FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC also concluded that, in patients who have not received prior immunosuppressant therapy and are anti-JCV antibody positive, the level of anti-JCV antibody response (index) is associated with risk of developing PML.
Croatian: • PRAC je također zaključio da je, u bolesnika koji prethodno nisu uzimali terapiju imunosupresiva i koji su pozitivni na anti-JCV protutijelo, razina (indeks) odgovora na antiJCV protutijelo povezana s rizikom od razvoja PML-a.
English: • The PRAC recommended that patients with low anti-JCV antibody index who have not received prior immunosuppressant therapy should be retested every six months once they reach the 2-year treatment point.
Croatian: • PRAC je preporučio da se bolesnici s niskim indeksom anti-JCV protutijela koji nisu prethodno uzimali terapiju imunosupresivima ponovno testiraju svakih šest mjeseci nakon što dosegnu točku liječenja od dvije godine.
English: Published data suggest that patients considered as having a high risk for PML development and who continue natalizumab treatment beyond 2 years of treatment may benefit from more frequent MRI screening e.g. every 3 to 6 months.
Croatian: Objavljeni podaci ukazuju na to da bolesnici za koje se smatra da imaju veći rizik za razvoj PML-a te koji nastavljaju liječenje natalizumabom dulje od dvije godine, mogu imati koristi od češćih skeniranja MR-om, npr. svakih tri do šest mjeseci.
English: Currently it is recommended that patients who are anti-JCV antibody negative should be tested for seroconversion twice yearly.
Croatian: Trenutačno se preporučuje da se bolesnici negativni na anti-JCV protutijelo dvaput godišnje testiraju na serokonverziju.
English: These findings support the current SmPC recommendation that physicians should remain vigilant for signs and symptoms of PML for approximately 6 months after natalizumab discontinuation, and that the same monitoring strategy should apply for up to 6 months after discontinuation.
Croatian: Ti nalazi potkrepljuju trenutačnu preporuku u Sažetku opisa svojstava lijeka da liječnici moraju biti na oprezu u pogledu znakova i simptoma PML-a u trajanju od otprilike šest mjeseci nakon prekida uzimanja natalizumaba te da se ista strategija praćenja treba primjenjivati do šest mjeseci nakon prekida.
English: Available data to date suggest that anti-JCV antibody index is correlated with the risk of PML in anti-JCV antibody positive patients with no prior immunosuppressant use.
Croatian: Dostupni podaci ukazuju na to da se indeks anti-JCV protutijela povezuje s rizikom od PML-a u bolesnika pozitivnih na anti-JCV protutijela, a bez prethodne upotrebe imunosupresiva.
English: PML development after discontinuation of natalizumab
Croatian: Razvoj PML-a nakon prekida liječenja natalizumabom
English: Anti-JCV antibody index for guiding MRI monitoring frequency
Croatian: Indeks anti-JCV protutijela za usmjeravanje učestalosti praćenja MR-om
English: In addition patients without prior immunosuppressant use and a low antibody index should also be tested every 6 months if they are treated beyond 2 years.
Croatian: Osim toga, bolesnici koji nisu prethodno uzimali imunosupresive i nemaju nizak indeks protutijela trebaju se testirati svakih šest mjeseci ako su liječeni dulje od dvije godine.
English: In patients with MRI lesions suggestive for PML, the MRI protocol should be extended to include contrast-enhanced T1-weighted imaging to detect inflammatory features and the possible coincidence of PML and PML-IRIS (Immune Reconstitution Inflammatory Syndrome), particularly during follow up.
Croatian: U bolesnika s lezijama na MR-u koje ukazuju na PML, MR protokol treba proširiti na uključivanje T1 mjerenog snimanja uz primjenu kontrasta kako bi se otkrili upalni sadržaji i moguće podudaranje PML-a i PML-a i IRIS-a (upalni sindrom imunološke rekonstitucije) osobito tijekom razdoblja praćenja.
English: For patients without prior immunosuppressant use and with high anti-JCV antibody index, no further antibody testing is required, as more frequent MRI screening should be considered if natalizumab treatment is continued for more than 2 years.
Croatian: Nije potrebno dodatno testiranje na protutijela u bolesnika koji nisu prethodno uzimali imunosupresive i imaju visok indeks anti-JCV protutijela jer je potrebno razmotriti češće snimanje MR-om ako se liječenje natalizumabom nastavi dulje od dvije godine.
