FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on Miglustat Gen.Orph can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/miglustat-genorph.
Croatian: Više informacija o lijeku Miglustat Gen.Orph nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/miglustat-genorph.
English: • adults (aged 18 years and above) with mild to moderate type-1 Gaucher disease.
Croatian: • odraslih (u dobi od 18 godina i starijih) s blagom do umjerenom Gaucherovom bolešću tipa 1.
English: Miglustat Gen.Orph received a marketing authorisation valid throughout the EU on 10 November 2017.
Croatian: Lijek Miglustat Gen.Orph dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 10. studenoga 2017.
English: The medicine can only be obtained with a prescription and treatment should be supervised by doctors who are experienced in the management of Gaucher disease.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje se mora provoditi pod nadzorom liječnika s iskustvom u liječenju Gaucherove bolesti.
English: • patients of all ages with Niemann-Pick type-C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
Croatian: • bolesnika svih dobi s Niemann-Pickovom bolešću tipa C, potencijalno smrtonosnom bolešću pri kojoj se glikosfingolipidi nakupljaju u stanicama mozga i drugdje u organizmu.
English: This means that Miglustat Gen.Orph contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Zavesca.
Croatian: To znači da Miglustat Gen.Orph sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Zavesca.
English: Miglustat Gen.Orph is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Croatian: Miglustat Gen.Orph primjenjuje se za liječenje neuroloških simptoma bolesti (simptoma koji utječu na mozak i živce).
English: Miglustat Gen.Orph is available as 100 mg capsules to be taken by mouth.
Croatian: Miglustat Gen.Orph dostupan je u obliku kapsula od 100 mg koje se uzimaju na usta.
English: Side effects reported with Miglustat Gen.Orph are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Miglustat Gen.Orph pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Miglustat Gen.Orph is used in patients who cannot receive the standard treatment of enzymereplacement therapy (ERT);
Croatian: Miglustat Gen.Orph koristi se samo u bolesnika koji ne mogu primiti standardnu enzimsku nadomjesnu terapiju (ERT);
English: Both diseases cause a build-up of fatty substances called glycosphingolipids in the body.
Croatian: Obje bolesti uzrokuju nakupljanje masnih tvari naziva glikosfingolipidi u organizmu.
English: Studies on the benefits and risks of the active substance in Gaucher disease have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Miglustat Gen.Orph.
Croatian: Ispitivanja koristi i rizika djelatne tvari u liječenju Gaucherove bolesti već su provedena s referentnim lijekom Zavesca i stoga ih nije potrebno ponavljati za Miglustat Gen.Orph.
English: Patients with this disease lack an enzyme called glucocerebrosidase, which results in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones.
Croatian: Bolesnicima s ovom bolešću nedostaje enzim naziva glukocerebrozidaza, koji rezultira glikosfingolipidom naziva glukozidceramid koji se nakuplja u različitim dijelovima organizma poput slezene, jetre i kostiju.
English: Because Miglustat Gen.Orph is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Miglustat Gen.Orph generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: What is Miglustat Gen.Orph and what is it used for?
Croatian: Što je Miglustat Gen.Orph i za što se koristi?
English: Miglustat Gen.Orph is used to treat the following patients:
Croatian: Miglustat Gen.Orph koristi se za liječenje sljedećih bolesnika:
English: Miglustat Gen.Orph is a ‘generic medicine'.
Croatian: Miglustat Gen.Orph je „generički lijek”.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Miglustat Gen.Orph 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 Miglustat Gen.Orph nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Miglustat Gen.Orph has been shown to have comparable quality and to be bioequivalent to Zavesca.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da lijek Miglustat Gen.Orph ima usporedivu kakvoću te da je bioekvivalentan s lijekom Zavesca.
English: Miglustat Gen.Orph is used to treat two inherited diseases that affect the way the body handles fats.
Croatian: Miglustat Gen.Orph primjenjuje se za liječenje dvije nasljedne bolesti koje utječu na način prerade masti u organizmu.
English: What measures are being taken to ensure the safe and effective use of Miglustat Gen.Orph?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Miglustat Gen.Orph?
English: For more information about using Miglustat Gen.Orph, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Miglustat Gen.Orph pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Miglustat Gen.Orph is intended for long-term use.
Croatian: Miglustat Gen.Orph namijenjen je za dugoročnu primjenu.
