natgillin/translations-raw huggingface dataset:
• use fragrance free, hypoallergenic beauty products
• uporabljajte hipoalergene kozmetične izdelke brez vonjev,
Interstitial lung disease / pneumonitis
Intersticijska pljučna bolezen / pnevmonitis
Median (95%
ROg (95 %
• a skin reaction on the palms of the hands or soles of the feet (including tingling, numbness,
• kožna reakcija na dlaneh ali stopalih (vključno z zbadanjem, odrevenelostjo, bolečino, oteklino ali rdečino),
Palmar-plantar erythrodysesthesia (PPE) was also common (>25%) when lapatinib was administered in combination with capecitabine.
Če je bil lapatinib uporabljen v kombinaciji s kapecitabinom, je bila pogosta (> 25 %) tudi palmarno-plantarna eritrodizestezija (PPE).
Iron oxide yellow (E172) Iron oxide red (E172)
Obloga tablete hipromeloza titanov dioksid (E171) makrogol (400) polisorbat 80 rumeni železov oksid (E172) rdeči železov oksid (E172)
The maximum oral dose of lapatinib that has been administered in clinical studies is 1800 mg once daily.
V kliničnih študijah je bil največji peroralni dnevni odmerek lapatiniba 1.800 mg enkrat na dan.
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.
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.
These adverse reactions were observed when lapatinib was administered in combination with letrozole.
Te neželene učinke so ugotovili, če je bil lapatinib uporabljen v kombinaciji z letrozolom.
Combination treatment with Tyverb and trastuzumab
Kombinirano zdravljenje z zdravilom Tyverb in trastuzumabom
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.
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.
Table 4 Progression-free survival and overall survival data (Tyverb / trastuzumab)
Preglednica 4 Podatki o preživetju brez napredovanja in celokupnem preživetju (zdravilo Tyverb/trastuzumab)
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.
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.
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).
Pri bolnikih s stanji, ki lahko okvarijo funkcijo levega prekata, je treba zdravilo Tyverb uporabljati previdno (vključno s sočasno uporabo potencialno kardiotoksičnih zdravil).
Systemic exposure to lapatinib is increased when administered with food.
Pri uporabi lapatiniba skupaj s hrano se sistemska izpostavljenost lapatinibu poveča.
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).
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.
Hypersensitivity reactions including anaphylaxis (see section 4.3) Metabolism and nutrition disorders Very common Anorexia
Bolezni imunskega sistema Redki preobčutljivostne reakcije, vključno z anafilaksijo (glejte poglavje 4.3) Presnovne in prehranske motnje
capecitabine (2500 mg/m2/day, days 1-14 q21 days)
kapecitabin (2.500 mg/m2/dan, od 1. do 14. dne 21-dnevnega ciklusa)
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.
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.
• being sick (vomiting)
• siljenje na bruhanje (navzea),
• severe skin reaction that might include: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever or any combination of these
• huda kožna reakcija, ki lahko vključuje izpuščaj, rdečo kožo, pojavljanje mehurjev na ustnicah,
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).
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).
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).
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).
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.
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 %).
Recovery of unchanged lapatinib in faeces accounts for a median 27% (range 3 to 67%) of an oral dose.
Z blatom se pri peroralni uporabi v povprečju izloči 27 % nespremenjenega lapatiniba (razpon od 3 do 67 %).
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).
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).
Tyverb is supplied in either blisters packs or bottles:
Zdravilo Tyverb je na voljo v pretisnih omotih ali plastenkah:
Concomitant treatment with substances that increase gastric pH should be avoided, as lapatinib solubility and absorption may decrease.
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.
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).
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).
Interstitial lung disease and pneumonitis
Intersticijska bolezen pljuč in pnevmonitis
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.
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.
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.
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.
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.
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.
In the HER2-negative population, there was no benefit in PFS when letrozole plus Tyverb was compared with letrozole plus placebo (see Table 6).
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).
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.
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 %).
Tyverb and for at least 5 days after the last dose.
Med jemanjem zdravila Tyverb in še najmanj 5 dni po zaužitju zadnjega odmerka zdravila ne smete dojiti.
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).
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.
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.
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.
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).
Priporočeni odmerek kapecitabina je 2.000 mg/m2/dan v dveh odmerkih vsakih 12 ur na 1.-14. dan
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).
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).
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.
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.
If you get other side effects
V primeru pojava drugih neželenih učinkov
Combination treatment with Tyverb and letrozole
Kombinirano zdravljenje z zdravilom Tyverb in letrozolom
The recommended dose of Tyverb is 1250 mg (i.e. five tablets) once daily continuously.
Priporočeni odmerek zdravila Tyverb je 1.250 mg (to je pet tablet) enkrat na dan neprekinjeno.
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).
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).
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 obsežno presnavlja, predvsem s CYP3A4 in CYP3A5, v manjšem obsegu tudi CYP2C19 in CYP2C8 do različnih oksidiranih presnovkov.
• 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.
