natgillin/translations-raw huggingface dataset:
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
POM+NO-deks vs VO-deks Log-rank vrednost p = < 0,001 (2-stranska) HR (95 % IZ) 0,53 (0,37; 0,74) Mediana KM: POM+NO-deks = NE [48,1 NE] Mediana KM: VO-deks = 34,0 [23,4; 39,9] Dogodki: POM+NO-deks = 75/284 VO-deks = 56/139
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.
O periferni nevropatiji kot neželenem učinku so poročali pri 12,3 % bolnikov, o venski emboliji ali trombozi (VTE) kot neželenem učinku pa pri 3,3 % bolnikov.
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.
V drugi študiji, v kateri so ocenjevali prispevek zaviralca CYP1A2 samega k spremembam presnove, je sočasno dajanje fluvoksamina samega s pomalidomidom zvečalo srednjo izpostavljenost pomalidomidu za 125 % z 90 % intervalom zaupanja [98 % do 157 %] v primerjavi s pomalidomidom samim.
• Shortness of breath (from serious chest infection, inflammation of the lung, heart failure or blood clot).
• zasoplost (zaradi hude okužbe v prsih, vnetja pljuč, srčnega popuščanja ali krvnega strdka);
• The need to contact their doctor immediately upon suspicion of pregnancy
• potrebo po takojšnjem obveščanju zdravnika pri sumu na nosečnost.
Markedly elevated levels of alanine aminotransferase and bilirubin have been observed in patients treated with pomalidomide (see section 4.8).
Pri bolnikih, zdravljenih s pomalidomidom, so opazili znatno zvišane ravni alanin aminotransferaze in bilirubina (glejte poglavje 4.8).
Imnovid works in a number of different ways:
Kako zdravilo Imnovid deluje Zdravilo Imnovid deluje na več različnih načinov:
Minimal or mild bile duct proliferation with associated increases in ALP and GGT were also observed at 1 mg/kg/day.
Pri odmerku 1 mg/kg/dan so opazili tudi minimalno ali blago proliferacijo žolčevoda s povezanim zvišanjem ALP in GGT.
Haemorrhagic events have included epistaxis, intracranial haemorrhage and gastrointestinal haemorrhage.
Hemoragični dogodki vključujejo epistakso, znotrajlobanjske krvavitve in gastrointestinalne krvavitve.
• The other ingredients are mannitol (E421), starch, pregelatinised, and sodium stearyl fumarate.
• Druge sestavine zdravila so manitol (E421), škrob, predgelirani, in natrijev stearilfumarat.
Consider dose interruption or discontinuation of pomalidomide treatment.
V poštev pride prekinitev odmerjanja ali prekinitev zdravljenja s pomalidomidom.
• 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.
• Ponovitev okužbe z virusom hepatitisa B, ki lahko povzroči porumenitev kože in oči, temno rjavo obarvan urin, bolečine v desni strani trebuha, zvišano telesno temperaturo, občutek slabosti (navzeo) ali bruhanje.
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).
NOAEL za mater je bila 10 mg/kg/dan in razvojna NOAEL < 10 mg/kg/dan (AUC24h je bila 418 ng•h/ml na 19. dan gestacije pri tem najnižjem testiranem odmerku, kar je podobno kot pri 4 mg kliničnem odmerku).
As per an interim analysis for Overall Survival (OS), using a cut-off of 15 September 2018 (median follow-up period of 26.2 months), median OS time from Kaplan-Meier estimates was 40.5 months for the Pom + Btz + LD-Dex arm and 30.5 months for the Btz + LD-Dex arm; HR = 0.91, 95% CI: 0.70, 1.18, with an overall event rate of 43.3%.
V skladu z nedavno vmesno analizo celokupnega preživetja (OS), z upoštevanjem datuma zaključka zbiranja podatkov 15. september 2018 (mediana obdobja spremljanja 26,2 meseca), je bil mediani čas OS po Kaplan-Meierjevi oceni 40,5 meseca za skupino Pom + Btz + NO-deks in 30,5 meseca za skupino Btz + NO-deks; HR = 0,91; 95 % IZ: 0,70; 1,18, s celokupno pogostnostjo dogodkov 43,3 %.
• 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.
• bo zdravnik pred vsakim zdravljenjem, vsaj vsake 4 tedne med zdravljenjem in vsaj 4 tedne po koncu zdravljenja naročil test nosečnosti.
