FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no adequate and well-controlled studies in pregnant women.
Slovenian: Ustreznih in dobro kontroliranih študij pri nosečnicah niso izvedli.
English: Anticipated interactions
Slovenian: Pričakovane interakcije
English: ) with clinically meaningful treatment effect.
Slovenian: ) s klinično pomembnim učinkom zdravljenja.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Slovenian: Zdravnik vas bo redno pregledoval in preverjal, ali zdravljenje dosega želeni učinek.
English: Your doctor, pharmacist or nurse will tell you exactly how many tablets to take and which days to take them on.
Slovenian: Zdravnik, farmacevt ali medicinska sestra vam bodo natančno razložili, koliko tablet morate vzeti in na kateri dan.
English: This will help you to remember to take your medicine.
Slovenian: To vam lahko pomaga, da ne pozabite vzeti zdravila.
English: Ask your doctor about options for effective contraception.
Slovenian: Zdravnika vprašajte, katere možnosti učinkovite kontracepcije so vam na izbiro.
English: They may differ from the general information in this leaflet.
Slovenian: Zdravnikova navodila se lahko razlikujejo od splošnih informacij, ki so v tem navodilu.
English: It is very important to follow your doctor's instructions.
Slovenian: Zelo pomembno je, da upoštevate zdravnikova navodila.
English: • If you have any problems with your liver or have previously had any type of liver disease.
Slovenian: • če imate kakršne koli težave z jetri ali ste kdaj imeli katero koli vrsto jetrne bolezni,
English: This includes in particular:
Slovenian: Med njimi so zlasti:
English: Overall response rate (ORR)
Slovenian: delež celokupnega odziva (ORR)
English: Substances that are substrates of transporters
Slovenian: Snovi, ki so substrati prenašalcev
English: If you think you may be allergic, ask your doctor for advice.
Slovenian: Če menite, da ste morda alergični, se posvetujte z zdravnikom.
English: Blocking these proteins can slow down the growth of cancer cells and delay the progression of your cancer.
Slovenian: Zaviranje teh beljakovin lahko upočasni rast rakavih celic in odloži napredovanje raka.
English: There were no reported cases of torsade de pointes.
Slovenian: O pojavljanju torsade de pointes niso poročali.
English: Grade 3* febrile neutropenia**
Slovenian: Stopnja 3* febrilna nevtropenija**
English: Data on differences in pharmacokinetics due to race are too limited to draw conclusions.
Slovenian: Podatkov o razlikah v farmakokinetiki zaradi rasne pripadnosti je tako malo, da ni mogoče potegniti zaključkov.
English: The treatment should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
Slovenian: Zdravljenje je treba nadaljevati, dokler ima bolnik od zdravljenja klinično korist oziroma do pojava nesprejemljivih toksičnih učinkov.
English: • Reduced level of phosphate in the blood
Slovenian: • znižana raven fosfatov v krvi,
English: The dose should be interrupted.
Slovenian: Odmerjanje zdravila je treba prekiniti.
English: Kisqali should be taken orally once daily with or without food.
Slovenian: Zdravilo Kisqali je treba jemati peroralno enkrat na dan skupaj s hrano ali brez nje.
English: Besides the atrophic changes seen in the testes, which showed a trend towards reversibility, all other changes were fully reversible after a 4-week treatment-free period.
Slovenian: Poleg atrofičnih sprememb v testisih, ki so kazale trend reverzibilnosti, so tudi vse druge spremembe v celoti izzvenele v obdobju po 4 tednih brez zdravljenja.
English: Hepatobiliary toxicity
Slovenian: Hepatobiliarna toksičnost
English: Kisqali may increase or decrease your blood levels of some other medicines.
Slovenian: Zdravilo Kisqali lahko zviša ali zniža vrednosti nekaterih drugih zdravil v krvi.
English: 27.5 (19.1, NE)
Slovenian: 27,5 (19,1; NO)
English: Patients should be encouraged to take their dose at approximately the same time each day, preferably in the morning.
