FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 In the context of a referral procedure under Article 31 of Directive 2001/83/EC.
Croatian: 1 U kontekstu postupka upućivanja u skladu sa člankom 31. Direktive 2001/83/EC.
English: More information can be found here.
Croatian: Više informacija dostupno je ovdje.
English: The average dose used was 600 to 800 mg per day.
Croatian: Prosječna doza koja je korištena bila je 600 do 800 mg na dan.
English: The usual treatment dose is between 400 mg and 1,200 mg per day taken in two or three divided doses.
Croatian: Uobičajena terapijska doza iznosi između 400 mg i 1 200 mg na dan i uzima se podijeljena u dvije ili tri doze.
English: In addition the CHMP considered that additional treatment options are needed for this rare disease.
Croatian: Nadalje, CHMP je uzeo u obzir da su potrebne dodatne opcije za liječenje ove rijetke bolesti.
English: The patient's liver function should also be checked weekly for one month when the dose is increased.
Croatian: Funkciju jetre bolesnika treba također tjedno kontrolirati tijekom jednog mjeseca ukoliko dođe do povećanja doze.
English: However, oral formulations (used by mouth) for the treatment of fungal infections were suspended in July 2013 because of the risk of liver injury.1
Croatian: No, oralne formulacije (primjena kroz usta) za liječenje gljivičnih infekcija suspendirane se u srpnju 2013. uslijed rizika od oštećenja jetre.1
English: It must also not be used in pregnant or breastfeeding women or patients who have QTc prolongation (disruption of the electrical activity of the heart).
Croatian: Ne smije se koristiti u trudnica ili dojilja ili bolesnika koji imaju prolongaciju QTc-a (poremećaj električne aktivnosti srca).
English: The dose is adjusted according to the levels of cortisol in the body, which is measured by regular checks of the urine or blood.
Croatian: Doza se prilagođava u skladu s razinama kortizola u tijelu koje se mjere redovitim provjerama urina ili krvi.
English: The main measure of effectiveness in these literature studies was the level of cortisol in the urine.
Croatian: Glavna mjera djelotvornosti u ovim ispitivanjima dostavljenima iz literature bila je koncentracija kortizola u urinu.
English: If liver enzyme levels in the blood increase beyond three times the normal maximum (a sign of possible liver problems) or in case of symptoms such as lack of appetite, nausea, vomiting, fatigue, jaundice, abdominal pain (stomach ache) or dark urine that may suggest a liver problem, treatment must be stopped.
Croatian: Ako su jetreni enzimi u krvi povišeni više od tri puta u odnosu na normalne maksimalne vrijednosti (znak mogućih oštećenja jetre) ili u slučaju simptoma poput izostanka apetita, mučnine, povraćanja, umora, žutice, abdominalne boli (trbuhobolje) ili tamnog urina, što može ukazivati na oštećenje jetre, liječenje se mora prekinuti.
English: Ketoconazole treatment was shown to normalise urine cortisol levels in 43 to 80% of patients.
Croatian: Terapija ketokonazolom rezultirala je normalizacijom razina kortizola u 43 do 80 % bolesnika.
English: The most serious side effects are liver problems which can be detected early through regular monitoring.
Croatian: Najčešće ozbiljne nuspojave su oštećenja jetre koja se mogu rano otkriti redovitim kontrolama.
English: Ketoconazole HRA is available as tablets (200 mg).
Croatian: Ketoconazole HRA dostupan je kao tablete (200 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ketoconazole HRA on 19 November 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Ketoconazole HRA na snazi u Europskoj uniji od 19. studenog 2014.
English: Blocking cortisol production will help to reduce cortisol levels in the body, thereby relieving the symptoms of the disease.
Croatian: Inhibiranje stvaranja kortizola pomaže pri smanjenu koncentracije kortizola u tijelu, te stoga ublažava simptome bolesti.
English: ketoconazole
Croatian: ketokonazol
English: Ketoconazole blocks the activity of a group of enzymes in the adrenal glands involved in the production of cortisol, such as 17 alpha-hydroxylase or 11β-hydroxylase.
