FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the immunosuppressive properties of fingolimod, vaccination against HPV should be considered prior to treatment initiation with fingolimod taking into account vaccination recommendations.
Slovenian: Zaradi imunosupresivnega delovanja fingolimoda je treba o cepljenju proti okužbi s HPV razmisliti pred začetkom zdravljenja s fingolimodom in pri tem upoštevati priporočila za cepljenje.
English: The frequency category was based on an estimated exposure of approximately 10,000 patients to fingolimod in all clinical trials.
Slovenian: Opredelitev kategorije pogostnosti temelji na oceni, da je bilo fingolimodu v vseh kliničnih študijah skupaj izpostavljenih približno 10.000 bolnikov.
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.
Slovenian: Varnostni profil je pri pediatričnih bolnikih podoben kot pri odraslih, zato opozorila in previdnostni ukrepi za odrasle veljajo tudi za pediatrične bolnike.
English: Your doctor may have to do a blood test in order to exclude such abnormalities.
Slovenian: Morda vam bo zdravnik opravil krvno preiskavo, da bi izključil možnost omenjenih nepravilnosti.
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.
Slovenian: Fingolimod se je pri zdravljenih živalih med dojenjem izločal v mleko v koncentracijah, ki so bile 2-3krat višje kot v plazmi doječih samic.
English: This medicinal product is for oral use.
Slovenian: Zdravilo je namenjeno za peroralno uporabo.
English: The maximal decline in heart rate is seen within 6 hours post dose, with 70% of the negative chronotropic effect achieved on the first day.
Slovenian: Do največjega znižanja srčne frekvence pride v 6 urah po odmerjanju, pri čemer v prvem dnevu pride do 70 % negativnega kronotropnega učinka.
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).
Slovenian: Če je prekinitev zdravljenja s fingolimodom res potrebna, je treba upoštevati možnost ponovitve izjemno visoke aktivnosti bolezni in bolnike opazovati glede ustreznih znakov in simptomov ter po potrebi uvesti ustrezno zdravljenje (glejte odstavek “Prekinitev zdravljenja” spodaj).
English: A core pharmacodynamic effect of Gilenya is a dose-dependent reduction of the peripheral lymphocyte count to 20-30% of baseline values.
Slovenian: Bistven farmakodinamičen učinek zdravila Gilenya je od odmerka odvisno znižanje števila perifernih limfocitov na 20-30 % izhodiščne vrednosti.
English: During and for up to two months after treatment with Gilenya vaccination may be less effective.
Slovenian: V času zdravljenja z zdravilom Gilenya in do dva meseca po njem je lahko cepljenje manj učinkovito.
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.
Slovenian: - V kontrolirani pediatrični študiji D2311 so o primerih epileptičnih napadov, tesnobe depresivnega razpoloženja in depresije poročali z večjo pogostnostjo pri bolnikih, ki so prejemali fingolimod, kot pri bolnikih, ki so prejemali interferon beta-1a.
English: The immune system effects of Gilenya may increase the risk of infections, including opportunistic infections (see section 4.8).
Slovenian: Učinki zdravila Gilenya na imunski sistem lahko povečajo tveganje za okužbe, tudi za oportunistične (glejte poglavje 4.8).
English: An ophthalmological evaluation is therefore recommended at 3-4 months after treatment initiation.
Slovenian: Zaradi tega je 3-4 mesece po začetku zdravljenja priporočeno opraviti oftalmološki pregled.
English: Use of Gilenya together with such medicines could intensify the effect on heartbeat in the first days after starting Gilenya.
Slovenian: Uporaba zdravila Gilenya skupaj s takimi zdravili bi lahko v prvih dneh po začetku jemanja zdravila Gilenya okrepila delovanje na srčni utrip.
English: Fingolimod should be stopped 2 months before planning a pregnancy (see section 4.4).
Slovenian: Z jemanjem fingolimoda je treba prenehati 2 meseca pred načrtovanjem nosečnosti (glejte poglavje 4.4).
English: The combination of fingolimod with potent CYP450 inducers should be used with caution.
Slovenian: Pri uporabi fingolimoda v kombinaciji z močnimi induktorji CYP450 je potrebna previdnost.
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.
Slovenian: Na začetku zdravljenja s fingolimodom pogosteje pride do prezgodnjih atrijskih kontrakcij, ne poveča pa se pogostnost atrijske fibrilacije/undulacije, ventrikularnih aritmij ali ektopičnih utripov.
English: As Gilenya causes a slight elevation of blood pressure, your doctor may want to check your blood pressure regularly.
