FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be advised to avoid prolonged sun exposure while taking Alecensa, and for at least 7 days after discontinuation of treatment.
Slovenian: Bolnikom je treba naročiti, naj se med jemanjem zdravila Alecensa in vsaj še 7 dni po koncu zdravljenja izogibajo dolgotrajnejšemu izpostavljanju soncu.
English: Glyceryl monooleate
Slovenian: Laktoza monohidrat
English: Dose modifications for elevation of CPK occurred in 3.2% of patients; withdrawal from Alecensa treatment did not occur due to CPK elevations.
Slovenian: Prilagoditve odmerka zaradi zvišanja CPK so bile potrebne pri 3,2 % bolnikov; ukinitve zdravljenja z zdravilom Alecensa zaradi zvišanj CPK ni bilo.
English: The signs may be similar to those from your lung cancer.
Slovenian: Znaki so lahko podobni znakom raka pljuč.
English: If patients experience symptomatic bradycardia or life-threatening events, concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products should be evaluated and Alecensa treatment should be adjusted as described in Table 2 (see sections 4.2 and 4.5, ‘P-gp substrates' and ‘BCRP substrates').
Slovenian: Če se bolniku pojavijo simptomatska bradikardija ali življenjsko ogrožujoči dogodki, je treba oceniti sočasna zdravila, za katera je znano, da povzročajo bradikardijo, in antihipertenzivna zdravila, odmerjanje zdravila Alecensa pa je treba prilagoditi, kot je opisano v preglednici 2 (glejte poglavji 4.2 in 4.5, Substrati P-gp in Substrati
English: In vitro studies indicate that neither alectinib nor its major active metabolite (M4) inhibits CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6 at clinically relevant concentrations.
Slovenian: Študije in vitro so pokazale, da niti alektinib niti njegov glavni aktivni presnovek (M4) pri klinično pomembnih koncentracijah ne zavirata izoencimov CYP1A2, CYP2B6, CYP2C9, CYP2C19 ali
English: Your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely:
Slovenian: Zdravnik vam lahko zmanjša odmerek, zdravljenje za krajši čas prekine ali pa zdravljenje ukine:
English: As alectinib inhibits P-gp, it is not expected that co-medication with P-gp inhibitors has a relevant effect on M4 exposure.
Slovenian: Ker alektinib zavira P-gp, ni pričakovati, da bi sočasna uporaba z zaviralci P-gp pomembno vplivala na izpostavljenost M4.
English: Blood and lymphatic system disorders Anaemia
Slovenian: Bolezni krvi in limfatičnega sistema anemija1
English: Alectinib demonstrated in vitro and in vivo activity against mutant forms of the ALK enzyme, including mutations responsible for resistance to crizotinib.
Slovenian: Alektinib se je in vitro in in vivo izkazal za aktivnega proti mutiranim oblikam encima ALK, vključno z mutacijami, odgovornimi za odpornost proti krizotinibu.
English: Population PK analysis supports dose proportionality for alectinib across the dose range of 300 to 900 mg under fed conditions.
Slovenian: Populacijska farmakokinetična analiza potrjuje sorazmernost z odmerkom v razponu odmerkov alektiniba od 300 do 900 mg, uporabljenih na poln želodec.
English: The most common adverse drug reactions (ADRs) (≥ 20%) were constipation (35%), oedema (30%, including oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema and localised oedema), and myalgia (28%, including myalgia and musculoskeletal pain).
Slovenian: Najpogostejši neželeni učinki (≥ 20 %) so bili zaprtost (35 %), edemi (30 %, vključno s perifernimi edemi, edemi, generaliziranimi edemi, edemi vek, periorbitalnimi edemi, edemi obraza in lokaliziranimi edemi) in mialgija (28 %, vključno z mialgijo in mišično-skeletnimi bolečinami).
English: ● if you have an inherited problem called ‘galactose intolerance', ‘congenital lactase deficiency' or
Slovenian: ● če imate katero od prirojenih motenj, imenovanih "intoleranca za galaktozo", "prirojeno pomanjkanje laktaze" ali "malabsorpcija glukoze-galaktoze".
English: As elimination of alectinib is predominantly through metabolism in the liver, hepatic impairment may increase the plasma concentration of alectinib and/or its major metabolite M4.