Nemudoma obvestite svojega zdravnika ob prvem znaku driske (mehko blato), saj je pomembno, da se ta obravnava takoj.
Microcrystalline cellulose Povidone (K30)
Jedro tablete mikrokristalna celuloza povidon (K30) natrijev karboksimetilškrob (vrsta A) magnezijev stearat
140 film-coated tablets Multipack: 140 (2 packs of 70) film-coated tablets.
Pakiranje po več enot vsebuje 140 (2 pakiranji po 70) filmsko obloženih tablet.
Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 5 tablets.
Pretisni omoti so po sredini perforirani, kar omogoča razdelitev pretisnih omotov v dnevni odmerek po 5 tablet.
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).
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).
Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 6 tablets.
Pretisni omoti so po sredini perforirani, kar omogoča razdelitev pretisnih omotov v dnevni odmerek po 6 tablet.
• 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):
• spremembe v delovanju jeter, ugotovljene na podlagi rezultatov krvnih preiskav (običajno blage in prehodne).
Very common Insomnia*
Psihiatrične motnje Zelo pogosti nespečnost*
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.
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.
Tyverb 250 mg film-coated tablets
Tyverb 250 mg filmsko obložene tablete
Tyverb is supplied in either blister packs or bottles.
Zdravilo Tyverb je na voljo v pretisnih omotih ali plastenkah.
Ask your doctor or pharmacist for advice before taking Tyverb if you are unsure.
Če ste kakor koli negotovi, se pred začetkom jemanja zdravila Tyverb posvetujte s svojim zdravnikom ali farmacevtom.
The recommended dose of Tyverb is 1000 mg (i.e. four tablets) once daily continuously.
Priporočeni odmerek je 1.000 mg zdravila Tyverb (tj. štiri tablete) enkrat na dan, neprekinjeno.
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.
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).
Lapatinib inhibits CYP3A4 in vitro at clinically relevant concentrations.
Lapatinib in vitro pri klinično pomembnih koncentracijah zavira CYP3A4.
Grapefruit juice should be avoided during treatment with Tyverb (see section 4.5).
Med zdravljenjem z zdravilom Tyverb bolnik ne sme uživati soka grenivke (glejte poglavje 4.5).
Other very common side effects
Drugi zelo pogosti neželeni učinki
Tyverb (1250 mg/day) + capecitabine (2000 mg/m2/day, days 1-14 q21 days)
Tyverb (1.250 mg/dan) + kapecitabin (2.000 mg/m2/dan, od 1. do 14. dne 21-dnevnega ciklusa)
Tyverb 250 mg film-coated tablets lapatinib
Tyverb 250 mg filmsko obložene tablete lapatinib
If you are prescribed Tyverb in combination with an aromatase inhibitor, the usual dose is 6 Tyverb tablets a day, as a single dose.
Če vam je zdravnik zdravilo Tyverb predpisal v kombinaciji z zaviralcem aromataze, je običajen odmerek 6 tablet zdravila Tyverb na dan, uporabljenih hkrati.
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).
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).
Table 6 Progression free survival data from Study EGF30008 (Tyverb / letrozole)
Preglednica 6 Podatki o preživetju brez napredovanja iz študije EGF30008
Because of the possible side effects of Tyverb, your ability to drive or operate machines could be affected.
Nekateri neželeni učinki zdravila Tyverb lahko vplivajo na sposobnost upravljanja vozil in strojev.
• Your doctor will also carry out tests to check your heart and liver function before and during treatment with Tyverb.
• Pred začetkom zdravljenja z zdravilom Tyverb bo zdravnik s preiskavami preveril delovanje srca in jeter.
Left ventricular ejection fraction (LVEF) decreases have been reported in approximately 1% of patients receiving lapatinib and were asymptomatic in more than 70% of cases.
O zmanjšanju iztisnega deleža levega prekata (LVEF; “left ventricular ejection fraction”) so poročali pri približno 1 % bolnikov, ki so se zdravili z lapatinibom.
No additional adverse reactions were reported to be associated with lapatinib in combination with trastuzumab.
Ni opisano, da bi bili z lapatinibom v kombinaciji s trastuzumabom povezani kakšni dodatni neželeni učinki.
OUTER CARTON (28-DAY, MULTIPACK)
ŠKATLA (PAKIRANJE PO VEČ ENOT ZA 28-DNEVNO ZDRAVLJENJE)
If you are prescribed Tyverb in combination with trastuzumab, the usual dose is 4 Tyverb tablets a day, as a single dose.
Če vam je zdravnik zdravilo Tyverb predpisal v kombinaciji s trastuzumabom, je običajen odmerek 4 tablete zdravila Tyverb na dan, uporabljenih hkrati.
If you are prescribed Tyverb in combination with capecitabine, the usual dose is 5 Tyverb tablets a day, as a single dose.
Če vam je zdravnik zdravilo Tyverb predpisal v kombinaciji s kapecitabinom, je običajen odmerek 5 tablet zdravila Tyverb na dan, uporabljenih hkrati.
