FrancophonIA/ELRC3.0 huggingface dataset:
English: The warnings and precautions listed above also apply to children and adolescents.
Croatian: Upozorenja i mjere opreza navedena iznad također vrijede i za djecu i adolescente.
English: Taking Gilenya at the same time each day will help you remember when to take your medicine.
Croatian: Uzimanje Gilenye u isto vrijeme svakoga dana pomoći će Vam da se sjetite kada trebate uzeti lijek.
English: Other dosing regimens have not been approved.
Croatian: Drugi režimi doziranja nisu odobreni.
English: This increases your risk of developing cancers, in particular skin cancers.
Croatian: To povećava rizik od nastajanja raka, naročito raka kože.
English: • Signs and symptoms of infection;
Croatian: • Znakovi i simptomi infekcije
English: Symptoms of a relapse may disappear completely when the relapse is over, but some problems may remain.
Croatian: Simptomi relapsa mogu potpuno nestati kada relaps završi, ali neke poteškoće mogu i ostati.
English: Specific measures are also included in the Physician Information Pack.
Croatian: Specifične mjere su također uključene i u informativni paket za liječnike.
English: Infections could be serious and life-threatening.
Croatian: Infekcije bi mogle biti ozbiljne i opasne po život.
English: Your doctor may monitor your electrocardiogram continuously during that time.
Croatian: Liječnik će Vam možda kontinuirano pratiti elektrokardiogram u tom razdoblju.
English: Do not store above 25°C.
Croatian: Ne čuvati na temperaturi iznad 25˚C.
English: Never take a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Characteristics in specific groups of patients
Croatian: Karakteristike u specifičnim skupinama bolesnika
English: • regularly applying sunscreen with a high degree of UV protection.
Croatian: • redovito nanosite kremu za sunčanje s visokim stupnjem UV zaštite.
English: If you are a woman, your doctor will also recommend HPV screening.
Croatian: Ako ste žena, Vaš liječnik će preporučiti i probir na HPV.
English: Patients may be monitored with continuous ECG during the first 6 hours.
Croatian: Bolesnike se može pratiti kontinuiranim EKG-om tijekom prvih 6 sati.
English: The safety and efficacy of Gilenya in children aged below 10 years have not yet been established.
Croatian: Sigurnost i djelotvornost Gilenye u djece u mlađe od 10 godina nije još ustanovljena.
English: The possibility of recurrence of exceptionally high disease activity should be considered.
Croatian: Potrebno je uzeti u obzir mogućnost ponovnog javljanja iznimno visoke aktivnosti bolesti.
English: Detailed information of adverse reactions with no recommendation should not be included in this section.
Croatian: Detaljne informacije o nuspojavama bez preporuke ne bi trebale biti uključene u ovom dijelu.
English: Your ability to drive and use machines may be impaired during and potentially after this time period.
Croatian: Vaša sposobnost upravljanja vozilima i strojevima mogla bi za to vrijeme biti narušena, a potencijalno i nakon tog vremenskog razdoblja.
English: Gilenya will stay in your body for up to 2 months after you stop taking it.
Croatian: Gilenya će ostati u Vašem tijelu do 2 mjeseca nakon što je prestanete uzimati.
English: S1P4 could partially contribute to the effect but was not the main receptor responsible for the lymphoid depletion.
Croatian: S1P4 bi mogao djelomično doprinositi učinku, ali nije glavni receptor odgovoran za limfoidnu depleciju.
English: In this case, it is recommended to repeat the first-dose observation period.
Croatian: U ovom slučaju preporučuje se ponoviti razdoblje motrenja prve doze.
English: This is called demyelination.
Croatian: To se zove demijelinizacija.
English: To switch from teriflunomide, your doctor may advise you to wait for a certain time or to go through an accelerated elimination procedure.
Croatian: Da biste se prebacili s teriflunomida, liječnik Vam može savjetovati da pričekate određeno vrijeme ili da prođete kroz postupak ubrzane eliminacije.
