natgillin/translations-raw huggingface dataset:
Diarrhoea responds well to proactive management (see section 4.4).
Proljev dobro reagira na proaktivno zbrinjavanje (vidjeti dio 4.4).
The effect of lapatinib on the QT-interval was evaluated in a single-blind, placebo-controlled, single sequence (placebo and active treatment) crossover study in patients with advanced solid tumours (EGF114271) (n=58).
Učinak lapatiniba na QT interval je procijenjen u jednostruko slijepom, placebom kontroliranom, ukriženom ispitivanju s jednom sekvencom (placebo i aktivno liječenje) u bolesnika s uznapredovalim solidnim tumorima (EGF114271) (n=58).
Systemic exposure (AUC) to lapatinib after a single oral 100 mg dose increased approximately 56% and 85% in patients with moderate and severe hepatic impairment, respectively.
Sistemska izloženost (AUC) lapatinibu nakon jednokratne oralne doze od 100 mg se povećala za oko 56% i 85% u ispitanika s umjerenim odnosno teškim oštećenjem funkcije jetre.
Tyverb has no influence on the ability to drive and use machines.
Tyverb ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Pre-treatment with a proton pump inhibitor (esomeprazole) decreased lapatinib exposure by an average of 27% (range: 6% to 49%).
Prethodna primjena inhibitora protonske pumpe (esomeprazola) snizila je izloženost lapatinibu za prosječno 27% (raspon od 6% do 49%).
The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see sections 4.4. and 5.1).
Bolesnice u registracijskom ispitivanju nisu bile prethodno liječene trastuzumabom ili inhibitorom aromataze (vidjeti dio 4.4 i 5.1).
Your doctor will advise you about the dose of your other anti-cancer medicine, and how to take it.
Liječnik će Vas savjetovati o dozi drugih antitumorskih lijekova koje trebate uzimati kao i o načinu njihova uzimanja.
The cardiac events observed in this study were comparable in nature and severity to those previously seen with lapatinib.
Kardiološki događaji zabilježeni u ovom ispitivanju po prirodi i težini se mogu usporediti s prethodno zabilježenim događajima s lapatinibom.
An additional increase in peak exposure of lapatinib can be expected when lapatinib is taken repeatedly with food (see sections 4.2 and 5.2) or concomitantly with strong CYP3A4 inhibitors.
Dodatno povećanje u vršnoj izloženosti lapatinibu može se očekivati kada se lapatinib opetovano uzima s hranom (vidjeti dijelove 4.2 i 5.2) ili istodobno sa snažnim inhibitorima CYP3A4.
During the 4-day treatment period, three doses of matching placebo were administered 12 hours apart in the morning and evening on Day 1 and in the morning on Day 2.
Tijekom četverodnevnog perioda liječenja, tri doze koje odgovaraju placebu su bile primijenjene u razmaku od 12 sati ujutro i navečer 1. dana, te ujutro 2. dan.
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.
U fazi III kliničkog ispitivanja kombinacije lijeka Tyverb i letrozola, od ukupnog broja bolesnika s metastatskim rakom dojke pozitivnim na hormonske receptore (populacija planirana za liječenje n= 642), 44% njih je bilo dobi ≥ 65 godina.
Of all patients randomised to treatment, 219 patients had tumours overexpressing the HER2 receptor, and this was the pre-specified primary population for the analysis of efficacy.
Od svih randomiziranih bolesnica za liječenje, 219 bolesnica je imalo tumore s prekomjernom ekspresijom HER2 receptora i to je bila prethodno definirana primarna skupina ispitanika za analizu djelotvornosti.
The effect of Tyverb during pregnancy is not known.
Učinak lijeka Tyverb na trudnoću nije poznat.
If you suffer from diarrhoea while taking Tyverb:
Ukoliko imate proljev dok uzimate Tyverb:
Hyperbilirubinaemia, hepatotoxicity (see section 4.4).
Hiperbilirubinemija, hepatotoksičnost (vidjeti dio 4.4).
