FrancophonIA/ELRC3.0 huggingface dataset:
English: Return of disease activity (rebound) after fingolimod discontinuation
Croatian: Povratak aktivnosti bolesti (povratni tj. „rebound“ učinak) nakon prekida primjene fingolimoda
English: Merkel cell carcinoma can also present as a firm painless nodule or mass.
Croatian: Karcinom Merkelovih stanica također se može pojaviti kao čvrsti bezbolni čvor ili masa.
English: Do not use this medicine after the expiry date which is stated on the carton and blister foil after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i foliji blistera iza oznake EXP.
English: Fingolimod was excreted in milk of treated animals during lactation at concentrations 2-fold to 3-fold higher than that found in maternal plasma.
Croatian: Fingolimod se izlučivao u mlijeku liječenih životinja tijekom laktacije u koncentracijama koje su za 2 do 3 puta više od onih koje se mogu naći u majčinoj plazmi.
English: If you forget to take Gilenya
Croatian: Ako ste zaboravili uzeti Gilenyu
English: Use of immunosuppressants soon after the discontinuation of Gilenya may lead to an additive effect on the immune system and caution is therefore indicated.
Croatian: Upotreba imunosupresiva ubrzo nakon prekida terapije Gilenyom mogla bi dovesti do aditivnog učinka na imunološki sustav pa je stoga potreban oprez.
English: If used during pregnancy, Gilenya can harm the unborn baby.
Croatian: Ako se koristi tijekom trudnoće, Gilenya može naškoditi nerođenom djetetu.
English: Fingolimod and fingolimod phosphate are not excreted intact in urine but are the major components in the faeces, with amounts representing less than 2.5% of the dose each.
Croatian: Fingolimod i fingolimodfosfat ne izlučuju se nepromijenjeni u mokraći nego su glavne komponente u fecesu, svaki u količini manjoj od 2,5% doze.
English: Gilenya has no or negligible influence on the ability to drive and use machines.
Croatian: Gilenya ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Your doctor will ask you to stay at the surgery or clinic for at least 6 hours, with hourly pulse and blood pressure measurements, after taking the first dose of Gilenya or after taking the first dose of 0.5 mg when you switch from a 0.25 mg daily dose, so that appropriate measures can be taken in the event of side effects that occur at the start of treatment.
Croatian: Liječnik će Vas zamoliti da ostanete u ambulanti ili klinici najmanje 6 sati, uz mjerenje pulsa i krvnog tlaka svakog sata, nakon uzimanja prve doze Gilenye ili nakon uzimanja prve doze od 0,5 mg kad se prebacujete s doze od 0,25 mg dnevno, kako bi se mogle poduzeti odgovarajuće mjere u slučaju nuspojava koje se javljaju na početku liječenja.
English: If this is the case, your doctor will delay the start of treatment with Gilenya until one month after the full course of vaccination is completed.
Croatian: Ako je to slučaj, liječnik će odgoditi početak liječenja Gilenyom dok ne prođe mjesec dana od dovršetka punog ciklusa cijepljenja.
English: Fingolimod phosphate binds at low nanomolar concentrations to sphingosine 1-phosphate (S1P) receptor 1 located on lymphocytes, and readily crosses the blood-brain barrier to bind to S1P receptor 1 located on neural cells in the central nervous system (CNS).
Croatian: Fingolimodfosfat se pri niskim nanomolarnim koncentracijama veže za sfingozin 1-fosfat (S1P) receptor 1 smješten na limfocitima te lako prelazi krvno-moždanu barijeru da bi se vezao za S1P receptor 1 smješten na živčanim stanicama u središnjem živčanom sustavu (SŽS).
English: T-wave inversion***
Croatian: Inverzija T-vala***
English: Food intake does not alter Cmax or exposure (AUC) of fingolimod.
Croatian: Unos hrane ne mijenja Cmax ili ekspoziciju (AUC) fingolimodu.
English: Use of Gilenya together with such medicines could intensify the effect on heartbeat in the first days after starting Gilenya.
Croatian: Upotreba Gilenye zajedno s takvim lijekovima mogla bi dodatno usporiti otkucaje srca u prvim danima nakon početka liječenja Gilenyom.
