FrancophonIA/ELRC3.0 huggingface dataset:
English: • Depending on the side effects you experience, your doctor may recommend lowering your dose or temporarily stopping your treatment.
Slovenian: • Zdravnik vam lahko glede na neželene učinke, ki se vam pojavijo, predpiše manjši odmerek ali pa zdravljenje začasno prekine.
English: The safety of lapatinib has been evaluated as monotherapy or in combination with other chemotherapies for various cancers in more than 20,000 patients, including 198 patients who received lapatinib in combination with capecitabine, 149 patients who received lapatinib in combination with trastuzumab and 654 patients who received lapatinib in combination with letrozole (see section 5.1).
Slovenian: Varnost lapatiniba so vrednotili tako pri samostojnem zdravljenju kot pri uporabi v kombinaciji z drugimi kemoterapevtiki pri različnih vrstah raka pri več kot 20.000 bolnikih, vključno z 198 bolniki, ki so prejemali lapatinib skupaj s kapecitabinom, 149 bolniki, ki so prejemali lapatinib v kombinaciji s trastuzumabom in 654 bolniki, ki so prejemali lapatinib skupaj z letrozolom (glejte poglavje 5.1).
English: (95% CI), p-value b
Slovenian: (95 % IZ), vrednost p b
English: The effect of Tyverb during pregnancy is not known.
Slovenian: Vpliv zdravila Tyverb na nosečnost ni znan.
English: There are no adequate data from the use of Tyverb in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi zdravila Tyverb pri nosečnicah.
English: In addition, per the protocol, patients were to be reported by the investigators as having progressed on their most recent trastuzumab containing regimen in the metastatic setting.
Slovenian: Poleg tega so morali raziskovalci, po protokolu, pri bolnicah ugotoviti napredovanje med uporabo zadnje sheme s trastuzumabom pri zdravljenju bolezni z metastazami.
English: Tyverb is used to treat certain types of breast cancer (HER2-overexpressing) which have spread beyond the original tumour or to other organs (advanced or metastatic breast cancer).
Slovenian: Zdravilo Tyverb uporabljamo za zdravljenje nekaterih vrst raka dojke (s čezmerno ekspresijo HER2), ki se je razširil zunaj prvotnega tumorja ali na druge organe (napredovali ali metastatski rak dojke).
English: Hepatotoxicity has occurred with Tyverb use and may in rare cases be fatal.
Slovenian: Pri uporabi zdravila Tyverb so poročali o pojavu hepatotoksičnosti, ki je v redkih primerih lahko usodna.
English: Co-administration of Tyverb with irinotecan (when administered as part of the FOLFIRI regimen) resulted in an approximate 40% increase in the AUC of SN-38, the active metabolite of irinotecan.
Slovenian: Sočasna uporaba zdravila Tyverb z irinotekanom (uporabljenim kot del sheme FOLFIRI) je za približno 40 % povečala AUC SN-38, aktivnega presnovka irinotekana.
English: An additional 75 patients were enrolled in the study between the time of the interim analysis and the end of the enrolment.
Slovenian: Med časom vmesne analize in koncem vključevanja je bilo v študijo vključenih še nadaljnjih 75 bolnikov.
English: 8.9 mos (6.7, 11.8)
Slovenian: 8,9 meseca (6,7; 11,8)
English: In rats, the incidence of benign haemangioma of the mesenteric lymph nodes was higher in some groups than in concurrent controls.
Slovenian: Pri podganah je bila incidenca benignih hemangiomov mezenteričnih bezgavk v nekaterih skupinah večja kot pri sočasni kontrolni skupini.
English: • in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.
Slovenian: • v kombinaciji z zaviralcem aromataze pri postmenopavzalnih ženskah z metastatsko boleznijo, pozitivno glede hormonskih receptorjev, ki trenutno niso namenjene za kemoterapijo.
English: 8.2 wks (7.4, 9.3)
Slovenian: 8,2 tedna (7,4; 9,3)
English: • verapamil - a medicine used to treat high blood pressure or heart problems (angina)
Slovenian: • verapamil - zdravilo za zdravljenje visokega krvnega tlaka ali težav s srcem (angine pektoris),
English: a. Estimate of the treatment hazard ratio, where <1 indicates a lower risk with letrozole 2.5 mg + lapatinib 1500 mg compared with letrozole 2.5 mg + placebo.