English: For natalizumab-treated patients with MS, who are at high risk of PML, brain MRI screening using a protocol that includes FLAIR (fluidattenuated inversion recovery), T2-weighted and diffusion -weighted imaging is recommended.
Croatian: Za bolesnike s MS-om koji su liječeni natalizumabom, a koji imaju visoki rizik od PML-a, preporučuje se skeniranje mozga MR-om upotrebom protokola koji uključuje FLAIR, T2 mjereno snimanje i difuzijski mjereno snimanje.
English: A mock-up of the updated physician information and management guideline can be found annexed to the RMP.
Croatian: Nacrt ažurirane Informacije za liječnike i Smjernica za liječenje može se naći u prilogu plana upravljanja rizikom.
English: The Committee, as a consequence, recommended the variation to the terms of the marketing authorisation for Tysabri.
Croatian: Povjerenstvo je slijedom toga preporučilo promjene u uvjetima za dobivanje odobrenja za stavljanje na tržište lijeka Tysabri.
English: Anti-JCV antibody ELISA
Croatian: Test na anti-JCV protutijela ELISA
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Tysabri.
Croatian: CHMP stoga preporučuje promjene u uvjetima za dobivanje odobrenja za stavljanje na tržište lijeka Tysabri.
English: MRI is considered to be a sensitive method to identify even small and asymptomatic PML lesions.
Croatian: MR se smatra osjetljivom metodom kojom se mogu otkriti čak i najmanje i asimptomatske lezije PML-a.
English: Anti-JCV antibody testing
Croatian: Ispitivanje anti-JCV protutijela
English: In view of all of the above, the PRAC concluded that the benefit-risk balance of Tysabri remains favourable subject to amendments to the product information and additional risk minimisation measures as described below.
Croatian: S obzirom na sve prethodno navedeno, PRAC je zaključio da omjer koristi i rizika za lijek Tysabri ostaje povoljan pod uvjetom da se uvedu izmjene u informacije o lijeku i dodatne mjere svođenja rizika na najmanju moguću mjeru kao što je u nastavku navedeno.
English: Therefore a number of risk minimisation measures in relation to PML are in place for Tysabri.
Croatian: Stoga za lijek Tysabri postoji niz mjera za smanjivanje rizika s obzirom na PML.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Tysabri remains favourable subject to the amendments to the product information described above.
Croatian: CHMP slijedom toga zaključuje da omjer koristi i rizika lijeka Tysabri ostaje povoljan pod uvjetom da se uvedu prethodno opisane izmjene u informacije o lijeku.
English: In view of the above, the Committee considered that the benefit-risk balance of Tysabri remains favourable subject to the agreed amendments to the product information and additional risk minimisation measures.
Croatian: S obzirom na sve prethodno navedeno, Povjerenstvo je zaključilo da omjer koristi i rizika ostaje povoljan pod uvjetom da se uvedu dogovorene izmjene u informacije o lijeku i dodatne mjere minimizacije rizika.
English: Since the auhtorisation of natalizumab, three main risk factors for PML have been identified:
Croatian: Utvrđena su tri glavna čimbenika rizika od odobrenja natalizumaba:
English: It must also not be used together with certain medicines such as:
Croatian: Također se ne smije uzimati s određenim lijekovima kao što su:
English: A negative test result means that the virus was not found.
Croatian: Negativan nalaz znači da virus nije pronađen.
English: Further information on Maviret can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Maviret.
Croatian: Više informacija o lijeku Maviret nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Maviret.
English: The recommended dose is three tablets once a day, with food, for 8, 12 or 16 weeks.
Croatian: Preporučena je doza tri tablete jedanput na dan s hranom, tijekom 8, 12 ili 16 tjedana.
English: Based on data available in adults, it is expected that Maviret is also effective in children with genotypes 5 and 6.
Croatian: Na temelju podataka dostupnih za odrasle, očekuje se da je Maviret učinkovit u djece s genotipovima 5 i 6.
English: Maviret received a marketing authorisation valid throughout the EU on 26 July 2017.
Croatian: Lijek Maviret dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 26. srpnja 2017.
English: Maviret (glecaprevir / pibrentasvir)
Croatian: Maviret (glekaprevir / pibrentasvir)
English: The medicine's effectiveness in clearing genotype 3 was slightly lower than for other genotypes (95%).
Croatian: Učinkovitost lijeka u čišćenju genotipa 3 pokazala se nešto manjom nego kod drugih genotipova (95 %).