English: Animal studies and in vitro experiments indicate that fingolimod may also act via interaction with S1P receptors on neural cells.
Croatian: Ispitivanja provedena na životinjama i in vitro pokusi ukazuju da bi fingolimod mogao djelovati i putem interakcije s S1P receptorima na živčanim stanicama.
English: Second-degree atrioventricular block was detected in less than 0.2% adult patients on Gilenya 0.5 mg.
Croatian: Atrioventrikularni blok drugog stupnja bio je uočen u manje od 0,2% odraslih bolesnika koji su primali Gilenyu 0,5 mg.
English: An ophthalmological evaluation is therefore recommended at 3-4 months after treatment initiation.
Croatian: Stoga se preporučuje učiniti oftalmološki pregled 3-4 mjeseca nakon početka terapije.
English: If JCV testing is undertaken, it should be considered that the influence of lymphopenia on the accuracy of anti-JCV antibody testing has not been studied in fingolimod-treated patients.
Croatian: Ako se provodi testiranje na JCV, potrebno je imati u vidu da utjecaj limfopenije na točnost testiranja na anti-JCV antitijela nije bio ispitan u bolesnika liječenih fingolimodom.
English: When switching from a 0.25 mg to a 0.5 mg daily dose, it is recommended to repeat the same first dose monitoring as for treatment initiation.
Croatian: Pri prebacivanju s doze od 0,25 mg dnevno na 0,5 mg dnevno, preporučuje se ponoviti isti oblik praćenja prve doze kao i na početka liječenja.
English: If after the 6-hour period you have a very slow or decreasing heart rate, or if your electrocardiogram shows abnormalities, you may need to be monitored for a longer period (at least 2 more hours and possibly overnight) until these have resolved.
Croatian: Ako nakon 6-satnog razdoblja imate vrlo spore otkucaje srca ili se otkucaji usporavaju, ili ako Vaš elektrokardiogram pokazuje nepravilnosti, možda će Vas trebati motriti tijekom duljeg razdoblja (najmanje još 2 sata, a moguće i preko noći) dok se poremećaji ne povuku.
English: Assessments of CBC are also recommended periodically during treatment, at month 3 and at least yearly thereafter, and in case of signs of infection.
Croatian: Preporučuje se učiniti KKS i periodički tijekom liječenja, nakon 3 mjeseca i najmanje jednom godišnje nakon toga, te u slučaju znakova infekcije.
English: The negative chronotropic effect of Gilenya persists beyond 6 hours and progressively attenuates over subsequent days of treatment (see section 4.4 for details).
Croatian: Negativni kronotropni učinak Gilenye traje i nakon 6 sati i progresivno se ublažava tijekom narednih dana liječenja (vidjeti dio 4.4 za pojedinosti).
English: Annualised rate of the number of new or newly enlarging T2 lesions n=106
Croatian: Anualizirana stopa broja novih ili novo povećavajućih T2 lezija n=106
English: Fingolimod was teratogenic in the rat when given at doses of 0.1 mg/kg or higher.
Croatian: Fingolimod je bio teratogen u štakora u dozama od 0,1 mg/kg ili višim.
English: High blood pressure
Croatian: Visoki krvni tlak
English: Further analyses of clinical trial data demonstrate consistent treatment effects in highly active subgroups of relapsing remitting multiple sclerosis patients.
Croatian: Daljnje analize podataka iz kliničkih ispitivanja pokazuju dosljedne učinke terapije u visoko aktivnim podskupinama bolesnika s relapsno-remitirajućim oblikom multiple skleroze.
English: Patients should be instructed to report symptoms of infection up to 2 months after discontinuation of fingolimod.
Croatian: Bolesnike treba uputiti da prijave simptome infekcije u razdoblju do 2 mjeseca nakon prestanka primjene fingolimoda.
English: You should not breast-feed while you are taking Gilenya.
Croatian: Ne smijete dojiti dok uzimate Gilenyu.
English: >6 to 8 hours after first dose o If, at the 6-hour time point, the heart rate is at the lowest value following the first dose, extend heart rate monitoring for at least 2 more hours and until the heart rate increases again.