Slovenian: Zdravilo Gilenya povzroča rahlo zvišanje krvnega tlaka, zato vam bo zdravnik verjetno redno meril krvni tlak.
English: In this case, it is recommended to repeat the first-dose observation period.
Slovenian: V tem primeru je priporočeno ponoviti obdobje spremljanja bolnika kot po prejemu prvega odmerka.
English: Your doctor will consider whether you need to have a vaccination against HPV before starting treatment.
Slovenian: Zdravnik bo presodil, ali morate pred začetkom zdravljenja opraviti še cepljenje proti okužbi s HPV.
English: If you need to have any blood tests, tell the doctor that you are taking Gilenya.
Slovenian: Če morate opraviti kakršnekoli krvne preiskave, povejte zdravniku, da jemljete zdravilo Gilenya.
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%)).
Slovenian: označenega fingolimoda so najbolj pomembne s fingolimodom povezane sestavine v krvi, sodeč po njihovem deležu pri AUC po 34 dneh po odmerjanju v celoti radioaktivno označenih sestavin: sam fingolimod (23 %), fingolimodijev fosfat (10 %) in neaktivni metaboliti (M3 metabolit s karboksilno kislino (8 %), M29 ceramidni metabolit (9 %) in M30 ceramidni metabolit (7 %)).
English: Patients with symptoms and signs consistent with cryptococcal meningitis (e.g. headache accompanied by mental changes such as confusion, hallucinations, and/or personality changes) should undergo prompt diagnostic evaluation.
Slovenian: Pri bolnikih s simptomi in znaki, ki lahko pomenijo kriptokokni meningitis (na primer glavobol s pridruženimi psihičnimi spremembami, kot so zmedenost, halucinacije in/ali osebnostne spremembe), je treba takoj uvesti diagnostično obravnavo.
English: Second-degree atrioventricular block was detected in less than 0.2% adult patients on Gilenya 0.5 mg.
Slovenian: Atrioventrikularni blok druge stopnje so ugotovili pri manj kot 0,2 % odraslih bolnikov, ki so jemali zdravilo Gilenya 0,5 mg.
English: Co-administration of fingolimod with oral contraceptives (ethinylestradiol and levonorgestrel) did not elicit any change in oral contraceptive exposure.
Slovenian: Sočasna uporaba fingolimoda in peroralnih kontracepcijskih sredstev (etinilestradiola in levonorgestrela) ni povzročila nobene spremembe glede izpostavljenosti peroralnim kontracepcijskim sredstvom.
English: In clinical trials, fingolimod was discontinued if the elevation exceeded 5 times the ULN.
Slovenian: V kliničnih študijah so jemanje fingolimoda prekinili, če je zvišanje preseglo 5-kratno vrednost ZMN.
English: Prior treatment with immunosuppressive or immunomodulatory therapies
Slovenian: Predhodno zdravljenje z imunosupresivnimi ali imunomodulatornimi zdravili
English: If you are a woman, your doctor will also recommend HPV screening.
Slovenian: Če ste ženska, vam bo zdravnik priporočil tudi opravljanje presejalnih testov za odkrivanje okužbe s HPV.
English: What you need to know before you take Gilenya
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Gilenya
English: You will probably not notice any symptoms but if you notice yellowing of your skin or the whites of your eyes, abnormally dark urine or unexplained nausea and vomiting, tell your doctor straight away.
Slovenian: Verjetno ne boste čutili nobenih simptomov, če pa bi opazili porumenevanje kože ali beločnic, nenormalno temno obarvan urin ali nepojasnjen občutek slabosti z bruhanjem, takoj obvestite zdravnika.
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).
Slovenian: Če je prekinitev zdravljenja krajša od zgoraj navedenih, je treba z zdravljenjem nadaljevati z naslednjim odmerkom po načrtovanem razporedu (glejte poglavje 4.4).
English: During the first twelve months of treatment your doctor will request blood tests to monitor your liver function.
Slovenian: Zdravnik bo predpisal, da prvih dvanajst mesecev zdravljenja opravljate preiskave krvi za določanje funkcije jeter.
English: channel (IKACh/GIRK) and that vasoconstriction seems to be mediated by a Rho kinase and calcium dependent mechanism.
Slovenian: channel, GIRK), vazokonstrikcija pa bi bila lahko posredovana z Rho kinazo in mehanizmom, ki je odvisen od kalcija.
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).
