FrancophonIA/ELRC3.0 huggingface dataset:
English: - cough, chest pain, or a worsening of existing respiratory symptoms.
Slovenian: - kašelj, bolečine v prsnem košu ali poslabšanje obstoječih dihalnih simptomov.
English: - If your next dose is in 4 hours or more, take the missed tablet as soon as you remember.
Slovenian: - Če morate naslednji odmerek vzeti čez 4 ure ali več, vzemite pozabljeno tableto takoj, ko se spomnite.
English: It is not known whether lorlatinib affects female fertility.
Slovenian: Ni znano, ali lorlatinib vpliva na plodnost pri ženskah.
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14-a of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:
English: Contains lactose (see leaflet for further information).
Slovenian: Vsebuje laktozo (za dodatne informacije glejte navodilo za uporabo).
English: Central nervous system effects (changes in cognition, mood or speech) Grade 2: Moderate
Slovenian: Učinki na osrednje živčevje (spremembe v kogniciji, razpoloženju ali govoru) 2. stopnja: zmerni
English: If you vomit after taking a dose of Lorviqua, do not take an extra dose, just take your next dose at the usual time.
Slovenian: Če po zaužitju odmerka zdravila Lorviqua bruhate, ne vzemite dodatnega odmerka, ampak vzemite naslednji odmerek ob običajnem času.
English: There are no data from the use of lorlatinib in pregnant women.
Slovenian: Podatkov o uporabi lorlatiniba pri nosečnicah ni.
English: Lorlatinib is not recommended during pregnancy or for women of childbearing potential not using contraception.
Slovenian: Lorlatiniba ni priporočljivo uporabljati med nosečnostjo ali pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: If a dose of Lorviqua is missed, then it should be taken as soon as the patient remembers unless it is less than 4 hours before the next dose, in which case the patient should not take the missed dose.
Slovenian: Če bolnik izpusti odmerek zdravila Lorviqua, ga mora vzeti takoj, ko se spomni, razen če do naslednjega odmerka manjka manj kot 4 ure; v tem primeru bolnik izpuščenega odmerka ne sme vzeti.
English: Men should seek advice on effective fertility preservation before treatment.
Slovenian: Moški se morajo pred zdravljenjem posvetovati glede učinkovite ohranitve plodnosti.
English: Treatment with lorlatinib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Slovenian: Zdravljenje z lorlatinibom mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih bolezni.
English: Effective contraception must be continued for at least 35 days after completing therapy (see section 4.6).
Slovenian: Učinkovito kontracepcijo je treba uporabljati še vsaj 35 dni po zaključku zdravljenja (glejte poglavje 4.6).
English: Monitor electrocardiogram (ECG) prior to initiating lorlatinib and monthly thereafter, particularly in patients with predisposing conditions to the occurrence of clinically significant cardiac events.
Slovenian: Spremljajte elektrokardiogram (EKG) pred uvedbo lorlatiniba in nato mesečno, zlasti pri bolnikih s stanji, zaradi katerih so dovzetnejši za pojav klinično pomembnih srčnih dogodkov.
English: Grapefruit products may also increase lorlatinib plasma concentrations and should be avoided.
Slovenian: Tudi izdelki iz grenivke lahko zvečajo koncentracije lorlatiniba v plazmi in se jim je treba izogibati.
English: Lorlatinib may reduce the effectiveness of hormonal contraceptive methods (for example, birth control pill); therefore, hormonal contraceptives may not be considered highly effective.
Slovenian: Lorlatinib lahko zmanjša učinkovitost hormonskih kontracepcijskih metod (na primer kontracepcijskih tabletk), zato hormonskih kontraceptivov ne smete šteti za visoko učinkovite.
English: g Speech effects (dysarthria, slow speech, speech disorder).
Slovenian: Učinki na govor (dizartrija, upočasnjen govor, motnja govora).
English: Lorlatinib should not be used during breast-feeding.
Slovenian: Lorlatiniba se ne sme uporabljati med dojenjem.
English: Brain metastases were present at baseline in 67% of patients.
Slovenian: Možganske metastaze so bile ob izhodišču prisotne pri 67 % bolnikov.
English: The geometric mean (% CV) oral clearance was 17.7 (39) L/h.
Slovenian: Geometrična sredina (% KV) peroralnega očistka je bila 17,7 (39) l/h.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1355/001 (120 film-coated tablets) EU/1/19/1355/003 (90 film-coated tablets)
Slovenian: EU/1/19/1355/001 (120 filmsko obloženih tablet) EU/1/19/1355/003 (90 filmsko obloženih tablet)
English: Carcinogenicity studies have not been conducted with lorlatinib.
