FrancophonIA/ELRC3.0 huggingface dataset:
English: Peripheral neuropathy occurred in 55.4 % of patients (10.8% Grade 3; 0.7% Grade 4).
Slovenian: Periferna nevropatija se je pojavila pri 55,4 % bolnikov (pri 10,8 % 3. stopnje; pri 0,7 % 4. stopnje).
English: At the end of the treatment you should return all unused capsules to the pharmacist.
Slovenian: Na koncu zdravljenja morate vse neporabljene kapsule vrniti farmacevtu.
English: Direct Healthcare Professional Communications (Prior to Launch)
Slovenian: Ključni elementi, ki morajo biti vsebovani Neposredno obvestilo za zdravstvene delavce (pred prihodom zdravila na trg)
English: No data are available on administration of pomalidomide to paediatric patients (< 18 years of age).
Slovenian: Podatki o dajanju pomalidomida pediatričnim bolnikom (< 18 let starosti) niso na voljo.
English: As a result of these tests, your doctor may change your dose of Imnovid or stop your treatment.
Slovenian: Zdravnik lahko na podlagi rezultatov preiskav spremeni vaš odmerek zdravila Imnovid ali prekine zdravljenje.
English: • Brochure for women patients of childbearing potential and their partners
Slovenian: • brošure za ženske v rodni dobi in njihove partnerje,
English: Stop taking Imnovid and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Slovenian: Takoj prenehajte jemati zdravilo Imnovid in pojdite takoj k zdravniku, če opazite katerega od naslednjih neželenih učinkov - morda potrebujete nujno zdravniško pomoč:
English: All Adverse Reactions /Frequency
Slovenian: Vsi neželeni učinki /pogostnost
English: In the Btz+LD-Dex arm, median PFS time was 7.1 months (95% CI: 5.88, 8.48).
Slovenian: V skupini Btz+NO-deks je bil mediani čas PFS 7,1 meseca (95 % IZ: 5,88; 8,48).
English: If pomalidomide is taken during pregnancy, a teratogenic effect of pomalidomide in humans is expected (see section 4.4).
Slovenian: Pri jemanju pomalidomida med nosečnostjo se pri ljudeh pričakuje teratogeni učinek (glejte poglavje 4.4).
English: Dexamethasone should be discontinued if the patient is unable to tolerate 10 mg if ≤ 75 years old or 8 mg if > 75 years old.
Slovenian: Deksametazon je treba ukiniti, če bolnik ne more prenašati odmerka 10 mg pri starosti ≤ 75 let ali 8 mg pri starosti > 75 let.
English: Thrombocytopenia was Grade 3 or 4 in 20.7-27.3% of patients, led to pomalidomide discontinuation in 0.7% of patients and was serious in 0.4-1.7% of patients (see sections 4.2 and 4.4).
Slovenian: Trombocitopenija je bila 3. ali 4. stopnje pri 20,7-27,3 % bolnikov, povzročila je ukinitev pomalidomida pri 0,7 % bolnikov in je bila resna pri 0,4-1,7 % bolnikov (glejte poglavji 4.2 in 4.4).
English: • If your partner becomes pregnant while you are taking Imnovid, tell your doctor straight away.
Slovenian: • Če vaša partnerica zanosi, medtem ko jemljete zdravilo Imnovid, to takoj povejte zdravniku.
English: Interrupt pomalidomide treatment.
Slovenian: Prekinite zdravljenje s pomalidomidom.
English: • To conduct a non-interventional post-authorisation registry of patients treated with pomalidomide for relapsed and refractory multiple myeloma to monitor the incidence of adverse drug reactions in the “real world situation” and to monitor the implementation and compliance of the Celgene PPP and controlled distribution system on a country basis in agreement with the relevant National Competent Authority (ie., monitoring of Patient Card completion).
