FrancophonIA/ELRC3.0 huggingface dataset:
English: • She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
Slovenian: • mora biti obveščena ter razumeti možne posledice nosečnosti in potrebo po takojšnjem posvetu,
English: The adverse reactions observed in patients treated with lenalidomide are listed below by system organ class and frequency.
Slovenian: Neželeni učinki, ki so jih opazili pri bolnikih, zdravljenih z lenalidomidom, so razvrščeni po organskih sistemih in pogostnosti.
English: • Dose adjustments, during treatment and restart of treatment, are recommended to manage grade 3 or 4 thrombocytopenia, neutropenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
Slovenian: • Prilagoditve odmerka med zdravljenjem in ponovnim začetkom zdravljenja so priporočene za zdravljenje trombocitopenije 3. ali 4. stopnje, nevtropenije ali drugih toksičnosti 3. ali 4. stopnje, za katere sodimo, da so povezane z lenalidomidom.
English: • Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception
Slovenian: • tudi če ima ženska v rodni dobi amenorejo, mora upoštevati vsa navodila za zanesljivo kontracepcijo;
English: Patients should be advised of the signs and symptoms of these reactions by their prescribers and should be told to seek medical attention immediately if they develop these symptoms.
Slovenian: Zdravniki, ki predpisujejo zdravilo, morajo bolnike poučiti o znakih in simptomih teh reakcij in jim svetovati, naj ob pojavu teh simptomov takoj poiščejo zdravniško pomoč.
English: These patients should be closely monitored for signs and symptoms of active HBV infection throughout therapy.
Slovenian: Te bolnike je treba ves čas zdravljenja skrbno spremljati glede znakov in simptomov aktivne okužbe s HBV.
English: The test should ensure the patient is not pregnant when she starts treatment with lenalidomide.
Slovenian: Test mora zagotavljati, da bolnica ob začetku zdravljenja z lenalidomidom ni noseča.
English: • Brochure for women patients of childbearing potential and their partners
Slovenian: • brošure za ženske v rodni dobi in njihove partnerje;
English: These cells collect in the bone marrow and divide, becoming out of control.
Slovenian: Te celice se kopičijo v kostnem mozgu in se nekontrolirano razmnožujejo.
English: These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heart beat, seizures, and sometimes death.
Slovenian: Te zaplete povzročijo razgradni produkti odmirajočih rakavih celic in lahko vključujejo: spremembe krvne slike; visoke vsebnosti kalija, fosforja, sečne kisline in nizke vsebnosti kalcija, ki posledično vodijo do sprememb delovanja ledvic, utripa srca, epileptičnih napadov in včasih smrt.
English: • Need to provide patients with appropriate patient educational brochure and patient card
Slovenian: • bolnikom je treba priskrbeti ustrezno izobraževalno brošuro in žepno opozorilno kartico za bolnika;
English: In an updated analysis of PFS, PFS2 and OS using a cut off of 3 March 2014 where the median follow-up time for all surviving subjects was 45.5 months, the results of the study are presented in Table 5:
Slovenian: V posodobljeni analizi PFS, PFS2 in OS, kjer je bil datum zaključka zbiranja podatkov 3. marec 2014 in mediana časa spremljanja za vse preživele bolnike 45,5 meseca, so rezultati študije prikazani v preglednici 5:
English: Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding.
Slovenian: Vsadki in intrauterini sistemi, ki sproščajo levonorgestrel, so povezani s povečanim tveganjem za okužbe v času vstavitve in neredne vaginalne krvavitve.
English: Second primary malignancies
Slovenian: Druge primarne malignosti
English: Reactivation of hepatitis B has been reported rarely in patients receiving lenalidomide who have previously been infected with the hepatitis B virus (HBV).
Slovenian: Redko so poročali o reaktivaciji hepatitisa B pri bolnikih, ki so prejemali lenalidomid in so bili predhodno okuženi z virusom hepatitisa B (HBV).
English: Population pharmacokinetic analyses included patients with ages ranging from 39 to 85 years old and indicate that age does not influence lenalidomide clearance (exposure in plasma).
Slovenian: Analize populacijske farmakokinetike so zajele bolnike, stare od 39 do 85 let, in kažejo, da starost ne vpliva na očistek lenalidomida (izpostavljenost v plazmi).
English: a: Two-tailed log rank test comparing survival curves between treatment groups.
Slovenian: a: Dvostranski test log rank za primerjavo krivulj preživetja med zdravljenima skupinama.
English: Co-administration of lenalidomide does not alter the pharmacokinetics of temsirolimus.
Slovenian: Sočasno dajanje lenalidomida ne spremeni farmakokinetike temsirolimusa.
