FrancophonIA/ELRC3.0 huggingface dataset:
English: In 295 patients who received lorlatinib at the recommended dose of 100 mg once daily and had a ECG measurement in Study A, lorlatinib was studied in a population of patients that excluded those with QTc interval > 470 msec.
Croatian: U 295 bolesnika, koji su primali lorlatinib u preporučenoj dozi od 100 mg jednom na dan i obavili mjerenje EKG-om tijekom ispitivanja A, lorlatinib je ispitivan u populaciji bolesnika gdje nisu bili uključeni oni bolesnici koji su imali korigirani QT interval > 470 ms.
English: If severe hypercholesterolaemia and/or hypertriglyceridaemia recur despite maximal lipid-lowering therapyb in accordance with respective prescribing information, reduce lorlatinib by 1 dose level.
Croatian: Ako se teška hiperkolesterolemija i/ili hipertrigliceridemija vrate unatoč maksimalno povećanoj terapiji za smanjenje koncentracije lipida b u skladu s odgovarajućim uputama o propisivanju, smanjite dozu lorlatiniba za 1 razinu.
English: Grade 3: Severe
Croatian: 3. stupanj: teški
English: • enzalutamide (used to treat prostate cancer)
Croatian: • enzalutamid (koristi se za liječenje raka prostate)
English: Concomitant administration of lorlatinib with CYP2B6 substrates (e.g. bupropion, efavirenz) may result in reduced plasma concentrations of the CYP2B6 substrate.
Croatian: Istodobna primjena lorlatiniba sa supstratima CYP2B6 (npr. bupropionom, efavirenzom) može dovesti do smanjenih koncentracija supstrata CYP2B6 u plazmi.
English: • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
Croatian: • primjene alektiniba ili ceritiniba kao prve terapije inhibitorom tirozin kinaze (engl. tyrosine kinase inhibitor, TKI) ALK ili
English: The median duration of hypercholesterolaemia and hypertriglyceridaemia was 381 and 405 days, respectively.
Croatian: Medijan trajanja hiperkolesterolemije i hipertrigliceridemije iznosio je 381 dan, odnosno 405 dana.
English: The most common cognitive effect of any grade was memory impairment (11.5%), and the most common Grade 3 or 4 reactions were cognitive effect and confusional state (0.7% each).
Croatian: Najčešći učinak na kognitivnu funkciju bilo kojeg stupnja bio je poremećaj pamćenja (11,5 %), a najčešće nuspojave 3. ili 4. stupnja bile su učinak na kognitivnu funkciju i stanje konfuzije (0,7 % svaka).
English: Lorlatinib dosing PR interval prolongation/Atrioventricular (AV) block
Croatian: Produljenje PR-intervala/atrioventrikularni (AV) blok
English: The ORR for Asians was 49.1% (95% CI: 35.1, 63.2) and 31.5% for non-Asians (95% CI: 21.1, 43.4).
Croatian: Stopa objektivnog odgovora za osobe azijskog porijekla iznosila je 49,1 % (95 % CI: 35,1; 63,2) i 31,5 % za osobe koje nisu azijskog porijekla (95 % CI: 21,1; 43,4).
English: Less than 1% of the administered dose is detected as unchanged lorlatinib in urine.
Croatian: Manje od 1 % primijenjene doze nađeno je u obliku nepromijenjenog lorlatiniba u mokraći.
English: Lorlatinib may cause foetal harm when administered to a pregnant woman.
Croatian: Lorlatinib može naštetiti fetusu ako se primjenjuje u trudnica.
English: h Vision disorder (including diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters).
Croatian: h Poremećaj vida (uključujući diplopiju, fotofobiju, fotopsiju, zamućeni vid, smanjenu oštrinu vida, oštećenje vida, zamućenja u vidnom polju).
English: If you accidentally take too many tablets, tell your doctor, pharmacist or nurse right away.
Croatian: Ako slučajno uzmete previše tableta, odmah obavijestite o tome svog liječnika ili ljekarnika.
English: Other adverse reactions Grade 1: Mild
Croatian: Druge nuspojave 1. stupanj: blage
English: Within each frequency grouping, undesirable effects are presented in order of decreasing medical seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane u padajućem nizu prema medicinskoj ozbiljnosti.
