FrancophonIA/ELRC3.0 huggingface dataset:
English: • This medicinal product contains 124 mg sodium per gram, equivalent to 6.2% of the WHO recommended maximum daily intake for sodium.
Slovenian: • To zdravilo vsebuje 124 mg natrija na gram, kar je enako 6,2 % največjega dnevnega vnosa natrija po priporočilu Svetovne zdravstvene organizacije Največji dnevni odmerek tega zdravila je enak 125 % največjega dnevnega vnosa natrija po priporočilu Svetovne zdravstvene organizacije.
English: The daily dose of PHEBURANE will be based on your body weight or body surface and adjusted according to your protein tolerance and diet. You will need regular blood tests to determine the correct daily dose.
Slovenian: Dnevni odmerek zdravila PHEBURANE vam bodo določili na podlagi vaše telesne mase ali telesne površine in bo prilagojen glede na vašo toleranco za beljakovine in glede na vašo prehrano.
English: Uncommon arrhythmia
Slovenian: Občasni aritmija
English: After the first opening, to be used within 45 days.
Slovenian: 3 leta Zdravilo morate porabiti v 45 dneh po prvem odprtju.
English: However PHEBURANE must be used along with a diet reduced in proteins, designed especially for you by the doctor and the dietician.
Slovenian: Zdravilo PHEBURANE pa morate kombinirati s prehrano z nizko vsebnostjo beljakovin, ki jo posebej za vas prilagodita zdravnik in dietetik.
English: The granules are packaged in a plastic bottle with child-resistant closure and a dessicant.
Slovenian: Zrnca so pakirana v plastenke z za otroke varno zaporko in sušilnim sredstvom.
English: Clinical efficacy and safety Based on studies of phenylacetylglutamine excretion in patients with urea cycle disorders it is possible to estimate that, for each gram of sodium phenylbutyrate administered, between 0.12 and 0.15 g of phenylacetylglutamine nitrogen are produced.
Slovenian: Na podlagi študij izločanja fenilacetilglutamina pri bolnikih z motnjami ciklusa sečnine lahko ocenimo, da se na vsak odmerjen gram natrijevega fenilbutirata proizvede med 0,12 in 0,15 g dušika v obliki fenilacetilglutamina.
English: Carton: One bottle with 174 g granules.
Slovenian: Škatla: ena plastenka s 174 g zrnc.
English: Only use the calibrated measuring spoon provided.
Slovenian: Uporabljajte le priloženo umerjeno odmerno žličko.
English: This medicine contains 124 mg (5.4 mmol) of sodium per 1 g of sodium phenylbutyrate.
Slovenian: To zdravilo vsebuje 124 mg (5,4 mmol) natrija na 1 g natrijevega fenilbutirata.
English: Very common amenorrhea, irregular menstruation
Slovenian: Motnje reprodukcije in dojk Zelo pogosti amenoreja, neredna menstruacija
English: PHEBURANE is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Slovenian: Zdravilo PHEBURANE je indicirano kot dodatno zdravljenje pri dolgoročnem obravnavanju motenj ciklusa sečnine, ki vključujejo pomanjkanje karbamoilfosfat-sintaze, ornitin-transkarbamoilaze ali argininosukcinat-sintaze.
English: PHEBURANE contains sodium and sucrose
Slovenian: Zdravilo PHEBURANE vsebuje natrij in saharozo.
English: See section 4.
Slovenian: povidon K25.
English: A calibrated measuring spoon is provided.
Slovenian: Priložena je umerjena odmerna žlička.
English: Repeated dosing with phenylacetate showed evidence of an induction of clearance.
Slovenian: Pri ponavljajočem se odmerjanju fenilacetata so opazili indukcijo očistka.
English: There are no or limited amount of data from the use of sodium phenylbutyrate in pregnant women.
Slovenian: Nosečnost Podatkov o uporabi natrijevega fenilbutirata pri nosečnicah ni ali so omojeni.
English: Because of its slow dissolution, PHEBURANE should not be administered by nasogastric or gastrostomy tubes.
Slovenian: Ker se zdravilo PHEBURANE raztaplja počasi, ga ne smemo dajati prek gastrostome ali nazogastrične cevke.
English: Studies with high intravenous doses of phenylacetate showed non-linear pharmacokinetics characterised by saturable metabolism to phenylacetylglutamine.