Slovenian: Študij kancerogenosti z lorlatinibom niso izvedli.
English: Due to the limited data on this population, no dose recommendation can be made for patients aged 65 years and older (see section 5.2).
Slovenian: Zaradi omejenih podatkov pri tej populaciji za bolnike, stare 65 let in več, priporočil o odmerjanju ni mogoče dati (glejte poglavje 5.2).
English: Age, gender, race, body weight, and phenotype
Slovenian: Starost, spol, rasa, telesna masa in fenotip
English: These symptoms could be signs of pancreatitis.
Slovenian: Ti simptomi so lahko znak vnetja trebušne slinavke (pankreatitisa).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred začetkom jemanja tega zdravila posvetujte z zdravnikom.
English: Also some medicines can affect the way Lorviqua works.
Slovenian: Prav tako lahko nekatera zdravila vplivajo na delovanje zdravila Lorviqua.
English: The primary efficacy endpoint in the Phase 2 portion of the study was objective response rate (ORR), including intracranial (IC)-ORR, as per Independent Central Review (ICR) according to modified response evaluation criteria in solid tumours (modified RECIST version 1.1).
Slovenian: Primarni opazovani dogodek kot merilo učinkovitosti v delu študije, ki je predstavljal 2. fazo, je bil objektivni odziv na zdravljenje (ORR - Objective Response Rate), vključno z intrakranialnim (ICintracranial) ORR, glede na neodvisno centralno preverjanje (ICR - Independent Central Review) v skladu z modificiranimi merili za ocenjevanje odziva pri solidnih tumorjih (RECIST - Response Evaluation Criteria in Solid Tumours) (modificirana merila RECIST, različica 1.1).
English: You must not drink grapefruit juice or eat grapefruit while on treatment with Lorviqua as they may change the amount of Lorviqua in your body.
Slovenian: Med zdravljenjem z zdravilom Lorviqua ne smete piti soka grenivke ali uživati grenivke, saj lahko spremenita količino zdravila Lorviqua v vašem telesu.
English: The plasma half-life of lorlatinib after a single 100 mg dose was 23.6 hours.
Slovenian: Plazemski razpolovni čas lorlatiniba po enkratnem 100 mg odmerku je bil 23,6 ure.
English: Patients on low sodium diets should be informed that this product is essentially “sodium-free”.
Slovenian: Bolnike na dieti z nadzorovanim vnosom natrija je treba obvestiti, da je to zdravilo v bistvu 'brez natrija'.
English: These tests are to check the level of cholesterol, triglycerides and the enzymes amylase or lipase in your blood before you start treatment with Lorviqua and regularly during treatment.
Slovenian: Te preiskave so namenjene preverjanju ravni holesterola, trigliceridov ter encimov amilaze in lipaze v krvi, preden se začnete zdraviti z zdravilom Lorviqua in redno med zdravljenjem.
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.
Slovenian: Demografske značilnosti 139 bolnikov z ALK-pozitivnim napredovalim NSCLC po zdravljenju z najmanj 1 ALK TKI druge generacije so bile naslednje: 56 % ženski spol, 48 % belopolti, 38 % azijsko poreklo in mediana starost 53 let (razpon: 29-83 let), pri čemer je bilo 16 % bolnikov starih ≥ 65 let.
English: The most common adverse reactions that led to dose reductions were oedema and peripheral neuropathy.
Slovenian: Najpogostejša neželena učinka, zaradi katerih so zmanjšali odmerek, sta bila edem in periferna nevropatija.
English: If you have any questions about how Lorviqua works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če imate kakršnakoli vprašanja o tem, kako deluje zdravilo Lorviqua, ali zakaj so vam predpisali to
English: Fertility and pregnancy
Slovenian: Plodnost in nosečnost
English: There is no antidote for lorlatinib.
Slovenian: Antidota za lorlatinib ni.
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.
Slovenian: Takoj povejte zdravniku, če se počutite bolj utrujeni kot običajno, če se koža in očesne beločnice obarvajo rumeno, urin postane temnejši ali rjav (barve čaja), imate občutek siljenja na bruhanje, bruhate ali imate pomanjkanje apetita, bolečino na desni strani trebuha, imate srbečico ali se vam hitreje kot običajno pojavijo podplutbe.
English: The tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing).
