FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians should observe patients for signs of bleeding including epistaxes, especially with use of concomitant medicinal products known to increase the risk of bleeding (see section 4.8).
Croatian: Liječnici trebaju obratiti pozornost na znakove krvarenja, uključujući epistakse, posebice u slučaju istodobne primjene lijekova za koje se zna da povećavaju rizik od krvarenja (vidjeti dio 4.8).
English: The Educational brochures for patients should be of 3 types:
Croatian: Trebale bi postojati 3 vrste edukacijskih knjižica za bolesnike:
English: Peripheral neuropathy occurred in 55.4 % of patients (10.8% Grade 3; 0.7% Grade 4).
Croatian: Periferna neuropatija razvila se u 55,4% bolesnika (10,8% 3. stupnja; 0,7% 4. stupnja).
English: In addition, findings consistent with acute myelogenous leukemia led to euthanasia of 1 monkey; clinical observations and clinical pathology and/or bone marrow alterations observed in this animal were consistent with immunosuppression.
Croatian: Uz to, nalazi sukladni akutnoj mijeloičnoj leukemiji doveli su do eutanazije jednog majmuna; klinička opažanja i klinička patologija i/ili promjene koštane srži opažene u te životinje odgovarali su mijelosupresiji.
English: Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma.
Croatian: Liječenje treba započeti i provoditi pod nadzorom liječnika iskusnog u liječenju multiplog mijeloma.
English: The use of erythropoietic agents carries a risk of thrombotic events including thromboembolism.
Croatian: Primjena eritropoetskih lijekova podrazumijeva rizik od trombotskih događaja uključujući tromboemboliju.
English: The primary toxicities observed in monkeys were associated with the haematopoietic/lymphoreticular systems.
Croatian: Primarne toksičnosti opažene u majmuna bile su povezane s krvotvornim/limforetikularnim sustavom.
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:
Croatian: Prestanite uzimati Imnovid i odmah posjetite liječnika ako primijetite neku od sljedećih ozbiljnih nuspojava - možda će Vam trebati hitna medicinska pomoć:
English: Use diuretics as needed and decrease dose by one dose level.
Croatian: Primijeniti diuretike prema potrebi i smanjiti dozu za jednu razinu.
English: No data are available on administration of pomalidomide to paediatric patients (< 18 years of age).
Croatian: Nema dostupnih podataka o primjeni pomalidomida kod pedijatrijskih bolesnika (u dobi <18 godina).
English: Therefore, erythropoietic agents, as well as other agents that may increase the risk of thromboembolic events, should be used with caution.
Croatian: Eritropoetske lijekove, i druge lijekove koji mogu povećati rizik od tromboze, treba stoga primjenjivati oprezno.
English: Pomalidomide is also a substrate of P-glycoprotein in vitro.
Croatian: Pomalidomid je također supstrat P-glikoproteina in vitro.
English: Pomalidomide is distributed in semen of healthy subjects at a concentration of approximately 67% of plasma level at 4 hours post-dose (approximately Tmax) after 4 days of once daily dosing at 2 mg.
Croatian: Pomalidomid se distribuira u sjeme zdravih ispitanika u koncentraciji od približno 67% razine u plazmi 4 sata nakon doziranja (približni Tmax) nakon 4 dana primjene doze od 2 mg jedanput na dan.
English: The pharmacokinetic parameters were modestly changed in hepatically impaired patients (defined by Child-Pugh criteria) compared to healthy subjects.
Croatian: Farmakokinetički parametri bili su skromno promijenjeni u bolesnika s oštećenom funkcijom jetre (definiranom na temelju Child-Pugh kriterija) u usporedbi sa zdravim ispitanicima.
English: The following can be considered to be examples of suitable methods of contraception:
Croatian: Sljedeće se metode kontracepcije smatraju djelotvornim:
English: • If your partner becomes pregnant while you are taking Imnovid, tell your doctor straight away.
Croatian: • Ako Vaša partnerica zatrudni dok uzimate Imnovid, odmah obavijestite svojega liječnika.
English: No peripheral neuropathy reactions were reported as serious, and peripheral neuropathy led to dose discontinuation in 0.3% of patients (see section 4.4).
Croatian: Nijedna nuspojava u vidu periferne neuropatije nije bila zabilježena kao ozbiljna, a periferna neuropatija dovela je do prestanka primjene u 0,3% bolesnika (vidjeti dio 4.4).
English: Hepatic impairment has a modest effect on the pharmacokinetics of pomalidomide (see section 5.2).