English: • Corticosteroids, due to a possible added effect on the immune system.
Croatian: • Kortikosteroide, zbog mogućeg dodatnog učinka na imunološki sustav.
English: It must be repeated at suitable intervals.
Croatian: Test se mora ponavljati u odgovarajućim intervalima.
English: Otherwise, it may not be possible for the doctor to understand the results of the test, and for certain types of blood test your doctor may need to take more blood than usual.
Croatian: U suprotnom, Vaš liječnik možda neće moći razumjeti rezultate pretraga, a za određene vrste krvnih pretraga liječnik će možda morati uzeti više od uobičajene količine krvi.
English: Fingolimod is extensively distributed to body tissues with a volume of distribution of about 1,200260 litres.
Croatian: Fingolimod se ekstenzivno distribuira u tjelesna tkiva, s volumenom distribucije od približno 1200260 litara.
English: During routine MRI (in accordance with national and local recommendations), physicians should pay attention to PML suggestive lesions.
Croatian: Tijekom rutinskog MR-a (u skladu s nacionalnim i lokalnim preporukama) liječnici trebaju obratiti pozornost na lezije koje upućuju na PML.
English: Other medicines and Gilenya Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Gilenya Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: * p<0.05, ** p<0.001, compared to interferon beta-1a.
Croatian: * p<0,05, ** p<0,001, u usporedbi s interferonom beta-1a.
English: Specialised pre-natal monitoring will be performed.
Croatian: Provest će se specijalizirano prenatalno praćenje.
English: Posterior reversible encephalopathy syndrome (PRES)*
Croatian: Sindrom posteriorne reverzibilne encefalopatije (PRES)*
English: • Cases of seizure, including status epilepticus, have been reported.
Croatian: • Zabilježeni su slučajevi napadaja, uključujući status epilepticus.
English: The apparent absolute oral bioavailability is 93% (95% confidence interval: 79-111%).
Croatian: Apsolutna peroralna bioraspoloživost iznosi 93% (95%-tni interval pouzdanosti: 79-111%).
English: Expanded Disability Status Score (EDSS) was between 0 and 5.5.
Croatian: Expanded Disability Status Score) iznosio je između 0 i 5,5.
English: Frequencies were defined using 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: Učestalosti su definirane prema sljedećoj podjeli: 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: MRI findings may be apparent before clinical signs or symptoms.
Croatian: Nalazi MR-a mogu biti očigledni prije kliničkih znakova ili simptoma.
English: Gilenya can be taken with or without food.
Croatian: Gilenya se može uzimati s hranom ili bez nje.
English: Suspension of treatment during serious infections should be considered.
Croatian: Potrebno je razmotriti obustavljanje liječenja tijekom ozbiljnih infekcija.
English: The majority of patients were Tanner stage 2 or higher (94.4%) and were >40 kg (95.3%).
Croatian: Većina bolesnika je bila s Tanner stupnjem 2 ili višim i imali su >40 kg (95,3%).
English: Your white blood cell count (lymphocyte count) may also remain low during this time and the side effects described in this leaflet may still occur.
Croatian: Broj Vaših bijelih krvnih stanica (broj limfocita) također bi mogao ostati nizak za to vrijeme, a nuspojave opisane u ovoj uputi još uvijek bi se mogle pojaviti.
English: Clinical experience and pharmacokinetic information in patients aged above 65 years are limited.
Croatian: Kliničko iskustvo i farmakokinetičke informacije u bolesnika starijih od 65 su ograničeni.
English: The relationship of such events to Gilenya is uncertain.
Croatian: Povezanost tih događaja s Gilenyom nije sigurna.
English: Swallow each capsule whole
Croatian: Progutati svaku kapsulu cijelu
English: There are no data available for paediatric patients below 10 years old.
Croatian: Nema dostupnih podataka u pedijatrijskih bolesnika mlađih od 10 godina.