English: The geometric mean (% CV) oral clearance was 17.7 (39) L/h.
Croatian: Geometrijska sredina (% koeficijent varijacije) klirensa nakon peroralne primjene iznosila je 17,7 (39) l/h.
English: The Eastern Cooperative Oncology Group (ECOG) performance status at baseline was 0 or 1 in 96% patients.
Croatian: Eastern Cooperative Oncology Group, ECOG) na početku ispitivanja iznosio je 0 ili 1.
English: Your doctor may check for problems with your heart during treatment with Lorviqua.
Croatian: Liječnik će možda provjeriti jesu li se u Vas pojavili srčani problemi tijekom liječenja lijekom Lorviqua.
English: A total of 139 patients with ALK-positive advanced NSCLC after treatment with at least one second-generation ALK TKI were enrolled in the Phase 2 portion of the study.
Croatian: Ukupno 139 bolesnika s uznapredovalim NSCLC-om pozitivnim na ALK nakon liječenja najmanje jednim inhibitorom tirozin kinaze ALK druge generacije bilo je uključeno u dio ispitivanja faze 2.
English: Lorviqua 25 mg is provided in blisters of 10 tablets, which are available in packs containing 90 tablets (9 blisters) or 120 tablets (12 blisters).
Croatian: Lorviqua 25 mg dostupna je u blisterima s po 10 tableta koji se nalaze u pakiranjima od 90 tableta (9 blistera) ili 120 tableta (12 blistera).
English: NR (4.1, NR)
Croatian: ND (4,1; ND)
English: The plasma half-life of lorlatinib after a single 100 mg dose was 23.6 hours.
Croatian: Nakon pojedinačne doze od 100 mg poluvijek lorlatiniba u plazmi bio je 23,6 sati.
English: Lorviqua is for oral use.
Croatian: Lorviqua je za peroralnu primjenu.
English: In vitro, lorlatinib has a low potential to cause drug-drug interactions by induction of CYP1A2.
Croatian: In vitro lorlatinib ima mali potencijal za uzrokovanje interakcija lijekova indukcijom CYP1A2.
English: At 100 mg once daily, the geometric mean (% coefficient of variation [CV]) peak plasma concentration was 577 (42) ng/mL and the AUC24 was 5,650 (39) ng·h/mL in patients with cancer.
Croatian: Pri dozi od 100 mg primijenjenoj jednom na dan geometrijska sredina (% koeficijent varijacije) vršne koncentracije u plazmi iznosila je 577 (42) ng/ml, dok je AUC24 iznosio 5650 (39) ng·h/ml u bolesnika s rakom.
English: If concurrent use of the strong CYP3A4/5 inhibitor is discontinued, lorlatinib should be resumed at the dose used prior to the initiation of the strong CYP3A4/5 inhibitor and after a washout period of 3 to 5 half-lives of the strong CYP3A4/5 inhibitor.
Croatian: Ako se prekine istodobna primjena snažnog inhibitora CYP3A4/5, potrebno je nastaviti s lorlatinibom u dozi koja se primjenjivala prije uvođenja snažnog inhibitora CYP3A4/5 te nakon razdoblja potpune eliminacije lijeka iz organizma (engl. washout period) od 3 do 5 poluvjekova snažnog inhibitora CYP3A4/5.
English: If no pacemaker placed, resume lorlatinib at 1 reduced dose level only when symptoms resolve and PR interval is less than 200 msec.
Croatian: Ako nije ugrađen elektrostimulator srca, nastavite s dozom lorlatiniba smanjenom za 1 razinu tek kada se simptomi povuku, a PR-interval bude manji od 200 ms.
English: In addition, the effect of a single oral dose of lorlatinib (50 mg, 75 mg, and 100 mg) with and without 200 mg once daily itraconazole was evaluated in a 2-way crossover study in 16 healthy volunteers.
Croatian: Nadalje, učinak pojedinačne peroralno primijenjene doze lorlatiniba (50 mg, 75 mg i 100 mg), uz primjenu 200 mg itrakonazola jednom na dan i bez te primjene, procijenjen je u dvosmjernom ukriženom ispitivanju na 16 zdravih dobrovoljaca.
