natgillin/translations-raw huggingface dataset:
The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential. 
Pogoji programa za preprečevanje nosečnosti morajo biti izpolnjeni za vse bolnice, razen če obstajajo zanesljivi dokazi, da bolnica ne more zanositi.
If a patient is currently using combined oral contraception the patient should switch to one of the effective methods listed above. 
Če bolnica trenutno uporablja kombinirano peroralno kontracepcijo, mora preiti na eno od zgoraj navedenih zanesljivih metod.
• how much lenalidomide you should take 
• koliko lenalidomida morate jemati;
• The need to avoid foetal exposure 
• potrebo po izogibanju fetalni izpostavljenosti;
If you are aged 75 years or older or have moderate to severe kidney problems - your doctor will check you carefully before starting treatment. 
Če ste stari 75 let ali več ali imate zmerne do hude težave z ledvicami, vas bo zdravnik skrbno pregledal, preden bo začel z zdravljenjem.
Rd vs MPT 
Rd proti MPT
7.5 mg once daily2 15 mg every other day 
7,5 mg enkrat na dan2 15 mg vsak drugi dan
Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell. 
Diseminirani plazmocitom je vrsta raka, ki prizadene določeno vrsto belih krvnih celic, ki se imenujejo plazmatke.
• She should be capable of complying with effective contraceptive measures 
• mora biti zmožna upoštevati zanesljive kontracepcijske ukrepe;
a The median is based on the Kaplan-Meier estimate. 
a Mediana temelji na Kaplan-Meierjevi oceni.
Lenalidomide is produced as a racemic mixture. 
Lenalidomid se izdeluje v obliki racematne zmesi.
Patients should be advised to promptly report febrile episodes, a treatment interruption and/or dose reductions may be required (see section 4.2). 
Bolnike je treba opozoriti, da morajo takoj poročati primere zvišane telesne temperature, morda bo potrebna prekinitev zdravljenja in/ali zmanjšanje odmerka (glejte poglavje 4.2).
The MAH should agree on the implementation of the patient card system in each Member State. 
Imetnik dovoljenja za promet z zdravilom se mora dogovoriti o izvajanju sistema opozorilnih kartic za bolnika v vsaki državi članici.
Therefore, lenalidomide is unlikely to cause any clinically relevant medicinal product interactions when co-administered with substrates of these enzymes. 
Zato ni verjetno, da bi lenalidomid povzročal kakšno klinično pomembno medsebojno delovanje zdravil, kadar ga dajemo sočasno s substrati teh encimov.
• Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential). 
• starost ≥ 50 let in naravna amenoreja ≥ 1 leto (amenoreja po zdravljenju raka ali med dojenjem ne izključuje zmožnosti zanositve)
Cases of allergic reaction/hypersensitivity reactions have been reported. 
Poročali so o primerih alergijskih reakcij/preobčutljivostnih reakcij.
• if you have or have ever had previous viral infection, particularly hepatitis B infection, varicella zona, HIV. 
• če imate ali ste kadar koli prej imeli predhodno virusno okužbo, posebno okužbo s hepatitisom B, noricami zoster, HIV.
The increased risk of secondary primary malignancies associated with lenalidomide is relevant also in the context of NDMM after stem cell transplantation. 
Zvečano tveganje sekundarnih primarnih malignosti, povezanih z lenalidomidom, je pomembno tudi v kontekstu NDDP po presaditvi matičnih celic.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Bolniki z redko dedno intoleranco za galaktozo, popolnim pomanjkanjem aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
• Use in patients with hepatic and/or renal impairment 
• uporabo pri bolnikih z jetrno in/ali ledvično okvaro
The following can be considered to be examples of suitable methods of contraception: 
Primeri ustreznih kontracepcijskih metod so:
The MAH should agree the final text of the healthcare profesional's information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below. 
Imetnik dovoljenja za promet z zdravilom se mora s pristojnimi nacionalnimi organi v vsaki državi članici dogovoriti o končnem besedilu vsebin paketa s podatki za zdravstvene delavce ter zagotoviti, da gradiva vsebujejo ključne elemente, kot je opisano spodaj.
• Need for adequate contraception (even if woman has amenorrhoea) and definition of adequate contraception 
• potrebo po ustrezni kontracepciji (tudi, če ima ženska amenorejo) in opredelitev ustrezne kontracepcije,
• Febrile neutropenia (6.0%) 
• febrilna nevtropenija (6,0 %);
PD = progressive disease; PR = partial response; R = lenalidomide; SD = stable disease; VGPR = very good partial response. 
