FrancophonIA/ELRC3.0 huggingface dataset:
English: When?
Slovenian: Kdaj?
English: Each vial is intended for single use only.
Slovenian: Vsaka viala je namenjena samo enkratni uporabi.
English: However, in some cases ITP developed years later.
Slovenian: Vendar se je v nekaterih primerih ITP razvila leta kasneje.
English: Occasionally allergic reactions could occur.
Slovenian: Občasno se lahko pojavijo alergijske reakcije.
English: Classical biotransformation studies have not been conducted.
Slovenian: Klasičnih študij biotransformacije niso izvedli.
English: • Procedures for proper handling and disposal should be observed.
Slovenian: • Upoštevajte postopke pravilnega ravnanja in odstranjevanja.
English: It is important you understand these risks and how to monitor for them.
Slovenian: Pomembno je, da razumete ta tveganja in načine spremljanja njihove prisotnosti.
English: Not known (frequency cannot be estimated from the available data):
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: Therefore, it is important to tell your doctor about all medicines you are taking.
Slovenian: Zato je pomembno, da zdravniku navedete vsa zdravila, ki jih jemljete.
English: However, these changes did not affect fertility and were therefore considered to be non-adverse.
Slovenian: Vendar te spremembe niso vplivale na plodnost, zato se štejejo za neškodljive.
English: Two treatment courses may reduce MS activity for up to 6 years.
Slovenian: Dva postopka zdravljenja lahko zmanjšata aktivnost MS za do 6 let.
English: The maximum daily dose is one infusion.
Slovenian: Največji dnevni odmerek je ena infuzija.
English: These results were obtained from a post hoc analysis and should be interpreted cautiously.
Slovenian: Ti rezultati so bili dobljeni s post-hoc analizo, zato jih je treba tolmačiti previdno.
English: Educational Materials for Healthcare Providers are also available:
Slovenian: Na voljo so tudi izobraževalna gradiva za zdravstvene delavce:
English: What is multiple sclerosis?
Slovenian: Kaj je multipla skleroza?
English: Duration of extension
Slovenian: Trajanje podaljšanja
English: 3 Estimated using a mixed model for repeated measures.
Slovenian: 3 Ocenjeno z mešanim modelom za ponavljajoče se meritve.
English: Summary of the safety profile in clinical studies
Slovenian: Povzetek varnostnega profila v kliničnih študijah
English: It is also possible to develop a herpes infection for the first time.
Slovenian: Obstaja tudi možnost, da se herpesna okužba pojavi prvič.
English: This may be a serious medical condition that can be life threatening.
Slovenian: To je lahko resno zdravstveno stanje, ki lahko ogrozi življenje.
English: Testing is needed even if you are feeling well and your MS symptoms are under control.
Slovenian: Preiskave so potrebne tudi, če se počutite dobro in so simptomi MS obvladani.
English: 88397 Biberach an der Riss GERMANY
Slovenian: 88397 Biberach an der Riss NEMČIJA
English: • decreased/weak immune system
Slovenian: • zmanjšan/šibek imunski sistem
English: The benefits and risks of 5 or more treatment courses have not been established.
Slovenian: Koristi in tveganja 5 ali več stopenj zdravljenja niso povsem ugotovljeni.
English: In addition, these conditions may occur beyond 4 years, therefore, you must continue to look for signs and symptoms, even after you no longer need to do monthly blood and urine tests.
Slovenian: Poleg tega se lahko te bolezni pojavijo po več kot 4 letih, zato morate še naprej ostati pozorni na njihove znake in simptome tudi potem, ko ne potrebujete več mesečnih preiskav krvi in urina.
English: In general, the infections can be treated with standard medicines.
Slovenian: Na splošno se lahko okužbe zdravijo s standardnimi zdravili.
English: In 79.5% of cases, ITP onset occurred within 4 years after first exposure.
Slovenian: V 79,5 % primerih se je ITP pojavila v 4 letih po prvi izpostavljenosti.