English: How to store Lorviqua 6.
Croatian: Kako čuvati lijek Lorviqua 6.
English: In the prostate, minimal to mild glandular atrophy was observed in dogs at dose equivalent to human clinical exposure at the recommended posology).
Croatian: U pasa je opažena minimalna do blaga žljezdana atrofija u prostati pri dozi koja odgovara kliničkoj izloženosti ljudi pri preporučenom doziranju).
English: a Hypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia).
Croatian: Hiperkolesterolemija (uključuje povećane razine kolesterola u krvi, hiperkolesterolemiju).
English: Each pack contains 90 film-coated tablets in 9 blisters or 120 film-coated tablets in 12 blisters.
Croatian: Jedno pakiranje sadrži 90 filmom obloženih tableta u 9 blistera ili 120 filmom obloženih tableta u 12 blistera.
English: Following oral administration of a 100 mg radiolabelled dose of lorlatinib, a mean 47.7% of the radioactivity was recovered in urine and 40.9% of the radioactivity was recovered in faeces, with overall mean total recovery of 88.6%.
Croatian: Nakon peroralne primjene radioaktivno obilježene doze lorlatiniba od 100 mg, srednja vrijednost radioaktivnosti nađene u mokraći bila je 47,7 %, a u stolici 40,9 % te je srednja vrijednost ukupno nađene radioaktivnosti iznosila 88,6 %.
English: This is because it may harm your baby.
Croatian: To je zato jer taj lijek može naškoditi
English: If a strong CYP3A4/5 inhibitor must be co-administered, the starting lorlatinib dose of 100 mg once daily should be reduced to once daily 75 mg dose (see sections 4.5 and 5.2).
Croatian: Ako je potrebno istodobno primijeniti snažan inhibitor CYP3A4/5, mora se sniziti početna doza lorlatiniba od 100 mg jednom na dan na dozu od 75 mg jednom na dan (vidjeti dijelove 4.5 i 5.2).
English: What you need to know before you take Lorviqua
Croatian: Što morate znati prije nego počnete uzimati lijek Lorviqua
English: Permanently discontinue lorlatinib.
Croatian: Trajno prekinite primjenu lorlatiniba.
English: One prior ALK TKIa with or without prior chemotherapy
Croatian: Jedan prethodan TKI ALK s prethodnom kemoterapijom ili bez nje
English: Česká republika
Croatian: Slovenská republika
English: Tell your doctor right away about changes in your heart beat (fast or slow), light-headedness, fainting, dizziness or shortness of breath.
Croatian: Odmah se obratite svom liječniku i obavijestite ga o promjenama u otkucajima srca (brzi ili spori), ako osjetite ošamućenost, nesvjesticu, omaglicu ili nedostatak zraka.
English: See Possible side effects in section 4 for more information.
Croatian: Za dodatne informacije pogledajte „Moguće nuspojave“ u dijelu 4.
English: The main efficacy results for Study A are included in Tables 3 and 4.
Croatian: A navedeni su u tablicama 3 i 4.
English: First degree AV block: Symptomatic
Croatian: AV blok prvog stupnja: simptomatski
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).
Croatian: Zbog mogućeg povećanja razina lipaza i amilaza, bolesnike je potrebno pratiti prije početka liječenja lorlatinibom i redovito nakon toga prema kliničkoj potrebi (vidjeti dio 4.2).
English: In vitro studies indicated that lorlatinib may have the potential to inhibit P-glycoprotein (P-gp, systemically and at the gastrointestinal [GI] tract), BCRP (GI tract), OATP1B1, OATP1B3, OCT1, MATE1 and OAT3 at clinically relevant concentrations.
Croatian: In vitro ispitivanja pokazala su da lorlatinib može imati potencijal za inhibiciju P-glikoproteina (P-gp, sistemski i u probavnom traktu), proteina rezistencije raka dojke (BCRP, u probavnom traktu), OATP1B1, OATP1B3, OCT1, MATE1 i OAT3 pri klinički značajnim koncentracijama.
