FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitors, ATC code: L01XE44
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE44
English: Consider no dose modification or reduce by 1 dose level, as clinically indicated.
Croatian: Razmislite o tome da ne mijenjate dozu ili je smanjite za 1 razinu doze, prema kliničkoj potrebi.
English: Population pharmacokinetic analyses in patients with advanced NSCLC and healthy volunteers indicate that there are no clinically relevant effects of age, gender, race, body weight, and phenotypes for CYP3A5 and CYP2C19.
Croatian: Populacijske farmakokinetičke analize u bolesnika s uznapredovalim NSCLC-om i u zdravih dobrovoljaca pokazuju da nema klinički značajnih učinaka dobi, spola, rase, tjelesne težine i fenotipova CYP3A5 i CYP2C19.
English: The most frequently reported adverse reactions were hypercholesterolaemia (84.4%), hypertriglyceridaemia (67.1%), oedema (54.6%), peripheral neuropathy (47.8%), cognitive effects (28.8%), fatigue (28.1%), weight increased (26.4%) and mood effects (22.7%).
Croatian: Najčešće zabilježene nuspojave bile su hiperkolesterolemija (84,4 % ), hipertrigliceridemija (67,1 %), edem (54,6 %), periferna neuropatija (47,8 %), učinci na kognitivne funkcije (28,8 %), umor (28,1 %), povećana tjelesna težina (26,4 %) i učinci na raspoloženje (22,7 %).
English: - If your next dose is in less than 4 hours away, skip the missed tablet.
Croatian: - Ako trebate uzeti svoju sljedeću dozu za manje od 4 sata, preskočite propuštenu tabletu.
English: Progression-free survival Median, months (95% CI)
Croatian: Preživljenje bez napredovanja bolesti medijan, mjeseci (95 % CI)
English: In embryo-foetal toxicity studies, conducted in rats and rabbits, respectively, increased embryolethality and lower foetal body weights and malformations were observed.
Croatian: U ispitivanjima embriofetalne toksičnosti provedenim na štakorima i kunićima, opažene su povećana smrtnost embrija, smanjena tjelesna težina fetusa i malformacije.
English: Lipase/Amylase increase Grade 3: Severe
Croatian: Povećane razine lipaze/amilaze 3. stupanj: teške
English: It is not known whether lorlatinib affects female fertility.
Croatian: Nije poznato utječe li lorlatinib na plodnost žena.
English: Pneumonitis (including interstitial lung disease, pneumonitis).
Croatian: i Pneumonitis (uključujući intersticijsku plućnu bolest, pneumonitis).
English: • rifampicin (used to treat tuberculosis)
Croatian: • rifampicin (koristi se za liječenje tuberkuloze)
English: Peak lorlatinib concentrations in plasma are rapidly reached with the median Tmax of 1.2 hours following a single 100 mg dose and 2.0 hours following multiple dosing of 100 mg once daily.
Croatian: Vršne koncentracije lorlatiniba u plazmi dosegnute su brzo, s medijanom Tmax od 1,2 sata nakon primjene pojedinačne doze od 100 mg i 2,0 sata nakon višestrukog doziranja od 100 mg jednom na dan.
English: • First dose reduction: 75 mg taken orally once daily
Croatian: • prvo smanjenje doze: 75 mg peroralno jednom na dan
English: In plasma, a benzoic acid metabolite of lorlatinib resulting from the oxidative cleavage of the amide and aromatic ether bonds of lorlatinib was observed as a major metabolite, accounting for 21% of the circulating radioactivity.
Croatian: U plazmi je metabolit benzoatne kiseline, dobiven oksidativnim cijepanjem amidnih i aromatskih eterskih veza lorlatiniba, opažen kao glavni metabolit odgovoran za 21 % cirkulirajuće radioaktivnosti.
English: Dose reductions due to adverse reactions occurred in 23.4% of patients receiving lorlatinib.
Croatian: Smanjenja doze zbog nuspojava provedena su u 23,4 % bolesnika koji su primali lorlatinib.
English: Patient demographics of the 139 ALK-positive advanced NSCLC patients after treatment with at least one second-generation ALK TKI, were 56% female, 48% White, 38% Asian, and the median age was 53 years (range: 29-83 years) with 16% of patients ≥ 65 years of age.
