FrancophonIA/ELRC3.0 huggingface dataset:
English: At 40 mg, 5 of 6 subjects reported mild chest tightness or discomfort which was clinically consistent with small airway reactivity.
Slovenian: Pri odmerku 40 mg je 5 od 6 preiskovancev opisalo blag občutek stiskanja v prsnem košu oziroma nelagodje, kar se je klinično ujemalo z majhno odzivnostjo dihalnih poti.
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.
Slovenian: Zdravilo Gilenya multiple skleroze ne pozdravi, pomaga pa zmanjšati število zagonov in upočasni napredovanje telesne invalidnosti zaradi multiple skleroze.
English: Caution is also indicated when stopping fingolimod therapy due to the risk of a rebound (see “Return of disease activity (rebound) after fingolimod discontinuation” above).
Slovenian: Previdnost je potrebna tudi pri prenehanju zdravljenja s fingolimodom, saj obstaja tveganje za povratni učinek (glejte odstavek “Ponovna aktivacija bolezni (povratni učinek) po prekinitvi uporabe fingolimoda” zgoraj).
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).
Slovenian: Na osnovi izkušenj pri ljudeh je po podatkih iz obdobja po prihodu zdravila na trg mogoče sklepati, da je uporaba fingolimoda povezana z 2-kratnim povečanjem tveganja za pomembne prirojene nepravilnosti, če se fingolimod jemlje med nosečnostjo, v primerjavi s pogostnostjo teh nepravilnosti, ki jo opažajo v splošni populaciji (2-3 % po podatkih registra EUROCAT).
English: Your doctor may want you to undergo an eye examination 3 to 4 months after starting Gilenya treatment.
Slovenian: Zdravnik vas bo morda napotil na pregled oči tudi 3 do 4 mesece po začetku jemanja zdravila Gilenya.
English: • Patients should report immediately symptoms indicating low heart rate (such as dizziness, vertigo, nausea or palpitations) after the first dose of GILENYA;
Slovenian: • Bolniki morajo takoj obvestiti zdravnika v primeru simptomov, ki kažejo na znižanje srčne frekvence (kot so omotičnost, vrtoglavica, slabost ali palpitacije) po prvem odmerjanju zdravila GILENYA.
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%).
Slovenian: Pogostnost prirojenih nepravilnosti pri otrocih, ki so bili izpostavljeni zdravilu Gilenya v času nosečnosti, je približno dvakrat tolikšna kot pogostnost takih nepravilnosti v splošni populaciji (v kateri je pogostnost prirojenih nepravilnosti približno 2-3 %).
English: o Physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves, in the GILENYA pregnancy registry.
Slovenian: o Zdravnike se spodbuja, da noseče bolnice vključijo (oziroma se noseče bolnice registrirajo same) v register izpostavljenosti nosečnic zdravilu GILENYA.
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.
Slovenian: Priporočena je izvedba postopka pospešenega izločanja, ki je za teriflunomid opredeljen v povzetku glavnih značilnosti zdravila, druga možnost pa je vmesno obdobje brez zdravljenja, ki ne sme biti krajše od 3,5 meseca.
English: Caution should be exercised with substances that may inhibit CYP3A4 (protease inhibitors, azole antifungals, some macrolides such as clarithromycin or telithromycin).
Slovenian: Previdnost je potrebna pri sočasni uporabi učinkovin, ki bi lahko zavirale CYP3A4 (zaviralcev proteaz, azolnih antimikotikov, nekaterih makrolidov, kot sta klaritromicin in telitromicin).
English: Gilenya is not expected to have an influence on your ability to drive and use machines.
Slovenian: Zdravilo Gilenya predvidoma ne vpliva na vašo sposobnost vožnje in upravljanja s stroji.
English: However, if you have forgotten to take your treatment for up to 2 weeks, you can take the next dose as planned.
Slovenian: Če pa ste pozabili jemati zdravilo in ga niste vzeli največ 2 tedna, lahko vzamete naslednji odmerek po razporedu.
English: In MS inflammation destroys the protective sheath (called myelin) around the nerves in the CNS and stops the nerves from working properly.
Slovenian: Pri multipli sklerozi vnetje uničuje zaščitno ovojnico (imenovano mielin) okrog živcev v centralnem živčevju in preprečuje, da bi živci ustrezno delovali.
English: Slow heart rate usually returns to normal within one month.
Slovenian: Počasno bitje srca se večinoma vrne na normalno hitrost v enem mesecu.
