FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor right away about changes in your heart beat (fast or slow), light-headedness, fainting, dizziness or shortness of breath.
Slovenian: Takoj obvestite zdravnika o spremembah srčnega utripa (pospešen ali upočasnjen utrip), vrtoglavici, omedlevici, omotici ali kratki sapi.
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.
Slovenian: Populacijske farmakokinetične analize pri bolnikih z napredovalim NSCLC in pri zdravih prostovoljcih kažejo, da starost, spol, rasa, telesna masa ter fenotipi CYP3A5 in CYP2C19 nimajo klinično pomembnih vplivov.
English: In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring, including LVEF assessment, should be considered.
Slovenian: Pri bolnikih, pri katerih se med zdravljenjem pojavijo pomembni srčni znaki/simptomi, je treba razmisliti o spremljanju srca, vključno z oceno LVEF.
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).
Slovenian: Pri bolnikih, ki so prejemali lorlatinib, so opazili učinke na osrednje živčevje, vključno s spremembami v kognitivni funkciji, razpoloženju ali govoru (glejte poglavje 4.8).
English: Other medicines and Lorviqua
Slovenian: Druga zdravila in zdravilo Lorviqua
English: - Swallow the tablets whole and do not crush, chew or dissolve the tablets.
Slovenian: - Tablete pogoltnite cele in jih ne drobite, žvečite ali raztapljajte.
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).
Slovenian: V preučevani populaciji je bila največja srednja vrednost spremembe intervala PR od izhodišča 16,4 ms (2-stranski 90 % zgornji IZ 19,4 ms) (glejte poglavja 4.2, 4.4 in 4.8).
English: • rifampicin (used to treat tuberculosis)
Slovenian: • rifampicin (uporablja se za zdravljenje tuberkuloze),
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.
Slovenian: Pri bolnikih z dejavniki tveganja za srce in bolnikih s stanji, ki lahko vplivajo na LVEF, je treba razmisliti o spremljanju srca, vključno z oceno LVEF ob izhodišču in med zdravljenjem.
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.
Slovenian: Mediani čas do pojava zvečanja vrednosti lipaze in amilaze v serumu je 70 dni (razpon: od 7 do 696 dni) oziroma 41 dni (razpon: od 7 do 489 dni).
English: It is unknown whether lorlatinib and its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se lorlatinib in njegovi presnovki izločajo v materino mleko.
English: In vitro studies with drug transporters
Slovenian: Študije in vitro s prenašalci zdravil
English: Overall efficacy results in Study A by prior treatment
Slovenian: Rezultati celokupne učinkovitosti v študiji A glede na predhodno zdravljenje
English: If you are able to have children, you must use highly effective contraception (for example, double-barrier contraception such as condom and diaphragm) while on treatment and for at least 5 weeks after stopping treatment.
Slovenian: Če lahko zanosite, morate med zdravljenjem in še vsaj 5 tednov po prenehanju zdravljenja uporabljati visoko učinkovito kontracepcijo (npr. kontracepcijo z dvojno pregrado, kot sta kondom in diafragma).
English: Risk of pancreatitis should be considered in patients receiving lorlatinib due to concomitant hypertriglyceridemia and/or a potential intrinsic mechanism.
Slovenian: Pri bolnikih, ki prejemajo lorlatinib, je treba zaradi sočasne hipertrigliceridemije in/ali morebitnega intrinzičnega mehanizma upoštevati tveganje za pankreatitis.
English: • First dose reduction: 75 mg taken orally once daily
Slovenian: • Prvo zmanjšanje odmerka: 75 mg peroralno enkrat na dan;
English: • medicines containing St. John's wort (Hypericum perforatum, a herbal preparation)
Slovenian: • zdravila, ki vsebujejo šentjanževko (Hypericum perforatum, pripravek rastlinskega izvora).
English: In embryo-foetal toxicity studies, conducted in rats and rabbits, respectively, increased embryolethality and lower foetal body weights and malformations were observed.
Slovenian: V študijah embriofetalne toksičnosti na podganah in kuncih so opazili zvečano smrtnost zarodkov ter manjšo telesno maso in malformacije zarodkov.
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.
Slovenian: Za nadaljnjo potrditev učinkovitosti lorlatiniba pri bolnikih, ki so napredovali po zdravljenju z alektinibom ali ceritinibom kot prvim zdravilom ALK TKI, mora imetnik DzP izvesti prospektivno študijo z eno skupino za preučevanje bolnikov v takem okviru.
