natgillin/translations-raw huggingface dataset:
Supportive care for diarrhoea and constipation should include the use of standard antidiarroheal and laxative medicinal products, respectively.
Podporna nega pri diareji in zaprtju mora vključevati uporabo standardnih antidiaroikov oziroma odvajal.
Tell your doctor about the missed dose at your next visit.
Ob naslednjem obisku pri zdravniku mu povejte o pozabljenem odmerku zdravila.
The MAH shall agree the content and format of the educational material with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se mora z nacionalnimi pristojnimi organi dogovoriti glede vsebine in oblike izobraževalnega gradiva.
All-causality Grade 3 or 4 Electrocardiogram QT prolonged was reported in 27 (1.6%) out of 1722 patients (see sections 4.2, 4.4, 4.5 and 5.2).
O podaljšanju intervala QT stopnje 3 ali 4 na elektrokardiogramu zaradi kateregakoli vzroka so poročali pri 27 (1,6 %) od 1.722 bolnikov (glejte poglavja 4.2, 4.4, 4.5 in 5.2).
• If you have been told that you have an abnormality of your heart tracing after an electrocardiogram (ECG) known as prolonged QT interval.
• če so vam povedali, da imate nepravilnost v delovanju srca, imenovano podaljšanje intervala QT, ki so jo zaznali pri spremljanju elektrokardiograma (EKG).
There is no antidote for XALKORI.
Antidota za zdravilo XALKORI ni.
XALKORI 250 mg hard capsules EU/1/12/793/003
XALKORI 250 mg trde kapsule EU/1/12/793/003
In patients with new onset of Grade 4 visual loss, crizotinib treatment should be discontinued and ophthalmological evaluation should be performed.
Pri bolnikih, pri katerih se na novo pojavi izguba vida stopnje 4, je treba prekiniti zdravljenje s krizotinibom in opraviti oftalmološki pregled.
Grade 2, 3 Bradycardiad,e Symptomatic, may be severe and medically significant, medical intervention indicated
d,e simptomatska, lahko huda in medicinsko pomembna; indicirana zdravstvena intervencija
There was a numerical improvement in overall survival (OS) in the patients treated with crizotinib, although this improvement was not statistically significant.
Pri bolnikih, zdravljenih s krizotinibom, je prišlo do številčnega izboljšanja v skupnem preživetju (OS - Overall Survival), vendar to izboljšanje ni bilo statistično pomembno.
In addition, a decrease in heart rate was found to be associated with increasing crizotinib plasma concentration (see section 4.4), with a maximum mean reduction of 17.8 beats per minute (bpm) after 8 hours on Cycle 2 Day 1.
Poleg tega so ugotovili, da je upočasnitev srčnega utripa povezana z naraščajočo koncentracijo krizotiniba v plazmi (glejte poglavje 4.4), pri čemer je bil največji povprečni upad za 17,8 utripov na minuto po 8 urah v 1. dnevu 2. cikla.
Crizotinib should be administered with caution in these patients and periodic monitoring of electrocardiograms (ECG), electrolytes and renal function is required.
Pri teh bolnikih je treba krizotinib uporabljati previdno, potrebno pa je tudi redno spremljanje elektrokardiogramov (EKG), elektrolitov in delovanja ledvic.
Either ALK-positive or ROS1-positive NSCLC status should be established prior to initiation of crizotinib therapy.
Status ALK-pozitivnega ali ROS1-pozitivnega NSCLC je treba določiti pred začetkom zdravljenja s krizotinibom.
Study 1001
Študija 1001
No visual disturbances associated with crizotinib appeared to be related to changes in best corrected visual acuity, the vitreous, the retina, or the optic nerve.
Nobena motnja vida, povezana s krizotinibom, ni bila povezana s spremembami v najboljši korigirani ostrini vida, steklovino, mrežnico ali vidnim živcem.
• Medicines for high blood pressure called beta-blockers such as atenolol, propranolol, labetolol.
• zdravila za zdravljenje visokega krvnega tlaka, imenovana beta blokatorji, kot so atenolol,
The aqueous solubility of crizotinib is pH dependent, with low (acidic) pH resulting in higher solubility.
Topnost krizotiniba v vodnem mediju je odvisna od pH, pri čemer nižji (kisel) pH povzroči večjo topnost.
No starting dose adjustment is required (see sections 5.1 and 5.2).
Starejši bolniki Prilagajanje začetnega odmerka ni potrebno (glejte poglavji 5.1 in 5.2).
