FrancophonIA/ELRC3.0 huggingface dataset:
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
Slovenian: Zdravnik lahko zmanjša vaš odmerek, za krajši čas prekine zdravljenje ali pa ga trajno prekine: - kašelj, kratka sapa, bolečine v prsnem košu ali poslabšanje težav z dihanjem, - počasen utrip (50 utripov na minuto ali manj), občutek utrujenosti, omotičnosti ali omedlevice ali izguba zavesti, - bolečina v trebuhu, bolečina v hrbtu, občutek siljenja na bruhanje, bruhanje, srbenje, porumenelost kože in beločnic, - spremembe v duševnem stanju, spremembe v kogniciji, vključno z zmedenostjo, izgubo spomina in zmanjšano sposobnostjo koncentracije, spremembe razpoloženja, vključno z razdražljivostjo in nihanjem razpoloženja, ter spremembe govora, vključno z oteženim govorom, kot je nerazločen ali upočasnjen govor.
English: Lorviqua 100 mg is provided in blisters of 10 tablets, which are available in packs containing 30 tablets (3 blisters).
Slovenian: Zdravilo Lorviqua 100 mg je na voljo v pretisnih omotih po 10 tablet, ki so na voljo v pakiranjih, ki vsebujejo 30 tablet (3 pretisne omote).
English: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate.
Slovenian: Jedro tablete: mikrokristalna celuloza, kalcijev hidrogenfosfat, natrijev karboksimetilškrob, magnezijev stearat.
English: Grade 3: Severe
Slovenian: 3. stopnja: hudi
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.
Slovenian: Študije in vitro so pokazale, da je lorlatinib časovno odvisen zaviralec in tudi induktor CYP3A4/5 ter da pri človeku aktivira pregnanski receptor X (PXR - Pregnane-X-Receptor), pri čemer je neto učinek in vivo indukcija.
English: Patients received lorlatinib orally at the recommended dose of 100 mg once daily, continuously.
Slovenian: Bolniki so neprekinjeno prejemali lorlatinib v priporočenem odmerku 100 mg peroralno enkrat na dan.
English: Blood and lymphatic system disorders Anaemia
Slovenian: Bolezni krvi in limfatičnega sistema anemija zelo pogosti
English: Lipase and amylase increase
Slovenian: Zvečanje vrednosti lipaze in amilaze
English: Česká republika
Slovenian: Slovenská republika
English: If AV block does not resolve, placement of a permanent pacemaker may be considered.
Slovenian: Če AV-blok ne izzveni, lahko razmislite o vstavitvi trajnega srčnega spodbujevalnika.
English: What Lorviqua contains - The active substance is lorlatinib.
Slovenian: Kaj vsebuje zdravilo Lorviqua - Učinkovina je lorlatinib.
English: Lorlatinib demonstrated marked antitumour activity in mice bearing tumour xenografts that express echinoderm microtubule-associated protein-like 4 (EML4) fusions with ALK variant 1 (v1), including ALK mutations L1196M, G1269A, G1202R, and I1171T.
Slovenian: V predkliničnih študijah je lorlatinib v preskusih z rekombinantnimi encimi in celičnih preskusih zaviral katalitične aktivnosti nemutirane ALK in klinično pomembne mutirane kinaze ALK. Lorlatinib je pokazal izrazito protitumorsko aktivnost pri miših s heterolognimi tumorskimi presadki, ki izražajo fuzije z mikrotubuli povezane beljakovine 4 (EML4 - Echinoderm Microtubule-Associated ProteinLike 4) iglokožcev z varianto ALK 1 (v1), vključno z mutacijami ALK L1196M, G1269A, G1202R in I1171T.
English: Lorlatinib dosing PR interval prolongation/Atrioventricular (AV) block
Slovenian: Podaljšanje intervala PR/atrioventrikularni (AV) blok
English: Psychiatric disorders Mood effectsc Hallucinationsd
Slovenian: Psihiatrične motnje učinki na razpoloženje halucinacije zelo pogosti pogosti
English: Clinical studies that were conducted excluded patients with AST or ALT > 2.5 × ULN, or if due to underlying malignancy, > 5.0 × ULN or with total bilirubin > 1.5 × ULN.
Slovenian: Opravljene klinične študije niso vključevale bolnikov z vrednostjo AST ali ALT > 2,5 × ZMN oziroma > 5,0 × ZMN ali vrednostjo celokupnega bilirubina > 1,5 × ZMN v primeru osnovne maligne bolezni.
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).
