FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that DuoPlavin is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single DuoPlavin tablet simplifies treatment for patients as they will need to take fewer tablets.
Slovenian: CHMP je menil, da je zdravilo DuoPlavin primerljivo s tabletami s klopidogrelom in acetilsalicilno kislino, ki se jemljejo ločeno, in zaključil, da kombinacija obeh zdravilnih učinkovin v eni tableti zdravila DuoPlavin poenostavi zdravljenje bolnikov, saj bodo lahko zaužili manj tablet.
English: DuoPlavin must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in DuoPlavin.
Slovenian: Zdravila DuoPlavin ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) klopidogrel, nesteroidna protivnetna zdravila (kot je acetilsalicilna kislina) ali katero koli drugo sestavino zdravila DuoPlavin.
English: DuoPlavin is used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Slovenian: Zdravilo DuoPlavin se uporablja za preprečevanje težav, ki jih povzročajo krvni strdki in zatrditev arterij, kot je srčni napad, pri odraslih, ki že jemljejo klopidogrel in acetilsalicilno kislino.
English: DuoPlavin is taken as one tablet once a day in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
Slovenian: Zdravilo DuoPlavin se jemlje kot ena tableta enkrat na dan namesto tablete s klopidogrelom in tablete z acetilsalicilno kislino, ki ju je bolnik pred tem jemal ločeno.
English: Why has DuoPlavin been approved?
Slovenian: Zakaj je bilo zdravilo DuoPlavin odobreno?
English: DuoPlavin was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.
Slovenian: Zdravilo DuoPlavin se je izkazalo za primerljivo s klopidogrelom in acetilsalicilno kislino, vzetima ločeno, zato se lahko uporablja namesto tablet s klopidogrelom in acetilsalicilno kislino, ki so jih bolniki jemali doslej.
English: Both active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Slovenian: Obe zdravilni učinkovini zdravila DuoPlavin, klopidogrel in acetilsalicilna kislina, sta „zaviralca agregacije trombocitov“.
English: How has DuoPlavin been studied?
Slovenian: Kako je bilo zdravilo DuoPlavin raziskano?
English: What is DuoPlavin used for?
Slovenian: Za kaj se zdravilo DuoPlavin uporablja?
English: How does DuoPlavin work?
Slovenian: Kako zdravilo DuoPlavin deluje?
English: How is DuoPlavin used?
Slovenian: Kako se zdravilo DuoPlavin uporablja?
English: Further information on Pelmeg can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pelmeg.
Slovenian: Nadaljnje informacije o zdravilu Pelmeg so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/pelmeg.
English: What measures are being taken to ensure the safe and effective use of Pelmeg?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pelmeg?
English: This means that Pelmeg is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: An overview of Pelmeg and why it is authorised in the EU
Slovenian: Pregled zdravila Pelmeg in zakaj je odobreno v EU
English: The most common side effect with Pelmeg (which may affect more than 1 in 10 people) is pain in the bones.
Slovenian: Najpogostejši neželeni učinek zdravila Pelmeg (ki se lahko pojavi pri več kot 1 bolniku od 10) je bolečina v kosteh.
English: What are the risks associated with Pelmeg?
Slovenian: Kakšna tveganja so povezana z zdravilom Pelmeg?
English: Why is Pelmeg authorised in the EU?
Slovenian: Zakaj je zdravilo Pelmeg odobreno v EU?
English: As for all medicines, data on the use of Pelmeg are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Pelmeg stalno spremljajo.
English: Side effects reported with Pelmeg are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Pelmeg, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What is Pelmeg and what is it used for?
Slovenian: Kaj je zdravilo Pelmeg in za kaj se uporablja?
English: Other information about Pelmeg
Slovenian: Druge informacije o zdravilu Pelmeg
English: What benefits of Pelmeg have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Pelmeg izkazalo v študijah?
English: The reference medicine for Pelmeg is Neulasta.
