natgillin/translations-raw huggingface dataset:
A calibrating measuring spoon which dispenses up to 3 g of sodium phenylbutyrate is provided with the medicine.
Zdravilu je priložena umerjena odmerna žlička, ki odmeri do 3 g natrijevega fenilbutirata.
How to store PHEBURANE
Shranjevanje zdravila PHEBURANE
If you get any side effects, talk to your doctor or pharmacist.
Če opazite katerega koli izmed neželeni učinkov, se posvetujte s zdravnikom ali farmacevtom.
Posology
zrnca
75011 Paris
makrogol 1500,
Dosage
disgevzija
• PHEBURANE is considered high in sodium.
• zdravilo PHEBURANE sodi med zdravila z visoko vsebnostjo natrija.
Renal and hepatic impairment
Bolniki z oslabljenim delovanjem jeter in ledvic
Patients who have taken very high doses of sodium phenylbutyrate experienced:
Če ste vzeli večji odmerek zdravila PHEBURANE, kot bi smeli Pri bolnikih, ki so vzeli zelo velike odmerke natrijevega fenilbutirata, so se pojavili:
FrostPharma AB Puh/Tel: +35 875 32 51 209 info@frostpharma.com
Puh/Tel: +35 875 32 51 209
• Breast-feeding.
fenilacetilglutamina.
The other ingredients are: sugar spheres (sucrose and maize starch, see section 2 ‘PHEBURANE contains sucrose), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
Druge sestavine zdravila so: sladkorne kroglice (saharoza in koruzni škrob, glejte poglavje 2 „Zdravilo
Excretion
gastritis
What you need to know before you take PHEBURANE 3.
Kaj je zdravilo PHEBURANE in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo PHEBURANE
Common oedema
Pogosti edem
• Pregnancy.
• dojenje
Package leaflet: Information for the patient PHEBURANE 483 mg/g granules
Navodilo za uporabo PHEBURANE 483 mg/g zrnca natrijev fenilbutirat
White to off-white granules.
zrnca Zrnca so bela ali belkasta.
Pregnancy and breast-feeding
Presnovne in pehranske motnje
Age, gender, race
Starost, spol, rasa
Response was assessed every 4 weeks until disease progression.
Odziv so vrednotili na vsake 4 tedne do napredovanja bolezni.
Median overall survival was not reached in either regimen.
Mediana celokupnega preživetja ni bila dosežena pri nobenem režimu.
The doctor may also adjust the doses of the other medicines.
Zdravnik lahko prilagodi tudi odmerke drugih zdravil.
• Risk management plan (RMP)
Načrt za obvladovanje tveganj (RMP)
A risk to newborns/infants cannot be excluded and therefore breast-feeding should be discontinued.
Tveganja za dojenega novorojenca/otroka ne moremo izključiti in zato je treba z dojenjem prenehati.
Median (months) p-value*
Mediana (meseci) p-vrednost*
No animal data are available.
Podatkov pri živalih ni.
Take the medicine pack with you.
Ovojnino zdravila vzemite s seboj.
The median age was 66 years, range 38-91 years; 58% of patients were older than 65 years.
Mediana starost je bila 66 let, razpon od 38 do 91 let, 58 % bolnikov je bilo starejših od 65 let.
Recommended actions
Priporočeni ukrepi
Prior to initiating a new cycle of therapy:
Pred začetkom novega cikla zdravljenja:
The patient should be evaluated for underlying causes and provide supportive care, as necessary.
Pri bolniku je treba oceniti osnovne vzroke in po potrebi zagotoviti podporno oskrbo.
Eighty five percent of the population was White, 9% Asian and 2% Black.
85 % populacije je bilo belcev, 9 % Azijcev in 2 % črne rase.
Progression-Free Survival Events, n (%)
Preživetje brez napredovanja bolezni Dogodki, n (%)
Primary refractory, defined as best response of stable disease or disease progression on all prior therapies, was documented in 6% of patients.
Primarna neodzivnost, opredeljena kot najboljši odziv stabilne bolezni ali napredovanje bolezni po vseh predhodnih terapij, je bila dokumentirana pri 6 % bolnikov.