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C.
Slovenian: Kemijska in fizikalna stabilnost med uporabo je bila dokazana za 8 ur pri 2 C - 8 C.
English: Recommended laboratory tests for monitoring patients
Slovenian: Priporočene laboratorijske preiskave za spremljanje bolnikov
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (including any vaccinations or herbal medecines).
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali bi lahko jemali katero koli zdravilo (vključno s cepivi ali zdravili rastlinskega izvora).
English: The difference was statistically significant (p=0.0002).
Slovenian: Razlika je bila statistično značilna (p=0,0002).
English: Clinical studies did not include any patients aged over 61 years old.
Slovenian: V klinične študije niso bili vključeni bolniki, starejši od 61 let.
English: As with all therapeutic proteins, there is potential for immunogenicity.
Slovenian: Kot pri vseh terapevtskih proteinih obstaja možnost imunogenosti.
English: No characteristics at study entry identified patients who would later receive one or more additional courses.
Slovenian: Nobena značilnost ob vstopu v raziskavo ni identificirala bolnikov, ki bi pozneje prejeli enega ali več dodatnih ciklov.
English: These are conditions in which your immune system mistakenly attacks your body.
Slovenian: To so bolezni, pri katerih imunski sistem zmotno napade vaše telo.
English: It can also help to slow down or reverse some of the signs and symptoms of MS.
Slovenian: Pripomore tudi k upočasnitvi ali izginotju določenih znakov in simptomov MS.
English: Date of first authorisation: 12 September 2013 Date of latest renewal: 2 July 2018
Slovenian: Datum zadnjega podaljšanja: 2. Julij 2018
English: A risk to the suckling newborn/infant cannot be excluded.
Slovenian: Tveganja za novorojenčka/dojenčka ni možno izključiti.
English: In case of serious reactions, the infusion may be slowed down or even stopped.
Slovenian: V primeru resnih reakcij vam lahko infuzijo upočasnijo ali celo prekinejo.
English: Care should be taken to ensure the sterility of the prepared solution.
Slovenian: Potrebna je previdnost, da se zagotovi sterilnost pripravljene raztopine.
English: • In case of a severe adverse event
Slovenian: • v primeru hudega neželenega učinka,
English: Listeria infection can cause serious illness, including meningitis, but can be treated with appropriate medicines.
Slovenian: Okužba z listerijo lahko povzroči hudo bolezen, vključno z meningitisom, vendar jo je mogoče zdraviti z ustreznimi zdravili.
English: The antibody has an approximate molecular weight of 150 kD.
Slovenian: Protitelo ima približno molekulsko maso 150 kD.
English: Frequencies are defined according to 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).
Slovenian: Pogostnost je razvrščena po naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 to < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: If affected, stop these activities until you feel better.
Slovenian: Če zdravilo na vas deluje na tak način, prekinite te dejavnosti, dokler se ne počutite bolje.
English: There is 1 vial in each carton.
Slovenian: V vsaki škatli je ena viala.
English: These improvements were subsequently maintained, but no firm conclusions can be made with regards to the longer-term efficacy (e.g. 3 and 4 years after additional treatment courses) because many patients completed the study before reaching these time points.
Slovenian: Ta izboljšanja so se nato ohranila, toda glede dolgoročne učinkovitosti (npr. 3 in 4 leta po dodatnih ciklusih) ni mogoče narediti trdnih sklepov, ker so številni bolniki dokončali študijo, preden so dosegli te časovne točke.
English: Atrial fibrillation*
Slovenian: atrijska fibrilacija*
English: The safety and efficacy of LEMTRADA in children with MS aged 0 to 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila LEMTRADA pri otrocih z MS, starih od 0 do 18 let, še nista bili dokazani.
English: LEMTRADA is not intended to be used in children and adolescents below 18 years old as it has not been studied in MS patients below 18 years old.