Slovenian: • Voditi neintervencijski register bolnikov, zdravljenih s pomalidomidom zaradi recidivnega in refraktarnega diseminiranega plazmocitoma, po pridobitvi dovoljenja za promet, za spremljanje incidence neželenih učinkov zdravila v "resničnih situacijah" in za spremljanje izvajanja programa preprečevanja nosečnosti družbe Celgene, ter nadzorovanega sistema distribucije v posameznih državah, v dogovoru z ustreznim pristojnim nacionalnim organom (tj. spremljanje izpolnitve bolnikove kartice).
English: Pomalidomide is extensively metabolised prior to excretion, with the resulting metabolites eliminated primarily in the urine.
Slovenian: Pomalidomid se pred izločanjem izčrpno presnovi, presnovki pa se izločijo pretežno v urinu.
English: Survival Time (weeks)
Slovenian: Čas preživetja (tedni)
English: Peripheral neuropathy occurred in 12.3% of patients (1.0% Grade 3 or 4).
Slovenian: Periferna nevropatija se je pojavila pri 12,3 % bolnikov (pri 1,0 % 3. ali 4. stopnje).
English: For patients > 75 years of age, the starting dose of dexamethasone is:
Slovenian: Za bolnike, stare > 75 let, je začetni odmerek deksametazona:
English: Pomalidomide is not anticipated to cause clinically relevant pharmacokinetic drug-drug interactions due to P450 isoenzyme inhibition or induction or transporter inhibition when co-administered with substrates of these enzymes or transporters.
Slovenian: Ne pričakuje se, da bi pomalidomid povzročil klinično pomembno farmakokinetično medsebojno delovanje zdravil zaradi zaviranja ali spodbujanja izoencima P450 ali zaviranja prenašalcev, če se uporablja sočasno s substrati teh encimov ali prenašalcev.
English: Patients with a history of severe rash associated with lenalidomide or thalidomide should not receive pomalidomide (see section 4.4).
Slovenian: Bolniki z anamnezo hudega izpuščaja, ki je bil povezan z zdravljenjem z lenalidomidom ali s talidomidom, ne smejo prejemati pomalidomida (glejte poglavje 4.4).
English: • A fall in the number of red and white blood cells and platelets at the same time (pancytopenia), which will make you more prone to bleeding and bruising.
Slovenian: • hkratno zmanjšanje števila rdečih in belih krvnih celic in trombocitov (pancitopenija), zaradi katere boste bolj nagnjeni h krvavitvam in podplutbam.
English: Dexamethasone should be discontinued if the patient is unable to tolerate 8 mg if ≤ 75 years old or 4 mg if > 75 years old.
Slovenian: Deksametazon je treba ukiniti, če bolnik ne more prenašati odmerka 8 mg pri starosti ≤ 75 let ali 4 mg pri starosti > 75 let.
English: • Description of the PPP and categorisation of patients based on sex and childbearing potential o Algorithm for implementation of PPP o Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure
Slovenian: • opis PPN in razvrstitev bolnikov po spolu in zmožnosti zanositve: o algoritem za izvajanje PPN, o opredelitev žensk v rodni dobi (ŽRD) in ukrepov, ki jih mora zdravnik izvajati v primeru negotovosti.
English: • Pomalidomide in combination with bortezomib and dexamethasone In randomised study CC-4047-MM-007, 278 patients received pomalidomide, bortezomib and dexamethasone (Pom+Btz+Dex arm).
Slovenian: • Pomalidomid v kombinaciji z bortezomibom in deksametazonom V randomizirani študiji CC-4047-MM-007 je 278 bolnikov prejemalo pomalidomid, bortezomib in deksametazon (skupina s Pom+Btz+deks).
English: Do not use Imnovid if you notice any damage or signs of tampering to medicine packaging.
Slovenian: Ne uporabljajte zdravila Imnovid, če opazite, da je bila ovojnina poškodovana ali kaže znake zlorabe.
English: The Educational Healthcare Professional's Kit
Slovenian: Paket izobraževalnih gradiv za zdravstvene delavce
English: In rabbits, pomalidomide at dosages ranging from 10 to 250 mg/kg produced embryo-foetal developmental malforma tions.
Slovenian: Pri kuncih so razponi odmerka pomalidomida od 10 do 250 mg/kg povzročili embriofetalne razvojne deformacije.