Liver function tests including ALT, AST, and total bilirubin should be monitored once a week during the first 2 months of treatment, then once a month and as clinically indicated, with more frequent repeat testing for Grades 2, 3 or 4 elevations.
Delovanje jeter, vključno z ALT, AST in skupnim bilirubinom, je treba preveriti enkrat na teden v prvih 2 mesecih zdravljenja, potem pa enkrat na mesec in kot je klinično indicirano; ponovitve preverjanj pa morajo biti pogostejše pri povečanjih vrednosti stopnje 2, 3 ali 4.
e. Per data cutoff date 30 November 2013.
e. na dan zaključka zajema podatkov 30. novembra 2013
• Bupropion, used to treat depression and smoking cessation.
• bupropion, ki se uporablja za zdravljenje depresije ter pri odvajanju od kajenja,
The majority of patients on the crizotinib arm in randomised Phase 3 Studies 1007 and 1014 (>50%) reported visual disturbances; which occurred at a frequency of 4 to 7 days each week, lasted up to 1 minute, and had mild or no impact (scores 0 to 3 out of a maximum score of 10) on daily activities as captured by the VSAQ-ALK questionnaire.
Večina bolnikov (> 50 %) v skupini s krizotinibom v randomiziranih študijah 3. faze, Študij 1007 in 1014, je poročala o motnjah vida, ki so se pojavljale s pogostnostjo od 4 do 7 dni na teden, trajale do 1 minute in so imele ničen ali blag vpliv (rezultat 0 do 3 od skupno 10 točk) na vsakdanje dejavnosti, kar so ocenili z vprašalnikom VSAQ-ALK.
The primary efficacy endpoint was ORR according to RECIST.
Primarni, na učinkovitost nanašajoči se opazovani dogodek je bil ORR po merilih RECIST.
Your doctor may stop XALKORI treatment and refer you to an ophthalmologist.
Zdravnik lahko prekine zdravljenje z zdravilom XALKORI in vas napoti k oftalmologu.
What you need to know before you take XALKORI
Kaj morate vedeti, preden boste vzeli zdravilo XALKORI
Crizotinib is an inhibitor of OCT1 and OCT2 in vitro.
Krizotinib je zaviralec OCT1 in OCT2 in vitro.
e. For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation.
e) Pri bolnikih, ki se zdravijo z odmerkom 250 mg enkrat na dan, ali tistih, pri katerih so odmerek zmanjšali na 250 mg enkrat na dan, zdravljenje med pregledom prekinite.
The primary metabolic pathways in humans were oxidation of the piperidine ring to crizotinib lactam and O-dealkylation, with subsequent Phase 2 conjugation of O-dealkylated metabolites.
Najpomembnejši presnovni poti pri ljudeh sta bili oksidacija piperidinske verige do krizotinib laktama in O-dealkilacija, s poznejšo fazo 2 konjugacije O-dealkiliranih presnovkov.
This leaflet was last revised in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano MM/LLLL.
No specific studies with crizotinib have been conducted in animals to evaluate the effect on fertility; however, crizotinib is considered to have the potential to impair reproductive function and fertility in humans based on findings in repeat-dose toxicity studies in the rat.
Na živalih niso opravili nobenih posebnih študij s krizotinibom za oceno vpliva na plodnost; vendar pa krizotinib velja za snov, ki bi, glede na ugotovitve študij toksičnosti pri ponavljajočih se odmerkih na podganah, lahko neugodno vplivala na sposobnost razmnoževanja in plodnost pri ljudeh.
• Increased levels of the enzyme alkaline phosphatase in the blood (an indicator of organ malfunction or injury, particularly liver, pancreas, bone, thyroid gland, or gall bladder).
• povišane ravni encima alkalne fosfataze v krvi (ki kažejo na nepravilno delovanje ali poškodbo organov, predvsem jeter, trebušne slinavke, kosti, ščitnice ali žolčnika)
Of the 1084 patients who experienced vision disorder, 95% had events that were mild in severity.
Izmed 1.084 bolnikov, pri katerih se je pojavila motnja vida, je bila pri 95 % resnost teh dogodkov blaga.
Of the 30 patients, an ophthalmic abnormality of any type was reported in 14 (36.8%) patients and no ophthalmic finding was seen in 16 (42.1%) patients.
