natgillin/translations-raw huggingface dataset:
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of. 
Bolnikom je treba priporočiti, da svojega partnerja ali skrbnika obvestijo o svojem zdravljenju, saj bi ti lahko opazili simptome, ki se jih bolnik ne zaveda.
Patients with known risk factors for infections should be closely monitored. 
Bolnike z znanimi dejavniki tveganja za okužbe je treba skrbno spremljati.
• Ringing in the ears (tinnitus) 
• zvonjenje v ušesih (tinitus);
If any of the above applies to you, tell your doctor before starting treatment. 
Če karkoli od zgoraj navedenega velja za vas, to povejte zdravniku, preden začnete z zdravljenjem.
In IFM 2005-02, the adverse reactions were from the maintenance treatment period only. 
V študiji IFM 2005-02 so bili neželeni učinki samo iz obdobja vzdrževalnega zdravljenja.
A second analysis identified events that occurred after the start of maintenance treatment. 
V drugi analizi so ugotovili dogodke po začetku vzdrževalnega zdravljenja.
Lenalidomide has minor or moderate influence on the ability to drive and use machines. 
Lenalidomid ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
In particular, tell your doctor or nurse if you are taking any of the following medicines: 
Zdravniku ali medicinski sestri še zlasti povejte, če jemljete katero od naslednjih zdravil:
Table 4: Summary of overall efficacy data 
Preglednica 4: Povzetek celokupnih podatkov o učinkovitosti
Lenalidomide is taken on certain days over 4 weeks (28 days). 
Zdravilo Lenalidomide se jemlje na določene dneve znotraj 4 tednov (28 dni).
• Description of risk of SPM 
• opis tveganja SPM;
• on what days of your treatment cycle to take each medicine. 
• na katere dni cikla zdravljenja jemljete vsako zdravilo.
Common Sepsis◊, Sinusitis◊ 
pogosti sepsa◊, sinusitis◊
If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day. 
Če je minilo več kot 12 ur, odkar je bolnik pozabil vzeti odmerek ob običajnem času, bolnik tega odmerka ne sme vzeti, ampak mora vzeti naslednji odmerek naslednji dan ob običajnem času.
• do not put pressure on the center of the capsule, as this can cause it to break. 
• ne pritiskajte na osrednji del kapsule, ker bi jo s tem lahko prelomili.
Otherwise, decrease by one dose level at start of next cycle. 
Sicer v začetku naslednjega cikla odmerek zmanjšajte za eno raven.
OTHER SPECIAL WARNING(S), IF NECESSARY WARNING: Risk of severe birth defects. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA OPOZORILO: Tveganje hudih prirojenih okvar.
Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment for safe disposal. 
Bolnikom je treba naročiti, da nikoli ne dajo svojega zdravila drugim in da po koncu zdravljenja vrnejo neporabljene kapsule farmacevtu za varno odstranitev.
It is recommended to press only on one end of the capsule to remove it from the blister thereby reducing the risk of capsule deformation or breakage. 
Priporočljivo je pritisniti samo na en konec kapsule, da jo odstranite iz pretisnega omota, s čimer boste zmanjšali nevarnost, da bi se kapsula deformirala ali prelomila.
These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). 
Vse to so lahko znaki resne in potencialno smrtno nevarne bolezni možganov, ki se imenuje progresivna multifokalna levkoencefalopatija (PML).
• less than 12 hours have passed - take your capsule immediately. 
• je minilo manj kot 12 ur - kapsulo vzemite takoj;
f Median follow-up post-ASCT for all surviving subjects. 
f Mediana spremljanja po ASCT za vse preživele bolnike.
These patients should be monitored closely, especially during the first cycle or dose-escalation, and appropriate precautions taken. 
Te bolnike je treba skrbno spremljati, posebno med prvim ciklom ali ob zvečanju odmerka, in pri njih uvesti ustrezne previdnostne ukrepe.
