnih stanica), periferna neuropatija (oštećenje živaca u rukama i stopalima što uzrokuje trnce i utrnulost), mučnina (slabost), periferni edem (oticanje, osobito gležnjeva i stopala), povraćanje te infekcija nosa i grla.
English: What measures are being taken to ensure the safe and effective use of Ninlaro?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ninlaro?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ninlaro on 21/11/2016.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Ninlaro u promet koje je na snazi u Europskoj uniji od 21. studenoga 2016.
English: Ninlaro has been given ‘conditional approval'.
Croatian: Za lijek Ninlaro izdano je „uvjetno odobrenje”.
English: The full EPAR for Ninlaro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Ninlaro nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is given together with two other medicines, lenalidomide and dexamethasone, to patients who have received at least one prior treatment.
Croatian: Daje se zajedno s drugim dvama lijekovima, lenalidomidom i deksametazonom, bolesnicima koji su primili najmanje jednu prethodnu terapiju.
English: Ninlaro has been investigated in one main study involving 722 adults with multiple myeloma whose disease had not got better or had come back after previous treatment.
Croatian: Lijek Ninlaro ispitan je u jednom glavnom ispitivanju koje je uključivalo 722 odrasle osobe s multiplim mijelomom čije se stanje nakon prethodnog liječenja nije poboljšalo ili kod kojih se bolest vratila.
English: This 4-week treatment cycle should be continued until the disease gets worse or side effects become unacceptable.
Croatian: S ovim ciklusom liječenja u trajanju od četiri tjedna treba nastaviti sve dok se bolest ne pogorša ili dok bolesnik ne razvije neprihvatljive nuspojave.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ninlaro have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ninlaro također se nalaze u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It is not intended to provide practical advice on how to use Ninlaro.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Ninlaro.
English: Other information about Ninlaro
Croatian: Ostale informacije o lijeku Ninlaro
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ninlaro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Ninlaro nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Ninlaro does not seem to significantly increase the frequency of serious side effects when added to lenalidomide and dexamethasone, and offers the convenience of patients being able to take the capsules at home.
Croatian: Čini se da lijek Ninlaro ne povećava znatno učestalost ozbiljnih nuspojava kada se dodaje lenalidomidu i deksametazonu i bolesnicima pruža pogodnost uzimanja kapsula kod kuće.
English: The European Medicines Agency therefore decided that Ninlaro's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi lijeka Ninlaro nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: Because the number of patients with multiple myeloma is low, the disease is considered ‘rare', and Ninlaro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 September
Croatian: Budući da je broj bolesnika s multiplim mijelomom nizak, bolest se smatra „rijetkom” te se Ninlaro označava kao lijek za rijetku bolest od 27. rujna 2011.
English: The company that markets Ninlaro will provide the final data from the main study on the effects of the medicine on overall survival.
Croatian: Tvrtka koja lijek Ninlaro stavlja u promet pružit će konačne podatke iz glavnog ispitivanja o učincima lijeka na ukupno preživljenje.
English: In a subsequent similar study involving 115 patients, many with advanced disease, those receiving Ninlaro with lenalidomide and dexamethasone lived on average for 6.7 months without their disease getting worse compared with 4 months in those receiving placebo with lenalidomide and dexamethasone.
Croatian: U naknadnom sličnom ispitivanju koje je uključivalo 115 bolesnika, među kojima je kod mnogih bolest uznapredovala, oni koji su primali Ninlaro s lenalidomidom i deksametazonom živjeli su u prosjeku 6,7 mjeseci bez pogoršanja bolesti u usporedbi s 4 mjeseca u onih koji su primali placebo s lenalidomidom i deksametazonom.
English: Ninlaro is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow).
Croatian: Ninlaro je lijek protiv raka koji se primjenjuje za liječenje odraslih osoba s multiplim mijelomom (rak koštane srži).
English: Ninlaro can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma.
Croatian: Lijek Ninlaro izdaje se samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju multiplog mijeloma.
English: The active substance in Ninlaro, ixazomib, is a proteasome inhibitor.
Croatian: Djelatna tvar u lijeku Ninlaro, iksazomib, inhibitor je proteazoma.
English: What are the risks associated with Ninlaro?
Croatian: Koji su rizici povezani s lijekom Ninlaro?
English: Since Ninlaro has been granted a conditional approval, the company that markets Ninlaro will provide further data on the benefits of this medicine from other studies, including a study in patients who have not been treated before.
Croatian: Budući da je lijek Ninlaro dobio uvjetno odobrenje, tvrtka koja lijek stavlja u promet pružit će dodatne podatke o koristima ovoga lijeka iz drugih ispitivanja, uključujući ispitivanje na bolesnicima koji nisu prethodno liječeni.
English: However, because of the uncertainty regarding the size of the improvement following a later analysis, further confirmatory data will need to be provided by the company that markets the medicine.
Croatian: Međutim, zbog dvojbi u pogledu razine poboljšanja nakon naknadne analize, tvrtka koja lijek stavlja u promet trebat će pružiti dodatne potvrdne podatke.
English: The study compared Ninlaro with placebo (a dummy treatment), both taken together with lenalidomide and dexamethasone.
Croatian: U ispitivanju je lijek Ninlaro uspoređen s placebom (prividnim liječenjem), pri čemu su se obje terapije uzimale zajedno s lenalidomidom i deksametazonom.
English: The dose may be reduced also in patients with moderately or severely reduced liver function and patients with severely reduced kidney function.
Croatian: Jednako tako, doza će se možda morati smanjiti u bolesnika s umjerenim ili teškim oštećenjem jetre ili bolesnika s teškim oštećenjem bubrega.
English: What information is still awaited for Ninlaro?
Croatian: Koje se još informacije očekuju o lijeku Ninlaro?