Slovenian: a. Ocena razmerja ogroženosti zdravljenja, pri čemer < 1 pomeni manjše tveganje z letrozolom 2,5 mg + lapatinibom 1500 mg v primerjavi z letrozolom 2,5 mg + placebom.
English: There are limited data on the use of Tyverb / capecitabine and Tyverb / trastuzumab in patients aged ≥ 65 years.
Slovenian: Podatkov o uporabi kombinacij Tyverb/kapecitabin in Tyverb/trastuzumab pri bolnikih, starih ≥ 65 let, je malo.
English: The risk of lapatinib-induced hepatotoxicity was associated with carriage of the HLA alleles DQA1*02:01 and DRB1*07:01 (see section 4.4).
Slovenian: Tveganje za hepatotoksičnost, povzročeno z lapatinibom, je povezano s prisotnostjo HLA-alelov DQA1*02:01 in DRB1*07:01 (glejte poglavje 4.4).
English: To minimise variability in the individual patient, administration of Tyverb should be standardised in relation to food intake, for example always to be taken one hour before a meal (see sections 4.5 and 5.2 for information on absorption).
Slovenian: Zaradi zmanjšanja variabilnosti pri posameznem bolniku je treba jemanje zdravila Tyverb standardizirati glede na obrok hrane, na primer tako, da ga bolnik vedno jemlje pred obrokom (za podatke o absorpciji glejte poglavji 4.5 in 5.2).
English: Do not take Tyverb
Slovenian: Ne jemljite zdravila Tyverb
English: Concomitant administration of Tyverb with capecitabine, letrozole or trastuzumab did not meaningfully alter the pharmacokinetics of these medicinal products (or the metabolites of capecitabine) or lapatinib.
Slovenian: Pri sočasni uporabi zdravila Tyverb in kapecitabina, letrozola ali trastuzumaba se farmakokinetika teh zdravil (ali presnovkov kapecitabina) ali lapatiniba ni pomembneje spremenila.
English: Food effects on lapatinib exposure
Slovenian: Vpliv hrane na izpostavljenost lapatinibu
English: 70 film-coated tablets 84 film-coated tablets 105 film-coated tablets 140 film-coated tablets
Slovenian: 70 filmsko obloženih tablet 84 filmsko obloženih tablet 105 filmsko obloženih tablet 140 filmsko obloženih tablet
English: In patients who took up to 5000 mg of lapatinib, symptoms observed include known lapatinib associated events (see section 4.8) and in some cases sore scalp and/or mucosal inflammation.
Slovenian: Med simptomi pri bolnikih, ki so vzeli do 5.000 mg lapatiniba, so bili znani učinki, ki spremljajo lapatinib (glejte poglavje 4.8), in v nekaterih primerih občutljivo lasišče in/ali vnetje sluznic.
English: Dosing of lapatinib one hour after a meal results in approximately 2-3 times higher systemic exposure, compared to dosing one hour before a meal (see sections 4.5 and 5.2).
Slovenian: Uporaba lapatiniba eno uro po obroku povzroči približno 2- do 3-krat večjo sistemsko izpostavljenost v primerjavi z uporabo eno uro pred obrokom (glejte poglavji 4.5 in 5.2).
English: Lapatinib is predominantly metabolised by CYP3A (see section 5.2).
Slovenian: Lapatinib se v glavnem presnavlja s CYP3A (glejte poglavje 5.2).
English: Tyverb with food and drink
Slovenian: Zdravilo Tyverb skupaj s hrano in pijačo
English: The study enrolled patients who had not received prior therapy for their metastatic disease.
Slovenian: Študija je zajela bolnice, ki niso bile predhodno zdravljene za metastatsko bolezen.
English: In a large, randomised clinical trial of Tyverb monotherapy (n=1,194), the cumulative frequency of severe liver injury (ALT >5 times the upper limit of normal, NCI CTCAE grade 3) at 1 year of treatment was 2.8% overall.
Slovenian: V velikem randomiziranem kliničnem preskušanju monoterapije z zdravilom Tyverb (n = 1.194) je bila celotna kumulativna pogostnost hude okvare jeter (ALT > 5-kratna zgornja normalna meja, stopnje 3 po NCI CTCAE) po 1 letu zdravljenja 2,8 %.