Other intrinsic factors 
Drugi intrinzični dejavniki
Tests and checks 
Preiskave in kontrolni pregledi
• Guidance on handling lenalidomide for patients, caregivers and family members 
• smernice za ravnanje z lenalidomidom za bolnike, skrbnike in družinske člane;
This requirement includes women of childbearing potential who practice absolute and continuous abstinence. 
Ta zahteva vključuje ženske v rodni dobi, ki upoštevajo popolno in neprekinjeno abstinenco.
• you should take lenalidomide at about the same time on the scheduled days. 
• Lenalidomid morate jemati na načrtovane dni približno ob istem času.
The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception. 
Tveganje za vensko trombembolijo se nadaljuje 4−6 tednov po prekinitvi jemanja kombinirane peroralne kontracepcije.
Developmental toxicity studies were previously conducted in rabbits. 
Študije razvojne toksičnosti so predhodno opravili na kuncih.
Although it was observed at maternotoxic levels they may be attributable to a direct effect. 
Čeprav so te učinke opazili pri odmerkih, ki so bili maternalno toksični, so lahko tudi posledica neposrednega učinka.
• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses 
• spolni odnosi samo z moškim partnerjem, ki so mu opravili vazektomijo; vazektomijo je treba potrditi z dvema negativnima preiskavama sperme;
Summary of results of efficacy analyses as of cut-off date for extended follow-uppooled studies MM-009 and MM-010 (cut-offs 23 July 2008 and 2 March 2008, respectively) 
Povzetek rezultatov analiz učinkovitosti na datum zaključka podaljšanega sledenja - zbrani študiji MM-009 in MM-010 (zaključek 23. julija 2008 oziroma 2. marca 2008)
You will take these other medicines at the start of treatment and then continue to take lenalidomide on its own. 
V začetku zdravljenja boste jemali tudi ta druga zdravila, nato pa boste jemali samo lenalidomid.
• the capsules can be taken either with or without food. 
• Kapsule se lahko jemljejo s hrano ali brez nje.
Response rate 
Stopnja odgovora
• She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide. 
• mora potrditi, da razume tveganja in nujne previdnostne ukrepe, povezane z uporabo lenalidomida.
If any of these apply to you, do not take lenalidomide . 
Če se karkoli od navedenega nanaša na vas, ne vzemite lenalidomida.
Rd vs Rd18 
Rd proti Rd18
Table 7 summarises the results of the follow-up efficacy analyses - pooled studies MM-009 and MM-010. 
V preglednici 7 je povzetek rezultatov sledilnih analiz učinkovitosti - združenih študij MM-009 in MM-010.
Effective measures to avoid pregnancy must be taken (see sections 4.4 and 4.6). 
Uporabiti je treba zanesljive ukrepe za preprečevanje nosečnosti (glejte poglavji 4.4 in 4.6).
In both studies, treatment was to continue until disease progression. 
V obeh študijah je zdravljenje trajalo do napredovanja bolezni.
The Educational brochures for patients should be of 3 types: 
Izobraževalne brošure za bolnike morajo biti treh vrst:
If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms. 
Če ste te simptome imeli že pred zdravljenjem z lenalidomidom, zdravnika obvestite o kakršni koli spremembi teh simptomov.
• if you have had blood clots in the past - you have an increased risk of developing blood clots in the veins and arteries during treatment 
• če ste v preteklosti imeli krvne strdke - imate zvečano tveganje za nastanek krvnih strdkov v venah in arterijah med zdravljenjem;
Lenalidomide is poorly metabolized as 82% of the dose is excreted unchanged in urine. 
Lenalidomid se slabo presnavlja, saj se 82 % odmerka izloči nespremenjenega z urinom.
The renal clearance of lenalidomide exceeds the glomerular filtration rate and therefore is at least actively secreted to some extent. 
Ledvični očistek lenalidomida presega stopnjo glomerulne filtracije, zato se vsaj do neke mere aktivno izloča.
