FrancophonIA/ELRC3.0 huggingface dataset:
English: As a precaution, and taking into account special populations with potentially prolonged elimination time such as hepatic impairment, all male patients taking pomalidomide must meet the following conditions:
Slovenian: Kot varnostni ukrep in z upoštevanjem posebnih populacij s potencialno podaljšanim časom izločanja, kot je okvara jeter, morajo vsi moški bolniki, ki jemljejo pomalidomid, izpolnjevati naslednje pogoje:
English: • you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels.
Slovenian: • ste imeli srčni napad, imate popuščanje srca, imate težave z dihanjem ali če kadite, imate visok krvni tlak ali visoke ravni holesterola;
English: • at least every month after that for as long as you are taking Imnovid.
Slovenian: • po tem pa najmanj enkrat mesečno, dokler jemljete zdravilo Imnovid.
English: You may also experience an uneven heartbeat.
Slovenian: Morda boste imeli neenakomeren srčni utrip.
English: Duration of the treatment with Imnovid You should continue the cycles of treatment until your doctor tells you to stop.
Slovenian: Trajanje zdravljenja z zdravilom Imnovid S cikli zdravljenja nadaljujte, dokler vam zdravnik ne pove, da prenehajte.
English: • She should be capable of complying with effective contraceptive measures
Slovenian: • mora biti zmožna upoštevati zanesljive kontracepcijske ukrepe,
English: Patients must avoid situations where dizziness or confusion may be a problem and not to take other medicinal products that may cause dizziness or confusion without first seeking medical advice.
Slovenian: Bolniki se morajo izogibati situacijam, kjer omotičnost in zmedenost lahko predstavljata težavo, in ne smejo uporabljati zdravil, ki lahko povzročijo omotičnost in zmedenost, ne da bi prej vprašali zdravnika za nasvet.
English: If you suffer from liver or kidney problems your doctor will check your condition very carefully whilst you are receiving this medicine.
Slovenian: Če imate težave z jetri ali ledvicami, bo zdravnik skrbno preverjal vaše stanje, medtem ko jemljete to zdravilo.
English: • The recommended starting dose of bortezomib will be worked out by your doctor and based on your height and weight (1.3 mg/m2 body surface area).
Slovenian: • Priporočeni začetni odmerek bortezomiba bo določil vaš zdravnik na podlagi vaše telesne višine in telesne mase (1,3 mg/m2 telesne površine).
English: The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception.
Slovenian: Tveganje za vensko trombembolijo se nadaljuje 4−6 tednov po prekinitvi jemanja kombinirane peroralne kontracepcije.
English: • After completing each 4-week cycle, start a new one.
Slovenian: • Po dokončanju vsakega 4-tedenskega cikla začnite z novim.
English: • She acknowledges that she understands the hazards and necessary precautions associated with the use of pomalidomide.
Slovenian: • mora potrditi, da razume tveganja in nujne previdnostne ukrepe, povezane z uporabo pomalidomida.
English: • Feeling down (depressed mood).
Slovenian: • občutek potrtosti (depresivno razpoloženje),
English: Hepatitis B virus status should be established before initiating treatment with pomalidomide.
Slovenian: Status virusa hepatitisa B je treba ugotoviti pred začetkom zdravljenja s pomalidomidom.
English: Pregnancy, contraception and breast-feeding - information for women and men The following must be followed as stated in the Imnovid Pregnancy Prevention Programme.
Slovenian: Nosečnost, kontracepcija in dojenje - informacije za ženske in moške Naslednje morate upoštevati, kot je navedeno v programu za preprečevanje nosečnosti za zdravilo Imnovid.
English: There was no maternal toxicity observed in this study.
Slovenian: V tej študiji niso opazili toksičnosti za mater.
English: This results in damage to the bones and kidneys.
Slovenian: To poškoduje kosti in ledvice.
English: • each time your doctor writes a prescription for you, he will ensure you understand the necessary measures that have to be taken to prevent pregnancy.
