FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Pomalidomid se vezuje izravno na protein cereblon (CRBN), dio kompleksa ligaze E3 koji uključuje protein 1 koji se veže na oštećeno mjesto deoksiribonukleinske kiseline (engl. deoxyribonucleic acid damage-binding protein 1, DDB1), kulin 4 (CUL4) i regulator kulina 1 (Roc1) i može inhibirati autoubikvitinaciju CRBN-a unutar tog kompleksa.
English: The predominant metabolic pathways of excreted radioactivity are hydroxylation with subsequent glucuronidation, or hydrolysis.
Croatian: Glavni metabolički putevi kojima se izlučuje radioaktivnost su hidroksilacija s naknadnom glukuronidacijom ili hidroliza.
English: In clinical studies, patients received prophylactic acetylsalicylic acid or alternative antithrombotic therapy.
Croatian: U kliničkim ispitivanjima, bolesnici su primali profilaksu acetilsalicilatnom kiselinom ili alternativnu antitrombotsku terapiju.
English: Pomalidomide also inhibits angiogenesis by blocking the migration and adhesion of endothelial cells.
Croatian: Pomalidomid također inhibira angiogenezu blokadom migracije i adhezije endotelnih stanica.
English: Not Known Hepatitis B reactivation
Croatian: Nepoznato reaktivacija hepatitisa B
English: Pomalidomide was found to impact negatively on fertility and be teratogenic in animals.
Croatian: Otkriveno je da pomalidomid negativno utječe na plodnost i da je teratogen u životinja.
English: Treat with insulin or oral hypoglycaemic agents as needed.
Croatian: Liječiti inzulinom ili peroralnim hipoglikemicima prema potrebi.
English: In clinical studies, no dose adjustment was required in elderly (> 65 years) patients exposed to pomalidomide (see section 4.2).
Croatian: U kliničkim ispitivanjima nije bila potrebna prilagodba doze u starijih (u dobi >65 godina) bolesnika izloženih pomalidomidu (vidjeti dio 4.2).
English: Dyspepsia = Grade 1-2
Croatian: Dispepsija = 1. do 2. stupnja
English: In order to assist patients in avoiding foetal exposure to pomalidomide, the Marketing Authorisation Holder will provide educational material to health care professionals to reinforce the warnings about the expected teratogenicity of pomalidomide, to provide advice on contraception before therapy is started, and to provide guidance on the need for pregnancy testing.
Croatian: Kako bi pomogao bolesnicima u izbjegavanju izloženosti fetusa pomalidomidu, nositelj odobrenja će zdravstvene radnike snabdjeti edukacijskim materijalima da naglasi upozorenja o očekivanoj teratogenosti pomalidomida, pruži savjet o kontracepciji prije početka terapije te ponudi smjernice o potrebi testiranja na trudnoću.
English: • by stopping the myeloma cells developing
Croatian: • zaustavljanjem razvoja stanica mijeloma
English: The test should ensure the patient is not pregnant when she starts treatment with pomalidomide.
Croatian: Test treba potvrditi da bolesnica nije trudna u vrijeme početka liječenja pomalidomidom.
English: Resume at one dose level lower than previous dose at next cycle (adverse event must be resolved or improved to ≤ Grade 2 before restarting dosing).
Croatian: U sljedećem ciklusu nastaviti liječenje u dozi koja je za jednu razinu niža od prethodne (prije ponovnog početka doziranja štetni događaj mora se povući ili smanjiti na ≤2. stupanj).
English: This results in damage to the bones and kidneys.
Croatian: Posljedica je oštećenje kostiju i bubrega.
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).
Croatian: To je zato što Vam lijek kojim se liječite može prouzročiti pad broja krvnih stanica koje pomažu u borbi protiv infekcije (leukociti) i broja stanica koje pomažu zaustaviti krvarenje (trombociti).
English: Maintain dose and treat with histamine (H2) blockers or equivalent.
Croatian: Održavati dozu i liječiti blokatorima histaminskih H2 receptora ili ekvivalentnim lijekom.
English: Pomalidomide was not mutagenic in bacterial and mammalian mutation assays, and did not induce chromosomal aberrations in human peripheral blood lymphocytes or micronuclei formation in polychromatic erythrocytes in bone marrow of rats administered doses up to 2000 mg/kg/day.
Croatian: Pomalidomid nije bio mutagen u testovima mutacije na bakterijama i stanicama sisavaca i nije inducirao kromosomske aberacije u ljudskim limfocitima periferne krvi ili stvaranje mikronukleusa u polikromatskm eritrocitima u koštanoj srži štakora kojima su se primjenjivale doze do 2000 mg/kg na dan.
