FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were randomised to letrozole 2.5 mg once daily plus Tyverb 1500 mg once daily or letrozole with placebo.
Slovenian: Bolnice so randomizirali na letrozol 2,5 mg enkrat na dan v kombinaciji z zdravilom Tyverb 1.500 mg enkrat na dan ali na letrozol s placebom.
English: Very common Headache
Slovenian: Pogosti glavobol*
English: Trastuzumab (loading dose of 8mg/kg followed by 6mg/kg q3 weekly infusions)
Slovenian: Trastuzumab (polnilni odmerek 8 mg/kg, nato 6 mg/kg v infuzijah na 3 tedne )
English: Asymptomatic and symptomatic cases of overdose have been reported in patients being treated with Tyverb.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Tyverb, so poročali o asimptomatskih in simptomatskih primerih prevelikega odmerjanja.
English: Missed doses should not be replaced and the dosing should resume with the next scheduled daily dose (see section 4.9).
Slovenian: Bolnik mora zdravljenje nadaljevati z naslednjim predvidenim dnevnim odmerkom (glejte poglavje 4.9).
English: Less than 2% of the administered oral dose (as lapatinib and metabolites) excreted in urine.
Slovenian: Po peroralni uporabi se z urinom izloči manj kot 2 % odmerka (v obliki lapatiniba in presnovkov).
English: OUTER CARTON (14 DAY, SINGLE PACK)
Slovenian: ŠKATLA (ENOJNO PAKIRANJE ZA 14-DNEVNO ZDRAVLJENJE)
English: • if you have any kidney problems
Slovenian: • če imate kakršne koli težave z ledvicami,
English: 70 film-coated tablets 84 film-coated tablets
Slovenian: filmsko obložena tableta 70 filmsko obloženih tablet 84 filmsko obloženih tablet
English: • collapse or blackout.
Slovenian: • kolaps ali izgubo zavesti.
English: Adverse reactions should be carefully monitored if Tyverb is co-administered with irinotecan, and a reduction in the dose of irinotecan should be considered.
Slovenian: Ob sočasni uporabi zdravila Tyverb z irinotekanom je treba natančno kontrolirati neželene učinke in morebiti zmanjšati odmerek irinotekana.
English: Rash was generally low grade and did not result in discontinuation of treatment with lapatinib.
Slovenian: Izpuščaj je bil običajno blažji in zdravljenja z lapatinibom ni bilo treba prekiniti.
English: • unusual hair loss or thinning
Slovenian: • neobičajno izpadanje ali redčenje las.
English: Each pack of Tyverb contains 70 or 84 tablets in aluminium foil blisters of 10 or 12 tablets each.
Slovenian: Ena škatla zdravila Tyverb vsebuje 70 ali 84 tablet v pretisnih omotih iz aluminijske folije.
English: LVEF decreases were reported in 6.7 % of patients who received lapatinib in combination with trastuzumab, as compared to 2.1 % of patients who received lapatinib alone.
Slovenian: O zmanjšanju LVEF so poročali pri 6,7 % bolnikov, ki so prejemali lapatinib v kombinaciji s trastuzumabom, in pri 2,1 % bolnikov, ki so prejemali samo lapatinib.
English: Discontinuation or interruption of dosing with Tyverb may be considered when a patient develops toxicity greater than or equal to grade 2 on the NCI CTCAE.
Slovenian: Zdravljenje z zdravilom Tyverb je treba ukiniti ali prekiniti, če se pri bolniku pojavijo toksični učinki stopnje 2 ali večje po NCI CTCAE.
English: Number (%) with event Kaplan-Meier estimate, months a
Slovenian: KaplanMeierjeva ocena, meseci a
English: • cisapride - a medicine used to treat certain digestive system problems
Slovenian: • cisaprid - zdravilo za zdravljenje nekaterih prebavnih težav,
English: In rats, growth retardation was observed in pups which were exposed to lapatinib via breast milk.