Slovenian: • bo zdravnik vsakič, ko vam predpiše zdravilo, preveril, da razumete potrebne ukrepe za preprečevanje nosečnosti;
English: Action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Slovenian: Z ustreznimi ukrepi je treba poskusiti zmanjšati vse dejavnike tveganja, na katere je mogoče vplivati (npr. kajenje, hipertenzija in hiperlipidemija).
English: Infection was the most common non haematological toxicity.
Slovenian: Okužbe Okužbe so bile najpogostejša nehematološka toksičnost.
English: Before and during the treatment with Imnovid you will have regular blood tests.
Slovenian: Pred zdravljenjem z zdravilom Imnovid in med njim boste imeli redne krvne preiskave.
English: Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Slovenian: V idealnem primeru se test nosečnosti, izdaja recepta in izdaja zdravila opravijo na isti dan.
English: • you have a high total amount of tumour throughout the body, including your bone marrow.
Slovenian: • imate veliko skupno tumorsko maso po vsem telesu, vključno v kostnem mozgu.
English: Dosing is continued or modified based upon clinical and laboratory findings (see section 4.4).
Slovenian: Odmerjanje se nadaljuje ali spreminja glede na klinične in laboratorijske izvide (glejte poglavje 4.4).
English: What Imnovid is and what it is used for
Slovenian: Kaj je zdravilo Imnovid in za kaj ga uporabljamo
English: • Premature ovarian failure confirmed by a specialist gynaecologist
Slovenian: • prezgodnja odpoved jajčnikov, ki jo potrdi specialist ginekolog,
English: • The need to avoid fetal exposure
Slovenian: • potrebo po izogibanju fetalni izpostavljenosti,
English: • That the patient should not give pomalidomide to any other person
Slovenian: • opozorilo, da bolnik ne sme dajati pomalidomida nobeni drugi osebi;
English: • Sore or dry mouth.
Slovenian: • vneta ali suha usta,
English: What you need to know before you take Imnovid
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Imnovid
English: • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
Slovenian: • spolni odnosi samo z moškim partnerjem, ki so mu opravili vazektomijo; vazektomijo je treba potrditi z dvema negativnima preiskavama sperme,
English: This is because your medicine may cause a fall in the number of blood cells that help fight infection (white cells) and in the number of cells that help to stop bleeding (platelets).
Slovenian: To je zato, ker lahko to zdravilo povzroči zmanjšanje števila krvnih celic, ki pomagajo pri premagovanju okužb (bele krvne celice) in števila krvnih celic, ki pomagajo pri zaustavljanju krvavitev (trombociti).
English: Each pack contains 14 or 21 capsules.
Slovenian: Vsako pakiranje vsebuje 14 ali 21 kapsul.
English: • some antibiotics (for example ciprofloxacin, enoxacin)
Slovenian: • nekatere antibiotike (na primer ciprofloksacin, enoksacin),
English: **ANC - Absolute Neutrophil Count; ***CBC - Complete Blood Count.
Slovenian: **ANC - absolutno število nevtrofilcev (Absolute Neutrophil Counts); ***CKS - celotna krvna slika.
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 je lahko veljaven največ 4 tedne, recepti za vse druge bolnike pa so lahko veljavni največ 12 tednov.
English: Summary of overall efficacy data are presented in Table 10 using a cut-off date of 26 Oct 2017.
Slovenian: Povzetek celotnih podatkov učinkovitosti kaže preglednica 10, uporabljen je bil datum zaključka zbiranja podatkov 26. oktober 2017.
English: Patients with known risk factors for thromboembolism - including prior thrombosis - should be closely monitored.
Slovenian: Bolnike z znanimi dejavniki tveganja za trombembolijo, vključno s predhodno trombozo, je treba skrbno nadzirati.
English: Prophylaxis with acetylsalicylic acid (and other anticoagulants in high risk patients) was mandatory for all patients in clinical studies.