Slovenian: Tablete je treba pogoltniti cele (pred zaužitjem tablet ne smemo žvečiti, zdrobiti ali razpoloviti).
English: All target organ findings with the exception of hepatic bile duct hyperplasia were partially to fully reversible.
Slovenian: Vsa opažanja na tarčnih organih, razen hiperplazije hepatičnega žolčevoda, so bila delno ali popolnoma reverzibilna.
English: Continue lorlatinib at the same dose without interruption.
Slovenian: Nadaljujte zdravljenje z lorlatinibom v istem odmerku brez prekinitve.
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z lorlatinibom za vse podskupine pediatrične populacije pri karcinomu pljuč (drobnoceličnem in nedrobnoceličnem karcinomu) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If hormonal contraception is unavoidable it must be used in combination with a condom.
Slovenian: Če se hormonski kontracepciji ni mogoče izogniti, jo je treba kombinirati z uporabo kondomov.
English: Permanently discontinue lorlatinib if ILD/pneumonitis recurs or fails to recover after 6 weeks of lorlatinib hold and steroid treatment.
Slovenian: Trajno prekinite zdravljenje z lorlatinibom, če se ILD/pnevmonitis ponovi ali se po 6 tednih prekinitve zdravljenja z lorlatinibom in zdravljenja s steroidi ne izboljša.
English: a Alectinib, brigatinib, or ceritinib.
Slovenian: alektinib, brigatinib ali ceritinib
English: The most frequent adverse reaction that led to permanent discontinuations was cognitive effects.
Slovenian: Najpogostejši neželeni učinek, zaradi katerega so trajno prekinili zdravljenje, je bil učinek na kognitivne funkcije.
English: Secondary endpoints included duration of response (DOR), IC-DOR, time-to-tumour response (TTR), and progression-free survival (PFS).
Slovenian: Sekundarni opazovani dogodki so vključevali trajanje odziva (DOR - Duration of Response), IC-DOR, čas do odziva tumorja na zdravljenje (TTR - Time-to-Tumour Response) in preživetje brez napredovanja bolezni (PFS - Progression-Free Survival).
English: The oxidative cleavage metabolite is pharmacologically inactive.
Slovenian: Presnovek, ki nastane z oksidativno cepitvijo, je farmakološko neaktiven.
English: What Lorviqua is and what it is used for 2.
Slovenian: Kaj je zdravilo Lorviqua in za kaj ga uporabljamo 2.
English: Hypersensitivity to lorlatinib or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na lorlatinib ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: You will have blood tests before you start treatment and during your treatment.
Slovenian: Pred začetkom zdravljenja in med zdravljenjem vam bodo opravili krvne preiskave.
English: Withhold dose until toxicity is less than or equal to Grade 1.
Slovenian: Prekinite odmerjanje, dokler toksičnost ni nižja od ali enaka 1. stopnji.
English: These are listed under Do not take Lorviqua, at the start of section 2.
Slovenian: Ta zdravila so navedena v razdelku Ne jemljite zdravila Lorviqua na začetku poglavja 2.
English: Within these effects, terms from SOC Nervous system disorders were more frequently reported than terms from SOC Psychiatric disorder.
Slovenian: V sklopu teh učinkov so pogosteje poročali o izrazih iz organskega sistema ''Bolezni živčevja'' kot o izrazih iz organskega sistema ''Psihiatrične motnje''.
English: Your doctor may do blood tests to check your liver function.
Slovenian: Zdravnik bo morda opravil krvne preiskave in preveril delovanje jeter.
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).
Slovenian: V populaciji za ocenjevanje celokupne učinkovitosti s 139 bolniki je imelo 56 bolnikov potrjen objektivni odziv po ICR z medianim TTR 1,4 meseca (razpon: od 1,2 do 16,6 meseca).
English: Patients should be monitored for lipase and amylase elevations prior to the start of lorlatinib treatment and regularly thereafter as clinically indicated (see section 4.2).
Slovenian: Bolnike je treba spremljati glede zvečanja vrednosti lipaze in amilaze pred začetkom zdravljenja z lorlatinibom in nato redno med zdravljenjem, kot je klinično indicirano (glejte poglavje 4.2).
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.
Slovenian: • Če se z zdravilom Lorviqua zdravi vaš partner, mora med zdravljenjem in še vsaj 14 tednov po zaključku zdravljenja uporabljati kondom.
English: Central nervous system effects
Slovenian: Učinki na osrednje živčevje
English: Other side effects of Lorviqua may include:
Slovenian: Drugi neželeni učinki zdravila Lorviqua so lahko:
English: Film-coating: Hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (E171), iron oxide black (E172), and iron oxide red (E172).