• Low blood level of phosphate (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
• nizko raven fosfatov v krvi (hipofosfatemija), ki lahko povzroča mišično šibkost in razdražljivost ali zmedenost,
• The need to use condoms if sexual partner is pregnant or a WCBP and has no contraception (even if man has had vasectomy) o During pomalidomide treatment (including dose interruptions) o For 7 days following final dose
• potrebo po uporabi kondomov, če je spolna partnerica noseča ali ŽRD in ne uporablja kontracepcije (tudi, če je moški imel vazektomijo) o med zdravljenjem s pomalidomidom (vključno s prekinitvami odmerjanja) o še 7 dni po zadnjem odmerku;
• 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%).
• Pomalidomid v kombinaciji z bortezomibom in deksametazonom Bolezni krvi in limfatičnega sistema, o katerih so najpogosteje poročali, so bile nevtropenija (46,8 %), trombocitopenija (36,7 %) in anemija (28,4 %).
Pomalidomide has direct anti-myeloma tumoricidal activity, immunomodulatory activities and inhibits stromal cell support for multiple myeloma tumour cell growth.
Pomalidomid deluje tumoricidno neposredno proti plazmocitomu, ima imunomodulatorno aktivnost ter zavira podporo stromalnih celic za celično rast tumorja diseminiranega plazmocitoma.
• Levonorgestrel-releasing intrauterine system
• intrauterini sistem, ki sprošča levonorgestrel,
• Numbness, tingling or burning sensation to the skin, pains in hands or feet (peripheral sensory neuropathy).
• odrevenelost, mravljinčenje ali pekoč občutek na koži, bolečine v dlaneh ali stopalih (periferna senzorična nevropatija),
For each subsequent drop < 25 x 109/l
• Pri vsakem nadaljnjem zmanjšanju < 25 x 109/l
• 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.
• 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.
Always take your medicines exactly as your doctor has told you.
Pri jemanju zdravil vedno natančno upoštevajte navodila zdravnika.
• High blood level of calcium (hypercalcaemia), which may cause slowing reflexes and skeletal muscle weaknesses.
• visoko raven kalcija v krvi (hiperkalciemija), ki lahko povzroči upočasnitev refleksov in oslabelost skeletnih mišic,
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%).
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 %
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%).
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 %).
Angioedema and severe dermatologic reactions including SJS, TEN and DRESS have been reported with the use of pomalidomide (see section 4.8).
Pri uporabi pomalidomida so poročali so o angioedemu in hudih dermatoloških reakcijah, vključno s SJS, TEN in DRESS (glejte poglavje 4.8).
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).
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).
On haemodialysis days, patients should take their pomalidomide dose following haemodialysis.
Tiste dni, ko imajo bolniki hemodializo, naj svoj odmerek pomalidomida vzamejo po hemodializi.
Interstitial lung disease (ILD)
Intersticijska pljučna bolezen (IPB)
Pomalidomide is administered in combination with bortezomib and dexamethasone, as shown in Table 1.
Pomalidomid se uporablja v kombinaciji z bortezomibom in deksametazonom, kot je prikazano v preglednici 1.
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.
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.
How to take Imnovid Imnovid must be given to you by a doctor with experience in treating multiple myeloma.
Zdravilo Imnovid vam sme dati samo zdravnik, ki ima izkušnje z zdravljenjem diseminiranega plazmocitoma.
• The need to stop pomalidomide immediately upon suspicion of pregnancy
• potrebo po takojšnji prekinitvi zdravljenja s pomalidomidom pri sumu na nosečnost,
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.
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.
• 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
• 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,
All Adverse Reactions (ADRs) reported in clinical trial MM-007 in patients treated with pomalidomide in combination with bortezomib and dexamethasone.
Vsi neželeni učinki (NUZ), o katerih so poročali v kliničnem preskušanju MM-007 pri bolnikih, zdravljenih s pomalidomidom v kombinaciji z bortezomibom in deksametazonom.
Kaplan-Meier curve for PFS for the ITT population is provided in Figure 2.
Krivulja po Kaplan-Meier za PFS za populacijo ITT je na sliki 2.
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).
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).
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.
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.
• Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
• tablete za zaviranje ovulacije le s progesteronom (t. j. dezogestrel).
• 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).
• 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).
The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28day treatment cycle.
Priporočeni začetni odmerek deksametazona je 40 mg peroralno enkrat na dan na 1., 8., 15. in 22. dan vsakega 28-dnevnega cikla zdravljenja.
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
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
Medicine name
IME ZDRAVILA
Increased cardiac anomalies were seen at all doses with significant increases at 250 mg/kg/day.
Pri vseh odmerkih z močnim zvišanjem pri 250 mg/kg/dan so opazili zvišanje srčnih anomalij.
IMN: Imnovid; BOR: Bortezomib; DEX: Dexamethasone
• IMN: Imnovid; BOR: bortezomib; deks: deksametazon 1. do 8. cikel
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:
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:
Propotion of Patients
Delež bolnikov
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.
