FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: A haemoglobin concentration above 12 g/dl should lead to discontinuation of erythropoietic agents.
Slovenian: Če je koncentracija hemoglobina nad 12 g/dl, je treba prekiniti uporabo eritropoetskih zdravil.
English: Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Slovenian: V idealnem primeru se morajo test nosečnosti, izdaja recepta in izdaja zdravila opraviti na isti dan.
English: Lenalidomide Accord hard capsules should be taken orally at about the same time on the scheduled days.
Slovenian: Trde kapsule zdravila Lenalidomide Accord je treba jemati peroralno na načrtovane dni ob približno istem času.
English: 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).
Slovenian: 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).
English: Women of childbearing potential / Contraception in males and females Women of childbearing potential should use effective method of contraception.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijsko metodo.
English: Therefore, induction leading to reduced efficacy of medicinal products, including hormonal contraceptives, is not expected if lenalidomide is administered alone.
Slovenian: Zato se ne pričakuje spodbujanja, ki bi znižalo učinek zdravila, vključno s hormonskimi kontraceptivi, če se lenalidomid daje sam.
English: Requirements in the event of pregnancy
Slovenian: Zahteve v primeru nosečnosti:
English: Prophylactic antithrombotic medicinal products should be recommended, especially in patients with additional thrombotic risk factors.
Slovenian: Priporočiti je treba uporabo profilaktičnih antitrombotikov, zlasti pri bolnikih z dodatnimi dejavniki tveganja za trombozo.
English: Treatment with lenalidomide may cause virus to become active again, in patients who carry the virus, resulting in a recurrence of the infection.
Slovenian: Zdravljenje z lenalidomidom lahko povzroči, da virus pri bolnikih, ki ga prenašajo, spet postane aktiven, kar povzroči ponovitev okužbe.
English: This is because lenalidomide can affect the way some other medicines work.
Slovenian: Lenalidomid lahko vpliva na način delovanja nekaterih drugih zdravil.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The contribution of renal excretion to total clearance in subjects with normal renal function was 90%, with 4% of lenalidomide eliminated in faeces.
Slovenian: Prispevek ledvičnega izločanja k skupnemu očistku pri osebah z normalnim delovanjem ledvic je bil 90 %, pri čemer se 4 % lenalidomida izloči z blatom.
English: Lenalidomide has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations.
Slovenian: Lenalidomida niso formalno preiskovali pri bolnikih z okvaro jeter in zanje ni posebnih priporočil za odmerjanje.
English: The capsules should be swallowed whole, preferably with water, either with or without food.
Slovenian: Kapsule je treba pogoltniti cele, po možnosti z vodo, s hrano ali brez nje.
English: Dose adjustment (days 1 to 21 of repeated 28-day cycles)
Slovenian: Prilagoditev odmerka (od 1. do 21. dne, v ponavljajočih se 28-dnevnih ciklih)
English: • a chemotherapy medicine called ‘melphalan' and
Slovenian: • s kemoterapevtskim zdravilom, ki se imenuje ‘melfalan', in
English: Carcinogenicity studies with lenalidomide have not been conducted.
Slovenian: Študij kancerogenosti z lenalidomidom niso opravili.
English: • Grade 4 neutropenia (see section 4.4).
Slovenian: • nevtropenija 4. stopnje (glejte poglavje 4.4).
English: 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:
Slovenian: 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:
English: • Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Slovenian: • povzetek glavnih značilnosti zdravila (SmPC), navodilo za uporabo in označevanje.
English: Action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Slovenian: Z ustreznimi ukrepi je treba poskusiti zmanjšati tiste dejavnike tveganja, na katere lahko vplivamo (npr. kajenje, hipertenzija in hiperlipidemija).
English: e Exploratory endpoint (PFS2).
Slovenian: e Končni cilj raziskave (PFS2).
English: d The p-value is based on the unstratified log-rank test of Kaplan-Meier curve differences between the indicated treatment arms.
Slovenian: d Vrednost p temelji na nestratificiranem testu log-rank razlik med Kaplan-Meierjevimi krivuljami za navedene skupine zdravljenja.