English: - It is recommended that paediatric patients complete all immunisations in accordance with current immunisation guidelines before starting Gilenya therapy (see “Infections” above).
Slovenian: - Za pediatrične bolnike je priporočeno, da vsa cepljenja v skladu z veljavnimi smernicami za cepljenje opravijo pred začetkom zdravljenja z zdravilom Gilenya (glejte zgoraj pod naslovom “Okužbe”).
English: Depression and anxiety are known to occur with increased frequency in the multiple sclerosis population.
Slovenian: Znano je, da se depresija in tesnoba pogosteje pojavljata v populaciji bolnikov z multiplo sklerozo.
English: Since there is a potential risk of malignant skin growths, patients treated with fingolimod should be cautioned against exposure to sunlight without protection.
Slovenian: Zaradi tveganja za pojav malignih kožnih sprememb je treba bolnike, ki prejemajo fingolimod, opozoriti, naj se brez zaščite ne izpostavljajo sončni svetlobi.
English: Due to the long half-life of natalizumab, elimination usually takes up to 2-3 months following discontinuation.
Slovenian: Zaradi dolgega razpolovnega časa natalizumaba traja njegovo izločanje iz organizma običajno največ 2-3 mesece po prekinitvi zdravljenja.
English: 9/l, if confirmed, should lead to treatment interruption until recovery, because in clinical studies, fingolimod treatment was interrupted in patients with absolute lymphocyte count <0.2x10
Slovenian: 9/l, je treba zdravljenje prekiniti do normalizacije, ker so v kliničnih študijah pri bolnikih z absolutnim številom limfocitov <0,2x10
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.
Slovenian: Če mislite, da imate okužbo ali zvišano telesno temperaturo, če se počutite tako, kot da imate gripo, ali imate glavobol, ki ga spremlja otrdel vrat, preobčutljivost na svetlobo, občutek slabosti in/ali zmedenost (te težave lahko povzroča glivična okužba in so lahko simptomi meningitisa), takoj obvestite zdravnika, ker je stanje lahko resno in življenjsko nevarno.
English: Monocytes are unaffected by fingolimod.
Slovenian: Na monocite fingolimod ne vpliva.
English: Anti-neoplastic, immunomodulatory or immunosuppressive therapies should not be co-administered due to the risk of additive immune system effects (see sections 4.3 and 4.4).
Slovenian: Antineoplastičnih, imunomodulatornih oziroma imunosupresivnih zdravil se ne sme uporabljati sočasno zaradi tveganja za aditivne učinke na imunski sistem (glejte poglavji 4.3 in 4.4).
English: If liver transaminases rise above 5 times the ULN, more frequent monitoring should be instituted, including serum bilirubin and alkaline phosphatase (ALP) measurement.
Slovenian: Če se koncentracije jetrnih aminotransferaz zvišajo nad 5-kratno vrednost ZMN, je treba uvesti pogostejše preiskave, vključno z določanjem vrednosti bilirubina in alkalne fosfataze (AF) v serumu.
English: • Four cases without identified confounders and with supportive chronology and clinical course with improvement/recovery following discontinuation of fingolimod.
Slovenian: • Pri štirih primerih niso ugotovili nobenih drugih možnih vzročnih dejavnikov, povezavo pa potrjuje kronološki potek in narava kliničnih dogodkov z izboljšanjem oziroma okrevanjem po prekinitvi uporabe fingolimoda.
English: Overall, the treatment-related effects of fingolimod in juvenile animals were comparable to those seen in adult rats at similar dose levels, with the exception of changes in bone mineral density and neurobehavioural impairment (reduced auditory startle response) observed at doses of 1.5 mg/kg and higher in juvenile animals and the absence of smooth muscle hypertrophy in the lungs of the juvenile rats.
Slovenian: Na splošno so bili z zdravljenjem povezani učinki fingolimoda na mladiče primerljivi z učinki, ki so jih opažali pri odraslih podganah pri podobnih odmernih ravneh, z izjemo sprememb mineralne kostne gostote in nevrovedenjskih motenj (zmanjšane reakcije zdrznjenja na slušni dražljaj), ki so jih pri mladičih živali opažali pri odmerjanju 1,5 mg/kg ali več, in odsotnosti hipertrofije gladkih mišic v pljučih pri podganjih mladičih.
English: During routine MRI (in accordance with national and local recommendations), physicians should pay attention to PML suggestive lesions.
Slovenian: Zdravniki morajo biti med rednim MR slikanjem (v skladu z nacionalnimi in lokalnimi priporočili) pozorni na lezije, ki bi lahko bile znak PML.
