natgillin/translations-raw huggingface dataset:
Do not take Tyverb 
Ne jemljite zdravila Tyverb
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. 
Pri sočasni uporabi zdravila Tyverb in kapecitabina, letrozola ali trastuzumaba se farmakokinetika teh zdravil (ali presnovkov kapecitabina) ali lapatiniba ni pomembneje spremenila.
Food effects on lapatinib exposure 
Vpliv hrane na izpostavljenost lapatinibu
70 film-coated tablets 84 film-coated tablets 105 film-coated tablets 140 film-coated tablets 
70 filmsko obloženih tablet 84 filmsko obloženih tablet 105 filmsko obloženih tablet 140 filmsko obloženih tablet
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. 
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.
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). 
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).
Lapatinib is predominantly metabolised by CYP3A (see section 5.2). 
Lapatinib se v glavnem presnavlja s CYP3A (glejte poglavje 5.2).
Tyverb with food and drink 
Zdravilo Tyverb skupaj s hrano in pijačo
The study enrolled patients who had not received prior therapy for their metastatic disease. 
Študija je zajela bolnice, ki niso bile predhodno zdravljene za metastatsko bolezen.
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. 
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 %.
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. 
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.
Tyverb is prescribed to be taken in combination with another anti-cancer medicine. 
Zdravilo Tyverb zdravniki predpisujejo v kombinaciji z dodatnim zdravilom proti raku.
Other toxicities 
Drugi toksični učinki
Lapatinib has been associated with reports of pulmonary toxicity including interstitial lung disease and pneumonitis (see section 4.8). 
Pri uporabi lapatiniba so poročali o toksičnih učinkih na pljuča, vključno z intersticijsko pljučno boleznijo in pnevmonitisom (glejte poglavje 4.8).
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. 
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.
The efficacy and safety of lapatinib in combination with trastuzumab in metastatic breast cancer were evaluated in a randomised trial. 
Učinkovitost in varnost lapatiniba v kombinaciji s trastuzumabom pri metastatskem raku dojke so ocenili v randomiziranem preskušanju.
• pimozide - a medicine used to treat certain mental health problems 
• pimozid - zdravilo za zdravljenje nekaterih težav z duševnim zdravjem,
Table 5 Summary of PFS and OS in studies with hormone receptor negative 
Preglednica 5 Povzetek preživetja brez napredovanja (PFS) in celokupnega preživetja (OS) v študijah negativnih hormonskih receptorjev
Tyverb should be taken either at least one hour before, or at least one hour after food. 
Zdravilo Tyverb je treba jemati vsaj eno uro pred ali vsaj eno uro po obroku ali prigrizku.
Data are available on the efficacy and safety of Tyverb in combination with capecitabine relative to trastuzumab in combination with capecitabine. 
Na voljo so podatki o učinkovitosti in varnosti zdravila Tyverb v kombinaciji s kapecitabinom v primerjavi s trastuzumabom v kombinaciji s kapecitabinom.
It is not known whether lapatinib is excreted in human milk. 
Ni znano, če se lapatinib izloča z materinim mlekom.
- The active substance in Tyverb is lapatinib. 
- Učinkovina zdravila Tyverb je lapatinib.
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. 
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.
Other medicines and Tyverb 
Druga zdravila in zdravilo Tyverb
Symptomatic LVEF decreases were observed in approximately 0.3% of patients who received lapatinib. 
Simptomatsko zmanjšanje LVEF so opazili pri približno 0,3 % bolnikov, ki so prejemali lapatinib.
Patients eligible for enrolment had HER2-overexpressing, locally advanced or metastatic breast cancer, progressing after prior treatment that included taxanes, anthracyclines and trastuzumab. 
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.
Investigator-assessed PFS 
PFS po oceni raziskovalca
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE07 
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), druga zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz, oznaka ATC: L01XE07
• rosuvastatin - a medicine used to treat high cholesterol 
• rosuvastatin - zdravilo za zdravljenje zvišanega holesterola,
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. 
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.
Lapatinib is a substrate for the transport proteins Pgp and BCRP. 
Lapatinib je substrat za transportna proteina Pgp in BCRP.
Patients who had objective disease progression after receiving at least 4 weeks of treatment with lapatinib monotherapy were eligible to crossover to combination therapy. 
Bolnice, ki jim je bolezen po vsaj 4 tednih monoterapije z lapatinibom objektivno napredovala, so lahko navzkrižno prešle na kombinirano zdravljenje.
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. 
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.
The cumulative frequency in DQA1*02:01 and DRB1*07:01 allele carriers was 10.3% and in non-carriers was 0.5%. 