English: This overview was last updated in 03-2019.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 3. 2019.
English: What measures are being taken to ensure the safe and effective use of Maviret?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Maviret?
English: Other information about Maviret
Croatian: Ostale informacije o lijeku Maviret
English: What is Maviret and what is it used for?
Croatian: Što je Maviret i za što se primjenjuje?
English: Results were similar for genotypes 2 and 4-6.
Croatian: Nalazi su slični i za genotip 2 te genotipove od 4 do 6.
English: The duration of treatment depends on whether patients have liver cirrhosis (scarring of the liver) or whether they have received previous treatments with pegylated interferon and ribavirin, with or without sofosbuvir, or sofosbuvir and ribavirin.
Croatian: Trajanje liječenja ovisi tome imaju li bolesnici cirozu jetre (ožiljke na jetri) ili jesu li se prethodno liječili pegiliranim interferonom i ribavirinom, sa sofosbuvirom ili bez njega, ili sofosbuvirom i ribavirinom.
English: In addition, results showed that the way the medicine was absorbed, modified and removed from the body was similar to that in adults.
Croatian: Osim toga, nalazi su pokazali da se lijek apsorbira, modificira i uklanja iz tijela slično kao i u odraslih osoba.
English: The fact that Maviret can be given without ribavirin and without dose adjustments in patients with severe kidney problems is a further advantage in comparison with similar medicines.
Croatian: Činjenica da se Maviret može davati bez ribavirina i bez prilagodbe doze za bolesnike s teškim bubrežnim problemima dodatna je prednost u usporedbi sa sličnim lijekovima.
English: The most common side effects with Maviret (which may affect more than 1 in 10 people) are headache and tiredness.
Croatian: Najčešće nuspojave lijeka Maviret (koje se mogu javiti u više od 1 na 10 osoba) su glavobolja i umor.
English: The European Medicines Agency therefore decided that Maviret'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 Maviret nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: What are the risks associated with Maviret?
Croatian: Koji su rizici povezani s lijekom Maviret?
English: Maviret must not be used in patients with severely reduced liver function.
Croatian: Maviret ne smiju uzimati bolesnici sa znatno smanjenom jetrenom funkcijom.
English: Side effects reported with Maviret are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Maviret pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Maviret has been shown to be highly effective in clearing the hepatitis C virus from the blood, particularly in patients who have not been treated previously or who do not have cirrhosis.
Croatian: Utvrđeno je da je Maviret vrlo učinkovit u čišćenju virusa hepatitisa C iz krvi, posebno kod osoba koje prethodno nisu primale terapiju ili koje nemaju cirozu.
English: With regard to its safety, Maviret's pattern of side effects raises no particular concern.
Croatian: S obzirom na njegovu sigurnost, nuspojave lijeka Maviret ne izazivaju posebnu zabrinutost.
English: As for all medicines, data on the use of Maviret are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Maviret kontinuirano se prate.
English: Glecaprevir blocks the action of a protein called NS3/4A protease, while pibrentasvir blocks a protein called NS5A.
Croatian: Glekaprevir inhibira djelovanje proteina proteaze NS3/4A, dok pibrentasvir inhibira protein NS5A.
English: • rifampicin (antibiotic usually used to treat tuberculosis);
Croatian: • rifampicin (antibiotik koji se obično primjenjuje za liječenje tuberkuloze);
English: There are 6 varieties (genotypes) of the hepatitis C virus and Maviret has been shown to be effective at clearing all genotypes from the blood.
Croatian: Postoji šest tipova (genotipova) virusa hepatitisa C i pokazalo se da Maviret učinkovito čisti sve genotipove iz krvi.
English: An overview of Maviret and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Maviret i zašto je odobren u EU-u
English: Maviret is available as tablets that contain 100 mg glecaprevir and 40 mg pibrentasvir.
Croatian: Maviret je dostupan u obliku tableta koje sadržavaju 100 mg glekaprevira i 40 mg pibrentasvira.
English: • carbamazepine, phenobarbital, phenytoin, primidone (medicines for epilepsy);
Croatian: • karbamazepin, fenobarbital, fenitoin, primidon (lijekovi za liječenje epilepsije);
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Maviret 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 Maviret nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Why is Maviret authorised in the EU?
Croatian: Zašto je lijek Maviret odobren u EU-u?