Slovenian: Zdravilo LEMTRADA ni namenjeno uporabi pri otrocih in mladostnikih, mlajših od 18 let, saj ni bilo preučeno pri bolnikih z MS, mlajših od 18 let.
English: Initial treatment of 2 courses:
Slovenian: Začetno zdravljenje z 2 cikloma:
English: In order to reduce the chance of getting an infection, your doctor will check if other medicines you are taking might be affecting your immune system.
Slovenian: Da se zmanjša verjetnost okužbe, bo vaš zdravnik preveril, ali morda katero drugo zdravilo, ki ga jemljete, vpliva na vaš imunski sistem.
English: The incidence of antibodies is highly dependent on the sensitivity and specificity of the assay.
Slovenian: Pojavnost protiteles je zelo odvisna od občutljivosti in specifičnosti testa.
English: For further information on autoimmune reactions, infections and other information.
Slovenian: z dodatnimi informacijami o avtoimunskih reakcijah in okužbah ter drugimi informacijami.
English: Additional follow-up provided data through a median of 4.8 years (maximum 6.7).
Slovenian: Dodatno spremljanje je zagotovilo podatke za mediano 4,8 leta (največ 6,7 leta).
English: If severe infusion reactions occur, the intravenous infusion should be discontinued immediately.
Slovenian: Če se pojavijo hude z infuzijo povezane reakcije, je treba intravensko infundiranje nemudoma prekiniti.
English: There have been no studies to assess the carcinogenic or mutagenic potential of alemtuzumab.
Slovenian: Študij za oceno kancerogenega ali mutagenega potenciala alemtuzumaba niso opravili.
English: Long-term efficacy data
Slovenian: Podatki o dolgoročni učinkovitosti
English: Reactions have occurred following any of the doses and also after course number 2.
Slovenian: Reakcije so se pojavile po katerem koli odmerku in tudi po ciklusu številka 2.
English: To help you better understand the duration of the effects of treatment and the length of required follow-up, please refer to the diagram below.
Slovenian: Za boljše razumevanje trajanja učinkov zdravljenja in dolžine zahtevanega sledenja glejte spodnjo shemo.
English: If you cannot reach your doctor, you must seek immediate medical attention.
Slovenian: Če ne morete govoriti s svojim zdravnikom, morate poiskati nujno zdravniško oskrbo.
English: Figure 1: Time to 6 Month Confirmed Disability Worsening in Study 2
Slovenian: Slika 1: Čas do 6-mesečnega potrjenega poslabšanja prizadetosti v študiji 2
English: This must be diagnosed and treated early, as otherwise the effects can be serious or even fatal.
Slovenian: To bolezen je treba prepoznati in zdraviti čim prej, saj so lahko njeni učinki resni ali celo smrtno nevarni.
English: Sanofi Belgium Leonardo Da Vincilaan 19 B-1831 Diegem Belgium
Slovenian: Sanofi Belgium Leonardo Da Vincilaan 19 B-1831 Diegem Belgija
English: • You should monitor their test results and remain vigilant for symptoms of adverse events.
Slovenian: • Rezultate preiskav morate spremljati in biti pozorni na simptome neželenih učinkov.
English: • Other medicinal products should not be added to the LEMTRADA infusion solution or simultaneously infused though the same intravenous line.
Slovenian: • Druga zdravila se ne smejo dodajati infuziji zdravila LEMTRADA ali sočasno infundirati po isti intravenski liniji.
English: Up to two additional treatment courses, as needed, may be considered (see section 5.1):
Slovenian: Razmisliti je mogoče o največ dveh dodatnih ciklusih zdravljenja, kot je potrebno (glejte poglavje 5.1):
English: • It is extremely important that your patient understands the commitment to having periodic testing performed (for 4 years after last infusion) even if they are asymptomatic and their MS disease is well controlled.
Slovenian: • Izjemno pomembno je, da bolnik razume obveznost glede rednih preiskav (še štiri leta po zadnji infuziji), čeprav je asimptomatičen in je MS dobro obvladana.
