FrancophonIA/ELRC3.0 huggingface dataset:
English: An accelerated elimination procedure as defined in the teriflunomide summary of product characteristics is recommended or alternatively washout period should not be shorter than 3.5 months.
Croatian: Preporučuje se postupak ubrzane eliminacije kako je definiran u sažetku opisa svojstava lijeka za teriflunomid, u suprotnom razdoblje ispiranja ne smije biti kraće od 3,5 mjeseca.
English: It was concluded that bradycardia could be mediated primarily by activation of inward-rectifying potassium channel or G-protein activated inwardly rectifying K
Croatian: Zaključeno je da bi bradikardija mogla biti posredovana prvenstveno aktivacijom ulazno-ispravljačkog kalijevog kanala (engl. inward-rectifying potassium channel) ili ulazno-ispravljačkog K
English: Additional PML cases have occurred in patients who had been treated previously with natalizumab, which has a known association with PML.
Croatian: Dodatni slučajevi PMLa su se pojavili u bolesnika koji su prethodno liječeni natalizumabom, koji ima već poznatu poveznicu s PML-om.
English: A core pharmacodynamic effect of Gilenya is a dose-dependent reduction of the peripheral lymphocyte count to 20-30% of baseline values.
Croatian: Ključni farmakodinamički učinak Gilenye je o dozi ovisno smanjenje broja perifernih limfocita na 20-30% od početnih vrijednosti.
English: The incidence of non-Hodgkin's lymphoma (B-cell and T-cell) cases was higher in clinical trials than expected in the general population.
Croatian: Incidencija slučajeva ne-Hodgkinovog limfoma (B-stanica i T-stanica) bila je veća u kliničkim ispitivanjima od očekivane incidencije u općoj populaciji.
English: The MAH shall ensure that in each Member State (MS) where GILENYA is marketed, all physicians who intend to prescribe GILENYA are provided with an updated Physician Information Pack, including:
Croatian: Nositelj odobrenja će osigurati da u svakoj državi članici u kojoj se GILENYA nalazi na tržištu, svi liječnici koji namjeravaju propisivati GILENYU dobiju ažurirani informativni paket za liječnike koji uključuje:
English: If you need to have any blood tests, tell the doctor that you are taking Gilenya.
Croatian: Ako trebate obaviti ikakve krvne pretrage, recite liječniku da uzimate Gilenyu.
English: To open: While pressing tab 1 firmly, pull on tab 2.
Croatian: Uputa za otvaranje: Čvrsto pritisnite karticu 1 i istodobno povucite karticu 2.
English: In MS inflammation destroys the protective sheath (called myelin) around the nerves in the CNS and stops the nerves from working properly.
Croatian: Kod MS-a upala uništava zaštitnu ovojnicu (koja se naziva mijelin) oko živaca u SŽS-u i sprječava živce da funkcioniraju kako treba.
English: Some patients presented with blurred vision or decreased visual acuity, but others were asymptomatic and diagnosed on routine ophthalmological examination.
Croatian: Neki su bolesnici imali zamućen vid ili smanjenu vidnu oštrinu, ali drugi su slučajevi bili asimptomatski i dijagnosticirani na redovitom oftalmološkom pregledu.
English: In case of T-wave inversion, the prescriber should ensure that there are no associated myocardial ischaemia signs or symptoms.
Croatian: U slučaju inverzije T-vala liječnik koji je propisao lijek treba provjeriti da nema povezanih znakova ili simptoma ishemije miokarda.
English: Progressive multifocal leukoencephalopathy (PML)** Cryptococcal infections** Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common:
Croatian: Progresivna multifokalna leukoencefalopatija (PML)** Kriptokokne infekcije** Dobroćudne, zloćudne i nespecificirane novotvorevine (uključujući ciste i polipe) Često:
English: Subjects on fingolimod treatment have a normal bronchodilator response to inhaled beta-agonists.
Croatian: Ispitanici koji primaju terapiju fingolimodom imaju normalan bronhodilatacijski odgovor na inhalirane beta-agoniste.
English: If the overdose constitutes first exposure to Gilenya, it is important to monitor patients with a continuous (real time) ECG and hourly measurement of heart rate and blood pressure, at least during the first 6 hours (see section 4.4).