Croatian: Ketokonazol inhibira djelovanje grupe enzima u nadbubrežnim žlijezdama koje sudjeluju u stvaranju kortizola, poput 17 alfa-hidroksilaze ili 11β-hidroksilaze.
English: Because the number of patients with Cushing's syndrome is low, the disease is considered ‘rare', and Ketoconazole HRA was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 April 2012.
Croatian: Budući da je broj bolesnika s Cushingovim sindromom nizak, bolest se smatra „rijetkom” te se Ketoconazole HRA označava kao lijek za liječenje rijetkih bolesti od 23. travnja 2012.
English: This is a summary of the European public assessment report (EPAR) for Ketoconazole HRA.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Ketoconazole HRA.
English: Because ketoconazole is a well-known substance, and its use in Cushing's syndrome is well established, the applicant presented data from the published literature on more than 800 patients with Cushing's syndrome who were treated with ketoconazole either alone or in combination with other treatments.
Croatian: Budući da je ketokonazol dobro poznata tvar, te je njegova primjena u slučaju Cushingovog sindroma dobro utvrđena, podnositelj zahtjeva dostavio je podatke iz objavljene literature za više od 800 bolesnika s Cushingovim sindromom koji su bili liječeni ketokonazolom kao monoterapijom ili u kombinaciji s drugim terapijama.
English: Ketoconazole can still be found in topical medicines (medicines applied to the skin) to treat fungal infections.
Croatian: Ketokonazol se još uvijek koristi u topikalnim lijekovima (lijekovima koji se primjenjuju na kožu) za liječenje gljivičnih infekcija.
English: Regarding its safety the CHMP considered that the risk of liver problems can be managed through appropriate measures.
Croatian: Vezano uz sigurnu primjenu, CHMP je zaključio da su rizici od oštećenja jetre upravljivi odgovarajućim mjerama.
English: It can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in treating patients with Cushing syndrome who has access to appropriate facilities to assess the patient's response.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s Cushingovim sindromom koji ima pristup odgovarajućoj opremi za praćenje odgovora bolesnika.
English: The full EPAR and risk management plan summary for Ketoconazole HRA can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Ketoconazole HRA nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ketoconazole HRA is a medicine used to treat adults and children above the age of 12 years with Cushing's syndrome.
Croatian: Ketoconazole HRA je lijek koji se koristi za liječenje odraslih osoba i djece starije od 12 godina s Cushingovim sindromom.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ketoconazole HRA 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 za lijek Ketoconazole HRA dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The most common side effects with Ketoconazole HRA are adrenal insufficiency (too low a level of the hormones produced by the adrenal gland), nausea (feeling sick), vomiting, abdominal pain (stomach ache), diarrhoea, pruritus (itching), rash and increase in blood levels of liver enzymes.
Croatian: Najčešće nuspojave lijeka Ketoconazole HRA su adrenalna insuficijencija (preniska razina hormona koj proizvodi nadbubrežna žlijezda), mučnina (osjećaj slabosti), povraćanje, abdominalna bol (trbuhobolja), proljev, pruritus (svrbež), osip i povišene razine jetrenih enzima u krvi.
English: Ketoconazole HRA must also not be used together with certain medicines that may increase the risk of serious side effects.
Croatian: Ketoconazole HRA ne smije se također koristiti zajedno s određenim lijekovima koji mogu povećati rizik od ozbiljnih nuspojava.
English: It is not intended to provide practical advice on how to use Ketoconazole HRA.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Ketoconazole HRA.
English: The active substance in Ketoconazole HRA, ketoconazole, is a well known substance that has been authorised for several decades for the treatment of fungal infections.
Croatian: Djelatna tvar lijeka Ketoconazole HRA, ketokonazol, dobro je poznata tvar koja je odobrena već nekoliko desetljeća za liječenje gljivičnih infekcija.
English: The patient's liver function should be checked with blood tests before treatment is started and regularly for the following 6 months.