Kumulativna pogostnost je bila pri nosilcih alelov DQA1*02:01 in DRB1*07:01 10,3 % in pri nenosilcih 0,5 %.
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. 
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.
However, the occurrence of docetaxel-induced neutropenia was increased. 
Povečalo pa se je pojavljanje nevtropenije zaradi docetaksela.
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). 
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).
No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population. 
Podatkov o učinkovitosti te kombinacije v primerjavi s kombinacijo trastuzumaba in zaviralca aromataze pri tej populaciji bolnic ni.
There is more advice on reducing the risk of diarrhoea at the end of section 4. 
Več nasvetov o zmanjšanju tveganja driske je na koncu poglavja 4.
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. 
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.
There was no evidence of carcinogenicity in mice. 
Pri miših niso ugotovili znakov kancerogenosti.
Response rate, % (95% CI) 
Delež odziva, % (95 % IZ)
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). 
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).
In vitro studies indicate that lapatinib is a substrate for the transporters BCRP (ABCG1) and p-glycoprotein (ABCB1). 
In vitro študije kažejo, da je lapatinib substrat za prenašalce BCRP (ABCG1) in p-glikoprotein (ABCB1).
The half-life of lapatinib measured after single doses increases with increasing dose. 
Razpolovni čas lapatiniba, izmerjen po enkratnih odmerkih, se je povečeval s povečevanjem odmerka.
Diarrhoea was the most common adverse reaction resulting in discontinuation of treatment when lapatinib was administered in combination with capecitabine, or with letrozole. 
Driska je bila najpogostejši neželeni učinek, zaradi katerega je bilo treba zdravljenje prekiniti, če je bil lapatinib uporabljen v kombinaciji s kapecitabinom ali letrozolom.
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. 
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.
The ΔΔQTcF exceeded the 5 ms threshold and the upper bound 90% CIs exceeded the 10 ms threshold at multiple time points. 
Pri večih časovnih točkah je vrednost ΔΔQTcF presegala mejno vrednost 5 ms, zgornja meja 90-odstotnega IZ pa je presegala mejno vrednost 10 ms.
Randomisation was stratified by sites of disease and by time from discontinuation of prior adjuvant anti-oestrogen therapy. 
Randomizacija je bila stratificirana po mestu bolezni in po času od prenehanja predhodnega adjuvantnega antiestrogenskega zdravljenja.
Systemic exposure to lapatinib is also affected by the timing of administration in relation to food intake. 
Na sistemsko izpostavljenost lapatinibu vpliva tudi čas uporabe glede na zaužitje hrane.
Caution is advised in patients with severe renal impairment as there is no experience of Tyverb in this population (see section 5.2). 
Pri bolnikih s hudo okvaro ledvic svetujemo previdnost, saj pri tej skupini bolnikov nimamo izkušenj z uporabo zdravila Tyverb (glejte poglavje 5.2).
Effects of other medicinal products on lapatinib 
Vpliv drugih zdravil na lapatinib
The bioavailability and thereby the plasma concentrations of lapatinib are increased by food, in relation to the content and timing of the meal. 
Hrana poveča biološko uporabnost in s tem koncentracijo lapatiniba v plazmi, odvisno od sestave in časa obroka.
• 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). 
• 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).
telithromycin - medicines used to treat infections 
telitromicin - zdravila za zdravljenje okužb,
EU/1/07/440/001 70 tablets EU/1/07/440/003 84 tablets 
EU/1/07/440/001 70 tablet EU/1/07/440/003 84 tablet
You should not use Tyverb if you are pregnant unless your doctor specifically recommends it. 
Če ste noseči, zdravila Tyverb ne smete jemati, razen če vam tako izrecno naroči zdravnik.
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. 
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.
• pains in muscles or joints 
• bolečine v mišicah ali sklepih,
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). 
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).
Median (95% CI) Stratified Hazard ratio b 
Mediana (95 % IZ) Stratificirano razmerje ogroženosti b
Please refer to the full prescribing information of trastuzumab. 
Glejte celotne informacije za predpisovanje trastuzumaba.
Insufficient data are available in patients with hepatic impairment to provide a dose adjustment recommendation (see section 5.2). 
Zaradi nezadostnih podatkov pri bolnikih z okvaro jeter priporočil za prilagoditev odmerka ne moremo podati (glejte poglavje 5.2).
Tyverb treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products. 
Zdravljenje z zdravilom Tyverb sme uvesti le zdravnik, ki ima izkušnje z uporabo protitumorskih zdravil.