PD = napredujoča bolezen; PR = delni odgovor; R = lenalidomid; SD = stabilna bolezen; VGPR = zelo dober delni odgovor.
However, it is not known whether there is an interaction during clinical use (concomitant treatment with dexamethasone). 
Vendar ni znano, ali obstaja interakcija med klinično uporabo (sočasno zdravljenje z deksametazonom).
Patients who had previous allergic reactions while treated with thalidomide should be monitored closely, as a possible cross-reaction between lenalidomide and thalidomide has been reported in the literature. 
Bolnike, ki so imeli predhodne alergijske reakcije med zdravljenjem s talidomidom, je treba skrbno nadzirati, ker so v literaturi poročali o možni navzkrižni reakciji med lenalidomidom in talidomidom.
b The 95% CI about the median. 
b 95 % IZ okrog mediane.
The Cmax was similar between healthy subjects and patients with renal impairment. 
Vrednost Cmax je bila pri zdravih osebah in bolnikih z ledvično okvaro podobna.
If PML is confirmed, lenalidomide must be permanently discontinued. 
Če je PML potrjen, je treba zdravljenje z lenalidomidom trajno prekiniti.
Physicians should monitor patients at regular intervals and should consider PML in the differential diagnosis in patients with new or worsening neurological symptoms, cognitive or behavioural signs or symptoms. 
Zdravniki morajo bolnike v rednih intervalih spremljati in pri diferencialni diagnozi bolnikov, pri katerih se pojavijo novi ali poslabšajo obstoječi nevrološki simptomi, kognitivni ali vedenjski znaki ali simptomi, upoštevati možnost prisotnosti PML.
The primary efficacy endpoint in both studies was time to progression (TTP). 
Primarni cilj za dokaz učinkovitosti v obeh študijah je bil čas do napredovanja bolezni (TTP - time to progression).
This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure (this condition is called ‘Tumour Lysis Syndrome'). 
To lahko povzroči stanje, ko tumor med razpadanjem povzroči nenavadno visoko raven kemijskih snovi v krvi, kar lahko povzroči odpoved ledvic (to stanje se imenuje ‘sindrom tumorske lize').
Both patient populations presented a median age of 63 years, with a comparable male to female ratio. 
Mediana starosti je bila v obeh populacijah bolnikov 63 let, s primerljivim razmerjem moških in žensk.
• press only one end of the capsule out to push it through the foil 
• pritisnete samo na en konec kapsule in jo s tem potisnete skozi folijo;
• how much of the other medicines you should take in combination with lenalidomide , if any 
• koliko, če sploh kaj, drugih zdravil morate jemati v kombinaciji z lenalidomidom;
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Initial dose and regimen for Rd and Rd18 were adjusted according to age and renal function (see section 4.2). 
Začetni odmerek in shemo odmerjanja za Rd in Rd18 so prilagodili starosti in funkciji ledvic (glejte poglavje 4.2).
• That the patient should not give Lenalidomide Accord to any other person 
• opozorilo, da bolnik ne sme dajati zdravila Lenalidomide Accord nobeni drugi osebi;
However, dexamethasone is known to be a weak to moderate inducer of CYP3A4 and is likely to also affect other enzymes as well as transporters. 
Vendar pa je znano, da je deksametazon šibek do zmeren spodbujevalec encima CYP3A4 ter da je verjetno, da vpliva tudi na druge encime in transportne beljakovine.
In vitro, lenalidomide is a substrate of P-gp, but is not a P-gp inhibitor. 
In vitro je lenalidomid substrat P-gp, ni pa zaviralec P-gp.
The prescriber must inform male and female patients about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme and provide patients with appropriate patient educational brochure, patient card and/or equivalent tool in accordance to the national implemented patient card system. 
Zdravnik, ki predpisuje zdravilo, mora opozoriti bolnike in bolnice na pričakovano teratogeno tveganje in na stroge ukrepe preprečevanja nosečnosti, kot so podrobno opisani v programu za preprečevanje nosečnosti, in nuditi bolnicam ustrezno izobraževalno brošuro za bolnike, opozorilno kartico za bolnika in/ali enakovredno orodje v skladu z nacionalno uveljavljenim sistemom opozorilne kartice za bolnika.
A haemoglobin concentration above 12 g/dl should lead to discontinuation of erythropoietic agents. 
Če je koncentracija hemoglobina nad 12 g/dl, je treba prekiniti uporabo eritropoetskih zdravil.
Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day. 
V idealnem primeru se morajo test nosečnosti, izdaja recepta in izdaja zdravila opraviti na isti dan.