English: - If your next dose is in less than 4 hours away, skip the missed tablet.
Slovenian: - Če morate naslednji odmerek vzeti čez manj kot 4 ure, pozabljeno tableto izpustite.
English: Intracranial* efficacy results in Study A by prior treatment Efficacy parameter
Slovenian: Rezultati intrakranialne učinkovitosti v študiji A * glede na predhodno zdravljenje
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%).
Slovenian: Najpogostejši učinek na razpoloženje katerekoli stopnje je bil razdražljivost (6,1 %), ki je bila tudi najpogostejši neželeni učinek 3. ali 4. stopnje (1,0 %).
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.
Slovenian: Pri 295 bolnikih v študiji A, ki so prejemali lorlatinib v priporočenem odmerku 100 mg enkrat na dan in so jim izmerili EKG, so lorlatinib preučevali v populaciji bolnikov, iz katere so bili izključeni bolniki z intervalom QTc > 470 ms.
English: Each pack contains 30 film-coated tablets in 3 blisters.
Slovenian: Eno pakiranje vsebuje 30 filmsko obloženih tablet v 3 pretisnih omotih.
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).
Slovenian: Med 31 bolniki s potrjenim IC objektivnim odzivom tumorja na zdravljenje in vsaj eno merljivo možgansko metastazo ob izhodišču po ICR je bil mediani IC-TTR 1,4 meseca (razpon: od 1,2 do 16,2 meseca).
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.
Slovenian: Od 139 bolnikov jih je 20 % prejemalo 1 predhodni ALK TKI, z izjemo krizotiniba, 47 % bolnikov je prejemalo 2 predhodna ALK TKI, 33 % bolnikov pa je prejemalo 3 ali več predhodnih ALK TKI.
English: The Eastern Cooperative Oncology Group (ECOG) performance status at baseline was 0 or 1 in 96% patients.
Slovenian: Pri 96 % bolnikov je bilo stanje zmogljivosti po skupini ECOG (Eastern Cooperative Oncology Group) ob izhodišču 0 ali 1.
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.
Slovenian: Zunaj razpona odmerkov od 10 do 200 mg je na voljo le malo podatkov, vendar po enkratnem odmerku pri AUCinf in Cmax niso opazili odstopanj od linearnosti.
English: Concomitant administration of lorlatinib with CYP2B6 substrates (e.g. bupropion, efavirenz) may result in reduced plasma concentrations of the CYP2B6 substrate.
Slovenian: Sočasno dajanje lorlatiniba in substratov CYP2B6 (npr. bupropion, efavirenz) lahko povzroči zmanjšanje koncentracij substrata CYP2B6 v plazmi.
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).
Slovenian: V študiji, izvedeni pri zdravih prostovoljcih, je bila sočasna uporaba lorlatiniba in rifampicina, močnega induktorja CYP3A4/5, povezana z zvečanjem vrednosti alanin-aminotransferaze (ALT) in aspartat-aminotransferaze (AST), brez zvečanja vrednosti celokupnega bilirubina in alkalne fosfataze (glejte poglavje 4.5).
English: Do not breast-feed while taking this medicine and for 7 days after the last dose.
Slovenian: - Dojenje Med jemanjem tega zdravila in še 7 dni po zadnjem odmerku ne dojite.
English: Withhold lorlatinib until symptoms have returned to baseline and consider initiating corticosteroids.
Slovenian: Prekinite zdravljenje z lorlatinibom, dokler se simptomi ne vrnejo na izhodiščno raven, in razmislite o uvedbi kortikosteroidov.
English: As lorlatinib is metabolised in the liver, hepatic impairment is likely to increase lorlatinib plasma concentrations.
Slovenian: Ker se lorlatinib presnavlja v jetrih, je verjetno, da okvara jeter zveča koncentracije lorlatiniba v plazmi.
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.
Slovenian: Če sočasno zdravljenje z močnim zaviralcem CYP3A4/5 prekinete, je treba zdravljenje z lorlatinibom nadaljevati v odmerku, ki ste ga uporabili pred uvedbo močnega zaviralca CYP3A4/5 in po obdobju izpiranja od 3 do 5 razpolovnih časov močnega zaviralca CYP3A4/5.
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.