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. 
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.
The following adverse reactions have been reported to have a causal association with lapatinib alone or lapatinib in combination with capecitabine, trastuzumab or letrozole. 
O naslednjih neželenih učinkih so poročali kot vzročno povezanih z lapatinibom samim ali lapatinibom v kombinaciji s kapecitabinom, trastuzumabom ali letrozolom.
Administration of Tyverb to patients with moderate to severe hepatic impairment should be undertaken with caution due to increased exposure to the medicinal product. 
Pri zdravljenju bolnikov z zmerno do hudo okvaro jeter je potrebna previdnost, saj obstaja možnost večje izpostavljenosti zdravilu.
In the prevention of CNS metastases in the metastatic and early breast cancer settings the observed activity was limited. 
Za preprečevanje metastaz v osrednjem živčevju pri metastatskem in zgodnjem raku dojke je bila ugotovljena omejena aktivnost.
Please refer to the full prescribing information of capecitabine. 
Glejte celotno informacijo za predpisovanje kapecitabina.
The growth inhibitory effects of lapatinib were evaluated in trastuzumab-conditioned cell lines. 
Zaviralni učinek lapatiniba na rast so proučevali na s trastuzumabom tretiranih celičnih linijah.
Symptoms may include skin rash, blisters and skin peeling. 
Med njihovimi simptomi so lahko izpuščaj na koži, mehurji in lupljenje kože.
Lapatinib produced a maximum mean concentration of 3920 (3450-4460) ng/ml (geometric mean/95% CI), exceeding the geometric mean Cmax.ss and 95% CI values observed following the approved dosing regimens. 
Največja srednja koncentracija lapatiniba je bila 3920 (3450 - 4460) ng/ml (geometrična sredina/95-odstotni IZ) in je presegala geometrično sredino Cmax v stanju dinamičnega ravnovesja in vrednosti 95-odstotnega IZ, ki so jih opazovali pri uporabi zdravila v skladu z odobrenim odmerjanjem.
There is a positive relationship between lapatinib plasma concentrations and ΔΔQTcF. 
Med koncentracijami lapatiniba v plazmi in vrednostmi ΔΔQTcF obstaja pozitivna povezava.
Tyverb film-coated tablets are oval, biconvex, yellow film-coated, with ‘GS XJG' marked on one side. 
Tyverb filmsko obložene tablete so ovalne, obojestransko izbočene, rumene, filmsko obložene tablete z oznako ‘GS XJG' na eni strani.
• eat low-fat, high protein foods instead of fatty or spicy foods 
• namesto mastne ali začinjene hrane uživajte malo mastno hrano, bogato z beljakovinami,
Bottles Tyverb is also available in plastic bottles containing 70, 84, 105 or 140 tablets. 
Zdravilo Tyverb je na voljo tudi v plastenkah, ki vsebujejo 70, 84, 105 ali 140 tablet.
• if you have lung disease 
• če imate bolezen pljuč,
Eligible patients were women with Stage IV ErbB2 gene amplified (or protein overexpressing) metastatic breast cancer who had been exposed to treatment with anthracyclines and taxanes. 
Primerne bolnice so bile bolnice z metastatskim rakom dojke stadija IV z amplifikacijo gena ErbB2 (ali čezmerno ekspresijo beljakovine), ki so bile izpostavljene zdravljenju z antraciklini in taksani.
• if you have any liver problems 
• če imate kakršne koli težave z jetri,
At the start of therapy, the patients bowel pattern and any other symptoms (e.g. fever, cramping pain, nausea, vomiting, dizziness and thirst) should be determined, to allow identification of changes during treatment and to help identify patients at greater risk of diarrhoea. 
Na začetku zdravljenja je treba ugotoviti bolnikov ritem odvajanja in morebitne simptome (npr. zvišano telesno temperaturo, krčevite bolečine, navzeo, bruhanje, omotičnost ali žejo): to omogoča odkritje sprememb med zdravljenjem in pomaga prepoznati osebe, ki imajo večje tveganje driske.
There was also an increase in renal infarcts and papillary necrosis in female rats at exposures 7 and 10-fold compared to humans given 1250 mg of lapatinib once daily. 
Opazili so tudi več ledvičnih infarktov in papilarne nekroze pri podganjih samicah med izpostavljenostmi, ki so bile 7- in 10-krat tolikšne kot pri človeku med uporabo 1.250 mg lapatiniba enkrat na dan.
It cannot be excluded that lapatinib will affect the pharmacokinetics of substrates of BCRP (e.g. topotecan) and OATP1B1 (e.g. rosuvastatin) (see section 5.2). 