Slovenian: Bolnikom je treba naročiti, naj vzamejo odmerek zdravila vsak dan ob približno istem času, najbolje zjutraj.
English: Enter weekdays starting with the 1st day of treatment.
Slovenian: Vpišite dneve v tednu in začnite s 1. dnem zdravljenja.
English: All patients had an ECOG performance status of 0 or 1.
Slovenian: Vse bolnice so imele oceno stanja zmogljivosti po lestvici ECOG 0 ali 1.
English: Patients should be instructed to avoid grapefruit or grapefruit juice.
Slovenian: Bolnikom je treba naročiti, naj se izogibajo uživanju grenivk in njihovega soka.
English: Ribociclib 334 294 277 257 240 227 207 196 188 176 164 132 97 46 Placebo 334 279 265 239 219 196 179 156 138 124 110 93
Slovenian: število še ogroženih bolnikov čas ribociklib 334 294 277 257 240 227 207 196 188 176 164 132 97 46 placebo 334 279 265 239 219 196 179 156 138 124 110 93
English: levofloxacin and azithromycin.
Slovenian: levofloksacin in azitromicin,
English: Demographics and baseline disease characteristics were balanced and comparable between study arms.
Slovenian: Demografske in izhodiščne karakteristike bolezni so bile med obema študijskima skupinama uravnovešene in primerljive.
English: Appropriate monitoring of serum electrolytes (including potassium, calcium, phosphorus and magnesium) should be performed before initiating treatment, at the beginning of the first 6 cycles and then as clinically indicated.
Slovenian: Ustrezno spremljanje koncentracij elektrolitov v serumu (vključno s koncentracijami kalija, kalcija, fosforja in magnezija) je treba izvajati pred začetkom zdravljenja, nato na začetku prvih 6 ciklusov in kasneje kot je klinično indicirano.
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) or PA/alu/PVC (polyamide/aluminium/polyvinylchloride) blisters containing 14 or 21 film-coated tablets.
Slovenian: Pretisni omoti iz PVC/PCTFE (polivinilklorida/poliklorotrifluoroetilena) ali iz PA/alu/PVC (poliamida/aluminija/polivinilklorida) vsebujejo 14 ali 21 filmsko obloženih tablet.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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); and not known (cannot be estimated from the available data).
Slovenian: Pri tem ustrezna kategorija pogostnosti posameznega neželenega učinka temelji na naslednjem dogovoru (CIOMS III): 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 (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: In vitro interaction data
Slovenian: In vitro podatki o interakcijah
English: 200 mg*/day * If further dose reduction below 200 mg/day is required, the treatment should be permanently discontinued.
Slovenian: 200 mg*/dan * Če bi bilo treba odmerek zmanjšati na manj kot 200 mg na dan, je treba zdravljenje ukiniti.
English: Kisqali should not be used during pregnancy since it may harm your unborn baby.
Slovenian: Zdravila Kisqali se v nosečnosti ne sme uporabljati, ker lahko škoduje nerojenemu otroku.
English: Kisqali may have minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Kisqali ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: The cyclin D-CDK4/6 complex regulates cell cycle progression through phosphorylation of the retinoblastoma protein (pRb).
Slovenian: Kompleks ciklin D-CDK4/6 uravnava potek celičnega ciklusa s fosforilacijo retinoblastomskega proteina (pRb).
English: Soya lecithin
Slovenian: Sojin lecitin
English: The European Medicines Agency has waived the obligation to submit the results of studies with Kisqali in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Kisqali za vse podskupine pediatrične populacije z rakom dojke (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Your doctor will discuss with you the potential risks of taking Kisqali during pregnancy.
Slovenian: Zdravnik vam bo pojasnil možna tveganja, ki jih predstavlja jemanje zdravila Kisqali v času nosečnosti.
English: Therefore, Kisqali is unlikely to affect substrates of these enzymes.
Slovenian: Zdravilo Kisqali torej verjetno ne vpliva na substrate navedenih encimov.
English: No overall differences in safety or effectiveness of Kisqali were observed between these patients and younger patients (see section 4.2).