Tyverb / aromatase inhibitor combination posology
Odmerjanje kombinacije Tyverb/zaviralec aromataze
An increase in the incidence and severity of diarrhoea and neutropenia has been observed with this combination in clinical studies.
Med uporabo te kombinacije so v kliničnih študijah opažali večjo incidenco in izrazitost driske in nevtropenije.
The recommended dose of Tyverb is 1500 mg (i.e. six tablets) once daily continuously.
Priporočeni odmerek je 1.500 mg zdravila Tyverb (tj. šest tablet) enkrat na dan, neprekinjeno.
Lapatinib inhibits CYP2C8 in vitro at clinically relevant concentrations.
Lapatinib in vitro pri klinično pomembnih koncentracijah zavira CYP2C8.
Median PFS, weeks (95% CI) Hazard ratio 0.71 (0.53, 0.96) P-value Objective response rate (ORR) Odds ratio 0.4 (0.2, 0.9) P-value Clinical benefit rate (CBR) Odds ratio 0.4 (0.2, 0.8) P-value
Mediano PBN, tedni (95 % IZ) Razmerje tveganj Vrednost p 0,019 Objektivni delež odziva (ODO) Razmerje obetov Vrednost p 0,021 Delež klinične koristi (DKK) Razmerje obetov Vrednost p 0,003 IZ = interval zaupanja čezmerna ekspresija HER2 = IHC 3+ in/ali FISH-pozitivni HER2-negativni = IHC 0, 1+ ali 2+ in/ali FISH-negativni Delež klinične koristi je po definiciji obsegal popoln odziv, delen odziv in  6 mesecev stabilno bolezen.
Lapatinib pharmacokinetics have not been specifically studied in patients with renal impairment or in patients undergoing haemodialysis.
Pri bolnikih z okvaro ledvic in bolnikih, ki se zdravijo s hemodializo, farmakokinetike lapatiniba niso posebej preučevali.
Each pack of Tyverb contains 70 film-coated tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 10 tablets each.
Odmerjanje kombinacije zdravila Tyverb/kapecitabin Ena škatla zdravila Tyverb vsebuje 70 filmsko obloženih tablet v pretisnih omotih (poliamid / aluminij / polivinilklorid / aluminij).
LVEF decreases were reported in 2.5 % of patients who received lapatinib in combination with capecitabine, as compared to 1.0 % with capecitabine alone.
O zmanjšanju iztisnega deleža levega prekata so poročali pri 2,5 % bolnikov, ki so prejemali lapatinib v kombinaciji s kapecitabinom, v primerjavi z 1,0 % bolnikov, ki so prejemali samo kapecitabin.
Tyverb 1500 mg / day + Letrozole 2.5 mg /day
Tyverb 1500 mg/dan + letrozol 2,5 mg/dan letrozol 2,5 mg/dan + placebo
Breast-feeding must be discontinued in women who are receiving therapy with Tyverb and for at least 5 days after the last dose.
Med zdravljenjem z zdravilom Tyverb mora ženska prenehati z dojenjem in ne sme dojiti še najmanj 5 dni po zaužitju zadnjega odmerka zdravila.
Tyverb may be reintroduced at a lower dose (reduced from 1000 mg/day to 750 mg/day, from 1250 mg/day to 1000 mg/day or from 1500 mg/day to 1250 mg/day) when diarrhoea resolves to grade 1 or less.
Ko se driska zmanjša na stopnjo 1 ali manj, je mogoče zdravilo Tyverb znova uvesti v nižjem odmerku (znižanje s 1.000 mg/dan na 750 mg/dan, s 1.250 mg/dan na 1.000 mg/dan ali s 1.500 mg/dan na 1.250 mg/dan).
The incidence of PPE was similar in the lapatinib plus capecitabine and capecitabine alone treatment arms.
Pojavnost PPE je bila v skupinah, ki so prejemale lapatinib v kombinaciji s kapecitabinom, podobna kot v skupinah, ki so prejemale samo kapecitabin.
Co-administration of Tyverb with moderate inhibitors of CYP3A4 should proceed with caution and clinical adverse reactions should be carefully monitored.
Pri sočasni uporabi zdravila Tyverb in zmernih zaviralcev CYP3A4 je potrebna previdnost.
There are no adequate data from the use of Tyverb in women of childbearing potential.
O uporabi zdravila Tyverb pri ženskah v rodni dobi ni dovolj podatkov.
Diarrhoea, including severe diarrhoea, has been reported with Tyverb treatment (see section 4.8).
Pri zdravljenju z zdravilom Tyverb so poročali o pojavu driske, vključno s hudo drisko (glejte poglavje 4.8).
Lapatinib has been associated with reports of decreases in LVEF (see section 4.8).
Pri uporabi lapatiniba so poročali o zmanjšanju LVEF; “left ventricular ejection fraction” (glejte poglavje 4.8).
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
[samo škatla] Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
• if you have inflammation of the lung
• če imate vnetje pljuč,