Slovenian: Referenčno zdravilo za zdravilo Pelmeg je zdravilo Neulasta.
English: Pelmeg is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Slovenian: Zdravilo Pelmeg se daje v obliki enkratnega odmerka v jakosti 6 mg, ki se injicira pod kožo vsaj 24 ur po koncu vsakega ciklusa kemoterapije (zdravljenja z zdravili proti raku).
English: Pelmeg can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Slovenian: Predpisovanje in izdaja zdravila Pelmeg je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem rakavih obolenj ali krvnih bolezni.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pelmeg have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pelmeg upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about using Pelmeg, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Pelmeg glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The safety of Pelmeg has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Slovenian: Varnost zdravila Pelmeg je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Neulasta.
English: All these data were considered sufficient to conclude that Pelmeg will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Slovenian: Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Pelmeg pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Neulasta.
English: Because Pelmeg is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pelmeg.
Slovenian: Zdravilo Pelmeg je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti pegfilgrastima, izvedenih z zdravilom Neulasta, z zdravilom Pelmeg ni treba ponavljati.
English: The active substance in Pelmeg, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Slovenian: Učinkovina zdravila Pelmeg, pegfilgrastim, je sestavljena iz filgrastima, ki je zelo podoben človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
English: Pelmeg is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Slovenian: Zdravilo Pelmeg ni namenjeno uporabi pri bolnikih s krvnim rakom, tj. kronično mieloično levkemijo ali mielodisplastičnimi sindromi (boleznimi, pri katerih nastajajo velike količine nenormalnih krvnih celic, ki se lahko razvijejo v levkemijo).
English: Pelmeg is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Slovenian: Pelmeg je zdravilo, ki se uporablja pri bolnikih z rakom za pomoč pri nevtropeniji (zmanjšanem številu nevtrofilcev, vrste belih krvnih celic), ki je pogost neželeni učinek pri zdravljenju raka, zaradi katerega pa so bolniki dovzetnejši za okužbe.
English: For the full list of side effects and restrictions with Pelmeg, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Pelmeg glejte navodilo za uporabo.
English: How does Pelmeg work?
Slovenian: Kako zdravilo Pelmeg deluje?
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelmeg has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Pelmeg po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Neulasta in da se po telesu enako prenaša.
English: In Pelmeg, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Slovenian: V zdravilu Pelmeg je filgrastim „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
English: Pelmeg is a ‘biosimilar medicine'.
Slovenian: Zdravilo Pelmeg je „podobno biološko zdravilo“.
English: Studies have also shown that giving Pelmeg produces similar levels of the active substance in the body to giving Neulasta.
Slovenian: Študije so pokazale tudi, da zdravilo Pelmeg vzpostavi podobne ravni učinkovine v telesu kot zdravilo Neulasta.
English: Therefore, the Agency's view was that, as for Neulasta, the benefit of Pelmeg outweighs the identified risk and it can be authorised for use in the EU.
Slovenian: Agencija je menila, da koristi zdravila Pelmeg enako kot pri zdravilu Neulasta odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: Laboratory studies comparing Pelmeg with Neulasta have shown that the active substance in Pelmeg is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Pelmeg primerjali z zdravilom Neulasta, so pokazale, da je učinkovina zdravila Pelmeg po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Neulasta.
English: How is Pelmeg used?
Slovenian: Kako se zdravilo Pelmeg uporablja?
English: Time (Months)
Slovenian: čas (meseci)
English: Approximate diameter: 9.1 mm.
Slovenian: Približen premer: 9,1 mm.
English: A risk to the newborn/infant cannot be excluded.
Slovenian: Tveganja za novorojenčka/otroka ni mogoče izključiti.
English: Date of first authorisation: 06 May 2015 Date of latest renewal: 22 March 2017
Slovenian: Datum prve odobritve: 06. maj 2015 Datum zadnjega podaljšanja: 22. marec 2017
English: The median time to first dose reduction due to any reason was 8 weeks.