The median age was 73 in the 3 arms. 
Mediana starosti v vseh 3 skupinah je bila 73 let.
Lenalidomide works by affecting the body's immune system and directly attacking the cancer. 
Zdravilo Lenalidomide deluje tako, da vpliva na imunski sistem telesa in neposredno napada raka.
Your doctor may adjust your dose of lenalidomide or stop your treatment based on the results of your blood tests and on your general condition. 
Zdravnik lahko prilagodi odmerek lenalidomida ali prekine zdravljenje na podlagi rezultatov krvnih preiskav ali vašega splošnega stanja.
Any unused product or waste material should be returned to the pharmacist for safe disposal in accordance with local requirements. 
Neuporabljeno zdravilo ali odpadni material vrnite farmacevtu za varno odstranjevanje v skladu z lokalnimi predpisi.
If you are taking lenalidomide in combination with other medicines, you should refer to the package leaflets for these medicines for further information on their use and effects. 
Če jemljete lenalidomid v kombinaciji z drugimi zdravili, glejte navodila za uporabo teh zdravil za nadaljnje informacije o njihovi uporabi in učinkih.
• Dose is modified based upon clinical and laboratory findings (see section 4.4). 
• Odmerek spreminjajte na podlagi kliničnih in laboratorijskih izvidov (glejte poglavje 4.4).
Patients should be advised to promptly report febrile episodes. 
Bolnikom je treba svetovati, da o febrilnih epizodah nemudoma obvestijo zdravnika.
• Infection of the sinuses that surround the nose 
• okužba sinusov, ki obdajajo nos;
A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria: 
Za bolnico ali partnerico moškega bolnika velja, da lahko zanosi, razen če izpolnjuje vsaj eno od naslednjih meril:
• Pneumonias (10.6%; combined term) from IFM 2005-02 
• pljučnice (10,6 %; kombiniran izraz) v študiji IFM 2005-02,
• Women of childbearing potential unless all of the conditions of the Pregnancy Prevention 
• ženske v rodni dobi, razen če izpolnjujejo vse pogoje programa za preprečevanje nosečnosti
Infection with or without neutropenia 
Okužba z nevtropenijo ali brez nje
• Difficulty getting an erection 
• težave pri doseganju erekcije;
In addition to the above adverse reactions identified from the pivotal clinical trials, the following table is derived from data gathered from post-marketing data. 
Poleg zgoraj navedenih neželenih učinkov, ugotovljenih v ključnih kliničnih preskušanjih, je bila naslednja preglednica sestavljena iz podatkov, zbranih v obdobju trženja.
• The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding 
• bolnica upošteva vse pogoje programa za preprečevanje nosečnosti, vključno s potrditvijo, da jih ustrezno razume;
Regular monitoring of visual ability is recommended. 
Priporočljivo je redno spremljanje vida.
Prior to prescribing (and where appropriate, and in agreement with the National Competent Authority, prior to dispensing) all healthcare professionals who intend to prescribe (and dispense) Lenalidomide Accord are provided with a physician information pack containing the following: 
Pred predpisovanjem (in kjer je ustrezno, in v dogovoru s pristojnimi nacionalnimi organi, pred izdajanjem) bodo vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali (in izdajali) zdravilo Lenalidomide Accord, prejeli paket s podatki za zdravnike, ki vsebuje naslednje:
The MAH shall implement a pregnancy prevention programme (PPP) in each Member State. 
Imetnik dovoljenja za promet z zdravilom mora izvajati program za preprečevanje nosečnosti (PPN) v vsaki državi članici.
Though this risk is not yet fully characterized, it should be kept in mind when considering and using lenalidomide in this setting. 
Čeprav to tveganje še ni povsem pojasnjeno, ga je potrebno upoštevati pri odločanju in zdravljenju z lenalidomidom v teh okoliščinah.