Croatian: Demografski podaci za 139 bolesnika s uznapredovalim NSCLC-om pozitivnim na ALK nakon liječenja najmanje jednim inhibitorom tirozin kinaze ALK druge generacije pokazuju da je među bolesnicima bilo 56 % žena, 48 % bijelaca, 38 % osoba azijskog porijekla, medijan dobi bio je 53 godine (u rasponu od 29 do 83 godine) dok je 16 % bolesnika imalo ≥ 65 godina.
English: Adverse reactions that represent the same medical concept or condition were grouped together and reported as a single adverse reaction in the table above.
Croatian: U tablici iznad, nuspojave koje predstavljaju isti medicinski pojam ili stanje svrstane su u istu skupinu i prijavljene kao jedna nuspojava.
English: d Hallucinations (including auditory hallucination, hallucination, visual hallucination).
Croatian: Halucinacije (uključuju slušnu halucinaciju, halucinaciju, vidnu halucinaciju).
English: What you need to know before you take Lorviqua 3.
Croatian: Što morate znati prije nego počnete uzimati lijek Lorviqua 3.
English: Median time of occurrence of increase in serum lipase and amylase is 70 days (range: 7 to 696 days) and 41 days (range: 7 to 489 days), respectively.
Croatian: Medijan vremena do pojave povećanja razine lipaze i amilaze u serumu iznosi 70 dana (raspon: od 7 do 696 dana), odnosno 41 dan (raspon: od 7 do 489 dana).
English: Lorlatinib is not mutagenic but is aneugenic in vitro and in vivo with a no observed effect level for aneugenicity approximately 16.5 times human clinical exposure at 100 mg based on AUC.
Croatian: Lorlatinib nije mutagen, ali je aneugeničan in vitro i in vivo s razinom pri kojoj nije uočen učinak za aneugeničnost koja je približno 16,5 puta veća od kliničke izloženosti u ljudi pri dozi od 100 mg na temelju AUC-a.
English: Any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g. dyspnoea, cough and fever) should be promptly evaluated for ILD/pneumonitis.
Croatian: U svakog bolesnika u kojeg se pogoršavaju respiratorni simptomi koji ukazuju na intersticijsku plućnu bolest/pneumonitis (npr. dispneja, kašalj i vrućica) treba odmah provesti pretrage na intersticijsku plućnu bolest/pneumonitis.
English: Lorlatinib is a selective, adenosine triphosphate (ATP)-competitive inhibitor of ALK and c-ros oncogene 1 (ROS1) tyrosine kinases.
Croatian: Lorlatinib je selektivan, adenozin trifosfat (ATP)-kompetitivan inhibitor ALK i c-ros onkogen 1 (ROS1) tirozin kinaza.
English: No tablet should be ingested if it is broken, cracked, or otherwise not intact.
Croatian: Tableta se ne smije uzeti ako je slomljena, napuknuta ili oštećena na neki drugi način.
English: Blood and lymphatic system disorders Anaemia
Croatian: Poremećaji krvi i limfnog sustava Anemija
English: In humans, lorlatinib undergoes oxidation and glucuronidation as the primary metabolic pathways.
Croatian: U ljudi lorlatinib podliježe oksidaciji i glukuronidaciji kao primarnim metaboličkim putevima.
English: Few data are available over the 10 to 200 mg dose range; however, no deviation from linearity was observed for AUCinf and Cmax after single dose.
Croatian: Malo je podataka dostupno o primjeni doze u rasponu od 10 do 200 mg, no nije opaženo odstupanje od linearnosti za AUCinf i Cmax nakon pojedinačne doze.
English: The exposure at the lowest doses with embryo-foetal effects in animals was equivalent to the human clinical exposure at 100 mg, based on AUC.
Croatian: Izloženost pri najnižim dozama koja je dovela do embriofetalnih učinaka u životinja odgovarala je, na temelju AUC-a, kliničkoj izloženosti ljudi pri dozi od 100 mg.
English: CNS adverse reactions were primarily cognitive effects (28.8%), mood effects (22.7%), and speech effects (9.8%), and were generally mild, transient, and reversible spontaneously upon dose delay and/or dose reduction (see sections 4.2 and 4.4).