English: Other special warnings and precautions for use
Slovenian: Druga posebna opozorila in previdnostni ukrepi
English: In the event of overdose, supportive care is advised.
Slovenian: Ob prevelikem odmerjanju se svetuje podporna nega.
English: In total 459 patients were enrolled into the study, with 152 patients randomised to MPR+R, 153 patients randomised to MPR+p and 154 patients randomised to MPp+p.
Slovenian: Vsega skupaj je bilo v študijo vključenih 459 bolnikov, od teh je bilo 152 bolnikov randomiziranih na MPR+R, 153 na MPR+p in 154 na MPp+p.
English: These patients discontinued at a higher rate due to intolerance (Grade 3 or 4 adverse events and serious adverse events), when compared to patients < 75 years.
Slovenian: Ti bolniki so pogosteje prenehali z zdravljenjem zaradi intolerance (neželeni dogodki 3. ali 4. stopnje in resni neželeni dogodki) kot bolniki, mlajši od 75 let.
English: • some medicines used to treat raised cholesterol - such as statins
Slovenian: • nekatera zdravila, ki se uporabljajo za zdravljenje povišanega holesterola, kot so statini
English: What Lenalidomide Accord is and what it is used for 2.
Slovenian: Kaj je zdravilo Lenalidomide Accord in za kaj ga uporabljamo 2.
English: • Description and management of thromboembolic risk including incidence rates from clinical trials and post-marketing experience
Slovenian: • opis in obvladovanje tveganja trombemboličnih pojavov, vključno s stopnjami pojavnosti v kliničnih preskušanjih in obdobju trženja zdravila
English: The pharmacokinetics of lenalidomide was studied in subjects with renal impairment due to nonmalignant conditions.
Slovenian: Farmakokinetiko lenalidomida so raziskovali pri osebah z okvaro ledvic zaradi nemalignih stanj.
English: • some medicines used to thin the blood - such as warfarin
Slovenian: • nekatera zdravila, ki se uporabljajo za redčenje krvi, kot je varfarin
English: On dialysis days, the dose should be administered following dialysis.
Slovenian: Ob dnevih z dializo je treba odmerek dati po dializi.
English: Prescriptions for women of childbearing potential can be for a maximum duration of 4 weeks, and prescriptions for all other patients can be for a maximum duration of 12 weeks.
Slovenian: Recept za ženske v rodni dobi se lahko izda za največ štiritedensko zdravljenje oziroma dvanajsttedensko zdravljenje za vse ostale bolnike.
English: Soft tissue and skeletal variations in the foetuses were also observed at 10 and 20 mg/kg/day.
Slovenian: Odstopanja mehkih tkiv in skeleta pri fetusih so opazili tudi pri odmerkih 10 in 20 mg/kg/dan.
English: Cases of hypothyroidism and cases of hyperthyroidism have been reported (see section 4.4 Thyroid disorders).
Slovenian: Poročali so o primerih hipotiroidizma in hipertiroidizma (glejte poglavje 4.4 Bolezni ščitnice).
English: • Medroxyprogesterone acetate depot
Slovenian: • depo medroksiprogesteronacetat;
English: In case of neutropenia, the physician should consider the use of growth factors in patient management.
Slovenian: V primeru nevtropenije mora zdravnik upoštevati možnost uporabe rastnih faktorjev pri obravnavi bolnika.
English: Lenalidomide is structurally related to thalidomide, which is known to induce severe peripheral neuropathy.
Slovenian: Lenalidomid je strukturno soroden talidomidu, za katerega je znano, da povzroča hudo periferno nevropatijo.
English: changes in the way things taste
Slovenian: tresavica, spremembe načina zaznavanja okusa stvari;
English: Lenalidomide is rapidly absorbed following oral administration in healthy volunteers, under fasting conditions, with maximum plasma concentrations occurring between 0.5 and 2 hours post-dose.
Slovenian: Lenalidomid se hitro absorbira po peroralni uporabi pri zdravih prostovoljcih na tešče, pri čemer so največje koncentracije v plazmi dosežene med 0,5 in 2 urama po odmerku.
English: The mechanisms of severe drug-induced hepatotoxicity remain unknown although, in some cases, pre-existing viral liver disease, elevated baseline liver enzymes, and possibly treatment with antibiotics might be risk factors.
Slovenian: Mehanizem hude hepatotoksičnosti, ki jo povzroči zdravilo, še ni znan, čeprav so dejavniki tveganja v nekaterih primerih lahko obstoječa virusna bolezen jeter, zvišane ravni jetrnih encimov ob izhodišču in možno zdravljenje z antibiotiki.