Croatian: Ako prekomjerna doza predstavlja prvo izlaganje lijeku Gilenya, važno je pratiti bolesnike s kontinuiranim („u stvarnom vremenu“) EKG-om i mjerenjima srčane frekvencije i krvnog tlaka svakog sata, najmanje tijekom prvih 6 sati (vidjeti dio 4.4).
English: Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation***
Croatian: Reakcije preosjetljivosti, uključujući osip, urtikariju i angioedem nakon početka liječenja***
English: These cases have been confounded by concomitant medicinal products and/or pre-existing disease.
Croatian: Ti su slučajevi nejasni zbog konkomitatnih lijekova i/ili bolesti koja je od ranije postojala.
English: If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned.
Croatian: Ako prekid liječenja traje kraće od navedenog, liječenje je potrebno nastaviti sa sljedećom dozom prema rasporedu.
English: Fingolimod is metabolised mainly by CYP4F2.
Croatian: Fingolimod se metabolizira uglavnom putem CYP4F2.
English: - If you suffer from depression or anxiety or if you become depressed or anxious while you are taking Gilenya, let your doctor know.
Croatian: - Ako patite od depresije ili tjeskobe ili ako postanete depresivni ili tjeskobni dok uzimate Gilenyu, obavijestite svog liječnika.
English: In case you do not have enough white blood cells, you may have to interrupt treatment with Gilenya.
Croatian: U slučaju da nemate dovoljno bijelih krvnih stanica, možda ćete morati prekinuti liječenje Gilenyom.
English: - Severe liver impairment (Child-Pugh class C).
Croatian: - Teško oštećenje jetre (Child-Pugh stadij C).
English: Lymphocyte counts progressively return to normal range within 1-2 months of stopping therapy in most patients (see section 5.1) although full recovery can take significantly longer in some patients.
Croatian: Broj limfocita u većine se bolesnika progresivno vraća u normalni raspon u roku od 1 do 2 mjeseca nakon prekida terapije (vidjeti dio 5.1), iako potpuni oporavak u nekih bolesnika može potrajati puno duže.
English: Juvenile animal studies
Croatian: Ispitivanja u juvenilnih životina
English: Your doctor will give you a card which explains why you should not become pregnant while taking Gilenya.
Croatian: Vaš liječnik dat će Vam karticu na kojoj je objašnjeno zašto ne smijete zatrudnjeti dok uzimate Gilenyu.
English: The frequency category was based on an estimated exposure of approximately 10,000 patients to fingolimod in all clinical trials.
Croatian: Kategorija učestalosti temeljila se na procijenjenoj izloženosti otprilike 10 000 bolesnika fingolimodu u svim kliničkim ispitivanjima.
English: If you believe your MS is getting worse (e.g. weakness or visual changes) or if you notice any new symptoms, talk to your doctor straight away, because these may be the symptoms of a rare brain disorder caused by infection and called progressive multifocal leukoencephalopathy (PML).
Croatian: Ako mislite da Vam se MS pogoršava (npr. slabost ili promjene vida) ili ako primijetite bilo kakve nove simptome, odmah se obratite svom liječniku, zato što bi to mogli biti simptomi rijetkog poremećaja mozga uzrokovanog infekcijom koji se zove progresivna multifokalna leukoencefalopatija (PML).
English: In patients with severe hepatic impairment (Child-Pugh class C), fingolimodphosphate Cmax was decreased by 22% and AUC was not substantially changed.
Croatian: U bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C), Cmax fingolimodfosfata bio je smanjen za 22%, a AUC nije bio znatno promijenjen.
English: If you have to restart Gilenya more than 2 weeks after you stop taking it, the effect on heart rate normally seen when treatment is first started may re-occur and you will need to be monitored at the doctor's surgery or clinic for re-initiation of treatment.
Croatian: Ako morate ponovo početi uzimati Gilenyu više od 2 tjedna nakon što ste je prestali uzimati, učinak na srčanu frekvenciju koji se obično javlja kada se liječenje prvi put započne mogao bi se ponovo pojaviti pa ćete trebati biti na praćenju u liječničkoj ambulanti ili klinici radi ponovnog započinjanja liječenja.