English: • Second dose reduction: 50 mg taken orally once daily
Croatian: • drugo smanjenje doze: 50 mg peroralno jednom na dan.
English: Lorviqua contains the active substance lorlatinib, a medicine that is used for treatment of adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC).
Croatian: Lorviqua sadrži djelatnu tvar lorlatinib, lijek koji se koristi za liječenje odraslih osoba s uznapredovalim stadijima oblika raka pluća koji se zove „rak pluća nemalih stanica“ (engl. non-small cell lung cancer, NSCLC).
English: Among the 31 patients with a confirmed IC objective tumour response and at least one measurable brain metastasis at baseline by ICR, the median IC-TTR was 1.4 months (range: 1.2 to 16.2 months).
Croatian: Među 31 bolesnikom s objektivnim IK tumorskim odgovorom i najmanje jednom mjerljivom metastazom u mozgu na početku ispitivanja potvrđenom neovisnom središnjom procjenom, medijan vremena do prvog IK tumorskog odgovora iznosio je 1,4 mjeseca (u rasponu od 1,2 do 16,2 mjeseca).
English: Seminiferous tubular degeneration and/or atrophy in the testes, and epididymal changes (inflammation and/or vacuolation) were observed in the rat and dog.
Croatian: U štakora i pasa opažene su degeneracija seminifernih tubula i/ili atrofija u testisima te epididimalne promjene (upala i/ili vakuolizacija).
English: inhibitors; or - you have been previously treated with crizotinib followed by another ALK inhibitor.
Croatian: a; ili - ako ste bili prethodno liječeni krizotinibom nakon kojeg je bio primijenjen neki drugi inhibitor ALK-a.
English: Foetal morphologic abnormalities included rotated limbs, supernumerary digits, gastroschisis, malformed kidneys, domed head, high arched palate, and dilation of ventricles of the brain.
Croatian: Morfološke abnormalnosti fetusa uključivale su zaokrenute udove, polidaktiliju, gastroshizu, malformaciju bubrega, kupolastu glavu, visoko nepce i dilataciju ventrikula mozga.
English: In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring, including LVEF assessment, should be considered.
Croatian: U bolesnika u kojih se tijekom liječenja razviju značajni znakovi/simptomi srčanih bolesti, potrebno je razmotriti praćenje srčane aktivnosti, uključujući procjenu istisne frakcije lijeve klijetke.
English: Your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely: - cough, shortness of breath, chest pain, or worsening breathing problems - slow pulse, (50 beats per minute or less), feeling tired, dizzy or faint, or losing consciousness - abdominal (belly) pain, back pain, nausea, vomiting, itching, yellowing of the skin and eyes - mental status changes; changes in cognition including confusion, memory loss, and reduced ability to concentrate; changes in mood including irritability and mood swings; and changes in speech including difficulty speaking, such as slurred or slow speech
Croatian: Liječnik Vam može smanjiti dozu, prekinuti liječenje na kraće vrijeme ili potpuno prekinuti liječenje: - kašalj, nedostatak zraka, bol u prsnom košu ili pogoršanje problema s disanjem - spor puls, (50 ili manje otkucaja u minuti), osjećaj umora, omaglice, nesvjestice ili gubljenje svijesti - bol u trbuhu, bol u leđima, mučnina, povraćanje, svrbež, žutilo kože i bjeloočnica - promjene mentalnog stanja; promjene u umnoj aktivnosti uključujući smetenost, gubitak pamćenja i smanjenu mogućnost koncentracije; promjene u raspoloženju uključujući razdražljivost i nagle promjene raspoloženja; promjene u govoru uključujući otežan govor, kao što je nerazgovijetan ili spor govor
English: Based on non-clinical safety findings, male fertility may be compromised during treatment with lorlatinib (see section 5.3).
Croatian: Na temelju nekliničkih rezultata o sigurnosti primjene, plodnost muškarca može biti smanjena tijekom liječenja lorlatinibom (vidjeti dio 5.3).
English: * In patients with at least one measurable brain metastasis at baseline.
Croatian: U bolesnika s najmanje jednom mjerljivom metastazom u mozgu na početku ispitivanja.
English: These are listed under Do not take Lorviqua, at the start of section 2.