Slovenian: Najpogostejši učinek na kognitivne funkcije katerekoli stopnje je bil okvara spomina (11,5 %), najpogostejša učinka 3. ali 4. stopnje pa učinek na kognitivne funkcije in zmedenost (oboje v 0,7 %).
English: Concurrent use of lorlatinib with medicinal products that are strong CYP3A4/5 inhibitors and grapefruit juice products may increase lorlatinib plasma concentrations.
Slovenian: Sočasna uporaba lorlatiniba in zdravil, ki so močni zaviralci CYP3A4/5, ter izdelkov z grenivkinim sokom lahko zveča koncentracije lorlatiniba v plazmi.
English: This medicinal product contains lactose as an excipient.
Slovenian: To zdravilo kot pomožno snov vsebuje laktozo.
English: Caution should be exercised when driving or operating machines as patients may experience CNS effects (see section 4.8).
Slovenian: Pri vožnji oziroma upravljanju strojev je potrebna previdnost, saj se pri bolnikih lahko pojavijo učinki na osrednje živčevje (glejte poglavje 4.8).
English: a Hypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia).
Slovenian: Hiperholesterolemija (vključno z zvečano vrednostjo holesterola v krvi, hiperholesterolemijo).
English: No information is available for patients with moderate or severe hepatic impairment.
Slovenian: Podatkov pri bolnikih z zmerno ali hudo okvaro jeter ni na voljo.
English: Less than 1% of the administered dose is detected as unchanged lorlatinib in urine.
Slovenian: V urinu so zaznali manj kot 1 % nespremenjenega lorlatiniba.
English: Hypercholesterolaemia/hypertriglyceridaemia
Slovenian: Hiperholesterolemija/hipertrigliceridemija
English: Each film-coated tablet contains 1.58 mg of lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 1,58 mg laktoze monohidrata.
English: You can help by reporting any side effects you may get.
Slovenian: Tudi sami lahko k temu prispevate tako, da poročate o kateremkoli neželenem il pojaviti pri vas.
English: In vitro studies indicated that lorlatinib may have the potential to inhibit UGT1A1.
Slovenian: Študije zaviranja UGT in vitro Študije in vitro so pokazale, da ima lorlatinib lahko potencial za zaviranje UGT1A1.
English: Other adverse reactions Grade 1: Mild
Slovenian: Drugi neželeni učinki 1. stopnja: blagi
English: Information for lorlatinib use in patients with severe renal impairment (CLcr < 30 mL/min) is limited (n = 1).
Slovenian: Podatki o uporabi lorlatiniba pri bolnikih s hudo okvaro ledvic (CLcr < 30 ml/min) so omejeni (n = 1).
English: No information is available for lorlatinib in patients with moderate or severe hepatic impairment.
Slovenian: Podatkov o uporabi lorlatiniba pri bolnikih z zmerno ali hudo okvaro jeter ni na voljo.
English: Lorviqua belongs to the group of medicines that inhibit an enzyme called anaplastic lymphoma kinase (ALK).
Slovenian: Zdravilo Lorviqua spada v skupino zdravil, ki zavirajo anaplastična limfomska kinaza (ALK).
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.
Slovenian: Zdravnik bo morda opravil nadaljnje preiskave in se lahko odloči za zmanjšanje odmerka zdravila Lorviqua ali prekinitev zdravljenja, če se pri vas pojavi naslednje: - težave z jetri.
English: The median duration of hypercholesterolaemia and hypertriglyceridaemia was 381 and 405 days, respectively.
Slovenian: Mediano trajanje hiperholesterolemije je bilo 381 dni, hipertrigliceridemije pa 405 dni.
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.
Slovenian: Glavne opažene toksičnosti so bile vnetje različnih tkiv (koža in vrat pri podganah ter pljuča, sapnik, koža, bezgavke in/ali ustna votlina, vključno z mandibularno kostjo, pri psih; povezano z zvečanjem števila belih krvnih celic, vrednosti fibrinogena in/ali globulina ter zmanjšanjem vrednosti albumina) in spremembe trebušne slinavke (z zvečanimi vrednostmi amilaze in lipaze), jeter, žolčnika in žolčevodov (z zvečanimi vrednostmi jetrnih encimov), reproduktivnega sistema pri moških, srčnožilnega sistema, ledvic in prebavil, perifernih živcev in osrednjega živčevja (potencial za funkcionalno kognitivno okvaro) pri odmerkih, enakovrednih odmerkom pri klinični izpostavljenosti pri človeku pri priporočenem odmerjanju.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Lorviqua.