Slovenian: V celoti niso opažali razlik v varnosti in učinkovitosti zdravila Kisqali med temi bolniki in mlajšimi bolniki (glejte poglavje 4.2).
English: Take the next dose at your usual time.
Slovenian: Naslednji odmerek vzemite ob običajnem času.
English: Clinical benefit rate (CBR)
Slovenian: a delež klinične koristi (CBR)
English: Children and adolescents Kisqali is not to be used in children and adolescents under 18 years of age.
Slovenian: Otroci in mladostniki Zdravilo Kisqali ni namenjeno uporabi pri otrocih in mladostnikih, ki so stari manj kot 18 let.
English: pravastatin or rosuvastatin.
Slovenian: pravastatin ali rosuvastatin,
English: Caution should be used in patients with severe renal impairment with close monitoring for signs of toxicity.
Slovenian: Previdnost je potrebna pri bolnikih s hudo okvaro ledvic, pri katerih je potrebno skrbno spremljanje glede znakov toksičnega delovanja.
English: c p-values are obtained from one-sided Cochran-Mantel-Haenszel chi-square test
Slovenian: c vrednosti p na osnovi enostranskega Cochran-Mantel-Haenszelovega hi-kvadrat testa
English: Table 6 Adverse drug reactions observed in the three phase III clinical studies
Slovenian: Preglednica 6 Neželeni učinki, ki so jih opažali v treh kliničnih študijah faze III
English: 0.593 (0.480 to 0.732)
Slovenian: 0,593 (0,480 do 0,732)
English: In case of QTcF prolongation during treatment, more frequent ECG monitoring is recommended.
Slovenian: V primeru, da v času zdravljenja pride do podaljšanja intervala QTcF, je priporočeno pogostejše snemanje EKG.
English: The safety and efficacy of Kisqali in children and adolescents aged below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Kisqali pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
English: • with uncontrolled or significant cardiac disease, including recent myocardial infarction,
Slovenian: • z neurejenim ali pomembnim srčnim obolenjem, kar vključuje nedaven miokardni infarkt,
English: Treatment with Kisqali should be initiated by a physician experienced in the use of anticancer therapies.
Slovenian: Zdravljenje z zdravilom Kisqali mora uvesti zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
English: ), with an estimated 41% reduction in relative risk of progression or death in favour of the Kisqali plus fulvestrant arm.
Slovenian: ), pri čemer je bilo ocenjeno 41-odstotno zmanjšanje relativnega tveganja za napredovanje bolezni ali smrt v korist skupine z zdravilom Kisqali in fulvestrantom.
English: The efficacy and safety of ribociclib have not been studied in patients with critical visceral disease.
Slovenian: Učinkovitosti in varnosti ribocikliba pri bolnikih s kritično visceralno boleznijo niso proučevali.
English: Numerous other metabolites were detected in both faeces and urine in minor amounts (≤2.78% of the administered dose).
Slovenian: V blatu in urinu so v majhnih količinah (≤ 2,78 % danega odmerka) našli tudi več drugih metabolitov.
English: Kisqali works by blocking proteins called cyclin-dependent kinases 4 and 6, which are important for the growth and division of cells.
Slovenian: Zdravilo Kisqali deluje tako, da zavira beljakovini, ki ju imenujemo od ciklina odvisni kinazi 4 in 6 in sta pomembni za razmnoževanje in delitev celic.
English: Patients enrolled in this study had a median age of 44 years (range 25 to 58) and 27.7% of patients were younger than 40 years old.
Slovenian: Mediana starost bolnic, ki so bile vključene v to študijo, je bila 44 let (od 25 do 58 let), 27,7 % bolnic je bilo starih manj kot 40 let.
English: Event-free probability (%)
Slovenian: verjetnost za odsotnost dogodka (%)
English: • Reduced level of calcium in the blood, which may sometimes lead to cramps
Slovenian: • znižana raven kalcija v krvi, ki v nekaterih primerih povzroča krče,
English: The absolute bioavailability of ribociclib is not known.