Croatian: Prije početka liječenja potrebno je provjeriti funkciju jetre bolesnika analizom krvi, a zatim su potrebne redovite kontrole svakih šest mjeseci.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ketoconazole HRA's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Ketoconazole HRA nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: What measures are being taken to ensure the safe and effective use of Ketoconazole HRA?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ketoconazole HRA?
English: The CHMP considered that the use of Ketoconazole HRA to treat Cushing's syndrome was well established in medical practice and documented in the scientific literature.
Croatian: CHMP je razmotrio primjenu lijeka Ketoconazole HRA za liječenje Cushingova sindroma kao i utvrđenu liječničku praksu i dokumentiranu znanstvenu literaturu.
English: The company that makes Ketoconazole HRA will also provide doctors who will use Ketoconazole HRA with a letter containing information regarding the risks of side effects, particularly of liver injury, and how to use the medicine properly.
Croatian: Proizvođač lijeka Ketoconazole HRA dostavit će liječnicima koji će koristiti lijek Ketoconazole HRA pismo koje sadrži informacije u vezi s rizicima od nuspojava, posebice oštećenja jetre, i o ispravnom načinu primjene lijeka.
English: What is Ketoconazole HRA and what is it used for?
Croatian: Što je Ketoconazole HRA i za što se koristi?
English: Ketoconazole can also block the production of other hormones produced by the adrenal gland which are often raised in Cushing's syndrome.
Croatian: Ketokonazol može također inhibirati stvaranje ostalih hormona koje proizvodi nadbubrežna žlijezda, a čija je razina često povišena u slučaju Cushingovog sindroma.
English: A risk management plan has been developed to ensure that Ketoconazole HRA is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Ketoconazole HRA.
English: Ketoconazole HRA must not be used in patients with liver disease or whose blood levels of liver enzymes are above a certain level.
Croatian: Ketoconazole HRA ne smije se koristiti u bolesnika s bolešću jetre ili čiji su jetreni enzimi iznad određene razine.
English: What are the risks associated with Ketoconazole HRA?
Croatian: Koji su rizici povezani s lijekom Ketoconazole HRA?
English: For more information about treatment with Ketoconazole HRA, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Ketoconazole HRA pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite 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 Ketoconazole HRA, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Ketoconazole HRA nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
Croatian: Cushingov sindrom je bolest za koju je karakteristično da adrenalne žlijezde, dvije žlijezde koje se nalaze iznad bubrega, prekomjerno luče hormone kortizol.
English: The company will also set up a registry of patients treated with Ketoconazole HRA in order to monitor the safety and effectiveness of the medicine.
Croatian: Tvrtka će također uspostaviti registar bolesnika liječenih lijekom Ketoconazole HRA za potrebe praćenja sigurne primjene i djelotvornosti lijeka.
English: The active substance in Ketoconazole HRA is ketoconazole.
Croatian: Djelatna tvar lijeka Ketoconazole HRA je ketokonazol.
English: Why is Ketoconazole HRA approved?
Croatian: Zašto je Ketoconazole HRA odobren?
English: For the full list of all side effects and restrictions with Ketoconazole HRA, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Ketoconazole HRA potražite u uputi o lijeku.
English: Other information about Ketoconazole HRA
Croatian: Ostale informacije o lijeku Ketoconazole HRA
English: For practical information about using Ketoconazole HRA, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Ketoconazole HRA pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: What benefits of Ketoconazole HRA have been shown in studies?
Croatian: Koje su koristi lijeka Ketoconazole HRA utvrđene u ispitivanjima?
English: How is Ketoconazole HRA used?
Croatian: Kako se koristi Ketoconazole HRA?
English: How does Ketoconazole HRA work?
Croatian: Kako djeluje Ketoconazole HRA?
English: Further information on Ebymect can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ebymect.
Croatian: Više informacija o lijeku Ebymect dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/ebymect.
English: Ebymect must not be used in:
Croatian: Ebymect se ne smije primjenjivati u:
English: This authorisation was based on the authorisation granted to Xigduo in 2014 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju koje je 2014. izdano za lijek Xigduo („informirani pristanak”).