Croatian: Nuspojave u središnjem živčanom sustavu bile su prvenstveno učinci na kognitivne funkcije (28,8 %), učinci na raspoloženje (22,7 %) i učinci na govor (9,8 %) te su uglavnom bile blage, prolazne i povukle su se spontano pri odgodi u primjeni doze i/ili smanjenju doze (vidjeti dijelove 4.2 i 4.4).
English: Film-coating: Hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (E171), iron oxide black (E172), and iron oxide red (E172).
Croatian: Film ovojnica: hipromeloza, laktoza hidrat, makrogol, triacetin, titanijev dioksid (E171), crni željezov oksid (E172) i crveni željezov oksid (E172).
English: Lorlatinib demonstrated marked antitumour activity in mice bearing tumour xenografts that express echinoderm microtubule-associated protein-like 4 (EML4) fusions with ALK variant 1 (v1), including ALK mutations L1196M, G1269A, G1202R, and I1171T.
Croatian: Lorlatinib je pokazao izrazitu antitumorsku aktivnost u miševa koji nose tumorske ksenografte koji izražavaju EML4 (engl. echinoderm microtubule-associated protein-like 4) fuzije s ALK-inačicom 1 (v1), uključujući mutacije ALK-a L1196M, G1269A, G1202R i I1171T.
English: In the study population, the maximum mean change from baseline for PR interval was 16.4 msec (2-sided 90% upper CI 19.4 msec) (see sections 4.2, 4.4 and 4.8).
Croatian: U ispitivanoj populaciji, maksimalna srednja vrijednost promjene od početne vrijednosti za PR interval iznosila je 16,4 ms (gornja granica dvostranog 90 %-tnog CI-a iznosila je 19,4 ms) (vidjeti dijelove 4.2, 4.4 i 4.8).
English: Lipase and amylase increase
Croatian: Povećane razine lipaze i amilaze
English: Permanently discontinue lorlatinib if ILD/pneumonitis recurs or fails to recover after 6 weeks of lorlatinib hold and steroid treatment.
Croatian: Trajno prekinite primjenu lorlatiniba ako su se intersticijska plućna bolest/pneumonitis vratili ili nema oporavka nakon 6 tjedana od prekida liječenja lorlatinibom i početka liječenja steroidima.
English: After oral administration of lorlatinib tablets, the mean absolute bioavailability is 80.8% (90% CI: 75.7, 86.2) compared to intravenous administration.
Croatian: Nakon peroralne primjene tableta lorlatiniba srednja vrijednost apsolutne bioraspoloživosti iznosi 80,8 % (90 % CI: 75,7; 86,2) u usporedbi s intravenskom primjenom.
English: Grapefruit products may also increase lorlatinib plasma concentrations and should be avoided.
Croatian: Proizvodi koji sadrže grejpfrut također mogu povećati koncentracije lorlatiniba u plazmi te ih je potrebno izbjegavati.
English: • If your male partner is being treated with Lorviqua, he must use a condom during treatment and for at least 14 weeks after completing therapy.
Croatian: • Ako se Vaš partner liječi lijekom Lorviqua, mora koristiti prezervativ tijekom liječenja i najmanje 14 tjedana nakon završetka terapije.
English: Continue lorlatinib at the same dose without interruption.
Croatian: Nastavite s primjenom iste doze lorlatiniba bez prekida.
English: Tell your doctor right away if you feel more tired than usual, your skin and whites of your eyes turn yellow, your urine turns dark or brown (tea colour), you have nausea, vomiting, or decreased appetite, you have pain on the right side of your stomach, you have itching, or if you bruise more easily than usual.
Croatian: Odmah obavijestite svog liječnika ako se osjećate neuobičajeno umorni, požute Vam koža i bjeloočnice, mokraća postane tamna ili smeđa (boje čaja), osjećate mučninu, povraćate ili Vam se apetit smanjio, imate bolove na desnoj strani trbuha, imate svrbež ili ako Vam modrice nastaju lakše nego obično.
English: As lorlatinib is metabolised in the liver, hepatic impairment is likely to increase lorlatinib plasma concentrations.
Croatian: Budući da se lorlatinib metabolizira u jetri, vjerojatno je da će oštećenje funkcije jetre povećati koncentracije lorlatiniba u plazmi.