English: The active substance in Miglustat Gen.Orph, miglustat, blocks an enzyme called glucosylceramide synthase.
Croatian: Djelatna tvar u lijeku Miglustat Gen.Orph, miglustat, sprječava djelovanje enzima naziva glukozilceramid sintaza.
English: An overview of Miglustat Gen.Orph and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Miglustat Gen.Orph i zašto je odobren u EU-u
English: As for every medicine, the company provided studies on the quality of Miglustat Gen.Orph.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja kakvoće lijeka Miglustat Gen.Orph.
English: As for all medicines, data on the use of Miglustat Gen.Orph are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Miglustat Gen.Orph kontinuirano se prate.
English: Therefore, the Agency's view was that, as for Zavesca, the benefit of Miglustat Gen.Orph outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Miglustat Gen.Orph, kao i od lijeka Zavesca, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: Why is Miglustat Gen.Orph authorised in the EU?
Croatian: Zašto je lijek Miglustat Gen.Orph odobren u EU-u?
English: What are the benefits and risks of Miglustat Gen.Orph?
Croatian: Koje su koristi i rizici lijeka Miglustat Gen.Orph?
English: Other information about Miglustat Gen.Orph
Croatian: Ostale informacije o lijeku Miglustat Gen.Orph
English: How does Miglustat Gen.Orph work?
Croatian: Kako djeluje Miglustat Gen.Orph?
English: How has Miglustat Gen.Orph been studied?
Croatian: Kako se Miglustat Gen.Orph primjenjuje?
English: These can usually be treated by your doctor.
Croatian: Njih obično može liječiti Vaš liječnik.
English: The tablets should be swallowed with a glass of water.
Croatian: Tablete se moraju progutati s čašom vode.
English: - If you are taking Neomycin or other antibiotics.
Croatian: - ako uzimate neomicin ili druge antibiotike.
English: The nominal alpha value for this analysis was 0.0094.
Croatian: Nominalna alfa-vrijednost za ovu analizu iznosila je 0,0094.
English: This medicine may also affect the results of some blood tests.
Croatian: Ovaj lijek može utjecati i na rezultate nekih krvnih pretraga.
English: 20024 Garbagnate Milanese Italy
Croatian: 20024 Garbagnate Milanese Italija
English: Laboratory parameter, (in % of samples investigated)
Croatian: Laboratorijski parametar, (u % ispitanih uzoraka)
English: The absolute bioavailability is not known.
Croatian: Apsolutna biološka raspoloživost nije poznata.
English: If you have missed a dose, take it as soon as you remember.
Croatian: Ako ste zaboravili uzeti dozu lijeka, uzmite je čim se sjetite.
English: Doxorubicin/Irinotecan
Croatian: Doksorubicin/irinotekan
English: Always take this medicine exactly as your doctor has told you to.
Croatian: Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao Vaš liječnik.
English: Similar effects were not induced in adult dogs.
Croatian: U odraslih pasa slični učinci nisu izazvani.
English: Analyses of demographic data suggest that there is no relationship between pharmacokinetics and age (up to 65 years), gender or body weight.
Croatian: Analiza demografskih podataka upućuje na to da ne postoji međuodnos između farmakokinetike i dobi (do 65 godina), spola ili tjelesne težine.
English: Date of first authorisation: 19 July 2006 Date of latest renewal: 21 July 2011
Croatian: Datum prvog odobrenja: 19. srpnja 2006.
English: Dose reductions were only partially successful in alleviating adverse reactions.
Croatian: Sniženja doze bila su samo djelomično uspješna u ublažavanju nuspojava.
English: The safety and efficacy of Nexavar in children and adolescents aged < 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Nexavar u djece i adolescenata u dobi do 18 godina nisu još ustanovljene.
English: This booklet was last revised in {month YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {mjesec GGGG}.
English: Effects of other antibiotics have not been studied, but will likely depend on their ability to interfere with microorganisms with glucuronidase activity.
Croatian: Učinci drugih antibiotika nisu istraživani ali će vjerojatno ovisiti o njihovoj sposobnosti interferencije s mikroorganizmima koji iskazuju aktivnost glukuronidaze.
English: The median delivered cumulative radioactive iodine activity before enrollment was approximately 14.8 GBq.
Croatian: Medijan kumulativne aktivnosti primijenjenog radioaktivnog joda prije uključenja bio je približno 14,8 GBq.