Lenalidomide Accord hard capsules should be taken orally at about the same time on the scheduled days. 
Trde kapsule zdravila Lenalidomide Accord je treba jemati peroralno na načrtovane dni ob približno istem času.
Patients should be carefully assessed for their ability to tolerate lenalidomide in combination, with consideration to age, ISS stage III, ECOG PS≤2 or CLcr<60 mL/min (see sections 4.2 and 4.8). 
Bolnike morate skrbno oceniti glede njihove sposobnosti prenašanja lenalidomida v kombinaciji, z upoštevanjem starosti, stadija III ISS, ECOG PS≤2 ali CLcr<60 ml/min (glejte poglavji 4.2 in 4.8).
Women of childbearing potential / Contraception in males and females Women of childbearing potential should use effective method of contraception. 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijsko metodo.
Therefore, induction leading to reduced efficacy of medicinal products, including hormonal contraceptives, is not expected if lenalidomide is administered alone. 
Zato se ne pričakuje spodbujanja, ki bi znižalo učinek zdravila, vključno s hormonskimi kontraceptivi, če se lenalidomid daje sam.
Requirements in the event of pregnancy 
Zahteve v primeru nosečnosti:
Prophylactic antithrombotic medicinal products should be recommended, especially in patients with additional thrombotic risk factors. 
Priporočiti je treba uporabo profilaktičnih antitrombotikov, zlasti pri bolnikih z dodatnimi dejavniki tveganja za trombozo.
Treatment with lenalidomide may cause virus to become active again, in patients who carry the virus, resulting in a recurrence of the infection. 
Zdravljenje z lenalidomidom lahko povzroči, da virus pri bolnikih, ki ga prenašajo, spet postane aktiven, kar povzroči ponovitev okužbe.
This is because lenalidomide can affect the way some other medicines work. 
Lenalidomid lahko vpliva na način delovanja nekaterih drugih zdravil.
According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be performed for women of childbearing potential as outlined below. 
V skladu z lokalno prakso je treba pri ženskah v rodni dobi opraviti test nosečnosti pod zdravniškim nadzorom, z občutljivostjo vsaj 25 mi.e./ml, kot je opisano spodaj.
The evaluation for PML should be based on neurological examination, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV. 
Vrednotenje PML mora temeljiti na nevrološkem pregledu, magnetnoresonančnem slikanju možganov in analizi cerebrospinalne tekočine za ugotavljanje prisotnosti DNK virusa JC (JCV) s pomočjo testa verižne reakcije s polimerazo (PCR) ali na biopsiji možganov s testiranjem na prisotnost JCV.
The contribution of renal excretion to total clearance in subjects with normal renal function was 90%, with 4% of lenalidomide eliminated in faeces. 
Prispevek ledvičnega izločanja k skupnemu očistku pri osebah z normalnim delovanjem ledvic je bil 90 %, pri čemer se 4 % lenalidomida izloči z blatom.
Lenalidomide has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations. 
Lenalidomida niso formalno preiskovali pri bolnikih z okvaro jeter in zanje ni posebnih priporočil za odmerjanje.
The capsules should be swallowed whole, preferably with water, either with or without food. 
Kapsule je treba pogoltniti cele, po možnosti z vodo, s hrano ali brez nje.
Dose adjustment (days 1 to 21 of repeated 28-day cycles) 
Prilagoditev odmerka (od 1. do 21. dne, v ponavljajočih se 28-dnevnih ciklih)
• a chemotherapy medicine called ‘melphalan' and 
• s kemoterapevtskim zdravilom, ki se imenuje ‘melfalan', in
Carcinogenicity studies with lenalidomide have not been conducted. 
Študij kancerogenosti z lenalidomidom niso opravili.
• Grade 4 neutropenia (see section 4.4). 
• nevtropenija 4. stopnje (glejte poglavje 4.4).
As a precaution and taking into account special populations with prolonged elimination time such as renal impairment, all male patients taking lenalidomide must meet the following conditions: 
Kot varnostni ukrep in ob upoštevanju posebnih populacij, ki imajo podaljšan čas odstranjevanja iz telesa, na primer pri ledvični okvari, morajo vsi moški bolniki, ki jemljejo lenalidomid, izpolnjevati naslednje pogoje:
• Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling. 
• povzetek glavnih značilnosti zdravila (SmPC), navodilo za uporabo in označevanje.
Action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia). 