Slovenian: Študije z visokimi intravenskimi odmerki fenilacetata so odkrile nelinearno farmakokinetiko, katere značilnost je presnova v fenilacetilglutamin, pri kateri pride do nasičenja.
English: Phenylbutyrate is rapidly absorbed under fasting conditions.
Slovenian: Fenilbutirat se pri tešči osebi hitro absorbira.
English: You should take PHEBURANE by mouth.
Slovenian: Zdravilo PHEBURANE morate jemati peroralno (skozi usta).
English: Phenylbutyrate is known to be oxidised to phenylacetate which is enzymatically conjugated with glutamine to form phenylacetylglutamine in the liver and kidney.
Slovenian: Za fenilbutirat je znano, da se oksidira v fenilacetat, ki se v jetrih in ledvicah encimsko konjugira z glutaminom v fenilacetilglutamin.
English: In normal volunteers gender differences were found in the pharmacokinetic parameters of phenylbutyrate and phenylacetate (AUC and Cmax about 30 - 50 % greater in females), but not phenylacetylglutamine.
Slovenian: Pri zdravih prostovoljcih so bile med spoloma opažene razlike v farmakokinetičnih parametrih fenilbutirata in fenilacetata (vrednosti AUC in Cmaks.
English: Bottle: 174 g granules.
Slovenian: Plastenka: 174 g zrnc.
English: After a single oral dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylbutyrate were detected 15 minutes after dosing.
Slovenian: Po enkratnem peroralnem odmerku 5 g natrijevega fenilbutirata v obliki zrnc se merljive količine fenilbutirata v plazmi pojavijo že po 15 minutah.
English: Citrulline or arginine supplementation is required for patients diagnosed with neonatal-onset form of carbamyl phosphate synthetase or ornithine transcarbamylase deficiency at a dose of 0.17 g/kg/day or 3.8 g/m2/day.
Slovenian: Za bolnike z diagnozo neonatalnega pojava pomanjkanja karbamoilfosfat-sintaze je potrebno dopolnjevanje prehrane s citrulinom v odmerku 0,17 g/kg/dan oziroma pri pomanjkljivosti ornitin transkarbamoilaze dopolnjevanje prehrane z argininom v odmerku 3,8 g/m2/dan.
English: More frequent monitoring of plasma ammonia levels is advised when these medicinal products have to be used.
Slovenian: Če se dajejo ta zdravila, svetujemo pogostejše nadzorovanje plazemskih koncentracij amoniaka.
English: Carcinogenicity and fertility studies have not been conducted with sodium phenylbutyrate.
Slovenian: Študije kancerogenosti in vpliva na sposobnost razmnoževanja z natrijevim fenilbutiratom niso bile izvedene.
English: In case of mixture of the granules with solid foods or liquid it is important that it is taken immediately after mixing.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Če zrnca mešate s čvrsto hrano ali pijačami, je pomembno, da jih zaužijete takoj po mešanju.
English: Do not use PHEBURANE if you are pregnant, because this medicine can harm your unborn baby.
Slovenian: Nosečnost in dojenje Ne jemljite zdravila PHEBURANE med nosečnostjo, saj lahko škoduje vašemu otroku.
English: Content of clinically important electrolytes
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Vsebnost klinično pomembnih elektrolitov
English: Fertility There is no evidence available on the effect of sodium phenylbutyrate on fertility.
Slovenian: O učinkih natrijevega fenilbutirata na plodnost ni na voljo nobenih podatkov.
English: How to take PHEBURANE
Slovenian: Kako jemati zdravilo PHEBURANE
English: The elimination half-life was estimated to be 1.3 and 2.4 hours, respectively.
Slovenian: Razpolovni čas izločanja je bil za fenilacetat 1,3 ure, za fenilacetilglutamin pa 2,4 ure.
English: Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys.
Slovenian: Fenilacetat je presnovno dejavna spojina, ki se z acetilacijo konjugira z glutaminom v fenilacetilglutamin.
English: PHEBURANE 483 mg/g {For carton only}
Slovenian: PHEBURANE 483 mg/g [samo zunanja ovojnina]
English: If you are uncertain if your medicines contain these substances, you should check with your doctor or pharmacist.
Slovenian: Če ste negotovi o uporabi navedenih učinkovin, preverite pri svojem zdravniku ali farmacevtu.
English: Concurrent administration of probenecid may affect renal excretion of the conjugation product of sodium phenylbutyrate.
