FrancophonIA/ELRC3.0 huggingface dataset:
English: Pomalidomide has direct anti-myeloma tumoricidal activity, immunomodulatory activities and inhibits stromal cell support for multiple myeloma tumour cell growth.
Slovenian: Pomalidomid deluje tumoricidno neposredno proti plazmocitomu, ima imunomodulatorno aktivnost ter zavira podporo stromalnih celic za celično rast tumorja diseminiranega plazmocitoma.
English: • Levonorgestrel-releasing intrauterine system
Slovenian: • intrauterini sistem, ki sprošča levonorgestrel,
English: • Numbness, tingling or burning sensation to the skin, pains in hands or feet (peripheral sensory neuropathy).
Slovenian: • odrevenelost, mravljinčenje ali pekoč občutek na koži, bolečine v dlaneh ali stopalih (periferna senzorična nevropatija),
English: For each subsequent drop < 25 x 109/l
Slovenian: • Pri vsakem nadaljnjem zmanjšanju < 25 x 109/l
English: • He understands that if his female partner becomes pregnant whilst he is taking pomalidomide or 7 days after he has stopped taking pomalidomide, he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Slovenian: • mora razumeti, da mora takoj obvestiti lečečega zdravnika, če njegova partnerica zanosi v času, ko on jemlje pomalidomid ali 7 dni po prenehanju jemanja pomalidomida, in da je priporočljivo, da partnerico takoj napoti k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji, da oceni stanje in bolnici ustrezno svetuje.
English: Always take your medicines exactly as your doctor has told you.
Slovenian: Pri jemanju zdravil vedno natančno upoštevajte navodila zdravnika.
English: • High blood level of calcium (hypercalcaemia), which may cause slowing reflexes and skeletal muscle weaknesses.
Slovenian: • visoko raven kalcija v krvi (hiperkalciemija), ki lahko povzroči upočasnitev refleksov in oslabelost skeletnih mišic,
English: In the HD-Dex arm, median PFS time was 8.0 weeks (95% CI: 7.0, 9.0); the estimated 26-week event-free survival rate was 12.15% (±3.63%).
Slovenian: V skupini VO-deks je bil mediani čas PFS 8,0 tednov (95 % IZ: 7,0; 9,0); ocenjena 26-tedenska stopnja preživetja brez dogodkov je bila 12,15 %
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%).
Slovenian: Za populacijo z namenom zdravljenja (ITT - Intention to Treat) je bil mediani čas PFS po pregledu Neodvisnega presojevalnega odbora (IRAC - Independent Review Adjudication Committee) na podlagi kriterijev IMWG 15,7 tednov (95 % IZ: 13,0; 20,1) v skupini POM + NO-deks; ocenjena 26-tedenska stopnja preživetja brez dogodkov je bila 35,99 % (± 3,46 %).
English: Angioedema and severe dermatologic reactions including SJS, TEN and DRESS have been reported with the use of pomalidomide (see section 4.8).
Slovenian: Pri uporabi pomalidomida so poročali so o angioedemu in hudih dermatoloških reakcijah, vključno s SJS, TEN in DRESS (glejte poglavje 4.8).
English: Therefore, the maternal NOAEL was 1000 mg/kg/day, and the NOAEL for developmental toxicity was < 25 mg/kg/day (AUC24h was 34340 ng•h/mL on Gestation Day 17 at this lowest dose tested, and the exposure ratio was 85-fold relative to a 4 mg clinical dose).
Slovenian: Zato je bila NOAEL za mater 1.000 mg/kg/dan in NOAEL za razvojno toksičnost < 25 mg/kg/dan (AUC24h je bila 34.340 ng•h/ml na 17. dan gestacije pri tem najnižjem testiranem odmerku, razmerje izpostavljenosti pa je bilo 85-kratnik glede na 4 mg klinični odmerek).
English: On haemodialysis days, patients should take their pomalidomide dose following haemodialysis.
Slovenian: Tiste dni, ko imajo bolniki hemodializo, naj svoj odmerek pomalidomida vzamejo po hemodializi.
English: Interstitial lung disease (ILD)
Slovenian: Intersticijska pljučna bolezen (IPB)
English: Pomalidomide is administered in combination with bortezomib and dexamethasone, as shown in Table 1.
Slovenian: Pomalidomid se uporablja v kombinaciji z bortezomibom in deksametazonom, kot je prikazano v preglednici 1.
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.
Slovenian: Seznam neželenih učinkov po začetku trženja zdravila v obliki preglednice Poleg zgornjih neželenih učinkov, ugotovljenih v ključnih kliničnih preskušanjih, naslednja preglednica 9 navaja podatke, zbrane v obdobju spremljanja zdravila po začetku trženja.