Slovenian: Profilaksa z acetilsalicilno kislino (in drugimi antikoagulanti pri bolnikih z velikim tveganjem) je bila obvezna za vse bolnike v kliničnih študijah.
English: • Flu-like symptoms (influenza).
Slovenian: • gripi podobni simptomi (influenca),
English: This is because this medicine is expected to harm the unborn baby.
Slovenian: To je zato, ker se pričakuje, da bo zdravilo nerojenemu otroku škodovalo.
English: 95% confidence interval about the median overall survival time.
Slovenian: 95 % interval zaupanja glede mediane časa celokupnega preživetja.
English: If you become pregnant despite the prevention measures: • you must stop the treatment immediately and talk to your doctor straight away.
Slovenian: Če kljub preprečevalnim ukrepom zanosite: • se morate takoj prenehati zdraviti in se posvetovati s svojim zdravnikom.
English: Genotoxicity/carcinogenicity
Slovenian: Genotoksičnost/kancerogenost
English: • High blood levels of sugar.
Slovenian: • zvišana raven sladkorja v krvi,
English: A female patient or a female partner of a male patient is considered of non-childbearing potential if she meets at least one of the following criteria:
Slovenian: Za bolnico ali partnerico moškega bolnika velja, da ne more zanositi, če izpolnjuje vsaj eno od naslednjih meril:
English: • Description of the PPP
Slovenian: • opis PPN,
English: Pomalidomide also inhibits angiogenesis by blocking the migration and adhesion of endothelial cells.
Slovenian: Pomalidomid zavira tudi angiogenezo, tako da blokira migracijo in adhezijo endotelijskih celic.
English: • you have or have had neuropathy (nerve damage causing tingling or pain in your hands or feet).
Slovenian: • imate ali ste imeli nevropatijo (okvaro živcev, ki povzroča ščemenje ali bolečine v rokah ali nogah);
English: If affected, patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with pomalidomide.
Slovenian: Prizadete bolnike je treba poučiti, naj ne vozijo avtomobila, upravljajo strojev ali opravljajo nevarnih del, medtem ko se zdravijo s pomalidomidom.
English: Neutropenia*
Slovenian: Nevtropenija*
English: Your doctor will advise you of how and when to take Imnovid if you have kidney problems and are receiving dialysis treatment.
Slovenian: Zdravnik vam bo svetoval, kako in kdaj jemljite zdravilo Imnovid, če imate težave z ledvicami in vas zdravijo z dializo.
English: The p-value is based on a stratified log-rank test with the same stratification factors as the above Cox model.
Slovenian: Vrednost p temelji na stratificiranem testu log-rank z enakimi stratifikacijskimi faktorji kot zgornji Coxov model.
English: Your doctor may recommend you take additional treatments (e.g. warfarin) or lower the dose of Imnovid to reduce the chance that you get blood clots.
Slovenian: Vaš zdravnik vam lahko priporoča dodatno zdravljenje (npr. varfarin) ali nižje odmerke zdravila Imnovid, da zmanjša možnost nastanka krvnih strdkov;
English: • Need for effective contraception and definition of effective contraception
Slovenian: • potrebo po zanesljivi kontracepciji in opredelitev zanesljive kontracepcije,
English: • certain antidepressants such as fluvoxamine.
Slovenian: • nekatere antidepresive, na primer fluvoksamin.
English: Median OS time from Kaplan-Meier estimates has not been reached for the Pom + LD-Dex, but would be expected to be at least 48 weeks, which is the lower boundary of the 95% CI.
Slovenian: Mediana časa celokupnega preživetja po oceni Kaplan-Meier ni bila dosežena za POM + NO-deks, vendar bi po pričakovanjih trajala vsaj 48 tednov, kar je spodnja meja 95 % IZ.
English: This can result in kidney problems.
Slovenian: To lahko povzroči težave z ledvicami.
English: • She understands the expected teratogenic risk to the unborn child
Slovenian: • razume pričakovano tveganje za teratogene učinke pri nerojenem otroku,
English: • Male patients unable to follow or comply with the required contraceptive measures (see section 4.4).