English: The half-life of lenalidomide increased from approximately 3.5 hours in subjects with creatinine clearance > 50 mL/min to more than 9 hours in subjects with reduced renal function < 50 mL/min.
Slovenian: Razpolovni čas lenalidomida se je povečal s približno 3,5 ure pri osebah, pri katerih je bil kreatininski očistek > 50 ml/min, na več kot 9 ur pri osebah z okvarjenim delovanjem ledvic (< 50 ml/min).
English: In patients with newly diagnosed multiple myeloma aged 75 years and older who received lenalidomide, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation.
Slovenian: Pri bolnikih z novo diagnosticiranim diseminiranim plazmocitomom, starih 75 let ali več, ki so prejemali lenalidomid, je bila večja incidenca resnih neželenih učinkov in neželenih učinkov, ki so privedli do prekinitve zdravljenja.
English: • Stroke, fainting
Slovenian: • kap, omedlevanje;
English: Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the lenalidomide treatment may be restarted at the original dose dependent upon a benefit risk assessment.
Slovenian: Ko je bolnik stabiliziran z antikoagulacijskim zdravljenjem in so morebitni zapleti s trombemboličnim dogodkom pod nadzorom, se lahko ponovno uvede zdravljenje z lenalidomidom z začetnim odmerkom, ob upoštevanju ocene koristi in tveganja.
English: Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia.
Slovenian: Intrauterini vložki, ki sproščajo baker, na splošno niso priporočljivi zaradi možnega tveganja za nastanek okužb ob času vstavitve in izgubo krvi med menstruacijo, kar lahko ogrozi bolnice z nevtropenijo ali trombocitopenijo.
English: • Breathlessness especially when lying down (which may be a symptom of heart failure)
Slovenian: • zasoplost, zlasti med ležanjem (kar je lahko simptom srčnega popuščanja);
English: Dexamethasone is a weak to moderate enzyme inducer and its effect on warfarin is unknown.
Slovenian: Deksametazon je šibek do zmeren spodbujevalec encimov in njegov vpliv na varfarin ni znan.
English: Do not use this medicine after the expiry date, which is stated on the carton and blister after ‘EXP'.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na kartonski škatli in pretisnem omotu poleg oznake ‘EXP' ali ‘Uporabno do'.
English: • Venous thromboembolism (deep vein thrombosis, pulmonary embolism) (see section 4.4)
Slovenian: • venska trombembolija (globoka venska tromboza in pljučna embolija) (glejte poglavje 4.4);
English: However, in the main multiple myeloma registration trials where the efficacy and safety were established for lenalidomide, the medicinal product was administered without regard to food intake.
Slovenian: Vendar pa so v glavnih registracijskih preskušanjih pri bolnikih z diseminiranim plazmocitomom, kjer so ugotavljali učinkovitost in varnost lenalidomida, zdravilo dajali ne glede na vnos hrane.
English: b: Two-tailed continuity-corrected chi-square test.
Slovenian: b: Dvostranski test hi-kvadrat s popravkom kontinuitete.
English: Blood donation You should not donate blood during treatment and for 1 week after the end of treatment.
Slovenian: Darovanje krvi Med zdravljenjem in še 1 teden po koncu zdravljenja ne smete darovati krvi.
English: Do not use this medicine if you notice any damage or signs of tampering to the pack.
Slovenian: • Ne uporabite tega zdravila, če opazite, da je bila ovojnina poškodovana ali kaže znake zlorabe.
English: However, renal impairment did not alter the oral absorption of lenalidomide.
Slovenian: Vendar ledvična okvara ni spremenila absorpcije po peroralnem odmerku lenalidomida.
English: If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
Slovenian: Če bolnica ne uporablja zanesljive kontracepcije, jo je treba napotiti k ustrezno usposobljenemu zdravniku, ki ji bo svetoval, za katero kontracepcijsko metodo naj se odloči, da jo lahko začne uporabljati.
English: In both studies, the baseline demographic and disease-related characteristics were comparable between the len/dex and placebo/dex groups.
Slovenian: V obeh študijah so bile izhodiščna demografija in značilnosti, povezane z boleznijo, primerljive med skupinama len/deks in placebo/deks.
English: In the presence of lenalidomide, cereblon binds substrate proteins Aiolos and Ikaros which are lymphoid transcriptional factors, leading to their ubiquitination and subsequent degradation resulting in cytotoxic and immunomodulatory effects.
Slovenian: Cereblon v prisotnosti lenalidomida veže substratni beljakovini Aiolos in Ikaros, ki sta limfoidna transkripcijska faktorja, kar povzroči njuno ubikvitinacijo in posledično degradacijo, ki povzroči citotoksične in imunomodulacijske učinke.