English: Very Common Pneumonia (bacterial, viral and fungal infections, including opportunistic infections)
Slovenian: Infekcijske in parazitske bolezni zelo pogosti pljučnica (bakterijske, virusne in glivične okužbe, vključno z oportunističnimi okužbami)
English: Imnovid is expected to cause severe birth defects and may lead to the death of an unborn baby.
Slovenian: Pričakuje se, da bo zdravilo Imnovid povzročilo hude okvare pri nerojenem otroku in bi lahko povzročilo njegovo smrt.
English: • Dizziness, tremor.
Slovenian: • omotica, tresenje,
English: • Decreased ability to move or feel (sensation) in your hands, arms, feet and legs because of nerve damage (peripheral sensorimotor neuropathy).
Slovenian: • zmanjšana zmožnost gibanja ali občutkov (senzacij) v dlaneh, zgornjih udih, stopalih in spodnjih udih zaradi okvar živcev (periferna senzorimotorična nevropatija),
English: Pomalidomide must be discontinued permanently for angioedema.
Slovenian: Pri angioedemu je treba zdravljenje s pomalidomidom trajno ukiniti.
English: At 250 mg/kg/day, fetal malformations included limb anomalies (flexed and/or rotated fore- and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia); moderate dilation of the lateral ventricle in the brain; abnormal placement of the right subclavian artery; absent intermediate lobe in the lungs; low-set kidney; altered liver morphology; incompletely or not ossified pelvis; an increased average for supernumerary thoracic ribs and a reduced average for ossified tarsals.
Slovenian: Pri odmerku 250 mg/kg/dan so deformacije zarodka vključevale anomalije udov (zviti in/ali obrnjeni sprednji in/ali zadnji udi, nepritrjeni ali odsotni prsti) in povezane deformacije okostja (neokostenela dlančnica, neporavnani prstnica in dlančnica, odsotni prsti, neokostenela prstnica in kratka, neokostenela ali zvita golenica); zmerna razširitev lateralnega možganskega ventrikla; nenormalen položaj desne subklavijske arterije; odsoten vmesni pljučni lobus; nizka lega ledvic; spremenjena oblika jeter; nepopolna ali neokostenela medenica; zvišano povprečje odvečnih torakalnih reber in zmanjšano povprečje okostenelih nartov.
English: Infection
Slovenian: Infekcije
English: • That pomalidomide may cause thrombocytopenia and the need for regular blood tests
Slovenian: • da pomalidomid lahko povzroča trombocitopenijo; potrebne so redne krvne preiskave;
English: The pharmacokinetic parameters were modestly changed in hepatically impaired patients (defined by Child-Pugh criteria) compared to healthy subjects.
Slovenian: Farmakokinetični parametri pri bolnikih z okvaro jeter (opredeljeno po Child-Pughovih kriterijih) so bili v primerjavi z zdravimi osebami nekoliko spremenjeni.
English: Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking pomalidomide and dexamethasone, combined oral contraceptive pills are not recommended (see also section 4.5).
Slovenian: Zaradi povečanega tveganja za vensko trombembolijo pri bolnicah z diseminiranim plazmocitomom, ki jemljejo pomalidomid in deksametazon, uporaba kombiniranih peroralnih kontracepcijskih tablet ni priporočena (glejte tudi poglavje 4.5).
English: The most commonly reported serious adverse reaction was pneumonia (11.5%).
Slovenian: Resni neželeni učinek, o katerem so poročali najpogosteje, je bila pljučnica (11,5 %).
English: The mean increases in exposure to pomalidomide in each of these impairment groups are not of a magnitude for which adjustments in schedule or dose are required (see section 4.2).
Slovenian: Srednja zvečanja izpostavljenosti pomalidomidu v skupinah s temi okvarami niso bila tako velika, da bi bile potrebne prilagoditve sheme ali odmerka (glejte poglavje 4.2).
English: At 100 and 250 mg/kg/day, there were slight increases in post-implantation loss and slight decreases in fetal body weights.