Croatian: Oštećenje funkcije jetre ima skromni učinak na farmakokinetiku pomalidomida (vidjeti dio 5.2).
English: These immunosuppressive effects resulted in early euthanasia of 4 monkeys due to poor health condition (watery stool, inappetence, reduced food intake, and weight loss); histopathologic evaluation of these animals showed chronic inflammation of the large intestine and villous atrophy of the small intestine.
Croatian: Ovi imunosupresivni učinci rezultirali su ranom eutanazijom 4 majmuna zbog lošeg zdravstvenog stanja (vodenasta stolica, inapetencija, smanjen unos hrane i gubitak na tjelesnoj težini); patohistološki pregled ovih životinja pokazao je kroničnu upalu debelog crijeva i atrofiju resica tankog crijeva.
English: The 3 predominant metabolites in urine (formed via hydrolysis or hydroxylation with subsequent glucuronidation) account for approximately 23%, 17%, and 12%, respectively, of the dose in the urine.
Croatian: Tri glavna metabolita u mokraći (nastala hidrolizom ili hidroksilacijom uz naknadnu glukuronidaciju) čine 23%, 17% odnosno 12% doze u mokraći.
English: Very Common Decreased appetite
Croatian: Vrlo često smanjen apetit
English: Pomalidomide is absorbed with a maximum plasma concentration (Cmax) occurring between 2 and 3 hours and is at least 73% absorbed following administration of single oral dose.
Croatian: Pomalidomid se apsorbira uz maksimalnu koncentraciju u plazmi (Cmax) koja nastaje između 2 i 3 sata uz najmanje 73%-tnu apsorpciju nakon primjene jedne peroralne doze.
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).
Croatian: Zbog povećanog rizika od venske tromboembolije u bolesnika s multiplim mijelomom koji uzimaju pomalidomid i deksametazon, ne preporučuju se kombinirane peroralne kontracepcijske tablete (vidjeti također dio 4.5).
English: If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
Croatian: Ako za bolesnicu nije utvrđena djelotvorna kontracepcija, bolesnicu se mora uputiti odgovarajuće osposobljenom zdravstvenom radniku za savjet o kontracepciji kako bi je mogla početi primjenjivati.
English: Based on in vitro data, pomalidomide is not an inhibitor or inducer of cytochrome P-450 isoenzymes, and does not inhibit any drug transporters that were studied.
Croatian: Na temelju podataka in vitro, pomalidomid nije ni inhibitor niti induktor izoenzima citokroma P-450 i ne inhibira nijedan od prijenosnika koji su bili ispitani.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „EXP“.
English: The Direct Healthcare Professional Communication shall consist of two parts:
Croatian: Pisma zdravstvenim radnicima sastojat će se od dva dijela:
English: Co-administration of pomalidomide with the strong CYP3A4/5 and P-gp inhibitor ketoconazole, or the strong CYP3A4/5 inducer carbamazepine, had no clinically relevant effect on exposure to pomalidomide.
Croatian: Istodobna primjena pomalidomida s jakim inhibitorom CYP3A4/5 i P-gp-a ketokonazolom, ili jakim induktorom CYP3A4/5 karbamazepinom, nije imala klinički važnog učinka na izloženost pomalidomidu.
English: What Imnovid contains
Croatian: Što Imnovid sadrži
English: Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Croatian: Bolesnike treba upozoriti da nikada ne daju svoj lijek drugoj osobi te da sve neiskorištene kapsule vrate svom ljekarniku nakon završetka liječenja.
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.
Croatian: Pojedinosti Programa prevencije trudnoće treba dogovoriti s nadležnim državnim tijelima u svakoj državi članici i isti ustrojiti prije stavljanja lijeka u promet.
English: • Safety advice for women of childbearing potential o The need to avoid foetal exposure o Description of the PPP o Need for effective contraception (even if woman has amenorrhoea) and definition of effective contraception
Croatian: • Sigurnosni savjeti za žene u reproduktivnoj dobi o potreba za izbjegavanjem fetalne izloženosti o opis Programa prevencije trudnoće o potreba za djelotvornom kontracepcijom (čak i ako žena ima amenoreju) i definicija djelotvorne kontracepcije
English: The efficacy of contraceptive steroids may be reduced during cotreatment with dexamethasone (see section 4.5).
Croatian: Djelotvornost steroidnih kontraceptiva može biti umanjena tijekom istodobnog liječenja deksametazonom (vidjeti dio 4.5).