Croatian: >6 do 8 sati nakon prve doze o Ako je, nakon 6 sati, srčana frekvencija na najnižoj vrijednosti nakon prve doze, produljiti praćenje srčane frekvencije još najmanje 2 sata te dok se srčana frekvencija ponovno ne povisi.
English: If Gilenya is used during pregnancy, there is a risk of harm to the unborn baby.
Croatian: Ako se Gilenya koristi tijekom trudnoće, postoji rizik da se naškodi nerođenom djetetu.
English: The safety profile in paediatric patients is similar to that in adults and the warnings and precautions for adults therefore also apply to paediatric patients.
Croatian: Sigurnosni profil u pedijatrijskih bolesnika sličan je onom u odraslih i stoga upozorenja i mjere opreza za odrasle također vrijede i za pedijatrijske bolesnike.
English: In multiple sclerosis clinical studies first-degree atrioventricular block (prolonged PR interval on ECG) was detected after treatment initiation in adult and paediatric patients.
Croatian: U kliničkim ispitivanjima multiple skleroze, atrioventrikularni blok prvog stupnja (produljeni PR interval u elektrokardiogramu) bio je uočen nakon početka terapije u odraslih i pedijatrijskih bolesnika.
English: If you think you have an infection, have fever, feel like you have the flu, or have a headache accompanied by stiff neck, sensitivity to light, nausea, and/or confusion (these may be caused by a fungal infection and may be symptoms of meningitis), contact your doctor straight away, because it could be serious and life-threatening.
Croatian: Ako mislite da imate infekciju, ili imate vrućicu, osjećate se kao da imate gripu, ili imate glavobolju popraćenu ukočenim vratom, osjetljivošću na svjetlost, mučninom i/ili smetenošću (to može biti uzrokovano gljivičnom infekcijom te mogu biti simptomi meningitisa), odmah kontaktirajte svog liječnika jer se može raditi o ozbiljnom i po život opasnom stanju.
English: MRI may be considered as part of increased vigilance in patients considered at increased risk of PML.
Croatian: MR se može smatrati dijelom povećanog opreza u bolesnika za koje se smatra da su izloženi povećanom riziku od PML-a.
English: Since the initiation of Gilenya treatment is also associated with slowing of the heart rate (see also section 4.8, Bradyarrhythmia), concomitant use of these substances during Gilenya initiation may be associated with severe bradycardia and heart block.
Croatian: Budući da je započinjanje liječenja Gilenyom također povezano s usporavanjem srčane frekvencije (vidjeti također dio 4.8, Bradiaritmija), istodobna primjena tih lijekova tijekom započinjanja liječenja Gilenyom mogla bi biti povezana s teškom bradikardijom i srčanim blokom.
English: In multiple sclerosis clinical studies the concomitant treatment of relapses with a short course of corticosteroids was not associated with an increased rate of infection.
Croatian: U kliničkim ispitivanjima multiple skleroze istodobno liječenje relapsa kratkotrajnom primjenom kortikosteroida nije bilo povezano s povećanom stopom infekcija.
English: o Prompt diagnostic evaluation should be performed in patient with symptoms and signs consistent with cryptococcal meningitis; appropriate treatment, if diagnosed, should be initiated.
Croatian: Potrebno je provesti hitnu dijagnostičku evaluaciju u bolesnika sa simptomima i znakovima koji odgovaraju kriptokoknom meningitisu; u slučaju dijagnoze potrebno je započeti odgovarajuće liječenje.
English: Therefore, if you are a woman of childbearing potential: - before you start treatment with Gilenya your doctor will inform you about the risk to an unborn baby and ask you to do a pregnancy test in order to ensure that you are not pregnant,
Croatian: Stoga, ako ste žena reproduktivne dobi: - prije nego što započnete liječenje Gilenyom liječnik će Vas informirati o riziku za nerođeno dijete i zatražiti da napravite test na trudnoću, kako bi provjerio da niste trudni,
English: Interference with serological testing
Croatian: Utjecaj na serološke pretrage
English: Resumption of therapy will be dependent on whether or not another cause of liver injury is determined and on the benefits to patient of resuming therapy versus the risks of recurrence of liver dysfunction.