Slovenian: Pri odmerkih 100 in 250 mg/kg/dan so opazili rahlo zvišanje izgube po ugnezditvi in rahlo znižanje telesne mase zarodka.
English: Population pharmacokinetic analyses showed that the pomalidomide pharmacokinetic parameters were not remarkably affected in renally impaired patients (defined by creatinine clearance or estimated glomerular filtration rate [eGFR]) compared to patients with normal renal function (CrCl ≥60 mL/minute).
Slovenian: Populacijske farmakokinetične analize so pokazale, da pri bolnikih z okvaro ledvic (opredeljeno z očistkom kreatinina ali ocenjeno hitrostjo glomerulne filtracije [eGFR - estimated glomerular filtration rate]) farmakokinetični parametri pomalidomida niso bili bistveno spremenjeni v primerjavi z bolniki z normalno funkcijo ledvic (CrCl ≥60 ml/minuto).
English: A medically supervised pregnancy test should be repeated at least every 4 weeks, including at least 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.
Slovenian: Test nosečnosti pod zdravniškim nadzorom je treba ponoviti vsaj vsake 4 tedne, vključno z vsaj 4 tedne po koncu zdravljenja, razen v primeru potrjene sterilizacije jajcevodov.
English: Pomalidomide is structurally related to thalidomide.
Slovenian: Pomalidomid je strukturno soroden talidomidu.
English: • A core text as agreed by the CHMP.
Slovenian: • osrednjega besedila, kot ga je odobril Odbor za zdravila za uporabo v humani medicini (CHMP)
English: • Rapid breathing, rapid pulse, fever and chills, passing very little to no urine, nausea and vomiting, confusion, unconsciousness (due to infection of blood called sepsis or septic shock).
Slovenian: • pospešeno dihanje, pospešen srčni utrip, zvišana telesna temperatura in mrzlica, izločanje zelo malo ali nič urina, navzea in bruhanje, zmedenost, nezavest (zaradi okužbe krvi, ki se imenuje sepsa ali septični šok);
English: Neutropenia and thrombocytopenia tended to occur more frequently within the first 2 cycles of treatment with pomalidomide.
Slovenian: Nevtropenija in trombocitopenija sta kazali nagnjenje k pogostnejšemu pojavljanju v prvih 2 ciklih zdravljenja s pomalidomidom.
English: • Safety advice relevant to all patients o Description and management of thrombocytopenia including incidence rates from clinical studies o Description and management of cardiac failure o Disposal of unwanted medicine o Local country specific arrangements for a prescription for pomalidomide to be dispensed
Slovenian: • varnostne nasvete, primerne za vse bolnike: o opis ter obvladovanje trombocitopenije, vključno s stopnjo incidence v kliničnih študijah, o opis in obvladovanje srčnega popuščanja, o odstranjevanje odvečnega zdravila, o lokalne, za državo značilne dogovore glede predpisovanja in izdajanja pomalidomida.
English: Appropriate caution should be exercised when considering the treatment of such patients with pomalidomide.
Slovenian: Ko se ocenjuje možnost zdravljenja teh bolnikov s pomalidomidom je potrebna ustrezna previdnost.
English: If recovery from toxicities is prolonged beyond 14 days, then the dose of dexamethasone will be resumed at one dose level lower than the previous dose.
Slovenian: Če se okrevanje zaradi toksičnosti podaljša za več kot 14 dni, nadaljujte z odmerkom, za eno raven manjšim od predhodnega odmerka.
English: Stop using pomalidomide if you develop these symptoms and contact your doctor or seek medical attention immediately.
Slovenian: Če se vam pojavijo ti simptomi, prenehajte uporabljati pomalidomid in se takoj posvetujte z zdravnikom oziroma poiščite zdravniško pomoč.
English: • Imnovid and dexamethasone are taken in ‘treatment cycles'.
Slovenian: • Zdravilo Imnovid in deksametazon se jemljeta v ‘ciklih zdravljenja'.
English: Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups, stratified by age (≤75 vs >75),diseases population (refractory to both lenalidomide and bortezomib vs not refractory to both active substances), and prior number of anti myeloma therapy (=2 vs >2).