Slovenian: Pri uporabi živih atenuiranih cepiv obstaja tveganje za okužbo, zato se je uporabi takih cepiv treba izogibati (glejte poglavji 4.4 in 4.8).
English: The safety profile in pediatric patients is similar to adults and therefore the warnings and precautions in adults also apply for pediatric patients.
Slovenian: Varnostni profil je pri pediatričnih bolnikih podoben kot pri odraslih in zato opozorila in previdnostni ukrepi za odrasle veljajo tudi za pediatrične bolnike.
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).
Slovenian: Če mislite, da se vaša multipla skleroza slabša (če opažate na primer šibkost ali spremembe vida) ali če opažate kakršnekoli nove simptome, se takoj posvetujte s svojim zdravnikom, ker gre morda za simptome redke možganske bolezni, ki jo povzroča okužba, imenujemo pa jo progresivna multifokalna levkoencefalopatija (PML).
English: In case you do not have enough white blood cells, you may have to interrupt treatment with Gilenya.
Slovenian: V primeru, da v vaši krvi ne bo dovolj belih krvnih celic, boste morali morda prekiniti zdravljenje z zdravilom Gilenya.
English: The cases reported were heterogeneous in nature, mainly non-Hodgkin's lymphoma, including B-cell and T-cell lymphomas.
Slovenian: Poročani neželeni učinki so bili po naravi raznoliki, večinoma je šlo za ne-Hodgkinov limfom, vključno z B-celičnimi in T-celičnimi limfomi.
English: Do not use this medicine after the expiry date which is stated on the carton and blister foil after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake Uporabno do/EXP.
English: Further analyses of clinical trial data demonstrate consistent treatment effects in highly active subgroups of relapsing remitting multiple sclerosis patients.
Slovenian: Nadaljnje analize podatkov iz kliničnih študij so pokazale take učinke zdravljenja tudi pri podskupinah bolnikov z zelo aktivno recidivno-remitentno multiplo sklerozo.
English: • Patients should inform their doctor straight away if there is worsening of multiple sclerosis after stopping treatment with GILENYA.
Slovenian: • Bolnice morajo takoj obvestiti zdravnika, če pride do poslabšanja multiple skleroze po prekinitvi zdravljenja z zdravilom GILENYA.
English: Potent inhibitors of transporter proteins are not expected to influence fingolimod disposition.
Slovenian: Močni zaviralci transportnih proteinov po vsej verjetnosti ne vplivajo na odstranjevanje fingolimoda.
English: Cases of PML have occurred after approximately 2-3 years of monotherapy treatment without previous exposure to natalizumab.
Slovenian: Primeri PML so se pojavljali po približno 2 do 3 letih samostojnega zdravljenja brez predhodne izpostavljenosti natalizumabu.
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).
Slovenian: Pred začetkom zdravljenja je treba ženske v rodni dobi opozoriti na tveganje, ki ga uporaba fingolimoda pomeni za plod, imeti morajo negativen izvid testa nosečnosti in uporabljati učinkovito kontracepcijo v času zdravljenja in še 2 meseca po prekinitvi zdravljenja (glejte poglavji 4.3 in 4.6 ter informacije v paketu izobraževalnih gradiv za zdravnike).
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.
Slovenian: V kliničnih študijah multiple skleroze so po začetku zdravljenja ugotovili atrioventrikularni blok prve stopnje (podaljšan interval PR na EKG posnetku) pri odraslih in pediatričnih bolnikih.
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)
Slovenian: Zelo redki (lahko se pojavijo pri največ 1 od 10.000 ljudi): - nepravilnost v elektrokardiogramu (inverzija vala T), - tumor, ki se razvije zaradi okužbe s humanim herpes virusom 8 (Kaposijev sarkom).
English: Caution patients against exposure to sunlight without protection.
Slovenian: Bolnike je treba opozoriti, naj se brez zaščite ne izpostavljajo sončni svetlobi.
English: MS is a long-term condition that affects the central nervous system (CNS), comprised of the brain and spinal cord.
Slovenian: Multipla skleroza (MS) je dolgotrajna bolezen, ki prizadene centralni živčni sistem (CŽS), ki ga sestavljajo možgani in hrbtenjača.
English: MRI findings may be apparent before clinical signs or symptoms.
Slovenian: Znaki na MR posnetkih so lahko razvidni pred pojavljanjem kliničnih znakov oziroma simptomov.
English: Depression and anxiety have also been reported in paediatric patients treated with fingolimod.
Slovenian: O depresiji in tesnobi so poročali tudi pri pediatričnih bolnikih, ki so prejemali fingolimod.