English: Ebymect contains two different active substances, which work in different ways:
Croatian: Ebymect sadrži dvije djelatne tvari koje različito djeluju:
English: The majority of these data had already been used in the authorisation of Forxiga.
Croatian: Većina tih podataka već je korištena za izdavanje odobrenja za lijek Forxiga.
English: Ebymect received a marketing authorisation valid throughout the EU on 15 November 2015.
Croatian: Ebymect je dobio odobrenje za stavljanje u promet koje je na snazi u EU-u od 15. studenoga 2015.
English: Other information about Ebymect
Croatian: Ostale informacije o lijeku Ebymect
English: What measures are being taken to ensure the safe and effective use of Ebymect?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ebymect?
English: • patients with reduced liver function;
Croatian: bolesnika sa smanjenom funkcijom jetre,
English: What is Ebymect and what is it used for?
Croatian: Što je Ebymect i za što se koristi?
English: Side effects reported with Ebymect are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ebymect pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: • patients who are intoxicated with alcohol (drunkenness) or who regularly drink excessive amounts of alcohol.
Croatian: bolesnika pod utjecajem alkohola (u stanju pijanosti) ili onih koji redovito konzumiraju prekomjerne količine alkohola.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ebymect 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 Ebymect nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: HbA1c is a substance in the blood which gives an indication of how well the blood glucose is controlled.
Croatian: HbA1c je tvar u krvi koja pokazuje koliko se dobro kontrolira razina glukoze u krvi.
English: Ebymect can also be used to replace dapagliflozin and metformin taken as separate tablets.
Croatian: Ebymect se također može primjenjivati kao zamjena za dapagliflozin i metformin koji se uzimaju kao zasebne tablete.
English: As for all medicines, data on the use of Ebymect are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Ebymect kontinuirano se prate.
English: A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease.
Croatian: U dugoročnom ispitivanju na više od 17 000 bolesnika s dijabetesom tipa 2 promatrani su učinci dapagliflozina na kardiovaskularne bolesti (povezane sa srcem i cirkulacijom).
English: Ebymect is available as tablets containing 5 mg of dapagliflozin with 850 mg of metformin and as 5 mg of dapagliflozin with 1,000 mg of metformin.
Croatian: Ebymect je dostupan u obliku tableta koje sadrže 5 mg dapagliflozina s 850 mg metformina i u tabletama koje sadrže 5 mg dapagliflozina s 1 000 mg metformina.
English: An overview of Ebymect and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ebymect i zašto je odobren u EU-u
English: What are the risks associated with Ebymect?
Croatian: Koji su rizici povezani s lijekom Ebymect?
English: The European Medicines Agency decided that Ebymect's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Ebymect nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Why is Ebymect authorised in the EU?
Croatian: Zašto je lijek Ebymect odobren u EU-u?
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Croatian: Kao rezultat djelovanja obje aktivne tvari, smanjuje se razina glukoze u krvi, što pomaže pri kontroli dijabetesa tipa 2.
English: • patients with severe reduction in kidney function or with conditions that could alter kidney function, such as dehydration, severe infection or shock;
Croatian: bolesnika s ozbiljnim smanjenjem funkcije bubrega ili sa stanjima koja mogu promijeniti funkciju bubrega poput dehidracije, teške infekcije ili šoka,
English: For further information about using Ebymect, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Ebymect pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: • patients with diseases that could cause tissue hypoxia (reduced levels of oxygen in body tissues), such as heart or lung failure (where the heart and lungs do not work as well as they should), recent heart attack or shock;
Croatian: bolesnika s bolestima koje mogu izazvati hipoksiju tkiva (snižene razine kisika u tjelesnim tkivima), poput zatajenja srca ili pluća (pri čemu srce i pluća ne funkcioniraju pravilno), nedavnog srčanog udara ili šoka,
English: The recommended dose is 1 tablet taken twice a day with a meal; the strength should be chosen so that in total, patients receive 10 mg of dapagliflozin each day and the same (or almost the same) dose of metformin they were taking before starting Ebymect.