Slovenian: Na podlagi modela sorazmernih ogroženosti po Coxu s primerjavo funkcij tveganja, povezanih z zdravljenimi skupinami, stratificiranimi po starosti (≤ 75 v primerjavi z > 75), bolezni prebivalstva (neodzivni na lenalidomid in bortezomib v primerjavi z odzivnimi na obe učinkovini) in predhodnim številom terapij proti plazmocitomu (= 2 v primerjavi z > 2).
English: In patients receiving combination therapy with pomalidomide in clinical studies, infection occurred in 55.0-80.2% of patients (24.0-30.9% Grade 3 or 4).
Slovenian: Pri bolnikih, ki so v kliničnih študijah prejemali kombinirano zdravljenje s pomalidomidom, so se okužbe pojavile pri 55,0-80,2 % bolnikov (pri 24,0-30,9 % 3. ali 4. stopnje).
English: • Brief background on pomalidomide and its licensed indication
Slovenian: • povzetek podatkov o pomalidomidu in indikaciji, za katero je odobren;
English: This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na kapsulo, kar v bistvu pomeni "brez natrija".
English: Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude ILD.
Slovenian: Pri bolnikih z akutnim nastopom ali nepojasnjenim poslabšanjem pljučnih simptomov je treba opraviti skrbno presojo in izključiti možnost IPB.
English: Pomalidomide doses as high as 50 mg as a single dose in healthy volunteers, and 10 mg as once-daily multiple doses in multiple myeloma patients have been studied without reported serious adverse reactions related to overdose.
Slovenian: Preučili so enkratne odmerke pomalidomida do 50 mg pri zdravih prostovoljcih in 10 mg večkratni odmerek enkrat na dan pri bolnikih z diseminiranim plazmocitomom brez poročil o resnih neželenih učinkih, povezanih s prevelikim odmerjanjem.
English: Regular monitoring of liver function is recommended for the first 6 months of treatment with pomalidomide and as clinically indicated thereafter.
Slovenian: Priporočamo, da prvih 6 mesecev zdravljenja s pomalidomidom redno spremljate delovanje jeter, nato pa skladno s kliničnimi indikacijami.
English: During the treatment with Imnovid you have an increased risk of getting blood clots in your veins and arteries.
Slovenian: Med zdravljenjem z zdravilom Imnovid je tveganje za pojav krvnih strdkov v venah in arterijah večje.
English: Two sided 95% CIb
Slovenian: Dvostranski 95 % IZb
English: A medically supervised pregnancy test should be performed during the consultation, when pomalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Slovenian: Test nosečnosti pod zdravniškim nadzorom je treba opraviti med posvetom, ko se predpiše pomalidomid, ali v 3 dneh pred obiskom pri zdravniku, ki predpiše zdravilo, po tem ko je bolnica vsaj 4 tedne že uporabljala zanesljivo kontracepcijo.
English: The median is based on the Kaplan-Meier estimate.
Slovenian: Mediana temelji na oceni Kaplan-Meier.
English: • Requirements in the event of pregnancy o Instructions to stop pomalidomide immediately upon suspicion of pregnancy if female patients o Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice o Local contact details for reporting of any suspected pregnancy o Pregnancy reporting form
Slovenian: • zahteve v primeru nosečnosti: o navodila za takojšnjo prekinitev zdravljenja s pomalidomidom v primeru suma na nosečnost pri bolnicah, o potrebo po napotitvi k zdravniku specialistu za teratologijo ali z izkušnjami na področju teratologije in njeni diagnostiki zaradi ocene in svetovanja, o kontaktne podatke za poročanje kakršnegakoli suma na nosečnost, o obrazec za poročanje o nosečnosti.
English: • For Cycles 9 and onwards: 10 mg once daily on Days 1, 2, 8 and 9 of each 21-day cycle.
Slovenian: • za cikel 9 in naprej: 10 mg enkrat na dan na 1., 2., 8. in 9. dan vsakega 21-dnevnega cikla.