English: Nexavar may reduce fertility in both men and women.
Croatian: Nexavar može smanjiti plodnost i u muškaraca i u žena.
English: What Nexavar is and what it is used for
Croatian: Što je Nexavar i za što se koristi
English: It is important to take this medicine at about the same times each day, so that there is a steady amount in the bloodstream.
Croatian: Ovaj lijek je važno uzimati svaki dan otprilike u isto vrijeme, tako da u krvi bude prisutna ista količina lijeka.
English: Other medicines and Nexavar
Croatian: Drugi lijekovi i Nexavar
English: In some cases this was not associated with apparent intra-abdominal tumour.
Croatian: U nekim slučajevima nije bilo povezanosti s jasnim intraabdominalnim tumorom.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder .
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Eight metabolites of sorafenib have been identified, of which five have been detected in plasma.
Croatian: Pronađeno je osam metabolita sorafeniba, od kojih pet u plazmi.
English: The PFS analysis was conducted at 342 events in 769 patients.
Croatian: Analiza PFS-a obuhvatila je 342 događaja u 769 bolesnika.
English: The study was stopped after a planned interim analysis of OS had crossed the prespecified efficacy boundary.
Croatian: Ispitivanje je prekinuto nakon što je planirana privremena analiza ukupnog preživljenja prešla granice prespecificirane djelotvornosti.
English: Gastrointestinal perforation is an uncommon event and has been reported in less than 1% of patients taking sorafenib.
Croatian: Gastrointestinalna perforacija je manje česti događaj i prijavljena je u manje od 1% bolesnika koji uzimaju sorafenib.
English: Such events are either uncommon or less frequent than uncommon.
Croatian: Takve su nuspojave ili manje česte ili rjeđe od manje čestih.
English: Therefore repeat evaluations of benefit and risk is recommended taking anti-tumour activity and tolerability into account.
Croatian: Stoga se preporučuje ponovna procjena koristi i rizika, pri čemu se uzima u obzir antitumorsko djelovanje i podnošljivost.
English: Furthermore, the sorafenib batch tested in the standard genotoxicity battery included 0.34 % PAPE.
Croatian: Nadalje, proizvodna serija sorafeniba, podvrgnuta standardnoj bateriji testova genotoksičnosti, sadržavala je 0,34% PAPE.
English: - If you are going to have surgery, or if you had an operation recently.
Croatian: - ako se spremate podvrći, ili ste nedavno bili podvrgnuti kirurškom zahvatu.
English: Secondary endpoints included overall survival (OS), tumour response rate and duration of response.
Croatian: Sekundarni ishodi ispitivanja uključivali su ukupno preživljenje (OS), stopu odgovora tumora i trajanje odgovora.
English: - The active substance is sorafenib.
Croatian: - Djelatna tvar je sorafenib.
English: The elimination half-life of sorafenib is approximately 25 - 48 hours.
Croatian: Poluvijek eliminacije sorafeniba iz organizma iznosi otprilike 25-48 sati.
English: This medicinal product could have potential risk for the environment.
Croatian: Ovaj lijek može predstavljati mogući rizik za okoliš.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data).
Croatian: Prema učestalosti, nuspojave su definirane kao: vrlo česte (≥ 1/10), česte (≥ 1/100 i < 1/10), manje česte (≥1/1000 i < 1/100), rijetke (≥1/10 000 i < 1/1000), nepoznate (ne može se procijeniti iz dostupnih podataka).
English: Baseline demographics and patient characteristics were well balanced for both treatment groups.
Croatian: Početni demografski podaci i značajke bolesnika bili su uravnoteženo raspodjeljeni u obje terapijske skupine.
English: - If you are taking irinotecan or are given docetaxel, which are also medicines for cancer.
Croatian: - ako uzimate irinotekan ili docetaksel, koji su također lijekovi kojima se liječi rak.
English: Nexavar might affect the way your wounds heal.
Croatian: Nexavar može utjecati na način cijeljenja Vaših rana.
English: No subject showed a QTcB or QTcF >500 msec during the post-treatment ECG monitoring (see section 4.4).
Croatian: Nijedan ispitanik nije pokazao QTcB ili QTcF > 500 ms tijekom EKG praćenja nakon liječenja (vidjeti dio 4.4).
English: Women of childbearing potential must use effective contraception during treatment.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja.