Croatian: Nastavak terapije ovisit će o tome je li utvrđen neki drugi uzrok oštećenja jetre ili ne te o koristi od nastavka terapije za bolesnika, naspram rizika od ponovne pojave disfunkcije jetre.
English: Animal studies have shown that this redistribution reduces the infiltration of pathogenic lymphocytes, including pro-inflammatory Th17 cells, into the CNS, where they would be involved in nerve inflammation and nervous tissue damage.
Croatian: Ispitivanja provedena na životinjama pokazala su da ova preraspodjela smanjuje infiltraciju patogenih limfocita, uključujući pro-upalne Th17 stanice u SŽS, gdje bi one bile uključene u razvoj upale živaca i oštećenje živčanog tkiva.
English: Rare cases of peripheral arterial occlusive disease occurred in patients treated with fingolimod at higher doses (1.25 mg).
Croatian: Pojavili su se rijetki slučajevi periferne arterijske okluzivne bolesti u bolesnika liječenih fingolimodom u višim dozama (1,25 mg).
English: The mechanism of action of bradycardia and vasoconstriction were also studied in vitro in guinea pigs and isolated rabbit aorta and coronary artery.
Croatian: Mehanizam djelovanja bradikardije i vazokonstrikcije ispitivan je također in vitro u zamoraca i izoliranoj aorti i koronarnoj arteriji kunića.
English: Before initiation of treatment, women of childbearing potential must be informed of this risk to the foetus, must have a negative pregnancy test and must use effective contraception during treatment and for 2 months after treatment discontinuation (see sections 4.3 and 4.6 and the information contained in the Physician Information Pack).
Croatian: Prije početka liječenja žene reproduktivne dobi moraju biti informirane o riziku za fetus, moraju imati negativan rezultat testa za trudnoću i moraju koristiti učinkovitu kontracepciju tijekom liječenja i 2 mjeseca nakon prestanka liječenja (vidjeti dijelove 4.3 i 4.6 te informacije koje sadrži informativni paket za liječnike).
English: For DLCO the reductions at month 24 were 3.3% for fingolimod 0.5 mg and 2.7% for placebo.
Croatian: Za DLCO, smanjenje u 24. mjesecu iznosilo je 3,3% za fingolimod 0,5 mg i 2,7% za placebo.
English: You must not use Gilenya together with such medicines as this could intensify the effect on the immune system (see also “Do not take Gilenya”).
Croatian: Ne smijete upotrebljavati Gilenyu zajedno s takvim lijekovima jer bi to moglo pojačati učinak na imunološki sustav (pogledajte također „Nemojte uzimati Gilenyu“).
English: Gilenya should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy (see section 5.2).
Croatian: Gilenyu treba primjenjivati s oprezom u bolesnika u dobi od 65 godina ili više, zbog nedostatnih podataka o sigurnosti i djelotvornosti (vidjeti dio 5.2).
English: Conduction abnormalities were typically transient and asymptomatic.
Croatian: Poremećaji provođenja obično su bili prolazni i asimptomatski.
English: Other strong CYP3A4 enzyme inducers, for example rifampicin, phenobarbital, phenytoin, efavirenz and St. John's Wort, may reduce the AUC of fingolimod and its metabolite at least to this extent.
Croatian: Drugi snažni induktori enzima CYP3A4, primjerice rifampicin, fenobarbital, fenitoin, efavirenz i gospina trava mogu smanjiti AUC fingolimoda i njegovog metabolita barem do te mjere.
English: The pregnancy-specific patient reminder card, to be provided to all patients, their parents (or legal representatives), and caregivers, as applicable.
Croatian: Kartica za bolesnice s podsjetnikom specifična za pitanje trudnoće koju je potrebno dati svim bolesnicama, njihovim roditeljima (ili pravnim zastupnicima) i skrbnicima, ako je primjenjivo.
English: Data from preclinical studies do not suggest that fingolimod would be associated with an increased risk of reduced fertility (see section 5.3).
Croatian: Podaci iz pretkliničkih ispitivanja ne ukazuju na to da bi fingolimod mogao biti povezan s povećanim rizikom od smanjene plodnosti (vidjeti dio 5.3).