Slovenian: Če ste negotovi, se pred začetkom jemanja zdravila Lorviqua posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Information for lorlatinib use in patients with severe (CLcr: < 30 mL/min) renal impairment is very limited.
Slovenian: Podatki o uporabi lorlatiniba pri bolnikih s hudo (CLcr: < 30 ml/min) okvaro ledvic so zelo omejeni.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer (as MA holder logo)
Slovenian: Pfizer (kot logotip imetnika dovoljenja za promet z zdravilom)
English: Introduce or modify lipid-lowering therapyb in accordance with respective prescribing information; continue lorlatinib at same dose.
Slovenian: Uvedite ali prilagodite zdravljenje z zdravilom za zniževanje ravni lipidov b skladno z ustreznimi navodili za predpisovanje zdravila; nadaljujte zdravljenje z lorlatinibom v istem odmerku.
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
Slovenian: 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.
Slovenian: Sočasno dajanje lorlatiniba je pri bolnikih povzročilo zmanjšanje vrednosti AUC peroralnega midazolama, kadar so midazolam dajali samostojno, kar kaže na to, da je lorlatinib induktor CYP3A4/5.
English: What you need to know before you take Lorviqua
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Lorviqua
English: Lorlatinib dosing
Slovenian: Odmerjanje lorlatiniba
English: h Vision disorder (including diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters).
Slovenian: Motnja vida (vključno z diplopijo, fotofobijo, fotopsijo, zamegljenim vidom, zmanjšano ostrino vida, poslabšanjem vida, motnjavami v steklovini).
English: Each film-coated tablet contains 4.20 mg of lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 4,20 mg laktoze monohidrata.
English: Seminiferous tubular degeneration and/or atrophy in the testes, and epididymal changes (inflammation and/or vacuolation) were observed in the rat and dog.
Slovenian: Pri podganah in psih so opazili degeneracijo semenskih cevk in/ali atrofijo v modih ter spremembe epididimisa (vnetje in/ali vakuolizacija).
English: Oedema (including generalised oedema, oedema, oedema peripheral, peripheral swelling, swelling).
Slovenian: Edem (vključno z generaliziranim edemom, edemom, perifernim edemom, perifernim otekanjem, otekanjem).
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.
Slovenian: Lorlatinib 150 mg, ki so ga dajali peroralno enkrat na dan 15 dni, je zmanjšal vrednosti AUCinf in Cmax enkratnega peroralnega odmerka 2 mg midazolama (občutljiv substrat CYP3A) za 61 % oziroma 50 %, kar pomeni, da je lorlatinib zmeren induktor CYP3A.
English: Hyperlipidaemia
Slovenian: Hiperlipidemija
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).
Slovenian: Bolnice morajo med zdravljenjem z lorlatinibom uporabljati visoko učinkovito nehormonsko metodo kontracepcije, saj lahko lorlatinib povzroči, da hormonski kontraceptivi postanejo neučinkoviti (glejte poglavji 4.5 in 4.6).
English: - Pregnancy
Slovenian: - Nosečnost
English: Foetal morphologic abnormalities included rotated limbs, supernumerary digits, gastroschisis, malformed kidneys, domed head, high arched palate, and dilation of ventricles of the brain.
Slovenian: Morfološke nepravilnosti zarodkov so vključevale zasukane okončine, nadštevilne prste, gastroshizo, malformacije ledvic, kupolasto glavo, nebo z visokim lokom in dilatacijo možganskih prekatov.
English: If you forget to take Lorviqua
Slovenian: Če ste pozabili vzeti zdravilo Lorviqua
English: No increases in the mean QTc were observed at the mean observed lorlatinib concentrations in this study.
Slovenian: Pri srednjih opaženih koncentracijah lorlatiniba v tej študiji niso opazili zvečanja srednje vrednosti QTc.
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).
Slovenian: Lorlatinib so preučevali pri populaciji bolnikov, iz katere so izključili bolnike z AV-blokom druge ali tretje stopnje (razen v primeru vstavljenega srčnega spodbujevalnika) ali s katerimkoli AV-blokom z intervalom PR > 220 ms.
English: In plasma, a benzoic acid metabolite of lorlatinib resulting from the oxidative cleavage of the amide and aromatic ether bonds of lorlatinib was observed as a major metabolite, accounting for 21% of the circulating radioactivity.
Slovenian: V plazmi so kot prevladujoči presnovek lorlatiniba opazili presnovek v obliki benzojske kisline, ki nastane po oksidativni cepitvi amidnih in aromatskih etrskih vezi lorlatiniba in prispeva 21 % radioaktivnosti v obtoku.
English: Breast-feeding should be discontinued during treatment with lorlatinib and for 7 days after the final dose.
