FrancophonIA/ELRC3.0 huggingface dataset:
English: Lorlatinib 150 mg orally once daily for 15 days decreased AUCinf and Cmax of a single oral 2 mg dose of midazolam (a sensitive CYP3A substrate) by 61% by 50%, respectively; hence, lorlatinib is a moderate CYP3A inducer.
Croatian: Lorlatinib primijenjen u dozi od 150 mg peroralno jednom na dan tijekom 15 dana smanjio je AUCinf i Cmax pojedinačne peroralno primijenjene doze od 2 mg midazolama (supstrat osjetljiv na CYP3A) za 61 % odnosno 50 %; dakle, lorlatinib je umjereni induktor CYP3A.
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
Croatian: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
English: Concurrent administration of lorlatinib in patients resulted in decreased oral midazolam AUC when midazolam was administered alone, suggesting that lorlatinib is an inducer of CYP3A4/5.
Croatian: Istodobna primjena lorlatiniba u bolesnika dovela je do smanjenog AUC-a peroralno primijenjenog midazolama kada se midazolam primjenjivao sam, što ukazuje da je lorlatinib induktor CYP3A4/5.
English: The main toxicities observed were inflammation across multiple tissues (skin and cervix of rats and lung, trachea, skin, lymph nodes and/or the oral cavity including mandibular bone of dogs; associated with increases in white blood cells, fibrinogen, and/or globulin and decreases in albumin) and changes in the pancreas (with increases in amylase and lipase), hepatobiliary system (with increases in liver enzymes), male reproductive system, cardiovascular system, kidneys and gastrointestinal tract, peripheral nerves and the CNS (potential for cognitive functional impairment) at dose equivalent to human clinical exposure at the recommended posology.
Croatian: Glavne opažene toksičnosti bile su upale različitih tkiva (kože i vrata maternice u štakora te pluća, dušnika, kože, limfnih čvorova i/ili usne šupljine, uključujući mandibularnu kost u pasa; povezane s povišenim vrijednostima bijelih krvnih stanica, fibrinogena i/ili globulina te smanjenim vrijednostima albumina) i promjene u gušterači (s povišenim vrijednostima amilaza i lipaza), hepatobilijarnom sustavu (s povišenim vrijednostima jetrenih enzima), muškom reproduktivnom sustavu, kardiovaskularnom sustavu, bubrezima i probavnom traktu, perifernim živcima i središnjem živčanom sustavu (potencijal za oštećenje kognitivnih funkcija) pri dozi koja odgovara kliničkoj izloženosti ljudi pri preporučenom doziranju.
English: If you forget to take Lorviqua
Croatian: Ako ste zaboravili uzeti lijek Lorviqua
English: Talk to your doctor before taking Lorviqua: - if you have high levels of blood cholesterol or triglycerides - if you have high levels of the enzymes known as amylase or lipase in the blood or a condition such as pancreatitis that can raise the levels of these enzymes - if you have problems with your heart, including heart failure, slow heart rate, or if electrocardiogram (ECG) results show that you have an abnormality of the electrical activity of your heart known as prolonged PR interval or AV block.
Croatian: Obratite se svom liječniku prije nego uzmete lijek Lorviqua: - ako imate visoke razine kolesterola ili triglicerida u krvi - ako imate visoke razine enzima poznatih kao amilaze ili lipaze u krvi ili stanje poput upale gušterače (pankreatitis) koje može povećati razine navedenih enzima - ako imate problema sa srcem, uključujući zatajenje srca, sporu brzinu srčanih otkucaja ili ako rezultati elektrokardiograma (EKG-a) pokazuju da imate abnormalnu električnu aktivnost srca poznatu kao produljeni PR-interval ili AV blok - ako kašljete, osjećate bol u prsnom košu, nedostatak zraka, pogoršanje dišnih simptoma ili ste prije imali plućnu bolest koja se zove pneumonitis.
English: Patients on low sodium diets should be informed that this product is essentially “sodium-free”.
Croatian: Bolesnici na prehrani s niskim udjelom natrija trebaju znati da ovaj lijek sadrži zanemarive količine natrija.
English: If you stop taking Lorviqua
Croatian: Ako prestanete uzimati lijek Lorviqua
English: Pfizer Luxembourg SARL filiāle Latvijā
Croatian: Pfizer Luxembourg SARL filialas Lietuvoje Tel.