Slovenian: Pri podganjih mladičih, ki so bili med dojenjem izpostavljeni lapatinibu, so poročali o zaostanku v rasti.
English: On the combination arm, there were 4 (2%) progressions in the central nervous system as compared with the 13 (6%) progressions on the capecitabine alone arm.
Slovenian: V skupini s kombiniranim zdravljenjem je bolezen napredovala v centralno živčevje pri 4 bolnikih (2 %) v primerjavi s 13 bolniki (6 %) v skupini, ki je prejemala samo kapecitabin.
English: • use fragrance free, hypoallergenic beauty products
Slovenian: • uporabljajte hipoalergene kozmetične izdelke brez vonjev,
English: Interstitial lung disease / pneumonitis
Slovenian: Intersticijska pljučna bolezen / pnevmonitis
English: Median (95%
Slovenian: ROg (95 %
English: • a skin reaction on the palms of the hands or soles of the feet (including tingling, numbness,
Slovenian: • kožna reakcija na dlaneh ali stopalih (vključno z zbadanjem, odrevenelostjo, bolečino, oteklino ali rdečino),
English: Palmar-plantar erythrodysesthesia (PPE) was also common (>25%) when lapatinib was administered in combination with capecitabine.
Slovenian: Če je bil lapatinib uporabljen v kombinaciji s kapecitabinom, je bila pogosta (> 25 %) tudi palmarno-plantarna eritrodizestezija (PPE).
English: Iron oxide yellow (E172) Iron oxide red (E172)
Slovenian: Obloga tablete hipromeloza titanov dioksid (E171) makrogol (400) polisorbat 80 rumeni železov oksid (E172) rdeči železov oksid (E172)
English: The maximum oral dose of lapatinib that has been administered in clinical studies is 1800 mg once daily.
Slovenian: V kliničnih študijah je bil največji peroralni dnevni odmerek lapatiniba 1.800 mg enkrat na dan.
English: The clinical status of the patient and the safety profile of lapatinib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Slovenian: Pri presojanju sposobnosti bolnika za opravila, ki zahtevajo presojo in motorične ter kognitivne sposobnosti, je treba upoštevati tako klinično stanje bolnika kot varnostni profil lapatiniba.
English: These adverse reactions were observed when lapatinib was administered in combination with letrozole.
Slovenian: Te neželene učinke so ugotovili, če je bil lapatinib uporabljen v kombinaciji z letrozolom.
English: Combination treatment with Tyverb and trastuzumab
Slovenian: Kombinirano zdravljenje z zdravilom Tyverb in trastuzumabom
English: The full prescribing information of the co-administered medicinal product should be consulted for relevant details of their posology including any dose reductions, contraindications and safety information.
Slovenian: Za pomembne podrobnosti o sočasno uporabljanih zdravilih (vključno s podatki o njihovem odmerjanju, tudi o morebitnem zmanjšanju odmerka, kontraindikacijah in podatkih o varnosti) je treba upoštevati celotna navodila za predpisovanje teh zdravil.
English: Table 4 Progression-free survival and overall survival data (Tyverb / trastuzumab)
Slovenian: Preglednica 4 Podatki o preživetju brez napredovanja in celokupnem preživetju (zdravilo Tyverb/trastuzumab)
English: LVEF was evaluated in all patients (using echocardiogram [Echo] or multi gated acquisition scan [MUGA]) prior to initiation of treatment with Tyverb to ensure baseline LVEF was within the institutions normal limits.
Slovenian: Pred začetkom zdravljenja z zdravilom Tyverb je bila pri vseh bolnikih ovrednotena vrednost LVEF (ehokardiografsko [Echo] ali s preiskavo multiplo prožene angiografije [MUGA]) in izhodiščna vrednost LVEF v mejah normalne vrednosti.