Slovenian: Mediana časa do prvega znižanja odmerka iz katerega koli vzroka je bila 8 tednov.
English: The micronucleus test in TK6 cells was positive.
Slovenian: Mikronukleusni test v celicah TK6 je bil pozitiven.
English: They contain white to almost white powder.
Slovenian: Vsebujejo bel do skoraj bel prašek.
English: Criteria
Slovenian: Kriteriji
English: Your doctor will monitor your condition to see that the treatment is having the desired effect.
Slovenian: Zdravnik bo nadzoroval vaše stanje in preverjal, ali ima zdravljenje željen učinek.
English: Medical treatment may be necessary.
Slovenian: Morda bo potrebna zdravniška pomoč.
English: (symptomatic, may be severe and medically significant, medical intervention indicated)
Slovenian: (simptomatska, lahko huda in zdravstveno pomembna, potrebni so zdravstveni ukrepi)
English: Cannot be sold separately.
Slovenian: Ni namenjen ločeni prodaji.
English: Includes cases reported within the clustered terms:
Slovenian: Vključeni so primeri, o katerih so poročali z združenimi izrazi:
English: The main efficacy data for both studies are summarised in Table 6.
Slovenian: Najpomembnejši podatki o učinkovitosti iz obeh študij so prikazani v preglednici 6.
English: System organ class Preferred term
Slovenian: Organski sistem prednostni izraz
English: Then take the next capsules at the usual time.
Slovenian: Nato vzemite naslednje kapsule ob običajnem času.
English: This is a long-term treatment, possibly lasting for months.
Slovenian: Zdravljenje je dolgotrajno, lahko traja več mesecev.
English: Effects of age, gender, and race
Slovenian: Vpliv starosti, spola in rasne pripadnosti
English: Your doctor will tell you exactly how many tablets you need to take.
Slovenian: Zdravnik vam bo naročil, koliko tablet morate vzeti.
English: 92.1% of patients had adenocarcinoma.
Slovenian: 92,1 % bolnikov je imelo adenokarcinom.
English: A risk for induction of other PXR regulated enzymes apart from CYP3A4 cannot be completely excluded.
Slovenian: Možnosti za indukcijo drugih s PXR reguliranih encimov (poleg CYP3A4), ni mogoče povsem izključiti.
English: (life-threatening consequences, urgent intervention indicated)
Slovenian: (z življenjsko nevarnimi posledicami, potrebni so nujni ukrepi)
English: Bradycardia a
Slovenian: bradikardija a
English: Then take the next tablets at the usual time.
Slovenian: Nato vzemite naslednje tablete ob običajnem času.
English: It is particularly important that you mention any of the following medicines.
Slovenian: Posebej pomembno je, da zdravniku poveste, če jemljete katero od naslednjih zdravil.
English: Agents that are substrates of transporters
Slovenian: Zdravila, ki so substrati prenašalcev
English: These may be symptoms of a high level of sugar in the blood.
Slovenian: To so lahko simptomi zvišane ravni sladkorja v krvi.
English: The purpose of these tests is to check your liver function.
Slovenian: S temi preiskavami preverja delovanje vaših jeter.
English: Zykadia is not recommended during pregnancy unless the potential benefit outweighs the potential risk to the baby.
Slovenian: Uporaba zdravila Zykadia v nosečnosti ni priporočena, razen če potencialne koristi odtehtajo možno tveganje za otroka.
English: Do not take Zykadia: if you are allergic to ceritinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Zykadia: če ste alergični na ceritinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Your doctor will discuss with you the potential risks of taking Zykadia during pregnancy.
Slovenian: Zdravnik vam bo pojasnil možna tveganja jemanja zdravila Zykadia v času nosečnosti.
English: Most of these severe/life-threatening cases improved or resolved with interruption of treatment.