Slovenian: Lorlatinib hitro doseže največje koncentracije v plazmi, z medianim Tmax 1,2 ure po enkratnem odmerku 100 mg in 2,0 uri po večkratnem odmerjanju 100 mg enkrat na dan.
English: Grade 2: Moderate
Slovenian: 2. stopnja: zmerni
English: d Hallucinations (including auditory hallucination, hallucination, visual hallucination).
Slovenian: Halucinacije (vključno s slušnimi halucinacijami, halucinacijami, vidnimi halucinacijami).
English: What you need to know before you take Lorviqua 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Lorviqua 3.
English: During treatment with lorlatinib and for at least 14 weeks after the final dose, male patients with female partners of childbearing potential must use effective contraception, including a condom, and male patients with pregnant partners must use condoms.
Slovenian: Med zdravljenjem z lorlatinibom in še vsaj 14 tednov po zadnjem odmerku morajo bolniki, ki imajo partnerice v rodni dobi, uporabljati učinkovito kontracepcijo, vključno s kondomom, bolniki z nosečimi partnericami pa morajo uporabljati kondome.
English: If a hormonal method of contraception is unavoidable, then a condom must be used in combination with the hormonal method.
Slovenian: Če se hormonski metodi kontracepcije ni mogoče izogniti, je treba to metodo kombinirati z uporabo kondomov.
English: • carbamazepine, phenytoin (used to treat epilepsy)
Slovenian: • karbamazepin, fenitoin (uporabljata se za zdravljenje epilepsije),
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.
Slovenian: Pri odmerku 100 mg enkrat na dan pri bolnikih z rakom je bila geometrična sredina (% koeficienta variance [KV]) največje koncentracije v plazmi 577 (42) ng/ml, vrednost AUC24 pa je bila 5.650 (39) ng·h/ml.
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.
Slovenian: Okrajšave: ALK = anaplastična limfomska kinaza; IZ = interval zaupanja; ICR = neodvisno centralno preverjanje (Independent Central Review); n = število bolnikov; NR = niso dosegli (Not Reached); TKI = zaviralec tirozin-kinaze (Tyrosine Kinase Inhibitor).
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%.
Slovenian: Po peroralnem dajanju radioaktivno označenega 100 mg odmerka lorlatiniba so v urinu zaznali povprečno 47,7 % radioaktivnosti, v blatu pa 40,9 %; celokupna povprečna zaznana radioaktivnost je bila 88,6 %.
English: Pneumonitis (including interstitial lung disease, pneumonitis).
Slovenian: Pnevmonitis (vključno z intersticijsko boleznijo pljuč, pnevmonitisom).
English: - mood or memory problems, such as change in your mood (including depression, euphoria and mood swings), irritability, aggression, agitation, anxiety or a change in your personality and episodes of confusion.
Slovenian: - težave z razpoloženjem ali spominom, kot so spremembe razpoloženja (vključno z depresijo, evforijo in nihanjem razpoloženja), razdražljivost, agresivnost, vznemirjenje, tesnoba ali spremembe osebnosti in epizode zmedenosti.
English: b Per ICR.
Slovenian: Glede na ICR.
English: Each pack contains 90 film-coated tablets in 9 blisters or 120 film-coated tablets in 12 blisters.
Slovenian: Eno pakiranje vsebuje 90 filmsko obloženih tablet v 9 pretisnih omotih ali 120 filmsko obloženih tablet v 12 pretisnih omotih.
English: Adverse reactions of increase in serum cholesterol or triglycerides were reported in 84.4% and 67.1% of patients, respectively.
Slovenian: O zvečanju vrednosti holesterola ali trigliceridov v serumu kot o neželenih učinkih so poročali pri 84,4 % oziroma 67,1 % bolnikov.
English: If no pacemaker placed, resume lorlatinib at 1 reduced dose level only when symptoms resolve and PR interval is less than 200 msec.
Slovenian: Če srčnega spodbujevalnika ne boste vstavili, nadaljujte zdravljenje z lorlatinibom v odmerku, zmanjšanem za 1 odmerno raven, vendar le, če simptomi izzvenijo in je interval PR krajši od 200 ms.
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).
Slovenian: Pri teh bolnikih sta se blaga ali zmerna neželena učinka hiperholesterolemije oziroma hipertrigliceridemije pojavila pri 67,8 % oziroma 50,5 % bolnikov (glejte poglavje 4.4).