English: In a study in 47 children aged between 12 and 18 years with genotypes 1 to 4 and without cirrhosis, all patients tested negative for the virus after 12 weeks of treatment.
Croatian: U ispitivanju kojim je bilo obuhvaćeno 47 djece između 12 i 18 godina bez ciroze, s genotipovima od 1 do 4, svi su pacijenti imali negativne nalaze na virus nakon 12 tjedana liječenja.
English: Maviret is an antiviral medicine used to treat adults and adolescents aged 12 years and older with chronic (long-term) hepatitis C, an infectious disease that affects the liver, which is caused by the hepatitis C virus.
Croatian: Maviret je protuvirusni lijek koji se primjenjuje u odraslih osoba i adolescenata u dobi od 12 godina i starijih za liječenje kroničnog (dugotrajnog) hepatitisa C, zarazne bolesti koja zahvaća jetru, a uzrokuje ju virus hepatitisa C.
English: This study is being carried out in light of data suggesting that patients treated with medicines belonging to the same class as Maviret and who have had liver cancer could be at risk of their cancer returning early.
Croatian: To ispitivanje provodi se s obzirom na podatke koji upućuju na to da bi liječenje lijekovima koji pripadaju istom razredu kao Maviret moglo osobe koje su bolovale od raka jetre izložiti opasnosti od ranog povratka raka.
English: • atorvastatin, simvastatin (medicines for lowering cholesterol levels in the blood);
Croatian: • atorvastatin, simvastatin (lijekovi za smanjenje razine kolesterola u krvi);
English: In 8 main studies involving over 2,300 adults with hepatitis C, 99% of non-cirrhotic patients with genotype 1, the most common genotype, tested negative for the virus after 8 weeks of Maviret treatment and 97% cirrhotic patients were negative after 12 weeks.
Croatian: U osam glavnih ispitivanja u koje je bilo uključeno više od 2 300 odraslih osoba oboljelih od hepatitisa C, nalazi 99 % osoba bez ciroze s genotipom 1, koji je najučestaliji genotip, bili su negativni na virus nakon osam tjedana liječenja lijekom Maviret, a nalazi 97 % osoba s cirozom bili su negativni na virus nakon 12 tjedana.
English: By blocking these proteins, Maviret stops the hepatitis C virus from multiplying and infecting new cells.
Croatian: Inhibirajući te proteine Maviret zaustavlja umnožavanje virusa hepatitisa C i inficiranje novih stanica.
English: How does Maviret work?
Croatian: Kako djeluje Maviret?
English: For more information about using Maviret, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Maviret pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The company that markets Maviret will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Maviret.
Croatian: Tvrtka koja stavlja lijek Maviret u promet provest će ispitivanje na bolesnicima koji su prije imali rak jetre kako bi se procijenio rizik od njegova vraćanja nakon liječenja protuvirusnim lijekom s izravnim djelovanjem kao što je Maviret.
English: Maviret can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in the management of patients with hepatitis C virus infection.
Croatian: Maviret se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju osoba oboljelih od infekcije virusom hepatitisa C.
English: The active substances in Maviret, glecaprevir and pibrentasvir, block two proteins essential for the hepatitis C virus to multiply.
Croatian: Djelatne tvari lijeka Maviret, glekaprevir i pibrentasvir, inhibiraju djelovanje dvaju proteina koji su neophodni za umnožavanje virusa hepatitisa C.
English: What benefits of Maviret have been shown in studies?
Croatian: Koje su koristi od lijeka Maviret utvrđene u ispitivanjima?
English: • ethinyl estradiol-containing products (such as contraceptive medicines);
Croatian: • lijekovi koji sadržavaju etinilestradiol (kao što su kontracepcijski lijekovi);
English: Maviret contains the active substances glecaprevir and pibrentasvir.
Croatian: Maviret sadržava djelatne tvari glekaprevir i pibrentasvir.
English: How is Maviret used?
Croatian: Kako se Maviret primjenjuje?
English: For the full list of restrictions and side effects with Maviret, see the package leaflet.
Croatian: Potpuni popis ograničenja i nuspojava zabilježenih pri primjeni lijeka Maviret potražite u uputi o lijeku.