English: The European Medicines Agency has waived the obligation to submit the results of studies with lorlatinib in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell carcinoma) (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lorlatiniba u svim podskupinama pedijatrijske populacije za karcinom pluća (karcinom malih i nemalih stanica) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Other side effects of Lorviqua may include:
Croatian: Druge nuspojave lijeka Lorviqua mogu uključivati:
English: Objective response rateb (95% CI) Complete response, n Partial response, n Duration of response Median, months (95% CI)
Croatian: Stopa objektivnog odgovora (95 % CI) potpuni odgovor, n djelomični odgovor, n Trajanje odgovora medijan, mjeseci (95 % CI)
English: Changes in blood pressure and heart rate, and QRS complex and PR interval were also observed in animals after acute dosing (approximately 2.6 times the human clinical exposure at 100 mg after a single dose based on Cmax).
Croatian: Promjene u krvnom tlaku i srčanoj frekvenciji te QRS-kompleksu i PRintervalu bile su opažene i u životinja nakon akutnog doziranja (na temelju Cmax pri izloženosti približno 2,6 puta većoj od kliničke izloženosti ljudi pri dozi od 100 mg nakon pojedinačne doze).
English: Median time to onset for cognitive, mood and speech effects was 92, 44 and 42 days, respectively.
Croatian: Medijan vremena do pojave učinka na kognitivnu funkciju, učinka na raspoloženje i učinka na govor iznosio je 92, 44 odnosno 42 dana.
English: In order to further confirm the efficacy and safety of lorlatinib in the treatment of patients with ALK-positive NSCLC, the MAH should submit the clinical study report of the phase III study CROWN (1006) comparing lorlatinib versus crizotinib for the first-line treatment of advanced ALK-positive NSCLC.
Croatian: Kako bi se dodatno potvrdila djelotvornost i sigurnost lorlatiniba u liječenju bolesnika s NSCLC-om pozitivnim na ALK, nositelj odobrenja treba dostaviti izvješće kliničkog ispitivanja iz ispitivanja faze 3 CROWN (1006) koje uspoređuje lorlatinib i krizotinib za prvu liniju liječenja uznapredovalog NSCLC-a pozitivnog na ALK.
English: Administration of lorlatinib with a high fat, high calorie meal resulted in 5% higher exposure compared to fasted conditions.
Croatian: Primjena lorlatiniba s visokokaloričnim obrokom s visokim udjelom masti rezultirala je 5 % većom izloženosti u usporedbi s primjenom natašte.
English: Each pack contains 30 film-coated tablets in 3 blisters.
Croatian: Jedno pakiranje sadrži 30 filmom obloženih tableta u 3 blistera.
English: Lorlatinib dose reduction levels are summarised below:
Croatian: Razine smanjenja doze lorlatiniba sažete su u nastavku:
English: It is unknown whether lorlatinib and its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se lorlatinib i njegovi metaboliti u majčino mlijeko.
English: There are no data from the use of lorlatinib in pregnant women.
Croatian: Nema podataka o primjeni lorlatiniba u trudnica.
English: • medicines containing St. John's wort (Hypericum perforatum, a herbal preparation)
Croatian: • lijekove koji sadrže gospinu travu (Hypericum perforatum, biljni pripravak).
English: Objective response rateb (95% CI) Complete response, n Partial response, n Duration of intra-cranial response Median, months (95% CI)
Croatian: Stopa objektivnog odgovora (95 % CI) potpuni odgovor, n djelomični odgovor, n Trajanje intrakranijalnog odgovora medijan, mjeseci (95 % CI)
English: Clinical studies that were conducted excluded patients with AST or ALT > 2.5 × ULN, or if due to underlying malignancy, > 5.0 × ULN or with total bilirubin > 1.5 × ULN.
Croatian: Provedena klinička ispitivanja isključila su bolesnike s AST-om ili ALT-om > 2,5 × GGN, odnosno > 5,0 × GGN ako je to uzrokovano osnovnom malignom bolešću, ili s ukupnim bilirubinom > 1,5 × GGN.
English: Of those, mild or moderate adverse reactions of hypercholesterolaemia or hypertriglyceridaemia occurred in 67.8% and 50.5% of patients, respectively (see section 4.4).
Croatian: Među njima, blage ili umjerene nuspojave hiperkolesterolemije ili hipertrigliceridemije pojavile su se u 67,8 %, odnosno 50,5 % bolesnika (vidjeti dio 4.4).