If lenalidomide is taken during pregnancy, a teratogenic effect in humans is expected.
V primeru prejemanja lenalidomida med nosečnostjo, se pričakuje teratogeni učinek pri ljudeh.
The baseline demographics and disease characteristics were balanced and comparable between the study regimens.
Izhodiščne demografske lastnosti in značilnosti bolezni so bile v študiji uravnotežene in primerljive med obema režimoma zdravljenja.
• Do not let the contents of the capsule come into contact with your skin.
• Vsebina kapsule ne sme priti v stik s kožo.
It should not be crushed, chewed, or opened (see section 6.6).
Kapsule se ne sme drobiti, žvečiti ali odpirati (glejte poglavje 6.6).
Twenty five percent of patients had a creatinine clearance of < 60 mL/min.
25 % bolnikov je imelo kreatininski očistek < 60 ml/min.
The safety and efficacy of ixazomib in children below 18 years of age have not been established.
Varnost in učinkovitost iksazomiba pri otrocih, mlajših od 18 let, nista bili dokazani.
Direct contact with the capsule contents should be avoided.
Izogibati se morate neposrednemu stiku z vsebino kapsule.
The steady-state volume of distribution is 543 L.
Volumen porazdelitve v stanju dinamičnega ravnovesja znaša 543 litrov.
Duration of the treatment with NINLARO You should continue treatment until your doctor tells you to stop.
Trajanje zdravljenja z zdravilom NINLARO Z zdravljenjem morate nadaljevati, dokler vam zdravnik ne naroči, da prenehajte.
For the purposes of this study, refractory disease was defined as disease progression on treatment or progression within 60 days after the last dose of lenalidomide or a proteasome inhibitor.
Za namene te študije je neodzivna bolezen opredeljena kot napredovanje bolezni ob zdravljenju ali napredovanje v 60 dneh po zadnjem odmerku lenalidomida ali zaviralca proteasoma.
Discontinue treatment regimen.
Režim zdravljenja ukinite.
The patient should be monitored for symptoms of peripheral neuropathy.
Bolnika je treba spremljati glede simptomov periferne nevropatije.
Before starting NINLARO and during treatment, you will have blood tests to check that you have enough blood cells.
Pred začetkom zdravljenja z zdravilom NINLARO in med zdravljenjem bo zdravnik s krvnimi preiskavami preverjal, če je število krvnih celic dovolj visoko.
Transporter-based interactions
Interakcije na osnovi prenašalcev
For these toxicities, the first dose modification step is to withhold/reduce lenalidomide.
Pri teh toksičnih učinkih je prvi korak prilagoditve odmerka zadržanje/zmanjšanje odmerka lenalidomida.
† Standardised MedDRA Queries (SMQs)
† Standardizirane MedDRA poizvedbe (SMQ)
The mean absolute oral bioavailability is 58%.
Srednja absolutna biološka uporabnost pri peroralni uporabi je 58 %.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. november 2016 Datum zadnjega podaljšanja: 16. septembra 2019
The terminal half-life (t1/2) of ixazomib was 9.5 days.
Končni razpolovni čas (t1/2) iksazomiba je 9,5 dni.
Effect of ixazomib on other medicinal products
Vpliv iksazomiba na druga zdravila
The conditions of the Pregnancy Prevention Programme for lenalidomide must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.
Izpolnjeni morajo biti pogoji programa za preprečevanje nosečnosti za vse bolnice, razen v primeru zanesljivih dokazov, da bolnica ni zmožna zanositi.
Delayed or missed doses
Odloženi ali izpuščeni odmerki
• Take NINLARO at least one hour before or at least two hours after food.
• Zdravilo NINLARO vzemite vsaj eno uro pred ali vsaj dve uri po hrani.
Patients that changed therapies prior to disease progression were eligible for enrolment, as well as those with controlled cardiovascular conditions.
Bolniki, ki so spremenili zdravljenje pred napredovanjem bolezni, so bili primerni za vključitev, prav tako pa tudi bolniki z nadzorovanimi kardiovaskularnimi boleznimi.