English: A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275)………………………………...15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)........................15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)…………………………………………………………….….15 micrograms HA**
Croatian: A/Michigan/45/2015 (H1N1)pdm09 - sličan soj (A/Michigan/45/2015, NYMC X-275) ................................ 15 mikrograma HA** A/Hong Kong/4801/2014 (H3N2) - sličan soj (A/Hong Kong/4801/2014, NYMC X-263B) ........................... 15 mikrograma HA** B/Brisbane/60/2008 - sličan soj (B/Brisbane/60/2008, divlji tip) ............................................................ 15 mikrograma HA**
English: Per 0.1 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin
Croatian: Po dozi od 0,1 ml umnoženi na oplođenim kokošjim jajima od zdravih pilećih jata ** hemaglutinin
English: Influenza virus (inactivated, split) of the following strains*:
Croatian: --1 Virus influence (inaktiviran, fragmentiran) sljedećih sojeva*:
English: Administration
Croatian: Doza
English: MA (EU) number (Invented) name Strength Pharmaceutical
Croatian: Broj (EU) odobrenja
English: 09 November 2015
Croatian: 09. studeni 2015.
English: The safety and efficacy of dapagliflozin in children aged 0 to < 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost dapagliflozina u djece u dobi od 0 < 18 godina nisu još ustanovljene.
English: - feeling hungry, headache, change in vision
Croatian: - osjećaj gladi, glavobolja, promjene vida
English: - a change in your mood or feeling confused.
Croatian: - promjene raspoloženja ili osjećaj smetenosti.
English: - shaking, sweating, feeling very anxious, fast heart beat
Croatian: - drhtanje, znojenje, snažan osjećaj tjeskobe, ubrzani otkucaji srca
English: These are the signs of low blood sugar:
Croatian: Ovo su znakovi niske razine šećera u krvi:
English: Other medicines and Edistride
Croatian: Drugi lijekovi i Edistride
English: Contact your doctor as soon as possible if you have any of the following side effects: Very common (may affect more than 1 in 10 people)
Croatian: Što prije obavijestite liječnika ako se pojavi bilo koja od navedenih nuspojava: Vrlo česte (mogu se javiti u više od 1 na 10 osoba)
English: A meta-analysis of cardiovascular events in the clinical program was performed.
Croatian: Provedena je metaanaliza kardiovaskularnih događaja u kliničkom programu.
English: Fifty-one percent (51 %) of the subjects were men, 84 % were White, 9 % were Asian, 3 % were Black and 4 % were of other racial groups.
Croatian: Među ispitanicima je bilo 51% muškaraca, 84% bijelaca, 9% azijskog podrijetla, 3% crnaca i 4% pripadnika drugih rasnih skupina.
English: • if you are 75 years old or older, you should not start taking Edistride.
Croatian: • ako imate 75 ili više godina, ne smijete početi uzimati lijek Edistride.
English: • if you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking Edistride.
Croatian: • ako uzimate neki drugi lijek za šećernu bolest koji sadrži “pioglitazon”, ne smijete početi uzimati lijek Edistride.
English: Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italy
Croatian: Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italija
English: More information is given below in Other medicines and Edistride.
Croatian: Više informacija možete pronaći niže u dijelu Drugi lijekovi i Edistride.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Edistride, and during treatment:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Edistride i tijekom liječenja:
English: What Edistride looks like and contents of the pack
Croatian: Kako Edistride izgleda i sadržaj pakiranja
English: Check with your doctor, phamacist or nurse if you are not sure.
Croatian: Provjerite s liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni.
English: Patients with baseline HbA1c ≥ 9 %
Croatian: Bolesnici s početnom HbA1c ≥ 9%
English: Stop taking Edistride and see a doctor as soon as possible if you notice any of the following serious side effects:
Croatian: Prestanite uzimati lijek Edistride i što prije se javite liječniku ako se pojavi bilo koja od navedenih ozbiljnih nuspojava:
English: • Edistride is used if your diabetes cannot be controlled with other medicines for diabetes, diet and exercise.
Croatian: • Edistride se primjenjuje ako se šećerna bolest ne može kontrolirati drugim lijekovima za liječenje šećerne bolesti, dijetom i tjelovježbom.
English: Edistride is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
Croatian: Edistride je indicirana u odraslih u dobi od 18 i više godina sa šećernom bolešću tipa 2 za poboljšanje regulacije glikemije kao:
English: Edistride is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (aged 18 years and older).
Croatian: Edistride se primjenjuje za liječenje jedne vrste šećerne bolesti koja se naziva "šećerna bolest tipa 2" u odraslih bolesnika (u dobi od 18 ili više godina).