Slovenian: Izločanje alektiniba poteka pretežno s presnovo v jetrih, zato lahko okvara jeter zveča koncentracijo alektiniba in/ali njegovega glavnega presnovka M4 v plazmi.
English: When Alecensa is co-administered with P-gp substrates (e.g., digoxin, dabigatran etexilate, topotecan, sirolimus, everolimus, nilotinib and lapatinib), appropriate monitoring is recommended.
Slovenian: Če zdravilo Alecensa uporabljamo sočasno s substrati P-gp (takšni so npr. digoksin, dabigatran eteksilat, topotekan, sirolimus, everolimus, nilotinib in lapatinib), je priporočljiv ustrezen nadzor.
English: rheumatoid arthritis)
Slovenian: (npr. revmatoidnega artritisa),
English: ● Do not breast-feed while taking this medicine.
Slovenian: ● Med jemanjem tega zdravila ne dojite.
English: At the time of entry in the study, 99% of patients had stage IV disease, 61% had brain metastases and in 96% of patients tumours were classified as adenocarcinoma.
Slovenian: Ob vstopu v študijo je imelo 99 % bolnikov bolezen v IV. stadiju, 61 % jih je imelo metastaze v možganih in 96 % tumorjev je bilo opredeljenih kot adenokarcinom.
English: Effects of alectinib on other medicinal products
Slovenian: Učinki alektiniba na druga zdravila
English: Increased alkaline phosphatase**
Slovenian: zelo pogosti zvišana alkalna fosfataza**
English: No patients had events of Grade ≥ 3 severity.
Slovenian: Noben bolnik ni imel učinkov, ki bi bili po izrazitosti stopnje 3 ali več.
English: Dose modification is not required in case of asymptomatic bradycardia (see section 4.2).
Slovenian: V primeru asimptomatske bradikardije odmerka ni treba prilagoditi (glejte poglavje 4.2).
English: ● Do not take this medicine after the expiry date which is stated on the carton and either the blister or the bottle after EXP.
Slovenian: ● Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu ali plastenki poleg oznak Uporabno do ali EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Therefore, no dose adjustment is required for co-administered CYP3A substrates.
Slovenian: Zato odmerka sočasno uporabljenih substratov CYP3A ni treba prilagoditi.
English: ● lung inflammation (pneumonitis).
Slovenian: ● vnetje pljuč (pnevmonitis).
English: ● New or worsening signs of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness (potential signs of muscle problems).
Slovenian: ● novi bolezenski znaki ali poslabšanje znakov mišičnih težav, kot so nepojasnjena mišična bolečina ali mišična bolečina, ki ne preneha, občutljivost ali šibkost (morebitni znaki mišičnih težav);
English: If you have any questions about how Alecensa works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.
Slovenian: Če imate vprašanja o tem, kako deluje zdravilo Alecensa ali zakaj ste ga dobili, vprašajte zdravnika,
English: Grade 3 or 4 ALT or AST elevations were each observed in 5% of patients receiving Alecensa versus 15% and 11% of patients receiving crizotinib in the phase III clinical trial BO28984.
Slovenian: Zvišanja ALT ali AST stopnje 3 ali 4 so opazili pri 5 % bolnikov, ki so prejemali zdravilo Alecensa, v primerjavi s 15 % in 11 % bolnikov, ki so prejemali krizotinib v kliničnem preskušanju faze III BO28984.
English: ● The active substance is alectinib.
Slovenian: ● Učinkovina je alektinib.
English: ● Capsule content: lactose monohydrate (see section 2 ‘Alecensa contains lactose'), hydroxypropylcellulose, sodium laurilsulfate (see section 2 ‘Alecensa contains sodium'), magnesium stearate and carmellose calcium
Slovenian: ● Vsebina kapsule: laktoza monohidrat (glejte poglavje 2, "Zdravilo Alecensa vsebuje laktozo"), hidroksipropilceluloza, natrijev lavrilsulfat (glejte poglavje 2, "Zdravilo Alecensa vsebuje natrij"), magnezijev stearat in kalcijev karmelozat.
English: The effect on the combined exposure of alectinib and M4 was minor, reducing Cmax and AUCinf by 4% and 18%, respectively.