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'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija v 25 mg ali 100 mg tableti, kar v bistvu pomeni "brez natrija".
English: Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitors, ATC code: L01XE44
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinskih kinaz; oznaka ATC: L01XE44
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.
Slovenian: Uporabo lorlatiniba pri zdravljenju ALK-pozitivnega napredovalega NSCLC po zdravljenju z najmanj 1 ALK TKI druge generacije so preučevali v študiji A, multicentrični študiji 1./2.
English: Lorviqua is for oral use.
Slovenian: Zdravilo Lorviqua je za peroralno uporabo.
English: Monitor ECG/symptoms potentially related to AV block closely.
Slovenian: Skrbno spremljajte EKG/simptome, ki so lahko povezani z AV-blokom.
English: - pain in the back or abdomen (belly), yellowing of the skin and eyes (jaundice), nausea or vomiting.
Slovenian: - bolečina v hrbtu ali trebuhu, porumenelost kože in beločnic (zlatenica), občutek siljenja na bruhanje ali bruhanje.
English: uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Slovenian: V preglednici 2 navedeni neželeni učinki so razvrščeni glede na organski sistem in pogostnost na naslednji način: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
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).
Slovenian: IC-ORR je bil pri Azijcih 54,5 % (95 % IZ: 32,2; 75,6), pri Neazijcih pa 46,4 % (95 %IZ: 27,5; 66,1).
English: At steady-state, the systemic exposure (AUC24 and Cmax) increased less than proportionally over the 10 to 200 mg dose range.
Slovenian: V stanju dinamičnega ravnovesja se je sistemska izpostavljenost (AUC24 in Cmax) v razponu odmerkov od 10 do 200 mg povečevala manj kot sorazmerno.
English: Administration of lorlatinib with a high fat, high calorie meal resulted in 5% higher exposure compared to fasted conditions.
Slovenian: Po dajanju lorlatiniba skupaj z obrokom z visoko vsebnostjo maščob in kalorij je bila izpostavljenost 5 % večja v primerjavi z dajanjem na tešče.
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.
Slovenian: Mediani čas do pojava hudega zvečanja vrednosti holesterola in trigliceridov v serumu je 201 dan (razpon: od 42 do 518 dni) oziroma 127 dni (razpon: od 15 do 358 dni).
English: No tablet should be ingested if it is broken, cracked, or otherwise not intact.
Slovenian: Če je tableta zlomljena, razpokana ali kakorkoli drugače poškodovana, je ne smemo zaužiti.
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.
Slovenian: Če se huda hiperholesterolemija in/ali hipertrigliceridemija ponovita kljub zdravljenju z največjim odmerkom zdravila za zniževanje ravni lipidov b skladno z ustreznimi navodili za predpisovanje zdravila, zmanjšajte odmerek lorlatiniba za 1 odmerno raven.
English: • Second dose reduction: 50 mg taken orally once daily
Slovenian: • Drugo zmanjšanje odmerka: 50 mg peroralno enkrat na dan.
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).
Slovenian: Če je sočasno dajanje močnega zaviralca CYP3A4/5 nujno, je treba začetni odmerek lorlatiniba 100 mg enkrat na dan zmanjšati na odmerek 75 mg enkrat na dan (glejte poglavji 4.5 in 5.2).
English: The recommended dose is 100 mg lorlatinib taken orally once daily.
Slovenian: Priporočeni odmerek je 100 mg lorlatiniba peroralno enkrat na dan.
English: • enzalutamide (used to treat prostate cancer)
Slovenian: • enzalutamid (uporablja se za zdravljenje raka prostate),
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%).
Slovenian: Najpogostejši učinek na govor katerekoli stopnje je bil dizartrija (4,1 %), najpogostejši učinek 3. ali 4. stopnje pa upočasnjen govor (0,3 %).
English: Progression-free survival Median, months (95% CI)
Slovenian: Preživetje brez napredovanja bolezni mediana, meseci (95 % IZ)
English: An alternative concomitant medicinal product with less potential to inhibit CYP3A4/5 should be considered.
Slovenian: Razmisliti je treba o drugem sočasnem zdravilu z manjšim potencialom za zaviranje CYP3A4/5.
English: The use of lorlatinib has been associated with increases in serum cholesterol and triglycerides (see section 4.8).