English: • Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as beta interferon, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate or alemtuzumab.
Slovenian: • zdravila, ki zavirajo ali spreminjajo delovanje imunskega sistema, vključno z drugimi zdravili za multiplo sklerozo, kot so interferon beta, glatiramer acetat, natalizumab, mitoksantron, teriflunomid, dimetil fumarat ali alemtuzumab.
English: • Physicians should provide patients/parents/caregivers with the patient/parents/caregiver guide and with the pregnancy-specific patient reminder card.
Slovenian: • Zdravnik mora bolniku/staršem/skrbniku priskrbeti vodnik za bolnika/starše/skrbnika in opozorilno kartico za bolnico glede nosečnosti.
English: Outcome results are shown in Table 1.
Slovenian: Rezultati so prikazani v preglednici 1.
English: HPS is a rare condition that has been described in association with infections, immunosuppression and a variety of autoimmune diseases.
Slovenian: Hemofagocitni sindrom je redka bolezen, ki so jo opisovali v povezavi z okužbami, zaviranjem imunosti in več različnimi avtoimunskimi boleznimi.
English: Symptoms of PRES are usually reversible but may evolve into ischaemic stroke or cerebral haemorrhage.
Slovenian: Simptomi sindroma posteriorne reverzibilne encefalopatije so običajno reverzibilni, lahko pa se razvijejo v ishemično možgansko kap ali možgansko krvavitev.
English: Treatment with Gilenya will be overseen by a doctor who is experienced in the treatment of multiple sclerosis.
Slovenian: Zdravljenje z zdravilom Gilenya bo nadzoroval zdravnik z izkušnjami pri zdravljenju multiple skleroze.
English: You will be evaluated by a cardiologist (heart specialist) to advise how you should start treatment with Gilenya, including overnight monitoring.
Slovenian: Pregledal vas bo kardiolog (specialist za srce), da bo svetoval, na kakšen način morate začeti zdravljenje z zdravilom Gilenya, kar vključuje tudi opazovanje preko noči.
English: Surveillance should include vigilance for both skin malignancies and mycosis fungoides.
Slovenian: Spremljanje bolnikovega stanja mora vključevati posebno pozornost glede malignomov na koži in fungoidne mikoze.
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).
Slovenian: Pri bolnikih, ki so stari 65 let ali več, je pri uporabi zdravila Gilenya potrebna previdnost zaradi nezadostnih podatkov o varnosti in učinkovitosti zdravila (glejte poglavje 5.2).
English: • Recommendation for overnight monitoring after the first dose (or if the first dose monitoring applies during treatment re-initiation): o Extend heart rate monitoring for at least overnight in a medical facility and until resolution of findings in patients requiring pharmacological intervention during monitoring at treatment initiation/re-initiation.
Slovenian: • Priporočila za spremljanje bolnika preko noči po prejemu prvega odmerka (ali v primeru ponovitve spremljanja kot po prejemu prvega odmerka pri ponovni uvedbi zdravljenja): o Spremljanje srčne frekvence v zdravstveni ustanovi je treba podaljšati najmanj preko noči in dokler ugotovljene motnje ne izzvenijo pri bolnikih, pri katerih je bilo treba v času spremljanja ob uvedbi oziroma ponovni uvedbi zdravljenja farmakološko ukrepati.
English: Gilenya can generally be started immediately after discontinuation of interferon or glatiramer acetate.
Slovenian: Zdravljenje z zdravilom Gilenya je običajno mogoče začeti takoj po prekinitvi zdravljenja z interferonom oziroma z glatiramer acetatom,
English: Not known (frequency cannot be estimated from the available data): - Allergic reactions, including symptoms of rash or itchy hives, swelling of lips, tongue or face, which are more likely to occur on the day you start Gilenya treatment - Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Slovenian: Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov): - alergijske reakcije, vključno s simptomi izpuščaja ali koprivnice, otekanjem ustnic, jezika ali obraza, do česar z večjo verjetnostjo pride na dan, ko bolnik začne jemati zdravilo Gilenya, - tveganje za redko okužbo možganov, imenovano progresivna multifokalna levkoencefalopatija (PML).
English: While you are taking Gilenya (and for up to 2 months after you stop taking it), you may get infections more easily.
Slovenian: V času, ko jemljete zdravilo Gilenya (in še do 2 meseca po prekinitvi jemanja), ste lahko bolj dovzetni za okužbe.