Croatian: Oni su navedeni na početku dijela 2 pod naslovom Nemojte uzimati lijek Lorviqua.
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
Croatian: Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: Withhold lorlatinib until recovery of hypercholesterolaemia and/or hypertriglyceridaemia to moderate or mild severity grade.
Croatian: Ne primjenjujte lorlatinib dok se hiperkolesterolemija i/ili hipertrigliceridemija ne vrate na umjereni ili blagi stupanj težine.
English: Population pharmacokinetic analyses have shown that lorlatinib exposure was not clinically meaningfully altered in patients with mild hepatic impairment (n = 50).
Croatian: Populacijske farmakokinetičke analize pokazale su da se izloženost lorlatinibu nije klinički značajno promijenila u bolesnika s blagim oštećenjem funkcije jetre (n = 50).
English: Nervous system disorders Cognitive effectse Peripheral neuropathyf Headache Speech effectsg
Croatian: Poremećaji živčanog sustava Učinci na kognitivne funkcije Periferna neuropatija Glavobolja
English: The IC ORR was 54.5% for Asians (95% CI: 32.2, 75.6) and 46.4% for non-Asians (95% CI: 27.5, 66.1).
Croatian: Stopa IK objektivnog odgovora iznosila je 54,5 % za osobe azijskog porijekla (95 % CI: 32,2; 75,6) i 46,4 % za osobe koje nisu azijskog porijekla (95 % CI: 27,5; 66,1).
English: An alternative concomitant medicinal product with less potential to inhibit CYP3A4/5 should be considered.
Croatian: Potrebno je razmotriti istodobnu primjenu nekog drugog lijeka koji ima manji potencijal za inhibiciju CYP3A4/5.
English: Concurrent use of lorlatinib with medicinal products that are strong CYP3A4/5 inhibitors and grapefruit juice products may increase lorlatinib plasma concentrations.
Croatian: Istodobna primjena lorlatiniba s lijekovima koji su snažni inhibitori CYP3A4/5 i proizvodima koji sadrže sok od grejpfruta može povećati koncentracije lorlatiniba u plazmi.
English: Lorlatinib dosing
Croatian: Doziranje lorlatiniba
English: Lorviqua contains lactose
Croatian: Lorviqua sadrži laktozu
English: b Hypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia).
Croatian: Hipertrigliceridemija (uključuje povećane razine triglicerida u krvi, hipertrigliceridemiju).
English: Peripheral neuropathy (including burning sensation, carpal tunnel syndrome, dysaesthesia, formication, gait disturbance, hypoaesthesia, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity,
Croatian: f Periferna neuropatija (uključujući osjećaj žarenja, sindrom karpalnog tunela, disesteziju, mravinjanje, poremećaj hoda, hipoesteziju, mišićnu slabost, neuralgiju, perifernu neuropatiju, neurotoksičnost, paresteziju, perifernu senzornu neuropatiju, paralizu peronealnog živca, senzorni poremećaj).
English: If symptoms and the second degree AV block resolve or if patients revert to asymptomatic first degree AV block, resume lorlatinib at 1 reduced dose level.
Croatian: Ako se simptomi i AV blok drugog stupnja povuku ili ako se bolesnik vrati na asimptomatski AV blok prvog stupnja, nastavite primjenjivati dozu lorlatiniba smanjenu za 1 razinu.
English: No increases in the mean QTc were observed at the mean observed lorlatinib concentrations in this study.
Croatian: U ovom ispitivanju nisu opažena povećanja srednje vrijednosti korigiranog QT intervala pri srednjim vrijednostima zabilježenih koncentracija lorlatiniba.
English: Strong cytochrome P-450 (CYP) 3A4/5 inhibitors
Croatian: Snažni inhibitori citokroma P-450 (CYP) 3A4/5
English: In vitro studies indicated that lorlatinib is a time-dependent inhibitor as well as an inducer of CYP3A4/5 and it activates the human pregnane-X-receptor (PXR), with the net effect in vivo being induction.
Croatian: In vitro ispitivanja pokazala su da je lorlatinib o vremenu ovisan inhibitor, a također i induktor CYP3A4/5 te da aktivira ljudski pregnanski receptor X (PXR), dok je njegov neto učinak in vivo indukcija.
