FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: Srednje vrijednosti povećanja izloženosti pomalidomidu u svakoj od ovih skupina s oštećenjem funkcije jetre nisu takvog raspona da bi zahtijevale prilagodbu rasporeda primjene ili doze (vidjeti dio 4.2).
English: Pomalidomide has a mean total body clearance (CL/F) of approximately 7-10 L/hr.
Croatian: Ukupni prosječni klirens pomalidomida iz organizma (CL/F) približno 7 - 10 l/h.
English: Other ≥ Grade 3 pomalidomide-related adverse events
Croatian: Drugi štetni događaji ≥3. stupnja povezani s pomalidomidom
English: (E133), and white ink.
Croatian: (E133) i bijelu tintu.
English: Do not use while pregnant or breast-feeding.
Croatian: Ne primjenjivati u trudnoći ili u razdoblju dojenja.
English: Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis (see sections 4.6 and 5.3).
Croatian: Otkriveno je da je pomalidomid teratogen u štakora i kunića kad se primjenjuje tijekom razdoblja glavne organogeneze (vidjeti dijelove 4.6 i 5.3).
English: • Changes in the way things taste.
Croatian: • promjene osjeta okusa
English: Pomalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash.
Croatian: O prekidu ili ukidanju primjene pomalidomida treba razmisliti u slučaju osipa na koži 2. do 3. stupnja.
English: • That pomalidomide may cause thrombocytopenia and the need for regular blood tests
Croatian: • da pomalidomid može prouzročiti trombocitopeniju te potrebu za redovitim krvnim pretragama
English: Uncommon Cerebrovascular accident
Croatian: Manje često cerebrovaskularni incident
English: Additionally, pomalidomide inhibits the proliferation of lenalidomide-resistant multiple myeloma cell lines and synergises with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumour cell apoptosis.
Croatian: Uz to, inhibira proliferaciju staničnih linija multiplog mijeloma rezistentnih na lenalidomid i sinergistički djeluje s deksametazonom inducirajući apoptozu tumorskih stanica u staničnim linijama osjetljivim i onima rezistentnim na lenalidomid.
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
Croatian: • Zahtjevi u slučaju trudnoće o upute za prekid uzimanja pomalidomida odmah nakon sumnje na trudnoću u bolesnica o potreba da se uputi na pregled i savjetovanje liječniku specijaliziranom ili iskusnom u liječenju i dijagnosticiranju teratogenih učinaka/poremećaja o lokalni kontakt podaci za prijavljivanje svake sumnje na trudnoću o obrazac za prijavu trudnoće.
English: • Numbness, tingling or burning sensation to the skin, pains in hands or feet (peripheral sensory neuropathy).
Croatian: • utrnulost, trnci ili osjećaj žarenja kože, bolovi u šakama ili stopalima (periferna senzorna neuropatija)
English: • Pomalidomide in combination with bortezomib and dexamethasone The most commonly reported blood and lymphatic system disorders were neutropenia (46.8%), thrombocytopenia (36.7%) and anaemia (28.4%).
Croatian: • Pomalidomid u kombinaciji s bortezomibom i deksametazonom Najčešće zabilježeni poremećaji krvi i limfnog sustava bili su neutropenija (46,8%), trombocitopenija (36,7%) i anemija (28,4%).
English: When Imnovid is used with dexamethasone, in people who have had at least two other treatments, it can stop multiple myeloma getting worse:
Croatian: Kada se Imnovid primjenjuje s deksametazonom u osoba koje su primile najmanje dvije druge terapije, može zaustaviti pogoršanje multiplog mijeloma:
English: 31 August 2023
Croatian: 31. kolovoza
English: Median OS time for the HD-Dex arm was 34 weeks (95% CI: 23.4, 39.9).
Croatian: Medijan razdoblja ukupnog preživljenja u skupini koja je primala HD-Dex iznosio je 34 tjedna (95% CI: 23,4; 39,9).
English: What Imnovid is and what it is used for What you need to know before you take Imnovid How to take Imnovid
Croatian: Što je Imnovid i za što se koristi Što morate znati prije nego počnete uzimati Imnovid Kako uzimati Imnovid
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.
Croatian: • niske razine magnezija u krvi (hipomagnezijemija) što može prouzročiti umor, opću slabost, grčeve u mišićima i razdražljivost te može rezultirati niskim razinama kalcija (hipokalcijemija), što može prouzročiti utrnulost i trnce u šakama, stopalima ili usnama, grčeve u mišićima, slabost u mišićima, ošamućenost, smetenost
English: The No Observed Adverse Effect Level (NOAEL) was 0.1 mg/kg/day (0.5-fold exposure ratio relative to a 4 mg clinical dose).