Slovenian: Sočasno dajanje probenecida lahko vpliva na izločanje konjugiranega produkta natrijevega fenilbutirata preko ledvic.
English: After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine were detected 30 and 60 minutes respectively after dosing.
Slovenian: Po enkratnem odmerku 5 g natrijevega fenilbutirata v obliki zrnc so se merljive količine fenilacetata pojavile po 30 minutah, merljive količine fenilacetilglutamina pa po 60 minutah po odmerjanju.
English: PHEBURANE 483 mg/g granules sodium phenylbutyrate
Slovenian: PHEBURANE 483 mg/g zrnca natrijev fenilbutirat
English: A calibrated dosing spoon is provided which dispenses up to 3g of sodium phenylbutyrate by graduation of 250 mg.
Slovenian: Priložena je odmerna žlička, s katero v korakih po 250 mg odmerimo 3 g natrijevega fenilbutirata.
English: As the body breaks down protein after eating, waste nitrogen, in the form of ammonia, accumulates because the body cannot eliminate it. Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Slovenian: Ker telo razgradi zaužite beljakovine, se odpadni dušik v obliki amoniaka kopiči, saj ga telo ne zmore odstraniti.
English: Each gram of granules contains 483 mg of sodium phenylbutyrate.
Slovenian: En gram zrnc vsebuje 483 mg natrijevega fenilbutirata.
English: PHEBURANE 483 mg/g granules
Slovenian: PHEBURANE 483 mg/g zrnca
English: In case of any doubt, ask your doctor or pharmacist.
Slovenian: Če ste v dvomih, se posvetujte s svojim zdravnikom ali farmacevtom.
English: Increased weight
Slovenian: Povečana telesna masa
English: Name and address of the manufacturer(s) responsible for batch release Lucane Pharma
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
English: • If you get any side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte s zdravnikom ali farmacevtom.
English: The active substance is sodium phenylbutyrate.
Slovenian: Učinkovina je natrijev fenilbutirat.
English: Common rash, abnormal skin odor
Slovenian: Pogosti izpuščaj, nenormalen telesni vonj
English: • PHEBURANE contains 124 mg (5.4 mmol) of sodium per gram of sodium phenylbutyrate, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose.
Slovenian: • Zdravilo PHEBURANE vsebuje 124 mg (5,4 mmol) natrija na gram natrijevega fenilbutirata,
English: • are breast-feeding.
Slovenian: • Navodilo shranite.
English: The mean time to peak concentration was 3.55 and 3.23 hours, respectively, and the mean peak concentration was 45.3 and 62.8 μg/ml, respectively.
Slovenian: Povprečni čas do najvišje koncentracije je bil za fenilacetat 3,55 ure, za fenilacetilglutamin pa 3,23 ure.
English: A calibrating measuring spoon which dispenses up to 3 g of sodium phenylbutyrate is provided with the medicine.
Slovenian: Zdravilu je priložena umerjena odmerna žlička, ki odmeri do 3 g natrijevega fenilbutirata.
English: How to store PHEBURANE
Slovenian: Shranjevanje zdravila PHEBURANE
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželeni učinkov, se posvetujte s zdravnikom ali farmacevtom.
English: Posology
Slovenian: zrnca
English: 75011 Paris
Slovenian: makrogol 1500,
English: Dosage
Slovenian: disgevzija
English: • PHEBURANE is considered high in sodium.
Slovenian: • zdravilo PHEBURANE sodi med zdravila z visoko vsebnostjo natrija.
English: Renal and hepatic impairment
Slovenian: Bolniki z oslabljenim delovanjem jeter in ledvic
English: Patients who have taken very high doses of sodium phenylbutyrate experienced:
Slovenian: Če ste vzeli večji odmerek zdravila PHEBURANE, kot bi smeli Pri bolnikih, ki so vzeli zelo velike odmerke natrijevega fenilbutirata, so se pojavili:
English: FrostPharma AB Puh/Tel: +35 875 32 51 209 info@frostpharma.com
Slovenian: Puh/Tel: +35 875 32 51 209
English: • Breast-feeding.
Slovenian: fenilacetilglutamina.
English: The other ingredients are: sugar spheres (sucrose and maize starch, see section 2 ‘PHEBURANE contains sucrose), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
Slovenian: Druge sestavine zdravila so: sladkorne kroglice (saharoza in koruzni škrob, glejte poglavje 2 „Zdravilo
English: Excretion
Slovenian: gastritis
English: What you need to know before you take PHEBURANE 3.