*P-value is based on the stratified log-rank test. †Hazard ratio is based on a stratified Cox's proportional hazard regression model.
*p-vrednost na osnovi stratificiranega testa log-rank †Razmerje ogroženosti (RO) na osnovi stratificiranega Coxovega regresijskega modela proporcionalnih hazardov.
In the Phase 3 study (C16010), 10 patients (5 in each treatment regimen) had severe renal impairment at baseline.
V študiji 3. faze je (C16010) 10 bolnikov (5 bolnikov pri vsakem režimu zdravljenja) imelo hudo okvaro ledvic ob izhodišču študije.
FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14-a(4) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
The following convention is used for the classification of the frequency of an adverse drug reaction (ADR): very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Pogostnost neželenih učinkov je v nadaljevanju navedena v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
In case of severe gastrointestinal events, monitoring of serum potassium level is recommended.
V primeru hudih gastrointestinalnih težav, je priporočljivo nadzirati vrednosti kalija v serumu.
Of the 5 patients in the ixazomib regimen, one patient had a confirmed partial response and 3 confirmed stable disease (however 2 were unconfirmed partial response and 1 was an unconfirmed very good partial response).
Od 5 bolnikov pri režimu zdravljenja z iksazomibom je en bolnik imel potrjen delni odziv, 3 bolniki pa potrjeno stabilno bolezen (2 bolnika z nepotrjenim delnim odzivom in 1 bolnik z nepotrjenim zelo dobrim delnim odzivom).
There are no data for the use of ixazomib in pregnant women.
Podatkov o uporabi iksazomiba pri nosečnicah ni.
Ixazomib should be taken at approximately the same time on days 1, 8, and 15 of each treatment cycle at least 1 hour before or at least 2 hours after food (see section 5.2).
Iksazomib je treba vzeti približno isti čas na 1., 8. in 15. dan vsakega cikla zdravljenja, in sicer vsaj 1 uro pred ali vsaj 2 uri po hrani (glejte poglavje 5.2).
Ixazomib AUC increases in a dose proportional manner over a dose range of 0.2-10.6 mg.
Vrednost AUC iksazomiba se povečuje proporcionalno v razponu odmerkov od 0,2 do 10,6 mg.
The Phase 3 study excluded patients who were refractory to lenalidomide or proteasome inhibitors and patients who received more than three prior therapies.
Iz študije 3. faze so izključili bolnike, ki so bili neodzivni na lenalidomid ali zaviralce proteasoma, in bolnike, ki so se predhodno zdravili z več kot tremi oblikami zdravljenja.
Quality of life as assessed by global health scores (EORTC QLQ-C30 and MY-20) was maintained during treatment and was similar in both treatment regimens in the Phase 3 study (C16010).
Kakovost življenja, ocenjena z globalnimi zdravstvenimi rezultati (EORTC QLQ C30 in MY 20) se je ohranila med zdravljenjem in je bila podobna pri obeh režimih zdravljenja v študiji 3. faze (C16010).
Your doctor will examine you and you will be monitored closely during treatment.
Zdravnik vas bo naročal na redne kontrolne preglede in skrbno nadziral zdravljenje.
The primary endpoint was progression-free survival (PFS) according to the 2011 International Myeloma Working Group (IMWG) Consensus Uniform Response Criteria as assessed by a blinded independent review committee (IRC) based on central laboratory results.
Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (PFS; “progression-free survival”) po poenotenih kriterijih odziva iz leta 2011, ki jih je pripravila mednarodna delovna skupina za mielom (IMWG; “International Myeloma Working Group”), kar je ovrednotil zaslepljeni neodvisni odbor za presojo odziva (IRC; “independent review committee”) na osnovi centralnih laboratorijskih rezultatov.
Studies of fertility and early embryonic development and pre- and post-natal toxicology were not conducted with ixazomib, but evaluation of reproductive tissues was conducted in the general toxicity studies.
