FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies showed that Ocrevus was more effective than interferon beta-1a at reducing the number of relapses in patients with relapsing forms of multiple sclerosis.
Croatian: Ispitivanja su pokazala da je lijek Ocrevus djelotvorniji od interferona beta-1a u smanjivanju broja relapsa u bolesnika s relapsirajućim oblicima multiple skleroze.
English: Studies have shown that Ocrevus is effective at reducing the number of relapses and it can also reduce the worsening of symptoms in some patients.
Croatian: Ispitivanja su pokazala da je lijek Ocrevus učinkovit u smanjivanju broja relapsa te da također može ublažiti pogoršanje simptoma u nekih bolesnika.
English: Ocrevus is given as an infusion (drip) into a vein.
Croatian: Ocrevus se primjenjuje intravenskom infuzijom (drip).
English: For more information about treatment with Ocrevus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Ocrevus pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Ocrevus treatment also provided some benefit in patients with primary progressive multiple sclerosis, a condition for which treatments are urgently needed.
Croatian: Određena korist od liječenja lijekom Ocrevus također je zabilježena u bolesnika s primarno progresivnom multiplom sklerozom, stanjem koje treba hitno liječiti.
English: How is Ocrevus used?
Croatian: Kako se Ocrevus koristi?
English: What benefits of Ocrevus have been shown in studies?
Croatian: Koje su koristi od lijeka Ocrevus utvrđene u ispitivanjima?
English: For practical information about using Ocrevus, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Ocrevus bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: How does Ocrevus work?
Croatian: Kako djeluje Ocrevus?
English: Ocrevus contains the active substance ocrelizumab.
Croatian: Ocrevus sadrži djelatnu tvar okrelizumab.
English: • adults with relapsing forms of multiple sclerosis (RMS), where the patient has flare-ups (relapses)
Croatian: • odrasle osobe s relapsirajućim oblicima multiple skleroze (RMS), kada bolesnik ima pogoršanja simptoma (relapse) nakon kojih slijede razdoblja s blažim simptomima ili bez njih;
English: For the full list of side effects reported with Ocrevus, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih prilikom primjene lijeka Ocrevus potražite u uputi o lijeku.
English: Older patients (≥ 65 years old)
Croatian: Stariji bolesnici (≥ 65 godina)
English: Safety data are based on literature (mainly retrospective studies).
Croatian: Podaci o sigurnosti se temelje na literaturi (uglavnom retrospektivna ispitivanja).
English: France Tel: + 33 1 40 33 93 14
Croatian: Tel: + 33 1 40 33 93 14
English: After opening: 1 year.
Croatian: Nakon otvaranja: 1 godina.
English: For information on the product, please contact:
Croatian: Za informacije o lijeku molimo kontaktirajte:
English: There are also links to other websites about rare diseases and treatments.
Croatian: Tamo se također nalaze poveznice na druge stranice o rijetkim bolestima i liječenjima istih.
English: Ask your doctor for advice.
Croatian: Obratite se svom liječniku za savjet.
English: Overall, the disease-free interval was 7 months (2 to 16 months).
Croatian: Ukupno, razdoblje bez bolesti je bilo 7 mjeseci (2 do 16 mjeseci).
English: Tell your doctor immediately, who may decide to temporarily stop treatment.
Croatian: Obavijestite odmah svog liječnika koji može odlučiti privremeno prekinuti liječenje.
English: Date of first authorisation: 28 April 2004 Date of last renewal: 28 April 2009
Croatian: Datum posljednje obnove: 28. travnja 2009.
English: • Risk management plan (RMP)
Croatian: • Plan upravljanja rizikom (RMP) Nije primjenjivo.
English: 63800 COURNON D'AUVERGNE FRANCE
Croatian: 63800 COURNON D'AUVERGNE FRANCUSKA
English: Treatment should be initiated and followed by a suitably experienced specialist.
Croatian: Liječenje mora započeti i pratiti liječnik specijalist s odgovarajućim iskustvom.
English: If you take more Lysodren than you should
Croatian: Ako uzmete više Lysodrena nego što ste trebali
English: Its biochemical mechanism of action is unknown.
Croatian: Njegov biokemijski mehanizam djelovanja nije poznat.
English: These symptoms may reveal complications for which specific medication could be appropriate.
Croatian: Ovi simptomi mogu ukazati na komplikacije za koje mogu biti primjereni određeni lijekovi.
English: Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Croatian: Molimo obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).
Croatian: Za više informacija o testiranju uzoraka obratite se nositelju odobrenja za stavljanje lijeka u promet ili njegovom lokalnom predstavniku (vidjeti dio 7.).