English: It was often self-limiting and relatively mild, although severity and outcome was unknown in many cases.
Slovenian: Pogosto je bila samoomejujoča in razmeroma blaga, vendar njena izrazitost in izid v številnih primerih nista znana.
English: CDI is a measure for sustained disability improvement.
Slovenian: CDI je merilo trajnejšega zmanjšanja prizadetosti.
English: Safety profile in long-term follow-up
Slovenian: Varnostne značilnosti med dolgoročnim spremljanjem
English: Lymphocytes repopulate over time with B-cell recovery usually completed within 6 months.
Slovenian: Limfociti se sčasoma znova naselijo, pri čemer je obnovitev celic B običajno zaključena v 6 mesecih.
English: There are certain signs and symptoms that you should look out for yourself.
Slovenian: Na nekatere znake in simptome morate biti pozorni sami.
English: If you live in a region where tuberculosis infections are common, you may be at greater risk of infection with tuberculosis.
Slovenian: Če živite v področju, kjer je pogosta tuberkuloza, je pri vas lahko prisotno večje tveganje za tuberkulozo.
English: Both cases were serious, were identified early through clinical and laboratory monitoring, and had a positive outcome after treatment.
Slovenian: V obeh primerih je bila bolezen resna in je bila odkrita s kliničnimi in laboratorijskimi preiskavami, po zdravljenju pa je bil izid pozitiven.
English: LEMTRADA does not cure MS, but it can reduce the number of MS relapses.
Slovenian: Zdravilo LEMTRADA ne ozdravi MS, vendar lahko zmanjša število recidivov MS.
English: 4.5/3.8 years
Slovenian: 4,5/3,8 let
English: Patients with other concomitant autoimmune diseases (besides MS).
Slovenian: Bolniki z drugimi sočasnimi avtoimunskimi boleznimi (poleg MS).
English: Mean Age (years) Mean/Median Disease duration
Slovenian: Izhodiščne lastnosti Povprečna starost (leta) Povprečno/mediano trajanje bolezni
English: Several of the patients reported were below 40 years of age and had no risk factors for ischemic heart disease.
Slovenian: Več bolnikov, o katerih so poročali, je bilo mlajših od 40 let in niso imeli dejavnikov tveganja za ishemično srčno bolezen.
English: He/She will advise you what is right for you and your baby.
Slovenian: Zdravnik/zdravnica vam bo svetoval(a) o najboljši izbiri za vas in vašega otroka.
English: 1 Co-primary endpoints: ARR & CDW.
Slovenian: 1 Sočasni primarni končni točki: ARR in CDW.
English: The number of normal sperm was significantly reduced (<10%) relative to controls and the percent abnormal sperm (detached heads or no heads) were significantly increased (up to 3%).
Slovenian: Število normalnih semenčic se je pomembno zmanjšalo (<10 %) v primerjavi s kontrolnimi živalmi, odstotek nenormalnih semenčic (z odstranjenimi glavicami ali brez njih) pa je bil pomembno povečan (do 3 %).
English: However, there may be benefits of breast milk (which can help protect a baby from infections), so talk to your doctor if you are planning to breast-feed your baby.
Slovenian: Vendar ima materino mleko lahko koristne učinke (ki lahko zaščitijo otroka pred okužbami), zato se posvetujte z zdravnikom, če nameravate svojega otroka dojiti.
English: • inflammation of the gallbladder with or without gallstones
Slovenian: • vnetje žolčnika z ali brez žolčnih kamnov
English: However, research suggests immunomodulatory effects through the depletion and repopulation of lymphocytes, including:
Slovenian: Vendar raziskave kažejo na imunomodulatorne učinke preko osiromašenja in ponovne naselitve limfocitov, vključno s:
English: Do not freeze or shake.
Slovenian: Ne zamrzujte ali stresajte.
English: When you have medical treatment, even if it is not for your MS, show the Patient Alert Card to the doctor.