English: Co-administration with a high-fat and high-calorie meal in healthy volunteers reduces the extent of absorption, resulting in an approximately 20% decrease in area under the concentration versus time curve (AUC) and 50% decrease in Cmax in plasma.
Slovenian: Sočasno dajanje z visokokaloričnim obrokom z visoko vsebnostjo maščob je pri zdravih prostovoljcih zmanjšalo obseg absorpcije, kar je povzročilo približno 20 % zmanjšanje površine pod krivuljo koncentracije po času (AUC) in 50 % zmanjšanje Cmax v plazmi.
English: Lenalidomide must be discontinued for exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected, and should not be resumed following discontinuation for these reactions.
Slovenian: Lenalidomid je treba ukiniti pri eksfoliativnem ali buloznem izpuščaju ali če posumimo na SJS, TEN ali DRESS in ga po ukinitvi zaradi teh reakcij ne smemo spet začeti dajati.
English: Patients and physicians are advised to be observant for signs and symptoms of bleeding, including petechiae and epistaxes, especially in patients receiving concomitant medicinal products susceptible to induce bleeding (see section 4.8, Haemorrhagic disorders).
Slovenian: Za bolnike in zdravnike velja nasvet, naj bodo pozorni na znake in simptome krvavitev, vključno s petehijami in epistakso, posebno še pri bolnikih, ki sočasno prejemajo zdravila, ki lahko povzročijo krvavitev (glejte poglavje 4.8, Hemoragične bolezni).
English: In total 1623 patients were enrolled into the study, with 535 patients randomised to Rd, 541 patients randomised to Rd18 and 547 patients randomised to MPT.
Slovenian: Vsega skupaj je bilo v študijo vključenih 1.623 bolnikov, od teh je bilo 535 bolnikov randomiziranih na Rd, 541 bolnikov na Rd18 in 547 bolnikov na MPT.
English: • Documentation of childbearing status potential
Slovenian: • dokumentacijo o statusu zmožnosti zanositve;
English: The median age was 71 in the MPR+R and MPR+p arms and 72 in the MPp+p arm.
Slovenian: Mediana starosti je bila 71 let v skupinah z MPR+R in MPR+p in 72 let v skupini z MPp+p.
English: In these studies, rabbits were administered 3, 10 and 20 mg/kg/day orally.
Slovenian: Pri teh študijah so kunci prejemali peroralno 3, 10 in 20 mg/kg/dan.
English: Lenalidomide treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Slovenian: Zdravljenje z zdravilom Lenalidomide mora nadzorovati zdravnik z izkušnjami pri zdravljenju raka.
English: Educational Brochures for patients
Slovenian: Izobraževalne brošure za bolnike
English: Lenalidomide is not an enzyme inducer.
Slovenian: Lenalidomid ni spodbujevalec encimov.
English: • Hives, itching, increased sweating, dehydration
Slovenian: • koprivnica, srbenje, povečano znojenje, dehidracija;
English: Elderly No dedicated clinical studies have been conducted to evaluate pharmacokinetics of lenalidomide in the elderly.
Slovenian: Posebnih kliničnih študij za ocenjevanje farmakokinetike lenalidomida pri starejših niso opravili.
English: Dispensing of lenalidomide to women of childbearing potential should occur within 7 days of the prescription and following a medically supervised negative pregnancy test result.
Slovenian: Ženskam v rodni dobi se mora lenalidomid izdati v 7 dneh po izdaji recepta in slediti medicinsko nadzorovanemu negativnemu rezultatu testa nosečnosti.
English: Tell your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
Slovenian: Povejte svojemu zdravniku, če imate hude bolečine v želodcu, vročino, slabost, bruhate, imate kri v blatu ali spremenjeno odvajanje blata.
English: Very Common Renal failure (including acute)◊
Slovenian: Bolezni sečil zelo pogosti odpoved ledvic (vključno z akutno) ◊
English: Consequently, patients with known risk factors for thromboembolism - including prior thrombosisshould be closely monitored.
Slovenian: Posledično je treba bolnike z znanimi dejavniki tveganja za trombembolijo, vključno s predhodnimi trombozami, skrbno spremljati.
English: Cases have generally been reported in patients taking concomitant dexamethasone or prior treatment with other immunosuppressive chemotherapy.
Slovenian: O teh primerih so poročali praviloma pri bolnikih, ki so sočasno jemali deksametazon ali ki so se predhodno zdravili z drugo imunosupresivno kemoterapijo.