English: An ECG at 6 hours should also be performed and, in some circumstances, monitoring may involve an overnight stay;
Croatian: Također treba obaviti EKG nakon 6 sati, a u nekim okolnostima praćenje može uključivati i boravak preko noći;
English: Fingolimod absorption is slow (tmax of 12-16 hours) and extensive (≥85%).
Croatian: Apsorpcija fingolimoda je spora (tmax 12-16 sati) i opsežna (≥85%).
English: 84 capsules (3 packs of 28)
Croatian: 84 kapsula (3 pakiranja od 28)
English: Your doctor may decide to keep you under observation at the time you take the next dose.
Croatian: Liječnik će možda odlučiti staviti Vas na promatranje u vrijeme kada uzmete sljedeću dozu.
English: - Severe active infections, active chronic infections (hepatitis, tuberculosis).
Croatian: - Teške aktivne infekcije, aktivne kronične infekcije (hepatitis, tuberkuloza).
English: If these effects are pronounced, tell your doctor, because you may need treatment right away.
Croatian: Ako su ti učinci izraženi obratite se svom liječniku jer će Vam možda odmah biti potrebno liječenje.
English: - if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na fingolimod li neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: PML is a serious condition that may lead to severe disability or death.
Croatian: PML je ozbiljna bolest koja može dovesti do teške onesposobljenosti ili smrti.
English: After 12 months (month 36), 856 patients (93%) were still enrolled.
Croatian: Nakon 12 mjeseci (36. mjesec), 856 bolesnika (93%) bilo je još uvijek uključeno.
English: Inhaled salmeterol has also been shown to have a modest positive chronotropic effect.
Croatian: Pokazalo se i da inhalirani salmeterol ima skromni pozitivni kronotropni učinak.
English: Fingolimod has been studied in combination with atenolol and diltiazem.
Croatian: Fingolimod je bio ispitivan u kombinaciji s atenololom i diltiazemom.
English: Neutrophil count decreased * Not reported in Studies FREEDOMS, FREEDOMS II and TRANSFORMS.
Croatian: Smanjeni broj neutrofila * Nije zabilježeno u ispitivanjima FREEDOMS, FREEDOMS II i TRANSFORMS.
English: They usually did not require treatment and resolved within the first 24 hours on treatment.
Croatian: Obično nisu zahtijevali terapiju i povukli su se unutar prva 24 sata liječenja.
English: If myocardial ischaemia is suspected, it is recommended to seek advice from a cardiologist.
Croatian: Ako se sumnja na ishemiju miokarda, preporučuje se potražiti savjet kardiologa.
English: PML can only occur in the presence of a JCV infection.
Croatian: PML se može javiti samo u prisutnosti infekcije JCV-om.
English: The moles may itch, bleed or ulcerate - Convulsion, fits (more frequent in children and adolescents than in adults)
Croatian: Madeži mogu svrbjeti, krvariti ili ulcerirati - konvulzije, napadaji (češće u djece i adolescenata nego u odraslih)
English: Both studies included adult patients who had experienced ≥2 relapses in the prior 2 years or ≥1 relapse during the prior year.
Croatian: Oba su ispitivanja uključivala odrasle bolesnike koji su doživjeli ≥2 relapsa u prethodne 2 godine ili ≥1 relapsa tijekom prethodne godine.
English: Herpes viral infections Bronchitis
Croatian: Infekcije virusom herpesa Bronhitis
English: There are very limited data available in children between 10-12 years old (see sections 4.4, 4.8 and
Croatian: Dostupni su vrlo ograničeni podaci u djece između 10-12 godina starosti (vidjeti dijelove 4.4, 4.8 i
English: The following information is particularly important for children and adolescents and their caregivers: - Before you start Gilenya, your doctor will check your vaccination status.
