natgillin/translations-raw huggingface dataset:
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).
Patients between 18 and 70 years of age with active MM requiring treatment and without prior progression after initial therapy were eligible.
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.
Therefore, a teratogenic effect of lenalidomide is expected and lenalidomide is contraindicated during pregnancy (see section 4.3).
Zato se pričakuje teratogeni učinek lenalidomida in lenalidomid je med nosečnostjo kontraindiciran (glejte poglavje 4.3).
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.
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.
These symptoms may be due to inflammation of the pancreas.
Ti simptomi so lahko posledica vnetja trebušne slinavke;
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.
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.
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.
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.
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,.
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.
If you take more lenalidomide than you should If you take more lenalidomide than was prescribed, tell your doctor immediately.
Če ste vzeli večji odmerek lenalidomida, kot bi smeli Če ste vzeli večji odmerek lenalidomida, kot vam je zdravnik predpisal, ga takoj obvestite.
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.
Pri bolnikih in zdravih prostovoljcih se največja koncentracija (Cmax) in površina pod krivuljo koncentracije po času (AUC) večata sorazmerno z večanjem odmerka.
The prescriber must ensure that for women of childbearing potential:
Zdravnik, ki predpiše zdravilo, mora pri ženskah v rodni dobi zagotoviti, da:
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.
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.
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.
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.
• That the patient should tell their doctor about any adverse events
• opozorilo, da mora bolnik zdravniku poročati o kakršnihkoli neželenih učinkih;
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.
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.
Common C-reactive protein increased
Preiskave pogosti zvečanje vrednosti C-reaktivnega proteina
Interactions with P-glycoprotein (P-gp) inhibitors
Interakcije z zaviralci P-glikoproteina (P-gp)
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.
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.
It is not known whether lenalidomide is excreted in human milk.
Ni znano, ali se lenalidomid izloča v materino mleko.
If you forget to take lenalidomideIf you forget to take lenalidomide at your regular time and
Če ste pozabili vzeti lenalidomid ob rednem času in:
• That patients should be capable of complying with the requirements for the safe use of
• bolniki morajo biti sposobni upoštevati zahteve za varno uporabo zdravila Lenalidomide
The demographics and disease-related baseline characteristics of the patients were well balanced in all 3 arms.
Demografske značilnosti in z boleznijo povezane izhodiščne značilnosti bolnikov so bile dobro uravnovešene v vseh 3 skupinah.
All patients received prophylactic anticoagulation (low molecular weight heparin, warfarin, heparin, low-dose acetylsalicylic acid during the study.
Vsi bolniki so med študijo prejemali profilaktično antikoagulacijo terapijo (heparin majhne molekulske mase, varfarin, heparin, acetilsalicino kislino v majhnem odmerku).
All patient brochures should contain the following elements:
Vse brošure za bolnike morajo vsebovati naslednje elemente:
• She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
• mora biti obveščena ter razumeti možne posledice nosečnosti in potrebo po takojšnjem posvetu,
The adverse reactions observed in patients treated with lenalidomide are listed below by system organ class and frequency.
Neželeni učinki, ki so jih opazili pri bolnikih, zdravljenih z lenalidomidom, so razvrščeni po organskih sistemih in pogostnosti.
• 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.
• 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.
• Even if a woman of childbearing potential has amenorrhea she must follow all the advice on effective contraception
• tudi če ima ženska v rodni dobi amenorejo, mora upoštevati vsa navodila za zanesljivo kontracepcijo;
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.
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.
These patients should be closely monitored for signs and symptoms of active HBV infection throughout therapy.
Te bolnike je treba ves čas zdravljenja skrbno spremljati glede znakov in simptomov aktivne okužbe s HBV.
The test should ensure the patient is not pregnant when she starts treatment with lenalidomide.
Test mora zagotavljati, da bolnica ob začetku zdravljenja z lenalidomidom ni noseča.
• Brochure for women patients of childbearing potential and their partners
• brošure za ženske v rodni dobi in njihove partnerje;
These cells collect in the bone marrow and divide, becoming out of control.