Slovenian: Kaj je zdravilo PHEBURANE in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo PHEBURANE
English: Common oedema
Slovenian: Pogosti edem
English: • Pregnancy.
Slovenian: • dojenje
English: Package leaflet: Information for the patient PHEBURANE 483 mg/g granules
Slovenian: Navodilo za uporabo PHEBURANE 483 mg/g zrnca natrijev fenilbutirat
English: White to off-white granules.
Slovenian: zrnca Zrnca so bela ali belkasta.
English: Pregnancy and breast-feeding
Slovenian: Presnovne in pehranske motnje
English: Age, gender, race
Slovenian: Starost, spol, rasa
English: Response was assessed every 4 weeks until disease progression.
Slovenian: Odziv so vrednotili na vsake 4 tedne do napredovanja bolezni.
English: Median overall survival was not reached in either regimen.
Slovenian: Mediana celokupnega preživetja ni bila dosežena pri nobenem režimu.
English: The doctor may also adjust the doses of the other medicines.
Slovenian: Zdravnik lahko prilagodi tudi odmerke drugih zdravil.
English: • Risk management plan (RMP)
Slovenian: Načrt za obvladovanje tveganj (RMP)
English: A risk to newborns/infants cannot be excluded and therefore breast-feeding should be discontinued.
Slovenian: Tveganja za dojenega novorojenca/otroka ne moremo izključiti in zato je treba z dojenjem prenehati.
English: Median (months) p-value*
Slovenian: Mediana (meseci) p-vrednost*
English: No animal data are available.
Slovenian: Podatkov pri živalih ni.
English: Take the medicine pack with you.
Slovenian: Ovojnino zdravila vzemite s seboj.
English: The median age was 66 years, range 38-91 years; 58% of patients were older than 65 years.
Slovenian: Mediana starost je bila 66 let, razpon od 38 do 91 let, 58 % bolnikov je bilo starejših od 65 let.
English: Recommended actions
Slovenian: Priporočeni ukrepi
English: Prior to initiating a new cycle of therapy:
Slovenian: Pred začetkom novega cikla zdravljenja:
English: The patient should be evaluated for underlying causes and provide supportive care, as necessary.
Slovenian: Pri bolniku je treba oceniti osnovne vzroke in po potrebi zagotoviti podporno oskrbo.
English: Eighty five percent of the population was White, 9% Asian and 2% Black.
Slovenian: 85 % populacije je bilo belcev, 9 % Azijcev in 2 % črne rase.
English: Progression-Free Survival Events, n (%)
Slovenian: Preživetje brez napredovanja bolezni Dogodki, n (%)
English: Primary refractory, defined as best response of stable disease or disease progression on all prior therapies, was documented in 6% of patients.
Slovenian: Primarna neodzivnost, opredeljena kot najboljši odziv stabilne bolezni ali napredovanje bolezni po vseh predhodnih terapij, je bila dokumentirana pri 6 % bolnikov.
English: If lenalidomide is taken during pregnancy, a teratogenic effect in humans is expected.
Slovenian: V primeru prejemanja lenalidomida med nosečnostjo, se pričakuje teratogeni učinek pri ljudeh.
English: The baseline demographics and disease characteristics were balanced and comparable between the study regimens.
Slovenian: Izhodiščne demografske lastnosti in značilnosti bolezni so bile v študiji uravnotežene in primerljive med obema režimoma zdravljenja.
English: • Do not let the contents of the capsule come into contact with your skin.
Slovenian: • Vsebina kapsule ne sme priti v stik s kožo.
English: It should not be crushed, chewed, or opened (see section 6.6).
Slovenian: Kapsule se ne sme drobiti, žvečiti ali odpirati (glejte poglavje 6.6).
English: Twenty five percent of patients had a creatinine clearance of < 60 mL/min.
Slovenian: 25 % bolnikov je imelo kreatininski očistek < 60 ml/min.
English: The safety and efficacy of ixazomib in children below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost iksazomiba pri otrocih, mlajših od 18 let, nista bili dokazani.
English: Direct contact with the capsule contents should be avoided.
Slovenian: Izogibati se morate neposrednemu stiku z vsebino kapsule.
English: The steady-state volume of distribution is 543 L.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja znaša 543 litrov.
English: Duration of the treatment with NINLARO You should continue treatment until your doctor tells you to stop.