Slovenian: Absolutna biološka uporabnost ribocikliba ni znana.
English: These kinases are activated upon binding to D-cyclins and play a crucial role in signalling pathways which lead to cell cycle progression and cellular proliferation.
Slovenian: Navedeni kinazi se aktivirata z vezavo na ciklin D in imata pomembno vlogo v signalnih poteh, ki omogočajo potek celičnega ciklusa in proliferacijo celic.
English: Initiate appropriate medical therapy and monitor as clinically indicated.
Slovenian: Uvesti je treba ustrezno zdravljenje in spremljati stanje kot je klinično indicirano.
English: Updated results for overall response and clinical benefit rates are displayed in Table 8.
Slovenian: Dopolnjeni rezultati glede celokupnega odziva in deleža klinične koristi so prikazani v preglednici 8.
English: In the preclinical models tested so far, intact pRb was required for ribociclib activity.
Slovenian: Pri predkliničnih modelih, ki so jih do zdaj preskusili, je bil za aktivnost ribocikliba potreben intakten pRb.
English: In the phase III clinical studies, 83.2% (89/107) of grade 3 or 4 ALT or AST elevation events occurred within the first 6 months of treatment.
Slovenian: V kliničnih študijah faze III je do 83,2 % (89/107) epizod zvišanja vrednosti ALT ali AST stopnje 3 ali 4 prišlo v prvih 6 mesecih zdravljenja.
English: These effects can be linked to a direct anti-proliferative effects on the testicular germ cells resulting in atrophy of the seminiferous tubules.
Slovenian: Te učinke je mogoče povezati z neposrednim zaviranjem proliferacije zarodnih celic v testisih, ki povzroči atrofijo semenskih cevk.
English: In 6 healthy male subjects, following a single oral dose of [
Slovenian: Pri 6 zdravih moških preiskovancih, ki so prejeli enkraten peroralni odmerek s [
English: The exposure to ribociclib was higher in milk than in plasma.
Slovenian: Koncentracija ribocikliba je v mleku višja kot v plazmi.
English: Take your dose once a day for 3 weeks followed by a 1-week break.
Slovenian: Odmerke jemljite enkrat na dan 3 tedne, nato pa 1 teden ne jemljite zdravila.
English: Before you take Kisqali, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines or supplements obtained without a prescription, because these may influence the effect of Kisqali.
Slovenian: Preden začnete jemati zdravilo Kisqali, obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, kar vključuje zdravila in prehranska dopolnila, ki jih lahko dobite brez zdravniškega recepta, saj lahko vplivajo na delovanje zdravila Kisqali.
English: • Everolimus, used for several types of cancer and tuberous sclerosis (also used to prevent the rejection of an organ transplant).
Slovenian: • everolimus, ki ga uporabljamo pri več vrstah raka in pri tuberozni sklerozi (uporabljamo ga tudi za preprečevanje zavrnitve presadka).
English: A more mature update of overall survival data (30 November 2018 cut-off) is provided in Table 11 and Figures 4 and 5.
Slovenian: Z bolj zrelimi podatki (zbranimi do presečnega datuma 30. novembra 2018) dopolnjen prikaz celokupnega preživetja je podan v preglednici 11 in na slikah 4 in 5.
English: You should therefore be cautious when driving or using machines during your treatment with Kisqali.
Slovenian: Iz tega razloga morate biti previdni, kadar v času zdravljenja z zdravilom Kisqali vozite ali upravljate stroje.
English: Genotoxicity studies in bacterial in vitro systems and in mammalian in vitro and in vivo systems with and without metabolic activation did not reveal any evidence for a genotoxic potential of ribociclib.
Slovenian: V študijah genotoksičnosti v bakterijskih in vitro sistemih in v sesalskih in vitro in in vivo sistemih z metabolično aktivacijo ali brez nje niso našli dokazov za genotoksični potencial ribocikliba.
English: Kisqali is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Kisqali ni priporočeno uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: Instead, wait until it is time for your next dose and then take your usual dose.