English: - Pregnancy
Croatian: - Trudnoća
English: For those patients who develop PR prolongation, dose modification may be required (see section 4.2).
Croatian: U bolesnika koji razviju produljenje PR intervala može biti potrebna prilagodba doze (vidjeti dio 4.2).
English: Lorlatinib should be withheld and/or permanently discontinued based on severity (see section 4.2).
Croatian: Ovisno o težini stanja, potrebno je privremeno obustaviti i/ili trajno prekinuti primjenu lorlatiniba (vidjeti dio 4.2).
English: No starting dose adjustments are recommended for patients with mild or moderate renal impairment.
Croatian: Ne preporučuju se prilagodbe početne doze za bolesnike s blagim ili umjerenim oštećenjem funkcije bubrega.
English: Frequency category All Grades
Croatian: Svi stupnjevi stupanj
English: Introduce or modify lipid-lowering therapyb in accordance with respective prescribing information; continue lorlatinib at same dose.
Croatian: Uvedite ili prilagodite terapiju za smanjenje koncentracije lipida b u skladu s odgovarajućim uputama o propisivanju; nastavite s primjenom iste doze lorlatiniba.
English: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.
Croatian: Jezgra tablete: mikrokristalična celuloza, kalcijev hidrogenfosfat, natrijev škroboglikolat, magnezijev stearat.
English: Your doctor may do further assessments and may decide to reduce the dose of Lorviqua or stop your treatment if you develop: - liver problems.
Croatian: Liječnik će možda obaviti dodatne procjene i odlučiti smanjiti dozu lijeka Lorviqua ili prekinuti liječenje ako se u Vas pojave: - problemi s jetrom.
English: Caution should be exercised when driving or operating machines as patients may experience CNS effects (see section 4.8).
Croatian: Nužan je oprez pri upravljanju vozilima ili strojevima budući da se u bolesnika mogu pojaviti učinci na središnji živčani sustav (vidjeti dio 4.8).
English: Information for lorlatinib use in patients with severe renal impairment (CLcr < 30 mL/min) is limited (n = 1).
Croatian: Podaci o primjeni lorlatiniba u bolesnika s teškim oštećenjem funkcije bubrega (CLcr < 30 ml/min) su ograničeni (n = 1).
English: Patients received lorlatinib orally at the recommended dose of 100 mg once daily, continuously.
Croatian: Bolesnici su neprekidno primali lorlatinib u preporučenoj dozi od 100 mg peroralno jednom na dan.
English: Male fertility may be compromised during treatment with lorlatinib (see section 5.3).
Croatian: Plodnost muškarca može biti smanjena tijekom liječenja lorlatinibom (vidjeti dio 5.3).
English: If subsequent ECG does not show second degree AV block, resume lorlatinib at 1 reduced dose level.
Croatian: Ako sljedeći EKG ne pokazuje AV blok drugog stupnja, nastavite primjenjivati dozu lorlatiniba smanjenu za 1 razinu.
English: - hallucinations (seeing or hearing things that are not there)
Croatian: Česte: mogu zahvatiti do 1 na 10 osoba - halucinacije (ako vidite ili čujete nešto što nije stvarno)
English: Musculoskeletal and connective tissue disorders Arthralgia Myalgiak
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Artralgija Mialgija
English: Left ventricular ejection fraction decrease
Croatian: Smanjenje istisne frakcije lijeve klijetke
English: Lorviqua belongs to the group of medicines that inhibit an enzyme called anaplastic lymphoma kinase (ALK).
Croatian: Lorviqua pripada skupini lijekova koji koče enzim koji se zove kinaza anaplastičnog limfoma (engl. anaplastic lymphoma kinase, ALK).
English: Lorlatinib dosing Hypercholesterolaemia or hypertriglyceridaemia Mild hypercholesterolaemia (cholesterol between ULN and 300 mg/dL or between ULN and 7.75 mmol/L)
Croatian: Doziranje lorlatiniba Hiperkolesterolemija ili hipertrigliceridemija blaga hiperkolesterolemija (kolesterol između GGN-a i 300 mg/dl ili između GGN-a i 7,75 mmol/l)
English: Secondary endpoints included duration of response (DOR), IC-DOR, time-to-tumour response (TTR), and progression-free survival (PFS).
Croatian: Sekundarne mjere ishoda uključivale su trajanje odgovora, trajanje IK odgovora, vrijeme do prvog tumorskog odgovora i preživljenje bez napredovanja bolesti.
