natgillin/translations-raw huggingface dataset:
• Need for adequate contraception and definition of adequate contraception
• potrebo po ustrezni kontracepciji in opredelitev primerne kontracepcije;
Safety advice relevant to all patients
Varnostne nasvete, primerne za vse bolnike:
5 mg once daily.
5 mg enkrat na dan.
Recommended dose adjustments in patients with impaired renal function are described in section 4.2.
Priporočene prilagoditve odmerkov pri bolnikih z okvaro ledvic so opisane v poglavju 4.2.
Not applicable ª Dose reduction for both medicinal products can be managed independently
*Odmerke za obe zdravili lahko zmanjšujemo neodvisno.
Lenalidomide should not be used in children and adolescents from birth to less than 18 years because of safety concerns (see section 5.1).
Zdravila Lenalidomide se ne sme uporabljati pri otrocih in mladostnikih od rojstva do starosti 18 let zaradi pomislekov glede varnosti (glejte poglavje 5.1).
Starting dose (10 mg)
Začetni odmerek (10 mg)
• Premature ovarian failure confirmed by a specialist gynaecologist
• prezgodnja odpoved jajčnikov, ki jo potrdi specialist ginekolog;
• Tumour lysis syndrome - metabolic complications that can occur during treatment of cancer and sometimes even without treatment.
• sindrom tumorske lize - presnovni zapleti, ki se lahko pojavijo med zdravljenjem raka in včasih celo brez zdravljenja.
• Rejection of solid organ transplant (such as kidney, heart).
• zavrnitev presajenega organa (kot so ledvice, srce).
Also, some other medicines can affect the way lenalidomide works.
Tudi nekatera druga zdravila lahko vplivajo na način delovanja lenalidomida.
Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.
Zdravnik, ki zdravilo predpiše, mora skrbno oceniti odmerek deksametazona, ki ga bo uporabil, ter ob tem upoštevati stanje in status bolezni bolnika.
A conservative approach was applied to determine the adverse reactions from CALGB 100104.
Pri določanju neželenih učinkov v študiji CALGB 100104 so uporabili konzervativen pristop.
The results for the study, using a cut-off of 1 February 2016, are presented in Table 4
Rezultati študije, kjer je bil datum zaključka zbiranja podatkov 1. februar 2016, so prikazani v preglednici 4.
• if you are allergic to lenalidomide or any of the other ingredients of this medicine listed in section 6.
• če ste alergični na lenalidomid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Hepatitis B virus status should be established before initiating treatment with lenalidomide.
Status virusa hepatitisa B je treba ugotoviti pred začetkom zdravljenja z lenalidomidom.
On day 1 of next cycle, continue G-CSF as needed and maintain dose of lenalidomide if neutropenia was the only DLT.
1. dan naslednjega cikla nadaljujte z G-CSF po potrebi in vzdržujte odmerek lenalidomida, če je bila nevtropenija edina DLT.
• Increased blood pressure or a fall in blood pressure, slow, fast or irregular heart beat
• zvišan krvni tlak ali znižanje krvnega tlaka, počasen, hiter ali nepravilen srčni utrip;
• Impaired balance, difficulty moving
• težave z ravnotežjem, težave pri gibanju;
The ECOG performance status was comparable between both groups, as was the number and type of prior therapies.
Status zmogljivosti po lestvici ECOG (Eastern Cooperative Oncology Group) je bil pri obeh skupinah primerljiv, prav tako kot število in vrsta predhodnih zdravljenj.
• Changes to a protein in the blood that can cause swelling of the arteries (vasculitis)
• spremembe beljakovine v krvi, ki lahko povzroči otekanje arterij (vaskulitis);
• Previous bilateral salpingo-oophorectomy, or hysterectomy
• predhodna bilateralna salpingo-ooforektomija ali histerektomija;
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1;
• some medicines used for heart problems - such as digoxin
• nekatera zdravila, ki se uporabljajo za težave s srcem, kot je digoksin
There is no specific experience in the management of lenalidomide overdose in patients, although in dose-ranging studies some patients were exposed to up to 150 mg, and in single-dose studies, some patients were exposed to up to 400 mg.
Ni izkušenj z obravnavanjem prevelikega odmerjanja lenalidomida pri bolnikih, čeprav so bili v študijah intervalov odmerjanja nekateri bolniki izpostavljeni odmerkom do 150 mg, v študijah z enim odmerkom pa so bili nekateri bolniki izpostavljeni odmerkom do 400 mg.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v Modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
If dose increased (15 mg) a
Če odmerek zvečamo (15 mg) a
• You must also use effective methods of contraception (see ‘Contraception' below).