English: Caution should be taken if Tyverb is to be administered to patients with conditions that could impair left ventricular function (including coadministration with potentially cardiotoxic medicinal products).
Slovenian: Pri bolnikih s stanji, ki lahko okvarijo funkcijo levega prekata, je treba zdravilo Tyverb uporabljati previdno (vključno s sočasno uporabo potencialno kardiotoksičnih zdravil).
English: Systemic exposure to lapatinib is increased when administered with food.
Slovenian: Pri uporabi lapatiniba skupaj s hrano se sistemska izpostavljenost lapatinibu poveča.
English: Lapatinib has also been shown in vitro to inhibit these efflux transporters, as well as the hepatic uptake transporter OATP 1B1, at clinically relevant concentrations (IC50 values were equal to 2.3 µg/ml).
Slovenian: In vitro je bilo tudi dokazano, da lapatinib pri klinično pomembnih koncentracijah (IC50 vrednosti so bile enake 2,3 µg/ml) zavira iznosne “efflux” prenašalce in tudi jetrne vnosne “uptake” prenašalce OATP 1B1.
English: Hypersensitivity reactions including anaphylaxis (see section 4.3) Metabolism and nutrition disorders Very common Anorexia
Slovenian: Bolezni imunskega sistema Redki preobčutljivostne reakcije, vključno z anafilaksijo (glejte poglavje 4.3) Presnovne in prehranske motnje
English: capecitabine (2500 mg/m2/day, days 1-14 q21 days)
Slovenian: kapecitabin (2.500 mg/m2/dan, od 1. do 14. dne 21-dnevnega ciklusa)
English: Tyverb is prescribed in combination with trastuzumab, for patients who have hormone receptornegative metastatic breast cancer and have had other treatment for advanced or metastatic breast cancer before.
Slovenian: Zdravilo Tyverb predpisujejo v kombinaciji s trastuzumabom za bolnike z metastatskim rakom dojke, negativnim glede hormonskih receptorjev, ki so pred tem prejemali druga zdravila za napredovali ali metastatski rak dojke.
English: • being sick (vomiting)
Slovenian: • siljenje na bruhanje (navzea),
English: • severe skin reaction that might include: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever or any combination of these
Slovenian: • huda kožna reakcija, ki lahko vključuje izpuščaj, rdečo kožo, pojavljanje mehurjev na ustnicah,
English: Patients were randomised to receive either oral lapatinib 1000 mg once daily plus trastuzumab 4 mg/kg administered as an intravenousloading dose, followed by 2 mg/kg intravenous weekly (N = 148), or oral lapatinib 1500 mg once daily (N = 148).
Slovenian: Bolnice so randomizirali ali na prejemanje peroralnega lapatiniba 1.000 mg enkrat na dan in trastuzumaba 4 mg/kg, uporabljenega kot intravenski polnilni odmerek, ki mu je sledil odmerek 2 mg/kg intravensko vsak teden (N=148), ali na prejemanje peroralnega lapatiniba 1.500 mg enkrat na dan (N=148).
English: Co-administration of Tyverb with orally administered medicinal products with narrow therapeutic windows that are substrates of CYP3A4 and /or CYP2C8 should be avoided (see section 4.5).
Slovenian: Sočasni uporabi zdravila Tyverb skupaj s peroralnimi zdravili z ozkim terapevtskim oknom, ki so substrati za CYP3A4 in/ali CYP2C8, se je treba izogibati (glejte poglavje 4.5).
English: In the Tyverb plus capecitabine arm 8 patients (3.2%) experienced CNS as site of first progression, compared with 12 patients (4.8%) in the trastuzumab plus capecitabine arm.
Slovenian: V kraku s kombinacijo zdravila Tyverb in kapecitabina je bilo osrednje živčevje mesto prvega napredovanja pri 8 bolnicah (3,2 %), v kraku s kombinacijo trastuzumaba in kapecitabina pa pri 12 bolnicah (4,8 %).