English: If you take more Imnovid than you should, talk to a doctor or go to a hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Imnovid, kot bi smeli Če ste vzeli večji odmerek zdravila Imnovid, kot bi smeli, se pogovorite z zdravnikom ali pojdite takoj v bolnišnico.
English: There is no relevant use of pomalidomide in children aged 0-17 years for the indication of multiple myeloma.
Slovenian: Uporaba pomalidomida pri otrocih, starih 0 do 17 let, za indikacijo diseminiranega plazmocitoma ni primerna.
English: • Swelling caused by fluid.
Slovenian: • otekanje, ki ga povzroča tekočina,
English: Other serious adverse reactions reported included pyrexia (4.0%), lower respiratory tract infection (2.9%), pulmonary embolism (2.9%), influenza (2.9%), and acute kidney injury (2.9%).
Slovenian: Med drugimi resnimi neželenimi učinki, o katerih so poročali, so bili pireksija (4,0 %), infekcije spodnjih dihal (2,9 %), pljučna embolija (2,9 %), gripa (2,9 %) in akutna okvara ledvic (2,9 %).
English: • Pomalidomide in combination with dexamethasone
Slovenian: • Pomalidomid v kombinaciji z deksametazonom
English: Patients should not adjust the dose to make up for a missing dose on previous days.
Slovenian: Bolnik ne sme prilagajati odmerka, da bi nadomestil odmerek, zamujen prejšnji dan.
English: Cycle 9 and onwards
Slovenian: 9. cikel in naprej
English: ANC return to ≥ 1 x 109/l
Slovenian: • ANC se vrne na ≥1 x 109/l
English: The primary efficacy endpoint was Progression Free Survival (PFS) assessed by an Independent Response Adjudication Committee (IRAC) according to the IMWG criteria using the intent to treat population (ITT).
Slovenian: Primarni cilj študije za dokaz učinkovitosti je bilo preživetje brez napredovanja (PFS - progression free survival), ki ga je ocenjeval neodvisni presojevalni odbor (IRAC - Independent Response Adjudication Committee) po kriterijih IMWG z uporabo populacije z namenom zdravljenja (ITT - Intention to Treat -).
English: The 1-year event free rate was 52.6% (± 5.72%) for the Pom + LD-Dex arm and 28.4% (± 7.51%) for the HD-Dex arm.
Slovenian: Enoletna stopnja brez dogodkov je bila 52,6 % (± 5,72 %) za skupino POM + NO-deks in 28,4 % (± 7,51 %) za skupino VO-deks.
English: Co-administration of multiple doses of up to 4 mg pomalidomide with 20 mg to 40 mg dexamethasone (a weak to moderate inducer of several CYP enzymes including CYP3A) to patients with multiple myeloma had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide administered alone.
Slovenian: Sočasno dajanje več odmerkov do 4 mg pomalidomida z 20 mg do 40 mg deksametazona (šibek do zmeren spodbujevalec številnih encimov CYP, vključno s CYP3A) bolnikom z diseminiranim plazmocitomom ni imelo vpliva na farmakokinetiko pomalidomida v primerjavi z dajanjem samega pomalidomida.
English: For each subsequent drop < 0.5 x 109/l
Slovenian: • Pri vsakem nadaljnjem zmanjšanju < 0,5 x 109/l
English: • Low blood levels of magnesium (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability and may result in low blood levels of calcium (hypocalcaemia), which may cause numbness and, or tingling of hands, feet, or lips, muscle cramps, muscle weakness, light-headedness, confusion.
Slovenian: • nizka raven magnezija v krvi (hipomagneziemija), ki lahko povzroča utrujenost, splošno šibkost, mišične krče, razdražljivost in lahko povzroči nizko raven kalcija v krvi (hipokalciemija), ki lahko povzroči odrevenelost in/ali mravljinčenje dlani, stopal ali ustnic, mišične krče, mišično šibkost, vrtoglavost, zmedenost,
English: ADRs reported in post-marketing use in patients treated with pomalidomide.
Slovenian: NUZ, o katerih so poročali pri uporabi po začetku trženja zdravila pri bolnikih, zdravljenih s pomalidomidom.