Slovenian: Filmska obloga: hipromeloza, laktoza monohidrat, makrogol, triacetin, titanov dioksid (E171), črni železov oksid (E172) in rdeči železov oksid (E172).
English: This is because Lorviqua can affect the way some other medicines work.
Slovenian: Zdravilo Lorviqua lahko namreč vpliva na delovanje nekaterih drugih zdravil.
English: Serum cholesterol and triglycerides should be monitored before initiation of lorlatinib; 2, 4 and 8 weeks after initiating lorlatinib; and regularly thereafter.
Slovenian: Holesterol in trigliceride v serumu je treba spremljati pred uvedbo lorlatiniba, 2, 4 in 8 tednov po uvedbi lorlatiniba ter redno v nadaljevanju zdravljenja.
English: Median time to onset for cognitive, mood and speech effects was 92, 44 and 42 days, respectively.
Slovenian: Mediani čas do pojava učinkov na kognitivne funkcije, razpoloženje oziroma govor je bil 92, 44 oziroma 42 dni.
English: This is because it is not known if Lorviqua can pass into breast milk and could therefore harm your baby.
Slovenian: Ni namreč znano, ali zdravilo Lorviqua prehaja v materino mleko, s čimer bi lahko škodovalo vašemu otroku.
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.
Slovenian: Če obstaja kakršnakoli možnost, da med jemanjem tega zdravila zaplodite otroka, morate med zdravljenjem in še vsaj 14 tednov po zaključku zdravljenja uporabljati kondom.
English: Also, at steady-state lorlatinib plasma exposures are lower than those expected from single dose pharmacokinetics, indicative of a net time-dependent auto-induction effect.
Slovenian: Prav tako so bile v stanju dinamičnega ravnovesja izpostavljenosti lorlatinibu v plazmi manjše od pričakovanih glede na farmakokinetiko po enkratnem odmerku, kar kaže na neto časovno odvisni samoindukcijski učinek.
English: Two of these ALK mutants, G1202R and I1171T, are known to confer resistance to alectinib, brigatinib, ceritinib, and crizotinib.
Slovenian: Za dve od navedenih mutiranih ALK, G1202R in I1171T, je znano, da povzročata odpornost proti alektinibu, brigatinibu, ceritinibu in krizotinibu.
English: Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events; ECG=electrocardiogram; HMG CoA=3-hydroxy-3-methylglutaryl coenzyme A; NCI=National Cancer Institute; ULN=upper limit of normal.
Slovenian: Okrajšave: CTCAE = merila NCI za poenoteno terminologijo neželenih dogodkov (National Cancer Institute Common Terminology Criteria for Adverse Events); EKG = elektrokardiogram; HMG CoA = 3-hidroksi-3-metilglutaril koencim A; NCI = nacionalni inštitut za rakava obolenja (National Cancer Institute); ZMN = zgornja meja normale.
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.
Slovenian: Vse bolnike, pri katerih pride do poslabšanja respiratornih simptomov, ki kažejo na ILD/pnevmonitis (npr. dispneja, kašelj in zvišana telesna temperatura), je treba takoj pregledati glede ILD/pnevmonitisa.
English: Lorlatinib is a selective, adenosine triphosphate (ATP)-competitive inhibitor of ALK and c-ros oncogene 1 (ROS1) tyrosine kinases.
Slovenian: Lorlatinib je selektivni adenozin trifosfat (ATP - Adenosine Triphosphate)-kompetitivni zaviralec tirozin-kinaz ALK in onkogena c-ros 1 (ROS1).
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).
Slovenian: Neželeni učinki na osrednje živčevje so bili predvsem učinki na kognitivne funkcije (28,8 %), učinki na razpoloženje (22,7 %) in učinki na govor (9,8 %) ter so bili na splošno blagi, prehodni in so spontano izzveneli po zakasnitvi odmerka in/ali zmanjšanju odmerka (glejte poglavji 4.2 in 4.4).
English: Median duration of cognitive, mood and speech effects was 224, 83 and 106 days, respectively.
Slovenian: Mediano trajanje učinkov na kognitivne funkcije, razpoloženje oziroma govor je bilo 224, 83 oziroma 106 dni.
English: Lipase/Amylase increase Grade 3: Severe
Slovenian: Zvečanje vrednosti lipaze/amilaze 3. stopnja: hudi
English: See Lorviqua contains lactose and Lorviqua contains sodium in section 2.