English: Do not take a double dose to make up for the forgotten one.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: INSTRUCTIONS FOR USE
Croatian: UPUTE ZA UPORABU
English: If you are pregnant or planning to become pregnant, tell your doctor.
Croatian: Ako ste trudni ili planirate zatrudnjeti obratite se svom liječniku.
English: What Lysodren is and what it is used for
Croatian: Što je Lysodren i za što se koristi
English: Leucopoenia has been reported in 8 to 12 % of patients.
Croatian: Leukopenija je opisana u 8 do 12% bolesnika.
English: The target plasma concentration is usually reached within a period of 3 to 5 months.
Croatian: Ciljna koncentracija u plazmi obično se dostiže unutar razdoblja od 3 do 5 mjeseci.
English: After intravenous administration, 25% of the dose was excreted as metabolites within 24 hours.
Croatian: Nakon intravenske primjene, 25% doze se izlučuje kao metaboliti unutar 24 sata.
English: The name of my Doctor is: Phone: ……………………………….
Croatian: Telefon: ……………………………….
English: However, this result should be cautiously taken since the examination of the mitotane effects was not the primary endpoint of the study.
Croatian: Međutim, ovaj rezultat treba uzimati s oprezom jer ispitivanje učinaka mitotana nije bio primarni cilj ove studije.
English: There were recurrences in 40% of children; the survival rate at 5 years was 49%.
Croatian: U 40% djece bolest došlo je do povrata bolesti; petogodišnja stopa preživljenja je bila 49%.
English: Autoimmune hepatitis has been reported in 7 % of patients with no other information on mechanism.
Croatian: Autoimuni hepatitis je prijavljen u 7% bolesnika bez dodatnih informacija o mehanizmu nastanka.
English: Skin rashes which have been reported in 5 to 25 % of patients do not seem to be dose related.
Croatian: Kožni osipi opisani u 5 do 25% bolesnika ne čine se povezanim s dozom lijeka.
English: In terms of overall survival, four studies conclude that mitotane treatment does not increase the survival rate whereas five find an increase in the survival rate.
Croatian: U vezi s ukupnim preživljenjem, četiri ispitivanja zaključuju da liječenje mitotanom ne povećava stopu preživljenja dok pet ispitivanja pokazuju povećanje stope preživljenja.
English: Ambulatory patients should be warned not to drive or use machines.
Croatian: Ambulantne bolesnike treba upozoriti da ne upravljaju vozilima i da ne rade na strojevima.
English: Some of these effects (anorexia) may constitute the hallmark of initial central nervous system impairment.
Croatian: Neki od tih poremećaja (anoreksija) mogu biti znak početnog oštećenja središnjeg živčanog sustava.
English: Lysodren should be given to pregnant women only if clearly needed and if the clinical benefit clearly outweighs any potential risk to the foetus.
Croatian: Lysodren treba dati trudnicama samo ako je to jasno potrebno i ako je klinička korist jasno veća od mogućeg rizika za fetus.
English: A starting dose higher than 6 g/day is generally not recommended.
Croatian: Općenito se ne preporučuje početna doza viša od 6 g dnevno.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX23
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: ostali antineoplastici, ATK oznaka: L01XX23
English: Nervous system undesirable effects occur in approximately 40 % of patients.
Croatian: Nuspojave od strane živčanog sustava događaju se u oko 40% bolesnika.
English: 76-78, avenue du Midi
Croatian: CENTRE SPECIALITES PHARMACEUTIQUES 76-78, avenue du Midi
English: Tel: + 33 1 40 33 93 14 medinfo-rd@hra-pharma.com
Croatian: HRA Pharma Rare Diseases Tel: + 33 1 40 33 93 14 medinfo-rd@hra-pharma.com
English: This should be taken into account when interpreting the results of hormonal assays and may result in gynaecomastia.
Croatian: To treba uzeti u obzir kada se tumače rezultati određivanja hormona, a može rezultirati ginekomastijom.
English: More than 80 % of patients treated with mitotane have shown at least one type of undesirable effect.
Croatian: Više od 80% bolesnika liječenih mitotanom pokazalo je najmanje jednu vrstu nuspojava.
English: Your doctor may prescribe you some hormonal treatment (steroids) while you are taking Lysodren.
Croatian: Liječnik Vam može propisati liječenje određenim hormonima (steroidi) dok uzimate Lysodren.
English: Mitotane has not been studied in a comprehensive clinical development program.
Croatian: Mitotan nije ispitan u opsežnim programima kliničkog razvoja.