Croatian: No Observed Adverse Effect Level, NOAEL) iznosila je 0,1 mg/kg na dan (0,5 puta veći omjer izloženosti u odnosu na kliničku dozu od 4 mg).
English: (E172) and white ink.
Croatian: (E172) i bijelu tintu.
English: Common (may affect up to 1 in 10 people):
Croatian: Često (mogu se pojaviti u do 1 na 10 osoba):
English: Common Depression Insomnia
Croatian: Često depresija nesanica
English: • She understands the need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment
Croatian: • razumije potrebu za djelotvornom kontracepcijom, bez prekida, najmanje 4 tjedna prije početka liječenja te kroz cjelokupno trajanje liječenja kao i najmanje 4 tjedna nakon završetka liječenja
English: • Brochure for women patients of childbearing potential and their partners
Croatian: • knjižice za bolesnice u reproduktivnoj dobi i njihove partnere
English: • High blood level of calcium (hypercalcaemia), which may cause slowing reflexes and skeletal muscle weaknesses.
Croatian: • visoka razina kalcija u krvi (hiperkalcijemija) što može prouzročiti usporene reflekse i slabost mišića
English: Thalidomide is a known human teratogen that causes severe life-threatening birth defects.
Croatian: Talidomid je poznati teratogen za ljude koji uzrokuje teške životno ugrožavajuće prirođene anomalije.
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
Croatian: • Sigurnosni savjeti koji vrijede za sve bolesnike o opis i zbrinjavanje trombocitopenije, uključujući stope incidencije iz kliničkih ispitivanja o opis i zbrinjavanje zatajenja srca o zbrinjavanje lijeka koji više nije potreban o specifični lokalni zahtjevi za propisivanjem i izdavanjem pomalidomida
English: Neutrophil count decreased White blood cell count decreased Platelet count decreased Alanine aminotransferase increased
Croatian: Često snižen broj neutrofila snižen broj bijelih krvnih stanica snižen broj trombocita povišena alanin aminotransferaza
English: Uncommon Decreased appetite
Croatian: Manje često smanjen apetit
English: st relapse and approximately 73% of patients received bortezomib as prior treatment.
Croatian: U približno 40% bolesnika to je bio prvi recidiv, a oko 73% bolesnika primalo je bortezomib kao prethodnu terapiju.
English: The MAH should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Croatian: 3. Nositelj odobrenja treba se dogovoriti s nacionalnim nadležnim tijelom pojedine države članice o konačnom tekstu pisma zdravstvenim radnicima te sadržaju paketa s informacijama za liječnika te osigurati da materijali sadrže ključne elemente opisane u nastavku.
English: • High blood levels of potassium, which may cause abnormal heart rhythm.
Croatian: • visoke razine kalija u krvi koje mogu prouzročiti abnormalan srčani ritam
English: In rats, chronic administration of pomalidomide at doses of 50, 250, and 1000 mg/kg/day for 6 months was well tolerated.
Croatian: Štakori su dobro podnosili kroničnu primjenu pomalidomida u dozama od 50, 250 i 1000 mg/kg na dan tijekom 6 mjeseci.
English: Haematological events Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma, followed by anaemia and thrombocytopenia.
Croatian: Neutropenija je bila najčešće zabilježena hematološka nuspojava 3. ili 4. stupnja kod bolesnika s relapsnim/refraktornim oblikom multiplog mijeloma nakon koje su slijedile anemija i trombocitopenija.
English: • Disposal of unwanted medicine
Croatian: • zbrinjavanje lijeka koji više nije potreban
English: Very Common Muscular weakness Back pain
Croatian: Vrlo često mišićna slabost bol u leđima
English: Pomalidomide is administered in combination with bortezomib and dexamethasone, as shown in Table 1.
Croatian: Pomalidomid se primjenjuje u kombinaciji s bortezomibom i deksametazonom, kako je prikazano u tablici 1.
English: In a second study to evaluate the contribution of a CYP1A2 inhibitor alone to metabolism changes, co-administration of fluvoxamine alone with pomalidomide increased mean exposure to pomalidomide by 125% with a 90% confidence interval [98% to 157%] compared to pomalidomide alone.
Croatian: U drugom ispitivanju, u kojem je procijenjen doprinos samo inhibitora CYP1A2 na promjene metabolizma, istodobna primjena samog fluvoksamina s pomalidomidom povećala je srednju vrijednost izloženosti pomalidomidu za 125% uz 90%-tni interval pouzdanosti [98% do 157%] u usporedbi sa samim pomalidomidom.