Slovenian: Počakajte na čas, ko morate vzeti naslednji odmerek po razporedu, in takrat vzemite samo običajni odmerek.
English: Do not stop taking Kisqali unless your doctor tells you to.
Slovenian: Zdravila Kisqali ne prenehajte jemati, razen če vam to naroči vaš zdravnik.
English: C] ribociclib, 91.7% of the total administered radioactive dose was recovered within 22 days; faeces was the major route of excretion (69.1%), with 22.6% of the dose recovered in urine.
Slovenian: C] označenega ribocikliba, se je 91,7 % celotnega danega radioaktivnega odmerka izločilo v 22 dneh, pri čemer je bila glavna pot izločanja z blatom (69,1 % odmerka ), z urinom pa se je izločilo 22,6 % danega odmerka.
English: Binding of ribociclib to human plasma proteins in vitro was approximately 70% and was independent of concentration (10 to 10000 ng/ml).
Slovenian: In vitro se pri človeku ribociklib veže na beljakovine v plazmi v približno 70 % in sicer neodvisno od koncentracije (v okviru od 10 do 10.000 ng/ml).
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Slovenian: VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ PODATKOV V MODREM OKENCU)
English: If you are a woman of childbearing potential you should have a negative pregnancy test before starting treatment with Kisqali.
Slovenian: Če ste ženska v rodni dobi, morate imeti negativen izvid nosečnostnega testa, preden se začnete zdraviti z zdravilom Kisqali.
English: Do not change the Kisqali dose or schedule without talking to your doctor.
Slovenian: Odmerka zdravila Kisqali ali razporeda odmerjanja ne spreminjajte sami, ne da bi se posvetovali s svojim zdravnikom.
English: Based on its severity, neutropenia was managed by laboratory monitoring, dose interruption and/or dose modification.
Slovenian: Nevtropenijo so glede na izraženost obvladovali z laboratorijskim spremljanjem in prekinitvami in/ali prilagajanjem odmerka.
English: 44.2% patients were older than 65 years, including 69 patients older than 75 years.
Slovenian: 44,2 % bolnic je bilo starejših od 65 let, kar vključuje 69 bolnic, ki so bile starejše od 75 let.
English: Febrile neutropenia was reported in about 1.4% of patients exposed to Kisqali in the phase III studies.
Slovenian: O febrilni nevtropeniji so poročali pri približno 1,4 % bolnikov, ki so bili v študijah faze III izpostavljeni zdravilu Kisqali.
English: Kisqali tablets should be swallowed whole (tablets should not be chewed, crushed or split before swallowing).
Slovenian: Tablete zdravila Kisqali je treba pogoltniti cele (pred zaužitjem se jih ne sme gristi, drobiti ali lomiti).
English: Kisqali should be used together with 2.5 mg letrozole or another aromatase inhibitor or with 500 mg fulvestrant.
Slovenian: Zdravilo Kisqali je treba uporabljati skupaj z 2,5 mg letrozola ali drugim zaviralcem aromataze ali s 500 mg fulvestranta.
English: Drug-drug interaction studies between ribociclib and oral contraceptives have not been conducted (see section 4.6)
Slovenian: Študij medsebojnega delovanja med ribociklibom in peroralnimi kontraceptivi niso izvajali (glejte poglavje 4.6).
English: • Some medicines used as antipsychotics such as haloperidol.
Slovenian: • nekatera zdravila, ki jih uporabljamo kot antipsihotike, kot je haloperidol,
English: If dose reduction is required, the recommended dose reduction guidelines are listed in Table 1.
Slovenian: Za primere, ko je potrebno odmerek zmanjšati, so v preglednici 1 navedene priporočene smernice za zmanjševanje odmerka.
English: Some side effects could be serious Tell your doctor immediately if you get any of the following symptoms during treatment with Kisqali:
Slovenian: Nekateri neželeni učinki so lahko resni Takoj obvestite zdravnika, če v času zdravljenja z zdravilom Kisqali opazite katerega od naslednjih simptomov:
English: The median duration of exposure to Kisqali treatment across the pooled phase III studies dataset was 16.5 months, with 61.7% patients exposed ≥12 months.