English: The cases reported were heterogeneous in nature, mainly non-Hodgkin's lymphoma, including B-cell and T-cell lymphomas.
Croatian: Prijavljeni slučajevi bili su heterogeni po prirodi, uglavnom ne-Hodgkinovi limfomi, uključujući i limfome B-stanica i T-stanica.
English: Some cases of disseminated herpes infection, including fatal cases, have been reported even at the 0.5 mg dose.
Croatian: Neki slučajevi diseminirane infekcije herpesom, uključujući i smrtne slučajeve, zabilježeni su čak i uz dozu od 0,5 mg.
English: After stopping Gilenya you may have to wait for 6-8 weeks before starting a new MS treatment.
Croatian: Nakon prestanka uzimanja Gilenye možda ćete trebati pričekati 6-8 tjedana prije nego što započnete novu terapiju za MS.
English: C] fingolimod, the major fingolimod-related components in blood, as judged from their contribution to the AUC up to 34 days post dose of total radiolabelled components, are fingolimod itself (23%), fingolimod phosphate (10%), and inactive metabolites (M3 carboxylic acid metabolite (8%), M29 ceramide metabolite (9%) and M30 ceramide metabolite (7%)).
Croatian: C] fingolimoda, glavne komponente u krvi povezane s fingolimodom, procijenjene prema njihovom doprinosu AUC-u do 34 dana nakon doze ukupnih radiooznačenih komponenti, sam su fingolimod (23%), fingolimodfosfat (10%) i inaktivni metaboliti (M3 metabolit karboksilne kiseline (8%), M29 ceramidni metabolit (9%) i M30 ceramidni metabolit
English: The same may apply if you are resuming Gilenya after a break in treatment, depending on both how long the break was and how long you had been taking Gilenya before the break.
Croatian: Isto vrijedi i ako nastavljate liječenje Gilenyom nakon prekida liječenja, ovisno o tome koliko je dug bio prekid i koliko ste dugo prije prekida uzimali Gilenyu.
English: In clinical studies, transaminase elevations occurred at any time during treatment although the majority occurred within the first 12 months.
Croatian: U kliničkim ispitivanjima, povišenja transaminaza događala su se u bilo koje vrijeme tijekom liječenja, iako se većina dogodila tijekom prvih 12 mjeseci liječenja.
English: - In the controlled paediatric trial D2311, cases of seizures, anxiety, depressed mood and depression have been reported with a higher incidence in patients treated with fingolimod compared to patients treated with interferon beta-1a.
Croatian: - U kontroliranom pedijatrijskom ispitivanju D2311 prijavljeni su slučajevi napadaja, anksioznosti, depresivnog raspoloženja i depresije s višom incidencijom u bolesnika liječenih fingolimodom u usporedbi s bolesnicima liječenima interferonom beta-1a.
English: Patients should be referred to a dermatologist if suspicious lesions are detected.
Croatian: Bolesnike je potrebno uputiti dermatologu ako se otkriju sumnjive lezije.
English: Co-administration of fingolimod with oral contraceptives (ethinylestradiol and levonorgestrel) did not elicit any change in oral contraceptive exposure.
Croatian: Istodobna primjena fingolimoda s oralnim kontraceptivima (etinilestradiolom i levonorgestrelom) nije uzrokovala nikakvu promjenu u ekspoziciji oralnom kontraceptivu.
English: As the actual duration of these effects is unknown, initiating treatment with Gilenya after alemtuzumab is not recommended unless the benefits of such treatment clearly outweigh the risks for the individual patient.
Croatian: Budući da je stvarno trajanje tih učinaka nepoznato, ne preporučuje se započeti liječenje Gilenyom nakon alemtuzumaba, osim ako koristi takvog liječenja očito premašuju rizike za pojedinog bolesnika.
English: • Doctors will provide counselling before treatment initiation and regularly thereafter regarding the teratogenic risk of GILENYA and required actions to minimise this risk.
Croatian: • Liječnici će pružiti savjetovanje prije početka liječenja te redovito nakon toga o teratogenom riziku GILENYE i potrebnim mjerama da se rizik minimizira.