Slovenian: Če se boste zdravili, tudi če ne zaradi MS, zdravniku pokažite opozorilno kartico za bolnika.
English: During post-marketing use, rare, serious, sometimes fatal and unpredictable adverse events from various organ systems have been reported.
Slovenian: V obdobju po prihodu zdravila na trg so poročali o redkih, resnih, včasih smrtnih in nepredvidljivih neželenih učinkih na različne organske sisteme.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden prejmete to zdravilo.
English: In MS your immune system mistakenly attacks the protective layer (myelin) around the nerve fibres, causing inflammation.
Slovenian: Pri MS vaš imunski sistem zmotno napada zaščitno ovojnico (mielin) okoli živčnih vlaken in povzroči vnetje.
English: Each infusion will take approximately 4 hours.
Slovenian: Ena infuzija traja približno štiri ure.
English: Study 3 (phase 2 study CAMMS223) evaluated the safety and efficacy of LEMTRADA in patients with RRMS over the course of 3 years.
Slovenian: V študiji 3 (študija 2. faze CAMMS223) so ocenjevali varnost in učinkovitost zdravila LEMTRADA pri bolnikih z RRMS v obdobju 3 let.
English: • polysorbate 80 (E433)
Slovenian: • polisorbat 80 (E433)
English: When the inflammation causes symptoms this is often called an “attack” or a “relapse”.
Slovenian: Pojav, ko vnetje povzroči simptome, običajno imenujemo „napad“ ali „recidiv“.
English: Median % Change in Brain Parenchymal Fraction
Slovenian: Mediana % sprememba v deležu možganskega parenhima
English: Read all of this leaflet carefully before you are administered this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Missed doses should not be given on the same day as a scheduled dose.
Slovenian: Zamujenih odmerkov se ne sme dajati na isti dan kot načrtovani odmerek.
English: Early detection and treatment of nephropathies may decrease the risk of poor outcomes.
Slovenian: Zgodnje odkrivanje in zdravljenje nefropatij lahko zmanjša tveganje slabega izida.
English: Patients who participated in CAMMS223, CAMMS323, or CAMMS32400507 (see baseline characteristics above)
Slovenian: Bolniki, ki so sodelovali v CAMMS223, CAMMS323 ali CAMMS32400507 (glejte izhodiščne značilnosti zgoraj)
English: The initial treatment you will receive will consist of one infusion per day for 5 days (course 1) and one infusion per day for 3 days one year later (course 2).
Slovenian: Začetno zdravljenje bo zajemalo eno infuzijo na dan 5 dni (1. postopek) in eno infuzijo na dan 3 dni eno leto kasneje (2. postopek).
English: The study provides efficacy and safety through a median of 6 years from entry into Studies 1 and 2.
Slovenian: Študija je zagotovila podatke o učinkovitost in varnosti za mediano 6 let od vključitve bolnikov v 1. in 2. študijo.
English: CB9 8PU United Kingdom
Slovenian: CB9 8PU Velika Britanija
English: This analysis includes data from Phase 3 studies only (CAMMS324 and CAMMS323) due to differences in the MRI acquisition algorithms between the Phase 2 and Phase 3 studies.
Slovenian: Ta analiza vključuje le podatke iz študij 3. faze (CAMMS324 in CAMMS323), ker se algoritmi pridobivanja MRposnetkov med študijami 2. in 3. faze razlikujejo.
English: LEMTRADA is used if your MS is highly active despite that you have been treated with at least one other medicine for MS or if your MS is rapidly evolving.
Slovenian: Zdravilo LEMTRADA se uporablja, če imate zelo aktivno MS, čeprav ste prejemali že vsaj eno drugo zdravilo za MS, ali če se vam MS razvija hitro.
English: Disability1 (Confirmed Disability Worsening [CDW] 2
Slovenian: Prizadetost2 (Potrjeno poslabšanje prizadetosti [confirmed disability worsening - CDW]
English: Symptoms have been reported to occur within a few months to four years following the initiation of treatment.