English: No overall differences in efficacy and safety of the combination of Tyverb and letrozole were observed between these patients and patients < 65 years of age.
Slovenian: V celoti niso ugotovili razlik v učinkovitosti in varnosti kombinacije zdravila Tyverb in letrozola pri teh bolnikih v primerjavi z bolniki, mlajšimi od 65 let.
English: Tyverb is prescribed to be taken in combination with another anti-cancer medicine.
Slovenian: Zdravilo Tyverb zdravniki predpisujejo v kombinaciji z dodatnim zdravilom proti raku.
English: Other toxicities
Slovenian: Drugi toksični učinki
English: Lapatinib has been associated with reports of pulmonary toxicity including interstitial lung disease and pneumonitis (see section 4.8).
Slovenian: Pri uporabi lapatiniba so poročali o toksičnih učinkih na pljuča, vključno z intersticijsko pljučno boleznijo in pnevmonitisom (glejte poglavje 4.8).
English: If erythema multiforme or life-threatening reactions such as Stevens-Johnson syndrome, or toxic epidermal necrolysis (e.g. progressive skin rash often with blisters or mucosal lesions) are suspected, discontinue treatment with Tyverb.
Slovenian: V primeru suma na multiformni eritem ali na smrtno nevarne reakcije, kot sta Stevens-Johnsonov sindrom ali toksična epidermalna nekroliza (npr. napredujoč kožni izpuščaj, pogosto z mehurji ali lezijami sluznice), je treba zdravljenje z zdravilom Tyverb prekiniti.
English: The efficacy and safety of lapatinib in combination with trastuzumab in metastatic breast cancer were evaluated in a randomised trial.
Slovenian: Učinkovitost in varnost lapatiniba v kombinaciji s trastuzumabom pri metastatskem raku dojke so ocenili v randomiziranem preskušanju.
English: • pimozide - a medicine used to treat certain mental health problems
Slovenian: • pimozid - zdravilo za zdravljenje nekaterih težav z duševnim zdravjem,
English: Table 5 Summary of PFS and OS in studies with hormone receptor negative
Slovenian: Preglednica 5 Povzetek preživetja brez napredovanja (PFS) in celokupnega preživetja (OS) v študijah negativnih hormonskih receptorjev
English: Tyverb should be taken either at least one hour before, or at least one hour after food.
Slovenian: Zdravilo Tyverb je treba jemati vsaj eno uro pred ali vsaj eno uro po obroku ali prigrizku.
English: Data are available on the efficacy and safety of Tyverb in combination with capecitabine relative to trastuzumab in combination with capecitabine.
Slovenian: Na voljo so podatki o učinkovitosti in varnosti zdravila Tyverb v kombinaciji s kapecitabinom v primerjavi s trastuzumabom v kombinaciji s kapecitabinom.
English: It is not known whether lapatinib is excreted in human milk.
Slovenian: Ni znano, če se lapatinib izloča z materinim mlekom.
English: - The active substance in Tyverb is lapatinib.
Slovenian: - Učinkovina zdravila Tyverb je lapatinib.
English: LVEF decreases resolved or improved in more than 70 % of cases, in approximately 60 % of these on discontinuation of treatment with lapatinib, and in approximately 40 % of cases lapatinib was continued.
Slovenian: Po ukinitvi zdravljenja z lapatinibom se je zmanjšanje iztisnega deleža levega prekata popravilo ali izboljšalo pri več kot 70 % primerov, pri približno 60 % od teh po prenehanju zdravljenja z lapatinibom, pri približno 40 % pa se je zdravljenje z lapatinibom nadaljevalo.
English: Other medicines and Tyverb
Slovenian: Druga zdravila in zdravilo Tyverb
English: Symptomatic LVEF decreases were observed in approximately 0.3% of patients who received lapatinib.
Slovenian: Simptomatsko zmanjšanje LVEF so opazili pri približno 0,3 % bolnikov, ki so prejemali lapatinib.
English: Patients eligible for enrolment had HER2-overexpressing, locally advanced or metastatic breast cancer, progressing after prior treatment that included taxanes, anthracyclines and trastuzumab.