Od teh 30 bolnikov so o očesni motnji katerekoli vrste poročali pri 14 bolnikih (36,8 %), medtem ko pri 16 bolnikih (42,1 %) niso ugotovili nobenih očesnih motenj.
• Rifabutin, rifampicin, used to treat tuberculosis.
• rifabutin, rifampicin, ki se uporabljata za zdravljenje tuberkuloze,
In vitro studies demonstrated that CYP3A4/5 were the major enzymes involved in the metabolic clearance of crizotinib.
In vitro študije so pokazale, da so bili encimi CYP3A4/5 najpomembnejši encimi, ki so sodelovali pri izločanju krizotiniba iz telesa s presnovo.
Caution should be exercised in administering crizotinib in combination with medicinal products that are predominantly metabolised by these enzymes.
Potrebna je previdnost, kadar se krizotinib uporablja skupaj z zdravili, ki se presnavljajo pretežno preko teh encimov.
ALK and ROS1 testing
Preverjanje prisotnosti ALK in ROS1
Patients with mild (60≤ CLcr <90 mL/min) and moderate (30≤ CLcr <60 mL/min) renal impairment were enrolled in single-arm Studies 1001 and 1005.
Bolniki z blago (60 ≤ očistek kreatinina [CLcr] < 90 mL/min) in zmerno (30 ≤ CLcr < 60 mL/min) okvaro ledvic so bili vključeni v enoskupinski Študiji 1001 in 1005.
Efficacy data from randomised Phase 3 Study 1014 are summarised in Table 4, and the Kaplan-Meier curves for PFS and OS are shown in Figure 1 and 2, respectively.
Podatki o učinkovitosti iz randomizirane študije 3. faze, Študije 1014, so povzeti v preglednici 4, Kaplan-Meierjevi krivulji za PFS in OS pa sta prikazani na slikah 1 in 2.
Partial responses were observed in 20 of 45 patients with non-adenocarcinoma NSCLC for an ORR of 44%, and 9 of 22 patients with SCC NSCLC for an ORR of 41%, both of which were less than the ORR reported in Study 1005 (54%) for all patients.
Delne odzive so opazili pri 20 od 45 bolnikov z NSCLC, ki ni adenokarcinom, kar je predstavljalo 44 % ORR, in 9 od 22 bolnikov z NSCLC SCC, kar je predstavljalo 41 % ORR, to pa je bilo manj od ORR, o katerem so za vse bolnike poročali v Študiji 1005 (54 %).
Of note, the effectiveness of concomitant administration of oral contraceptives may be reduced.
Treba je biti pozoren na to, da se učinkovitost sočasno uporabljanih peroralnih kontraceptivov lahko zmanjša.
Most of the available information is available in patients with some specific histology type of ALK-positive NSCLC (adenocarcinoma) and limited information is available in the other histologies.
Večina razpoložljivih podatkov se nanaša na bolnike s posebnim histološkim tipom ALK-pozitivnega nedrobnoceličnega raka pljuč (adenokarcinoma), za druge histološke tipe pa so na voljo le omejeni podatki.
• Clarithromycin, telithromycin, erythromycin, antibiotics used to treat bacterial infections.
• klaritromicin, telitromicin, eritromicin, antibiotiki, ki se uporabljajo za zdravljenje bakterijskih okužb,
These medicines should be avoided during your treatment with XALKORI.
Uporabi teh zdravil se je med zdravljenjem z zdravilom XALKORI treba izogibati.
d. PFS data from Study 1005 included 807 patients in the safety analysis population who were identified by the FISH assay (data cutoff date 15 February 2012).
c. ocenjeno z uporabo Kaplan-Meierjeve metode d. V analizo varnosti so vključili podatke za PFS iz Študije 1005 pri 807 bolnikih, ki so jih identificirali s preiskavo FISH (na dan zaključka zajema podatkov 15. februarja 2012).
It is available in blister packs of 60 hard capsules and in plastic bottles of 60 hard capsules.
Na voljo je v pretisnih omotih s 60 trdimi kapsulami in plastenkah s 60 trdimi kapsulami.
Crizotinib can be administered with or without food (see section 4.2).
Krizotinib se lahko jemlje skupaj s hrano ali brez nje (glejte poglavje 4.2).
Crizotinib also demonstrated marked antitumour activity in mouse xenograft studies, where tumours were generated using a panel of NIH-3T3 cell lines engineered to express key ROS1 fusions identified in human tumours.