Slovenian: Med zdravljenjem z lorlatinibom in še 7 dni po zadnjem odmerku je treba prenehati z dojenjem.
English: If subsequent ECG does not show second degree AV block, resume lorlatinib at 1 reduced dose level.
Slovenian: Če naslednji EKG ne pokaže AV-bloka druge stopnje, nadaljujte zdravljenje z lorlatinibom v odmerku, zmanjšanem za 1 odmerno raven.
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).
Slovenian: Bolnice morajo med zdravljenjem z lorlatinibom uporabljati visoko učinkovito nehormonsko metodo kontracepcije, saj lahko lorlatinib povzroči, da hormonski kontraceptivi postanejo neučinkoviti (glejte poglavji 4.4 in 4.5).
English: For those patients who develop PR prolongation, dose modification may be required (see section 4.2).
Slovenian: Pri bolnikih, pri katerih se interval PR podaljša, bo morda treba prilagoditi odmerek (glejte poglavje 4.2).
English: No starting dose adjustments are recommended for patients with mild or moderate renal impairment.
Slovenian: Prilagajanje začetnih odmerkov pri bolnikih z blago ali zmerno okvaro ledvic ni priporočljivo.
English: - Contraception - information for men You should not father children during treatment with Lorviqua because this medicine could harm the baby.
Slovenian: Med zdravljenjem z zdravilom Lorviqua ne smete zaploditi otroka, saj bi to zdravilo lahko škodovalo otroku.
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.
Slovenian: Pri sočasnem dajanju lorlatiniba in močnih zaviralcev CYP3A4/5 (npr. boceprevir, kobicistat, itrakonazol, ketokonazol, posakonazol, troleandomicin, vorikonazol, ritonavir, paritaprevir v kombinaciji z ritonavirom in ombitasvirom in/ali dasabuvirom ter ritonavir v kombinaciji z elvitegravirom, indinavirom, lopinavirom ali tipranavirom) lahko pride do zvečanja koncentracij lorlatiniba v plazmi.
English: An alternative concomitant medicinal product with less potential to inhibit CYP3A4/5 should be considered (see section 4.5).
Slovenian: Razmisliti je treba o drugem sočasnem zdravilu z manjšim potencialom za zaviranje CYP3A4/5 (glejte poglavje 4.5).
English: How to store Lorviqua 6.
Slovenian: Shranjevanje zdravila Lorviqua 6.
English: Permanently discontinue lorlatinib.
Slovenian: Trajno prekinite zdravljenje z lorlatinibom.
English: Strong cytochrome P-450 (CYP) 3A4/5 inhibitors
Slovenian: Močni zaviralci citokroma P-450 (CYP) 3A4/5
English: See Possible side effects in section 4 for more information.
Slovenian: Za več informacij glejte razdelek Možni neželeni učinki v poglavju 4.
English: Lorlatinib dosing Hypercholesterolaemia or hypertriglyceridaemia Mild hypercholesterolaemia (cholesterol between ULN and 300 mg/dL or between ULN and 7.75 mmol/L)
Slovenian: Odmerjanje lorlatiniba Hiperholesterolemija ali hipertrigliceridemija blaga hiperholesterolemija (vrednost holesterola med ZMN in 300 mg/dl oziroma med ZMN in 7,75 mmol/l)
English: Recommended lorlatinib dose modifications for adverse reactions Adverse reactiona
Slovenian: Priporočeno prilagajanje odmerkov lorlatiniba zaradi neželenih učinkov Neželeni učinek
English: i
Slovenian: O
English: Re-challenge at same lorlatinib dose while maximising lipid-lowering therapyb in accordance with respective prescribing information.
Slovenian: Ponovno uvedite zdravljenje z lorlatinibom v istem odmerku ob hkratni uporabi največjega odmerka zdravila za zniževanje ravni lipidov b skladno z ustreznimi navodili za predpisovanje zdravila.
English: Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis have occurred with lorlatinib (see section 4.8).
Slovenian: Pri uporabi lorlatiniba so se pojavili hudi ali življenjsko ogrožajoči pljučni neželeni učinki, skladni z ILD/pnevmonitisom (glejte poglavje 4.8).
English: In vitro data indicate that lorlatinib is metabolised primarily by CYP3A4 and UGT1A4, with minor contribution from CYP2C8, CYP2C19, CYP3A5 and UGT1A3.
Slovenian: Podatki in vitro kažejo, da se lorlatinib presnavlja predvsem preko CYP3A4 in UGT1A4, v manjši meri pa preko CYP2C8, CYP2C19, CYP3A5 in UGT1A3.