Slovenian: • moški bolniki, ki niso sposobni slediti zahtevanim kontracepcijskim ukrepom ali ravnati v skladu z njimi (glejte poglavje 4.4),
English: No metabolites were present at >10% relative to parent or total radioactivity in plasma.
Slovenian: Presnovki niso bili prisotni z > 10 % glede na izhodno ali skupno radioaktivnost v plazmi.
English: • Loss of consciousness, fainting.
Slovenian: • izguba zavesti, omedlevica,
English: • The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding
Slovenian: • bolnica upošteva vse pogoje programa za preprečevanje nosečnosti, vključno s potrditvijo, da jih ustrezno razume,
English: Died n (%)
Slovenian: Umrli n (%)
English: A dose modification may be required (see section 4.2).
Slovenian: Odmerek bo morda treba prilagoditi (glejte poglavje 4.2).
English: • Previous bilateral salpingo-oophorectomy, or hysterectomy
Slovenian: • predhodna bilateralna salpingo-ooforektomija ali histerektomija,
English: The predominant metabolic pathways of excreted radioactivity are hydroxylation with subsequent glucuronidation, or hydrolysis.
Slovenian: Prevladujoča presnovna pot izločene radioaktivnosti je hidroksilacija s sledečo glukuronidacijo ali hidroliza.
English: Details of the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Slovenian: O podrobnostih PPN se je treba dogovoriti s pristojnimi nacionalnimi organi v vsaki državi članici in program uvesti pred prihodom zdravila na trg.
English: Also some other medicines can affect the way Imnovid works.
Slovenian: Tudi nekatera druga zdravila lahko vplivajo na način delovanja zdravila Imnovid.
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 naročiti, da poiščejo zdravniško pomoč, če se razvijejo simptomi, kot so zasoplost, bolečine v prsnem košu, oteklost rok ali nog.
English: For male patients taking pomalidomide, pharmacokinetic data has demonstrated that pomalidomide is present in human semen during treatment.
Slovenian: Za moške bolnike, ki jemljejo pomalidomid, so farmakokinetični podatki pokazali, da je pomalidomid med zdravljenjem prisoten v človeški spermi.
English: Use diuretics as needed and decrease dose by one dose level.
Slovenian: Uporabite diuretike, kot je potrebno, in odmerek zmanjšajte za eno raven.
English: Anticoagulation therapy (unless contraindicated) is recommended (see section 4.4).
Slovenian: Priporočljivo je antikoagulacijsko zdravljenje (razen če je kontraindicirano) (glejte poglavje 4.4).
English: It is also a substrate for P-glycoprotein.
Slovenian: Je tudi substrat za P-glikoprotein.
English: In monkeys, pomalidomide was evaluated in repeat-dose studies of up to 9 months in duration.
Slovenian: Pri opicah so pomalidomid ocenjevali v do 9 mesecev trajajočih študijah s ponavljajočim odmerkom.
English: In vitro binding of pomalidomide enantiomers to proteins in human plasma ranges from 12% to 44% and is not concentration dependent.
Slovenian: Razpon vezave enantiomerov pomalidomida in vitro na beljakovine v plazmi pri človeku je med 12 % do 44 % in ni odvisen od koncentracije.
English: Patients with serum total bilirubin > 1.5 x ULN (upper limit of normal range) were excluded from clinical studies.
Slovenian: Bolniki s skupnim bilirubinom v serumu > 1.5 x zgornja meja normalnega območja (ULN - upper limit of normal range) so bili izključeni iz kliničnih študij.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: 95% CI about the median.
Slovenian: 95 % IZ okrog mediane.
English: Following multiple doses, pomalidomide has an accumulation ratio of 27 to 31% on AUC.
Slovenian: Po večkratnem odmerjanju je razmerje kopičenja pomalidomida 27 do 31 % na AUC.