English: Median duration of cognitive, mood and speech effects was 224, 83 and 106 days, respectively.
Croatian: Medijan trajanja učinka na kognitivnu funkciju, učinka na raspoloženje i učinka na govor iznosio je 224, 83 odnosno 106 dana.
English: Permanent treatment discontinuation associated with adverse reactions occurred in 3.1% of patients receiving lorlatinib.
Croatian: Trajni prekid liječenja povezan s nuspojavama dogodio se u 3,1 % bolesnika koji su primali lorlatinib.
English: Adverse reactions of increase in serum cholesterol or triglycerides were reported in 84.4% and 67.1% of patients, respectively.
Croatian: Nuspojave povećanih razina kolesterola ili triglicerida u serumu zabilježene su u 84,4 % odnosno 67,1 % bolesnika.
English: Lorlatinib should be permanently discontinued if the patient is unable to tolerate the 50 mg dose taken orally once daily.
Croatian: Potrebno je trajno prekinuti primjenu lorlatiniba ako bolesnik ne podnosi dozu od 50 mg peroralno jednom na dan.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 25 mg or 100 mg tablet.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po tableti od 25 mg ili 100 mg.
English: If AV block does not resolve, placement of a permanent pacemaker may be considered.
Croatian: Ako se AV blok ne povuče, potrebno je razmotriti ugradnju trajnog elektrostimulatora srca.
English: Serum cholesterol and triglycerides should be monitored before initiation of lorlatinib; 2, 4 and 8 weeks after initiating lorlatinib; and regularly thereafter.
Croatian: Potrebno je pratiti kolesterol i trigliceride u serumu prije početka liječenja lorlatinibom; 2, 4 i 8 tjedana nakon početka liječenja lorlatinibom te nakon toga redovito.
English: In Study A, 2 patients (0.7%) had absolute Fridericia's correction QTc (QTcF) values > 500 msec and 5 patients (1.8%) had a change in QTcF from baseline > 60 msec.
Croatian: U ispitivanju A, 2 su bolesnika (0,7 %) imala apsolutne vrijednosti QT intervala korigiranog prema Fridericiji (QTcF) > 500 ms, dok je u 5 bolesnika (1,8 %) bila zabilježena promjena u QTcF intervalu od početne vrijednosti > 60 ms.
English: In non-clinical studies, lorlatinib inhibited catalytic activities of non-mutated ALK and clinically relevant ALK mutant kinases in recombinant enzyme and cell-based assays.
Croatian: U nekliničkim ispitivanjima lorlatinib je inhibirao katalitičke aktivnosti nemutiranog ALK-a i klinički značajnih mutiranih ALK kinaza u testovima temeljenim na rekombinantnim enzimima i stanicama.
English: b Lipid-lowering therapy may include: HMG CoA reductase inhibitor, nicotinic acid, fibric acid derivatives, or ethyl esters of omega-3 fatty acids.
Croatian: Terapija za smanjenje koncentracije lipida može uključivati: inhibitor HMG CoA reduktaze, nikotinsku kiselinu, derivate fibratne kiseline ili etilne estere omega-3 masnih kiselina.
English: • carbamazepine, phenytoin (used to treat epilepsy)
Croatian: • karbamazepin, fenitoin (koriste se za liječenje epilepsije)
English: In the overall efficacy population of 139 patients, 56 patients had a confirmed objective response by ICR with a median TTR of 1.4 months (range: 1.2 to 16.6 months).
Croatian: Što se tiče ukupne djelotvornosti u populaciji od 139 bolesnika, 56 bolesnika imalo je objektivni odgovor potvrđen neovisnom središnjom procjenom s medijanom vremena do prvog tumorskog odgovora od 1,4 mjeseca (u rasponu od 1,2 do 16,6 mjeseci).
English: Of the 139 patients, 20% received 1 prior ALK TKI, excluding crizotinib, 47% received 2 prior ALK TKIs, and 33% received 3 or more prior ALK TKIs.
Croatian: Od 139 bolesnika, 20 % prethodno je primilo 1 inhibitor tirozin kinaze ALK, ne uključujući krizotinib, 47 % prethodno je primilo 2 inhibitora tirozin kinaze ALK, a 33% je prethodno primilo 3 ili više inhibitora tirozin kinaze ALK.