Slovenian: Bolniki, ki so bili primerni za vključitev, so imeli čezmerno ekspresijo HER2, lokalno napredovali ali metastatski rak dojke, ki je napredoval po predhodnem zdravljenju, ki je vključevalo taksane, antracikline in trastuzumab.
English: Investigator-assessed PFS
Slovenian: PFS po oceni raziskovalca
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE07
Slovenian: Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE07
English: • rosuvastatin - a medicine used to treat high cholesterol
Slovenian: • rosuvastatin - zdravilo za zdravljenje zvišanega holesterola,
English: Tyverb is prescribed in combination with an aromatase inhibitor, for patients with hormone sensitive metastatic breast cancer (breast cancer that is more likely to grow in the presence of hormones), who are not currently intended for chemotherapy.
Slovenian: Zdravilo Tyverb predpisujejo v kombinaciji z zaviralcem aromataze za bolnike, ki imajo metastatski rak dojke, ki je hormonsko občutljiv (tj. rak dojke, katerega rast je v prisotnosti hormonov bolj verjetna), in trenutno niso namenjeni za kemoterapijo.
English: Lapatinib is a substrate for the transport proteins Pgp and BCRP.
Slovenian: Lapatinib je substrat za transportna proteina Pgp in BCRP.
English: Patients who had objective disease progression after receiving at least 4 weeks of treatment with lapatinib monotherapy were eligible to crossover to combination therapy.
Slovenian: Bolnice, ki jim je bolezen po vsaj 4 tednih monoterapije z lapatinibom objektivno napredovala, so lahko navzkrižno prešle na kombinirano zdravljenje.
English: In the phase III clinical study of Tyverb in combination with letrozole, of the total number of hormone receptor positive metastatic breast cancer patients (Intent to treat population N= 642), 44 % were ≥ 65 years of age.
Slovenian: V klinični študiji III. faze, v kateri so raziskovali zdravilo Tyverb v kombinaciji z letrozolom, je bilo 44 % celotnega števila bolnikov z metastatskim rakom dojke, pozitivnim glede hormonskih receptorjev (celotna populacija, n = 642), starih ≥ 65 let.
English: The cumulative frequency in DQA1*02:01 and DRB1*07:01 allele carriers was 10.3% and in non-carriers was 0.5%.
Slovenian: Kumulativna pogostnost je bila pri nosilcih alelov DQA1*02:01 in DRB1*07:01 10,3 % in pri nenosilcih 0,5 %.
English: Daily dosing of 1250 mg produces steady state geometric mean (coefficient of variation) Cmax values of 2.43 (76%) µg/ml and AUC values of 36.2 (79%) µg*hr/ml.
Slovenian: Pri dnevnem odmerku 1.250 mg so geometrijske srednje vrednosti v stanju dinamičnega ravnovesja (koeficient variacije) Cmax 2,43 (76 %) µg/ml, vrednosti AUC pa 36,2 (79 %) µg*ur/ml.
English: However, the occurrence of docetaxel-induced neutropenia was increased.
Slovenian: Povečalo pa se je pojavljanje nevtropenije zaradi docetaksela.
English: The recommended dose of trastuzumab is 4 mg/kg administered as an intravenous loading dose, followed by 2 mg/kg intravenous weekly (see section 5.1).
Slovenian: Priporočeni odmerek trastuzumaba je 4 mg/kg, uporabljen kot intravenski polnilni odmerek, ki mu sledi 2 mg/kg intravensko vsak teden (glejte poglavje 5.1).
English: No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.
Slovenian: Podatkov o učinkovitosti te kombinacije v primerjavi s kombinacijo trastuzumaba in zaviralca aromataze pri tej populaciji bolnic ni.
English: There is more advice on reducing the risk of diarrhoea at the end of section 4.
Slovenian: Več nasvetov o zmanjšanju tveganja driske je na koncu poglavja 4.
English: Women of childbearing potential should be advised to use adequate contraception and avoid becoming pregnant while receiving treatment with Tyverb and for at least 5 days after the last dose.
Slovenian: Ženskam v rodni dobi je treba svetovati, da naj za preprečitev nosečnosti med zdravljenjem z zdravilom Tyverb in še najmanj 5 dni po zaužitju zadnjega odmerka zdravila uporabljajo ustrezno kontracepcijsko metodo.
English: There was no evidence of carcinogenicity in mice.
Slovenian: Pri miših niso ugotovili znakov kancerogenosti.