English: Blood pressure should be monitored regularly and treated, if required, in accordance with standard medical practice.
Croatian: Krvni tlak bolesnika valja redovito nadzirati i, po potrebi, liječiti u skladu sa standardnom medicinskom praksom.
English: Dermatological toxicities
Croatian: Dermatološka toksičnost
English: Monitoring of renal function should be considered.
Croatian: Potrebno je razmotriti nadziranje funkcije bubrega.
English: Majority of patients had papillary carcinoma (56.8%), followed by follicular (25.4%) and poorly differentiated carcinoma (9.6%).
Croatian: Bolesnici su većinom imali papilarni karcinom (56,8%), zatim folikularni (25,4%) i slabo diferencirani karcinom (9,6%).
English: Before initiating treatment, physicians are recommended to carefully evaluate the prognosis in the individual patient considering maximum lesion size (see section 5.1), symptoms related to the disease (see section 5.1) and progression rate.
Croatian: Prije početka liječenja, liječnicima se preporučuje da pažljivo procijene prognozu pojedinog bolesnika uzimajući u obzir najveću veličinu lezije (vidjeti dio 5.1), simptome povezane s bolešću (vidjeti dio 5.1) i brzinu progresije bolesti.
English: The risk of reduced plasma concentrations of sorafenib should be considered before starting a treatment course with antibiotics.
Croatian: Rizik od smanjenja koncentracije sorafeniba u plazmi treba uzeti u obzir prije početka liječenja antibioticima.
English: What Nexavar is and what it is used for What you need to know before you take Nexavar How to take Nexavar
Croatian: Što je Nexavar i za što se koristi Što morate znati prije nego počnete uzimati Nexavar Kako uzimati Nexavar
English: If you could become pregnant use adequate contraception during treatment.
Croatian: Ukoliko biste mogli zatrudnjeti, za trajanja liječenja koristite odgovarajuću kontracepciju.
English: Increased lipase and amylase were very commonly reported.
Croatian: Povećane razine lipaze i amilaze često su prijavljivane.
English: Sorafenib should not be used during pregnancy unless clearly necessary, after careful consideration of the needs of the mother and the risk to the foetus.
Croatian: Sorafenib se ne smije primjenjivati u trudnica osim ukoliko nije neophodno, nakon pomnog razmatranja potrebe majke za ovim lijekom, i rizika koje on predstavlja za plod.
English: What Nexavar looks like and contents of the pack
Croatian: Kako Nexavar izgleda i sadržaj pakiranja
English: - If you get chest pain or heart problems.
Croatian: - ako se jave bol u prsištu ili srčane tegobe.
English: The effect of Nexavar may be decreased.
Croatian: Učinak lijeka Nexavar može biti smanjen.
English: Because sorafenib could harm infant growth and development (see section 5.3), women must not breast-feed during sorafenib treatment.
Croatian: S obzirom da sorafenib može utjecati na rast i razvoj dojenčeta (vidjeti dio 5.3), žene ne smiju dojiti tijekom liječenja sorafenibom.
English: CI=Confidence interval, HR=Hazard ratio (sorafenib over placebo) * statistically significant as the p-value was below the prespecified O'Brien Fleming stopping boundary of 0.0077 ** independent radiological review
Croatian: CI = Interval pouzdanosti, HR (engl. hazard ratio) = omjer hazarda (sorafenib u odnosu na placebo) * statistički značajno jer je p-vrijednost ispod prethodno određene O'Brien Flemingove granice prekida od 0,0077 ** neovisna radiološka izvješća
English: There are no clinically relevant differences in pharmacokinetics between Caucasian and Asian subjects.
Croatian: Nema klinički značajnih razlika u farmakokinetici između bijelaca i azijata.
English: Decreases in blood glucose, in some cases clinically symptomatic and requiring hospitalization due to loss of consciousness, have been reported during sorafenib treatment.
Croatian: Smanjenje glukoze u krvi, u nekim slučajevima klinički simptomatsko i koje zahtijeva hospitalizaciju zbog gubitka svijesti, zabilježeno je tijekom liječenja sorafenibom.
English: Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Croatian: Liječenje treba nastaviti sve dok se očituje njegova klinička korist, ili dok se ne jave neprihvatljivi toksični učinci.
English: Efficacy Parameter
Croatian: Parametar Djelotvornosti
English: In animals, sorafenib and/or its metabolites were excreted in milk.