• Tudi vi morate uporabljati zanesljive kontracepcijske metode (glejte ‘Kontracepcija' v nadaljevanju).
• Renal failure (including acute) (6.3%)
• odpoved ledvic (vključno z akutno) (6,3 %).
Data cut-off dates: 17 Dec 2009 and 01 Feb 2016
Datuma zaključka zbiranja podatkov: 17. december 2009 in 1. februar 2016
Multiple dosing does not cause marked medicinal product accumulation.
Večkratno odmerjanje ne povzroča bistvenega kopičenja zdravila.
Renal function (CLcr)
Delovanje ledvic (CLcr)
• Lung infection (9.4% [9.4% after the start of maintenance treatment]) from CALGB 100104
• okužba pljuč (9,4 % [9,4 % po začetku vzdrževalnega zdravljenja]) v študiji CALGB 100104.
If PML is suspected, further dosing must be suspended until PML has been excluded.
Če obstaja sum na PML, se mora nadaljnje odmerjanje prekiniti, dokler ni PML izključen.
c Based on Cox proportional hazards model comparing the hazard functions associated with the indicated treatment arms.
c Temelji na Coxovem modelu proporcionalnih tveganj, primerja funkcije tveganja, ki so povezane z navedenimi skupinami zdravljenja.
The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and/or dispensing controls, and the collecting of detailed data relating to the indication in order to monitor closely the off-label use within the national territory.
Nadzorovani sistem distribucije vključuje uporabo opozorilne kartice za bolnika in/ali enakovrednega orodja za kontrolo predpisovanja in/ali izdajanja zdravila in zbiranje natančnih podatkov v zvezi z indikacijami, kar omogoča natančno spremljanje nenamenske uporabe na nacionalnem območju.
For women of childbearing potential, lenalidomide is contraindicated unless all of the following are met:
Za ženske v rodni dobi je lenalidomid kontraindiciran, razen če so izpolnjeni vsi navedeni pogoji:
The patients at risk of TLS and TFR are those with high tumour burden prior to treatment.
Bolniki s tveganjem za sindrom tumorske lize in TFR so tisti, ki imajo pred zdravljenjem veliko tumorsko breme.
• Description and management of hypersensitivity and angioedema
• opis in obvladovanje preobčutljivosti in angioedema
• She understands the expected teratogenic risk to the unborn child
• razume pričakovano tveganje za teratogene učinke pri nerojenem otroku;
Your doctor will ask you to have a blood test:
Zdravnik bo opravil krvno preiskavo:
• Increases in your blood sugar level (diabetes)
• zvišanje ravni krvnega sladkorja (sladkorna bolezen);
• Pneumonia (9.8%)
• pljučnica (9,8 %);
Patients aged < 65 years at diagnosis who had undergone ASCT and had achieved at least a stable disease response at the time of hematologic recovery were eligible.
Primerni so bili bolniki, ki so bili ob postavitvi diagnoze stari < 65 let, pri katerih so opravili ASCT in so dosegli vsaj stabilen odgovor bolezni v času hematološkega okrevanja.
Medianf (min, max), months: all surviving patients
Spremljanje Medianaf (min, maks), meseci: vsi preživeli bolniki
• if you are pregnant, think you may be pregnant or are planning to become pregnant, as lenalidomide is expected to be harmful to an unborn child (see section 2, ‘Pregnancy, breastfeeding and contraception - information for women and men').
• če ste noseči, menite da bi lahko bili noseči ali načrtujete zanositev, ker se pričakuje, da je lenalidomid škodljiv za nerojenega otroka (glejte 2. poglavje ‘Nosečnost, dojenje in kontracepcija - informacije za ženske in moške');
• Explanation of the risk of neuropathy with long term use
• razlago tveganja za pojav nevropatije pri dolgotrajni uporabi,
A second analysis that identified events that occurred after the start of maintenance treatment suggests that the frequencies described in Table 1 may be higher than actually observed during the maintenance treatment period.
V drugi analizi so ugotovili dogodke, ki so se pojavili po začetku vzdrževalnega zdravljenja, in kaže, da so pogostnosti, navedene v preglednici 1, morda višje od dejanskih pogostnosti, ugotovljenih v obdobju vzdrževalnega zdravljenja.
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.