English: The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and /or dispensing controls, and the collection of detailed data relating to the indication in order to monitor the off-label use within the national territory.
Slovenian: Nadzorovani sistem razdeljevanja vključuje uporabo kartice za bolnika in/ali enakovredno orodje za nadzor predpisovanja in izdajanja in zbiranje podrobnih podatkov v zvezi z indikacijo zaradi natančnega nadzora nenamenske uporabe znotraj nacionalnega območja.
English: Educational materials, prescribing and dispensing restrictions
Slovenian: Izobraževalna gradiva, omejitve glede predpisovanja in izdajanja
English: When treated males on this study were mated with untreated females, all uterine parameters were comparable to the controls.
Slovenian: Pri parjenju zdravljenih samcev v tej študiji z nezdravljenimi samicami so bili vsi parametri v maternici primerljivi s kontrolami.
English: You must follow the Imnovid Pregnancy Prevention Programme.
Slovenian: Upoštevati morate program za preprečevanje nosečnosti za zdravilo Imnovid.
English: Effect of other medicinal products on pomalidomide
Slovenian: Učinek drugih zdravil na pomalidomid
English: The capsules should be swallowed whole, preferably with water, with or without food.
Slovenian: Kapsule je treba zaužiti cele, najbolje z vodo, s hrano ali brez nje.
English: Btz = bortezomib; CI = Confidence interval; CR = Complete response; DoR = Duration of response; HR = Hazard Ratio; LD-Dex = low-dose dexamethasone; OR = Odds ratio; ORR = Overall response rate; PFS = Progression free survival; POM = pomalidomide; PR = Partial Response; sCR = Stringent complete response VGPR = Very good partial response.
Slovenian: Btz = bortezomib; IZ = interval zaupanja; CR = popolni odziv (complete response); DoR = trajanje odziva (duration of response); HR = razmerje tveganja (hazard ratio); NO-deks = nizkoodmerni deksametazon; OR = razmerje verjetnosti (odds ratio); ORR = celotna odzivnost (overall response rate); PFS = preživetje brez napredovanja (progression free survival); POM = pomalidomid; PR = delen odziv (partial response); sCR = prepričljiv popoln odziv (stringent complete response); VGPR = zelo dober delen odziv (very good partial response).
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, če obstaja tveganje za zanositev,
English: Cycle 1-8
Slovenian: Cikel 1-8
English: Patients at greatest risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Slovenian: Bolniki z največjim tveganjem za sindrom tumorske lize so tisti, ki so imeli pred zdravljenjem največje tumorsko breme.
English: Treat with insulin or oral hypoglycaemic agents as needed.
Slovenian: Zdravite z insulinom ali peroralnimi hipoglikemičnimi zdravili po potrebi.
English: Pomalidomide (4 mg) Bortezomib (1.3 mg/m2) Dexamethasone (20 mg) * • •
Slovenian: pomalidomid (4 mg) bortezomib (1,3 mg/m2) deksametazon (20 mg) * • •
English: How much Imnovid to take with other medicines
Slovenian: Koliko zdravila Imnovid vzeti z drugimi zdravili
English: • Feeling confused.
Slovenian: • občutek zmedenosti,
English: This is because Imnovid can affect the way some other medicines work.
Slovenian: Zdravilo Imnovid lahko vpliva na način delovanja nekaterih drugih zdravil.
English: • Inability to pass urine.
Slovenian: • nezmožnost odvajanja urina,
English: Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups.
Slovenian: Na podlagi modela sorazmernih ogroženosti po Coxu s primerjavo funkcij tveganja, povezanih z zdravljenimi skupinami.
English: Pomalidomide binds directly to the protein cereblon (CRBN), which is part of an E3 ligase complex that includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4 (CUL4), and regulator of cullins-1 (Roc1), and can inhibit the auto-ubiquitination of CRBN within the complex.