Slovenian: Glejte Zdravilo Lorviqua vsebuje laktozo in Zdravilo Lorviqua vsebuje natrij v poglavju 2.
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.
Slovenian: Za nadaljnjo potrditev učinkovitosti in varnosti lorlatiniba pri zdravljenju bolnikov z ALK-pozitivnim NSCLC mora imetnik DzP predložiti poročilo klinične študije 3. faze CROWN (1006), v kateri so lorlatinib primerjali s krizotinibom kot zdravilo za prvo linijo zdravljenja napredovalega ALK-pozitivnega NSCLC.
English: Dose modification recommendations for toxicities and for patients who develop atrioventricular (AV) block are provided in Table 1.
Slovenian: Priporočila za prilagajanje odmerkov zaradi toksičnosti in pri bolnikih, pri katerih se pojavi atrioventrikularni (AV) blok, so navedena v preglednici 1.
English: In vitro binding of lorlatinib to human plasma proteins is 66% with moderate binding to albumin or to α1-acid glycoprotein.
Slovenian: Vezava lorlatiniba in vitro na beljakovine v plazmi pri človeku je 66 %, z zmerno vezavo na albumin ali α1-kisli glikoprotein.
English: Lorlatinib should be permanently discontinued if the patient is unable to tolerate the 50 mg dose taken orally once daily.
Slovenian: Zdravljenje z lorlatinibom je treba trajno prekiniti, če bolnik ne prenaša odmerka 50 mg peroralno enkrat na dan.
English: In vitro, lorlatinib has a low potential to cause drug-drug interactions by induction of CYP1A2.
Slovenian: In vitro ima lorlatinib majhen potencial za povzročanje medsebojnega delovanja med zdravili zaradi indukcije CYP1A2.
English: In vitro studies also indicated that lorlatinib is an inducer of CYP2B6 and activates the human constitutive androstane receptor (CAR).
Slovenian: Študije in vitro so pokazale tudi, da je lorlatinib induktor CYP2B6 in da pri človeku aktivira konstitutivni androstanski receptor (CAR - Constitutive Androstane Receptor).
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.
Slovenian: V študiji A sta imela 2 bolnika (0,7 %) absolutne vrednosti QTc s popravkom Fridericia (QTcF) > 500 ms, 5 bolnikov (1,8 %) pa je imelo spremembo vrednosti QTcF od izhodišča > 60 ms.
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%).
Slovenian: Najpogosteje poročani neželeni učinki so hiperholesterolemija (84,4 %), hipertrigliceridemija (67,1 %), edem (54,6 %), periferna nevropatija (47,8 %), učinki na kognitivne funkcije (28,8 %), utrujenost (28,1 %), zvečanje telesne mase (26,4 %) in učinki na razpoloženje (22,7 %).
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.
Slovenian: Izpostavljenost pri najmanjših odmerkih z učinki na zarodek in plod pri živalih je bila enakovredna klinični izpostavljenosti pri človeku pri odmerku 100 mg na osnovi vrednosti AUC.
English: Lorlatinib was also capable of penetrating the blood-brain barrier.
Slovenian: Lorlatinib je prav tako lahko prehajal skozi krvno-možgansko pregrado.
English: After oral administration of lorlatinib tablets, the mean absolute bioavailability is 80.8% (90% CI: 75.7, 86.2) compared to intravenous administration.
Slovenian: Po peroralnem dajanju tablet lorlatiniba je povprečna absolutna biološka uporabnost 80,8 % (90 % IZ: 75,7; 86,2) v primerjavi z intravenskim dajanjem.
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.
Slovenian: Lorlatinib ni mutagen, vendar je in vitro ter in vivo anevgen, pri čemer je odmerek brez opaznega učinka za anevgenost približno 16,5-kratnik klinične izpostavljenosti pri človeku pri odmerku 100 mg na osnovi vrednosti AUC.
English: Of these, 7 patients had a baseline PR > 200 msec.
Slovenian: Med njimi je imelo 7 bolnikov izhodiščni PR > 200 ms.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 25 mg or 100 mg tablet.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 25 mg ali 100 mg tableto.
English: Table 2 presents adverse reactions occurring in 295 adult patients treated with lorlatinib 100 mg once daily with advanced NSCLC from Study A.
Slovenian: V preglednici 2 so predstavljeni neželeni učinki, ki so se pojavili pri 295 odraslih bolnikih, ki so jih zdravili z lorlatinibom 100 mg enkrat na dan, z napredovalim NSCLC iz študije A.