English: Tyverb 250 mg tablets lapatinib
Slovenian: Tyverb 250 mg tablete lapatinib
English: Recovery of unchanged lapatinib in faeces accounts for a median 27% (range 3 to 67%) of an oral dose.
Slovenian: Z blatom se pri peroralni uporabi v povprečju izloči 27 % nespremenjenega lapatiniba (razpon od 3 do 67 %).
English: Patients were randomised to either Tyverb 1250 mg once daily (continuously) plus capecitabine (2000 mg/m2/day on days 1-14 every 21 days), or trastuzumab (loading dose of 8mg/kg followed by 6mg/kg q3 weekly infusions) plus capecitabine (2500mg/m2/day, days 1-14, every 21 days).
Slovenian: Bolnike so randomizirali bodisi na zdravilo Tyverb v odmerku 1250 mg enkrat na dan (stalno) v kombinaciji s kapecitabinom (2000 mg/m2/dan od 1. do 14. dne 21-dnevnega ciklusa) ali na trastuzumab (polnilni odmerek 8 mg/kg in nato 6 mg/kg v infuzijah na 3 tedne) v kombinaciji s kapecitabinom (2500 mg/m2/dan od 1. do 14. dne 21-dnevnega ciklusa).
English: Tyverb is supplied in either blisters packs or bottles:
Slovenian: Zdravilo Tyverb je na voljo v pretisnih omotih ali plastenkah:
English: Concomitant treatment with substances that increase gastric pH should be avoided, as lapatinib solubility and absorption may decrease.
Slovenian: Topnost lapatiniba je odvisna od pH. Sočasnemu zdravljenju z učinkovinami, ki zvišujejo pH vrednost želodčnega soka, se je treba izogibati, saj se lahko zmanjšata topnost in absorpcija lapatiniba.
English: Co-administration of Tyverb with orally administered medicinal products with narrow therapeutic windows that are substrates of CYP3A4 (e.g. cisapride, pimozide and quinidine) should be avoided (see sections 4.4 and 5.2).
Slovenian: Sočasni uporabi zdravila Tyverb s peroralnimi zdravili z ozkim terapevtskim oknom, ki so substrati za CYP3A4 (npr. cisaprid, pimozid in kinidin), se je treba izogibati (glejte poglavji 4.4 in 5.2).
English: Interstitial lung disease and pneumonitis
Slovenian: Intersticijska bolezen pljuč in pnevmonitis
English: Evaluation of cardiac function, including LVEF determination, should be conducted for all patients prior to initiation of treatment with Tyverb to ensure that the patient has a baseline LVEF that is within the institutions normal limits.
Slovenian: Pred začetkom zdravljenja z zdravilom Tyverb je treba pri vsakem bolniku oceniti delovanje srca, tudi vrednost LVEF, in se prepričati, da je izhodiščna vrednost LVEF znotraj normalnih vrednosti.
English: LVEF decreases were reported in 3.1 % of patients who received lapatinib in combination with letrozole as compared to 1.3 % of patients receiving letrozole plus placebo.
Slovenian: O zmanjšanju LVEF so poročali pri 3,1 % bolnikov, ki so prejemali lapatinib v kombinaciji z letrozolom, in pri 1,3 % bolnikov, ki so prejemali letrozol in placebo.
English: Tyverb may be restarted at a reduced dose (750 mg/day when administered with trastuzumab, 1000 mg/day when administered with capecitabine or 1250 mg/day when administered with an aromatase inhibitor) after a minimum of 2 weeks and if the LVEF recovers to normal and the patient is asymptomatic.
Slovenian: Zdravljenje z zdravilom Tyverb se lahko ponovno uvede v zmanjšanem odmerku (750 mg/dan, če je uporabljen s trastuzumabom, 1.000 mg/dan, če je uporabljen s kapecitabinom, ali 1.250 mg/dan, če je uporabljen z zaviralcem aromataze) po najmanj 2 tednih, če se vrednost LVEF normalizira in bolnik nima simptomov.