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.
Multiple myeloma generally cannot be cured.
Diseminirani plazmocitom na splošno ni ozdravljiv.
• Chest pain, chest infection.
• bolečina v prsih, okužba v prsnem košu,
Progression Free Survival (weeks)
Preživetje brez napredovanja (tedni)
• Weight loss.
• izguba teka,
The efficacy of contraceptive steroids may be reduced during cotreatment with dexamethasone (see section 4.5).
Pri sočasnem zdravljenju z deksametazonom se lahko zanesljivost kontracepcijskih steroidov zmanjša (glejte poglavje 4.5).
If powder from a broken Imnovid capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.
Če pride prašek pomalidomida v stik s kožo, kožo takoj in temeljito sperite z milom in vodo.
• Pomalidomide in combination with dexamethasone No dose adjustment is required for pomalidomide.
• Pomalidomid v kombinaciji z deksametazonom Odmerka pomalidomida ni treba prilagajati.
Tell your doctor if you are breast-feeding or intend to breast-feed.
Povejte zdravniku, če dojite ali nameravate dojiti.
Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin
občasni bazalnocelični karcinom kože ploščatocelični karcinom kože občasni bazalnocelični karcinom kože ploščatocelični karcinom kože
Oral pomalidomide dose
Peroralni odmerek pomalidomida
Other serious adverse reactions reported included febrile neutropenia (4.0%), neutropenia (2.0%), thrombocytopenia (1.7%) and VTE adverse reactions (1.7 %).
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 %).
• That he should not donate semen or sperm during therapy (including during dose interruptions) and for 7 days after discontinuation of pomalidomide treatment
• opozorilo, da ne sme darovati semena ali sperme med zdravljenjem (vključno s prekinitvami odmerjanja) in še 7 dni po končanem zdravljenju s pomalidomidom.
Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis (see section 5.3).
Pomalidomid je teratogen pri podganah in kuncih, če se daje v obdobju glavne organogeneze (glejte poglavje 5.3).
• 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).
• 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).
Thalidomide is a known human teratogen that causes severe life-threatening birth defects.
Talidomid je za človeka znana teratogena učinkovina, ki povzroča hude, smrtno nevarne okvare ploda.
For information on bortezomib given in combination with Imnovid, refer to the respective current SmPC.
Za informacije o bortezomibu, ki ga dajete v kombinaciji z zdravilom Imnovid, glejte zadevni veljavni SmPC.
However, dose interruption or resumption decisions are at the physician's discretion per Summary of Product Characteristics (SmPC).
Vendar pa so odločitve o prekinitvi ali ponovnem začetku odmerjanja prepuščene zdravnikovi presoji ob upoštevanju povzetka glavnih značilnosti zdravila (SmPC).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 5. avgust 2013
Data cutoff: 26 Oct 2017
Datum zaključka zbiranja podatkov: 26. oktober 2017.
> 75 years old Days 1, 8, 15 and 22 of each 28-day treatment cycle
> 75 let stari 1., 8., 15. in 22. dan vsakega 28-dnevnega cikla zdravljenja
• 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.
• 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.
Dose reduction in this table is applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone.
Zmanjšanje odmerka v tej preglednici se lahko uporablja za pomalidomid v kombinaciji z bortezomibom in deksametazonom in za pomalidomid v kombinaciji z deksametazonom.
Dyspepsia = Grade 1-2
Izpuščaj Izpuščaj = 2.-3. stopnje
The frequencies of adverse reactions are those reported in the pomalidomide plus dexamethasone arm of study CC-4047-MM-003 (n = 302).
Pogostnosti neželenih učinkov izhajajo iz poročil v skupini študije CC-4047-MM-003 (n = 302) za pomalidomid in deksametazon.
Muscle weakness ≥ Grade 2
Mišična oslabelost ≥ 2. stopnje
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.
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.
Dexamethasone dose reduction
Zmanjševanje odmerka deksametazona
You should not donate blood during treatment and for 7 days after the end of treatment.
Med zdravljenjem in še 7 dni po koncu zdravljenja ne smete darovati krvi.
Men Imnovid passes into human semen.
Moški Zdravilo Imnovid prehaja v spermo pri ljudeh.
Upper respiratory tract infection and pneumonia were the most frequently occurring infections.
Najpogostnejši okužbi sta bili okužba zgornjih dihal in pljučnica.
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)
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).
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.
• 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.
Therefore, pomalidomide can be administered without regard to food intake.
Zato se lahko pomalidomid daje s hrano ali brez nje.
• Low blood pressure, which may cause dizziness or fainting.
• nizek krvni tlak, ki lahko povzroči omotico ali omedlevico,
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.
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.
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%).
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 %).