Krizotinib je pokazal tudi izrazito protitumorsko aktivnost v študijah na miših s heterolognimi presadki, v katerih so tumorje ustvarili s pomočjo nabora celičnih linij NIH-3T3, proizvedenih za izražanje ključnih fuzij ROS1, odkritih v človeških tumorjih.
Other potential causes of ILD/pneumonitis should be excluded (see sections 4.2 and 4.4).
Izključiti je treba druge morebitne vzroke ILD/pnevmonitisa (glejte poglavji 4.2 in 4.4).
Warnings and precautions Talk to your doctor before taking XALKORI:
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila XALKORI se posvetujte z zdravnikom:
Efficacy data from Study 1007 are summarised in Table 5, and the Kaplan-Meier curves for PFS and OS are shown in Figure 3 and 4, respectively.
Podatki o učinkovitosti iz Študije 1007 so povzeti v preglednici 5, Kaplan-Meierjevi krivulji za PFS in OS pa sta prikazani na slikah 3 oziroma 4.
Hypersensitivity to crizotinib or to any of the excipients listed in section 6.1.
Preobčutljivost na krizotinib ali katerokoli pomožno snov, navedeno v poglavju 6.1.
• Abnormalities in liver blood tests.
• nenormalni izvidi krvnih preiskav delovanja jeter
The geometric mean volume of distribution (Vss) of crizotinib was 1772 L following intravenous administration of a 50 mg dose, indicating extensive distribution into tissues from the plasma.
Geometrična srednja vrednost volumna porazdelitve (Vss) krizotiniba je po intravenskem dajanju 50 mg odmerka znašala 1.772 l, kar nakazuje obsežno porazdelitev v tkiva iz plazme.
The antitumour efficacy of crizotinib was dose-dependent and correlated to pharmacodynamic inhibition of phosphorylation of ALK fusion proteins (including EML4-ALK and NPM-ALK) in tumours in vivo.
Protitumorska učinkovitost krizotiniba je bila odvisna od odmerka in je bila povezana s farmakodinamskim zavrtjem fosforilacije ALK fuzijskih beljakovin (vključno z EML4-ALK in NPM-ALK) v tumorjih in vivo.
• Antipsychotics, used to treat mental illness.
• antipsihotiki, ki se uporabljajo za zdravljenje duševnih bolezni,
Of note, no patients with SCC histology were randomised in the crizotinib arm in Study 1007 and no patients with SCC were enrolled in Study 1014 due to pemetrexed-based regimen being used as a comparator.
Treba je omeniti, da v Študijo 1007 v skupino s krizotinibom ni bil vključen noben bolnik s histologijo SCC, v študijo 1014 pa noben bolnik s SCC, saj se je za primerjavo uporabljal režim na podlagi pemetrekseda.
Crizotinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay.
Krizotinib ni deloval mutageno in vitro pri preskusu bakterijske reverzne mutacije (Amesov preskus).
Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, the predicted area under the plasma concentration-time curve at steady-state (AUCss) (95% CI) was 23%-37% higher in Asian patients (N=523) than in non-Asian patients (N=691).
Na podlagi populacijske farmakokinetične analize podatkov iz študij 1001, 1005 in 1007 je bila predvidena vrednost površine pod krivuljo plazemske koncentracije v odvisnosti od časa (AUCss) v stanju dinamičnega ravnovesja (95 % IZ) za 23 %-37 % večja pri azijskih bolnikih (n = 523) kot pri bolnikih, ki niso bili azijskega porekla (n = 691).
Therefore, administration of crizotinib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) may increase their therapeutic effect and adverse reactions.
Zato bi jemanje krizotiniba skupaj z zdravili, ki so substrati P-gp (npr. digoksin, dabigatran, kolhicin, pravastatin) lahko okrepilo njihov terapevtski učinek in neželene učinke.
In ALK-positive NSCLC patients, the frequency of adverse reactions was generally similar for patients <65 years of age and patients 65 years of age with the exception of oedema and constipation, which were reported with greater frequency (≥15% difference) in Study 1014 among patients treated with crizotinib 65 years of age.
Pri bolnikih z ALK-pozitivnim NSCLC je bila pogostnost neželenih učinkov na splošno podobna pri bolnikih < 65 let in bolnikih  65 let, z izjemo edema in zaprtosti, o katerih so v Študiji 1014 pogosteje ( 15 % razlika) poročali pri bolnikih  65 let, zdravljenih s krizotinibom.