English: Animal studies with similar substances have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama sa sličnim tvarima pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: 2.800 04010 Sermoneta (Latina) Italy or
Croatian: Via del Murillo Km. 2.800 04010 Sermoneta (Latina) Italija ili
English: This medicine should not be handled by persons other than the patient and his/her caregivers, and especially not by pregnant women.
Croatian: Ovim lijekom ne smije rukovati nitko osim bolesnika i njegovog/njezinog njegovatelja, a osobito ne trudnice.
English: Lysodren is available in plastic bottles of 100 tablets.
Croatian: Lysodren je dostupan u plastičnim bočicama od 100 tableta.
English: Mitotane apparently causes increased formation of 6-betahydroxy cholesterol.
Croatian: Mitotan očigledno uzrokuje povećano stvaranje 6-beta-hidroksi kolesterola.
English: Opportunistic mycosis
Croatian: Oportunističke mikoze
English: Therefore, steroid replacement may be necessary in these patients.
Croatian: Stoga u tih bolesnika može biti potrebno nadomjestiti steroidne hormone.
English: Prolonged bleeding time appears a frequent finding (90 %): although the exact mechanism of such an effect is unknown and its relation with mitotane or with the underlying disease is uncertain, it should be taken into account when surgery is considered.
Croatian: Produženo vrijeme krvarenja čini se čestim nalazom (90%): iako točan mehanizam takvog učinka i njegov odnos s mitotanom ili podležećom bolešću nije poznat, o njemu treba voditi računa kada se razmatra kirurški zahvat.
English: Indeed, neurologic toxicity has been associated with levels above 20 mg/l and therefore this threshold should not be reached.
Croatian: Neurološka toksičnost uistinu je povezana s razinama iznad 20 mg/l i stoga se taj prag ne smije dostići.
English: Pack size of 1 bottle.
Croatian: Veličina pakiranja: 1 bočica.
English: Paediatric patients The experience in children is limited.
Croatian: Pedijatrijska populacija Iskustvo primjene u djece je ograničeno.
English: Risk of adrenal insufficiency: All patients with non functional tumour and 75% of patients with functional tumour show signs of adrenal insufficiency.
Croatian: Rizik insuficijencije nadbubrežne žlijezde: Svi bolesnici s nefunkcionalnim tumorima i 75% bolesnika s funkcionalnim tumorima pokazuju znakove insuficijencije nadbubrežne žlijezde.
English: Dose adjustments, monitoring and discontinuation
Croatian: Prilagođavanje doze, praćenje i prekid primjene
English: Due to the prolonged half-life, significant serum concentrations may persist for weeks after cessation of therapy.
Croatian: Zbog produljenog poluvijeka, značajne koncentracije u serumu mogu se biti prisutne tjednima nakon prekida liječenja.
English: Bottle of 100 tablets.
Croatian: Bočica sa 100 tableta.
English: Concomitant use with spironolactone (see section 4.5)
Croatian: Istovremena uporaba sa spironolaktonom (vidjeti dio 4.5)
English: Women should be urged to seek medical advice if they experience gynaecological symptoms such as bleeding and/or pelvic pain.
Croatian: Žene je potrebno savjetovati da zatraže medicinski savjet ako primijete ginekološke simptome kao što su krvarenje i/ili bol u zdjelici.
English: In case of mild toxicity, the dose should be reduced until the maximum tolerated dose is attained.
Croatian: U slučaju blage toksičnosti dozu treba smanjiti do dostizanja maksimalne doze podnošenja.
English: After six months mitotane plasma levels were undetectable and the patient recovered clinically.
Croatian: Nakon 6 mjeseci razine mitotana u plazmi nije bilo moguće otkriti i bolesnik se klinički oporavio.
English: Mitotane plasma levels higher than 20 mg/l may be associated with severe undesirable effects and offer no further benefit in terms of efficacy.
Croatian: Razine mitotana u plazmi više od 20 mg/l mogu biti povezane s teškim neželjenim učincima i ne pružaju dodatnu korist u smislu djelotvornosti lijeka.
English: You must not use Lysodren with medicines containing spironolactone, often used as a diuretic for heart, liver or kidney diseases.
Croatian: Lysodren ne smijete koristiti s lijekovima koji sadrže spironolakton, koji se često koristi kao diuretik za bolesti srca, jetre ili bubrega.
English: Side effects may occur with certain frequencies, which are defined as follows: - very common: may affect more than 1 in 10 people - common: may affect up to 1 in 10 people - not known: frequency cannot be estimated from the available data
Croatian: Nuspojave se mogu javiti određenom učestalošću, što je definirano kako slijedi: - vrlo često: mogu zahvatiti više od 1 na 10 ljudi - često: mogu zahvatiti do 1 na 10 ljudi - nepoznato: učestalost se ne može procijeniti iz dostupnih podataka
English: The activity of liver enzymes (gamma-GT, aminotransferase, alkaline phosphatase) is commonly increased.