Te celice se kopičijo v kostnem mozgu in se nekontrolirano razmnožujejo.
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.
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.
• Need to provide patients with appropriate patient educational brochure and patient card
• bolnikom je treba priskrbeti ustrezno izobraževalno brošuro in žepno opozorilno kartico za bolnika;
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:
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:
Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding.
Vsadki in intrauterini sistemi, ki sproščajo levonorgestrel, so povezani s povečanim tveganjem za okužbe v času vstavitve in neredne vaginalne krvavitve.
Second primary malignancies
Druge primarne malignosti
Reactivation of hepatitis B has been reported rarely in patients receiving lenalidomide who have previously been infected with the hepatitis B virus (HBV).
Redko so poročali o reaktivaciji hepatitisa B pri bolnikih, ki so prejemali lenalidomid in so bili predhodno okuženi z virusom hepatitisa B (HBV).
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).
Analize populacijske farmakokinetike so zajele bolnike, stare od 39 do 85 let, in kažejo, da starost ne vpliva na očistek lenalidomida (izpostavljenost v plazmi).
a: Two-tailed log rank test comparing survival curves between treatment groups.
a: Dvostranski test log rank za primerjavo krivulj preživetja med zdravljenima skupinama.
Co-administration of lenalidomide does not alter the pharmacokinetics of temsirolimus.
Sočasno dajanje lenalidomida ne spremeni farmakokinetike temsirolimusa.
Other special warnings and precautions for use
Druga posebna opozorila in previdnostni ukrepi
In the event of overdose, supportive care is advised.
Ob prevelikem odmerjanju se svetuje podporna nega.
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.
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.
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.
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.
• some medicines used to treat raised cholesterol - such as statins
• nekatera zdravila, ki se uporabljajo za zdravljenje povišanega holesterola, kot so statini
What Lenalidomide Accord is and what it is used for 2.
Kaj je zdravilo Lenalidomide Accord in za kaj ga uporabljamo 2.
• Description and management of thromboembolic risk including incidence rates from clinical trials and post-marketing experience
• opis in obvladovanje tveganja trombemboličnih pojavov, vključno s stopnjami pojavnosti v kliničnih preskušanjih in obdobju trženja zdravila
The pharmacokinetics of lenalidomide was studied in subjects with renal impairment due to nonmalignant conditions.
Farmakokinetiko lenalidomida so raziskovali pri osebah z okvaro ledvic zaradi nemalignih stanj.
• some medicines used to thin the blood - such as warfarin
• nekatera zdravila, ki se uporabljajo za redčenje krvi, kot je varfarin
On dialysis days, the dose should be administered following dialysis.
Ob dnevih z dializo je treba odmerek dati po dializi.
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.
Recept za ženske v rodni dobi se lahko izda za največ štiritedensko zdravljenje oziroma dvanajsttedensko zdravljenje za vse ostale bolnike.
Soft tissue and skeletal variations in the foetuses were also observed at 10 and 20 mg/kg/day.
Odstopanja mehkih tkiv in skeleta pri fetusih so opazili tudi pri odmerkih 10 in 20 mg/kg/dan.
Cases of hypothyroidism and cases of hyperthyroidism have been reported (see section 4.4 Thyroid disorders).
Poročali so o primerih hipotiroidizma in hipertiroidizma (glejte poglavje 4.4 Bolezni ščitnice).
• Medroxyprogesterone acetate depot
• depo medroksiprogesteronacetat;
In case of neutropenia, the physician should consider the use of growth factors in patient management.
V primeru nevtropenije mora zdravnik upoštevati možnost uporabe rastnih faktorjev pri obravnavi bolnika.
Lenalidomide is structurally related to thalidomide, which is known to induce severe peripheral neuropathy.
Lenalidomid je strukturno soroden talidomidu, za katerega je znano, da povzroča hudo periferno nevropatijo.
changes in the way things taste
tresavica, spremembe načina zaznavanja okusa stvari;