Leukopenia was associated with a dose reduction for <0.5% of patients, and no patients permanently discontinued crizotinib treatment associated with leukopenia.
Levkopenija je bila povezana z zmanjšanjem odmerka pri < 0,5 % bolnikov, zaradi levkopenije pa zdravljenja s krizotinibom ni trajno prekinil noben bolnik.
• If your next dose is in less than 6 hours, skip the missed capsule.
• Če je do naslednjega odmerka, ki ga morate vzeti, manj kot 6 ur, pozabljeno kapsulo izpustite.
Based on nonclinical safety findings, male and female fertility may be compromised by treatment with XALKORI (see section 5.3).
Na osnovi predkliničnih izsledkov glede varnosti je lahko plodnost tako moških kot tudi žensk zaradi zdravljenja z zdravilom XALKORI zmanjšana (glejte poglavje 5.3).
A total of 259 (16%) of 1666 patients with at least 1 postbaseline vital sign assessment had a pulse rate <50 bpm.
Skupno 259 (16 %) od 1.666 bolnikov z vsaj 1 oceno življenjskih znakov po izhodišču je imelo srčni utrip < 50 utripov na minuto.
(HR=0.30; p-value <0.0001 for crizotinib compared with docetaxel).
(HR = 0,30, vrednost p < 0,0001 za krizotinib v primerjavi z docetakselom).
XALKORI may increase side effects associated with the following medicines:
Zdravilo XALKORI lahko okrepi neželene učinke, povezane z naslednjimi zdravili:
All-causality adverse events associated with permanent treatment discontinuation occurred in 302 (18%) patients of which the most frequent (≥1%) were interstitial lung disease (1%) and elevated transaminases (1%).
Neželeni učinki zaradi vseh vzrokov, povezani s trajno prekinitvijo zdravljenja, so se pojavili pri 302 (18 %) bolnikih, najpogostejša (≥ 1 %) med njimi pa sta bila intersticijska bolezen pljuč (1 %) in povečana vrednost transaminaz (1 %).
CTCAEa Grade
Stopnja CTCAE
• If you are currently treated with any of the medicines listed in section Other medicines and
• če trenutno jemljete katerokoli izmed zdravil, navedenih v poglavju Druga zdravila in zdravilo XALKORI.
Drug-induced ILD/pneumonitis should be considered in the differential diagnosis of patients with ILD-like conditions such as: pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonitis, pulmonary fibrosis, acute respiratory distress syndrome (ARDS), alveolitis, lung infiltration, pneumonia, pulmonary oedema, chronic obstructive pulmonary disease, pleural effusion, aspiration pneumonia, bronchitis, obliterative bronchiolitis, and bronchiectasis.
Na z zdravljenjem povezan ILD/pnevmonitis je treba pomisliti pri diferencialni diagnozi pri bolnikih s stanji, podobnimi ILD, kot so: pnevmonitis, radiacijski pnevmonitis, preobčutljivostni pnevmonitis, intersticijski pnevmonitis, pljučna fibroza, sindrom dihalne stiske pri odraslem (ARDS), alveolitis, pljučna infiltracija, pljučnica, pljučni edem, kronična obstruktivna pljučna bolezen, plevralni izliv, aspiracijska pljučnica, bronhitis, obliterativni bronhiolitis in bronhiektazija.
Following oral single dose administration in the fasted state, crizotinib is absorbed with median time to achieve peak concentrations of 4 to 6 hours.
Po peroralnem zaužitju enkratnega odmerka na tešče se krizotinib absorbira z medianim časom do dosega največjih koncentracij 4 do 6 ur.
XALKORI is an anticancer medicine containing the active substance crizotinib used to treat adults with a type of lung cancer called non-small cell lung cancer, that presents with a specific rearrangement or defect in either a gene called anaplastic lymphoma kinase (ALK) or a gene called ROS1.
XALKORI je zdravilo za zdravljenje rakavih bolezni, ki vsebuje učinkovino krizotinib, uporablja pa se za zdravljenje odraslih z vrsto pljučnega raka, imenovanega nedrobnocelični pljučni rak, pri katerem prihaja do specifične preureditve ali okvare na genu, imenovanem anaplastična limfom kinaza (ALK), ali na genu, imenovanem ROS1.
Withhold until recovery to Grade ≤2, then resume at the same dose schedule
Prekinite zdravljenje, dokler ne pride do izboljšanja na stopnjo ≤ 2, nato z zdravljenjem nadaljujte ob enakem načinu odmerjanja.