Croatian: Aktivnost jetrenih enzima (gama-GT, aminotransferaze, alkalne fosfataze) je često povećana.
English: If serious adverse reactions occur, such as neurotoxicity, treatment with mitotane may need to be temporarily interrupted.
Croatian: Ako se pojave ozbiljne nuspojave kao što je neurotoksičnost, liječenje mitotanom može biti potrebno privremeno prekinuti.
English: Frequency groupings are defined according to the following convention: 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), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Croatian: Skupine učestalosti su prikazane kako slijedi: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: You should swallow the tablets with a glass of water during meals containing fat-rich food.
Croatian: Tablete trebate progutati s čašom vode za vrijeme obroka koji sadrži hranu bogatu mastima.
English: For induction with cytochrome P450, see section 4.5.
Croatian: Za indukciju s citokromom P450, vidjeti dio 4.5.
English: Other medicines and Lysodren
Croatian: Drugi lijekovi i Lysodren
English: Liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], bilirubin levels) should be periodically monitored, especially during the first months of treatment or when it is necessary to increase the dose.
Croatian: Redovito treba provoditi testove jetrene funkcije (alanin transaminaza [ALT], aspartat transaminaza [AST], razine bilirubina), osobito tijekom prvih mjeseci liječenja ili kada je potrebno povećanje doze.
English: EXP After opening: 1 year
Croatian: Nakon otvaranja: 1 godina
English: Therefore, you should tell your doctor if you are using medicines containing any of the following active substances: - warfarin or other anticoagulants (blood thinners), used to prevent blood clots.
Croatian: Stoga obavijestite svog liječnika ako uzimate lijekove koji sadrže bilo koju od navedenih djelatnih tvari: - varfarin ili drugi antikoagulansi (lijekovi protiv zgrušavanja krvi) koji se koriste za sprječavanje nastanka krvnih ugrušaka.
English: Psychiatric disorders Confusion
Croatian: Psihijatrijski poremećaji Konfuzija
English: Non-clinical data on the general toxicity of mitotane is limited.
Croatian: Neklinički podaci o općoj toksičnosti mitotana su ograničeni.
English: If you accidentally miss a dose, just take the next dose as scheduled.
Croatian: U slučaju da propustite uzeti dozu lijeka, samo uzmite sljedeću dozu prema rasporedu.
English: Hypothyroidism and growth retardation may be also observed.
Croatian: Hipotiroidizam i retardacija rasta također mogu biti opaženi.
English: Store in the original packaging.
Croatian: Čuvati u originalnom pakiranju.
English: UNIQUE IDENTIFIER - 2D BARCODE
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: The usual starting dose for adults is 2 to 3 g (4 to 6 tablets) per day.
Croatian: Uobičajena početna doza za odrasle je 2 do 3 grama (4 do 6 tableta) dnevno.
English: The total daily dose may be divided in two or three doses according to patient's convenience.
Croatian: Ukupna dnevna doza može biti podijeljena u dvije ili tri doze kako odgovara bolesniku.
English: Clinical information comes mainly from a prospective trial (n= 24 patients) in children and adolescents aged at diagnosis from 5 months to 16 years (median age: 4 years) who had an unresectable primary tumour or who presented a tumour recurrence or a metastasic disease; most of the children (75%) presented with endocrine symptoms.
Croatian: Kliničke informacije uglavnom dolaze iz prospektivnih ispitivanja na djeci i adolescentima (n=24 bolesnika) u dobi od 5 mjeseci do 16 godina u trenutku postavljanja dijagnoze (medijan dobi: 4 godine) koji su imali inoperabilni primarni tumor ili rekurentni tumor ili metastatsku bolest; većina djece (75%) je imala endokrine simptome.
English: Mitotane plasma levels and the possible relationship with its efficacy were studied in the FIRM ACT trial, a randomized, prospective, controlled, open-label, multicenter, parallel-group study to compare the efficacy of etoposide, doxorubicin and cisplatin plus mitotane (EDP/M) to that of streptozotocin plus mitotane (Sz/M) as first-line treatment in 304 patients.
Croatian: Razine mitotana u plazmi i moguća povezanost s njegovom djelotvornošću proučavani su u ispitivanju FIRM ACT, randomiziranoj, prospektivnoj, kontroliranoj, otvorenoj, multicentričnoj studiji s paralelnim skupinama, kako bi se usporedila djelotvornost etopozida, doksorubicina i cisplatina plus mitotan (EDP/M) u odnosu na streptozotocin plus mitotan (Sz/M) kao prve linije liječenja na 304 bolesnika.