English: For the same reason, a decision to use prolonged concomitant treatment with corticosteroids should be taken after careful consideration.
Slovenian: Iz istega razloga se je za možnost dolgotrajne sočasne uporabe kortikosteroidov mogoče odločiti šele po skrbnem premisleku.
English: Fingolimod is excreted in milk of treated animals during lactation (see section 5.3).
Slovenian: Fingolimod se je med laktacijo izločal v mleko zdravljenih živali (glejte poglavje 5.3).
English: Gilenya helps to protect against attacks on the CNS by the immune system by reducing the ability of some white blood cells (lymphocytes) to move freely within the body and by stopping them from reaching the brain and spinal cord.
Slovenian: Zdravilo Gilenya pomaga zaščititi organizem pred napadi imunskega sistema na centralni živčni sistem, tako da zmanjšuje sposobnost nekaterih belih krvnih celic (limfocitov), da se prosto gibljejo po telesu, in tako, da jim preprečuje dostop do možganov in hrbtenjače.
English: When evaluating a patient with a suspected infection that could be serious, referral to a physician experienced in treating infections should be considered.
Slovenian: Pri pregledovanju bolnika s sumom na okužbo, ki je lahko resna, mora lečeči zdravnik pretehtati tudi možnost napotitve bolnika k zdravniku z izkušnjami pri zdravljenju infekcijskih bolezni.
English: Symptoms vary from patient to patient but typically involve walking difficulties, numbness, vision problems or disturbed balance.
Slovenian: Simptomi se razlikujejo od bolnika od bolnika, običajno pa vključujejo težave pri hoji, odrevenelost, težave z vidom ali motnje ravnotežja.
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.
Slovenian: Enako lahko velja tudi v primeru, da ponovno začenjate z uporabo zdravila Gilenya po prekinitvi zdravljenja, odvisno pa je tako od trajanja prekinitve kot od tega, kako dolgo ste jemali zdravilo Gilenya pred prekinitvijo.
English: Patients may be monitored with continuous ECG during the first 6 hours.
Slovenian: V prvih 6 urah je bolnik lahko spremljan z neprekinjenim snemanjem EKG.
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%.
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvaro jeter (Child-Pugh stopnje A, B ali C) niso opažali sprememb Cmax fingolimoda, AUC pa se je povečala za 12 %, 44 % oziroma 103 %.
English: • Recommendation for re-initiating GILENYA therapy after treatment interruption: The same first dose monitoring as for treatment initiation is recommended when treatment is interrupted for: o One day or more during the first 2 weeks of treatment; o More than 7 days during weeks 3 and 4 of treatment; o More than 2 weeks after at least 1 month of treatment.
Slovenian: • Priporočila za ponovno uvedbo zdravila GILENYA po prekinitvi zdravljenja: Enak postopek spremljanja kot ob prvi uvedbi zdravljenja je priporočen v primeru, ko je bilo zdravljenje prekinjeno: o za en dan ali več v prvih 2 tednih zdravljenja, o za več kot 7 dni v 3. in 4. tednu zdravljenja, o za več kot 2 tedna po najmanj 1 mesecu zdravljenja.
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.
Slovenian: V kliničnih študijah je bila pogostnost primerov ne-Hodgkinovega limfoma (B-celičnega in T-celičnega) večja od njihove pričakovane pogostnosti v splošni populaciji.
English: Therefore, blood pressure should be regularly monitored during treatment with Gilenya.
Slovenian: Iz tega razloga je treba med zdravljenjem z zdravilom Gilenya redno meriti krvni tlak.
English: ** PML and cryptococcal infections (including cases of cryptococcal meningitis) have been reported in the post-marketing setting (see section 4.4).
Slovenian: ** O PML in kriptokoknih okužbah (vključno s primeri kriptokoknega meningitisa) so poročali v okviru izkušenj po prihodu zdravila na trg (glejte poglavje 4.4).
English: Co-administration with potent CYP450 inducers
Slovenian: Sočasna uporaba z močnimi induktorji CYP450
English: When stopping GILENYA therapy due to pregnancy or for planning a pregnancy, the possible return of disease activity should be considered.
Slovenian: Pri prekinitvi uporabe zdravila GILENYA zaradi zanositve ali načrtovanja nosečnosti je treba upoštevati možnost ponovne aktivacije bolezni.
English: On initiation of Gilenya treatment it is recommended that patients be observed for a period of 6 hours (see section 4.4, Bradyarrhythmia).