Slovenian: Uporaba lorlatiniba je povezana z zvečanji vrednosti holesterola in trigliceridov v serumu (glejte poglavje 4.8).
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).
Slovenian: Zdravilo Lorviqua 25 mg je na voljo v pretisnih omotih po 10 tablet, ki so na voljo v pakiranjih, ki vsebujejo 90 tablet (9 pretisnih omotov) ali 120 tablet (12 pretisnih omotov).
English: Frequency category All Grades
Slovenian: Kategorija pogostnosti Vse stopnje % Stopnji 3-4
English: Repeat-dose toxicity
Slovenian: Toksičnost pri ponavljajočih odmerkih
English: b Lipid-lowering therapy may include: HMG CoA reductase inhibitor, nicotinic acid, fibric acid derivatives, or ethyl esters of omega-3 fatty acids.
Slovenian: Zdravila za zniževanje ravni lipidov lahko vključujejo: zaviralec reduktaze HMG CoA, nikotinsko kislino, derivate fibrične kisline (fibrate) ali etilne estre maščobnih kislin omega-3.
English: Interstitial lung disease/Pneumonitis
Slovenian: Intersticijska bolezen pljuč/pnevmonitis
English: The median time to onset for both hypercholesterolaemia and hypertriglyceridaemia was 15 days (range: 1 to 399 days).
Slovenian: Mediani čas do pojava hiperholesterolemije in hipertrigliceridemije je bil 15 dni (razpon: od 1 do 399 dni).
English: You should take special care when driving and using machines when taking Lorviqua because of its effects on your mental state.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med jemanjem zdravila Lorviqua morate biti zaradi njegovih učinkov na vaše duševno stanje pri vožnji in upravljanju strojev zelo previdni.
English: Unchanged lorlatinib was the major component of human plasma and faeces, accounting for 44% and 9.1% of total radioactivity, respectively.
Slovenian: Lorlatinib v nespremenjeni obliki je bil prevladujoča sestavina plazme in blata pri človeku, kjer je prispeval 44 % oziroma 9,1 % skupne radioaktivnosti.
English: This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Slovenian: Zdravilo je pridobilo tako imenovano „pogojno dovoljenje za promet“.
English: At single dose, lorlatinib systemic exposure (AUCinf and Cmax) increased in a dose-related manner over the 10 to 200 mg dose range.
Slovenian: Pri enkratnem odmerku se je sistemska izpostavljenost lorlatinibu (AUCinf in Cmax) povečevala v odvisnosti od odmerka v razponu odmerkov od 10 do 200 mg.
English: Among the 284 patients with PR interval < 200 msec, 14% had PR interval prolongation ≥ 200 msec after starting lorlatinib.
Slovenian: Med 284 bolniki z intervalom PR < 200 ms se je pri 14 % bolnikov interval PR po uvedbi lorlatiniba podaljšal na ≥ 200 ms. Podaljšanje intervala PR je bilo odvisno od koncentracije.
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving lorlatinib.
Slovenian: Ženskam v rodni dobi je treba svetovati, naj se med zdravljenjem z lorlatinibom izogibajo zanositvi.
English: During treatment with lorlatinib and for at least 14 weeks after the final dose, male patients with female partners of childbearing potential must use effective contraception, including a condom, and male patients with pregnant partners must use condoms (see section 4.6).
Slovenian: Med zdravljenjem z lorlatinibom in še vsaj 14 tednov po zadnjem odmerku morajo bolniki, ki imajo partnerice v rodni dobi, uporabljati učinkovito kontracepcijo, vključno s kondomom, bolniki z nosečimi partnericami pa morajo uporabljati kondome (glejte poglavje 4.6).
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).
Slovenian: Azijcih 49,1 % (95 % IZ: 35,1; 63,2), pri Neazijcih pa 31,5 % (95 % IZ: 21,1; 43,4).
English: k Myalgia (including musculoskeletal pain, myalgia).
Slovenian: Mialgija (vključno z mišično-skeletno bolečino, mialgijo).
English: Pfizer PFE, spol.
Slovenian: Česká republika Pfizer PFE, spol.
English: Initiate or increase the dose of lipid-lowering medicinal products, if indicated (see section 4.2).
Slovenian: Če je indicirano, uvedite ali povečajte odmerek zdravil za zniževanje ravni lipidov (glejte poglavje 4.2).