English: The experience in patients in this age group is very limited.
Croatian: Iskustva u bolesnika te dobne skupine su vrlo ograničena.
English: However, dichlorodiphenyltrichlorethane (DDT) and other polychlorinated biphenyl analogues are known to have deleterious effects on fertility, pregnancy and development, and mitotane could be expected to share these properties.
Croatian: Međutim, poznato je da diklordifeniltrikloretan (DDT) i drugi poliklorirani analozi bifenila imaju štetno djelovanje na plodnost, trudnoću i razvoj te je za očekivati da mitotan dijeli te značajke.
English: Tablets should be taken with a glass of water during meals containing fat-rich food (see section 4.5).
Croatian: Tabletu treba uzeti s čašom vode tijekom obroka hrane bogate mastima (vidjeti dio 4.5).
English: Always keep with you the Lysodren Patient Card included at the end of this leaflet.
Croatian: Uvijek imajte uz sebe Lysodren Karticu za bolesnika priloženu na kraju ove upute.
English: Although no specific information on pharmacodynamic interactions in the central nervous system is available, this should be borne in mind when co-prescribing medicinal products with central nervous system depressant action.
Croatian: Iako posebne informacije o farmakodinamičkim interakcijama u središnjem živčanom sustavu nisu dostupne o njima treba razmišljati kada se istovremeno propisuju lijekovi koji imaju sedativni učinak na središnji živčani sustav.
English: They are bisected on one side and impressed "BL" over "L1" on the other side.
Croatian: Tablete na jednoj strani imaju razdjelnu crtu, a na drugoj strani „BL” utisnuto iznad „L1”.
English: The genotoxic and carcinogenic potential of mitotane has not been investigated.
Croatian: Genotoksičnost i karcinogeni potencijal mitotana nisu ispitani.
English: If it is urgent to control Cushing's symptoms in highly symptomatic patients, higher starting doses between 4 - 6 g per day could be necessary and daily dose increased more rapidly (e.g. every week).
Croatian: Ako treba hitno kontrolirati simptome Cushingovog sindroma u bolesnika u kojih su simptomi jako izraženi, potrebne početne doze mogu biti više, između 4 - 6 g dnevno, a dnevna doza se povisuje češće (npr. svaki tjedan).
English: Other effects should be treated symptomatically.
Croatian: Ostale nuspojave treba simptomatski liječiti.
English: Liver enzymes levels normalize when the mitotane dose is decreased.
Croatian: Razine jetrenih enzima normaliziraju se kada se doza mitotana smanji.
English: Data on a limited number of exposed pregnancies indicate abnormalities on the adrenals of the foetus after exposure to mitotane.
Croatian: Podaci iz ograničenog broja izloženih trudnoća ukazuju na abnormalnosti nadbubrežnih žlijezda u fetusa nakon izlaganja mitotanu.
English: There are some data suggesting that mitotane plasma above 14 mg/l may result in enhanced efficacy (see section 5.1).
Croatian: Prema nekim podacima razine mitotana u plazmi iznad 14 mg/l mogu rezultirati povećanom djelotvornošću (vidjeti dio 5.1).
English: One case of encephalopathy has been observed in a paediatric patient five months after initiation of the treatment; this case was considered to be related to an increased mitotane plasma level of 34.5 mg/l.
Croatian: Jedan slučaj encefalopatije je opažen u pedijatrijskog bolesnika 5 mjeseci nakon početka liječenja; smatralo se da je taj slučaj bio povezan s povišenom razinom mitotana u plazmi od 34,5 mg/l.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU I UNUTARNJEM PAKIRANJU
English: Your doctor may start treatment at higher doses such as 4 to 6 g (8 to 12 tablets).
Croatian: Liječnik može započeti liječenje višim dozama, npr. sa 4 do 6 grama (8 do 12 tableta).
English: In two of the 3 patients, plasma levels of more than 14 mg/l were achieved within 15 days and in one of them levels above 20 mg/l were achieved within approximately 30 days.
Croatian: U dva od 3 bolesnika, razine više od 14 mg/l u plazmi postignute su unutar 15 dana, a u jednog od njih razine iznad 20 mg/l postignute su za oko 30 dana.
English: Like all medicines, Lysodren can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Dose may be reduced after 2 or 3 months according to the mitotane plasma levels or in case of serious toxicity.
Croatian: Nakon 2 do 3 mjeseca doza se može smanjiti sukladno razinama mitotana u plazmi ili u slučaju ozbiljne toksičnosti.