Slovenian: V večini teh hudih oziroma življenje ogrožujočih primerov je po prekinitvi zdravljenja prišlo do izboljšanja ali ozdravitve.
English: Other side effects are listed below.
Slovenian: Spodaj so navedeni drugi neželeni učinki.
English: In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each 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); 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 (ni mogoče oceniti iz razpoložljivih podatkov).
English: If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
Slovenian: Če jemljete katero od navedenih zdravil, vam bo zdravnik morda moral predpisati drugo zdravilo.
English: Only 1.3% of the administered oral dose is recovered in the urine.
Slovenian: Samo 1,3 % danega peroralnega odmerka se izloči z urinom.
English: Treatment with Zykadia should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products.
Slovenian: Zdravljenje z zdravilom Zykadia mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Slovenian: V vsaki skupini po organskem sistemu so neželeni učinki razvrščeni po pogostnosti, pri čemer so najpogostejši učinki navedeni najprej.
English: Bradycardia (bradycardia, sinus bradycardia)
Slovenian: c bradikardija (bradikardija, sinusna bradikardija)
English: The safety and efficacy of ceritinib in children and adolescents aged up to 18 years have not been established.
Slovenian: Varnost in učinkovitost ceritiniba pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
English: Women of childbearing potential/Contraception
Slovenian: Ženske v rodni dobi / kontracepcija
English: All of the patients were treated with at least one regimen prior to enrolment into the study and 84.0% with two or more regimens.
Slovenian: Vsi bolniki so pred vključitvijo v študijo že prejemali zdravila po najmanj enem režimu in 84,0 % bolnikov po dveh ali več režimih.
English: Take Zykadia once a day at about the same time each day with food (for example a snack or a full meal).
Slovenian: Zdravilo Zykadia vzemite enkrat na dan, in sicer vsak dan približno ob istem času skupaj s hrano (lahko na primer s prigrizkom ali polnim obrokom).
English: It may make the amount of Zykadia in your blood increase to a harmful level.
Slovenian: To bi lahko povečalo količino zdravila Zykadia v krvi na škodljivo raven.
English: A total of 55.8% of patients were female.
Slovenian: Skupno je bilo med bolniki 55,8 % žensk.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription such as vitamins or herbal supplements, because they might interact with Zykadia.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če gre za zdravila, ki ste jih dobili brez zdravniškega recepta, kot so vitamini ali zeliščna prehranska dopolnila, saj lahko pride do medsebojnega delovanja z zdravilom Zykadia.
English: Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Slovenian: Ugotavljanje ALK-pozitivnega statusa je treba izvajati v laboratorijih z dokazano strokovno usposobljenostjo za uporabo specifične tehnologije.
English: Secondary biotransformation pathways involving the primary biotransformation products included glucuronidation and dehydrogenation.
Slovenian: Med sekundarnimi potmi biotransformacije, ki vključujejo produkte primarne biotransformacije, sta glukuronidacija in dehidrogenacija.
English: Heart rate and blood pressure should be monitored regularly.
Slovenian: Bolnikom je treba redno meriti srčno frekvenco in krvni tlak.
English: The safety profile in patients aged 65 years or older was similar to that in patients less than 65 years of age (see section 4.2).
Slovenian: Varnostni profil zdravila je bil pri bolnikih, starih 65 let ali več, podoben kot pri bolnikih, ki so bili mlajši od 65 let (glejte poglavje 4.2).
English: A total of 57.4% of patients were female.
Slovenian: Skupno je bilo med bolniki 57,4 % žensk.
English: Your doctor will tell you exactly how many capsules you need to take.
Slovenian: Zdravnik vam bo naročil, koliko kapsul morate vzeti.
English: ALK testing
Slovenian: Testiranje prisotnosti ALK
English: The overall survival (OS) data was not mature with 107 deaths representing approximately 42.3% of the required events for the final OS analysis.