English: This medicine contains less than 1 mmol sodium (23 mg) per 25 mg or 100 mg tablet, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po tableti od 25 mg ili 100 mg, tj. zanemarive količine natrija.
English: Information for lorlatinib use in patients with severe (CLcr: < 30 mL/min) renal impairment is very limited.
Croatian: Podaci o primjeni lorlatiniba u bolesnika s teškim (CLcr: < 30 ml/min) oštećenjem funkcije bubrega vrlo su ograničeni.
English: Less than 1% of unchanged lorlatinib was detected in urine.
Croatian: U mokraći je nađeno manje od 1 % nepromijenjenog lorlatiniba.
English: k Myalgia (including musculoskeletal pain, myalgia).
Croatian: k Mialgija (uključujući bol u mišićno-koštanom sustavu, mialgiju).
English: Concomitant administration of lorlatinib with strong CYP3A4/5 inhibitors (e.g. boceprevir, cobicistat, itraconazole, ketoconazole, posaconazole, troleandomycin, voriconazole, ritonavir, paritaprevir in combination with ritonavir and ombitasvir and/or dasabuvir, and ritonavir in combination with either elvitegravir, indinavir, lopinavir or tipranavir) may increase lorlatinib plasma concentrations.
Croatian: Istodobna primjena lorlatiniba sa snažnim inhibitorima CYP3A4/5 (npr. boceprevirom, kobicistatom, itrakonazolom, ketokonazolom, posakonazolom, troleandomicinom, vorikonazolom, ritonavirom, paritaprevirom u kombinaciji s ritonavirom i ombitasvirom i/ili dasabuvirom te ritonavirom u kombinaciji bilo s elvitegravirom, indinavirom, lopinavirom ili tipranavirom) može povećati koncentracije lorlatiniba u plazmi.
English: • mitotane (used to treat cancer of the adrenal glands)
Croatian: • mitotan (koristi se za liječenje raka nadbubrežne žlijezde)
English: Lorviqua can be prescribed to you if - you have been previously treated with a medicine called alectinib or ceritinib, which are ALK
Croatian: - ako ste bili prethodno liječeni lijekom koji se zove alektinib ili ceritinib, koji su inhibitori ALK
English: In vitro data indicate that lorlatinib is metabolised primarily by CYP3A4 and UGT1A4, with minor contribution from CYP2C8, CYP2C19, CYP3A5 and UGT1A3.
Croatian: In vitro podaci pokazuju da se lorlatinib prvenstveno metabolizira putem CYP3A4 i UGT1A4 s manjim doprinosima CYP2C8, CYP2C19, CYP3A5 i UGT1A3.
English: Therefore, lorlatinib is not recommended in patients with moderate to severe hepatic impairment (see section 5.2).
Croatian: Stoga se primjena lorlatiniba ne preporučuje u bolesnika s umjerenim do teškim oštećenjem jetre (vidjeti dio 5.2).
English: An alternative concomitant medicinal product with less potential to inhibit CYP3A4/5 should be considered (see section 4.5).
Croatian: Potrebno je razmotriti istodobnu primjenu nekog drugog lijeka koji ima manji potencijal za inhibiciju CYP3A4/5 (vidjeti dio 4.5).
English: Re-challenge at same lorlatinib dose while maximising lipid-lowering therapyb in accordance with respective prescribing information.
Croatian: Ponovno primijenite istu dozu lorlatiniba i maksimalno povećajte terapiju za smanjenje koncentracije lipida b u skladu s odgovarajućim uputama o propisivanju.
English: The recommended dose is 100 mg lorlatinib taken orally once daily.
Croatian: Preporučena doza lorlatiniba je 100 mg, a uzima se peroralno jednom na dan.
English: Lorlatinib demonstrated activity in mice bearing orthotopic EML4-ALK or EML4-ALKL1196M brain tumour implants.
Croatian: Lorlatinib je pokazao aktivnost u miševa koji nose ortotopne implantate tumora na mozgu EML4-ALK ili EML4-ALK
English: • crizotinib and at least one other ALK TKI.
Croatian: • primjene krizotiniba i najmanje jednog drugog inhibitora tirozin kinaze ALK.