English: Pomalidomide is extensively metabolised prior to excretion, with the resulting metabolites eliminated primarily in the urine.
Croatian: Pomalidomid se opsežno metabolizira prije izlučivanja, a nastali metaboliti eliminiraju se prvenstveno mokraćom.
English: Do not use Imnovid if you notice any damage or signs of tampering to medicine packaging.
Croatian: Imnovid se ne smije upotrijebiti ako primijetite znakove oštećenja ili neovlaštenog rukovanja pakiranjem lijeka.
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.
Croatian: Evaluacijom oporavka životinja pokazalo se da su svi nalazi povezani s liječenjem bili reverzibilni nakon 8 tjedana od prestanka primjene lijeka, osim proliferacije intrahepatičkih žučnih vodova opažene u 1 životinje u skupini koja je primala 1 mg/kg na dan.
English: In monkeys, pomalidomide was evaluated in repeat-dose studies of up to 9 months in duration.
Croatian: Kod majmuna je pomalidomid evaluiran tijekom ispitivanja ponovljenih doza u trajanju do 9 mjeseci.
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants, ATC code: L04AX06
Croatian: Farmakoterapijska skupina: imunosupresivi, ostali imunosupresivi, ATK oznaka: L04AX06.
English: Pomalidomide is contraindicated during pregnancy and in women of childbearing potential, except when all the conditions for pregnancy prevention have been met, see section 4.3 and section 4.4.
Croatian: Pomalidomid je kontraindiciran tijekom trudnoće i kod žena u reproduktivnoj dobi, osim kad su zadovoljeni svi uvjeti za prevenciju trudnoće, vidjeti dio 4.3 i dio 4.4.
English: In the presence of pomalidomide in vitro, substrate proteins Aiolos and Ikaros are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects.
Croatian: U prisutnosti pomalidomida in vitro, proteinski supstrati Aiolos i Ikaros podliježu ubikvitinaciji i posljedičnoj degradaciji, što dovodi do izravnih citotoksičnih i imunomodulatornih učinaka.
English: • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o To ensure that all appropriate measures have been performed prior to pomalidomide being dispensed
Croatian: • od specifičnih nacionalnih zahtjeva dogovorenih s nacionalnim nadležnim tijelom u svezi s: o distribucijom lijeka o postupcima za osiguravanje poduzimanja svih odgovarajućih mjera prije početka izdavanja pomalidomida.
English: • Bleeding within the skull.
Croatian: • krvarenje unutar lubanje
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.
Croatian: Ako se oporavak od toksičnosti produlji više od 14 dana, primjenu deksametazona nastaviti u dozi koja je za jednu razinu niža od prethodne.
English: Stop using pomalidomide if you develop these symptoms and contact your doctor or seek medical attention immediately.
Croatian: Prestanite primjenjivati pomalidomid ako razvijete navedene simptome iobratite se liječniku ili odmah zatražite medicinsku pomoć.
English: • Premature ovarian failure confirmed by a specialist gynaecologist
Croatian: • prerano zatajivanje rada jajnika verificirano od strane ginekologa
English: As a precaution, all male patients taking pomalidomide should use condoms throughout treatment duration, during dose interruption and for 7 days after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception (see sections 4.3 and 4.4).
Croatian: Kao mjera opreza, svi muški bolesnici koji uzimaju pomalidomid trebaju upotrebljavati prezervative tijekom trajanja liječenja, za vrijeme prekida liječenja i 7 dana nakon završetka liječenja ako im je partnerica trudna ili u reproduktivnoj dobi te ne primjenjuje kontracepciju (vidjeti dijelove 4.3 i 4.4).
English: Educational materials, prescribing and dispensing restrictions
Croatian: Edukacijski materijali, ograničenja kod propisivanja i izdavanja lijeka
English: It is also a substrate for P-glycoprotein.
Croatian: On je također supstrat P-glikoproteina.
English: Patients with significant cardiac dysfunction (congestive heart failure [NY Heart Association Class III or IV]; myocardial infarction within 12 months of starting study; unstable or poorly controlled angina pectoris) were excluded from clinical studies with pomalidomide.
Croatian: Bolesnici sa značajno poremećenom srčanom funkcijom (kongestivno zatajenje srca [stupanj III ili IV prema NYHA klasifikaciji]; infarktom miokarda unutar 12 mjeseci od početka ispitivanja; nestabilnom ili slabo kontroliranom anginom pektoris) bili su isključeni iz kliničkih ispitivanja s pomalidomidom.
English: • You must follow the contraception advice described in this leaflet.