English: Response rate, % (95% CI)
Slovenian: Delež odziva, % (95 % IZ)
English: LVEF should continue to be evaluated during treatment with Tyverb to ensure that LVEF does not decline to an unacceptable level (see section 4.2).
Slovenian: Vrednost LVEF je treba spremljati tudi med zdravljenjem z zdravilom Tyverb in tako zagotoviti, da se vrednost ne zmanjša pod sprejemljivo vrednost (glejte poglavje 4.2).
English: In vitro studies indicate that lapatinib is a substrate for the transporters BCRP (ABCG1) and p-glycoprotein (ABCB1).
Slovenian: In vitro študije kažejo, da je lapatinib substrat za prenašalce BCRP (ABCG1) in p-glikoprotein (ABCB1).
English: The half-life of lapatinib measured after single doses increases with increasing dose.
Slovenian: Razpolovni čas lapatiniba, izmerjen po enkratnih odmerkih, se je povečeval s povečevanjem odmerka.
English: Diarrhoea was the most common adverse reaction resulting in discontinuation of treatment when lapatinib was administered in combination with capecitabine, or with letrozole.
Slovenian: Driska je bila najpogostejši neželeni učinek, zaradi katerega je bilo treba zdravljenje prekiniti, če je bil lapatinib uporabljen v kombinaciji s kapecitabinom ali letrozolom.
English: The efficacy and safety of Tyverb in combination with capecitabine in breast cancer patients with good performance status was evaluated in a randomised, phase III study.
Slovenian: Učinkovitost in varnost zdravila Tyverb v kombinaciji s kapecitabinom pri bolnikih z rakom dojke z dobro telesno zmogljivostjo so vrednotili z randomizirano študijo III. faze.
English: The ΔΔQTcF exceeded the 5 ms threshold and the upper bound 90% CIs exceeded the 10 ms threshold at multiple time points.
Slovenian: Pri večih časovnih točkah je vrednost ΔΔQTcF presegala mejno vrednost 5 ms, zgornja meja 90-odstotnega IZ pa je presegala mejno vrednost 10 ms.
English: Randomisation was stratified by sites of disease and by time from discontinuation of prior adjuvant anti-oestrogen therapy.
Slovenian: Randomizacija je bila stratificirana po mestu bolezni in po času od prenehanja predhodnega adjuvantnega antiestrogenskega zdravljenja.
English: Systemic exposure to lapatinib is also affected by the timing of administration in relation to food intake.
Slovenian: Na sistemsko izpostavljenost lapatinibu vpliva tudi čas uporabe glede na zaužitje hrane.
English: Caution is advised in patients with severe renal impairment as there is no experience of Tyverb in this population (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic svetujemo previdnost, saj pri tej skupini bolnikov nimamo izkušenj z uporabo zdravila Tyverb (glejte poglavje 5.2).
English: Effects of other medicinal products on lapatinib
Slovenian: Vpliv drugih zdravil na lapatinib
English: The bioavailability and thereby the plasma concentrations of lapatinib are increased by food, in relation to the content and timing of the meal.
Slovenian: Hrana poveča biološko uporabnost in s tem koncentracijo lapatiniba v plazmi, odvisno od sestave in časa obroka.
English: • in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).
Slovenian: • v kombinaciji s kapecitabinom za bolnike z napredovalo ali metastatsko boleznijo, ki je napredovala po predhodnem zdravljenju, ki je moralo vključevati antracikline in taksane ter zdravljenje s trastuzumabom v primeru metastaz (glejte poglavje 5.1).
English: telithromycin - medicines used to treat infections
Slovenian: telitromicin - zdravila za zdravljenje okužb,
English: EU/1/07/440/001 70 tablets EU/1/07/440/003 84 tablets
Slovenian: EU/1/07/440/001 70 tablet EU/1/07/440/003 84 tablet
English: You should not use Tyverb if you are pregnant unless your doctor specifically recommends it.
Slovenian: Če ste noseči, zdravila Tyverb ne smete jemati, razen če vam tako izrecno naroči zdravnik.
English: Patients should be monitored for symptoms of pulmonary toxicity (dyspnoea, cough, fever) and treatment discontinued in patients who experience symptoms which are NCI CTCAE grade 3 or greater.