• Certain types of skin tumour 
• nekatere vrste tumorjev kože;
Most of the invasive SPMs were solid tumour malignancies. 
Večina invazivnih SPM so bile malignosti s čvrstimi tumorji.
PML was reported several months to several years after starting the treatment with lenalidomide. 
O PML so poročali nekaj mesecev do nekaj let po začetku zdravljenja z lenalidomidom.
Thus, lenalidomide can be administered with or without food. 
Zato se lahko lenalidomid daje s hrano ali brez nje.
Details of the PPP including the set-up of national measures to assess the effectiveness of and compliance with the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product. 
Podrobnosti PPN, vključno z uvedbo nacionalnih ukrepov za ocenjevanje učinkovitosti in skladnosti s PPN, morajo biti dogovorjene s pristojnimi nacionalnimi organi in pripravljene pred prihodom zdravila na trg.
• Changes to blood thyroid hormone, low levels of calcium, phosphate or magnesium in the blood 
• spremembe ravni tiroidnega hormona v krvi, nizke ravni kalcija, fosfata ali magnezija v krvi;
In this study, two methods were used to classify renal function: the urinary creatinine clearance measured over 24 hours and the creatinine clearance estimated by CockcroftGault formula. 
V tej študiji so uporabljali dve metodi za razvrščanje delovanja ledvic: očistek kreatinina v urinu, merjen v obdobju, daljšem od 24 ur, in očistek kreatinina, ocenjen s Cockcroft-Gaultovo formulo.
Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow. 
Zdravnik lahko preveri, ali imate po vsem telesu, vključno s kostnim mozgom, veliko skupno tumorsko maso.
• If less than 12 hours has elapsed since missing a dose, the patient can take the dose. 
• Če je od pozabljenega odmerka minilo manj kot 12 ur, lahko bolnik vzame odmerek.
• You must not take lenalidomide if you are pregnant, as it is expected to be harmful to an unborn baby. 
• Lenalidomida ne smete jemati, če ste noseči, ker se pričakuje, da škoduje nerojenemu otroku.
• Serious allergic reaction that may begin as rash in one area but spread with extensive loss of skin over the whole body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis). 
• resna alergijska reakcija, ki se lahko začne kot izpuščaj v enem predelu, a se razširi z obsežnim odstopanjem kože po vsem telesu (Stevens-Johnsonov sindrom in/ali toksična epidermalna nekroliza);
Adverse reactions have been included under the appropriate category in the table below according to the highest frequency observed in any of the main clinical trials. 
Neželeni učinki so bili vključeni v ustrezno kategorijo v spodnji preglednici glede na največjo pogostnost, ki so jo opazili v kateremkoli od glavnih kliničnih preskušanj.
• Need for adequate contraception and definition of adequate contraception 
• potrebo po ustrezni kontracepciji in opredelitev primerne kontracepcije;
Safety advice relevant to all patients 
Varnostne nasvete, primerne za vse bolnike:
5 mg once daily. 
5 mg enkrat na dan.
Recommended dose adjustments in patients with impaired renal function are described in section 4.2. 
Priporočene prilagoditve odmerkov pri bolnikih z okvaro ledvic so opisane v poglavju 4.2.
Not applicable ª Dose reduction for both medicinal products can be managed independently 
*Odmerke za obe zdravili lahko zmanjšujemo neodvisno.
Lenalidomide should not be used in children and adolescents from birth to less than 18 years because of safety concerns (see section 5.1). 
Zdravila Lenalidomide se ne sme uporabljati pri otrocih in mladostnikih od rojstva do starosti 18 let zaradi pomislekov glede varnosti (glejte poglavje 5.1).
Starting dose (10 mg) 
Začetni odmerek (10 mg)
• Premature ovarian failure confirmed by a specialist gynaecologist 
• prezgodnja odpoved jajčnikov, ki jo potrdi specialist ginekolog;
• Tumour lysis syndrome - metabolic complications that can occur during treatment of cancer and sometimes even without treatment. 