Croatian: U životinja sorafenib i/ili njegovi metaboliti izlučivali su se u mlijeko.
English: In this case your doctor will interrupt the treatment.
Croatian: Vaš će liječnik prekinuti liječenje.
English: Metastases were present in the lungs in 86%, lymph node in 51% and bone in 27% of the patients.
Croatian: Metastaze su bile prisutne u plućima kod 86%, u limfnim čvorovima kod 51% i u kostima kod 27% bolesnika.
English: Environmental Risk Assessment information is available in the EPAR of this medicine (see section 6.6).
Croatian: Informacije o procjeni rizika za okoliš dostupne su u Europskom javnom izvješću o ocjeni ovog lijeka (EPAR) (vidjeti dio 6.6).
English: Table 1: All adverse reactions reported in patients in multiple clinical trials or through postmarketing use
Croatian: Tablica 1: Sve nuspojave prijavljene u bolesnika u višestrukim kliničkim ispitivanjima ili tijekom uporabe nakon stavljanja lijeka u promet
English: An interim analysis (second interim analysis) for overall survival was conducted at 367 deaths in 903 patients.
Croatian: Privremena analiza ukupnog preživljenja, (druga privremena analiza), provedena je kod 367 smrtnih slučajeva, zabilježenih u 903 bolesnika.
English: Before initiating Nexavar, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka Nexavar potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: This indicates that sorafenib is neither an inhibitor nor an inducer of these cytochrome P450 isoenzymes.
Croatian: To ukazuje da sorafenib nije inhibitor ni induktor ovih citokrom P450 izoenzima.
English: It works by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancer cells growing.
Croatian: Djeluje na način da usporava rast stanica raka i prekida opskrbu krvlju koja omogućuje rast stanica raka.
English: Following progression, patients were allowed to receive open label sorafenib.
Croatian: Nakon progresije, bolesnici su smjeli otvoreno primati sorafenib.
English: They come in calendar packs of 112 tablets: four transparent blister packs of 28 tablets each.
Croatian: Dostupne su u kalendarskim pakiranjima od 112 tableta: 4 prozirna blistera s 28 tableta u svakom.
English: If you are taking warfarin or phenprocoumon, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding.
Croatian: Uzimate li varfarin ili fenprokumon, lijekove koji razrjeđuju krv ne bi li spriječili stvaranje krvnih ugrušaka, rizik od pojave krvarenja može se povećati.
English: Psychiatric disorders depression
Croatian: Psihijatrijski poremećaji depresija
English: Sorafenib has been shown to prolong the QT/QTc interval (see section 5.1), which may lead to an increased risk for ventricular arrhythmias.
Croatian: Pokazalo se da sorafenib produljuje QT/QTc interval (vidjeti dio 5.1), što može dovesti do povećanog rizika pojave ventrikularnih aritmija.
English: Severe hypocalcaemia should be corrected to prevent complications such as QT-prolongation or torsade de pointes (see section QT prolongation).
Croatian: Tešku hipokalcemiju potrebno je korigirati kako bi se spriječile komplikacije poput produljenja QT-intervala ili torsade de pointes (vidjeti dio o produljenju QT-intervala).
English: It is recommended that sorafenib should be administered without food or with a low or moderate fat meal.
Croatian: Preporučuje se primjena sorafeniba bez hrane ili s obrokom s niskim ili umjerenim sadržajem masnoća.
English: Table 3: Efficacy results from study 3 (study 100554) in hepatocellular carcinoma
Croatian: Tablica 3: Rezultati djelotvornosti iz ispitivanja 3 (ispitivanje 100554) kod hepatocelularnog karcinoma
English: If you forget to take Nexavar
Croatian: Ako ste zaboravili uzeti Nexavar
English: Concomitant treatment with sorafenib resulted in a 21 % increase in the AUC of doxorubicin.
Croatian: Istodobna primjena sa sorafenibom rezultirala je porastom AUC doksorubicina za 21%.
English: Nexavar can cause rashes and skin reactions, especially on the hands and feet.
Croatian: Nexavar može uzrokovati osip i reakcije kože, posebice na šakama i stopalima.
English: Sorafenib therapy should be discontinued (see section 4.8).
Croatian: Terapiju sorafenibom treba prekinuti (vidjeti dio 4.8).