English: • She understands the need to commence the treatment as soon as lenalidomide is dispensed following a negative pregnancy test
Slovenian: • mora razumeti potrebo, da prične z zdravljenjem, brž ko je izdan lenalidomid po negativnem testu nosečnosti;
English: Results from human in vitro metabolism studies indicate that lenalidomide is not metabolised by cytochrome P450 enzymes suggesting that administration of lenalidomide with medicinal products that inhibit cytochrome P450 enzymes is not likely to result in metabolic medicinal product interactions in humans.
Slovenian: Rezultati študij presnove pri človeku in vitro kažejo, da lenalidomida ne presnavljajo encimi citokroma P450, kar kaže, da ni verjetno, da bi uporaba lenalidomida z zdravili, ki zavirajo encime citokroma P450, pri človeku povzročila presnovne interakcije med zdravili.
English: Myocardial infarction has been reported in patients receiving lenalidomide, particularly in those with known risk factors.
Slovenian: O miokardnem infarktu so poročali pri bolnikih, ki so prejemali lenalidomid, zlasti pri bolnikih z znanimi dejavniki tveganja.
English: Before and during the treatment with lenalidomide you will have regular blood tests as it may cause a fall in the blood cells that help fight infection (white blood cells) and help the blood to clot (platelets).
Slovenian: Pred zdravljenjem z lenalidomidom in med njim boste imeli redne krvne preiskave, ker lahko povzroči zmanjšanje števila krvnih celic, ki pomagajo pri premagovanju okužb (belih krvnih celic) in strjevanju krvi (trombocitov).
English: Out of 353 patients in the MM-009 and MM-010 studies who received lenalidomide/dexamethasone, 45.6% were aged 65 or over.
Slovenian: Od 353 bolnikov v študijah MM-009 in MM-010, ki so prejemali lenalidomid/deksametazon, je bilo 45,6 % bolnikov starih 65 let ali več.
English: Myocardial infarction has been reported in patients receiving lenalidomide, particularly in those with known risk factors and within the first 12 months when used in combination with dexamethasone.
Slovenian: O miokardnem infarktu so poročali pri bolnikih, ki so prejemali lenalidomid, zlasti pri bolnikih z znanimi dejavniki tveganja in v prvih 12 mesecih, kadar se je uporabljal skupaj z deksametazonom.
English: The AUC was increased by approximately 2.5, 4 and 5-fold in subjects with moderate renal impairment, severe renal impairment, and end-stage renal disease, respectively, compared to the group combining subjects with normal renal function and subjects with mild renal impairment.
Slovenian: AUC se je povečala za približno 2,5-krat pri bolnikih z zmerno okvaro ledvic, 4-krat pri bolnikih s hudo okvaro ledvic in 5-krat pri bolnikih s končno odpovedjo ledvic, v primerjavi s skupino, v kateri so bile združene osebe z normalnim delovanjem ledvic in osebe z blago okvaro ledvic.
English: Lenalidomide is primarily excreted by the kidney; patients with greater degrees of renal impairment can have impaired treatment tolerance (see section 4.4).
Slovenian: Lenalidomid se v glavnem izloča skozi ledvice; bolniki z višjimi stopnjami ledvične okvare lahko slabše prenašajo zdravljenje (glejte poglavje 4.4).
English: What you need to know before you take Lenalidomide Accord 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Lenalidomide Accord 3.
English: • A fall in the number of red blood cells which may cause anaemia leading to tiredness and weakness
Slovenian: • zmanjšanje števila eritrocitov, kar lahko povzroči anemijo, ki vodi v utrujenost in šibkost;
English: • When lenalidomide is used to treat multiple myeloma in patients who cannot have a bone marrow transplant or have had other treatments before, it is taken with other medicines (see section 1 ‘What lenalidomide is used for').
Slovenian: • Ko se lenalidomid uporablja za zdravljenje diseminiranega plazmocitoma pri bolnikih, ki niso primerni za presaditev kostnega mozga ali so bili predhodno zdravljeni, se jemlje z drugimi zdravili (glejte poglavje 1 ‘Za kaj uporabljamo lenalidomid ').
English: Tell your doctor or nurse if you are taking ,have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Lenalidomide Accord Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: • Understand the expected teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential
Slovenian: • morajo razumeti pričakovano tveganje za teratogene učinke, če spolno občujejo z nosečnico ali žensko v rodni dobi;
English: • Local contact details for reporting of any suspected pregnancy
Slovenian: • kontaktne podatke za poročanje kakršnegakoli suma na nosečnost,
English: • Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice
Slovenian: • potrebo po napotitvi k zdravniku specialistu ali zdravniku z izkušnjami na področju teratologije in njeni diagnostiki zaradi ocene in svetovanja,