• sindrom tumorske lize - presnovni zapleti, ki se lahko pojavijo med zdravljenjem raka in včasih celo brez zdravljenja.
• Rejection of solid organ transplant (such as kidney, heart). 
• zavrnitev presajenega organa (kot so ledvice, srce).
Also, some other medicines can affect the way lenalidomide works. 
Tudi nekatera druga zdravila lahko vplivajo na način delovanja lenalidomida.
Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient. 
Zdravnik, ki zdravilo predpiše, mora skrbno oceniti odmerek deksametazona, ki ga bo uporabil, ter ob tem upoštevati stanje in status bolezni bolnika.
A conservative approach was applied to determine the adverse reactions from CALGB 100104. 
Pri določanju neželenih učinkov v študiji CALGB 100104 so uporabili konzervativen pristop.
The results for the study, using a cut-off of 1 February 2016, are presented in Table 4 
Rezultati študije, kjer je bil datum zaključka zbiranja podatkov 1. februar 2016, so prikazani v preglednici 4.
• if you are allergic to lenalidomide or any of the other ingredients of this medicine listed in section 6. 
• če ste alergični na lenalidomid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Hepatitis B virus status should be established before initiating treatment with lenalidomide. 
Status virusa hepatitisa B je treba ugotoviti pred začetkom zdravljenja z lenalidomidom.
On day 1 of next cycle, continue G-CSF as needed and maintain dose of lenalidomide if neutropenia was the only DLT. 
1. dan naslednjega cikla nadaljujte z G-CSF po potrebi in vzdržujte odmerek lenalidomida, če je bila nevtropenija edina DLT.
• Increased blood pressure or a fall in blood pressure, slow, fast or irregular heart beat 
• zvišan krvni tlak ali znižanje krvnega tlaka, počasen, hiter ali nepravilen srčni utrip;
• Impaired balance, difficulty moving 
• težave z ravnotežjem, težave pri gibanju;
The ECOG performance status was comparable between both groups, as was the number and type of prior therapies. 
Status zmogljivosti po lestvici ECOG (Eastern Cooperative Oncology Group) je bil pri obeh skupinah primerljiv, prav tako kot število in vrsta predhodnih zdravljenj.
• Changes to a protein in the blood that can cause swelling of the arteries (vasculitis) 
• spremembe beljakovine v krvi, ki lahko povzroči otekanje arterij (vaskulitis);
• Previous bilateral salpingo-oophorectomy, or hysterectomy 
• predhodna bilateralna salpingo-ooforektomija ali histerektomija;
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
• Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1;
• some medicines used for heart problems - such as digoxin 
• nekatera zdravila, ki se uporabljajo za težave s srcem, kot je digoksin
There is no specific experience in the management of lenalidomide overdose in patients, although in dose-ranging studies some patients were exposed to up to 150 mg, and in single-dose studies, some patients were exposed to up to 400 mg. 
Ni izkušenj z obravnavanjem prevelikega odmerjanja lenalidomida pri bolnikih, čeprav so bili v študijah intervalov odmerjanja nekateri bolniki izpostavljeni odmerkom do 150 mg, v študijah z enim odmerkom pa so bili nekateri bolniki izpostavljeni odmerkom do 400 mg.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v Modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
If dose increased (15 mg) a 
Če odmerek zvečamo (15 mg) a
• You must also use effective methods of contraception (see ‘Contraception' below). 
• Tudi vi morate uporabljati zanesljive kontracepcijske metode (glejte ‘Kontracepcija' v nadaljevanju).
• Renal failure (including acute) (6.3%) 
• odpoved ledvic (vključno z akutno) (6,3 %).
Data cut-off dates: 17 Dec 2009 and 01 Feb 2016 
Datuma zaključka zbiranja podatkov: 17. december 2009 in 1. februar 2016
Multiple dosing does not cause marked medicinal product accumulation. 