English: 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.
Slovenian: 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.
English: The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoietic, and immunomodulatory properties.
Slovenian: Mehanizem delovanja lenalidomida vključuje antineoplastične, antiangiogenetske, proeritropoetske in imunomodulatorne lastnosti.
English: • Pregnancy test dates and results
Slovenian: • datume in rezultate testov nosečnosti.
English: Treatment cycle
Slovenian: Cikel zdravljenja
English: Some of these cases have progressed to acute hepatic failure resulting in discontinuation of lenalidomide and adequate antiviral treatment.
Slovenian: Nekateri od teh primerov so napredovali v akutno odpoved jeter, zaradi katere so ukinili lenalidomid in uvedli ustrezno protivirusno zdravljenje.
English: Patients may continue lenalidomide and dexamethasone therapy until disease progression or intolerance.
Slovenian: Bolniki smejo nadaljevati z zdravljenjem z lenalidomidom in deksametazonom do napredovanja bolezni ali intolerance.
English: Rd18 vs MPT
Slovenian: Rd18 proti MPT
English: • before treatment
Slovenian: • pred zdravljenjem,
English: 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:
Slovenian: 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:
English: Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Slovenian: Bolniki in zdravniki morajo biti pozorni na znake in simptome trombembolije.
English: No interaction study has been performed with oral contraceptives.
Slovenian: S peroralnimi kontraceptivi niso opravili študij interakcij.
English: 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.
Slovenian: 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.
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Slovenian: Bolnikom je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo simptomi, kot so zasoplost, bolečine v prsnem košu in otekanje rok ali nog.
English: Cases of hypothyroidism and cases of hyperthyroidism have been reported.
Slovenian: Poročali so o primerih hipotiroidizma in hipertiroidizma.
English: Lenalidomide is generally more soluble in organic solvents but exhibits the greatest solubility in 0.1N HCl buffer.
Slovenian: Lenalidomid je na splošno bolj topen v organskih topilih, vendar pa je najbolj topen v 0,1 N HCl raztopini.
English: The capsules should not be opened, broken or chewed.
Slovenian: Kapsul se ne sme odpirati, zdrobiti ali žvečiti.
English: 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).
Slovenian: 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).
English: If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Slovenian: Če se pri bolniku pojavijo kakršnikoli trombembolični dogodki, je treba zdravljenje prekiniti in uvesti standardno antikoagulacijsko zdravljenje.
English: • by stimulating part of the immune system to attack the cancer cells.
Slovenian: • spodbuja del imunskega sistema, da napada rakave celice.
English: 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.
Slovenian: Pred začetkom zdravljenja vprašajte zdravnika, ali je možno, da bi lahko zanosili, tudi če mislite, da to ni verjetno.
English: However with a longer follow-up, the difference in overall survival in favour of lenalidomide/ low dose dexamethasone tends to decrease.
Slovenian: Vendar pa pri daljšem spremljanju razlika v celokupnem preživetju v korist lenalidomida/deksametazona v manjšem odmerku kaže tendenco zmanjševanja.
English: • Need to provide comprehensive advice and counselling to patients
Slovenian: • potrebo po obsežnem posvetu in svetovanju bolnikov,
English: 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
Slovenian: 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.
English: If you think you may be allergic, ask your doctor for advice.
Slovenian: Če mislite, da ste alergični, se posvetujte z zdravnikom.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Patients with newly diagnosed multiple myeloma aged 75 years and older should be carefully assessed before treatment is considered (see section 4.4).
Slovenian: Bolnike z novo diagnosticiranim diseminiranim plazmocitomom, stare 75 let ali več, je treba skrbno oceniti, preden uvedemo zdravljenje (glejte poglavje 4.4).
English: Lenalidomide is taken in treatment cycles, each cycle lasting 28 days (see above ‘Treatment cycle').
Slovenian: Zdravilo Lenalidomide se jemlje v ciklih zdravljenja, ki trajajo po 28 dni (glejte ‘Cikel zdravljenja' zgoraj).
English: The results indicate that as renal function decreases (< 50 mL/min), the total lenalidomide clearance decreases proportionally resulting in an increase in AUC.