Intracranial Disease Control Rate (IC-DCR) at 12 weeks was 65% and 46% for crizotinib and chemotherapy-treated patients, respectively.
Intracranial Disease Control Rate) po 12 tednih je bil 65 % v skupini s krizotinibom in 46 % v skupini s kemoterapijo.
• Methadone, used to treat pain and for the treatment of opioid dependence.
• metadon, ki se uporablja za blaženje bolečin in za zdravljenje odvisnosti od opioidov,
In vitro studies in human hepatocytes indicated that crizotinib may induce pregnane X receptor (PXR)and constitutive androstane receptor (CAR)-regulated enzymes (e.g., CYP3A4, CYP2B6, CYP2C8, CYP2C9, UGT1A1).
In vitro študije na humanih hepatocitih so pokazale, da krizotinib lahko inducira encime, ki jih uravnavata pregnan X receptor (PXR) in konstitutivni androstanski receptor (CAR) (npr. CYP3A4, CYP2B6, CYP2C8, CYP2C9, UGT1A1).
The onset of vision disorders generally started within the first week of drug administration.
Motnje vida so se običajno pojavile v prvem tednu dajanja zdravila.
In vitro studies suggest that crizotinib is a substrate for P-glycoprotein (P-gp).
In vitro študije kažejo, da je krizotinib substrat za P-glikoprotein (P-gp).
• The recommended dose is one capsule of 250 mg taken orally twice daily (total amount
• Priporočeni odmerek je ena 250 mg kapsula, ki jo vzamete peroralno dvakrat na dan (skupna količina 500 mg).
Following single doses of crizotinib, the apparent plasma terminal half-life of crizotinib was 42 hours in patients.
Po enkratnih odmerkih krizotiniba je navidezni končni razpolovni čas izločanja krizotiniba iz plazme pri bolnikih znašal 42 ur.
• Phenytoin, carbamazepine or phenobarbital, anti-epileptics used to treat seizures or fits.
• fenitoin, karbamazepin ali fenobarbital, antiepileptiki, ki se uporabljajo za zdravljenje epileptičnih napadov ali krčev,
A monitoring of the QT interval should be made in case of combinations of such medicinal products (see sections 4.2 and 4.4).
V primeru sočasne uporabe takih zdravil je potreben nadzor intervala QT (glejte poglavji 4.2 in 4.4).
• Increased blood levels of creatinine (may indicate that kidneys are not functioning properly).
• povišane ravni kreatinina v krvi (lahko kažejo na nepravilno delovanje ledvic)
Other potential causes of ILD/pneumonitis should be excluded, and crizotinib should be permanently discontinued in patients diagnosed with treatment-related ILD/pneumonitis (see sections 4.2 and 4.8).
Izključiti je treba druge morebitne vzroke ILD/pnevmonitisa, pri bolnikih, pri katerih je diagnosticiran z zdravljenjem povezan ILD/pnevmonitis, pa trajno prekiniti zdravljenje s krizotinibom (glejte poglavji 4.2 in 4.8).
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine), used to treat migraine.
• ergot alkaloidi (npr. ergotamin, dihidroergotamin), ki se uporabljajo za zdravljenje migrene,
2013; OS is based on the last patient last visit date of 30 November 2016, and is based on a median follow up of approximately 46 months.
* PFS, delež objektivnega odziva in trajanje odziva so določili na dan zaključka zajema podatkov 30. novembra 2013; OS so določili na datum zadnjega obiska zadnjega bolnika 30. novembra 2016 in temelji na medianem času spremljanja približno 46 mesecev.
Grade 4 Bradycardiad,e,f Life-threatening consequences, urgent intervention indicated
d,e,f smrtno nevarne posledice; indicirana nujna intervencija
QTc prolongation has been observed in clinical studies in patients treated with crizotinib (see sections 4.8 and 5.2) which may lead to an increased risk for ventricular tachyarrhythmias (e.g., Torsade de Pointes) or sudden death.
V kliničnih študijah so pri bolnikih, zdravljenih s krizotinibom (glejte poglavji 4.8 in 5.2), opazili podaljšanje intervala QTc, kar lahko povzroči povečano tveganje za ventrikularne tahiaritmije (npr. Torsade de Pointes) ali nenadno smrt.
• Pimozide, used to treat mental illness.
• pimozid, ki se uporablja za zdravljenje duševnih bolezni,