English: Rifampin, a strong inducer of CYP3A4/5, administered at oral doses of 600 mg once daily for 12 days, reduced the mean lorlatinib area under curve (AUC) by 85% and Cmax by 76% of a single 100 mg oral dose of lorlatinib in healthy volunteers; increases in AST and ALT were also observed.
Croatian: Rifampicin, snažan induktor CYP3A4/5, primijenjen peroralno u dozama od 600 mg jednom na dan tijekom 12 dana, smanjio je u zdravih dobrovoljaca srednju vrijednost površine ispod krivulje (engl. area under the curve, AUC) lorlatiniba za 85 % i Cmax za 76 % kod pojedinačne peroralno primijenjene doze lorlatiniba od 100 mg; opažena su i povećanja AST-a i ALT-a.
English: In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including LVEF assessment at baseline and during treatment, should be considered.
Croatian: U bolesnika s čimbenicima srčanog rizika i bolesnika sa stanjima koja mogu utjecati na istisnu frakciju lijeve klijetke, potrebno je razmotriti praćenje srčane aktivnosti, uključujući procjenu istisne frakcije lijeve klijetke prije početka i tijekom liječenja.
English: Itraconazole, a strong inhibitor of CYP3A4/5, administered at oral doses of 200 mg once daily for 5 days, increased the mean lorlatinib AUC by 42% and Cmax by 24% of a single 100 mg oral dose of lorlatinib in healthy volunteers.
Croatian: Itrakonazol, snažan inhibitor CYP3A4/5, primijenjen peroralno u dozama od 200 mg jednom na dan tijekom 5 dana povećao je u zdravih dobrovoljaca srednju vrijednost AUC lorlatiniba za 42 % i Cmax za 24 % kod pojedinačne peroralne doze lorlatiniba od 100 mg.
English: The use of lorlatinib in the treatment of ALK-positive advanced NSCLC after treatment with at least one second-generation ALK TKI was investigated in Study A, a single-arm, multicentre Phase 1/2 study.
Croatian: Primjena lorlatiniba u liječenju uznapredovalog NSCLC-a pozitivnog na ALK nakon liječenja najmanje jednim inhibitorom tirozin kinaze ALK druge generacije, ispitivana je u ispitivanju A, multicentričnom ispitivanju faze 1/2 s jednom skupinom.
English: The median time to onset for both hypercholesterolaemia and hypertriglyceridaemia was 15 days (range: 1 to 399 days).
Croatian: Medijan vremena do pojave hiperkolesterolemije iznosio je 15 dana, jednako kao i do pojave hipertrigliceridemije (raspon: od 1 do 399 dana).
English: A highly effective non-hormonal method of contraception is required for female patients during treatment with lorlatinib, because lorlatinib can render hormonal contraceptives ineffective (see sections 4.5 and 4.6).
Croatian: Tijekom liječenja lorlatinibom potrebna je visokoučinkovita nehormonalna metoda kontracepcije za bolesnice jer hormonalna kontracepcijska sredstva mogu postati neučinkovita zbog djelovanja lorlatiniba (vidjeti dijelove 4.5 i 4.6).
English: Left ventricular ejection fraction (LVEF) decrease has been reported in patients receiving lorlatinib who had baseline and at least one follow-up LVEF assessment.
Croatian: Smanjenje istisne frakcije lijeve klijetke zabilježeno je u bolesnika koji primaju lorlatinib i koji su imali početnu procjenu i najmanje jednu kontrolnu procjenu istisne frakcije lijeve klijetke.
English: Your doctor may decide to reduce your dose of Lorviqua or stop your treatment.
Croatian: Liječnik će možda odlučiti smanjiti Vašu dozu lijeka Lorviqua ili prekinuti liječenje.
English: In vitro data indicate that lorlatinib is primarily metabolised by CYP3A4 and uridine diphosphate-glucuronosyltransferase (UGT)1A4, with minor contributions from CYP2C8, CYP2C19, CYP3A5 and UGT1A3.
Croatian: In vitro podaci pokazuju da se lorlatinib primarno metabolizira putem CYP3A4 i uridin-difosfat-glukuronoziltransferaze (UGT)1A4 s manjim doprinosima CYP2C8, CYP2C19, CYP3A5 i UGT1A3.
English: Very common Very common Very common
Croatian: Vrlo često Vrlo često Vrlo često Manje često
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.