Večkratno odmerjanje ne povzroča bistvenega kopičenja zdravila.
Renal function (CLcr) 
Delovanje ledvic (CLcr)
• Lung infection (9.4% [9.4% after the start of maintenance treatment]) from CALGB 100104 
• okužba pljuč (9,4 % [9,4 % po začetku vzdrževalnega zdravljenja]) v študiji CALGB 100104.
If PML is suspected, further dosing must be suspended until PML has been excluded. 
Če obstaja sum na PML, se mora nadaljnje odmerjanje prekiniti, dokler ni PML izključen.
c Based on Cox proportional hazards model comparing the hazard functions associated with the indicated treatment arms. 
c Temelji na Coxovem modelu proporcionalnih tveganj, primerja funkcije tveganja, ki so povezane z navedenimi skupinami zdravljenja.
The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and/or dispensing controls, and the collecting of detailed data relating to the indication in order to monitor closely the off-label use within the national territory. 
Nadzorovani sistem distribucije vključuje uporabo opozorilne kartice za bolnika in/ali enakovrednega orodja za kontrolo predpisovanja in/ali izdajanja zdravila in zbiranje natančnih podatkov v zvezi z indikacijami, kar omogoča natančno spremljanje nenamenske uporabe na nacionalnem območju.
For women of childbearing potential, lenalidomide is contraindicated unless all of the following are met: 
Za ženske v rodni dobi je lenalidomid kontraindiciran, razen če so izpolnjeni vsi navedeni pogoji:
The patients at risk of TLS and TFR are those with high tumour burden prior to treatment. 
Bolniki s tveganjem za sindrom tumorske lize in TFR so tisti, ki imajo pred zdravljenjem veliko tumorsko breme.
• Description and management of hypersensitivity and angioedema 
• opis in obvladovanje preobčutljivosti in angioedema
• She understands the expected teratogenic risk to the unborn child 
• razume pričakovano tveganje za teratogene učinke pri nerojenem otroku;
Your doctor will ask you to have a blood test: 
Zdravnik bo opravil krvno preiskavo:
• Increases in your blood sugar level (diabetes) 
• zvišanje ravni krvnega sladkorja (sladkorna bolezen);
• Pneumonia (9.8%) 
• pljučnica (9,8 %);
Patients aged < 65 years at diagnosis who had undergone ASCT and had achieved at least a stable disease response at the time of hematologic recovery were eligible. 
Primerni so bili bolniki, ki so bili ob postavitvi diagnoze stari < 65 let, pri katerih so opravili ASCT in so dosegli vsaj stabilen odgovor bolezni v času hematološkega okrevanja.
Medianf (min, max), months: all surviving patients 
Spremljanje Medianaf (min, maks), meseci: vsi preživeli bolniki
• if you are pregnant, think you may be pregnant or are planning to become pregnant, as lenalidomide is expected to be harmful to an unborn child (see section 2, ‘Pregnancy, breastfeeding and contraception - information for women and men'). 
• če ste noseči, menite da bi lahko bili noseči ali načrtujete zanositev, ker se pričakuje, da je lenalidomid škodljiv za nerojenega otroka (glejte 2. poglavje ‘Nosečnost, dojenje in kontracepcija - informacije za ženske in moške');
• Explanation of the risk of neuropathy with long term use 
• razlago tveganja za pojav nevropatije pri dolgotrajni uporabi,
A second analysis that identified events that occurred after the start of maintenance treatment suggests that the frequencies described in Table 1 may be higher than actually observed during the maintenance treatment period. 
V drugi analizi so ugotovili dogodke, ki so se pojavili po začetku vzdrževalnega zdravljenja, in kaže, da so pogostnosti, navedene v preglednici 1, morda višje od dejanskih pogostnosti, ugotovljenih v obdobju vzdrževalnega zdravljenja.