Slovenian: Ob uvedbi zdravila Gilenya je priporočeno opazovanje bolnikov v obdobju 6 ur (glejte poglavje 4.4 Bradiaritmija).
English: However, single fingolimod doses ≥5 mg (10-fold the recommended dose) are associated with a dose-dependent increase in airway resistance.
Slovenian: Enkratni odmerki fingolimoda ≥5 mg (10-krat višji od priporočenega odmerka) pa so povezani z od odmerka odvisnim povečanjem upora v dihalnih poteh.
English: In clinical studies, transaminase elevations occurred at any time during treatment although the majority occurred within the first 12 months.
Slovenian: V kliničnih študijah je do zvišanja vrednosti aminotransferaz prihajalo kadarkoli med zdravljenjem, v večini primerov pa v prvih 12 mesecih.
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).
Slovenian: Skupno je osnovni del študije s prejemanjem študijskega zdravila zaključilo 180 (84 %) bolnikov (n=99 [92,5 %] jih je prejemalo fingolimod, 81 [75 %] pa interferon beta-1a).
English: Results from two toxicity studies in juvenile rats showed slight effects on neurobehavioural response, delayed sexual maturation and a decreased immune response to repeated stimulations with keyhole limpet haemocyanin (KLH), which were not considered adverse.
Slovenian: Rezultati dveh študij toksičnosti na podganjih mladičih so pokazali blag vpliv na nevrovedenjski odziv, zakasnjeno spolno dozorevanje in zmanjšan imunski odziv na ponavljajoče dražljaje s hemocianinom morskega polža (keyhole limpet haemocyanin, KLH).
English: Your doctor will also carry out regular skin examinations during your treatment with Gilenya.
Slovenian: Zdravnik vam bo kožo redno pregledoval tudi med zdravljenjem z zdravilom Gilenya.
English: If you forget to take Gilenya
Slovenian: Če ste pozabili vzeti zdravilo Gilenya
English: - Patients with a baseline QTc interval ≥ 500 msec (see section 4.4).
Slovenian: - Bolniki z izhodiščnim trajanjem intervala QTc ≥500 msec (glejte poglavje 4.4).
English: - After Gilenya treatment is stopped, symptoms of MS can return and may become worse than they were before or during treatment.
Slovenian: - Po prekinitvi zdravljenja z zdravilom Gilenya se simptomi multiple skleroze lahko ponovijo in postanejo še bolj izraženi, kot so bili pred ali med zdravljenjem.
English: Possible signs of Merkel cell carcinoma include flesh-coloured or bluish-red, painless nodule, often on the face, head or neck.
Slovenian: Med možnimi znaki karcinoma Merklovih celic je nastanek nebolečega vozlička v barvi mesa ali modrikasto rdeče barve, pogosto na obrazu, glavi ali vratu.
English: When stopping fingolimod therapy for planning a pregnancy the possible return of disease activity should be considered (see section 4.4).
Slovenian: Pri prekinitvi zdravljenja s fingolimodom zaradi načrtovanja nosečnosti je treba upoštevati možnost ponovne aktivacije bolezni (glejte poglavje 4.4).
English: If cryptococcal meningitis is diagnosed, fingolimod should be suspended and appropriate treatment should be initiated.
Slovenian: Če je postavljena diagnoza kriptokoknega meningitisa, je treba odmerjanje fingolimoda prekiniti in uvesti ustrezno zdravljenje.
English: In such patients, treatment with Gilenya should be considered only if the anticipated benefits outweigh the potential risks.
Slovenian: Pri teh bolnikih lahko pride zdravljenje z zdravilom Gilenya v poštev samo v primeru, da pričakovane koristi presegajo potencialna tveganja.
English: Gilenya capsules should always be swallowed intact, without opening them.
Slovenian: Kapsule zdravila Gilenya je treba vedno zaužiti cele in nepoškodovane, ne da bi jih prej odprli.
English: Fingolimod is a sphingosine 1-phosphate receptor modulator.
Slovenian: Fingolimod je modulator receptorja za sfingozin-1-fosfat.
English: Formation of pharmacologically inactive non-polar ceramide analogues of fingolimod was also observed.
Slovenian: Opazili so tvorbo farmakološko neaktivnih nepolarnih ceramidnih analogov fingolimoda.
English: 98 capsules
Slovenian: 98 kapsul
English: Experience with Gilenya in elderly patients (over 65 years) is limited.
Slovenian: Obseg izkušenj z zdravilom Gilenya pri starejših bolnikih, ki so stari več kot 65 let, je omejen.