Slovenian: Poročali so, da se simptomi pojavijo od nekaj mesecev do štiri leta po začetku zdravljenja.
English: Before initiation of therapy, evaluation of immune serostatus could be considered according to local guidelines.
Slovenian: Pred začetkom zdravljenja lahko v skladu z lokalnimi smernicami pride v poštev ocena imunskega serološkega statusa.
English: For these reasons, comparison of the incidence of antibodies to LEMTRADA with the incidence of antibodies to other products may be misleading.
Slovenian: Zaradi tega je primerjava pojavnosti protiteles proti zdravilu LEMTRADA s pojavnostjo protiteles proti drugim zdravilom lahko zavajajoča.
English: LEMTRADA is not recommended for patients with inactive disease or those stable on current therapy.
Slovenian: Zdravilo LEMTRADA ni priporočljivo za bolnike z neaktivno boleznijo ali bolnike, ki so stabilni s trenutnim zdravljenjem.
English: Doses higher than the recommended dose may result in more serious or longer lasting infusion reactions (see section 4) or a stronger effect on the immune system.
Slovenian: Odmerki, ki so večji od priporočenih, lahko privedejo do resnejših ali dalj časa trajajočih z infuzijo povezanih reakcij (glejte poglavje 4) ali močnejšega učinka na imunski sistem.
English: From a microbiological point of view, it is recommended that the product should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba zdravilo nemudoma uporabiti.
English: Human Immunodeficiency Virus (HIV) infection.
Slovenian: Okužba z virusom človeške imunske pomanjkljivosti (HIV).
English: Other treatments to limit these reactions can also be given before the infusion or when you experience symptoms.
Slovenian: Za omejevanje teh reakcij se lahko pred infuzijo ali ob pojavu simptomov dajejo tudi druga zdravila.
English: The observation time should be extended (hospitalisation) as appropriate.
Slovenian: Čas opazovanja (hospitalizacijo) je treba podaljšati, če je potrebno.
English: Your doctor will explain to you what tests you will need.
Slovenian: Zdravnik vam bo pojasnil, katere preiskave je treba opraviti pri vas.
English: The ability to generate an immune response to any vaccine following LEMTRADA treatment has not been studied.
Slovenian: Sposobnost imunskega odziva na katero koli cepivo po zdravljenju z zdravilom LEMTRADA ni bila preučena.
English: • asthma
Slovenian: • astma
English: The pharmacokinetics of alemtuzumab in RRMS has not been studied in patients aged 55 years and older.
Slovenian: Farmakokinetika alemtuzumaba pri RRMS ni bila preizkušena na bolnikih, starih 55 let in več.
English: • sensation of spinning or loss of balance, migraine
Slovenian: • občutek vrtenja ali izguba ravnotežja, migrena
English: 2 Patient Guide:
Slovenian: 2 Vodnik za bolnike:
English: • tuberculosis
Slovenian: • tuberkoloza
English: Excipients with known effect
Slovenian: Pomožna snov z znanim učinkom
English: Therefore, it is recommended that all female patients have an annual screening performed, such as a cervical smear.
Slovenian: Zato je priporočljivo, da vse ženske opravljajo letne presejalne preglede, kot je bris materničnega vratu.
English: It is not known if LEMTRADA affects your response to a vaccine.
Slovenian: Ni znano, ali zdravilo LEMTRADA vpliva na vaš odziv na cepivo.
English: Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Conclusions cannot be made with available data on the effect of race and gender on the pharmacokinetics of alemtuzumab.
Slovenian: Na podlagi razpoložljivih podatkov ne moremo sklepati na vpliv rase in spola na farmakokinetiko alemtuzumaba.
English: Before initiation of therapy, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection, according to local guidelines.
Slovenian: Pred uvedbo zdravljenja je treba v skladu z lokalnimi smernicami vse bolnike pregledati glede aktivne in neaktivne ("latentne") okužbe s tuberkulozo.