Študije vplivov iksazomiba na plodnost in zgodnji embrionalni razvoj ter študije prenatalne in postnatalne toksičnosti niso bile izvedene, so pa vrednotenje vplivov na reproduktivna tkiva izvedli v študijah splošne toksičnosti.
If you vomit after taking a dose, do not take an extra dose.
Če potem, ko ste vzeli odmerek zdravila bruhate, ne smete vzeti dodatnega odmerka.
Do not use this medicine if you notice any damage or signs of tampering to medicine packaging.
Ne uporabljajte tega zdravila, če opazite kakršno koli poškodbo ali druge znake, da je bila ovojnina zdravila že odprta.
NINLARO is taken once a week (on the same day of the week) for the first 3 weeks of this cycle.
Zdravilo NINLARO se jemlje enkrat na teden (na isti dan v tednu) prve 3 tedne vsakega cikla zdravljenja.
Figure 2: Forest plot of progression-free survival in subgroups
Slika 2: Drevesni diagram (“forest plot”) preživetja brez napredovanja bolezni v podskupinah
Of the 5 patients in the placebo regimen, 2 had a confirmed very good partial response.
Od 5 bolnikov pri režimu zdravljenja s placebom sta 2 bolnika imela potrjen zelo dober delni odziv.
Take each NINLARO capsule whole with water at the same time each week, at least one hour before or no sooner than two hours after any food.
Kapsulo zdravila NINLARO pogoltnite celo skupaj z vodo vsak teden ob istem času, vsaj eno uro pred ali vsaj dve uri po kakršni koli hrani.
In the event of an overdose, monitor the patient for adverse reactions (section 4.8) and provide appropriate supportive care.
V primeru prevelikega odmerjanja je bolnika treba nadzirati glede pojava neželenih učinkov (glejte poglavje 4.8) in zagotoviti ustrezno podporno zdravljenje.
As NINLARO is given in combination with lenalidomide, you should adhere to the pregnancy prevention programme of lenalidomide because lenalidomide can be harmful to the unborn child.
Ker se zdravilo NINLARO uporablja v kombinaciji z lenalidomidom, se morate držati programa za preprečevanje nosečnosti, ki velja za lenalidomid, saj lahko lenalidomid škoduje nerojenemu otroku.
Ixazomib is 99% bound to plasma proteins and distributes into red blood cells with a blood-to-plasma AUC ratio of 10.
Iksazomib se v 99 % veže na proteine v plazmi in porazdeli v rdeče krvne celice pri čemer razmerje AUC kri-plazma znaša 10.
Seventy seven percent of patients relapsed after prior therapies and 11% were refractory to prior therapies.
Pri 77 % bolnikov je prišlo do ponovitve po predhodnih terapijah, 11 % bolnikov pa je bilo neodzivnih na predhodne terapije.
Day 1 Days 2 to 7
1. dan 2. do 7. dan
Table 1: Ixazomib dose reduction steps Recommended starting dose* First reduction to
Tabela 1: Koraki za zmanjšanje odmerka iksazomiba Priporočeni začetni odmerek* Prvo zmanjšanje do Drugo zmanjšanje do
Absolute neutrophil count < 500/mm3
Absolutno število nevtrofilcev < 500/mm3
Peripheral motor neuropathy was not commonly reported in either regimen (< 1%).
Poročila o periferni motorični nevropatiji niso bila pogosta pri nobenem režimu (< 1 %).
* Neutropenia (absolute neutrophil count)
* Nevtropenija (absolutno število nevtrofilcev)
Ixazomib Cmax was decreased by 4% and AUC was increased by 11%.
Vrednost Cmax iksazomiba se je zmanjšala za 4 %, vrednost AUC pa povečala za 11 %.
If you forget to take NINLARO
Če ste pozabili vzeti zdravilo NINLARO
A plasma cell is a blood cell that normally produces proteins to fight infections.
Plazmatke so krvne celice, ki normalno proizvajajo beljakovine, ki se borijo proti okužbam.
PRES is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, altered consciousness, and visual disturbances.
PRES je redko reverzibilno nevrološko obolenje, ki se lahko kaže z epileptičnimi napadi, hipertenzijo, glavobolom, motnjami zavesti in motnjami vida.