Slovenian: Vpliv na skupno izpostavljenost alektinibu in M4 je bil majhen, Cmax se je zmanjšala za 4 % in AUCinf za 18 %.
English: The major metabolite of alectinib (M4) has shown similar in vitro potency and activity.
Slovenian: Glavni presnovek alektiniba (M4) je in vitro pokazal podobno moč in aktivnost.
English: ● rapid loss of kidney function (kidney problems).
Slovenian: ● hitro poslabšanje delovanja ledvic (težave z ledvicami).
English: ● Do not take a double dose to make up for a missed dose.
Slovenian: ● Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Following a single oral administration of 600 mg with a high-fat, high-calorie meal, alectinib and M4 exposure was increased by around 3-fold relative to fasted conditions (see section 4.2).
Slovenian: Po enkratni uporabi 600 mg z zelo mastnim, visokokaloričnim obrokom se je izpostavljenost alektinibu in M4 povečala do približno 3-krat v primerjavi z uporabo na tešče (glejte poglavje 4.2).
English: ● alteration in sense of taste
Slovenian: ● spremenjeno zaznavanje okusov;
English: A summary of pooled analysis of CNS endpoints is presented in Table 6.
Slovenian: Povzetek združene analize opazovanih dogodkov v osrednjem živčevju je predstavljen v preglednici 6.
English: At the time of entry in the study, 99% of patients had stage IV disease, 60% had brain metastases and in 94% of patients tumours were classified as adenocarcinoma.
Slovenian: Ob vstopu v študijo je imelo 99 % bolnikov bolezen v IV. stadiju, 60 % jih je imelo metastaze v možganih in 94 % tumorjev je bilo opredeljenih kot adenokarcinom.
English: In vitro, alectinib and M4 show weak time-dependent inhibition of CYP3A4, and alectinib exhibits a weak induction potential of CYP3A4 and CYP2B6 at clinical concentrations.
Slovenian: Alektinib in M4 in vitro kažeta šibko časovno odvisno zavrtje CYP3A4; alektinib je v kliničnih koncentracijah pokazal šibek indukcijski potencial na CYP3A4 in CYP2B6.
English: The effectiveness of concomitant administration of oral contraceptives may be reduced.
Slovenian: Učinkovitost sočasno uporabljenih peroralnih kontraceptivov se lahko zmanjša.
English: Tell your doctor straight away if you get any of the following signs: yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal.
Slovenian: Takoj obvestite zdravnika, če se vam med zdravljenjem pojavi kateri od naslednjih znakov: porumenelost kože ali očesnih beločnic, bolečine v območju desne strani trebuha, temen urin, srbenje kože, občutek manjše lakote kot običajno, slabost ali bruhanje, občutek utrujenosti ali večja nagnjenost h krvavitvam ali modricam kot običajno;
English: White hard capsule of 19.2 mm length, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body.
Slovenian: Trda kapsula bele barve in dolžine 19,2 mm, ki ima na pokrovčku s črno barvo izpisano "ALE" in na telesu s črno barvo "150 mg".
English: Negligible amounts of alectinib and the active metabolite M4 are excreted unchanged in urine (< 0.2%
Slovenian: V urinu se izloči zanemarljiva količina nespremenjenega alektiniba in aktivnega presnovka M4 (< 0,2 % odmerka).
English: There were no fatal cases of ILD in any of the clinical trials.
Slovenian: V nobenem od kliničnih preskušanj ni bilo primerov IBP s smrtnim izidom.
English: Alecensa can cause severe or life-threatening inflammation of the lungs during treatment.
Slovenian: Zdravilo Alecensa lahko med zdravljenjem povzroči hudo ali življenjsko ogrožajoče vnetje pljuč.
English: Alecensa can cause side effects that you need to tell your doctor about straight away.
Slovenian: Zdravilo Alecensa lahko povzroči neželene učinke; če se ti pojavijo, morate takoj obvestiti zdravnika.
English: ● vomiting - if you vomit after taking a dose of Alecensa, do not take an extra dose, just take your next dose at the usual time
Slovenian: ● bruhanje - če po zaužitju odmerka zdravila Alecensa bruhate, ne vzemite dodatnega odmerka, temveč le vzemite naslednji odmerek ob običajnem času;
English: Heart rate less than 60 beats per minute (bpm).