English: The use of lorlatinib has been associated with increases in serum cholesterol and triglycerides (see section 4.8).
Croatian: Primjena lorlatiniba povezana je s povišenim kolesterolom i trigliceridima u serumu (vidjeti dio 4.8).
English: Lorviqua is only given to patients who have an alteration in the ALK gene, see How Lorviqua works below.
Croatian: Lorviqua se isključivo daje bolesnicima s promjenom u genu za ALK, vidjeti „Kako djeluje lijek Lorviqua“ u nastavku.
English: Withhold lorlatinib until symptoms resolve to less than or equal to Grade 2 or baseline.
Croatian: Ne primjenjujte lorlatinib dok se simptomi ne povuku na one manje od ili jednake 2. stupnju ili početnoj vrijednosti.
English: uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Croatian: Nuspojave navedene u tablici 2 prikazane su prema klasifikaciji organskih sustava i kategorijama učestalosti na temelju sljedeće podjele: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
English: Withhold lorlatinib until lipase or amylase returns to baseline.
Croatian: Ne primjenjujte lorlatinib dok se lipaze ili amilaze ne vrate na početne vrijednosti.
English: No information is available for lorlatinib in patients with moderate or severe hepatic impairment.
Croatian: Nema podataka o primjeni lorlatiniba u bolesnika s umjerenim ili teškim oštećenjem jetre.
English: Lorviqua 100 mg is provided in blisters of 10 tablets, which are available in packs containing 30 tablets (3 blisters).
Croatian: Lorviqua 100 mg dostupna je u blisterima s po 10 tableta koji se nalaze u pakiranjima od 30 tableta (3 blistera).
English: Population pharmacokinetic analyses have shown that lorlatinib exposure was not clinically meaningfully altered in patients with mild (n = 103) or moderate (n = 41) renal impairment (CLcr > 30 mL/min).
Croatian: Populacijske farmakokinetičke analize pokazale su da se izloženost lorlatinibu nije klinički značajno promijenila u bolesnika s blagim (n = 103) ili umjerenim (n = 41) oštećenjem funkcije bubrega (CLcr > 30 ml/min).
English: The most frequent adverse reaction that led to permanent discontinuations was cognitive effects.
Croatian: Najučestalija nuspojava koja je dovela do trajnih prekida liječenja bili su učinci na kognitivne funkcije.
English: Initiate or increase the dose of lipid-lowering medicinal products, if indicated (see section 4.2).
Croatian: Ako je indicirano, uvedite ili povećajte dozu lijekova za smanjenje koncentracije lipida (vidjeti dio 4.2).
English: Lorlatinib was studied in a population of patients that excluded those with second-degree or third-degree AV block (unless paced) or any AV block with PR interval > 220 msec. PR interval prolongation and AV block have been reported in patients receiving lorlatinib (see section 5.2).
Croatian: Lorlatinib je ispitivan u populaciji bolesnika koja nije uključivala one bolesnike koji su imali AV blok drugog ili trećeg stupnja (osim ako su imali elektrostimulator) ili bilo koji AV blok s PR-intervalom > 220 ms.
English: Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after:
Croatian: Lijek Lorviqua indiciran je kao monoterapija za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC), pozitivnim na kinazu anaplastičnog limfoma (engl. anaplastic lymphoma kinase, ALK) čija je bolest uznapredovala nakon:
English: If a strong CYP3A4/5 inhibitor must be concomitantly administered, a dose reduction of lorlatinib is recommended (see section 4.2).
Croatian: Ako se istodobno mora primijeniti snažan inhibitor CYP3A4/5, preporučuje se smanjenje doze lorlatiniba (vidjeti dio 4.2).
English: Oedema (including generalised oedema, oedema, oedema peripheral, peripheral swelling, swelling).
Croatian: l Edem (uključujući generalizirani edem, edem, periferni edem, periferno oticanje, oticanje).
English: Lorlatinib should not be used during breast-feeding.
Croatian: Lorlatinib se ne smije primjenjivati tijekom dojenja.
English: Second degree AV block Symptomatic
Croatian: AV blok drugog stupnja simptomatski