English: If you stop taking Lorviqua
Slovenian: Če ste prenehali jemati zdravilo Lorviqua
English: Population pharmacokinetic analyses have shown that lorlatinib exposure was not clinically meaningfully altered in patients with mild hepatic impairment (n = 50).
Slovenian: Populacijske farmakokinetične analize so pokazale, da se izpostavljenost lorlatinibu pri bolnikih z blago okvaro jeter (n =50) ne spremeni klinično pomembno.
English: Withhold lorlatinib until lipase or amylase returns to baseline.
Slovenian: Prekinite zdravljenje z lorlatinibom, dokler se vrednost lipaze ali amilaze ne vrne na izhodiščno raven.
English: Greater than or equal to Grade 3: Severe
Slovenian: 3. stopnja ali višja: hudi
English: Withhold lorlatinib until symptoms resolve to less than or equal to Grade 2 or baseline.
Slovenian: Prekinite zdravljenje z lorlatinibom, dokler simptomi ne izzvenijo na 2. stopnjo ali nižjo ali na izhodiščno vrednost.
English: Dosing interruption or dose reduction may be required based on individual safety and tolerability.
Slovenian: Glede na posameznikovo varnost in prenašanje zdravila bo morda potrebna prekinitev odmerjanja zdravila ali zmanjšanje odmerka.
English: Nervous system disorders Cognitive effectse Peripheral neuropathyf Headache Speech effectsg
Slovenian: Bolezni živčevja učinki na kognitivne funkcije periferna nevropatija glavobol učinki na govor zelo pogosti zelo pogosti zelo pogosti pogosti
English: Each film-coated tablet contains 25 mg of lorlatinib.
Slovenian: Ena filmsko obložena tableta vsebuje 25 mg lorlatiniba.
English: • mitotane (used to treat cancer of the adrenal glands)
Slovenian: • mitotan (uporablja se za zdravljenje raka nadledvičnih žlez),
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.
Slovenian: Če simptomi in AV-blok druge stopnje izzvenijo ali stanje bolnika preide v asimptomatski AV-blok prve stopnje, nadaljujte zdravljenje z lorlatinibom v odmerku, zmanjšanem za 1 odmerno raven.
English: Lorlatinib demonstrated activity in mice bearing orthotopic EML4-ALK or EML4-ALKL1196M brain tumour implants.
Slovenian: Pri lorlatinibu so dokazali aktivnost pri miših, ki so imele vsajen ortotopični model možganskega tumorja EML4-ALK ali EML4-ALK
English: Peripheral neuropathy (including burning sensation, carpal tunnel syndrome, dysaesthesia, formication, gait disturbance, hypoaesthesia, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity,
Slovenian: Periferna nevropatija (vključno s pekočim občutkom, sindromom karpalnega kanala, disestezijo, mravljinčenjem, motnjo pri hoji, hipestezijo, mišično oslabelostjo, nevralgijo, periferno nevropatijo, nevrotoksičnostjo, parestezijo, periferno senzorično nevropatijo, parezo peronealnega živca, motnjo čutil).
English: Based on non-clinical safety findings, male fertility may be compromised during treatment with lorlatinib (see section 5.3).
Slovenian: Na podlagi predkliničnih ugotovitev glede varnosti lahko zdravljenje z lorlatinibom ogrozi plodnost pri moških (glejte poglavje 5.3).
English: System organ class and adverse reaction
Slovenian: Organski sistem in neželeni učinek
English: b Hypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia).
Slovenian: Hipertrigliceridemija (vključno z zvečano vrednostjo trigliceridov v krvi, hipertrigliceridemijo).
English: If a strong CYP3A4/5 inhibitor must be concomitantly administered, a dose reduction of lorlatinib is recommended (see section 4.2).
Slovenian: Če je sočasno dajanje močnega zaviralca CYP3A4/5 nujno, je priporočljivo zmanjšanje odmerka lorlatiniba (glejte poglavje 4.2).
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.
Slovenian: Podatki in vitro kažejo, da se lorlatinib presnavlja predvsem preko CYP3A4 in uridin difosfat-glukuronoziltransferaze (UGT)1A4, v manjši meri pa preko CYP2C8, CYP2C19, CYP3A5 in UGT1A3.
English: Life-threatening hypercholesterolaemia (cholesterol over 500 mg/dL or over 12.92 mmol/L)
Slovenian: življenjsko ogrožajoča hiperholesterolemija (vrednost holesterola nad 500 mg/dl oziroma nad 12,92 mmol/l)