English: Overall, 180 (84%) of patients completed the core phase on study drug (n=99 [92.5%] on fingolimod, 81 [75%] on interferon beta-1a).
Croatian: Sveukupno, 180 (84%) bolesnika dovršilo je osnovnu fazu s ispitivanim lijekom (n=99 [92,5%] s fingolimodom, 81 [75%] s interferonom beta-1a).
English: If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned (see section 4.4).
Croatian: Ako prekid liječenja traje kraće od navedenog, liječenje treba nastaviti sljedećom dozom prema planiranom rasporedu (vidjeti dio 4.4).
English: In the multiple sclerosis studies, clinically relevant effects on prolongation of the QTc-interval have not been observed but patients at risk for QT prolongation were not included in clinical studies.
Croatian: U ispitivanjima multiple skleroze, klinički značajni učinci na produljenje QTc-intervala nisu bili uočeni, ali bolesnici s rizikom od produljenja QT intervala nisu bili uključeni u klinička ispitivanja.
English: If discontinuation of fingolimod is deemed necessary, the possibility of recurrence of exceptionally high disease activity should be considered and patients should be monitored for relevant signs and symptoms and appropriate treatment initiated as required (see “Stopping therapy” below).
Croatian: Ako se smatra da je prekid liječenja fingolimodom neophodan, potrebno je uzeti u obzir mogućnost ponovnog javljanja iznimno visoke aktivnosti bolesti i bolesnike treba pratiti u pogledu relevantnih znakova i simptoma te po potrebi započeti odgovarajuće liječenje (vidjeti „Prekid terapije“ dolje).
English: Posterior reversible encephalopathy syndrome (PRES) A condition called posterior reversible encephalopathy syndrome (PRES) has been rarely reported in MS patients treated with Gilenya.
Croatian: Sindrom posteriorne reverzibilne encefalopatije (PRES) Bolest koja se naziva sindromom posteriorne reverzibilne encefalopatije (PRES) rijetko je zabilježena u bolesnika s MS-om liječenih Gilenyom.
English: Do not restart Gilenya after stopping it for more than two weeks without seeking advice from your doctor.
Croatian: Ne započinjite ponovno uzimati Gilenyu nakon što ste je prestali uzimati na više od dva tjedna ako prethodno niste zatražili savjet svog liječnika.
English: Multipack: 84 (3 packs of 28) hard capsules.
Croatian: Višestruko pakiranje: 84 (3 pakiranja od 28) tvrdih kapsula.
English: Although most patients did not require medical intervention, one patient on Gilenya 0.5 mg received isoprenaline for asymptomatic second-degree Mobitz I atrioventricular block.
Croatian: Iako kod većine bolesnika nije bila potrebna liječnička intervencija, jedan je bolesnik koji je uzimao Gilenyu 0,5 mg primio izoprenalin zbog asimptomatskog atrioventrikularnog bloka drugog stupnja tipa Mobitz I.
English: With continued daily dosing, the lymphocyte count continues to decrease over a two-week period, reaching a minimal count of approximately 500 cells/microlitre or approximately 30% of baseline.
Croatian: Uz nastavak svakodnevnog doziranja, broj limfocita nastavlja se smanjivati tijekom razdoblja od dva tjedna te se postiže minimalni broj od približno 500 stanica po mikrolitru ili približno 30% od početne vrijednosti.
English: Therefore, before initiation of treatment in women of childbearing potential, a negative pregnancy test result must be available and counselling should be provided regarding the serious risk to the foetus.
Croatian: Stoga, prije početka liječenja u žena reproduktivne dobi mora se imati negativan rezultat testa za trudnoću te je potrebno osigurati savjetovanje o ozbiljnom riziku za fetus.
English: Fingolimod is unlikely to interact with substances mainly cleared by the CYP450 enzymes or by substrates of the main transporter proteins.
Croatian: Malo je vjerojatno da bi fingolimod stupao u interakcije s lijekovima koji se uglavnom metaboliziraju putem enzima CYP450 ili sa supstratima glavnih transportnih proteina.