Placebo + Lenalidomide and Dexamethasone (N = 362)
Placebo + lenalidomid in deksametazon (N = 362)
PVC-Aluminium /Aluminium blister sealed inside a wallet pack containing one capsule.
PVC-aluminij/aluminij pretisni omot z eno kapsulo, ki je zaprt v pakiranju v obliki listnice.
If the powder accidentally comes into contact with your skin, wash it off thoroughly with soap and water.
Če prašek po nesreči pride v stik s kožo, kožo temeljito umijte z milom in vodo.
Clinical data is limited but doses up to 12 mg have been reported in the randomised controlled trial.
Kliničnih podatkov je sicer malo, vendar pa so v randomiziranem nadzorovanem preskušanju poročali o uporabi odmerkov do 12 mg.
How and when to take NINLARO
Kako in kdaj vzeti zdravilo NINLARO
Women using hormonal contraceptives should additionally use a barrier method of contraception.
Ženske, ki uporabljajo hormonske kontraceptive, morajo dodatno uporabljati še mehansko obliko kontracepcije.
The capsule should be swallowed whole with water.
Kapsulo je treba pogoltniti celo skupaj z vodo.
A randomised, double-blind, placebo-controlled Phase 3 study was conducted in China (N=115) with a similar study design and eligibility criteria.
Na Kitajskem je bila izvedena randomizirana, dvojno slepa, s placebom nadzorovana študija tretje faze (N = 115) s podobno zasnovo in merili primernosti.
It is unknown whether ixazomib or its metabolites are excreted in human milk.
Ni znano, ali se iksazomib ali njegovi presnovki izločajo v materino mleko.
This is because other medicines can affect the way NINLARO works.
Druga zdravila lahko vplivajo na delovanje zdravila NINLARO.
However, ixazomib was negative in an in vivo comet assay in mice, in which percent tail DNA was assessed in the stomach and liver.
Vendar pa je bil iksazomib negativen pri in vivo testu komet pri miših, pri katerem je bil odstotek repne DNA ovrednoten v želodcu in jetrih.
Ixazomib is a low affinity substrate of P-gp.
Iksazomib je nizko afinitetni substrat za P-gp.
Therefore, women using oral hormonal contraceptives should additionally use a barrier method of contraception.
Zato morajo ženske, ki uporabljajo hormonske kontraceptive, dodatno uporabljati še mehansko obliko kontracepcije.
• Swallow the capsule whole with water.
• Kapsulo pogoltnite celo skupaj z vodo.
Twenty three percent of patients had light chain disease and 12% of patients had measurable disease by free light chain assay only.
23 % bolnikov je imelo bolezen lahkih verig, 12 % bolnikov pa je imelo bolezen merljivo le s testom prostih lahkih verig.
Ixazomib is an oral, highly selective and reversible proteasome inhibitor.
Iksazomib je peroralni, zelo selektivni in reverzibilni zaviralec proteasoma.
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: carbamazepine, phenytoin, rifampicin and St. John's wort (Hypericum perforatum).
Bodite še posebej pozorni, da boste zdravnika, farmacevta ali medicinsko sestro obvestili, če jemljete katero koli od naslednjih zdravil: karbamazepin, fenitoin, rifampicin ali šentjanževko (Hypericum perforatum).
Treatment should be continued until disease progression or unacceptable toxicity.
Zdravljenje se mora nadaljevati do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
Strong inducers may reduce the efficacy of ixazomib, therefore the concomitant use of strong CYP3A inducers such as carbamazepine, phenytoin, rifampicin and St. John's Wort (Hypericum perforatum), should be avoided (see sections 4.5 and 5.2).
Močni induktorji lahko zmanjšajo učinkovitost iksazomiba, zato se je sočasni uporabi močnih induktorjev CYP3A, kot so karbamazepin, fenitoin, rifampicin in šentjanževka (Hypericum perforatum), treba izogibati (glejte poglavji 4.5 in 5.2).
Therefore, the weight of evidence indicates that ixazomib is not considered to present a genotoxic risk.