Slovenian: Mediano trajanje izpostavljenosti zdravljenju z zdravilom Kisqali v naboru združenih podatkov študij faze III je bilo 16,5 meseca, pri čemer je bilo 61,7 % bolnikov izpostavljenih zdravljenju najmanj 12 mesecev.
English: • Antibiotics such as clarithromycin, telithromycin, moxifloxacin, rifampicin, ciprofloxacin,
Slovenian: • antibiotiki, kot so klaritromicin, telitromicin, moksifloksacin, rifampicin, ciprofloksacin,
English: Mark off circle for every tablet you take.
Slovenian: Krožec označite vsakokrat, ko vzamete tableto.
English: Do not take Kisqali: - if you are allergic to ribociclib, peanut, soya or any of the other ingredients of this medicine
Slovenian: Ne jemljite zdravila Kisqali: - če ste alergični na ribociklib, arašide, sojo ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • Swollen hands, ankles or feet (peripheral oedema)
Slovenian: • otekanje rok, gležnjev ali stopal (periferni edemi),
English: Patients who are hypersensitive to peanut or soya should not take Kisqali (see section 4.3).
Slovenian: Bolniki s preobčutljivostjo na arašide ali sojo ne smejo jemati zdravila Kisqali (glejte poglavje 4.3).
English: Kisqali with food and drink
Slovenian: Zdravilo Kisqali s hrano in pijačo
English: • Painful and frequent urination (signs of a urinary tract infection)
Slovenian: • boleče in pogosto uriniranje (znaki okužbe sečil),
English: Data in subjects with ESRD are limited (n=3) but indicate a similar or somewhat larger increase in ribociclib exposure compared to subjects with severe renal impairment.
Slovenian: Podatkov pri osebah s končno ledvično odpovedjo je malo (n = 3) vendar kažejo podobno oziroma nekoliko večje povečanje izpostavljenosti ribociklibu v primerjavi z osebami s hudo okvaro ledvic.
English: 21 film-coated tablets 42 film-coated tablets 63 film-coated tablets
Slovenian: filmsko obložena tableta 21 filmsko obloženih tablet 42 filmsko obloženih tablet 63 filmsko obloženih tablet
English: If you have any questions about how Kisqali works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.
Slovenian: Če imate kakršnokoli vprašanje o tem, kako zdravilo Kisqali deluje ali zakaj so vam predpisali to zdravilo, se obrnite na zdravnika, farmacevta ali medicinsko sestro.
English: • Shortness of breath, difficulty breathing
Slovenian: • zadihanost, oteženo dihanje,
English: After initiating treatment, liver function should be monitored (see sections 4.2 and 4.8).
Slovenian: Po začetku zdravljenja je treba spremljati delovanje jeter (glejte poglavji 4.2 in 4.8).
English: Baseline grade = 2: No dose interruption.
Slovenian: Izhodiščna vrednost = stopnji 2: Odmerjanja ni treba prekinjati.
English: • with electrolyte abnormalities.
Slovenian: • z elektrolitskimi nepravilnostmi.
English: • If you have or have had heart disorders or heart rhythm disorders, such as an irregular heartbeat, including a condition called prolonged QT syndrome (QT interval prolongation) or low levels of potassium, magnesium, calcium or phosphorus in your blood.
Slovenian: • če imate ali ste kdaj imeli katero od bolezni srca ali motnjo srčnega ritma, kot je neredno bitje srca, kar vključuje motnjo, ki jo imenujemo sindrom podaljšanega intervala QT ali če imate znižane vrednosti kalija, magnezija, kalcija ali fosforja v krvi.
English: Hazard ratio is based on unstratified Cox model.
Slovenian: Razmerje ogroženosti na osnovi nestratificiranega Coxovega modela.
English: • Strange taste in the mouth (dysgeusia)
Slovenian: • čuden okus v ustih (motnje okušanja, disgevzija),