English: In a fertility and early embryonic development study in rats, pomalidomide was administered to males and females at dosages of 25, 250, and 1000 mg/kg/day.
Croatian: Tijekom ispitivanja učinaka na plodnost i rani embrionalni razvoj štakora, pomalidomid je bio primjenjivan na mužjacima i ženkama u dozama od 25, 250 i 1000 mg/kg na dan.
English: No adverse findings were noted up to 1000 mg/kg/day (175-fold exposure ratio relative to a 4 mg clinical dose).
Croatian: Nije bilo zabilježenih štetnih učinaka pri dozama do 1000 mg/kg na dan (175 puta veći omjer izloženosti u odnosu na kliničku dozu od 4 mg).
English: Interstitial lung disease (ILD)
Croatian: Intersticijska bolest pluća (IBP)
English: In patients receiving combination therapy with pomalidomide in clinical studies, venous thromboembolic events (VTE) occurred in 3.3-11.5% of patients (1.3-5.4% Grade 3 or 4).
Croatian: U bolesnika koji su u kliničkim ispitivanjima primali kombiniranu terapiju s pomalidomidom, venski tromboembolijski događaji (VTE) zabilježeni su u 3,3 - 11,5% bolesnika (1,3 - 5,4% bili su 3. ili
English: KaplanMeier curve for PFS for the ITT population is provided in Figure 1.
Croatian: Kaplan-Meierova krivulja za PFS u ITT populaciji prikazana je na slici 1.
English: Uncommon Bronchitis Herpes zoster
Croatian: Manje često bronhitis herpes zoster
English: Repeat-dose toxicology studies
Croatian: Ispitivanja toksičnosti ponovljene doze
English: • On average, Imnovid when used with bortezomib and dexamethasone stopped multiple myeloma from coming back for up to 11 months - compared with 7 months for those patients who only used bortezomib and dexamethasone.
Croatian: • kada se Imnovid primjenjivao s bortezomibom i deksametazonom u prosjeku je zaustavio povratak multiplog mijeloma do 11 mjeseci - u usporedbi sa 7 mjeseci u bolesnika koji su uzimali samo bortezomib i deksametazon.
English: These cells grow out of control and accumulate in the bone marrow.
Croatian: Te se stanice nekontrolirano dijele i nakupljaju u koštanoj srži.
English: Adverse reactions tended to occur more frequently within the first 2 cycles of treatment with pomalidomide.
Croatian: Nuspojave su češće nastajale tijekom prva 2 ciklusa liječenja pomalidomidom.
English: Odds ratio is for Pom+Btz+LD-Dex:Btz+LD-Dex.
Croatian: Omjer izgleda odnosi se na Pom+Btz+LD-Dex:Btz+LD-Dex.
English: You should not donate semen or sperm during treatment and for 7 days after the end of treatment.
Croatian: Ne smijete donirati sjeme ili spermu tijekom liječenja i 7 dana nakon završetka liječenja.
English: POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.53 (0.37, 0.74) KM median: POM+LD-DEX=NE [48.1, NE] KM median: HD-DEX = 34.0[23.4, 39.9] Events: POM+LD-DEX=75/284 HD-DEX=56/139
Croatian: POM+LD-DEX vs HD-DEX Log-rang p-vrijednost = <0,001 (dvostrana) HR (95% CI) 0,53 (0,37; 0,74) KM medijan: POM+LD-DEX = NP [48,1, NP] KM medijan: HD-DEX = 34,0 [23,4; 39,9] Događaji: POM+LD-DEX = 75/284 HD-DEX = 56/139
English: • your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished.
Croatian: • Liječnik će organizirati testiranje na trudnoću prije liječenja, najmanje svaka 4 tjedna tijekom liječenja i najmanje 4 tjedna nakon završetka liječenja.
English: • Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to less white blood cells, which fight infection).
Croatian: • vrućicu, zimicu, bol u grlu, kašalj, afte u ustima ili bilo koje druge znakove infekcije (zbog sniženog broja bijelih krvnih stanica koje brane organizam od infekcije)
English: Unused medicinal product should be returned to the pharmacist.
Croatian: Neiskorišteni lijek treba vratiti ljekarniku.
English: Muscle weakness ≥ Grade 2
Croatian: Mišićna slabost ≥2. stupnja
English: Treatment with pomalidomide combined with dexamethasone should be given until disease progression or until unacceptable toxicity occurs.
Croatian: Terapiju pomalidomidom u kombinaciji s deksametazonom treba primjenjivati do progresije bolesti ili do pojave neprihvatljive toksičnosti.