Asymptomatic and symptomatic cases of overdose have been reported in patients being treated with Tyverb.
Prijavljeni su asimptomatski i simptomatski slučajevi predoziranja u bolesnika koji su liječeni lijekom Tyverb.
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).
U svrhu smanjenja varijabilnosti u pojedinog bolesnika primjenu lijeka Tyverb potrebno je standardizirati u odnosu na unos hrane, na primjer, uvijek ga uzimati jedan sat prije obroka (vidjeti dijelove 4.5 i 5.2 za informacije o apsorpciji).
HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+ with gene amplification or gene amplification alone.
Tumori koji pokazuju prekomjernu ekspresiju HER2 (ErbB2) definirani su rezultatom IHC3+, ili IHC2+ uz amplifikaciju gena, ili samom amplifikacijom gena.
Measurements, including electrocardiograms (ECGs) and pharmacokinetic samples, were taken at baseline and at the same time points on Day 2 and Day 4.
Mjerenja, uključujući elektrokardiograme (EKG) i farmakokinetičke uzorke, su provedena na početku i u istim vremenskim točkama 2. i 4. dana.
• if you have diarrhoea (see section 4).
• ako imate proljev (pogledajte dio 4.).
Tyverb is also available in multipacks containing 140 tablets that comprise 2 packs, each containing 70 tablets.
Tyverb je također dostupan u višestrukim pakiranjima koja sadrže 140 tableta, a sastoje se od 2 pakiranja, svako sa 70 tableta.
Patients who had objective disease progression after receiving at least 4 weeks of treatment with lapatinib monotherapy were eligible to crossover to combination therapy.
Bolesnici kojima je bolest objektivno progredirala nakon najmanje 4 tjedna liječenja monoterapijom lapatinibom mogli su prijeći na kombiniranu terapiju.
Lapatinib has been associated with reports of pulmonary toxicity including interstitial lung disease and pneumonitis (see section 4.8).
Lapatinib je povezan s prijavama plućne toksičnosti, uključujući intersticijsku bolest pluća i pneumonitis (vidjeti dio 4.8).
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.
U bolesnika koji su uzeli do 5000 mg lapatiniba primijećeni su simptomi koji uključuju s lapatinibom povezane događaje (vidjeti dio 4.8) i, u nekim slučajevima, osjetljivo vlasište i/ili upale sluznice.
Lapatinib is predominantly eliminated through metabolism by CYP3A4/5.
Lapatinib se uglavnom eliminira putem metabolizma pomoću CYP3A4/5.
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.
Ako se posumnja na pojavu eritema multiforme ili na reakcije opasne po život poput Stevens-Johnsonovog sindroma ili toksičnu epidermalnu nekrolizu (npr. progresivni kožni osip često s mjehurićima ili lezijama sluznica), potrebno je prekinuti liječenje lijekom Tyverb.
However, the occurrence of docetaxel-induced neutropenia was increased.
Ipak, porasla je pojavnost docetakselom inducirane neutropenije.
Final OS analysis (post-hoc analysis, 07 August 2013) Median follow-up (yrs) Deaths (%) Hazard ratio (95% CI), p-value Median values from Kaplan-Meier analysis; HR and p-values from Cox regression models adjusting for important prognostic factors.
Završna analiza OS-a (post-hoc analiza, 07. kolovoza 2013.) Medijan praćenja (godine) Smrtni ishodi (%) Omjer hazarda (95% CI), pvrijednost Vrijednosti medijana iz Kaplan-Meier-ove analize; Omjer hazarda i p-vrijednosti iz Cox regresijskog modela prilagođeni za važne prognostičke čimbenike. a.
A randomised Phase III study (EGF111438) (N=540) compared the effect of the two regimens on the incidence of CNS as site of first relapse in women with HER2 overexpressing metastatic breast cancer.
Randomizirano ispitivanje faze III (EGF111438) (N=450) uspoređivalo je učinak dva režima na incidenciju metastaza u CNS-u kao mjestu prvog relapsa u žena s metastatskim karcinomom dojke s prekomjernom HER2 ekspresijom.