English: In the HER2-negative population, there was no benefit in PFS when letrozole plus Tyverb was compared with letrozole plus placebo (see Table 6).
Slovenian: V HER2-negativni populaciji primerjava kombinacije letrozola in zdravila Tyverb ter letrozola in placeba ni pokazala ugodnega vpliva na preživetje brez napredovanja (glejte tabelo 6).
English: However, when lapatinib was administered in combination with trastuzumab in the metastatic setting, the incidence of cardiac events including LVEF decreases was higher (7%) versus the lapatinib alone arm (2%) in the pivotal trial.
Slovenian: V ključni študiji je bila incidenca dogodkov na srcu (vključno z zmanjšanjem LVEF) pri uporabi lapatiniba v kombinaciji s trastuzumabom v primeru metastaz višja (7 %) v primerjavi z lapatinibom samim (2 %).
English: Tyverb and for at least 5 days after the last dose.
Slovenian: Med jemanjem zdravila Tyverb in še najmanj 5 dni po zaužitju zadnjega odmerka zdravila ne smete dojiti.
English: In the rat preand postnatal development study, a decrease in pup survival occurred between birth and postnatal day 21 at doses of 60 mg/kg/day or higher (5 times the expected human clinical exposure).
Slovenian: Pri študijah vplivov na pre- in postnatalni razvoj so pri odmerkih 60 mg/kg/dan ali večjih (5-kratna pričakovana izpostavljenost človeka pri klinični uporabi) poročali o večji smrtnosti mladičev od rojstva do 21. dne po rojstvu.
English: Lapatinib was not clastogenic or mutagenic in a battery of assays including the Chinese hamster chromosome aberration assay, the Ames assay, human lymphocyte chromosome aberration assay and an in vivo rat bone marrow chromosome aberration assay.
Slovenian: Pri vrsti preskušanj, vključno s testom kromosomskih aberacij pri kitajskem hrčku, Amesovem testu, testu kromosomskih aberacij na humanih limfocitih ter in vivo testu kromosomskih aberacij na kostnem mozgu podgan klastogenega ali mutagenega delovanja lapatiniba niso opazili.
English: The recommended dose of capecitabine is 2000 mg/m2/day taken in 2 doses 12 hours apart on days 1-14 in a 21 day cycle (see section 5.1).
Slovenian: Priporočeni odmerek kapecitabina je 2.000 mg/m2/dan v dveh odmerkih vsakih 12 ur na 1.-14. dan
English: A concentration dependent increase in QTcF (maximum mean ΔΔQTcF 8.75 ms; 90% CI 4.08, 13.42) was observed in a dedicated QT study in patients with advanced solid tumours (see section 4.4).
Slovenian: V študiji intervala QT pri bolnikih z napredovalimi solidnimi tumorji so opazili od koncentracije odvisno podaljšanje intervala QTcF (z največjo povprečno vrednostjo ΔΔQTcF 8,75 ms; 90-odstoten IZ: 4,08; 13,42) (glejte poglavje 4.4).
English: Relative to dosing 1 hour before a low fat breakfast, mean AUC values were approximately 2- and 3-fold higher when lapatinib was administered 1 hour after a low fat or high fat meal, respectively.
Slovenian: Če je bil lapatinib uporabljen 1 uro po malo mastnem obroku, je bila povprečna AUC približno 2-krat večja kot v primeru uporabe 1 uro pred malo mastnim zajtrkom; če je bil uporabljen 1 uro po zelo mastnem obroku, pa je bila približno 3-krat večja kot v primeru uporabe 1 uro pred malo mastnim zajtrkom.
English: If you get other side effects
Slovenian: V primeru pojava drugih neželenih učinkov
English: Combination treatment with Tyverb and letrozole
Slovenian: Kombinirano zdravljenje z zdravilom Tyverb in letrozolom
English: The recommended dose of Tyverb is 1250 mg (i.e. five tablets) once daily continuously.