English: However, if you are over 75,
Croatian: Međutim, ako imate više od
English: Approximately 70% of patients were refractory to lenalidomide (71.2% in Pom+Btz+LD-Dex, 68.7 % in Btz+LD-Dex).
Croatian: Približno 70% bolesnika bilo je refraktorno na lenalidomid (71,2% u skupini Pom+Btz+LD-Dex, 68,7% u skupini Btz+LD-Dex).
English: Slight reduction in maternal body weight gain, significant reduction in triglycerides, and significant dec rease in absolute and relative spleen weights were observed at 100 and 250 mg/kg/day.
Croatian: Blago smanjeno povećanje tjelesne težine majki, značajno sniženje razine triglicerida i značajno snižene apsolutne i relativne težine slezene bili su opaženi pri dozama od 100 i 250 mg/kg na dan.
English: Add H2 blocker or equivalent and resume at one dose level lower than previous dose.
Croatian: Dodati H2 blokator ili ekvivalent i nastaviti liječenje u dozi koja je za jednu razinu niža od prethodne.
English: • Medroxyprogesterone acetate depot
Croatian: • depo preparat medroksiprogesteron acetata
English: The most commonly reported serious adverse reaction was pneumonia (9.3%).
Croatian: Najčešće zabilježena ozbiljna nuspojava bila je pneumonija (9,3%).
English: This condition is called tumour lysis syndrome.
Croatian: To se stanje naziva sindrom lize tumora.
English: The p-value is based on a stratified log-rank test.
Croatian: d p-vrijednost temelji se na nestratificiranom log-rang testu
English: In peripheral tissues, pomalidomide was preferentially taken up by tumors with apparent peripheral distribution clearance (Q/F) and apparent peripheral volume of distribution (V3/F) 3.7-fold and 8-fold higher, respectively, than that of healthy subjects.
Croatian: U perifernim tkivima pomalidomid su preuzimali prvenstveno tumori s prividnim klirensom periferne distribucije (Q/F) 3,7 puta i prividnim perifernim volumenom distribucije (V3/F) 8 puta višim nego što je to bilo u zdravih ispitanika.
English: Peripheral neuropathy led to discontinuation of bortezomib in approximately 12.9% of patients, pomalidomide in 1.8% and dexamethasone in 2.2 - 8.9% of patients, respectively.
Croatian: Periferna neuropatija dovela je prestanka primjene bortezomiba u približno 12,9% bolesnika, pomalidomida u 1,8% i deksametazona u 2,2 - 8,9% bolesnika.
English: • Prior to launch, all doctors who intend to prescribe pomalidomide and all pharmacists who may dispense pomalidomide receive a Direct Healthcare Professional Communication as described below.
Croatian: • prije stavljanja lijeka na tržište svi liječnici koji namjeravaju propisivati pomalidomid i svi ljekarnici koji bi mogli izdavati pomalidomid primiti priopćenje zdravstvenim radnicima kako je to opisano u nastavku;
English: • She understands the need and accepts to undergo pregnancy testing at least every 4 weeks except in case of confirmed tubal sterilisation
Croatian: • shvaća potrebu i prihvaća podvrgnuti se testiranju na trudnoću najmanje svaka 4 tjedna osim u slučaju potvrđenog podvezivanja jajovoda
English: If you are uncertain whether any of the conditions above apply to you, talk to your doctor, pharmacist or nurse before taking Imnovid.
Croatian: Ako niste sigurni odnosi li se bilo što od gore navedenoga na Vas, obratite se svojemu liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Imnovid.
English: CYP dependent metabolites account for approximately 43% of the total excreted radioactivity, while nonCYP dependent hydrolytic metabolites account for 25%, and excretion of unchanged pomalidomide accounted for 10% (2% in urine and 8% in faeces).
Croatian: Metaboliti ovisni o CYP čine približno 43% ukupno izlučene radioaktivnosti, metaboliti koji ne ovise o CYP čine 25%, dok je izlučivanje neizmijenjenog pomalidomida činilo 10% (2% u mokraći i 8% u stolici).
English: Following multiple doses, pomalidomide has an accumulation ratio of 27 to 31% on AUC.
Croatian: Nakon višekratnih doza, omjer nakupljanja pomalidomida u AUC-u iznosi od 27 do 31%.
English: Patients > 75 years of age started treatment with 20 mg dexamethasone.
Croatian: Bolesnici u dobi od >75 godina počeli su liječenje dozom od 20 mg deksametazona.
English: Patients should be monitored for haematological adverse reactions, especially neutropenia.
Croatian: Bolesnike valja nadzirati zbog hematoloških nuspojava, osobito neutropenije.