Tell your doctor or pharmacist if you notice any side effects not listed in this leaflet.
Odmah obavijestite svog liječnika ili ljekarnika ako primijetite nuspojave koje nisu navedene u ovoj uputi.
You should not use Tyverb if you are pregnant unless your doctor specifically recommends it.
Tyverb se ne smije uzimati u trudoći, osim ako to Vaš liječnik izričito ne preporuči.
Lapatinib alone (N=148 )
Samo lapatinib (N = 148)
Adverse reactions should be carefully monitored if Tyverb is co-administered with irinotecan, and a reduction in the dose of irinotecan should be considered.
Nuspojave je potrebno pažljivo nadzirati ukoliko se Tyverb primjenjuje istodobno s irinotekanom te je potrebno razmišljati i o mogućem smanjenju doze irinotekana.
The independent assessment of the data also demonstrated that Tyverb when given in combination with capecitabine significantly increased time to progression (Hazard Ratio 0.57 [95 % CI 0.43, 0.77] p=0.0001) compared to capecitabine alone.
Neovisna ocjena podataka također je pokazala da je Tyverb u kombinaciji s kapecitabinom značajno produžio vrijeme do progresije (omjer hazarda 0,57 [95% CI 0,43; 0,77] p=0,0001) u usporedbi s monoterapijom kapecitabinom.
In the HER2-overexpressing population, only 2 patients were enrolled who had received prior trastuzumab, 2 patients had received prior aromatase inhibitor therapy, and approximately half had received tamoxifen.
U populaciji s prekomjernom ekspresijom HER2 uključene su samo 2 bolesnice koje su prethodno primale trastuzumab, 2 bolesnice prethodno liječene inhibitorima aromataze, a približno polovica bolesnica primala je tamoksifen.
Diarrhoea generally occurs early during Tyverb treatment, with almost half of those patients with diarrhoea first experiencing it within 6 days.
Proljev se u pravilu pojavljuje rano tijekom liječenja lijekom Tyverb, a u gotovo polovice tih bolesnika se proljev prvi put javi unutar prvih 6 dana.
• 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.
• proljev (koji može dovesti do dehidracije i težih komplikacija) Obavijestite svog liječnika bez odlaganja kod prvih znakova proljeva (rijetke stolice) jer je važno da se odmah počne liječiti.
Symptoms may include skin rash, blisters and skin peeling.
Simptomi mogu uključivati kožni osip, mjehuriće i ljuštenje kože.
Lapatinib is not significantly renally excreted and is highly bound to plasma proteins, therefore haemodialysis would not be expected to be an effective method to enhance the elimination of lapatinib.
Lapatinib se ne izlučuje putem bubrega u značajnoj mjeri i uvelike se veže za proteine plazme te se stoga hemodijaliza ne smatra učinkovitom metodom za pojačanje eliminacije lapatiniba.
BLISTERS
Blisteri
8.2 wks (7.4, 9.3)
8,2 tjedana (7,4; 9,3)
Lapatinib is highly bound (greater than 99%) to albumin and alpha-1 acid glycoprotein.
Lapatinib se u visokoj mjeri (više od 99%) veže za albumin i alfa-1 kiseli glikoprotein.
• nail disorders - such as a tender infection and swelling of the cuticles Tell your doctor if you get any of these symptoms.
• Poremećaji noktiju - kao što su blage infekcije ili oticanje zanoktica Obavijestite svog liječnika ako Vam se pojavi bilo koji od ovih simptoma.
Data are available on the efficacy and safety of Tyverb in combination with capecitabine relative to trastuzumab in combination with capecitabine.
Dostupni su podaci o djelotvornosti i sigurnosti Tyverba u kombinaciji s kapecitabinom u odnosu na trastuzumab u kombinaciji s kapecitabinom.