Slovenian: Bolnike je treba nadzirati glede pojava pljučne toksičnosti (dispneja, kašelj, vročica); zdravljenje je treba prekiniti pri bolnikih, ki se jim pojavijo simptomi stopnje 3 ali več po NCI CTCAE.
English: • pains in muscles or joints
Slovenian: • bolečine v mišicah ali sklepih,
English: Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, use of antibiotics such as fluoroquinolones (especially if diarrhoea is persistent beyond 24 hours, there is fever, or grade 3 or 4 neutropenia) and interruption or discontinuation of Tyverb therapy (see section 4.2 - dose delay and dose reduction -diarrhoea).
Slovenian: V hudih primerih driske bo morda potrebno peroralno ali intravensko dajanje elektrolitov in tekočin, uporaba antibiotikov, npr. fluorokinolonov (zlasti če driska traja več kot 24 ur, če ima bolnik zvišano telesno temperaturo ali nevtropenijo stopnje 3 ali 4), ter prekinitev ali ukinitev zdravljenja z zdravilom Tyverb (glejte poglavje 4.2 - Odložitev zdravljenja in zmanjšanje odmerkaDriska).
English: Median (95% CI) Stratified Hazard ratio b
Slovenian: Mediana (95 % IZ) Stratificirano razmerje ogroženosti b
English: Please refer to the full prescribing information of trastuzumab.
Slovenian: Glejte celotne informacije za predpisovanje trastuzumaba.
English: Insufficient data are available in patients with hepatic impairment to provide a dose adjustment recommendation (see section 5.2).
Slovenian: Zaradi nezadostnih podatkov pri bolnikih z okvaro jeter priporočil za prilagoditev odmerka ne moremo podati (glejte poglavje 5.2).
English: Tyverb treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
Slovenian: Zdravljenje z zdravilom Tyverb sme uvesti le zdravnik, ki ima izkušnje z uporabo protitumorskih zdravil.
English: Caution should be taken if Tyverb is administered to patients with conditions that could result in prolongation of QTc (including hypokalemia, hypomagnesemia, and congenital long QT syndrome), co-administration of other medicinal product known to cause QT prolongation, or conditions that increase the exposure of lapatinib, such as co-administration of strong CYP3A4 inhibitors.
Slovenian: Previdnost je potrebna v primeru uporabe zdravila Tyverb pri bolnikih s stanji ali boleznimi, ki bi lahko podaljšale interval QTc (med takšnimi so hipokaliemija, hipomagneziemija in sindrom prirojenega podaljšanja intervala QT), pri sočasni uporabi drugih zdravil, ki podaljšujejo interval QT ali pri stanjih, ki povečujejo izpostavljenost lapatinibu, kot je sočasna uporaba močnih zaviralcev CYP3A4.
English: †, dyspnoea
Slovenian: †, dispneja
English: The following adverse reactions have been reported to have a causal association with lapatinib alone or lapatinib in combination with capecitabine, trastuzumab or letrozole.
Slovenian: O naslednjih neželenih učinkih so poročali kot vzročno povezanih z lapatinibom samim ali lapatinibom v kombinaciji s kapecitabinom, trastuzumabom ali letrozolom.
English: Administration of Tyverb to patients with moderate to severe hepatic impairment should be undertaken with caution due to increased exposure to the medicinal product.
Slovenian: Pri zdravljenju bolnikov z zmerno do hudo okvaro jeter je potrebna previdnost, saj obstaja možnost večje izpostavljenosti zdravilu.
English: In the prevention of CNS metastases in the metastatic and early breast cancer settings the observed activity was limited.
Slovenian: Za preprečevanje metastaz v osrednjem živčevju pri metastatskem in zgodnjem raku dojke je bila ugotovljena omejena aktivnost.
English: Please refer to the full prescribing information of capecitabine.
Slovenian: Glejte celotno informacijo za predpisovanje kapecitabina.
English: The growth inhibitory effects of lapatinib were evaluated in trastuzumab-conditioned cell lines.
Slovenian: Zaviralni učinek lapatiniba na rast so proučevali na s trastuzumabom tretiranih celičnih linijah.
English: Symptoms may include skin rash, blisters and skin peeling.
Slovenian: Med njihovimi simptomi so lahko izpuščaj na koži, mehurji in lupljenje kože.