Croatian: • Morate se pridržavati savjeta o sprječavanju začeća navedenih u ovoj uputi o lijeku.
English: Common Depression
Croatian: Često depresija
English: The median is based on Kaplan-Meier estimate.
Croatian: Medijan se temelji na Kaplan-Meierovoj procjeni.
English: • if you are pregnant or think you may be pregnant or are planning to become pregnant - this is because Imnovid is expected to be harmful to an unborn child. (Men and women taking this medicine must read the section “Pregnancy, contraception and breast-feeding - information for women and men” below).
Croatian: • Ako ste trudni ili mislite da biste mogli biti trudni ili planirate imati dijete jer se očekuje da će Imnovid štetno djelovati na nerođeno dijete. (Muškarci i žene koji uzimaju taj lijek moraju pročitati dio „Trudnoća, kontracepcija i dojenje - obavijesti za žene i muškarce“ u nastavku).
English: Significant cardiac dysfunction
Croatian: Značajni poremećaj srčane funkcije
English: Neutropenia did not lead to pomalidomide discontinuation in any patient and was infrequently serious.
Croatian: Ni u jednog bolesnika neutropenija nije dovela do prestanka primjene pomalidomida i rijetko je bila ozbiljna.
English: Your doctor may need to reduce the dose of Imnovid, bortezomib or dexamethasone or stop one or more of these medicines based on the results of your blood tests, your general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin and fluvoxamine) and if you experience side effects (especially rash or swelling) from treatment.
Croatian: Liječnik će Vam možda trebati smanjiti dozu Imnovida, bortezomiba ili deksametazona ili prekinuti primjenu jednog ili više od tih lijekova na temelju rezultata Vaših pretraga krvi, općeg stanja, drugih lijekova koje možda uzimate (npr. ciprofloksacin, enoksacin i fluvoksamin) te ako Vam liječenje prouzroči nuspojave (posebice osip ili oticanje).
English: The prescriber must inform the patient 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 with the national implemented patient card system.
Croatian: Liječnik koji propisuje lijek mora obavijestiti bolesnika o očekivanom teratogenom riziku i strogim mjerama prevencije trudnoće kako je to navedeno u Programu prevencije trudnoće te ponuditi bolesnicima odgovarajuću edukacijsku brošuru za bolesnike, karticu za bolesnika i/ili njezin ekvivalent u skladu s postojećim nacionalnim sustavom kartica za bolesnika.
English: Overall Survival (week)
Croatian: Ukupno preživljenje (tjedni)
English: • Look at the chart below to see what to take on each day of the 3-week cycle: o Each day, look down the chart and find the correct day to see which medicines to take.
Croatian: • U tablici u nastavku pogledajte što morate uzeti svakog dana 3-tjednog ciklusa: o Svaki dan pogledajte tablicu i potražite točan dan kako biste vidjeli koje lijekove morate uzeti.
English: In case of permanent discontinuation of any component of the treatment regimen, continuation of the remaining medicinal products is at the physician's discretion.
Croatian: U slučaju trajnog prekida primjene bilo koje komponente linije liječenja, o nastavku primjene ostalih lijekova odlučuje liječnik.
English: Anticoagulation therapy (unless contraindicated) is recommended, (such as acetylsalicylic acid, warfarin, heparin or clopidogrel), especially in patients with additional thrombotic risk factors.
Croatian: Preporučuje se antikoagulacijska terapija (osim ako je kontraindicirana), primjerice acetilsalicilatnom kiselinom, varfarinom, heparinom ili klopidogrelom, osobito kod bolesnika s dodatnim čimbenicima rizika za trombozu.
English: You may feel tired and weak, and short of breath and you are also more likely to get infections.
Croatian: Možda ćete osjećati umor i slabost te nedostatak zraka i postojat će veća vjerojatnost da dobijete infekciju.
English: • Clouding of your eye (cataract).
Croatian: • zamućenje oka (katarakta)
English: Stop dexamethasone dosing until the adverse event resolves to ≤ Grade 2.
Croatian: Prekinuti liječenje deksametazonom dok se štetni događaj ne povuče do ≤2. stupnja.
English: Psychiatric disorders Common Confusional state
Croatian: Psihijatrijski poremećaji Često konfuzno stanje
English: Complete blood counts should be monitored at baseline, weekly for the first 8 weeks and monthly thereafter.
Croatian: Kompletnu krvnu sliku treba provjeravati na početku liječenja, svaki tjedan tijekom prvih 8 tjedana te mjesečno nakon toga.
English: E3 ubiquitin ligases are responsible for the poly-ubiquitination of a variety of substrate proteins, and may partially explain the pleiotropic cellular effects observed with pomalidomide treatment.