Hypersensitivity reactions including anaphylaxis (see section 4.3) Metabolism and nutrition disorders Very common Anorexia
Reakcije preosjetljivosti uključujući anafilaksiju (vidjeti dio 4.3) Poremećaji metabolizma i prehrane Vrlo često
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).
Rizik od hepatotoksičnosti izazvane lapatinibom bio je povezan s nositeljstvom HLA alela DQA1*02:01 i DRB1*07:01 (vidjeti dio 4.4.).
In studies across the clinical development programme for lapatinib, cardiac events including LVEF decreases were reported in approximately 1% of patients.
U ispitivanjima koja su se provodila tijekom cijelog programa kliničkog razvoja lapatiniba, kardiološki događaji uključujući smanjenje LVEF prijavljeni su u oko 1% bolesnika.
Ask your doctor or pharmacist for advice before taking Tyverb if you are unsure.
Posavjetujte se s Vašim liječnikom ili ljekarnikom prije početka uzimanja Tyverba ako u nešto niste sigurni.
In rats, growth retardation was observed in pups which were exposed to lapatinib via breast milk.
Kod štakora je primijećeno zaostajanje u rastu kod mladunčadi koja je bila izložena lapatinibu putem majčinog mlijeka.
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.
Istodobna primjena lijeka Tyverb i irinotekana (kada se primjenjuje kao dio FOLFIRI protokola) uzrokovala je približno 40%-tno povećanje AUC za SN-38 koji je aktivni metabolit irinotekana.
Progression-free survival (PFS) was the primary endpoint of the study with response rate and overall survival (OS) as secondary endpoints.
Preživljenje bez progresije (PFS) bio je primarni ishod ispitivanja, a sekundarni ishodi bili su stopa odgovora i ukupno preživljenje (OS).
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.
U kombiniranom liječenju bilo je 4 (2%) progresije u središnjem živčanom sustavu u usporedbi s 13 (6%) progresija u monoterapiji kapecitabinom.
The relevance of these findings for humans is uncertain.
Značenje ovih nalaza za ljude nije poznato.
In a single case of a patient who took 9000 mg of Tyverb, sinus tachycardia (with otherwise normal ECG) was also observed.
U jednom je slučaju u bolesnika koji je uzeo 9000 mg lijeka Tyverb zabilježena sinusna tahikardija (uz inače normalan EKG nalaz).
• treatment-induced lung inflammation, which may cause shortness of breath or cough Tell your doctor immediately if you get either of these symptoms.
• upala pluća potaknuta primjenom lijeka, što može dovesti do nedostatka zraka ili kašlja Odmah obavijestite svog liječnika ako dobijete neki od ovih simptoma.
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.
No, kad se lapatinib primjenjivao u kombinaciji s trastuzumabom u metastatskom okruženju, incidencija kardioloških događaja uključujući smanjenje LVEF bila je viša (7%) u odnosu na skupinu koja je primala samo lapatinib (2%) u pivotalnom ispitivanju.
Co-administration of lapatinib with intravenous paclitaxel increased the exposure of paclitaxel by 23%, due to lapatinib inhibition of CYP2C8 and/or Pgp.
Istodobna primjena lapatiniba i intravenskog paklitaksela povećava izloženost paklitakselu za 23% zbog inhibicije CYP2C8 i/ili Pgp-a lapatinibom.
This previous treatment for metastatic breast cancer must have included trastuzumab.
To je prethodno liječenje metastatskog raka dojke moralo uključivati trastuzumab.
Prescribing physicians are advised to perform a skin examination prior to treatment and regularly during treatment.
Liječnicima propisivačima se preporučuje da izvrše pregled kože bolesnika prije početka liječenja te ih redovito prate tijekom liječenja.
Tyverb is supplied in either blisters packs or bottles:
Tyverb je dostupan u blisterima ili u bocama:
Lapatinib effect on CNS metastasis
Učinak lapatiniba na metastaze u CNS-u
Decreased left ventricular ejection fraction (see section 4.2 - dose reduction - cardiac events and section 4.4).