Slovenian: Priporočeni odmerek zdravila Tyverb je 1.250 mg (to je pet tablet) enkrat na dan neprekinjeno.
English: The results for the pharmacodynamics population (n=52) were consistent with those from the evaluable population (maximum ΔΔQTcF (90% CI) of 7.91 ms (4.13, 11.68) observed 10 hours after ingestion of the third dose of lapatinib 2000 mg).
Slovenian: Pri populaciji za oceno farmakodinamike (n=52) so bili rezultati 10 ur po zaužitju tretjega odmerka 2.000 mg lapatiniba podobni kot pri populaciji bolnikov, ki so bili primerni za ocenjevanje (največja vrednost ΔΔQTcF 7,91 ms (90-odstotni IZ; 4,13; 11,68).
English: Lapatinib undergoes extensive metabolism, primarily by CYP3A4 and CYP3A5, with minor contributions from CYP2C19 and CYP2C8 to a variety of oxidated metabolites, none of which account for more than 14% of the dose recovered in the faeces or 10% of lapatinib concentration in plasma.
Slovenian: Lapatinib se obsežno presnavlja, predvsem s CYP3A4 in CYP3A5, v manjšem obsegu tudi CYP2C19 in CYP2C8 do različnih oksidiranih presnovkov.
English: • diarrhoea (which may make you dehydrated and lead to more severe complications) Tell your doctor immediately at the first sign of diarrhoea (loose stool), as it is important that this is treated right away.
Slovenian: Nemudoma obvestite svojega zdravnika ob prvem znaku driske (mehko blato), saj je pomembno, da se ta obravnava takoj.
English: Microcrystalline cellulose Povidone (K30)
Slovenian: Jedro tablete mikrokristalna celuloza povidon (K30) natrijev karboksimetilškrob (vrsta A) magnezijev stearat
English: 140 film-coated tablets Multipack: 140 (2 packs of 70) film-coated tablets.
Slovenian: Pakiranje po več enot vsebuje 140 (2 pakiranji po 70) filmsko obloženih tablet.
English: Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 5 tablets.
Slovenian: Pretisni omoti so po sredini perforirani, kar omogoča razdelitev pretisnih omotov v dnevni odmerek po 5 tablet.
English: If the toxicity recurs, then Tyverb should be restarted at a lower dose (750 mg/day when administered with trastuzumab, 1000 mg/day when administered with capecitabine or 1250 mg/day when administered with an aromatase inhibitor).
Slovenian: Če se toksični učinki ponovijo, je treba zdravljenje ponovno uvesti v nižjem odmerku (750 mg/dan, če je uporabljen s trastuzumabom, 1.000 mg/dan, če je uporabljen s kapecitabinom, ali 1.250 mg/dan, če je uporabljen z zaviralcem aromataze).
English: Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 6 tablets.
Slovenian: Pretisni omoti so po sredini perforirani, kar omogoča razdelitev pretisnih omotov v dnevni odmerek po 6 tablet.
English: • blood tests results that show changes in liver function (usually mild and temporary) Rare side effects (may affect up to 1 in 1,000 people):
Slovenian: • spremembe v delovanju jeter, ugotovljene na podlagi rezultatov krvnih preiskav (običajno blage in prehodne).
English: Very common Insomnia*
Slovenian: Psihiatrične motnje Zelo pogosti nespečnost*
English: In oral carcinogenicity studies with lapatinib, severe skin lesions were seen at the highest doses tested which produced exposures based on AUC up to 2-fold in mice and male rats, and up to 15-fold in female rats, compared to humans given 1250 mg of lapatinib once daily.