English: How to take Imnovid Imnovid must be given to you by a doctor with experience in treating multiple myeloma.
Slovenian: Zdravilo Imnovid vam sme dati samo zdravnik, ki ima izkušnje z zdravljenjem diseminiranega plazmocitoma.
English: • The need to stop pomalidomide immediately upon suspicion of pregnancy
Slovenian: • potrebo po takojšnji prekinitvi zdravljenja s pomalidomidom pri sumu na nosečnost,
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.
Slovenian: Nevtropenija je bil najpogosteje poročani hematološki neželeni učinek 3. ali 4. stopnje pri bolnikih s ponovljenim/na zdravljenje odpornim diseminiranim plazmocitomom, sledili sta anemija in trombocitopenija.
English: • For Cycles 1 to 8: 10 mg once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle
Slovenian: • za cikle 1 do 8: 10 mg enkrat na dan na 1., 2., 4., 5., 8., 9., 11. in 12. dan vsakega 21-dnevnega cikla,
English: All Adverse Reactions (ADRs) reported in clinical trial MM-007 in patients treated with pomalidomide in combination with bortezomib and dexamethasone.
Slovenian: Vsi neželeni učinki (NUZ), o katerih so poročali v kliničnem preskušanju MM-007 pri bolnikih, zdravljenih s pomalidomidom v kombinaciji z bortezomibom in deksametazonom.
English: Kaplan-Meier curve for PFS for the ITT population is provided in Figure 2.
Slovenian: Krivulja po Kaplan-Meier za PFS za populacijo ITT je na sliki 2.
English: In patients receiving combination therapy with pomalidomide in clinical studies, neutropenia occurred in up to 46.8% of patients (41.7% Grade 3 or 4).
Slovenian: Pri bolnikih, ki so v kliničnih študijah prejemali kombinirano zdravljenje s pomalidomidom, se je nevtropenija pojavila pri največ 46,8 % bolnikov (pri 41,7 % 3. ali 4. stopnje).
English: The adverse reactions observed in patients treated with pomalidomide in combination with bortezomib and dexamethasone are listed in Table 7 by system organ class (SOC) and frequency for all adverse reactions and for Grade 3 or 4 adverse reactions.
Slovenian: Neželeni učinki, ki so jih opazili pri bolnikih, zdravljenih s pomalidomidom v kombinaciji z bortezomibom in deksametazonom, so našteti v preglednici 7 po organskih sistemih in pogostnosti za vse neželene učinke in za neželene učinke 3. ali 4. stopnje.
English: • Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
Slovenian: • tablete za zaviranje ovulacije le s progesteronom (t. j. dezogestrel).
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).
Slovenian: • imate ali ste v preteklosti imeli kombinacijo katerih izmed naslednjih simptomov: izpuščaj na obrazu ali razširjen izpuščaj, pordelo kožo, močno povišano telesno temperaturo, gripi podobne simptome, povečane bezgavke (znake hude kožne reakcije, imenovane reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms) ali sindrom preobčutljivosti za zdravilo, toksično epidermalno nekrolizo (TEN) ali Stevens-Johnsonov sindrom (SJS).
English: The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28day treatment cycle.
Slovenian: Priporočeni začetni odmerek deksametazona je 40 mg peroralno enkrat na dan na 1., 8., 15. in 22. dan vsakega 28-dnevnega cikla zdravljenja.
English: POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.45 (0.35, 0.59) Events: POM+LD-DEX=164/302 HD-DEX=103/153
Slovenian: Log-rank vrednost p = < 0,001 (2-stranska) HR (95 % IZ) 0,45 (0,35; 0,59) Dogodki: POM+NO-deks = 164/302 VO-deks = 103/153
English: Medicine name
Slovenian: IME ZDRAVILA
English: Increased cardiac anomalies were seen at all doses with significant increases at 250 mg/kg/day.
Slovenian: Pri vseh odmerkih z močnim zvišanjem pri 250 mg/kg/dan so opazili zvišanje srčnih anomalij.
English: IMN: Imnovid; BOR: Bortezomib; DEX: Dexamethasone
Slovenian: • IMN: Imnovid; BOR: bortezomib; deks: deksametazon 1. do 8. cikel
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:
Slovenian: Koristni učinki uporabe zdravila Imnovid z bortezomibom in deksametazonom Ko se zdravilo Imnovid uporablja skupaj z bortezomibom in deksametazonom pri ljudeh, ki so že imeli vsaj eno drugo zdravljenje, lahko ustavi slabšanje diseminiranega plazmocitoma:
English: Propotion of Patients
Slovenian: Delež bolnikov
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.