Croatian: Sljedeće informacije posebno su važne za djecu i adolescente i njihove skrbnike: - Prije nego počnete uzimati Gilenyu, Vaš liječnik će provjeriti Vaš status cijepljenja.
English: • Patients must use effective contraception while taking GILENYA.
Croatian: • Bolesnice moraju koristiti učinkovitu kontracepciju dok uzimaju GILENYU.
English: Fingolimod blood clearance is 6.32.3 l/h, and the average apparent terminal half-life (t1/2) is 6-9 days.
Croatian: Klirens fingolimoda iz krvi iznosi 6,32,3 l/h, a prosječni prividni terminalni poluvijek (t1/2) je 6-9 dana.
English: As a result, you may feel dizzy or tired, or be consciously aware of your heartbeat, or your blood pressure may drop.
Croatian: Kao rezultat toga mogli biste osjećati omaglicu ili umor, ili svjesno osjećati otkucaje srca, ili Vam krvni tlak može pasti.
English: A third study targeting the same adult patient population was completed after registration of Gilenya.
Croatian: Treće ispitivanje koje je bilo usmjereno na istu odraslu bolesničku populaciju dovršeno je nakon registracije Gilenye.
English: Date of first authorisation: 17 March 2011 Date of latest renewal: 23 November 2015
Croatian: Datum posljednje obnove odobrenja: 23. studeni 2015.
English: Women of childbearing potential / Contraception in females
Croatian: Žene reproduktivne dobi / Kontracepcija u žena
English: This post-dose effect persists over the following days, although usually to a milder extent, and usually abates over the next weeks.
Croatian: Taj učinak nakon doze ustraje nekoliko dana, iako obično u blažem obliku, i obično se povuče u narednim tjednima.
English: You should limit your exposure to the sun and UV rays by:
Croatian: Nužno je da ograničite izlaganje suncu i UV zrakama na način da:
English: - if, in the last 6 months, you have had heart attack, angina, stroke or warning of a stroke or certain types of heart failure.
Croatian: - ako ste u posljednjih 6 mjeseci doživjeli srčani udar, anginu, moždani udar ili upozorenje pred udar ili neku vrstu srčanog zatajenja.
English: Caution is required in this subgroup population (see “Paediatric population” in section 4.8).
Croatian: Potreban je oprez u ovoj podskupini populacije (vidjeti „Pedijatrijska populacija“ u dijelu 4.8).
English: The majority of cases occurred within the first 3-4 months of therapy.
Croatian: Većina slučajeva dogodila se u roku od prva 3-4 mjeseca liječenja.
English: Gilenya can also cause an irregular heartbeat, especially after the first dose.
Croatian: Gilenya može uzrokovati i nepravilne otkucaje srca, osobito nakon prve doze.
English: There were, nevertheless, more neurological and psychiatric disorders observed in the study.
Croatian: Ipak, u ispitivanju je uočeno više neuroloških i psihijatrijskih poremećaja.
English: Depressed mood
Croatian: Depresivno raspoloženje
English: Talk to your doctor if you have any concerns.
Croatian: Porazgovarajte sa svojim liječnikom ako ste oko bilo čega zabrinuti.
English: This has generally been observed within 12 weeks after stopping fingolimod, but has also been reported up to 24 weeks after fingolimod discontinuation.
Croatian: To se općenito uočilo unutar 12 tjedana nakon prekida primjene fingolimoda, ali je također prijavljeno i do 24 tjedna nakon prekida primjene fingolimoda.
English: If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus).
Croatian: Ako nikad niste imali vodene kozice, liječnik će Vam provjeriti imunitet protiv virusa koji ih uzrokuje (virus varicella zoster).
English: Symptoms might also arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML.
Croatian: Mogu se pojaviti i simptomi kojih možda nećete biti svjesni, kao što su promjene u raspoloženju ili ponašanju, gubitak pamćenja, poteškoće s govorom i komunikacijom, koje će Vaš liječnik morati podrobnije istražiti da bi isključio PML.