English: - It is recommended that paediatric patients complete all immunisations in accordance with current immunisation guidelines before starting Gilenya therapy (see “Infections” above).
Croatian: - Preporučuje se da pedijatrijski bolesnici dovrše sva cijepljenja u skladu s trenutnim smjernicama za imunizaciju prije započinjanja liječenja Gilenyom (vidjeti „Infekcije“ iznad).
English: Symptoms vary from patient to patient but typically involve walking difficulties, numbness, vision problems or disturbed balance.
Croatian: Simptomi se razlikuju od bolesnika do bolesnika, ali obično uključuju poteškoće u hodanju, utrnulost, probleme s vidom ili poremećaj ravnoteže.
English: Caution is needed in this subgroup due to very limited knowledge available from the clinical study.
Croatian: U ovoj podskupini potreban je oprez zbog vrlo ograničenog znanja dostupnog iz kliničkog ispitivanja.
English: Should a patient require pharmacological intervention during the first-dose monitoring, overnight monitoring in a medical facility should be instituted and the first-dose monitoring should be repeated after the second dose of Gilenya.
Croatian: Ako bolesnik treba farmakološku intervenciju tijekom praćenja prve doze, treba organizirati promatranje preko noći u medicinskoj ustanovi, a praćenje prve doze treba ponoviti nakon druge doze lijeka Gilenya.
English: Based on human experience, post-marketing data suggest that use of fingolimod is associated with a 2-fold increased risk of major congenital malformations when administered during pregnancy compared with the rate observed in the general population (2-3%; EUROCAT).
Croatian: Na temelju iskustva u ljudi, podaci iz razdoblja nakon stavljanja lijeka u promet ukazuju na to da je fingolimod povezan s dvostruko povećanim rizikom od većih kongenitalnih malformacija kad se koristi tijekom trudnoće u usporedbi sa stopom uočenom u općoj populaciji (2-3%; EUROCAT).
English: The majority of T and B lymphocytes regularly traffic through lymphoid organs and these are the cells mainly affected by fingolimod.
Croatian: Većina T i B limfocita redovito putuje kroz limfoidne organe i fingolimod uglavnom utječe na te stanice.
English: Before you start treatment with Gilenya your doctor will explain the risk to you and ask you to do a pregnancy test in order to ensure that you are not pregnant.
Croatian: Prije početka liječenja Gilenyom Vaš liječnik će Vam objasniti rizik i zatražiti da napravite test za trudnoću kako biste bili sigurni da niste trudni.
English: The use of live attenuated vaccines may carry a risk of infections and should therefore be avoided (see sections 4.4 and 4.8).
Croatian: Primjena živih atenuiranih cjepiva može predstavljati rizik za razvoj infekcije pa je zbog toga treba izbjegavati (vidjeti dijelove 4.4 i 4.8).
English: Possible signs of melanoma include moles which may change size, shape, elevation or colour over time, or new moles.
Croatian: Mogući znakovi melanoma uključuju madeže koji mijenjeju veličinu, oblik, uzdignutost ili boju tijekom vremena ili novi madeži.
English: *** Adverse drug reactions from spontaneous reports and literature **** The frequency category and risk assessment were based on an estimated exposure of more than 24,000 patients to fingolimod 0.5 mg in all clinical trials.
Croatian: *** Nuspojave na lijek prema spontanim prijavama i literaturi **** Kategorija učestalosti i ocjena rizika temeljile su se na procjeni izloženosti više od 24 000 bolesnika fingolimodu 0,5 mg u svim kliničkim ispitivanjima.
English: The combination of fingolimod with potent CYP450 inducers should be used with caution.
Croatian: Kombinaciju fingolimoda i snažnih induktora CYP450 potrebno je oprezno primjenjivati.
English: The rate of congenital malformations observed in babies exposed to Gilenya during pregnancy is about 2 times the rate observed in the general population (in whom the rate of congenital malformations is about 2-3%).
Croatian: Stopa urođenih mana uočena u beba koje su bile izložene Gilenyji tijekom trudnoće je oko 2 puta veća od stope uočene u općoj populaciji (u kojoj je stopa urođenih mana oko 2-3%).