Slovenian: a Srčna frekvenca manj kot 60 utripov na minuto.
English: A mild hypotensive effect has been observed in monkeys at around clinically relevant exposures.
Slovenian: Pri opicah so v območju klinično pomembne izpostavljenosti opažali blag hipotenziven učinek.
English: ● everolimus, a medicine used to treat certain types of cancer or used to prevent the body's immune system from rejecting a transplanted kidney, heart or liver
Slovenian: ● everolimus, zdravilo za zdravljenje nekaterih vrst raka ali za preprečevanje zavrnitve presajene ledvice, srca ali jeter zaradi imunskega odgovora telesa,
English: Caution should be exercised when driving or operating machines as patients may experience symptomatic bradycardia (e.g., syncope, dizziness, hypotension) or vision disorders while taking Alecensa (see section 4.8).
Slovenian: Bolniki morajo biti previdni pri vožnji in upravljanju strojev, ker se lahko med zdravljenjem z zdravilom Alecensa pojavi simptomatska bradikardija (npr. sinkopa, omotica, hipotenzija) ali motnje vida (glejte poglavje 4.8).
English: The trial met its primary endpoint at the primary analysis, demonstrating a statistically significant improvement in PFS by investigator.
Slovenian: Preskušanje je ob primarni analizi doseglo primarni opazovani dogodek, kar dokazuje statistično značilno izboljšanje preživetja brez napredovanja bolezni po oceni raziskovalca.
English: 16 patients did not have measurable disease at baseline according to the IRC and were not included in the IRC response evaluable population.
Slovenian: a 16 bolnikov po oceni IRC izhodiščno ni imelo merljive bolezni in zato niso bili vključeni v populacijo, pri kateri je IRC ocenil odziv.
English: Grade 2 or Grade 3 (symptomatic, may be severe and medically significant, medical intervention indicated)
Slovenian: lahko je huda in klinično pomembna, potrebno je medicinsko ukrepanje)
English: Central testing for ALK protein expression positivity of tissue samples from all patients by Ventana anti-ALK (D5F3) immunohistochemistry (IHC) was required before randomisation into the study.
Slovenian: Pred randomizacijo v študijo je bilo potrebno centralno testiranje vzorcev tkiv vseh bolnikov na pozitivno izraženost beljakovine ALK z imunohistokemijo (ICH) Ventana anti-ALK (D5F3).
English: (range 1 - 29)
Slovenian: (razpon: 1-29)
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Slovenian: Zdravniku, farmacevtu ali medicinski sestri morate povedati, če opazite katerega od naslednjih neželenih učinkov:
English: The accumulation ratio for the twice-daily 600 mg regimen was approximately 6-fold.
Slovenian: Razmerje kopičenja s shemo 600 mg dvakrat na dan je bilo približno 6-kratno.
English: Other medicines and Alecensa
Slovenian: Druga zdravila in zdravilo Alecensa
English: The main efficacy results from studies NP28673 and NP28761 are summarised in Table 5.
Slovenian: Glavni rezultati učinkovitosti iz študij NP28673 in NP28761 so povzeti v preglednici 5.
English: Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inducers (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum)).
Slovenian: Priporočljivo je ustrezno spremljanje bolnikov, ki sočasno jemljejo močne induktorje CYP3A (vključno z, vendar ne omejeno na karbamazepin, fenobarbital, fenitoin, rifabutin, rifampicin in šentjanževko (Hypericum perforatum)).
English: CNS-CR n (%)
Slovenian: Osrednje živčevje - CR n (%)
English: No case of bradycardia led to withdrawal from Alecensa treatment.
Slovenian: Noben primer bradikardije ni povzročil ukinitve zdravljenja z zdravilom Alecensa.
English: However, since alectinib elimination via the kidney is negligible, no dose adjustment is required in patients with severe renal impairment (see section 5.2).