Slovenian: Da bi bolnikom pomagali preprečiti izpostavitev ploda pomalidomidu, bo imetnik dovoljenja za promet z zdravilom priskrbel izobraževalno gradivo za zdravnike, v katerem bodo poudarjena opozorila o pričakovani teratogenosti pomalidomida.
English: Multiple myeloma generally cannot be cured.
Slovenian: Diseminirani plazmocitom na splošno ni ozdravljiv.
English: • Chest pain, chest infection.
Slovenian: • bolečina v prsih, okužba v prsnem košu,
English: Progression Free Survival (weeks)
Slovenian: Preživetje brez napredovanja (tedni)
English: • Weight loss.
Slovenian: • izguba teka,
English: The efficacy of contraceptive steroids may be reduced during cotreatment with dexamethasone (see section 4.5).
Slovenian: Pri sočasnem zdravljenju z deksametazonom se lahko zanesljivost kontracepcijskih steroidov zmanjša (glejte poglavje 4.5).
English: If powder from a broken Imnovid capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
Slovenian: Če pride prašek pomalidomida v stik s kožo, kožo takoj in temeljito sperite z milom in vodo.
English: • Pomalidomide in combination with dexamethasone No dose adjustment is required for pomalidomide.
Slovenian: • Pomalidomid v kombinaciji z deksametazonom Odmerka pomalidomida ni treba prilagajati.
English: Tell your doctor if you are breast-feeding or intend to breast-feed.
Slovenian: Povejte zdravniku, če dojite ali nameravate dojiti.
English: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin
Slovenian: občasni bazalnocelični karcinom kože ploščatocelični karcinom kože občasni bazalnocelični karcinom kože ploščatocelični karcinom kože
English: Oral pomalidomide dose
Slovenian: Peroralni odmerek pomalidomida
English: Other serious adverse reactions reported included febrile neutropenia (4.0%), neutropenia (2.0%), thrombocytopenia (1.7%) and VTE adverse reactions (1.7 %).
Slovenian: Med drugimi resnimi neželenimi učinki, o katerih so poročali, so bili febrilna nevtropenija (4,0 %), nevtropenija (2,0 %), trombocitopenija (1,7 %) in VTE (1,7 %).
English: • That he should not donate semen or sperm during therapy (including during dose interruptions) and for 7 days after discontinuation of pomalidomide treatment
Slovenian: • opozorilo, da ne sme darovati semena ali sperme med zdravljenjem (vključno s prekinitvami odmerjanja) in še 7 dni po končanem zdravljenju s pomalidomidom.
English: Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis (see section 5.3).
Slovenian: Pomalidomid je teratogen pri podganah in kuncih, če se daje v obdobju glavne organogeneze (glejte poglavje 5.3).
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).
Slovenian: • razširjen izpuščaj, visoka telesna temperatura, povečane bezgavke in vključenost drugih telesnih organov (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, znana tudi kot DRESS ali sindrom preobčutljivosti za zdravilo, toksična epidermalna nekroliza ali Stevens-Johnsonov sindrom).
English: Thalidomide is a known human teratogen that causes severe life-threatening birth defects.
Slovenian: Talidomid je za človeka znana teratogena učinkovina, ki povzroča hude, smrtno nevarne okvare ploda.
English: For information on bortezomib given in combination with Imnovid, refer to the respective current SmPC.
Slovenian: Za informacije o bortezomibu, ki ga dajete v kombinaciji z zdravilom Imnovid, glejte zadevni veljavni SmPC.
English: However, dose interruption or resumption decisions are at the physician's discretion per Summary of Product Characteristics (SmPC).
Slovenian: Vendar pa so odločitve o prekinitvi ali ponovnem začetku odmerjanja prepuščene zdravnikovi presoji ob upoštevanju povzetka glavnih značilnosti zdravila (SmPC).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 5. avgust 2013
English: Data cutoff: 26 Oct 2017
Slovenian: Datum zaključka zbiranja podatkov: 26. oktober 2017.
English: > 75 years old Days 1, 8, 15 and 22 of each 28-day treatment cycle
Slovenian: > 75 let stari 1., 8., 15. in 22. dan vsakega 28-dnevnega cikla zdravljenja
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.
Slovenian: • Poglejte spodnjo preglednico in si oglejte, kaj morate vzeti ob vsakem dnevu 4-tedenskega cikla: o vsak dan poglejte po razpredelnici navzdol in poiščite pravilni dan, da boste videli, kateri zdravili morate vzeti; o nekatere dni boste vzeli obe zdravili, nekatere dni samo eno zdravilo, nekatere dni pa sploh nobenega.