Croatian: Ubikvitin ligaze E3 odgovorne su za poliubikvitinaciju različitih proteinskih supstrata, što može djelomično objasniti pleiotropne stanične učinke opažene kod liječenja pomalidomidom.
English: Second primary malignancies
Croatian: Druge primarne maligne bolesti
English: The potential for such drug-drug interactions, including the potential impact of pomalidomide on the pharmacokinetics of combined oral contraceptives, has not been evaluated clinically (see section 4.4 Teratogenicity).
Croatian: Mogućnost takvih interakcija lijekova, uključujući mogući utjecaj pomalidomida na farmakokinetiku kombiniranih oralnih kontraceptiva, nije klinički evaluirana (vidjeti dio 4.4 Teratogenost).
English: Prophylactic antibiotics should be considered particularly in patients with neutropenia.
Croatian: Treba razmotriti profilaktičku uporabu antibiotika, posebice u bolesnica s neutropenijom.
English: Dispensing of pomalidomide to women of childbearing potential should occur within 7 days of the prescription and following a medically supervised negative pregnancy test result.
Croatian: Pomalidomid se ženama reproduktivne dobi treba izdati u roku od 7 dana od propisivanja i nakon medicinski nadziranog negativnog rezultata testa na trudnoću.
English: • you have ever had an allergic reaction such as rash, itching, swelling, feeling dizzy or trouble breathing while taking related medicines called ‘thalidomide' or ‘lenalidomide'.
Croatian: • Ako ste ikad imali alergijsku reakciju, kao što su osip, svrbež, otok, osjećaj omaglice i otežano disanje, dok ste uzimali slične lijekove koji se zovu “talidomid” ili “lenalidomid”.
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.
Croatian: VTE je zabilježen kao ozbiljna nuspojava u 1,7 - 4,3% bolesnika, reakcije sa smrtnim ishodom nisu bile zabilježene, a zbog VTE-a terapiju pomalidomidom prekinulo je do 1,8% bolesnika.
English: Pomalidomide is the major circulating component (approximately 70% of plasma radioactivity) in vivo in healthy subjects who received a single oral dose of [14C]-pomalidomide (2 mg).
Croatian: Pomalidomid je glavna komponenta u cirkulaciji (približno 70% radioaktivnosti u plazmi) in vivo u zdravih ispitanika koji su primili jednu peroralnu dozu [14C]-pomalidomida (2 mg).
English: • Look at the chart below to see what to take on each day of the 4-week cycle: o Each day, look down the chart and find the correct day to see which medicines to take.
Croatian: • U tablici u nastavku pogledajte što morate uzeti svakog dana 4-tjednog ciklusa: o Svaki dan pogledajte tablicu i potražite točan dan kako biste vidjeli koje lijekove morate uzeti.
English: If powder from pomalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Croatian: Ako prašak pomalidomida dođe u kontakt s kožom, kožu treba odmah temeljito oprati vodom i sapunom.
English: Reactivation of hepatitis B has been reported rarely in patients receiving pomalidomide in combination with dexamethasone who have previously been infected with the hepatitis B virus (HBV).
Croatian: Reaktivacija hepatitisa B rijetko je zabilježena u bolesnika koji primaju pomalidomid u kombinaciji s deksametazonom, a koji su prije bili zaraženi virusom hepatitisa B (HBV).
English: • by stopping the formation of blood vessels supplying the cancer cells.
Croatian: • zaustavljanjem stvaranja krvnih žila koje hrane stanice raka.
English: • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential)
Croatian: • dob ≥50 godina te prirodno amenoroična tijekom ≥1 godine (amenoreja nakon kemoterapije ili u razdoblju dojenja ne isključuje reproduktivni potencijal)
English: • Severe, persistent or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
Croatian: • težak, ustrajan ili krvav proljev (moguće s bolovima u trbuhu ili vrućicom) prouzročen bakterijom koja se naziva Clostridium difficile
English: Pomalidomide was detected in milk of lactating rats following administration to the mother.
Croatian: Pomalidomid je bio otkriven u mlijeku ženki štakora tijekom laktacije nakon primjene u majke.
English: If you become pregnant despite the prevention measures: • you must stop the treatment immediately and talk to your doctor straight away.
Croatian: U slučaju da zatrudnite iako se pridržavate mjera za sprječavanje trudnoće: • morate odmah prekinuti liječenje i bez odlaganja obratiti se liječniku.
English: The MAH shall implement a pregnancy prevention programme (PPP) in each Member State.