Slovenian: Ker je izločanje alektiniba skozi ledvice zanemarljivo, takšnim bolnikom odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Figure 1: Kaplan Meier Plot of INV Assessed PFS in BO28984 (ALEX)
Slovenian: Kaplan-Meierjeva krivulja PFS po oceni raziskovalca v preskušanju BO28984 (ALEX)
English: The absolute bioavailability of alectinib capsules was 36.9% (90% CI: 33.9%, 40.3%) under fed conditions in healthy subjects.
Slovenian: Absolutna biološka uporabnost alektiniba v obliki kapsul, uporabljenih na poln želodec pri zdravih osebah, je 36,9 % (90-% IZ: 33,9 %; 40,3 %).
English: 79639 Grenzach-Wyhlen
Slovenian: D-79639 Grenzach-Wyhlen Nemčija
English: Patients should also be advised to use a broad-spectrum Ultraviolet A (UVA)/ Ultraviolet B (UVB) sun screen and lip balm (SPF ≥50) to help protect against potential sunburn.
Slovenian: Prav tako jim je treba naročiti, naj za preprečitev sončnih opeklin uporabljajo širokospektralno sredstvo za sončenje in mazilo za ustnice (SPF ≥ 50), ki ščitita pred ultravijoličnimi žarki A in B (UVA in UVB).
English: What Alecensa is and what it is used for
Slovenian: Kaj je zdravilo Alecensa in za kaj ga uporabljamo
English: The majority of the events were of Grade 1 and 2 intensity; Grade 3 events were reported in 3.2% of the patients.
Slovenian: V večini primerov je šlo za zvišanje stopnje 1 ali 2; o zvišanju stopnje 3 so poročali pri 3,2 % bolnikov.
English: These studies were conducted in rats and monkeys at exposures equal to or greater than 2.6- and 0.5-fold, respectively, of the human exposure, measured by AUC, at the recommended dose of 600 mg twice daily.
Slovenian: Te študije so izvedli na podganah in opicah; izpostavljenost, merjena z AUC, je bila pri podganah ≥ 2,6-kratnik in pri opicah ≥ 0,5-kratnik izpostavljenosti pri človeku ob priporočenem odmerku 600 mg dvakrat na dan.
English: If you take Alecensa whilst using oral contraceptives, the oral contraceptives may be less effective.
Slovenian: Če jemljete zdravilo Alecensa sočasno s peroralnimi kontraceptivi, se lahko njihova učinkovitost zmanjša.
English: Female patients of child-bearing potential receiving Alecensa, must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alecensa (see sections 4.6 and 5.3).
Slovenian: Bolnice v rodni dobi morajo med zdravljenjem in še vsaj 3 mesece po zadnjem odmerku zdravila Alecensa uporabljati visoko učinkovito kontracepcijsko zaščito (glejte poglavji 4.6 in 5.3).
English: If a planned dose of Alecensa is missed, patients can make up that dose unless the next dose is due within 6 hours.
Slovenian: V primeru izpuščenega načrtovanega odmerka zdravila Alecensa lahko bolniki izpuščeni odmerek vzamejo, če je do naslednjega odmerka še več kot 6 ur.
English: If you stop taking Alecensa
Slovenian: Če ste prenehali jemati zdravilo Alecensa
English: The pharmacokinetic parameters for alectinib and its major active metabolite (M4) have been characterised in ALK-positive NSCLC patients and healthy subjects.
Slovenian: Farmakokinetične parametre alektiniba in njegovega glavnega aktivnega presnovka (M4) so določili pri bolnikih z ALK-pozitivnim nedrobnoceličnim rakom pljuč in pri zdravih osebah.
English: Alecensa blocks the action of an enzyme called ‘ALK tyrosine kinase'.
Slovenian: Zdravilo Alecensa zavira delovanje encima "ALK tirozin-kinaza".
English: Based on population pharmacokinetic analysis, the geometric mean (coefficient of variation %) steady-state Cmax, Cmin and AUC0-12hr for alectinib were approximately 665 ng/mL (44.3%), 572 ng/mL (47.8%) and 7430 ng*h/mL (45.7%), respectively.
Slovenian: Na podlagi populacijske farmakokinetične analize so bile geometrične sredine (koeficienti variacije %) v stanju dinamičnega ravnovesja Cmax, Cmin in AUC0-12 alektiniba približno 665 ng/ml (44,3 %), 572 ng/ml (47,8 %) in 7430 ng·h/ml (45,7 %).