Slovenian: Rezultati kažejo, da se z zmanjšanjem delovanja ledvic (< 50 ml/min) sorazmerno manjša skupni očistek lenalidomida, zaradi česar se poveča vrednost AUC.
English: Of the 704 patients evaluated in the MM-009 and MM-010 studies, 44.6% were aged 65 or over.
Slovenian: Od 704 bolnikov, ki so jih ocenili v študijah MM-009 in MM-010, je bilo 44,6 % bolnikov starih 65 let ali več.
English: You must follow the Lenalidomide Pregnancy Prevention Programme
Slovenian: Upoštevati morate program za preprečevanje nosečnosti za lenalidomid.
English: 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:
Slovenian: 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:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • Loss of sex drive (libido)
Slovenian: • izguba spolne sle (libida);
English: 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).
Slovenian: 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).
English: Patients between 18 and 70 years of age with active MM requiring treatment and without prior progression after initial therapy were eligible.
Slovenian: Primerni so bili bolniki, stari 18 do 70 let, z aktivnim DP, zaradi katerega je bilo potrebno zdravljenje, brez predhodnega napredovanja bolezni po začetnem zdravljenju.
English: Therefore, a teratogenic effect of lenalidomide is expected and lenalidomide is contraindicated during pregnancy (see section 4.3).
Slovenian: Zato se pričakuje teratogeni učinek lenalidomida in lenalidomid je med nosečnostjo kontraindiciran (glejte poglavje 4.3).
English: Some of the cases of herpes zoster reactivation resulted in disseminated herpes zoster, meningitis herpes zoster or ophthalmic herpes zoster requiring a temporary hold or permanent discontinuation of the treatment with lenalidomide and adequate antiviral treatment.
Slovenian: Nekateri primeri reaktivacije herpesa zostra so povzročili diseminiran herpes zoster, herpes zoster meningitis ali očesni herpes zoster, zaradi katerih je bila potrebna začasna prekinitev ali trajna ukinitev zdravljenja z lenalidomidom in ustrezno protivirusno zdravljenje.
English: These symptoms may be due to inflammation of the pancreas.
Slovenian: Ti simptomi so lahko posledica vnetja trebušne slinavke;
English: Population pharmacokinetic analyses indicate that body weight (33- 135 kg), gender, race and type of haematological malignancy do not have a clinically relevant effect on lenalidomide clearance in adult patients.
Slovenian: Analize populacijske farmakokinetike kažejo, da telesna masa (33-135 kg), spol, rasa in vrsta hematološke malignosti nimajo klinično pomembnega vpliva na očistek lenalidomida pri odraslih bolnikih.
English: As a precaution, and taking into account special populations with prolonged elimination time such as renal impairment, all male patients taking lenalidomide should use condoms throughout treatment duration, during dose interruption and for 1 week after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception.
Slovenian: 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, uporabljati kondom ves čas trajanja zdravljenja, med prekinitvijo odmerjanja in 1 teden po koncu zdravljenja, če je njihova partnerica noseča ali lahko zanosi in ne uporablja kontracepcije.
English: At doses of 5 to 25 mg/day, half-life in plasma is approximately 3 hours in healthy volunteers and ranges from 3 to 5 hours in patients with multiple myeloma,.
Slovenian: Pri odmerkih 5 do 25 mg/dan je razpolovni čas v plazmi približno 3 ure pri zdravih prostovoljcih; pri bolnikih z diseminiranim plazmocitomom pa od 3 do 5 ur.
English: If you take more lenalidomide than you should If you take more lenalidomide than was prescribed, tell your doctor immediately.
Slovenian: Če ste vzeli večji odmerek lenalidomida, kot bi smeli Če ste vzeli večji odmerek lenalidomida, kot vam je zdravnik predpisal, ga takoj obvestite.
English: In patients, as well as in healthy volunteers, the maximum concentration (Cmax) and area-under-theconcentration time curve (AUC) increase proportionally with increases in dose.
Slovenian: Pri bolnikih in zdravih prostovoljcih se največja koncentracija (Cmax) in površina pod krivuljo koncentracije po času (AUC) večata sorazmerno z večanjem odmerka.