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).
Croatian: Analize populacijske farmakokinetike pokazale su da u bolesnika s oštećenom funkcijom bubrega (definiranom na temelju klirensa kreatinina ili procjene brzine glomerularne filtracije [eGFR]) farmakokinetički parametri pomalidomida nisu značajno promijenjeni u usporedbi s bolesnicima s normalnom funkcijom bubrega (CrCl ≥60 ml/min).
English: • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) pomalidomide are provided with a physician information pack containing the following:
Croatian: • prije propisivanja (gdje je to prikladno, a u dogovoru s nadležnim državnim tijelom i prije izdavanja) svi zdravstveni radnici koji namjeravaju propisivati (i izdavati) pomalidomid dobiti paket s informacijama za liječnike koji sadrži sljedeće: o edukacijski materijal za zdravstvene radnike o edukacijske knjižice za bolesnike o kartice za bolesnike o sažetak opisa svojstava lijeka (SmPC), uputu o lijeku i označivanje.
English: If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50% (see sections 4.5 and 5.2).
Croatian: Ako se jaki inhibitori CYP1A2 (npr. ciprofloksacin, enoksacin i fluvoksamin) primjenjuju istodobno s pomalidomidom, dozu pomalidomida smanjite za 50% (vidjeti dijelove 4.5 i 5.2).
English: Medicine name
Croatian: Naziv lijeka
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).
Croatian: Na temelju Coxovog modela proporcionalnih hazarda kojim su se usporedile funkcije hazarda u terapijskim skupinama; stratificirano prema dobi (≤75 naspram >75), populacija s bolešću (refraktornom i na lenalidomid i na bortezomib naspram one koja nije refraktorna ni na jednu od te dvije djelatne tvari) te prethodni broj antimijelomskih terapija (=2 naspram >2).
English: • The breakdown of cancer cells resulting in the release of toxic compounds into the bloodstream
Croatian: • raspadanje stanica raka što ima za posljedicu oslobađanje toksičnih spojeva u krvotok (sindrom lize tumora).
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).
Croatian: • Nakon odobrenja, provest će se neintervencijsko prikupljanje podataka (registar) o bolesnicima s relapsnim i refraktornim oblikom multiplog mijeloma, liječenih pomalidomidom, a radi praćenja incidencije nuspojava na lijek u „stvarnim situacijama“ i nadzora provedbe i usklađenosti programa tvrtke Celgene za prevenciju trudnoće, primjene lijeka izvan odobrene indikacije te sustava kontrole distribucije na razini države u dogovoru s nacionalnim nadležnim tijelom (npr. nadzor ispunjavanja kartice bolesnika).
English: It is unknown whether pomalidomide is excreted in human milk.
Croatian: Nije poznato izlučuje li se pomalidomid u majčino mlijeko u ljudi.
English: Instructions on dose interruptions or reductions for pomalidomide related adverse reactions are outlined in the Table 2 and dose levels are defined in Table 3 below:
Croatian: Upute za prekid primjene ili smanjenje doze zbog nuspojava povezanih s pomalidomidom navedene su u tablici 2, a razine doza definirane su u tablici 3 u nastavku:
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).
Croatian: • ubrzano disanje, ubrzan puls, vrućica i zimica, oskudno mokrenje ili nemogućnost mokrenja, mučnina i povraćanje, smetenost, besvjesno stanje (zbog infekcije krvi koja se naziva sepsa ili septički šok)
English: Patients should not donate blood, semen or sperm during treatment (including during dose interruptions) and for 7 days following discontinuation of pomalidomide.
Croatian: Bolesnici ne smiju darivati krv, sjeme ili spermu tijekom liječenja (uključujući tijekom privremenih prekida liječenja) i 7 dana nakon prekida liječenja pomalidomidom.
English: Treatment with Imnovid may cause the hepatitis B virus to become active again in patients who carry the virus, resulting in a recurrence of the infection.
Croatian: • Ako imate ili ste imali infekciju hepatitisom B. Liječenje Imnovidom može prouzročiti da virus hepatitisa B ponovno postane aktivan u bolesnika koji taj virus nose, a posljedica je povratak infekcije.
English: Interrupt pomalidomide treatment for remainder of cycle.
Croatian: Prekinuti liječenje pomalidomidom do kraja ciklusa.
English: How to take Imnovid
Croatian: Kako uzimati Imnovid
English: • you experience or have experienced in the past a combination of any of the following symptoms: rash on face or extended rash, red skin, high fever, flu-like symptoms, enlarged lymph nodes (signs of severe skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis (TEN) or Stevens-Johnson Syndrome (SJS).
Croatian: • Ako imate ili ste imali kombinaciju bilo kojih od sljedećih simptoma: osip na licu ili prošireni osip, crvenilo kože, visoku vrućicu, simptome nalik gripi, povećane limfne čvorove (znakove teške kožne reakcije koja se naziva „reakcija na lijek s eozinofilijom i sistemskim simptomima“ (DRESS), poznata i kao sindrom preosjetljivosti na lijek, toksične epidermalne nekrolize (TEN) ili Stevens-Johnsonovog sindroma (SJS).
English: • one other medicine - called ‘dexamethasone' in people whose myeloma has become worse, despite having at least two other treatments - including lenalidomide and bortezomib.
Croatian: • s jednim lijekom koji se naziva deksametazon; to vrijedi za bolesnike kojima se stanje mijeloma pogoršalo, iako su liječeni s najmanje dvije druge terapije -uključujući lijekove lenalidomid i bortezomib.
English: LD-Dex (40 mg) was administered once per day on days 1, 8, 15 and 22 of a 28-day cycle.
Croatian: LD-Dex (40 mg) primjenjivao se jedanput na dan 1., 8., 15. i 22. dana 28-dnevnog ciklusa.
English: 95% confidence interval about the median progression free survival time.
Croatian: 95% interval pouzdanosti za medijan razdoblja ukupnog preživljenja bez progresije bolesti c
English: The maternal NOAEL was 10 mg/kg/day, and the developmental NOAEL was <10 mg/kg/day (AUC24h was 418 ng•h/mL on Gestation Day 19 at this lowest dose tested, which was similar to that obtained from a 4 mg clinical dose).
Croatian: NOAEL majki bio je 10 mg/kg na dan, a razvojni NOAEL iznosio je <10 mg/kg na dan (AUC24h je bio 418 ng•h/ml 19. dana gestacije pri ovoj najnižoj ispitanoj dozi, što je bilo slično onome koji se dobio pri kliničkoj dozi od 4 mg).
English: Acute kidney injury Chronic kidney injury Urinary retention
Croatian: Često akutno oštećenje bubrega kronično oštećenje bubrega urinarna retencija
English: Common Atrial fibrillation
Croatian: Često fibrilacija atrija
English: • Pomalidomide in combination with dexamethasone Patients with ongoing peripheral neuropathy ≥ Grade 2 were excluded from clinical studies.
Croatian: • Pomalidomid u kombinaciji s deksametazonom Bolesnici s prisutnom perifernom neuropatijom ≥2. stupnja bili su isključeni iz kliničkih ispitivanja.
English: If pregnancy occurs in a woman treated with pomalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Croatian: Ako žena liječena pomalidomidom zatrudni, liječenje se mora prekinuti i bolesnicu je potrebno uputiti liječniku specijaliziranom ili iskusnom u teratologiji na pregled i savjetovanje.
English: The p-value is based on a CMH test, stratified by age (<=75 vs >75), Prior number of antimyeloma regimens (1 vs >1), and Beta-2 microglobulin at screening (< 3.5 mg/L versus ≥ 3.5 mg/L - ≤ 5.5 mg/L versus > 5.5 mg/L).
Croatian: P-vrijednost temelji se na Cochran-Mantel-Haenszelovom testu stratificiranom za dob (≤75 naspram >75 godina), broju prethodnih linija liječenja protiv mijeloma (1 naspram >1) i beta-2 mikroglobulinu na probiru (<3,5 mg/l naspram ≥3,5 mg/l; ≤5,5 mg/l naspram >5,5 mg/l).
English: Therefore, the NOAEL for these observed effects was < 25 mg/kg/day (AUC 24h was 39960 ng•h/mL (nanogram•hour/millilitres) at this lowest dose tested, and the exposure ratio was 99-fold relative to a 4 mg clinical dose).
Croatian: Stoga, za ove opažene učinke NOAEL je bio <25 mg/kg na dan (AUC24h je bio 39960 ng•h/ml (nanogram•sat/mililitri) pri ovoj najnižoj ispitanoj dozi, a omjer izloženosti bio je 99 puta veći u odnosu na kliničku dozu od 4 mg).
English: Peripheral neuropathy adverse reactions were reported in 12.3% of patients and venous embolic or thrombotic (VTE) adverse reactions were reported in 3.3% of patients.
Croatian: Nuspojave periferne neuropatije bile su zabilježene u 12,3% bolesnika, a venska embolija ili tromboza (VTE) u 3,3% bolesnika.
English: • Chest pain, chest infection.
Croatian: • bol u prsnom košu, infekcija prsnog koša