Slovenian: Pomalidomid se veže neposredno na beljakovino cereblon (CRBN), ki je del kompleksa ligaze E3, ki vključuje beljakovino, ki se veže na poškodbe deoksiribonukleinske kisline (DDB1 - DNA damagebinding protein 1-), kulin 4 (CUL4) in kulinski regulator 1 (Roc1- regulator of cullins-1), in lahko inhibira avto-ubikvitinacijo CRBN v kompleksu.
English: Pomalidomide is partly metabolised by CYP1A2 and CYP3A4/5.
Slovenian: Pomalidomid delno presnavljata encima CYP1A2 in CYP3A4/5.
English: In clinical studies, patients received prophylactic acetylsalicylic acid or alternative antithrombotic therapy.
Slovenian: V kliničnih študijah so bolniki profilaktično prejemali acetilsalicilno kislino ali alternativno antitrombotično zdravljenje.
English: • Swelling of face, lips, tongue and throat, which may cause difficulty breathing (due to a serious type of allergic reaction called angioedema).
Slovenian: • otekanje obraza, ustnic, jezika in žrela, ki lahko povzroči težave z dihanjem (zaradi hude vrste alergijske reakcije, imenovane angioedem);
English: Confusion or mood alteration ≥ Grade 2
Slovenian: Zmedenost ali spremenjeno razpoloženje ≥ 2. stopnje
English: A teratogenic effect of pomalidomide in humans is expected.
Slovenian: Pričakuje se teratogeni učinek pomalidomida pri ljudeh.
English: If you forget to take Imnovid
Slovenian: Če ste pozabili vzeti zdravilo Imnovid
English: The effect of dexamethasone on warfarin is unknown.
Slovenian: Učinek deksametazona na varfarin ni znan.
English: Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Slovenian: Bolnikom in zdravnikom je treba svetovati, da opazujejo pojav znakov in simptomov trombembolije.
English: Your doctor will advise if you should stop or continue breast-feeding.
Slovenian: Vaš zdravnik vam bo svetoval, ali naj z dojenjem prenehate ali nadaljujete.
English: VTE was reported as serious in 1.7-4.3% of patients, no fatal reactions were reported, and VTE was associated with pomalidomide discontinuation in up to 1.8% of patients.
Slovenian: O resnih VTE so poročali pri 1,7-4,3 % bolnikov, o smrtnih primerih niso poročali, VTE pa so bili povezani z ukinitvijo pomalidomida pri do 1,8 % bolnikov.
English: The doctor may also change the dose or stop the medicine because of your general health.
Slovenian: Odmerek lahko zdravnik spremeni ali prekine uporabo zdravila tudi zaradi vašega splošnega stanja.
English: Other medicines and Imnovid
Slovenian: Druga zdravila in zdravilo Imnovid
English: Women of childbearing potential should use effective method of contraception.
Slovenian: Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijsko metodo.
English: • Do not take this medicine if you are pregnant or could become pregnant.
Slovenian: Ne jemljite tega zdravila, če ste noseči ali lahko zanosite.
English: Evaluation of recovery animals indicated that all treatment-related findings were reversible after 8 weeks of dosing cessation, except for proliferation of intrahepatic bile ducts observed in 1 animal in the 1 mg/kg/day group.
Slovenian: Ocenitev živali, ki so okrevale, je pokazala, da so bili vsi izsledki, povezani z zdravljenjem, reverzibilni v 8 tednih od prenehanja odmerjanja, razen proliferacije intrahepatičnga žolčevoda, kar so opazili pri 1 živali v skupini z odmerkom 1 mg/kg/dan.
English: The Direct Healthcare Professional Communication shall consist of two parts:
Slovenian: Neposredno obvestilo za zdravstvene delavce naj sestoji iz dveh delov:
English: Censored n (%)
Slovenian: Cenzurirano n (%)
English: Such patients may be at higher risk of hypersensitivity reactions and should not receive pomalidomide.
Slovenian: Pri takih bolnikih je morda tveganje za preobčutljivostne reakcije večje in ne smejo dobivati pomalidomida.