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.
Croatian: Ženama reproduktivne dobi recept može vrijediti najviše 4 tjedna, a svim drugim bolesnicima najviše 12 tjedana.
English: 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.
Croatian: Programa prevencije trudnoće, osim ako postoji pouzdan dokaz da bolesnik nije u reproduktivnoj dobi.
English: Appropriate caution should be exercised when considering the treatment of such patients with pomalidomide, including periodic monitoring for signs or symptoms of cardiac events.
Croatian: Kada se za takve bolesnike razmatra mogućnost liječenja pomalidomidom, potreban je odgovarajući oprez uključujući povremeno praćenje znakova ili simptoma srčanih događaja.
English: Insertion of copper-releasing intrauterine devices is not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with severe neutropenia or severe thrombocytopenia.
Croatian: Intrauterini ulošci koji oslobađaju bakar općenito se ne preporučuju zbog mogućih rizika od infekcije u vrijeme umetanja te gubitka krvi menstrualnim krvarenjem, što može ugroziti bolesnicu s teškom neutropenijom ili teškom trombocitopenijom.
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.
Croatian: • istodobno smanjenje broja crvenih i bijelih krvnih stanica te krvnih pločica (pancitopenija) zbog čega ćete biti skloniji krvarenju i nastanku modrica.
English: The majority of patients were male (59%) and white (79%); the median age for the overall population was 64 years (min, max: 35, 87 years).
Croatian: Većina bolesnika bili su muškarci (59%) i bijelci (79%); medijan dobi u populaciji bio je 64 godine (raspon 35 - 87 godina).
English: Interrupt dose until muscle weakness ≤ Grade 1.
Croatian: Prekinuti liječenje dok se ne postigne mišićna slabost ≤1. stupnja.
English: Pomalidomide is structurally related to thalidomide.
Croatian: Pomalidomid je strukturno srodan talidomidu.
English: To initiate a new cycle of pomalidomide, the neutrophil count must be  1 x 109/l and the platelet count must be  50 x 109/l.
Croatian: Da bi se moglo započeti s novim ciklusom terapije pomalidomidom, broj neutrofila mora biti ≥1 x 109/l, a broj trombocita ≥50 x 109/l.
English: Cardiac events, including congestive cardiac failure, pulmonary oedema and atrial fibrillation (see section 4.8), have been reported, mainly in patients with pre-existing cardiac disease or cardiac risk factors.
Croatian: Srčani događaji, uključujući kongestivno zatajenje srca, edem pluća i fibrilaciju atrija (vidjeti dio 4.8), zabilježeni su uglavnom u bolesnika s postojećom bolešću srca ili s čimbenicima rizika za srčanu bolest.
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.
Croatian: Ne očekuje se da će pomalidomid prouzročiti klinički važne farmakokinetičke interakcije lijekova zbog inhibicije ili indukcije izoenzima P450 ili inhibicije prijenosnika kad se primjenjuje istodobno sa supstratima tih enzima ili prijenosnika.
English: Stop taking Imnovid and see a doctor straight away if you notice any of the serious side effects listed above - you may need urgent medical treatment.
Croatian: Prestanite uzimati Imnovid i odmah se obratite liječniku ako opazite neku od prethodno navedenih ozbiljnih nuspojava - možda Vam je potrebna hitna medicinska pomoć.
English: Interrupt pomalidomide treatment.
Croatian: Prekinuti liječenje pomalidomidom.
English: • Imnovid and dexamethasone are taken in ‘treatment cycles'.
Croatian: • Imnovid i deksametazon uzimaju se u „ciklusima liječenja“.
English: Pomalidomide enhances T cell- and natural killer (NK) cell-mediated immunity and inhibits production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.
Croatian: Natural Killer, NK) i inhibira stvaranje proinflamatornih citokina (npr. TNF-α i IL-6) u monocitima.
English: Patients receiving pomalidomide either in combination with bortezomib and dexamethasone or in combination with dexamethasone have developed venous thromboembolic events (predominantly deep vein thrombosis and pulmonary embolism) and arterial thrombotic events (myocardial infarction and cerebrovascular accident).
Croatian: U bolesnika koji primaju pomalidomid u kombinaciji s bortezomibom i deksametazonom ili u kombinaciji s deksametazonom, nastali su venski tromboembolijski događaji (pretežno duboke venske tromboze i plućne embolije) te arterijski trombotski događaji (infarkt miokarda i cerebrovaskularni akcident).