Z ustreznimi ukrepi je treba poskusiti zmanjšati tiste dejavnike tveganja, na katere lahko vplivamo (npr. kajenje, hipertenzija in hiperlipidemija).
e Exploratory endpoint (PFS2). 
e Končni cilj raziskave (PFS2).
d The p-value is based on the unstratified log-rank test of Kaplan-Meier curve differences between the indicated treatment arms. 
d Vrednost p temelji na nestratificiranem testu log-rank razlik med Kaplan-Meierjevimi krivuljami za navedene skupine zdravljenja.
All patients should be advised to seek medical attention promptly at the first sign of infection (eg, cough, fever, etc) thereby allowing for early management to reduce severity. 
Vsem bolnikom morate svetovati, naj pri prvem znaku okužbe (npr. kašelj, zvišana telesna temperatura itn.) takoj poiščejo zdravniško pomoč, s čimer bo omogočeno zgodnje zdravljenje in s tem manjša resnost okužbe.
The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoietic, and immunomodulatory properties. 
Mehanizem delovanja lenalidomida vključuje antineoplastične, antiangiogenetske, proeritropoetske in imunomodulatorne lastnosti.
• Pregnancy test dates and results 
• datume in rezultate testov nosečnosti.
Treatment cycle 
Cikel zdravljenja
Some of these cases have progressed to acute hepatic failure resulting in discontinuation of lenalidomide and adequate antiviral treatment. 
Nekateri od teh primerov so napredovali v akutno odpoved jeter, zaradi katere so ukinili lenalidomid in uvedli ustrezno protivirusno zdravljenje.
Patients may continue lenalidomide and dexamethasone therapy until disease progression or intolerance. 
Bolniki smejo nadaljevati z zdravljenjem z lenalidomidom in deksametazonom do napredovanja bolezni ali intolerance.
Rd18 vs MPT 
Rd18 proti MPT
• before treatment 
• pred zdravljenjem,
The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that: 
Imetnik dovoljenja za promet z zdravilom se mora o podrobnostih sistema za nadzorovano distribucijo dogovoriti s pristojnimi nacionalnimi organi in izvajati ta program na državni ravni, da tako zagotovi naslednje:
Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism. 
Bolniki in zdravniki morajo biti pozorni na znake in simptome trombembolije.
No interaction study has been performed with oral contraceptives. 
S peroralnimi kontraceptivi niso opravili študij interakcij.
Findings from this study indicate that lenalidomide produced external malformations including non-patent anus and malformations of upper and lower extremities (bent, shortened, malformed, malrotated and/or absent part of the extremities, oligo and/or polydactyly) in the offspring of female monkeys who received the active substance during pregnancy. 
Ugotovitve te študije kažejo, da lenalidomid povzroča zunanje malformacije, vključno z neperforiranim anusom in malformacijami zgornjih in spodnjih udov (ukrivljene, skrajšane, malformirane, malrotirane in/ali manjkajoče dele udov, oligo in/ali polidaktilijo) pri mladičih samic opic, ki so med nosečnostjo prejemale to učinkovino.
Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling. 
Bolnikom je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo simptomi, kot so zasoplost, bolečine v prsnem košu in otekanje rok ali nog.
Cases of hypothyroidism and cases of hyperthyroidism have been reported. 
Poročali so o primerih hipotiroidizma in hipertiroidizma.
Lenalidomide is generally more soluble in organic solvents but exhibits the greatest solubility in 0.1N HCl buffer. 
Lenalidomid je na splošno bolj topen v organskih topilih, vendar pa je najbolj topen v 0,1 N HCl raztopini.
The capsules should not be opened, broken or chewed. 
Kapsul se ne sme odpirati, zdrobiti ali žvečiti.
The European Medicines Agency has waived the obligation to submit the results of studies with lenalidomide in all subsets of the paediatric population in multiple myeloma, (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z lenalidomidom za vse podskupine pediatrične populacije z diseminiranim plazmocitomom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started. 
Če se pri bolniku pojavijo kakršnikoli trombembolični dogodki, je treba zdravljenje prekiniti in uvesti standardno antikoagulacijsko zdravljenje.
• by stimulating part of the immune system to attack the cancer cells. 
• spodbuja del imunskega sistema, da napada rakave celice.
For women taking lenalidomide Before starting the treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely. 
Pred začetkom zdravljenja vprašajte zdravnika, ali je možno, da bi lahko zanosili, tudi če mislite, da to ni verjetno.
However with a longer follow-up, the difference in overall survival in favour of lenalidomide/ low dose dexamethasone tends to decrease. 