Croatian: Preporučena je doza jedna tableta dvaput dnevno uz obrok, pri čemu se jačina određuje tako da bolesnici ukupno prime 10 mg dapagliflozina svaki dan i istu (ili gotovo istu) dozu metformina koju su već uzimali prije početka uzimanja lijeka Ebymect.
English: The study indicated that dapagliflozin's effects were in line with those of other diabetes medicines that also work by blocking SGLT2.
Croatian: U ispitivanju je navedeno da su učinci dapagliflozina bili u skladu s onima iz drugih lijekova za liječenje dijabetesa koji isto tako djeluju na način da blokiraju SGLT2.
English: The most common side effects with Ebymect (which may affect more than 1 in 10 people) are hypoglycaemia (when used together with insulin or a sulphonylurea) and gastrointestinal symptoms (symptoms affecting the stomach and gut).
Croatian: Najčešće su nuspojave lijeka Ebymect (koje se mogu javiti u više od 1 na 10 osoba) hipoglikemija (kada se lijek primjenjuje zajedno s inzulinom ili sulfonilurejom) i gastrointestinalni simptomi (simptomi koji zahvaćaju želudac i crijeva).
English: When Ebymect is added to treatment with insulin or a medicine that helps the body to produce insulin, such as a sulphonylurea, the doctor may need to lower the dose of insulin or sulphonylurea to prevent hypoglycaemia (low blood sugar levels).
Croatian: Kada se lijek Ebymect dodaje terapiji inzulinom ili terapiji lijekom koji pospješuje proizvodnju inzulina u tijelu (kao što je sulfonilureja), liječnik će možda morati smanjiti dozu inzulina ili sulfonilureje radi sprečavanja hipoglikemije (niske razine šećera u krvi).
English: How does Ebymect work?
Croatian: Kako djeluje Ebymect?
English: It contains the active substances dapagliflozin and metformin.
Croatian: Sadrži djelatne tvari dapagliflozin i metformin.
English: • patients with any form of acute metabolic acidosis (build up of acid in the blood), such as diabetic ketoacidosis (high blood levels of acids called ketones) or lactic acidosis (build-up of lactic acid in the body);
Croatian: bolesnika koji imaju bilo koji oblik akutne metaboličke acidoze (nakupljanja kiseline u krvi) poput dijabetičke ketoacidoze (visoke razine kiselina u krvi koje se nazivaju „ketoni”) ili laktacidoze (nakupljanje mliječne kiseline u tijelu),
English: The Agency also noted that giving the combination of dapagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Croatian: Agencija je napomenula i da se primjenom kombinacije dapagliflozina i metformina u jednoj tableti može osigurati dodatna opcija liječenja za bolesnike s dijabetesom tipa 2 te da može doprinijeti pridržavanju terapije.
English: • metformin works mainly by reducing glucose production and reducing its absorption from the gut.
Croatian: metformin uglavnom djeluje tako da smanjuje proizvodnju glukoze i njezinu apsorpciju u crijevima.
English: Ebymect is a diabetes medicine that is used, together with diet and exercise in adults with type 2 diabetes.
Croatian: Ebymect je lijek za liječenje dijabetesa koji se, zajedno s dijetom i tjelovježbom, koristi u odraslih osoba oboljelih od dijabetesa tipa
English: As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine.
Croatian: Budući da se krv filtrira u bubrezima, SGLT2 sprečava izlučivanje glukoze iz krvotoka putem mokraće.
English: • patients with diabetic pre-coma (a dangerous condition that can occur in diabetes);
Croatian: bolesnika s dijabetičkom pretkomom (opasnim stanjem koje se javlja kod dijabetesa),
English: • dapagliflozin blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Croatian: dapagliflozin blokira djelovanje bjelančevine u bubrezima koja se naziva suprijenosnik natrija i glukoze 2 (SGLT2).