English: Withhold lorlatinib until symptoms have returned to baseline and consider initiating corticosteroids.
Croatian: Ne primjenjujte lorlatinib dok se simptomi ne vrate na početne vrijednosti i razmotrite uvođenje kortikosteroida.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving lorlatinib.
Croatian: Ženama reproduktivne dobi potrebno je savjetovati da izbjegavaju trudnoću dok primaju lorlatinib.
English: Central nervous system (CNS) effects have been observed in patients receiving lorlatinib, including changes in cognitive function, mood or speech (see section 4.8).
Croatian: U bolesnika koji su primali lorlatinib opaženi su učinci na središnji živčani sustav, uključujući promjene u kognitivnoj funkciji, raspoloženju ili govoru (vidjeti dio 4.8).
English: What Lorviqua is and what it is used for
Croatian: Što je Lorviqua i za što se koristi
English: Median time of occurrence of severe increase in serum cholesterol and triglycerides is 201 days (range: 42 to 518 days) and 127 days (range: 15 to 358 days), respectively.
Croatian: Medijan vremena pojave jakog povećanja kolesterola i triglicerida u serumu iznosi 201 dan (raspon: od 42 do 518 dana), odnosno 127 dana (raspon: od 15 do 358 dana).
English: The most common mood effect of any grade was irritability (6.1%), which was also the most common Grade 3 or 4 reaction (1.0%).
Croatian: Najčešći učinak na raspoloženje bilo kojeg stupnja bila je razdražljivost (6,1 %) te je ujedno bila i najčešća nuspojava 3. ili 4. stupnja (1,0 %).
English: The most common speech effect of any grade was dysarthria (4.1%), and the most common Grade 3 or 4 reaction was slow speech (0.3%).
Croatian: Najčešći učinak na govor bilo kojeg stupnja bila je dizartrija (4,1 %), a najčešća nuspojava 3. ili 4. stupnja bio je spori govor (0,3 %).
English: Pacemaker placement may be indicated for severe symptoms associated with AV block.
Croatian: Ugradnja elektrostimulatora srca može biti indicirana za teške simptome povezane s AV blokom.
English: In a study conducted in healthy volunteers, the concomitant use of lorlatinib and rifampin, a strong CYP3A4/5 inducer, was associated with increases of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) with no increase of total bilirubin and alkaline phosphatase (see section 4.5).
Croatian: U ispitivanju provedenom na zdravim dobrovoljcima istodobna primjena lorlatiniba i rifampicina, snažnog induktora CYP3A4/5, bila je povezana s povišenim vrijednostima alanin aminotransferaze (ALT-a) i aspartat aminotransferaze (AST-a) bez povećanja ukupnog bilirubina i alkalne fosfataze (vidjeti dio 4.5).
English: What Lorviqua is
Croatian: Što je Lorviqua
English: If there is any possibility that you may father a child while taking this medicine, you must use a condom during treatment, and for at least 14 weeks after completing therapy.
Croatian: Ako postoji mogućnost da Vaša partnerica zatrudni dok uzimate ovaj lijek, morate koristiti prezervativ tijekom liječenja i najmanje 14 tjedana nakon završetka terapije.
English: In order to further confirm the efficacy of lorlatinib in patients who progressed after alectinib or ceritinib as the first ALK TKI therapy, the MAH should conduct a prospective single arm study investigating patients in that same setting.
Croatian: Kako bi se dodatno potvrdila djelotvornost lorlatiniba u bolesnika čija je bolest uznapredovala nakon alektiniba ili ceritiniba kao prve terapije TKI ALK, nositelj odobrenja treba provesti prospektivno ispitivanje s jednom skupinom koje ispituje bolesnike u tom istom okruženju.
English: Within these effects, terms from SOC Nervous system disorders were more frequently reported than terms from SOC Psychiatric disorder.
Croatian: U sklopu ovih učinaka pojmovi iz klasifikacije organskih sustava navedeni u dijelu „Poremećaji živčanog sustava“ bili su češće zabilježeni od pojmova iz klasifikacije organskih sustava navedenih u dijelu „ Psihijatrijski poremećaji“.
English: Repeat-dose toxicity
Croatian: Toksičnost ponovljenih doza