English: HPS is a rare condition that has been described in association with infections, immunosuppression and a variety of autoimmune diseases.
Croatian: HPS je rijetka bolest koja se može javiti uz infekcije, imunosupresiju i razne autoimune bolesti.
English: Your doctor may want you to undergo an eye examination 3 to 4 months after starting Gilenya treatment.
Croatian: Vaš će liječnik možda zatražiti da obavite očni pregled 3 do 4 mjeseca nakon početka liječenja Gilenyom.
English: What you need to know before you take Gilenya
Croatian: Što morate znati prije nego počnete uzimati Gilenyu
English: It is contraindicated in women of childbearing potential (including female adolescents) not using effective contraception and in pregnant women.
Croatian: Kontraindicirana je u žena reproduktivne dobi (uključujući adolescentice) koje ne koriste učinkovitu kontracepciju i u trudnica.
English: Formation of pharmacologically inactive non-polar ceramide analogues of fingolimod was also observed.
Croatian: Također je zabilježena formacija farmakološki inaktivnih nepolarnih ceramidnih analoga fingolimoda.
English: If this risk is suspected, discontinuation of treatment should be considered by the physician on a case-bycase basis (see also section 4.4 “Infections” and “Cutaneous neoplasms” and section 4.8 “Lymphomas”).
Croatian: Ako se sumnja na taj rizik, potrebno je da liječnik razmotri prekid liječenja od slučaja do slučaja (vidjeti dio 4.4 „Infekcije“ i „Kožne neoplazme“ te dio 4.8 „Limfomi“).
English: Therefore, fingolimod is not expected to alter the pharmacokinetics of medicinal products that are CYP3A4 substrates.
Croatian: Stoga se ne očekuje da bi fingolimod promijenio famakokinetiku lijekova koji su supstrati CYP3A4.
English: Bradycardia was generally asymptomatic but some patients experienced mild to moderate symptoms, including hypotension, dizziness, fatigue and/or palpitations, which resolved within the first 24 hours after treatment initiation (see also sections 4.4 and 5.1).
Croatian: Bradikardija je općenito bila asimptomatska, ali neki su bolesnici osjetili blage do umjerene simptome, uključujući hipotenziju, omaglicu, umor i/ili palpitacije, a koji su se povukli unutar prva 24 sata od početka terapije (također vidjeti dijelove 4.4 i 5.1).
English: Kaposi's sarcoma****
Croatian: Kaposijev sarkom****
English: Before you start Gilenya, if you have or have had visual disturbances or other signs of swelling in the central vision area (macula) at the back of the eye, inflammation or infection of the eye (uveitis) or diabetes, your doctor may want you to undergo an eye examination.
Croatian: Prije nego što počnete uzimati Gilenyu, ako imate ili ste imali smetnje vida ili druge znakove oticanja u središnjem vidnom području (makuli) u stražnjem dijelu oka, upalu ili infekciju oka (uveitis) ili šećernu bolest, liječnik će možda zatražiti da obavite očni pregled.
English: Due to the potential for serious adverse reactions to fingolimod in nursing infants, women receiving Gilenya should not breastfeed.
Croatian: Zbog mogućnosti nastanka ozbiljnih nuspojava na fingolimod u dojenčadi, žene koje uzimaju Gilenyu ne smiju dojiti.
English: If this risk is suspected, discontinuation of treatment should be considered by the physician on a case-by-case basis.
Croatian: Ako se sumnja na ovaj rizik, liječnik treba razmotriti prekid liječenja od slučaja do slučaja.
English: Gilenya capsules should always be swallowed intact, without opening them.
Croatian: Kapsule Gilenye je uvijek potrebno progutati cijele, bez da ih se otvara.
English: Possible signs of Merkel cell carcinoma include flesh-coloured or bluish-red, painless nodule, often on the face, head or neck.
Croatian: Mogući znakovi karcinoma Merkelovih stanica uključuju bezbolnu kvržicu boje mesa ili plavkasto-crvenu, često na licu, glavi ili vratu.
English: In the absence of clinical symptoms, liver transaminases should be monitored at months 1, 3, 6, 9 and 12 on therapy and periodically thereafter.