Na osnovi dokazov lahko torej sklepamo, da iksazomib ne predstavlja genotoksičnega tveganja.
The recommended dose is one 4 mg capsule taken by mouth.
Priporočeni odmerek je ena 4 mg kapsula peroralno (skozi usta).
Fifty seven percent of patients were male.
57 % bolnikov je bilo moškega spola.
Ixazomib citrate, a prodrug, is a substance that rapidly hydrolyses under physiological conditions to its biologically active form, ixazomib.
Iksazomibijev citrat je predzdravilo, ki se v fizioloških pogojih hitro hidrolizira do biološke aktivne oblike iksazomiba.
The European Medicines Agency has waived the obligation to submit the results of studies with ixazomib in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z iksazomibom za vse podskupine pediatrične populacije pri zdravljenju diseminiranega plazmocitoma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Other medicines and NINLARO
Druga zdravila in zdravilo NINLARO
Ixazomib was positive in an in vitro clastogenicity test in human peripheral blood lymphocytes.
Iksazomib je bil pozitiven pri in vitro testu klastogenosti na humanih limfocitih iz periferne krvi.
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA citotoksično
If the capsule breaks, clean up the powder, taking care that it does not cause dust in the air.
Če se kapsula zdrobi, prašek previdno očistite brez dviganja prahu v zrak.
After administration of a single oral dose of 14C-ixazomib to 5 patients with advanced cancer, 62% of the administered radioactivity was excreted in urine and 22% in the faeces.
Po uporabi enkratnega peroralnega odmerka 14C iksazomiba pri 5 bolnikih z napredovalim rakom, se je 62 % uporabljene radioaktivnosti izločilo z urinom, 22 % pa z blatom.
Thrombocytopenia can be managed with dose modifications (see section 4.2) and platelet transfusions as per standard medical guidelines.
Trombocitopenijo se lahko obvladuje s spremembami odmerka (glejte poglavje 4.2) in s transfuzijami trombocitov v skladu s standardnimi smernicami.
Treatment for multiple myeloma involves killing myeloma cells and reducing the symptoms of the disease.
Zdravljenje diseminiranega plazmocitoma vključuje uničenje mielomskih celic in zmanjšanje simptomov bolezni.
NSMM-5001: The MAH should conduct a global, prospective, non-interventional, observational study in multiple myeloma patients and provide a report of descriptive data on 1,000 patients including 200 RRMM patients treated with ixazomib.
NSMM-5001: Imetnik dovoljenja za promet mora opraviti globalno, perspektivno, ne-intervencijsko, opazovalno študijo pri bolnikih z diseminiranim plazmocitomom, ter pripraviti poročilo opisnih podatkov na 1000 bolnikov, vključno z 200 bolniki RRMM, ki se zdravijo z iksazomibom.
Treatment continued until disease progression or unacceptable toxicities.
Zdravljenje se je nadaljevalo do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
Many of the patients enrolled in the study had advanced disease with Durie-Salmon Stage III (69%) at initial diagnosis and a treatment history of receiving at least 2 prior therapies (60%) and being thalidomide refractory (63%).
Veliko bolnikov, vključenih v študijo, je imelo pri začetni diagnozi III stadij bolezni glede na stopnjo razširjenosti bolezni po Durie-Salmonu (69 %) in zgodovino zdravljenja, kjer so prejeli vsaj 2 predhodni zdravljenji (60 %) ter so bili neodzivni na talidomid (63 %).
In the 9-month study (10 cycles) in dogs orally administered with a dosing schedule mimicking the clinical regimen (28-day cycle), microscopic neuronal effects were generally minimal in nature and only observed at 0.2 mg/kg (4 mg/m2).
Pri 9-mesečni študiji (10 ciklov) pri psih, ki so zdravilo prejemali peroralno po shemi odmerjanja, ki je posnemala režim klinične uporabe (28-dnevni cikel), so bili mikroskopski učinki na nevrone na splošno minimalni, opazili pa so jih le pri odmerku 0,2 mg/kg (4 mg/m2).