English: Dose reduction in this table is applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone.
Slovenian: Zmanjšanje odmerka v tej preglednici se lahko uporablja za pomalidomid v kombinaciji z bortezomibom in deksametazonom in za pomalidomid v kombinaciji z deksametazonom.
English: Dyspepsia = Grade 1-2
Slovenian: Izpuščaj Izpuščaj = 2.-3. stopnje
English: The frequencies of adverse reactions are those reported in the pomalidomide plus dexamethasone arm of study CC-4047-MM-003 (n = 302).
Slovenian: Pogostnosti neželenih učinkov izhajajo iz poročil v skupini študije CC-4047-MM-003 (n = 302) za pomalidomid in deksametazon.
English: Muscle weakness ≥ Grade 2
Slovenian: Mišična oslabelost ≥ 2. stopnje
English: The adverse reactions observed in patients treated with pomalidomide plus dexamethasone are listed below in Table 8 by system organ class (SOC) and frequency for all adverse reactions (ADRs) and for Grade 3 or 4 adverse reactions.
Slovenian: Neželeni učinki, ki so jih opazili pri bolnikih, zdravljenih s pomalidomidom in deksametazonom, so našteti spodaj v preglednici 8 po organskih sistemih in pogostnosti za vse neželene učinke zdravila (NUZ) in za neželene učinke 3. ali 4. stopnje.
English: Dexamethasone dose reduction
Slovenian: Zmanjševanje odmerka deksametazona
English: You should not donate blood during treatment and for 7 days after the end of treatment.
Slovenian: Med zdravljenjem in še 7 dni po koncu zdravljenja ne smete darovati krvi.
English: Men Imnovid passes into human semen.
Slovenian: Moški Zdravilo Imnovid prehaja v spermo pri ljudeh.
English: Upper respiratory tract infection and pneumonia were the most frequently occurring infections.
Slovenian: Najpogostnejši okužbi sta bili okužba zgornjih dihal in pljučnica.
English: Rash = Grade 4 or blistering (including angioedema, exfoliative or bullous rash or if Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspected)
Slovenian: Izpuščaj = 4. stopnja ali nastajanje mehurjev (vključno z angioedemom, eksfoliativnim ali buloznim izpuščajem ali če domnevamo, da bi lahko šlo za Stevens-Johnsonov sindrom (SJS), toksično epidermalno nekrolizo (TEN) ali reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms).
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.
Slovenian: • imate ali ste kdaj imeli okužbo s hepatitisom B. Zdravljenje z zdravilom Imnovid lahko pri bolnikih, ki so nosilci virusa, povzroči ponovno aktivacijo virusa hepatitisa B in s tem ponovitev okužbe.
English: Therefore, pomalidomide can be administered without regard to food intake.
Slovenian: Zato se lahko pomalidomid daje s hrano ali brez nje.
English: • Low blood pressure, which may cause dizziness or fainting.
Slovenian: • nizek krvni tlak, ki lahko povzroči omotico ali omedlevico,
English: Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
Slovenian: Zdravilo Imnovid v kombinaciji z bortezomibom in deksametazonom je indicirano za zdravljenje diseminiranega plazmocitoma pri odraslih bolnikih, ki so predhodno prejeli vsaj eno zdravljenje, vključno z lenalidomidom.
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%).
Slovenian: Neželeni učinki 3. ali 4. stopnje, o katerih so najpogosteje poročali, so bile bolezni krvi in limfatičnega sistema, vključno z nevtropenijo (41,7 %), anemijo (27 %) in trombocitopenijo (20,7 %); infekcijske in parazitske bolezni, vključno s pljučnico (9 %); splošne težave in spremembe na mestu aplikacije, vključno z utrujenostjo (4,7 %), pireksijo (3 %) in perifernim edemom (1,3 %).
English: The efficacy and safety of pomalidomide in combination with dexamethasone were evaluated in a Phase III multi-centre, randomised, open-label study (CC-4047-MM-003), where pomalidomide plus low-dose dexamethasone therapy (Pom+LD-Dex) was compared to high-dose dexamethasone alone (HD-Dex) in previously treated adult patients with relapsed and refractory multiple myeloma, who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Slovenian: Učinkovitost in varnost pomalidomida v kombinaciji z deksametazonom so ocenili v multicentrični, randomizirani, odprti študiji faze III (CC-4047-MM-003), v kateri so zdravljenje s pomalidomidom in nizkoodmernim deksametazonom (POM + NO-deks) primerjali s samo visokoodmernim deksametazonom (VO-deks) pri predhodno zdravljenih odraslih bolnikih s ponovljenim in na zdravljenje odpornim diseminiranim plazmocitomom, ki so predhodno prejemali vsaj dva režima zdravljenja, vključno z lenalidomidom in bortezomibom, in pri katerih je bilo po zadnjem zdravljenju dokazano napredovanje bolezni.