Vendar pa pri daljšem spremljanju razlika v celokupnem preživetju v korist lenalidomida/deksametazona v manjšem odmerku kaže tendenco zmanjševanja.
• Need to provide comprehensive advice and counselling to patients 
• potrebo po obsežnem posvetu in svetovanju bolnikov,
0.25 mg/kg ª If neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide 
0,25 mg/kg ª Če je nevtropenija edina toksičnost ne glede na raven odmerka, dodajte granulocitne kolonije stimulirajoči faktor (G-CSF) in vzdržujte raven odmerka lenalidomida.
If you think you may be allergic, ask your doctor for advice. 
Če mislite, da ste alergični, se posvetujte z zdravnikom.
Results of these analyses subsequently led to an unblinding in both studies, in order to allow patients in the placebo/dex group to receive treatment with the len/dex combination. 
Rezultati teh analiz so kasneje privedli do razkritja podatkov v obeh študijah, da bi bolniki v skupini placebo/deks, lahko prejemali zdravljenje s kombinacijo len/deks.
At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. 
Kadarkoli med zdravljenjem ali po njem zdravniku ali medicinski sestri takoj povejte, če: se pojavijo zamegljen vid, izguba vida ali dvojni vid, težave z govorom, šibkost v roki ali nogi, sprememba v načinu hoje ali težave z ravnotežjem, dolgotrajna omrtvelost, zmanjšana občutljivost ali izguba občutljivosti, izguba spomina ali zmedenost.
Patients with newly diagnosed multiple myeloma aged 75 years and older should be carefully assessed before treatment is considered (see section 4.4). 
Bolnike z novo diagnosticiranim diseminiranim plazmocitomom, stare 75 let ali več, je treba skrbno oceniti, preden uvedemo zdravljenje (glejte poglavje 4.4).
Lenalidomide is taken in treatment cycles, each cycle lasting 28 days (see above ‘Treatment cycle'). 
Zdravilo Lenalidomide se jemlje v ciklih zdravljenja, ki trajajo po 28 dni (glejte ‘Cikel zdravljenja' zgoraj).
The results indicate that as renal function decreases (< 50 mL/min), the total lenalidomide clearance decreases proportionally resulting in an increase in AUC. 
Rezultati kažejo, da se z zmanjšanjem delovanja ledvic (< 50 ml/min) sorazmerno manjša skupni očistek lenalidomida, zaradi česar se poveča vrednost AUC.
Of the 704 patients evaluated in the MM-009 and MM-010 studies, 44.6% were aged 65 or over. 
Od 704 bolnikov, ki so jih ocenili v študijah MM-009 in MM-010, je bilo 44,6 % bolnikov starih 65 let ali več.
You must follow the Lenalidomide Pregnancy Prevention Programme 
Upoštevati morate program za preprečevanje nosečnosti za lenalidomid.
In an analysis of PFS, PFS2, OS using a cut-off of April 2013 where the median follow up time for all surviving subjects was 62.4 months, the results of the study are presented in Table 6: 
V analizi PFS, PFS2, OS, kjer je bil datum zaključka zbiranja podatkov april 2013 in kjer je bila mediana časa spremljanja za vse preživele osebe 62,4 meseca, so rezultati študije predstavljeni v preglednici 6:
It is important to dose adjust patients with renal impairment in order to avoid plasma levels which may increase the risk for higher haematological adverse reactions or hepatotoxicity. 
Pri bolnikih z okvaro ledvic je pomembno prilagoditi odmerek, da se v plazmi preprečijo ravni, ki lahko povečajo tveganje za hematološke neželene učinke ali hepatotoksičnost.
If your female partner is pregnant or able to become pregnant, and she does not use effective methods of contraception, you must use condoms during treatment and 1 week after the end of treatment, even if you have had a vasectomy. 
Če je vaša partnerica noseča ali bi lahko zanosila in ne uporablja zanesljivih metod kontracepcije, morate med zdravljenjem in 1 teden po koncu zdravljenja uporabljati kondome, tudi če ste imeli vazektomijo.
• Loss of sex drive (libido) 
• izguba spolne sle (libida);
In general, study subjects had advanced-stage disease: of the total study population, 41% had ISS stage III, 9% had severe renal insufficiency (creatinine clearance [CLcr] < 30 mL/min). 
Na splošno rečeno so imeli preskušanci v študiji bolezen v napredovalem stadiju: od celotne populacije, vključene v študijo, jih je imelo 41 % ISS stadij III, 9 % hudo ledvično insuficienco (očistek kreatinina [CLcr] < 30 ml/min).