Vpliva lapatiniba na farmakokinetiko substratov za BCRP (npr. topotekan) in OATP1B1 (npr. rosuvastatin) ni mogoče izključiti (glejte poglavje 5.2).
b. Pike estimate of the treatment hazard ratio, <1 indicates a lower risk for Tyverb plus capecitabine compared with Trastuzumab plus capecitabine. 
b. Pikova ocena razmerja ogroženosti terapije < 1 kaže manjše tveganje s kombinacijo Tyverba in kapecitabina kot s kombinacijo trastuzumaba in kapecitabina.
Patients who carry the HLA alleles DQA1*02:01 and DRB1*07:01 have increased risk of Tyverb-associated hepatotoxicity. 
Bolniki-nosilci HLA-alelov DQA1*02:01 in DRB1*07:01 imajo večje tveganje za hepatotoksičnost, povezano z zdravilom Tyverb.
In healthy volunteers receiving ketoconazole, a strong CYP3A4 inhibitor, at 200 mg twice daily for 7 days, systemic exposure to lapatinib (100 mg daily) was increased approximately 3.6-fold, and half-life increased 1.7-fold. 
Pri zdravih prostovoljcih, ki so prejemali ketokonazol, močan zaviralec CYP3A4, v odmerku 200 mg dvakrat na dan 7 dni, se je sistemska izpostavljenost lapatinibu (100 mg na dan) povečala za približno 3,6-krat, razpolovni čas pa podaljšal za 1,7-krat.
Tyverb is also supplied in high density polyethylene bottles (HDPE) with a child resistant polypropylene closure containing 70, 84, 105 or 140 film-coated tablets. 
Zdravilo Tyverb je na voljo tudi v plastenkah iz polietilena visoke gostote (HDPE) z za otroke varnimi polipropilenskimi zaporkami, ki vsebujejo 70, 84, 105 ali 140 filmsko obloženih tablet.
Tyverb-induced diarrhoea is usually low-grade, with severe diarrhoea of NCI CTCAE grades 3 and 4 occurring in <10% and <1% of patients, respectively. 
Driska, ki jo povzroči zdravilo Tyverb, je po navadi nizke stopnje; huda driska stopnje 3 po NCI CTCAE se je pojavila pri < 10 % bolnikov, huda driska stopnje 4 pa pri < 1 % bolnikov.
• quinidine, digoxin - medicines used to treat certain heart problems 
• kinidin, digoksin - zdravili za zdravljenje nekaterih težav s srcem,
Table 2 Overall survival data from Study EGF100151 (Tyverb / capecitabine) 
Preglednica 2 Podatki o celotnem preživetju iz študije EGF100151 (Tyverb/kapecitabin)
What Tyverb looks like and contents of the pack 
Izgled zdravila Tyverb in vsebina pakiranja
Subjects who had not received prior trastuzumab* N 
Bolniki, ki predhodno niso prejemali trastuzumaba* N
Lapatinib is predominantly eliminated through metabolism by CYP3A4/5. 
Lapatinib se v glavnem izloča s presnovo s CYP3A4/5.
Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed on one side. 
filmsko obložena tableta (tableta) Ovalne, bikonveksne, rumene filmsko obložene tablete, z oznako “GS XJG” na eni strani.
Table 3 Analyses of investigator-assessed progression-free survival and overall survival 
Preglednica 3 Analize preživetja brez napredovanja (PFS-progression-free survival) po oceni raziskovalca in analize celotnega preživetja (OS-overall survival)
Don't drink grapefruit juice while you are being treated with Tyverb. 
Med zdravljenjem z zdravilom Tyverb ne smete piti soka grenivke.
Pulmonary arterial hypertension**. 
Pogostnost neznana pljučna arterijska hipertenzija**
Decreased left ventricular ejection fraction and QT interval prolongation 
Zmanjšanje iztisnega deleža levega prekata in podaljšanje intervala QT
Decreased left ventricular ejection fraction (see section 4.2 - dose reduction - cardiac events and section 4.4). 
Srčne bolezni Pogosti zmanjšan iztisni delež levega prekata (glejte poglavje 4.2 - Zmanjšanje odmerka - Srčni dogodki in poglavje 4.4)
OUTER CARTON AND BOTTLE LABEL 
ŠKATLA IN NALEPKA ZA PLASTENKO
Table 1 Time to progression data from Study EGF100151 (Tyverb / capecitabine) 
Preglednica 1 Podatki o času do napredovanja iz študije EGF100151 (Tyverb/kapecitabin)