English: PML is an opportunistic infection caused by John Cunningham virus (JCV), which may be fatal or result in severe disability.
Croatian: PML je oportunistička infekcija koju uzrokuje virus John Cunningham (JCV) i koja može biti smrtonosna ili imati za posljedicu tešku onesposobljenost.
English: In these cases your doctor will want you to undergo regular eye examinations in order to detect macular oedema.
Croatian: U tim slučajevima liječnik će htjeti da redovito obavljate očne preglede da bi se mogao otkriti makularni edem.
English: It should also be noted that a negative anti-JCV antibody test does not preclude the possibility of subsequent JCV infection.
Croatian: Valja također napomenuti da negativan test na anti-JCV antitijela ne isključuje mogućnost naknadne infekcije JCV-om.
English: Weight decreased*** Blood triglycerides increased
Croatian: Smanjena težina*** Povišeni trigliceridi u krvi
English: - Long-term safety data in the paediatric population are not available.
Croatian: - Podaci o sigurnosti dugoročne primjene u pedijatrijskih bolesnika nisu dostupni.
English: The desired effect of Gilenya treatment is to reduce the amount of white blood cells in your blood.
Croatian: Željeni učinak liječenja Gilenyom je smanjenje broja bijelih krvnih stanica u Vašoj krvi.
English: After 12 months (month 24), 882 patients (86%) were still enrolled.
Croatian: Nakon 12 mjeseci (24. mjesec), 882 bolesnika (86%) još uvijek je bilo uključeno.
English: The capsules should always be swallowed intact, without opening them.
Croatian: Kapsule je uvijek potrebno progutati cijele, bez da ih se otvara.
English: Approximately 15-20% of T lymphocytes have an effector memory phenotype, cells that are important for peripheral immune surveillance.
Croatian: Približno 15-20% T limfocita ima fenotip efektorskih memorijskih stanica, koje su važne za periferni imunološki nadzor.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA27
Croatian: Farmakoterapijska skupina: imunosupresivi, selektivni imunosupresivi, ATK oznaka: L04AA27
English: Gilenya does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS.
Croatian: Gilenya neće izliječiti MS, ali pomaže u smanjivanju broja relapsa i usporava napredovanje fizičke onesposobljenosti uzrokovane MS-om.
English: As this could potentially impair the efficacy, their co-administration should be used with caution.
Croatian: Budući da bi to potencijalno moglo narušiti djelotvornost, potreban je oprez kod njihove istodobne primjene.
English: Experience with Gilenya in elderly patients (over 65 years) is limited.
Croatian: Iskustvo s Gilenyom u starijih bolesnika (starijih od 65) je ograničeno.
English: Tell your doctor straight away if you experience any of these symptoms during your treatment with Gilenya, because it could be serious.
Croatian: Obratite se odmah svom liječniku ako osjetite bilo koji od tih simptoma tijekom liječenja Gilenyom, jer bi moglo biti ozbiljno.
English: Although the estimated risk appears to increase with cumulative exposure over time, an exact relationship with the duration of treatment is unknown.
Croatian: Mada se čini da procijenjeni rizik raste s kumulativnom izloženošću tijekom vremena, izravna veza s trajanjem liječenja je nepoznata.
English: Other vaccines may not work as well as usual if given during this period.
Croatian: Druga cjepiva možda neće djelovati kao inače ako se primaju tijekom ovog razdoblja.
English: If you develop problems with your skin, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis.
Croatian: Ako se jave problemi s kožom, liječnik Vas može uputiti dermatologu koji će nakon konzultacija možda odlučiti da morate dolaziti na redovite kontrole.
English: Severe exacerbation of disease after Gilenya discontinuation***
Croatian: Teška pogoršanja bolesti nakon prekida primjene Gilenye***
English: If you have questions about how long to take Gilenya, talk to your doctor or your pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo uzimati Gilenyu, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: A multidisciplinary consultation (i.e. infectious disease specialist) should be undertaken if re-initiation of fingolimod is warranted.