English: Patient demographics were consistent with that of a NSCLC ALK positive population.
Slovenian: Demografske značilnosti bolnikov so se skladale s tistimi v populaciji z ALK-pozitivnim nedrobnoceličnim rakom pljuč.
English: Alecensa 600 mg twice daily
Slovenian: Alecensa 600 mg dvakrat na dan
English: Appropriate monitoring is recommended for patients taking concomitant strong CYP3A inhibitors (including, but not limited to, ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole nefazodone, grapefruit or Seville oranges).
Slovenian: Priporočljivo je ustrezno spremljanje bolnikov, ki sočasno jemljejo močne zaviralce CYP3A (vključno z, vendar ne omejeno na ritonavir, sakvinavir, telitromicin, ketokonazol, itrakonazol, vorikonazol,
English: ● You should not become pregnant while taking this medicine.
Slovenian: ● Med jemanjem tega zdravila ne smete zanositi.
English: There are no available data on patients with extreme body weight (>130 kg) (see section 4.2).
Slovenian: 123 kg. Za bolnike z močno prekomerno telesno maso (> 130 kg) podatkov ni na voljo (glejte poglavje
English: Study NP28761
Slovenian: Študija NP28761
English: 20 patients did not have measurable disease at baseline according to the IRC and were not included in the IRC response evaluable population
Slovenian: b 20 bolnikov po oceni IRC izhodiščno ni imelo merljive bolezni in zato niso bili vključeni v populacijo, pri kateri je IRC ocenil odziv.
English: You need to apply sunscreen and lip balm with a Sun Protection Factor of 50 or higher to help prevent sunburn.
Slovenian: Za preprečitev sončnih opeklin morate uporabljati kremo za sončenje in zaščitno mazilo za ustnice, ki morata imeti zaščitni faktor 50 ali več.
English: The majority of events were Grades 1 or 2 and three patients (0.7%) had a Grade 3 event.
Slovenian: Večina teh učinkov je bila stopnje 1 ali 2, pri treh bolnikih (0,7 %) pa so bili stopnje 3.
English: Alectinib and M4 are not substrates of BCRP or organic anion-transporting polypeptide (OATP) 1B1/B3.
Slovenian: Alektinib in M4 nista substrata BCRP ali transportnega polipeptida organskih anionov (OATP - organic anion-transporting polypeptide)
English: Oral contraceptives If you take Alecensa whilst using oral contraceptives, the oral contraceptives may be less effective.
Slovenian: Peroralni kontraceptivi Če jemljete zdravilo Alecensa sočasno s peroralnimi kontraceptivi, se lahko njihova učinkovitost zmanjša.
English: Female patients of child-bearing potential receiving Alecensa must use highly effective contraceptive methods during treatment and for at least 3 months following the last dose of Alecensa.
Slovenian: Bolnice v rodni dobi, ki prejemajo zdravilo Alecensa, morajo med zdravljenjem in še vsaj 3 mesece po zadnjem odmerku zdravila Alecensa uporabljati visoko učinkovito kontracepcijsko zaščito.
English: ORR (IRC) in patients pre-treated with chemotherapy Responders N (%) [95% CI]
Slovenian: ORR (IRC) pri bolnikih, ki so predhodno prejemali kemoterapijo Odzivni bolniki n (%) [95-% IZ]
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Alecensa.
Slovenian: Če ste negotovi, se pred začetkom jemanja zdravila Alecensa posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: No adverse effects on male and female reproductive organs were observed in general toxicology studies (see section 5.3).
Slovenian: V splošnih toksikoloških študijah niso ugotovili neugodnih vplivov na reproduktivne organe samcev in samic (glejte poglavje 5.3).
English: The safety and efficacy of Alecensa were studied in a global randomised Phase III open label clinical trial (BO28984, ALEX) in ALK-positive NSCLC patients who were treatment naïve.
Slovenian: Varnost in učinkovitost zdravila Alecensa so proučevali v globalnem, randomiziranem, odprtem kliničnem preskušanju faze III (BO28984, ALEX) pri bolnikih z ALK-pozitivnim nedrobnoceličnim rakom pljuč, ki se predhodno še niso zdravili.