English: Although there are no data to establish that patients with pre-existing liver disease are at increased risk of developing elevated liver function tests when taking Gilenya, caution in the use of Gilenya should be exercised in patients with a history of significant liver disease.
Slovenian: Čeprav ni podatkov, ki bi pri bolnikih z že prisotno boleznijo jeter potrjevali povečano tveganje za zvišanje vrednosti testov jetrne funkcije v času jemanja zdravila Gilenya, je pri uporabi zdravila Gilenya pri bolnikih z anamnezo pomembne bolezni jeter potrebna previdnost.
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”).
Slovenian: Zdravila Gilenya ne smete uporabljati skupaj s takimi zdravili, saj bi lahko okrepila delovanje na imunski sistem (glejte tudi odstavek “Ne jemljite zdravila Gilenya”).
English: Adverse reactions reported with Gilenya 0.5 mg in Studies D2301 (FREEDOMS) and D2309 (FREEDOMS II) are shown below.
Slovenian: Spodaj so prikazani neželeni učinki, o katerih so poročali pri jemanju zdravila Gilenya 0,5 mg v študijah D2301 (FREEDOMS) in D2309 (FREEDOMS II).
English: Do not use Gilenya during pregnancy, if you are trying to become pregnant or if you are a woman who could become pregnant and you are not using effective contraception.
Slovenian: Zdravila Gilenya ne smete uporabljati, če ste noseči, če želite zanositi ali če ste ženska, ki lahko zanosi, pa ne uporabljate učinkovite kontracepcije.
English: You must use effective contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).
Slovenian: V času zdravljenja in še 2 meseca po zaključku zdravljenja morate uporabljati učinkovito kontracepcijo (glejte poglavje “Nosečnost in dojenje”).
English: Although no dose adjustments are needed in patients with mild or moderate hepatic impairment, caution should be exercised when initiating treatment in these patients (see sections 4.4 and 5.2).
Slovenian: Čeprav pri bolnikih z blago ali zmerno okvaro jeter ni potrebno prilagajanje odmerkov, je pri uvajanju zdravila tem bolnikom potrebna previdnost (glejte poglavji 4.4 in 5.2).
English: If you have severe liver problems, you should not take Gilenya.
Slovenian: Če imate hude težave z jetri, ne smete jemati zdravila Gilenya.
English: or - Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Slovenian: ali - bolniki s hitro razvijajočo se hudo recidivno remitentno multiplo sklerozo, opredeljeno z dvema ali več zagoni, ki bolnika onesposobijo, v enem letu in z eno ali več lezijami, ki so pri magnetno resonančnem slikanju možganov vidne po okrepitvi z gadolinijem, ali znatnim povečanjem površine lezij T2 v primerjavi s predhodnim nedavnim magnetno resonančnim slikanjem.
English: Conduct of a prospective cohort study assessing the incidence of cardiovascular adverse events in patients starting GILENYA treatment for relapsing remitting multiple sclerosis based on a CHMP approved protocol.
Slovenian: Do datuma izvesti prospektivno kohortno študijo za oceno pogostnosti kardiovaskularnih neželenih dogodkov pri bolnikih, ki začenjajo zdravljenje z zdravilom GILENYA zaradi recidivno-remitentne multiple skleroze po protokolu, ki ga je odobril odbor CHMP.
English: In these cases your doctor will want you to undergo regular eye examinations in order to detect macular oedema.
Slovenian: V tem primeru vam bo zdravnik naročil, da redno opravljate očesne preglede, da bi ugotovili, če je prišlo do makularnega edema.
English: Caution is required in these subgroups due to very limited knowledge available from the clinical study.
Slovenian: Pri teh podskupinah je potrebna previdnost, ker je poznavanje uporabe zdravila na osnovi klinične študije zelo omejeno.
English: Your doctor will give you a card which explains why you should not become pregnant while taking Gilenya.
Slovenian: Zdravnik vam bo izročil kartico, na kateri bo pojasnjeno, zakaj ne smete zanositi v času jemanja zdravila Gilenya.
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.
Slovenian: Ker je uvedba zdravila Gilenya povezana tudi z znižanjem srčne frekvence (glejte tudi poglavje 4.8, Bradiaritmija), lahko pri sočasni uporabi navedenih učinkovin v času uvajanja zdravila Gilenya pride do hude bradikardije in srčnega bloka.
English: Rare (may affect up to 1 in 1,000 people): - Cancer of the lymphatic system (lymphoma)
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 ljudi): - rak limfatičnega sistema (limfom).