Croatian: Potrebno je provesti multidisciplinarne konzultacije (tj. sa specijalistom za zarazne bolesti) ako je opravdano ponovno započinjanje terapije fingolimodom.
English: However, if you have forgotten to take your treatment for up to 2 weeks, you can take the next dose as planned.
Croatian: Međutim, ako ste zaboravili terapiju uzimati do 2 tjedna, možete uzeti sljedeću dozu prema planu.
English: After 34 days, the recovery of the administered dose is 89%.
Croatian: Nakon 34 dana, izluči se 89% primijenjene doze.
English: If you need to receive a vaccine, seek your doctor's advice first.
Croatian: Ako trebate primiti cjepivo, prvo se obratite svom liječniku za savjet.
English: Not known (frequency cannot be estimated from the available data): - Peripheral swelling
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): - periferno oticanje
English: Switch from other treatments to Gilenya
Croatian: Prebacivanje s drugih liječenja na Gilenyu
English: When evaluating a patient with a suspected infection that could be serious, referral to a physician experienced in treating infections should be considered.
Croatian: Prilikom procjene bolesnika sa sumnjom na infekciju koja bi mogla biti ozbiljna, potrebno je razmotriti upućivanje liječniku koji je iskusan u liječenju infekcija.
English: Laboratory tests involving the use of circulating mononuclear cells require larger blood volumes due to reduction in the number of circulating lymphocytes.
Croatian: Za laboratorijske pretrage koje uključuju korištenje cirkulirajućih mononuklearnih stanica potrebna je veća količina krvi zbog smanjenja broja cirkulirajućih limfocita.
English: Gilenya may affect your liver function.
Croatian: Gilenya može utjecati na funkciju Vaše jetre.
English: Influenza Sinusitis
Croatian: Gripa Sinusitis
English: As Gilenya causes a slight elevation of blood pressure, your doctor may want to check your blood pressure regularly.
Croatian: Budući da Gilenya uzrokuje blago povišenje krvnog tlaka, liječnik će možda htjeti redovito kontrolirati Vaš krvni tlak.
English: Do not take Gilenya - if you have a lowered immune response (due to an immunodeficiency syndrome, a disease or to medicines that suppress the immune system).
Croatian: Nemojte uzimati Gilenyu - ako imate oslabljen imunološki odgovor (uzrokovan sindromom imunodeficijencije, bolešću ili lijekovima koji oslabljuju imunološki sustav).
English: The preclinical safety profile of fingolimod was assessed in mice, rats, dogs and monkeys.
Croatian: Neklinički sigurnosni profil fingolimoda bio je procijenjen kod miševa, štakora, pasa i majmuna.
English: Therefore, Gilenya may be taken without regard to meals (see section 4.2).
Croatian: Stoga se Gilenya može uzimati bez obzira na obroke (vidjeti dio 4.2).
English: • Four cases without identified confounders and with supportive chronology and clinical course with improvement/recovery following discontinuation of fingolimod.
Croatian: • Četiri slučaja bez identificiranih zbunjujućih faktora i s potpornom kronologijom i kliničkim tijekom s poboljšanjem/oporavkom nakon prestanka terapije fingolimodom.
English: and, - you must use effective contraception while taking Gilenya and for two months after you stop taking it to avoid becoming pregnant.
Croatian: i - morate koristiti učinkovitu kontracepciju dok uzimate Gilenyu i još dva mjeseca nakon što je prestanete uzimati kako biste izbjegli trudnoću.
English: In rats, F1 generation pup survival was decreased in the early postpartum period at doses that did not cause maternal toxicity.
Croatian: U štakora, preživljenje mladunčadi F1 generacije bilo je smanjeno u ranom poslijeporođajnom razdoblju, pri dozama koje nisu uzrokovale maternalnu toksičnost.