English: The prescriber must ensure that for women of childbearing potential:
Slovenian: Zdravnik, ki predpiše zdravilo, mora pri ženskah v rodni dobi zagotoviti, da:
English: Serious side effects which may affect more than 1 in 10 people (very common) Lenalidomide may reduce the number of white blood cells that fight infection and also the blood cells which help the blood to clot (platelets) which may lead to bleeding disorders such as nosebleeds and bruising.
Slovenian: Resni neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnikov (zelo pogosti) Zdravilo Lenalidomide lahko zmanjša število levkocitov, ki sodelujejo v boju proti okužbam in tudi število krvnih celic, ki pomagajo pri strjevanju krvi (trombociti), kar lahko povzroči nepravilnosti v krvavitvah, kot so krvavitev iz nosu in modrice.
English: The demographics and disease-related baseline characteristics of the patients were well balanced in all 3 arms; notably, approximately 50% of the patients enrolled in each arm had the following characteristics; ISS Stage III, and creatinine clearance < 60 mL/min.
Slovenian: Demografske značilnosti in z boleznijo povezane izhodiščne značilnosti bolnikov so bile uravnovešene v vseh 3 skupinah; pomembno je, da je imelo približno 50 % bolnikov, vključenih v vsako skupino, naslednje značilnosti: ISS stadij III in očistek kreatinina < 60 ml/min.
English: • That the patient should tell their doctor about any adverse events
Slovenian: • opozorilo, da mora bolnik zdravniku poročati o kakršnihkoli neželenih učinkih;
English: The no observed adverse effect level (NOAEL) was considered to be less than 75 mg/kg/day, and is approximately 25-fold greater than the human daily exposure based on AUC exposure.
Slovenian: Odmerek, pri katerem niso opazili neželenih učinkov (NOAEL- no observed adverse effect level), je bil manj kot 75 mg/kg/dan, kar je približno 25-krat več kot dnevna izpostavljenost pri človeku na podlagi vrednosti AUC.
English: Common C-reactive protein increased
Slovenian: Preiskave pogosti zvečanje vrednosti C-reaktivnega proteina
English: Interactions with P-glycoprotein (P-gp) inhibitors
Slovenian: Interakcije z zaviralci P-glikoproteina (P-gp)
English: For other grade 3 or 4 toxicities judged to be related to lenalidomide, treatment should be stopped and only restarted at next lower dose level when toxicity has resolved to ≤ grade 2 depending on the physician's discretion.
Slovenian: Pri drugih toksičnostih 3. ali 4. stopnje, za katere sodite, da so povezane z lenalidomidom, prekinite zdravljenje in spet začnite z njim na naslednji nižji ravni odmerka šele, ko se bo toksičnost zmanjšala na ≤ 2.stopnjo, odvisno od zdravnikove presoje.
English: It is not known whether lenalidomide is excreted in human milk.
Slovenian: Ni znano, ali se lenalidomid izloča v materino mleko.
English: If you forget to take lenalidomideIf you forget to take lenalidomide at your regular time and
Slovenian: Če ste pozabili vzeti lenalidomid ob rednem času in:
English: • That patients should be capable of complying with the requirements for the safe use of
Slovenian: • bolniki morajo biti sposobni upoštevati zahteve za varno uporabo zdravila Lenalidomide
English: The demographics and disease-related baseline characteristics of the patients were well balanced in all 3 arms.
Slovenian: Demografske značilnosti in z boleznijo povezane izhodiščne značilnosti bolnikov so bile dobro uravnovešene v vseh 3 skupinah.
English: All patients received prophylactic anticoagulation (low molecular weight heparin, warfarin, heparin, low-dose acetylsalicylic acid during the study.
Slovenian: Vsi bolniki so med študijo prejemali profilaktično antikoagulacijo terapijo (heparin majhne molekulske mase, varfarin, heparin, acetilsalicino kislino v majhnem odmerku).
English: All patient brochures should contain the following elements:
Slovenian: Vse brošure za bolnike morajo vsebovati naslednje elemente: