FrancophonIA/ELRC3.0 huggingface dataset:
English: • Widespread rash, high body temperature, enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis or Stevens-Johnson Syndrome).
Croatian: • široko rasprostranjen osip, visoka tjelesna temperatura, povećani limfni čvorovi i zahvaćenost drugih tjelesnih organa (reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS), poznata i kao sindrom preosjetljivosti na lijek, toksična epidermalna nekroliza ili Stevens
English: • Dizziness, tremor.
Croatian: • omaglica, nevoljno drhtanje
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.
Croatian: Primjenu deksametazona treba prekinuti u slučaju da bolesnik ne podnosi 8 mg ako je u dobi
English: Common Febrile neutropenia
Croatian: Često febrilna neutropenija
English: Hypokalaemia Hyperglycaemia Hypomagnaesaemia Hypocalcaemia Hypophosphataemia Hyperkalaemia Hypercalcaemia
Croatian: Često hipokalijemija hiperglikemija hipomagnezijemija hipokalcijemija hipofosfatemija hiperkalijemija hiperkalcijemija
English: Brochure for male patients
Croatian: Knjižica za muške bolesnike
English: • That he should not donate semen or sperm during therapy (including during dose interruptions) and for 7 days after discontinuation of pomalidomide treatment
Croatian: • bolesnik ne smije darivati sjeme ili spermu tijekom liječenja (uključujući privremene prekide liječenja) i još 7 dana nakon prestanka liječenja pomalidomidom
English: • Numbness, itching, and a feeling of pins and needles on your skin (paraesthesia).
Croatian: • utrnulost, svrbež i osjećaj trnaca i bockanja u koži (parestezija)
English: • The printing ink contains: shellac, titanium dioxide (E171), simeticone, propylene glycol (E1520) and ammonium hydroxide (E527) (white ink) and shellac, iron oxide black (E172), propylene glycol (E1520) and ammonium hydroxide (E527) (black ink).
Croatian: • Tinta za označavanje sadrži: šelak, titanijev dioksid (E171), simetikon, propilenglikol (E1520) i amonijev hidroksid (E527) (bijela tinta) i šelak, crni željezov oksid (E172), propilenglikol (E1520) i amonijev hidroksid (E527) (crna tinta).
English: The most commonly reported Grade 3 or 4 adverse reactions were blood and lymphatic system disorders including neutropenia (41.7%), thrombocytopenia (27.3%) and anaemia (14.0%).
Croatian: Najčešće zabilježene nuspojave 3. ili 4. stupnja bile su poremećaji krvi i limfnog sustava koji su uključivali neutropeniju (41,7%), trombocitopeniju (27,3%) i anemiju (14,0%).
English: Platelet count return to ≥ 50 x 109/l
Croatian: Oporavak broja trombocita na ≥50 x 109/l
English: The most commonly reported Grade 3 or 4 adverse reactions were in the blood and lymphatic system disorders including neutropenia (41.7%), anaemia (27%) and thrombocytopenia (20.7%); in infections and infestations including pneumonia (9%); and in general disorders and administration site conditions including fatigue (4.7%), pyrexia (3%) and oedema peripheral (1.3%).
Croatian: Najčešće zabilježene nuspojave 3. ili 4. stupnja bile su poremećaji krvi i limfnog sustava koji su uključivali neutropeniju (41,7%), anemiju (27%) i trombocitopeniju (20,7%); infekcije i infestacije koje su uključivale pneumoniju (9%); i opći poremećaji i reakcije na mjestu primjene koji su uključivali umor (4,7%), pireksiju (3%) i periferne edeme (1,3%).
English: • Hives (urticaria).
Croatian: • koprivnjača (urtikarija)
English: Propylene glycol (E1520) Ammonium hydroxide (E527)
Croatian: propilenglikol (E1520) i amonijev hidroksid (E527).
English: • Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark browncoloured urine, right-sided abdominal pain, fever and feeling nauseous or being sick.
Croatian: • povratak infekcije hepatitisom B, što može prouzročiti žutu boju kože i očiju, tamno smeđu boju mokraće, bol na desnoj strani trbuha, vrućicu i osjećaj mučnine ili povraćanje; ako opazite bilo koji od tih simptoma, odmah se obratite liječniku.
English: Hyperglycaemia ≥ Grade 3
Croatian: Hiperglikemija ≥3. stupnja
English: Appropriate caution should be exercised when considering the treatment of such patients with pomalidomide.
Croatian: Kada se za takve bolesnike razmatra mogućnost liječenja pomalidomidom potreban je odgovarajući oprez.
English: Cycle 9 onwards
Croatian: Od 9. ciklusa nadalje
English: Data cutoff: 07 Sep 2012
Croatian: Podaci do: 07. rujna 2012.
English: • Urinary tract infection, which may cause a burning sensation when passing urine, or a need to pass urine more often.
Croatian: • infekcija mokraćnog sustava koja može izazvati osjećaj žarenja pri mokrenju ili potrebu za učestalijim mokrenjem
English: Common Hyperuricaemia
Croatian: Često hiperuricemija
English: Dyspepsia ≥ Grade 3
Croatian: Dispepsija ≥3. stupnja
English: For information on other medicinal products given in combination with Imnovid, refer to the respective current SmPC.
Croatian: Za informacije o drugim lijekovima koji se primjenjuju u kombinaciji s Imnovidom, vidjeti važeće sažetke opisa svojstava tih lijekova.
English: • Feeling confused.
Croatian: • osjećaj smetenosti
English: ≤ 75 years old Days 1, 8, 15 and 22 of each 28-day treatment cycle
Croatian: Dob ≤75 godina 1., 8., 15. i 22. dan svakog 28-dnevnog ciklusa
English: Upper respiratory tract infection and pneumonia were the most frequently occurring infections.
Croatian: Najčešće infekcije bile su infekcije gornjih dišnih puteva i pneumonija.
English: Dose modification instructions in this table are applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone.
Croatian: Upute za prilagodbu doze u ovoj tablici primjenjive su za pomalidomid u kombinaciji s bortezomibom i deksametazonom te za pomalidomid u kombinaciji s deksametazonom.
English: Patients in the Pom+LD-Dex arm were administered 4 mg pomalidomide orally on days 1 to 21 of each 28-day cycle.
Croatian: Bolesnici u skupini koja je primala Pom+LD-Dex primali su 4 mg pomalidomida peroralno od 1. do 21. dana svakog 28-dnevnog ciklusa.
English: Tell your doctor if you are breast-feeding or intend to breast-feed.
Croatian: Obratite se liječniku ako dojite ili namjeravate dojiti.
English: Dose reduction in this table is applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone.
Croatian: Smanjenje doze u ovoj tablici primjenjivo je za pomalidomid u kombinaciji s bortezomibom i deksametazonom te za pomalidomid u kombinaciji s deksametazonom.
English: After a median follow-up of 15.9 months, median PFS time was 11.20 months (95% CI: 9.66, 13.73) in the Pom+Btz+LD-Dex arm.
Croatian: Nakon medijana praćenja od 15,9 mjeseci, medijan PFS-a u skupini Pom+Btz+LD-Dex iznosio je 11,20 mjeseci (95% CI: 9,66; 13,73), dok je u skupini Btz+LD-Dex medijan PFS-a bio 7,1 mjesec (95% CI: 5,88; 8,48).
English: Instructions on dose interruptions or reductions for low-dose dexamethasone related adverse reactions are outlined in Tables 4 and 5 below.
Croatian: Prilagodba doze ili prekid primjene deksametazona Upute za prekid primjene ili smanjenje doze zbog nuspojava povezanih s niskim dozama deksametazona navedene su u tablicama 4 i 5 u nastavku.
English: Common Hypotension Hypertension
Croatian: Često hipotenzija hipertenzija
English: Refer also to the bortezomib SmPC.
Croatian: Vidjeti također sažetak opisa svojstava za bortezomib.
English: The benefit of using Imnovid with dexamethasone
Croatian: Korist od primjene Imnovida s deksametazonom
English: Dose level -3
Croatian: Razina doze -3
English: • The recommended starting dose of dexamethasone is 20 mg per day.
Croatian: • Preporučena početna doza deksametazona iznosi 20 mg na dan.
English: Data cutoff: 26 Oct 2017
Croatian: Podaci do: 26. listopada 2017.
English: • Brochure for male patients
Croatian: • knjižica za muške bolesnike.
English: • Swelling caused by fluid.
Croatian: • oticanje zbog nakupljanja tekućine
English: Iron oxide black (E172) Propylene glycol (E1520) Ammonium hydroxide (E527)
Croatian: crna tinta šelak željezov oksid crni (E172) propilenglikol (E1520) amonijev hidroksid (E527)
English: Dose Level -1
Croatian: Razina doze -1
English: • Inflammation of the liver (hepatitis) which can cause itchy skin, yellowing of the skin and the whites of the eyes (jaundice), pale coloured stools, dark coloured urine and abdominal pain.
Croatian: • upala jetre (hepatitis) što može prouzročiti svrbež kože, žutu boju kože i bjeloočnica (žutica),
English: Common Blood uric acid increased
Croatian: Često povišena mokraćna kiselina u krvi
English: The benefit of using Imnovid with bortezomib and dexamethasone When Imnovid is used with bortezomib and dexamethasone, in people who have had at least one other treatment, it can stop multiple myeloma getting worse:
Croatian: Kada se Imnovid primjenjuje s bortezomibom i deksametazonom u osoba koje su primile najmanje jednu drugu terapiju, može zaustaviti pogoršanje multiplog mijeloma:
English: Common Muscular weakness Back pain
Croatian: Često mišićna slabost bol u leđima
English: Instructions for dose interruptions or reductions for pomalidomide related adverse reactions are outlined in Table 2 and 3.
Croatian: Prilagodba doze ili prekid primjene pomalidomida Upute za prekid primjene ili smanjenje doze zbog nuspojava povezanih s pomalidomidom navedene su u tablicama 2 i 3.
English: Imnovid with bortezomib and dexamethasone
Croatian: Imnovid s bortezomibom i deksametazonom
English: • some antifungals such as ketaconazole
Croatian: • neke antimikotike kao što je ketokonazol
English: Uncommon Myocardial infarction
Croatian: Manje često infarkt miokarda
English: For the intention to treat (ITT) population, median PFS time by Independent Review Adjudication Committee (IRAC) review based on IMWG criteria was 15.7 weeks (95% CI: 13.0, 20.1) in the Pom + LD-Dex arm; the estimated 26-week event-free survival rate was 35.99% (±3.46%).
Croatian: Stopa preživljavanja bez progresije prema procjeni IRAC-a, a na temelju IMWG kriterija, bio je 15,7 tjedana (95% CI: 13,0; 20,1) u skupini bolesnika koji su primali Pom+LD-Dex; procijenjena stopa preživljenja bez događaja iznosila je 35,99% (±3,46%) na 26 tjedana.
English: Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies and institute treatment as indicated.
Croatian: Zbog moguće pojave drugih primarnih malignih bolesti liječnici trebaju, prije i tijekom liječenja, pozorno obraditi bolesnike uporabom standardnih testova probira i prema potrebi započeti liječenje.
English: OR (95% CI) e, p-valuef DoR (months) Mediana time (95% CI) b HRc (95% CI)
Croatian: Trajanje odgovora (mjeseci) Medijana (95% CI)b HRc (95% CI)
English: 14 hard capsules.
Croatian: Tvrda kapsula.
English: • Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of your skin or growths on your skin.
Croatian: • neke vrste raka kože (karcinom pločastih stanica i karcinom bazalnih stanica), koji mogu prouzročiti promjene u izgledu kože ili pojavu izraslina na koži; ako opazite bilo kakvu promjenu na koži dok uzimate Imnovid, obratite se liječniku što prije
English: Oedema ≥ Grade 3
Croatian: Edem ≥3. stupnja
English: Pomalidomide dose modification or interruption
Croatian: Prilagodba doze ili prekid primjene pomalidomida
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), brilliant blue FCF
Croatian: • Ovojnica kapsule sadrži: želatinu, titanijev dioksid (E171), indigotin (E132), brilliant blue FCF
English: • Constipation, diarrhoea or nausea.
Croatian: • zatvor, proljev ili mučnina
English: Common Diarrhoea Vomiting Abdominal pain Constipation
Croatian: Često proljev povraćanje bol u abdomenu konstipacija
English: > 75 years old Days 1, 8, 15 and 22 of each 28-day treatment cycle
Croatian: Dob >75 godina 1., 8., 15. i 22. dan svakog 28-dnevnog ciklusa
English: Progression Free Survival Based on IRAC Review of Response by IMWG Criteria (Stratified Log Rank Test) (ITT Population)
Croatian: Preživljenje bez progresije bolesti na temelju IRAC-ove analize odgovora prema kriterijima IMWG-a (stratificirani log-rang test) (ITT populacija)
English: In patients who received 1 prior antimyeloma line, median PFS time was 20.73 months (95% CI: 15.11, 27.99) in the Pom + Btz + LD-Dex arm and 11.63 months (95% CI: 7.52, 15.74) in the Btz + LD-Dex arm. A 46% risk reduction was observed with Pom + Btz + LD-Dex treatment (HR = 0.54, 95% CI: 0.36,
Croatian: U bolesnika koji su primili 1 prethodnu liniju terapije protiv mijeloma, medijan PFS-a bio je 20,73 mjeseca (95% CI: 15,11; 27,99) u skupini Pom+Btz+LD-Dex i 11,63 mjeseca (95% CI: 7,52; 15,74) u skupini Btz+LD-Dex.
English: • Heart attack (chest pain spreading to the arms, neck, jaw, feeling sweaty and breathless, feeling sick or vomiting).
Croatian: • srčani udar (bol u prsnom košu koji se širi u ruke, vrat, čeljust, znojenje i nedostatak zraka,
English: • Pomalidomide in combination with dexamethasone The most commonly reported adverse reactions in clinical studies have been blood and lymphatic system disorders including anaemia (45.7%), neutropenia (45.3%) and thrombocytopenia (27%); in general disorders and administration site conditions including fatigue (28.3%), pyrexia (21%) and oedema peripheral (13%); and in infections and infestations including pneumonia (10.7%).
Croatian: U kliničkim ispitivanjima, najčešće zabilježene nuspojave bile su poremećaji krvi i limfnog sustava koji su uključivali anemiju (45,7%), neutropeniju (45,3%) i trombocitopeniju (27%); opći poremećaji i reakcije na mjestu primjene koji su uključivali umor (28,3%), pireksiju (21%) i periferne edeme (13%); i infekcije i infestacije koje su uključivali pneumoniju (10,7%).
English: • Bone pain, back pain.
Croatian: • bol u kostima, bol u leđima
English: • Shortness of breath (dyspnoea).
Croatian: • nedostatak zraka (otežano disanje)
English: Pomalidomide dose reduction∞ Dose level
Croatian: Tablica 3. Smanjenje doze pomalidomida∞
English: Progression Free Survival (weeks)
Croatian: Preživljenje bez progresije bolesti (tjedni)
English: ▪ Pregnancy test regime ▪ Advice on suitable tests ▪ Before commencing treatment ▪ During treatment based on method of contraception ▪ After finishing treatment o Need to stop pomalidomide immediately upon suspicion of pregnancy o Need to tell treating doctor immediately upon suspicion of pregnancy
Croatian: ▪ režim testiranja na trudnoću ▪ savjeti o prikladnim testovima ▪ prije početka liječenja ▪ tijekom liječenja na temelju metode kontracepcije
English: • The recommended dose of Imnovid is 4 mg per day.
Croatian: • Preporučena doza Imnovida iznosi 4 mg na dan.
English: • Muscle spasm, muscle weakness.
Croatian: • grčevi u mišićima, slabost u mišićima
English: Resume at one dose level lower than previous dose.
Croatian: Nastaviti liječenje u dozi koja je za jednu razinu niža od prethodne.
English: • The recommended starting dose of Imnovid is 4 mg per day.
Croatian: • Preporučena početna doza Imnovida iznosi 4 mg na dan.
English: Mean exposure to pomalidomide increased by 51% with a 90% confidence interval [9% to 110%] in mildly hepatically impaired patients compared to healthy subjects.
Croatian: U bolesnika s blagim oštećenjem funkcije jetre, srednja vrijednost izloženosti pomalidomidu povećala se za 51% uz 90%-tni interval pouzdanosti [9% do 110%] u usporedbi sa zdravim ispitanicima.
English: Mean exposure to pomalidomide increased by 72% with a 90% confidence interval [24% to 138%] in severely hepatically impaired patients compared to healthy subjects.
Croatian: U bolesnika s teškim oštećenjem funkcije jetre, srednja vrijednost izloženosti pomalidomidu povećala se za 72% uz 90%-tni interval pouzdanosti [24% do 138%] u usporedbi sa zdravim ispitanicima.
English: Pomalidomide must be discontinued for exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected, and should not be resumed following discontinuation for these reactions.
Croatian: Pomalidomid se mora ukinuti u slučaju eksfolijativnog ili buloznog osipa, ili ako postoji sumnja na Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu ili reakciju na lijek s eozinofilijom i sistemskim simptomima te se više ne smije uvoditi u liječenje nakon prekida zbog navedenih reakcija.
English: • The recommended starting dose of dexamethasone is 40 mg per day.
Croatian: • Preporučena početna doza deksametazona iznosi 40 mg na dan.
English: Mean exposure to pomalidomide increased by 58% with a 90% confidence interval [13% to 119%] in moderately hepatically impaired patients compared to healthy subjects.
Croatian: U bolesnika s umjerenim oštećenjem funkcije jetre, srednja vrijednost izloženosti pomalidomidu povećala se za 58% uz 90%-tni interval pouzdanosti [13% do 119%] u usporedbi sa zdravim ispitanicima.
English: Hazard Ratio (Pom+LD-Dex:HD-Dex) 2-Sided 95% CI c
Croatian: omjer hazarda (Pom+LD-Dex:HD-Dex) [dvostrani 95% CIc] dvostrana p-vrijednost log-rang testad
English: Uncommon Blood uric acid increased
Croatian: Manje često povišena mokraćna kiselina u krvi
English: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin
Croatian: Manje često karcinom bazalnih stanica kože karcinom pločastih stanica kože
English: Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules
Croatian: Imnovid 1 mg tvrde kapsule Imnovid 2 mg tvrde kapsule Imnovid 3 mg tvrde kapsule Imnovid 4 mg tvrde kapsule
English: Pneumonia (bacterial, viral and fungal infections, including opportunistic infections)
Croatian: Često neutropenijska sepsa pneumonija (bakterijske, virusne i gljivične infekcije, uključujući oportunističke infekcije) bronhopneumonija infekcija dišnih puteva infekcija gornjih dišnih puteva
English: (tumour lysis syndrome).
Croatian: Johnsonov sindrom).
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132) and yellow iron oxide (E172) and white and black ink.
Croatian: • Ovojnica kapsule sadrži: želatinu, titanijev dioksid (E171), indigotin (E132) i žuti željezov oksid (E172) i bijelu i crnu tintu.
English: Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules pomalidomide
Croatian: Imnovid 1 mg tvrde kapsule Imnovid 2 mg tvrde kapsule Imnovid 3 mg tvrde kapsule Imnovid 4 mg tvrde kapsule pomalidomid
English: the recommended starting dose is 20 mg per day.
Croatian: 75 godina, preporučena početna doza iznosi 20 mg na dan.
English: Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups.
Croatian: b 95% interval pouzdanosti za medijan ukupnog razdoblja preživljenja c Na temelju Coxovog modela proporcionalnih hazarda kojim se uspoređuju funkcije hazarda u terapijskim skupinama.
English: Cerebrovascular accident Intracranial haemorrhage
Croatian: Manje često cerebrovaskularni incident intrakranijalno krvarenje
English: Imnovid with dexamethasone only
Croatian: Imnovid samo s deksametazonom
English: Imnovid contains sodium
Croatian: Imnovid sadrži natrij
English: Dose level -2
Croatian: Razina doze -2
English: Dexamethasone dose modification instructions Toxicity
Croatian: Tablica 4. Upute za prilagodbu doze deksametazona
English: Interstitial lung disease
Croatian: Često epistaksa intersticijska plućna bolest
English: ≤ 75 years old Dose (Cycle 1-8: Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21-day cycle Cycle ≥ 9: Days 1, 2, 8, 9 of a 21-day cycle)
Croatian: Dob ≤75 godina Doza (od 1. do 8. ciklusa: 1., 2., 4., 5., 8., 9., 11., 12. dan 21-dnevnog ciklusa; 9. ciklus i nadalje: 1., 2., 8., 9. dan 21-dnevnog ciklusa)
English: Imnovid 1 mg hard capsules Each hard capsule contains 1 mg of pomalidomide.
Croatian: Imnovid 3 mg tvrde kapsule Jedna tvrda kapsula sadrži 3 mg pomalidomida.
English: NE Two sided 95% CIb [48.1, NE] Hazard Ratio (Pom+LD-Dex:HD-Dex) [Two sided 95% CIc] Log-Rank Test Two sided P-Value d
Croatian: b omjer hazarda (Pom+LD-Dex:HD-Dex) 2-strani 95% CIc dvostrana p-vrijednost log-rang testad
English: Dexamethasone dose reduction
Croatian: Tablica 6. Smanjenje doze deksametazona
English: Bortezomib dose modification or interruption
Croatian: Prilagodba doze ili prekid primjene bortezomiba
English: • See the leaflets that come with bortezomib and dexamethasone for further information on their use and effects.
Croatian: • Dodatne informacije o primjeni i učincima bortezomiba i deksametazona pogledajte u uputama o lijeku koje se uz njih dobiju.
English: Common Confusional state
Croatian: Često konfuzno stanje
English: Hepatobiliary disorders Uncommon Hyperbilirubinaemia
Croatian: Poremećaji jetre i žuči Manje često hiperbilirubinemija
English: Titanium dioxide (E171) Indigotine (E132) Brilliant blue FCF (E133) White ink
Croatian: Imnovid 4 mg tvrde kapsule želatina titanijev dioksid (E171) indigotin (E132) brilliant blue FCF (E133) bijela tinta
English: Talk to your doctor, pharmacist or nurse before taking Imnovid if:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Imnovid:
English: Mannitol (E421) Starch, pregelatinised Sodium stearyl fumarate
Croatian: 6.1 Popis pomoćnih tvari Sadržaj kapsule manitol (E421) škrob, prethodno geliran natrijev stearilfumarat
English: • Stroke.
Croatian: • pad
English: Pregnancy, contraception and breast-feeding - information for women and men The following must be followed as stated in the Imnovid Pregnancy Prevention Programme.
Croatian: Trudnoća, kontracepcija i dojenje - obavijesti za žene i muškarce
English: How to store Imnovid Keep this medicine out of the sight and reach of children.
Croatian: Lijek čuvajte izvan pogleda i dohvata djece.
English: The frequencies of adverse reactions are those reported in the pomalidomide plus dexamethasone arm of study CC-4047-MM-003 (n = 302).
Croatian: Učestalosti nuspojava zabilježene u ispitivanju CC-4047-MM-003 odnose se na skupinu koja je primala pomalidomid s deksametazonom (n = 302).
English: 21 hard capsules.
Croatian: 14 tvrdih kapsula 21 tvrda kapsula
English: Very Common Hypokalaemia Hyperglycaemia
Croatian: Vrlo često hipokalijemija hiperglikemija
English: Non-cardiac chest pain Oedema
Croatian: Često nekardijalni bol u prsnom košu edem
English: > 75 years old Dose (Cycle 1-8: Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21-day cycle Cycle ≥ 9: Days 1, 2, 8, 9 of a 21-day cycle)
Croatian: Dob >75 godina Doza (od 1. do 8. ciklusa: 1., 2., 4., 5., 8., 9., 11., 12. dan 21-dnevnog ciklusa; 9. ciklus i nadalje: 1., 2., 8., 9. dan 21-dnevnog ciklusa)
English: Discontinue dexamethasone from treatment regimen.
Croatian: Ukinuti liječenje bolesnika deksametazonom.
English: A total of 559 patients were enrolled and randomised in the study: 281 in the Pom+Btz+LD-Dex arm and 278 in the Btz+LD-Dex arm. 54% of patients were male with median age for the overall population of 68 years (min, max: 27, 89 years).
Croatian: U ispitivanje je bilo uključeno i randomizirano ukupno 559 bolesnika: 281 u skupinu koja je primala Pom+Btz+LD-Dex i 278 u skupinu koja je primala Btz+LD-Dex.
English: Progression free survival (PFS), N Censored, n (%)
Croatian: Preživljenje bez progresije bolesti (PFS), N cenzurirani, n (%) s progresijom/umrli, n (%) Razdoblje bez progresije bolesti (tjedni) medijana dvostrani 95% CI
English: Dose Level
Croatian: Razina doze
English: • Low blood levels of sodium, which may cause tiredness and confusion, muscle twitching, fits
Croatian: • snižene razine natrija u krvi koje mogu prouzročiti umor i smetenost, trzanje mišića, napadaje (epileptične napadaje) ili komu
English: Grade 3−4 Adverse Reactions /Frequency
Croatian: Nuspojave 3. − 4. stupnja/učestalost
English: Pulmonary embolism Dyspnoea
Croatian: Često plućna embolija dispneja
English: How to store Imnovid
Croatian: Kako čuvati Imnovid
English: Common Intracranial haemorrhage
Croatian: Često intrakranijalno krvarenje