Slovenian: Podatki o celokupnem preživetju (overall survival, OS) še niso bili zreli: 107 smrti je predstavljalo približno 42,3 % dogodkov, ki so potrebni za končno analizo celokupnega preživetja.
English: The bioavailability of ceritinib is increased in the presence of food.
Slovenian: Biološka uporabnost ceritiniba je ob prisotnosti hrane povečana.
English: Of these patients 81 received ceritinib.
Slovenian: Med njimi je 81 bolnikov prejemalo ceritinib.
English: What Zykadia is and what it is used for
Slovenian: Kaj je zdravilo Zykadia in za kaj ga uporabljamo
English: In the ceritinib arm, 115 patients were treated with 750 mg once daily fasted.
Slovenian: V skupini s ceritinibom je bilo 115 bolnikov zdravljenih z odmerkom 750 mg enkrat na dan na tešče.
English: Patients with symptomatic CNS (central nervous system) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms, were excluded from the study.
Slovenian: Bolniki s simptomatskimi metastazami v centralnem živčnem sistemu, ki niso bili nevrološko stabilni ali so potrebovali povečane odmerke steroidov za obvladovanje simptomov centralnega živčnega sistema v dveh tednih pred pregledom, so bili iz študije izključeni.
English: Cases of hepatotoxicity occurred in 1.1% of patients receiving ceritinib in clinical studies.
Slovenian: Hepatotoksičnost se je pojavila pri 1,1 % bolnikov, ki so prejemali ceritinib v kliničnih študijah.
English: Severe or intolerable nausea, vomiting or diarrhoea despite optimal anti-emetic or anti-diarrhoeal therapy
Slovenian: Odmerjanje zdravila Zykadia hudi ali neznosni navzea, bruhanje ali diareja kljub optimalnemu antiemetičnemu oziroma antidiaroičnemu zdravljenju
English: Food can range from a light to a full meal (see section 5.2).
Slovenian: Hrano pri tem lahko predstavlja vse od lahkega do polnega obroka (glejte poglavje 5.2).
English: Limited efficacy data are available in elderly patients.
Slovenian: Na voljo je le malo podatkov o učinkovitosti pri starejših bolnikih.
English: In addition, 81 patients (69.8%) in the chemotherapy arm received subsequent Zykadia as first antineoplastic therapy after study treatment discontinuation.
Slovenian: Poleg tega je 81 bolnikov (69,8 %) iz skupine s kemoterapijo naknadno prejemalo zdravilo Zykadia kot prvo protitumorsko zdravilo po prekinitvi študijskega zdravljenja.
English: INTERMEDIATE CARTON OF PACK (WITHOUT BLUE BOX) CONTAINING 50 HARD CAPSULES
Slovenian: VMESNA ŠKATLA PAKIRANJA (BREZ PODATKOV V MODREM OKENCU), KI VSEBUJE 50 TRDIH KAPSUL
English: excessive thirst or increased frequency of urination.
Slovenian: prekomerna žeja ali pogostejše odvajanje vode.
English: Patients with severe renal impairment (CLcr <30 ml/min) were not included in the clinical studies of Zykadia (see section 4.2).
Slovenian: Bolniki s hudo okvaro ledvic (z očistkom kreatinina <30 ml/min) niso bili vključeni v klinične študije zdravila Zykadia (glejte poglavje 4.2).
English: Based on available data, ceritinib elimination via the kidney is negligible (1.3% of a single oral administered dose).
Slovenian: Po podatkih, ki so na voljo, je izločanje ceritiniba skozi ledvice zanemarljivo (1,3 % enkratnega peroralno danega odmerka).
English: Patients should be instructed to avoid grapefruit and grapefruit juice as they may inhibit CYP3A in the gut wall and may increase the bioavailability of ceritinib.
Slovenian: Bolnikom je treba naročiti, naj ne uživajo grenivke in grenivkinega soka, saj zavirata CYP3A v črevesni steni in lahko povečata biološko uporabnost ceritiniba.