Croatian: U odsutnosti kliničkih simptoma, jetrene transaminaze treba pratiti u 1., 3., 6., 9. i 12. mjesecu terapije te periodički nakon toga.
English: Your doctor will decide to stop treatment (see “If you stop taking Gilenya” in section 3, and also section 4, “Possible side effects”).
Croatian: Vaš liječnik će odlučiti da se prekine liječenje (vidjeti „Ako prestanete uzimati Gilenyu“ u dijelu 3 i također dio 4 „Moguće nuspojave“).
English: • Patients should report immediately symptoms indicating low heart rate (such as dizziness, vertigo, nausea or palpitations) after the first dose of GILENYA;
Croatian: • Bolesnici trebaju žurno prijaviti simptome koji upućuju na nisku srčanu frekvenciju (poput omaglice, vrtoglavice, mučnine ili palpitacija) nakon prve doze GILENYE;
English: When stopping GILENYA therapy due to pregnancy or for planning a pregnancy, the possible return of disease activity should be considered.
Croatian: Kad se prekida primjena GILENYE zbog trudnoće ili planiranja trudnoće, potrebno je uzeti u obzir mogući povratak aktivnosti bolesti.
English: Potent inhibitors of transporter proteins are not expected to influence fingolimod disposition.
Croatian: Ne očekuje se da bi potentni inhibitori transportnih proteina utjecali na bioraspoloživost fingolimoda.
English: Uncommon (may affect up to 1 in 100 people): - Low level of certain white blood cells (neutrophils) - Depressed mood - Nausea
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba): - niska razina određenih bijelih krvnih stanica (neutrofila) - depresivno raspoloženje - mučnina
English: With initiation of fingolimod treatment there is an increase in atrial premature contractions, but there is no increased rate of atrial fibrillation/flutter or ventricular arrhythmias or ectopy.
Croatian: U početku terapije fingolimodom dolazi do povećanja broja preuranjenih atrijskih kontrakcija, ali nema povećane stope fibrilacije/undulacije atrija, ventrikularnih aritmija ili ektopije.
English: Continuous (real time) ECG monitoring is recommended; o Perform an ECG at the end of the 6-hour monitoring period.
Croatian: Preporučuje se kontinuirano (‘u stvarnom vremenu') praćenje EKG-a; o Obaviti EKG na kraju 6-satnog razdoblja praćenja.
English: Fingolimod is transformed in humans by reversible stereoselective phosphorylation to the pharmacologically active (S)-enantiomer of fingolimod phosphate.
Croatian: Fingolimod se u ljudi transformira reverzibilnom stereoselektivnom fosforilacijom u farmakološki aktivni (S)-enantiomer fingolimodfosfata.
English: The main enzyme involved in the metabolism of fingolimod is partially identified and may be either CYP4F2 or CYP3A4.
Croatian: Glavni enzim uključen u metabolizam fingolimoda je djelomično identificiran i može biti ili CYP4F2 ili CYP3A4.
English: The immune system effects of Gilenya may increase the risk of infections, including opportunistic infections (see section 4.8).
Croatian: Učinci Gilenye na imunološki sustav mogli bi povećati rizik od infekcija, uključujući oportunističke infekcije (vidjeti dio 4.8).
English: In such patients, treatment with Gilenya should be considered only if the anticipated benefits outweigh the potential risks.
Croatian: U takvih bolesnika liječenje Gilenyom treba uzeti u obzir samo ako očekivane koristi premašuju potencijalne rizike.
English: Very rare (may affect up to 1 in 10,000 people): - Electrocardiogram anomaly (T-wave inversion) - Tumour related to infection with human herpes virus 8 (Kaposi's sarcoma)
Croatian: Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba): - promjena elektrokardiograma (inverzija T-vala) - tumor povezan s infekcijom humanim herpes virusom 8 (Kaposijev sarkom)
English: • Women exposed to GILENYA during pregnancy are encouraged to join the pregnancy exposure registry that monitors outcomes of pregnancy.
Croatian: • Žene koje su izložene GILENYI tijekom trudnoće potiču se da se uključe u Registar izloženosti fingolimodu u trudnoći koji prati ishode trudnoće.