Croatian: Adverse Events); EKG=elektrokardiogram; HMG CoA=3-hidroksi-3-metilglutaril-koenzim
English: Grade 2: Moderate
Croatian: 2. stupanj: umjereni
English: Recommended lorlatinib dose modifications for adverse reactions Adverse reactiona
Croatian: Preporučene prilagodbe doze lorlatiniba zbog nuspojava
English: Moderate hypercholesterolaemia (cholesterol between 301 and 400 mg/dL or between 7.76 and 10.34 mmol/L)
Croatian: umjerena hiperkolesterolemija (kolesterol između 301 i 400 mg/dl ili između 7,76 i 10,34 mmol/l)
English: No information is available for patients with moderate or severe hepatic impairment.
Croatian: Nisu dostupni podaci za bolesnike s umjerenim ili teškim oštećenjem funkcije jetre.
English: System organ class and adverse reaction
Croatian: Klasifikacija organskih sustava i nuspojave
English: Therefore, lorlatinib is not recommended in patients with severe renal impairment (see section 5.2).
Croatian: Stoga se primjena lorlatiniba ne preporučuje u bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: Table 2 presents adverse reactions occurring in 295 adult patients treated with lorlatinib 100 mg once daily with advanced NSCLC from Study A.
Croatian: Tablica 2 prikazuje nuspojave koje su se pojavile u 295 odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC), liječenih lorlatinibom u dozi od 100 mg jednom na dan, iz ispitivanja A.
English: Each film-coated tablet contains 25 mg of lorlatinib.
Croatian: Jedna filmom obložena tableta sadrži 25 mg lorlatiniba.
English: First degree AV block: Asymptomatic
Croatian: AV blok prvog stupnja: asimptomatski
English: Life-threatening hypercholesterolaemia (cholesterol over 500 mg/dL or over 12.92 mmol/L)
Croatian: hiperkolesterolemija koja je opasna po život (kolesterol iznad 500 mg/dl ili iznad 12,92 mmol/l)
English: INFORMATION IN BRAILLE Lorviqua 100 mg
Croatian: Lorviqua 100 mg
English: A highly effective non-hormonal method of contraception is required for female patients during treatment with lorlatinib, because lorlatinib can render hormonal contraceptives ineffective (see sections 4.4 and 4.5).
Croatian: Bolesnice moraju koristiti visokoučinkovitu nehormonalnu kontracepciju tijekom liječenja lorlatinibom jer hormonalna kontracepcijska sredstva mogu postati neučinkovita zbog djelovanja lorlatiniba (vidjeti dijelove 4.4 i 4.5).
English: Consider pacemaker placement if symptomatic AV block persists.
Croatian: Razmotrite ugradnju elektrostimulatora srca (engl. pacemaker) u slučaju dugotrajnog simptomatskog AV bloka.
English: (6.0, NR)
Croatian: 12,4 (6,0; ND)
English: - increase in cholesterol and triglycerides (fats in your blood that would be detected during blood tests) - limb or skin swelling - problems with your eyes, such as difficulty seeing out of one or both eyes, double vision, or perceived flashes of light - problems with the nerves in your arms and legs, such as pain, numbness, unusual sensations like burning or pins and needles, difficulty walking, or difficulty with usual activities of daily living such as writing - increased level of enzymes called lipase and/or amylase in the blood that would be detected during blood tests - low number of red blood cells known as anaemia that would be detected during blood tests - diarrhoea - constipation - pain in your joints - weight gain - headache - rash - muscle pain
Croatian: Vrlo česte: mogu zahvatiti više od 1 na 10 osoba - povećanje kolesterola i triglicerida (masnoće u Vašoj krvi koje se pokazuju tijekom krvnih pretraga) - oticanje udova ili kože - problemi s očima, poput poteškoće gledanja na jedno ili oba oka, dvostruke slike ili bljeskovi svjetla pred očima - problemi sa živcima u rukama i nogama, kao što je bol, utrnulost, neuobičajeni osjeti poput žarenja ili bockanja, otežano hodanje ili poteškoće kod uobičajenih aktivnosti svakodnevnog života poput pisanja - povećana razina enzima koji se zovu lipaze i/ili amilaze u krvi koja se pokazuje tijekom krvnih pretraga - nizak broj crvenih krvnih stanica poznat pod nazivom anemija koji se pokazuje tijekom krvnih pretraga - proljev - zatvor - bol u zglobovima - dobivanje na težini - glavobolja - osip - bol u mišićima
English: Abbreviations: ALK=anaplastic lymphoma kinase; CI=confidence interval; ICR=Independent Central Review; N/n=number of patients; NR=not reached; TKI= tyrosine kinase inhibitor.