English: 4.6 Fertility, pregnancy and lactation Women of childbearing potential / Contraception in males and females
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah
English: ≤ 75 years old Days 1, 8, 15 and 22 of each 28-day treatment cycle
Slovenian: ≤ 75 let stari 1., 8., 15. in 22. dan vsakega 28-dnevnega cikla zdravljenja
English: Patients in the Pom+Btz+LD-Dex arm were administered 4 mg pomalidomide orally on Days 1 to 14 of each 21-day cycle.
Slovenian: Bolnikom v skupini Pom+Btz+NO-deks so dajali 4 mg pomalidomida peroralno na 1. do 14. dan vsakega 21-dnevnega cikla.
English: KaplanMeier curve for PFS for the ITT population is provided in Figure 1.
Slovenian: Kaplan-Meierjeva krivulja za PFS za populacijo ITT je na sliki 1.
English: Recommended dosing scheme for Imnovid in combination with bortezomib and dexamethasone
Slovenian: Priporočena shema odmerjanja za zdravilo Imnovid v kombinaciji z bortezomibom in deksametazonom
English: • Pomalidomide in combination with bortezomib and dexamethasone The efficacy and safety of pomalidomide in combination with bortezomib and low -dose dexamethasone (Pom+Btz+LD-Dex) was compared with bortezomib and low-dose dexamethasone (Btz+LD-Dex) in a Phase III multi-centre, randomised, open-label study (CC-4047-MM-007), in previously treated adult patients with multiple myeloma, who had received at least one prior regimen, including lenalidomide and have demonstrated disease progression on or after the last therapy.
Slovenian: • Pomalidomid v kombinaciji z bortezomibom in deksametazonom Učinkovitost in varnost pomalidomida v kombinaciji z bortezomibom in nizkoodmernim deksametazonom (Pom+Btz+NO-deks) so primerjali z bortezomibom in nizkoodmernim deksametazonom (Btz+NO-deks) v multicentrični, randomizirani, odprti študiji faze III (CC-4047-MM007) pri predhodno zdravljenih odraslih bolnikih z diseminiranim plazmocitomom, ki so prejeli vsaj en predhoden režim zdravljenja, vključno z lenalidomidom, in pri katerih je bilo dokazano napredovanje bolezni ob ali po zadnjem zdravljenju.
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.
Slovenian: • Poglejte spodnjo preglednico in si oglejte, kaj morate vzeti ob vsakem dnevu 3-tedenskega cikla: o vsak dan poglejte po razpredelnici navzdol in poiščite pravilni dan, da boste videli, katera zdravila morate vzeti; o nekatere dni boste vzeli vsa tri zdravila, nekatere dni samo dve zdravili ali eno zdravilo, nekatere dni pa sploh nobenega.
English: Women and men taking Imnovid must not become pregnant or father a child.
Slovenian: Ženske, ki jemljejo zdravilo Imnovid, ne smejo zanositi, moški, ki jemljejo zdravilo Imnovid, pa ne smejo zaploditi otroka.
English: Mean normalised AUC exposure to pomalidomide was 98.2% with a 90% confidence interval [77.4% to 120.6%] in moderate renal impairment patients (eGFR ≥30 to ≤45 mL/minute/1.73 m2) compared to patients with normal renal function.
Slovenian: Srednja normalizirana AUC izpostavljenost pomalidomidu je bila 98,2 % z 90% intervalom zaupanja [77,4 % do 120,6 %] pri bolnikih z zmerno okvaro ledvic (eGFR ≥30 do ≤45 ml/minuto/1,73 m2) v primerjavi z bolniki z normalno funkcijo ledvic.
English: Fatigue, depressed level of consciousness, confusion, and dizziness have been reported with the use of pomalidomide.
Slovenian: Pri uporabi pomalidomida so poročali o utrujenosti, zmanjšani stopnji zavesti, zmedenosti in omotici.
English: • you must use effective methods of contraception for at least 4 weeks before starting treatment, for the whole time you are taking treatment, and until at least 4 weeks after stopping treatment.
Slovenian: • morate vsaj 4 tedne pred začetkom zdravljenja, ves čas jemanja zdravila in vsaj 4 tedne po koncu zdravljenja uporabljati zanesljivo kontracepcijsko metodo.