Slovenian: Trajanje zdravljenja z zdravilom NINLARO Z zdravljenjem morate nadaljevati, dokler vam zdravnik ne naroči, da prenehajte.
English: 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.
Slovenian: 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.
English: Discontinue treatment regimen.
Slovenian: Režim zdravljenja ukinite.
English: The patient should be monitored for symptoms of peripheral neuropathy.
Slovenian: Bolnika je treba spremljati glede simptomov periferne nevropatije.
English: Before starting NINLARO and during treatment, you will have blood tests to check that you have enough blood cells.
Slovenian: Pred začetkom zdravljenja z zdravilom NINLARO in med zdravljenjem bo zdravnik s krvnimi preiskavami preverjal, če je število krvnih celic dovolj visoko.
English: Lenalidomide is structurally related to thalidomide.
Slovenian: Lenalidomid je strukturno povezan s talidomidom.
English: Transporter-based interactions
Slovenian: Interakcije na osnovi prenašalcev
English: For these toxicities, the first dose modification step is to withhold/reduce lenalidomide.
Slovenian: Pri teh toksičnih učinkih je prvi korak prilagoditve odmerka zadržanje/zmanjšanje odmerka lenalidomida.
English: † Standardised MedDRA Queries (SMQs)
Slovenian: † Standardizirane MedDRA poizvedbe (SMQ)
English: The mean absolute oral bioavailability is 58%.
Slovenian: Srednja absolutna biološka uporabnost pri peroralni uporabi je 58 %.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. november 2016 Datum zadnjega podaljšanja: 16. septembra 2019
English: The terminal half-life (t1/2) of ixazomib was 9.5 days.
Slovenian: Končni razpolovni čas (t1/2) iksazomiba je 9,5 dni.
English: Effect of ixazomib on other medicinal products
Slovenian: Vpliv iksazomiba na druga zdravila
English: 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.
Slovenian: Izpolnjeni morajo biti pogoji programa za preprečevanje nosečnosti za vse bolnice, razen v primeru zanesljivih dokazov, da bolnica ni zmožna zanositi.
English: Delayed or missed doses
Slovenian: Odloženi ali izpuščeni odmerki
English: • Take NINLARO at least one hour before or at least two hours after food.
Slovenian: • Zdravilo NINLARO vzemite vsaj eno uro pred ali vsaj dve uri po hrani.
English: Patients that changed therapies prior to disease progression were eligible for enrolment, as well as those with controlled cardiovascular conditions.
Slovenian: Bolniki, ki so spremenili zdravljenje pred napredovanjem bolezni, so bili primerni za vključitev, prav tako pa tudi bolniki z nadzorovanimi kardiovaskularnimi boleznimi.
English: *P-value is based on the stratified log-rank test. †Hazard ratio is based on a stratified Cox's proportional hazard regression model.
Slovenian: *p-vrednost na osnovi stratificiranega testa log-rank †Razmerje ogroženosti (RO) na osnovi stratificiranega Coxovega regresijskega modela proporcionalnih hazardov.
English: In the Phase 3 study (C16010), 10 patients (5 in each treatment regimen) had severe renal impairment at baseline.
Slovenian: V študiji 3. faze je (C16010) 10 bolnikov (5 bolnikov pri vsakem režimu zdravljenja) imelo hudo okvaro ledvic ob izhodišču študije.
English: 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
Slovenian: 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:
English: 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).
Slovenian: 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).
English: In case of severe gastrointestinal events, monitoring of serum potassium level is recommended.
Slovenian: V primeru hudih gastrointestinalnih težav, je priporočljivo nadzirati vrednosti kalija v serumu.
English: 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).
Slovenian: 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).
English: There are no data for the use of ixazomib in pregnant women.
Slovenian: Podatkov o uporabi iksazomiba pri nosečnicah ni.
English: 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).
Slovenian: 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).
English: Ixazomib AUC increases in a dose proportional manner over a dose range of 0.2-10.6 mg.
Slovenian: Vrednost AUC iksazomiba se povečuje proporcionalno v razponu odmerkov od 0,2 do 10,6 mg.
English: The Phase 3 study excluded patients who were refractory to lenalidomide or proteasome inhibitors and patients who received more than three prior therapies.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Your doctor will examine you and you will be monitored closely during treatment.
Slovenian: Zdravnik vas bo naročal na redne kontrolne preglede in skrbno nadziral zdravljenje.