English: • Patients must use effective contraception while taking GILENYA.
Slovenian: • Bolnice morajo v času zdravljenja z zdravilom GILENYA uporabljati učinkovito kontracepcijo.
English: Initiation of treatment with Gilenya should be postponed for 1 month to allow full effect of vaccination to occur.
Slovenian: Začetek zdravljenja z zdravilom Gilenya je treba odložiti še za en mesec, da lahko cepljenje začne učinkovati v celoti.
English: • Precautions should be taken during the first dose of GILENYA and when patients are switched from 0.25 to 0.5 mg daily;
Slovenian: • previdnostne ukrepe je treba upoštevati pri prejemu prvega odmerka zdravila GILENYA in pri prehodu z odmerjanja 0,25 mg na 0,5 mg na dan;
English: o Women of child-bearing potential, including adolescent females, their parents (or legal representatives), and caregivers, should be counselled before treatment initiation and regularly thereafter about the serious risks of GILENYA to the foetus, facilitated by the pregnancy-specific patient reminder card.
Slovenian: o Ženskam v rodni dobi, kar vključuje tudi mladostnice, njihove starše (ali zakonite zastopnike) ter skrbnike, se je treba pred začetkom zdravljenja in redno tudi kasneje svetovati o resnih tveganjih zdravila GILENYA za plod in si pri tem pomagati z opozorilno kartico za bolnico glede nosečnosti.
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.
Slovenian: V tem primeru vam bo zdravnik odložil začetek zdravljenja z zdravilom Gilenya do konca prvega meseca po zaključku celotnega cepljenja.
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.
Slovenian: Število limfocitov se pri večini bolnikov postopoma vrne v okvir normalnih vrednosti v roku 1-2 mesecev po prekinitvi zdravljenja (glejte poglavje 5.1), pri nekaterih bolnikih pa vračanje k izhodiščnim vrednostim traja precej dlje.
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.
Slovenian: V študijah multiple skleroze niso opažali klinično pomembnega vpliva na podaljšanje intervala QT, vendar v klinične študije niso bili vključeni bolniki s povečanim tveganjem za podaljšanje intervala QT.
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.
Slovenian: Če bo po koncu 6-urnega obdobja opazovanja vaš srčni utrip zelo počasen, oziroma se bo njegova hitrost še zmanjševala, ali če bo vaš elektrokardiogram (EKG) pokazal nepravilnosti, vas bodo verjetno morali opazovati dalj časa (še najmanj 2 uri in morda tudi preko noči), dokler težave ne bodo izzvenele.
English: Slow heart rate (bradycardia) and irregular heartbeat At the beginning of treatment or after taking the first dose of 0.5 mg when you switch from a 0.25 mg daily dose, Gilenya causes the heart rate to slow down.
Slovenian: Počasno bitje srca (bradikardija) in nepravilno bitje srca Na začetku zdravljenja oziroma pri prejemu prvega 0,5-miligramskega odmerka po prehodu z odmerjanja 0,25 mg na dan zdravilo Gilenya povzroči, da se bitje srca upočasni.
English: Your chance of developing macular oedema is higher if you have diabetes or have had an inflammation of the eye called uveitis.
Slovenian: Možnost, da pride do makularnega edema pri vas, je povečana, če imate sladkorno bolezen ali ste preboleli očesno vnetje, imenovano uveitis.
English: • Patients will be informed by their doctor of the need for effective contraception while on treatment and for 2 months after discontinuation.
Slovenian: • Zdravnik bo bolnice obvestil, da morajo uporabljati učinkovito kontracepcijo v času zdravljenja in še 2 meseca po prekinitvi zdravljenja.
English: Symptoms of skin cancer may include abnormal growth or changes of skin tissue (e.g. unusual moles) with a change in colour, shape or size over time.
Slovenian: Simptomi kožnega raka lahko vključujejo nenormalno rast ali spremembe kožnega tkiva (na primer neobičajna kožna znamenja), ki sčasoma spreminjajo barvo, obliko ali velikost.
English: Women of childbearing potential must use effective contraception during treatment and for 2 months after discontinuation of Gilenya, since fingolimod takes approximately 2 months to eliminate from the body after treatment discontinuation (see section 4.4).
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo v času zdravljenja in še 2 meseca po prekinitvi uporabe zdravila Gilenya, saj po prekinitvi zdravljenja traja približno 2 meseca, da se fingolimod izloči iz telesa (glejte poglavje 4.4).