Croatian: Independent Central Review); N/n=broj bolesnika; ND=nije dostignuto; TKI=inhibitor tirozin kinaze.
English: Concomitant use with moderate CYP3A4/5 inducers should be avoided, if possible, as they may also reduce lorlatinib plasma concentrations (see section 4.5).
Croatian: Ako je moguće, potrebno je izbjeći istodobnu primjenu s umjerenim induktorima CYP3A4/5, jer oni također mogu smanjiti koncentracije lorlatiniba u plazmi (vidjeti dio 4.5).
English: If symptoms resolve, resume lorlatinib at 1 reduced dose level.
Croatian: Ako se simptomi povuku, nastavite primjenjivati dozu lorlatiniba smanjenu za 1 razinu.
English: Concomitant use of strong CYP3A4/5 inducers (see sections 4.4 and 4.5).
Croatian: Istodobna primjena snažnih induktora CYP3A4/5 (vidjeti dijelove 4.4 i 4.5).
English: Concomitant use with moderate CYP3A4/5 inducers should be avoided, if possible, as they may also reduce lorlatinib plasma concentrations (see section 4.4).
Croatian: Ako je moguće, potrebno je izbjeći istodobnu primjenu s umjerenim induktorima CYP3A4/5, jer oni također mogu smanjiti koncentracije lorlatiniba u plazmi (vidjeti dio 4.4).
English: Concomitant administration of lorlatinib with strong CYP3A4/5 inducers (e.g. rifampicin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's wort) may decrease lorlatinib plasma concentrations.
Croatian: Istodobna primjena lorlatiniba sa snažnim induktorima CYP3A4/5 (npr. rifampicinom, karbamazepinom, enzalutamidom, mitotanom, fenitoinom i gospinom travom) može smanjiti koncentracije lorlatiniba u plazmi.
English: Skin and subcutaneous tissue disorders Rashj
Croatian: Poremećaji kože i potkožnog tkiva Osip
English: Your doctor may investigate further and may decide to reduce the dose of Lorviqua.
Croatian: Liječnik će možda provesti dodatne preglede i možda će Vam smanjiti dozu lijeka Lorviqua.
English: Lorviqua inhibits a type of enzyme called tyrosine kinase and triggers the death of cancer cells in patients with alterations in genes for ALK. Lorviqua is only given to patients whose disease is due to an alteration in the gene for ALK tyrosine kinase.
Croatian: Lijek Lorviqua koči vrstu enzima koji se zove tirozin kinaza i potiče smrt stanica raka u bolesnika s promjenama u genima za ALK.
English: INFORMATION IN BRAILLE Lorviqua 25 mg
Croatian: Lorviqua 25 mg
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer (as MA holder logo)
Croatian: Pfizer (logo nositelja odobrenja)
English: Lorviqua 25 mg: each film-coated tablet (tablet) contains 25 mg lorlatinib.
Croatian: Lorviqua 25 mg: jedna filmom obložena tableta (tableta) sadrži 25 mg lorlatiniba.
English: Two or more prior ALK TKIs with or without prior chemotherapy
Croatian: Dva ili više prethodnih TKI ALK s prethodnom kemoterapijom ili bez nje (N = 48)
English: Of these, 7 patients had a baseline PR > 200 msec.
Croatian: Od svih bolesnika njih 7 imalo je početnu vrijednost PR-a > 200 ms.
English: The use of a strong CYP3A4/5 inducer with lorlatinib is contraindicated (see sections 4.3 and 4.4).
Croatian: Primjena snažnog induktora CYP3A4/5 s lorlatinibom je kontraindicirana (vidjeti dijelove 4.3 i 4.4).
English: Introduce the use of lipid-lowering therapyb or increase the dose of this therapyb in accordance with respective prescribing information or change to a new lipid-lowering therapyb.
Croatian: Uvedite terapiju za smanjenje koncentracije lipida b ili povećajte dozu ove terapije b u skladu s odgovarajućim uputama o propisivanju ili prijeđite na novu terapiju za smanjenje koncentracije lipida b.
English: 120 film-coated tablets
Croatian: 90 filmom obloženih tableta 120 filmom obloženih tableta