Smanjenje ejekcijske frakcije lijeve klijetke (vidjeti dio 4.2 - smanjenje doze - srčani događaji i dio 4.4).
Lapatinib was studied in pregnant rats and rabbits given oral doses of 30, 60, and 120 mg/kg/day.
Lapatinib je ispitivan na trudnim ženkama štakora i kunića kojima su dane oralne doze od 30, 60 i 120 mg/kg/dan.
• tiredness, feeling weak
• umor, osjećaj slabosti
Lapatinib did not significantly inhibit the following enzymes in human liver microsomes: CYP1A2, CYP2C9, CYP2C19, and CYP2D6 or UGT enzymes (in vitro IC50 values were greater than or equal to 6.9 µg/ml).
Lapatinib nije značajno inhibirao sljedeće enzime u mikrosomima ljudske jetre: CYP1A2, CYP2C9, CYP2C19 i CYP2D6 ili UGT enzime (in vitro IC50 vrijednosti bile su veće od ili jednake 6,9 μg/ml).
However, a few cases of acute renal failure have been reported secondary to severe dehydration due to diarrhoea.
Ipak, prijavljeno je nekoliko slučajeva akutnog zatajenja bubrega nakon teške dehidracije uslijed proljeva.
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.
Dnevno doziranje 1250 mg daje u stanju dinamičke ravnoteže geometrijske srednje vrijednosti (koeficijent varijacije) Cmax od 2,43 (76%) μg/ml i AUC vrijednosti od 36,2 (79%) μg*hr/ml.
The growth inhibitory effects of lapatinib were evaluated in trastuzumab-conditioned cell lines.
Inhibitorni učinci lapatiniba na rast procjenjivani su na staničnim linijama kondicioniranim trastuzumabom.
- The other ingredients are: microcrystalline cellulose, povidone (K30), sodium starch glycolate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol (400), polysorbate 80, iron oxide yellow (E172), and iron oxide red (E172).
- Pomoćne tvari su: mikrokristalična celuloza, povidon (K30), natrijev škroboglikolat (vrsta A), magnezijev stearat, hipromeloza, titanijev dioksid (E171), makrogol (400), polisorbat 80, žuti željezov oksid (E172), i crveni željezov oksid (E172).
- The active substance in Tyverb is lapatinib.
- Djelatna tvar u lijeku Tyverb je lapatinib.
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.
Lapatinib se opsežno metabolizira, prvenstveno pomoću CYP3A4 i CYP3A5, s manjim doprinosom CYP2C19 i CYP2C8, do niza oksidiranih metabolita od kojih niti jedan ne čini više od 14% doze koja se nađe u stolici ili 10% koncentracije lapatiniba u plazmi.
(95% CI), p-value b
(95% CI), p vrijednost b
Immune system disorders Rare
Poremećaji imunološkog sustava Rijetko
Bottles Tyverb is also available in plastic bottles containing 70, 84, 105 or 140 tablets.
Boce Tyverb je dostupan i u plastičnim bocama koje sadrže 70, 84, 105 ili 140 tableta.
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).
Sigurnost lapatiniba procjenjivana je u monoterapiji ili u kombinaciji s drugim kemoterapijama za različite vrste karcinoma u više od 20 000 bolesnika, uključujući 198 bolesnika koji su primali lapatinib u kombinaciji s kapecitabinom, 149 bolesnika koji su primali lapatinib u kombinaciji s trastuzumabom i 654 bolesnika koji su primali lapatinib u kombinaciji s letrozolom (vidjeti dio 5.1).
• if you have any liver problems
• ako imate bilo kakvih problema s jetrom
Tyverb is prescribed to be taken in combination with another anti-cancer medicine.
Tyverb se propisuje za liječenje u kombinaciji s drugim antitumorskim lijekovima.
Systemic exposure to lapatinib is increased when administered with food.
Sistemska izloženost lapatinibu povećava se kada se uzima s hranom.