Slovenian: Ti odmerki so (na podlagi AUC) povzročili izpostavljenosti, ki so bile pri miših in podganjih samcih do 2-krat tolikšne, pri podganjih samicah pa do 15-krat tolikšne kot pri človeku med uporabo 1.250 mg lapatiniba enkrat na dan.
English: Tyverb 250 mg film-coated tablets
Slovenian: Tyverb 250 mg filmsko obložene tablete
English: Tyverb is supplied in either blister packs or bottles.
Slovenian: Zdravilo Tyverb je na voljo v pretisnih omotih ali plastenkah.
English: Ask your doctor or pharmacist for advice before taking Tyverb if you are unsure.
Slovenian: Če ste kakor koli negotovi, se pred začetkom jemanja zdravila Tyverb posvetujte s svojim zdravnikom ali farmacevtom.
English: The recommended dose of Tyverb is 1000 mg (i.e. four tablets) once daily continuously.
Slovenian: Priporočeni odmerek je 1.000 mg zdravila Tyverb (tj. štiri tablete) enkrat na dan, neprekinjeno.
English: In the evaluable population (n=37), the maximum mean ΔΔQTcF (90% CI) of 8.75 ms (4.08, 13.42) was observed 10 hours after ingestion of the third dose of lapatinib 2000 mg.
Slovenian: V populaciji bolnikov, ki so bili primerni za ocenjevanje (n=37), so 10 ur po zaužitju tretjega odmerka 2.000 mg lapatiniba opažali največjo povprečno vrednost ΔΔQTcF 8,75 ms (90-odstotni IZ; 4,08; 13,42).
English: Lapatinib inhibits CYP3A4 in vitro at clinically relevant concentrations.
Slovenian: Lapatinib in vitro pri klinično pomembnih koncentracijah zavira CYP3A4.
English: Grapefruit juice should be avoided during treatment with Tyverb (see section 4.5).
Slovenian: Med zdravljenjem z zdravilom Tyverb bolnik ne sme uživati soka grenivke (glejte poglavje 4.5).
English: Other very common side effects
Slovenian: Drugi zelo pogosti neželeni učinki
English: Tyverb (1250 mg/day) + capecitabine (2000 mg/m2/day, days 1-14 q21 days)
Slovenian: Tyverb (1.250 mg/dan) + kapecitabin (2.000 mg/m2/dan, od 1. do 14. dne 21-dnevnega ciklusa)
English: Tyverb 250 mg film-coated tablets lapatinib
Slovenian: Tyverb 250 mg filmsko obložene tablete lapatinib
English: If you are prescribed Tyverb in combination with an aromatase inhibitor, the usual dose is 6 Tyverb tablets a day, as a single dose.
Slovenian: Če vam je zdravnik zdravilo Tyverb predpisal v kombinaciji z zaviralcem aromataze, je običajen odmerek 6 tablet zdravila Tyverb na dan, uporabljenih hkrati.
English: Co-administration of Tyverb with medicinal products with narrow therapeutic windows that are substrates of CYP2C8 (e.g. repaglinide) should be avoided (see sections 4.4 and 5.2).
Slovenian: Izogibati se je treba sočasni uporabi zdravila Tyverb in zdravil z ozkim terapevtskim oknom, ki so substrati CYP2C8 (npr. repaglinid) (glejte poglavji 4.4 in 5.2).
English: Table 6 Progression free survival data from Study EGF30008 (Tyverb / letrozole)
Slovenian: Preglednica 6 Podatki o preživetju brez napredovanja iz študije EGF30008
English: Because of the possible side effects of Tyverb, your ability to drive or operate machines could be affected.
Slovenian: Nekateri neželeni učinki zdravila Tyverb lahko vplivajo na sposobnost upravljanja vozil in strojev.
English: • Your doctor will also carry out tests to check your heart and liver function before and during treatment with Tyverb.
Slovenian: • Pred začetkom zdravljenja z zdravilom Tyverb bo zdravnik s preiskavami preveril delovanje srca in jeter.