English: When switching patients from another disease modifying therapy to Gilenya, the half-life and mode of action of the other therapy must be considered in order to avoid an additive immune effect whilst at the same time minimising the risk of disease reactivation.
Croatian: Kada se bolesnici prebacuju s neke druge terapije koja modificira tijek bolesti na Gilenyu, moraju se razmotriti poluvijek i način djelovanja te druge terapije da bi se izbjegao aditivni imunološki učinak te istovremeno minimalizirao rizik od ponovne aktivacije bolesti.
English: Fingolimod should be stopped 2 months before planning a pregnancy (see section 4.4).
Croatian: Potrebno je prekinuti primjenu fingolimoda 2 mjeseca prije planiranja trudnoće (vidjeti dio 4.4).
English: At 40 mg, 5 of 6 subjects reported mild chest tightness or discomfort which was clinically consistent with small airway reactivity.
Croatian: Pri 40 mg, 5 od 6 ispitanika prijavilo je blago stezanje ili osjećaj nelagode u prsima, koja je bila klinički u skladu s reaktivnošću malih dišnih puteva.
English: - During pregnancy and in women of childbearing potential not using effective contraception (see sections 4.4 and 4.6).
Croatian: - Tijekom trudnoće i u žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju (vidjeti dijelove 4.4 i 4.6).
English: o Treatment initiation in patients with severe active infection should be delayed until the infection is resolved.
Croatian: o Početak liječenja u bolesnika s teškom aktivnom infekcijom treba odgoditi dok se infekcija ne povuče.
English: Immunosuppressive effects
Croatian: Imunosupresivni učinak
English: Fingolimod is eliminated by oxidative biotransformation catalysed mainly via CYP4F2 and possibly other isoenzymes and subsequent fatty acid-like degradation to inactive metabolites.
Croatian: Fingolimod se eliminira oksidativnom biotransformacijom kataliziranom uglavnom putem CYP4F2 i moguće drugim izoenzimima, a zatim degradacijom sličnoj onoj kod masnih kiselina u inaktivne metabolite.
English: • Patients will be informed by their doctor of the need for effective contraception while on treatment and for 2 months after discontinuation.
Croatian: • Bolesnice će informirati njihov liječnik o potrebi za učinkovitom kontracepcijom tijekom liječenja i 2 mjeseca nakon prekida liječenja.
English: Starting other therapies during this interval will result in concomitant exposure to fingolimod.
Croatian: Početak liječenja nekim drugim lijekom tijekom ovog razdoblja imat će za posljedicu istodobnu ekspoziciju fingolimodu.
English: Outcome results are shown in Table 4.
Croatian: Rezultati ishoda prikazani su u Tablici 4.
English: In subjects with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, and C), no change in fingolimod Cmax was observed, but fingolimod AUC was increased respectively by 12%, 44%, and 103%.
Croatian: U ispitanika s blagim, umjerenim ili teškim oštećenjem jetre (Child-Pugh stadij A, B, i C) nije bila zamijećena nikakva promjena u Cmax fingolimoda, ali AUC fingolimoda bio je povišen za 12%, 44%, odnosno 103%.
English: Vigilance for skin lesions is warranted and a medical evaluation of the skin is recommended at initiation, and then every 6 to 12 months taking into consideration clinical judgement.
Croatian: Potrebno je pomno pratiti pojavu kožnih lezija, te se preporučuje provesti pregled kože na početku uzimanja lijeka, a zatim svakih 6 do 12 mjeseci prema kliničkoj prosudbi.
English: Animal studies have shown reproductive toxicity including foetal loss and organ defects, notably persistent truncus arteriosus and ventricular septal defect (see section 5.3).
Croatian: Ispitivanja provedena na životinjama pokazala su reproduktivnu toksičnost, uključujući i gubitak fetusa i oštećenja organa, osobito perzistirajući truncus arteriosus i ventrikularni septalni defekt (vidjeti dio 5.3).
English: After the first dose, the decline in heart rate starts within one hour, and is maximal within 6 hours.
Croatian: Nakon prve doze, usporenje srčane frekvencije započinje u roku od jednog sata i doseže maksimum u roku od 6 sati.