Croatian: 2. Nositelj odobrenja će provoditi Program prevencije trudnoće u svakoj državi članici.
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.
Croatian: Btz = bortezomib; CI = interval pouzdanosti; CR = potpuni odgovor; HR = omjer hazarda; LD-Dex = niska doza deksametazona; OR = omjer izgleda; ORR = stopa ukupnog odgovora; PFS = preživljenje bez progresije bolesti; POM = pomalidomid; PR = djelomičan odgovor; sCR = striktan potpuni odgovor; VGPR = vrlo dobar djelomičan odgovor a
English: • Difficulty in falling asleep or staying asleep.
Croatian: • nedostatak energije • teškoće s usnivanjem ili spavanjem
English: In addition to the above adverse reactions identified from the pivotal clinical trials, the following Table 9 is derived from data gathered from post-marketing surveillance.
Croatian: Uz prethodno navedene nuspojave identificirane u ključnim kliničkim ispitivanjima, u tablici 9 prikazani su podaci prikupljeni tijekom praćenja nakon stavljanja lijeka u promet.
English: Administration of pomalidomide in smokers, with smoking tobacco known to induce the CYP1A2 isoform, had no clinically relevant effect on exposure to pomalidomide compared to that exposure to pomalidomide observed in non-smokers.
Croatian: Primjena pomalidomida u pušača, pri čemu je poznato kako pušenje duhana inducira izoformu CYP1A2, nije imala klinički važan učinak na izloženost pomalidomidu u usporedbi s izloženošću pomalidomidu opaženoj u nepušača.
English: Strong CYP1A2 inhibitors
Croatian: Jaki inhibitori CYP1A2
English: Based on population pharmacokinetic analyses in healthy subjects and multiple myeloma patients, no significant influence of age (19-83 years) on oral clearance of pomalidomide was observed.
Croatian: Na temelju populacijskih farmakokinetičkih analiza u zdravih ispitanika i bolesnika s multiplim mijelomom nije opažen značajni utjecaj dobi (19 - 83 godina) na oralni klirens pomalidomida.
English: Note: CI=Confidence interval; IRAC=Independent Review Adjudication Committee; NE = Not Estimable.
Croatian: Napomena: CI = interval pouzdanosti; IRAC = neovisno povjerenstvo koje daje konačnu ocjenu kliničkog ispitivanja a
English: Fatal infections (Grade 5) occurred in 2.7-4.0% of patients.
Croatian: Smrtonosne infekcije (5. stupnja) nastale su u 2,7 - 4,0% bolesnika.
English: • See the leaflet that comes with dexamethasone for further information on its use and effects.
Croatian: • Pročitajte uputu o lijeku priloženu uz deksametazon za dodatne informacije o njegovoj primjeni i učincima.
English: The most commonly reported serious adverse reaction was pneumonia (11.5%).
Croatian: Najčešće zabilježena ozbiljna nuspojava bila je pneumonija (11,5%).
English: • Patient confirmation form ensuring that patients receive the appropriate counselling concerning the treatment, contraceptive methods and pregnancy prevention appropriate for their sex and childbearing status
Croatian: • Obrazac potvrde za bolesnika koji osigurava da su bolesnici uključeni u odgovarajuće savjetovanje vezano za liječenje, metode kontracepcije i prevenciju trudnoće koje je prikladno za njihov spol i reproduktivni status.
English: Patients with a prior history of serious allergic reactions associated with thalidomide or lenalidomide were excluded from clinical studies.
Croatian: Bolesnici koji su prije imali ozbiljne alergijske reakcije povezane s talidomidom ili lenalidomidom bili su isključeni iz kliničkih ispitivanja.
English: This includes vasectomised males who should wear a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential as seminal fluid may still contain pomalidomide in the absence of spermatozoa.
Croatian: To uključuje muškarce kojima je učinjena vazektomija koji moraju upotrebljavati prezervative pri spolnoj aktivnosti s trudnicom ili ženom reproduktivne dobi jer sjemena tekućina može sadržavati pomalidomid čak i u odsutnosti spermatozoida.
English: • Male patients unable to follow or comply with the required contraceptive measures (see section 4.4).
Croatian: • Muški bolesnici koji se ne mogu pridržavati traženih mjera kontracepcije (vidjeti dio 4.4).
English: • The active substance is pomalidomide.
Croatian: • Djelatna tvar je pomalidomid.
English: Clinically relevant drug-drug interactions are not anticipated when pomalidomide is coadministered with substrates of these pathways.
Croatian: Ne očekuju se klinički važne interakcije lijekova kad se pomalidomid primjenjuje istodobno sa supstratima ovih puteva.