English: Based on population PK analysis using a two-compartment model, healthy subjects and MM patients had comparable apparent clearance (CL/F) and apparent central volume of distribution (V2/F).
Croatian: Na temelju populacijske farmakokinetičke analize primjenom modela s dva odjeljka, zdravi ispitanici i bolesnici s multiplim mijelomom imali su sličan prividni klirens (CL/F) i prividni središnji volumen distribucije (V2/F).
English: Pack size of 14 or 21 capsules.
Croatian: Pakiranje sadrži 14 ili 21 kapsulu.
English: PFS (months) Mediana time (95% CI) b HR c (95% CI), p-valued ORR, n (%) sCR
Croatian: PFS (mjeseci) Medijana (95% CI)b HRc (95% CI), p-vrijednostd ORR, n (%) sCR
English: Coadministration with a high-fat and high-calorie meal slows the rate of absorption, decreasing mean plasma Cmax by approximately 27%, but has minimal effect on the overall extent of absorption with an 8% decrease in mean AUC.
Croatian: Istodobna primjena punomasnih i visokokaloričnih obroka kod zdravih dobrovoljaca usporava brzinu apsorpcije smanjujući srednju vrijednost Cmax u plazmi za približno 27%, ali minimalno utječe na ukupni opseg apsorpcije uz 8%-tno smanjenje srednje vrijednosti AUC-a.
English: A total of 455 patients were enrolled in the study: 302 in the Pom+LD-Dex arm and 153 in the HD-Dex arm.
Croatian: Ukupno je 455 bolesnika bilo uključeno u ispitivanje: 302 u skupinu koja je primala Pom+LD-Dex i 153 u skupinu koja je primala HD-Dex.
English: If powder from a broken Imnovid capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
Croatian: Ako prašak iz razlomljene kapsule Imnovida dođe u dodir s kožom, odmah temeljito isperite kožu vodom i sapunom.
English: Caution should be exercised when pomalidomide in combination with dexamethasone is used in patients previously infected with HBV, including patients who are anti-HBc positive but HBsAg negative.
Croatian: Potreban je oprez kada se pomalidomid u kombinaciji s deksametazonom primjenjuje u bolesnika koji su prije bili zaraženi virusom hepatitisa B, uključujući bolesnike koji su anti-HBc pozitivni, ali HBsAg negativni.
English: For women of childbearing potential, pomalidomide is contraindicated unless all of the following are met:
Croatian: Pomalidomid je kontraindiciran za žene u reproduktivnoj dobi, osim ako se ispune svi sljedeći zahtjevi:
English: At the end of the treatment you should return all unused capsules to the pharmacist.
Croatian: Na kraju liječenja trebate vratiti sve nepotrošene kapsule ljekarniku.
English: The patient card shall contain the following elements:
Croatian: Kartica za bolesnika sadržavat će sljedeće elemente:
English: A total of 226 (74.8%) of the Pom + LD-Dex patients and 95 (62.1%) of the HD-Dex patients were alive as of the cutoff date (07 Sep 2012).
Croatian: Ukupno je 226 (74,8%) bolesnika koji su primali Pom+LD-Dex i 95 (62,1%) bolesnika koji su primali HD-Dex bilo živo do datuma prestanka prikupljanja podataka (07. rujna 2012.).
English: Fatigue, depressed level of consciousness, confusion, and dizziness have been reported with the use of pomalidomide.
Croatian: Umor, snižena razina svijesti, konfuzija i omaglica prijavljeni su uz primjenu pomalidomida.
English: Some people feel tired, dizzy, faint, confused or less alert when taking Imnovid.
Croatian: Neke osobe osjećaju umor, omaglicu, nesvjesticu, smetenost ili smanjenu pozornost dok uzimaju Imnovid.
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Croatian: Bolesnicima s pozitivnim testom na infekciju virusom hepatitisa B preporučuje se da zatraže savjet liječnika s iskustvom u liječenju hepatitisa B.
English: On haemodialysis days, patients should take their pomalidomide dose following haemodialysis.
Croatian: U dane kad je primijenjena hemodijaliza, bolesnici trebaju uzeti svoju dozu pomalidomida nakon postupka hemodijalize.
English: • High blood levels of uric acid, which may cause a form of arthritis called gout.
Croatian: • visoke razine mokraćne kiseline u krvi, što može prouzročiti oblik artritisa pod nazivom giht
English: Infections led to pomalidomide discontinuation in 2.0-2.9% of patients.
Croatian: Infekcije su dovele do prestanka primjene pomalidomida u 2,0 - 2,9% bolesnika.