• topotecan, paclitaxel, irinotecan, docetaxel - medicines used to treat certain types of cancer
• topotekan, paklitaksel, irinotekan, docetaksel - lijekovi koji se primjenjuju u liječenju određenih tipova raka
The primary route of excretion for lapatinib and its metabolites is in faeces.
Primarni put izlučivanja lapatiniba i njegovih metabolita je stolicom.
Recovery of unchanged lapatinib in faeces accounts for a median 27% (range 3 to 67%) of an oral dose.
Ponovna pojava nepromijenjenog lapatiniba u stolici odgovara prosječno 27% (raspon 3 do 67%) oralne doze.
In healthy volunteers receiving carbamazepine, a CYP3A4 inducer, at 100 mg twice daily for 3 days and 200 mg twice daily for 17 days, systemic exposure to lapatinib was decreased approximately 72%.
U zdravih dobrovoljaca koji su primali karbamazepin, induktor CYP3A4, pri dozi od 100 mg dvaput dnevno tijekom 3 dana i 200 mg dvaput dnevno tijekom 17 dana, sistemska izloženost lapatinibu bila je smanjena za oko 72%.
• rash, dry skin, itching
• osip, suha koža, svrbež
Lapatinib, a 4-anilinoquinazoline, is an inhibitor of the intracellular tyrosine kinase domains of both EGFR (ErbB1) and of HER2 (ErbB2) receptors (estimated Ki app values of 3nM and 13nM, respectively) with a slow off-rate from these receptors (half-life greater than or equal to 300 minutes).
Lapatinib, 4-anilinokinazolin je inhibitor intracelularnih tirozin kinaznih domena i EFGR (ErbB1) i HER2 (ErbB2) receptora (utvrđene Ki app vrijednosti 3nM i 13nM, po istom redoslijedu) s polaganom stopom otpuštanja s ovih receptora (poluvijek dulji ili jednak 300 minuta).
Most cases of diarrhoea were grade 1 or 2 and did not result in discontinuation of treatment with lapatinib.
Većina slučajeva proljeva bila je 1. ili 2. stupnja te nije za posljedicu imala prekid liječenja lapatinibom.
Observed adverse reactions included dyspnoea, cardiac failure and palpitations.
Primijećene nuspojave uključivale su dispneju, zatajenje srca i palpitacije.
Food effects on lapatinib exposure
Učinci hrane na izloženost lapatinibu
• rosuvastatin - a medicine used to treat high cholesterol
• rosuvastatin - lijek koji se primjenjuje u liječenju visokog kolesterola
Randomisation was stratified by prior trastuzumab treatment and number of prior treatments for metastatic disease.
Randomizacija je stratificirana prema prethodnom liječenju trastuzumabom i broju prethodnih liječenja metastatske bolesti.
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).
Ne može se isključiti utjecaj lapatiniba na farmakokinetiku supstrata BCRP (npr. topotekan) i OATP1B1 (npr. rosuvastatin) (vidjeti dio 5.2).
The bioavailability and thereby the plasma concentrations of lapatinib are increased by food, in relation to the content and timing of the meal.
Bioraspoloživost, stoga i koncentracije lapatiniba u plazmi, povećavaju se prilikom jela, ovisno o sastavu i vremenu obroka.
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.
Procjena omjera hazarda liječenja, gdje < 1 ukazuje na manji rizik s letrozol 2,5 mg + lapatinib 1500 mg u usporedbi s letrozol 2,5 mg + placebo.
Furthermore, depending on type of food the bioavailability is approximately 2-3 times higher when lapatinib is taken 1 hour after food compared with 1 hour before the first meal of the day (see sections 4.2 and 5.2).
Nadalje, ovisno o vrsti hrane, bioraspoloživost je približno 2-3 puta veća kada se lapatinib uzme 1 sat nakon jela u usporedbi s uzimanjem 1 sat prije prvog obroka u danu (vidjeti dijelove 4.2 i
Rash was generally low grade and did not result in discontinuation of treatment with lapatinib.
Osip je općenito bio niskog stupnja težine i nije rezultirao prekidom liječenja lapatinibom.