natgillin/translations-raw huggingface dataset:
What information is still awaited for Tyverb?
Katere informacije o zdravilu Tyverb še pričakujemo?
The company that makes Tyverb will provide an updated analysis of the effects of Tyverb on survival times of patients in the main study.
Družba, ki izdeluje zdravilo Tyverb, bo predložila posodobljeno analizo učinkov zdravila Tyverb na čas preživetja bolnikov v glavni študiji.
It will also perform a study comparing the effects of treatment containing Tyverb and a treatment containing trastuzumab on the spread of cancer to the brain.
Opravila bo tudi študijo primerjave učinkov zdravljenja, ki vključuje zdravilo Tyverb, in zdravljenja, ki vključuje trastuzumab, na širjenje raka v možgane.
Other information about Tyverb:
Druge informacije o zdravilu Tyverb:
The European Commission granted a marketing authorisation valid throughout the European Union for Tyverb to Glaxo Group Limited on 10 June 2008.
Evropska komisija je dovoljenje za promet z zdravilom Tyverb, veljavno po vsej Evropski uniji, odobrila družbi Glaxo Group Limited dne 10. junija 2008.
The full EPAR for Tyverb can be found here.
Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo Tyverb je na voljo tukaj.
Pharmaceutical Form Film-coated tablet Film-coated tablet
Filmsko obložena tableta Filmsko obložena tableta
Route of administration Oral use Oral use
Peroralna uporaba Peroralna uporaba
Packaging Blister (PA/ Alu/ PVC/ Alu) Blister (PA/ Alu/ PVC/ Alu)
Pretisni omot (PA/ Alu/ PVC/ Alu) Pretisni omot (PA/ Alu/ PVC/ Alu)
Package size 70 tablets 2x70 tablets
70 tablet 2x70 tablet
Oval, biconvex, yellow film-coated tablets, with “ GS XJG ” debossed on one side.
Ovalne, bikonveksne, rumene filmsko obložene tablete, z oznako “ GS XJG ” na eni strani.
Tyverb, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2).
Zdravilo Tyverb je v kombinaciji s kapecitabinom indicirano za zdravljenje bolnikov z napredovalim ali metastatskim rakom dojke s prekomerno izraženim ErbB2 (HER2).
Patients should have progressive disease following prior therapy which must include anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).
Bolniki morajo imeti progresivno bolezen po predhodnem zdravljenju, ki mora vključevati antracikline in taksane ter zdravljenje s trastuzumabom v primeru metastaz (glejte poglavje 5. 1).
Lapatinib treatment should only be initiated by a physician experienced in the administration of anti- cancer agents.
Zdravljenje z lapatinibom sme uvesti le zdravnik, ki ima izkušnje z uporabo protitumorskih zdravil.
ErbB2 overexpressing tumours are defined by IHC3+, or IHC2+ and gene amplification or gene amplification alone.
Tumorji s prekomerno ekspresijo ErbB2 so opredeljeni z IHC3+ ali IHC2+ in amplifikacijo gena ali amplifikacijo gena samo.
Gene amplification should be performed using an accurate and validated assay.
Amplifikacijo gena je treba dokazati z zanesljivim in uveljavljenim testom.
Lapatinib is taken in combination with capecitabine.
Lapatinib se uporablja v kombinaciji s kapecitabinom.
The recommended dose of lapatinib is 1250 mg (i. e. five tablets) once daily continuously.
Priporočeni odmerek lapatiniba je 1. 250 mg (to je pet tablet) enkrat na dan neprekinjeno.
The daily dose should not be divided.
Dnevnega odmerka se ne sme deliti.
Lapatinib should be taken either at least one hour before, or at least one hour after food.
Lapatinib je treba jemati vsaj eno uro pred ali vsaj eno uro po obroku ali prigrizku.
To minimise variability in the individual patient, administration of lapatinib should be standardised in relation to food intake, for example always be taken before a meal (see sections 4.5 and 5.2 for information on absorption).
Zaradi zmanjšanja variabilnosti pri posameznem bolniku je treba jemanje lapatiniba standardizirati glede na obrok hrane, na primer tako, da ga bolnik vedno jemlje pred obrokom (za podatke o absorpciji glejte poglavji 4. 5 in 5. 2).
Missed doses should not be replaced and the dosing should resume with the next scheduled daily dose (see section 4.9).
Bolnik mora zdravljenje nadaljevati z naslednjim predvidenim dnevnim odmerkom (glejte poglavje 4. 9).
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 21 - dnevnega cikla (glejte poglavje 5. 1).
Capecitabine should be taken with food or within 30 minutes after food.
Kapecitabin je treba jemati skupaj s hrano ali 30 minut po obroku.
2 Lapatinib should be discontinued in patients with symptoms associated with decreased left ventricular ejection fraction (LVEF) that are National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 3 or greater or if their LVEF drops below the institutions lower limit of normal (see section 4.4).
Zdravljenje z lapatinibom je treba prekiniti pri bolnikih s simptomi, povezanimi z zmanjšanjem iztisnega deleža levega prekata (LVEF; “ left ventricular ejection fraction ”) stopnje 3 ali večje po enotnih merilih neželenih dogodkov (NCI CTCAE; “ National Cancer Institute Common Terminology
Lapatinib may be restarted at a reduced dose (1000 mg/ day) after a minimum of 2 weeks and if the LVEF recovers to normal and the patient is asymptomatic.
Zdravljenje z lapatinibom se lahko ponovno uvede v zmanjšanem odmerku (1. 000 mg/ dan) po najmanj 2 tednih, če se vrednost LVEF normalizira in bolnik nima simptomov.
Lapatinib should be discontinued in patients who experience pulmonary symptoms which are NCI CTCAE grade 3 or greater (see section 4.4).
Zdravljenje z lapatinibom je treba prekiniti pri bolnikih, ki imajo pljučne simptome stopnje 3 ali večje po NCI CTCAE (glejte poglavje 4. 4).
Discontinuation or interruption of dosing with lapatinib may be considered when a patient develops toxicity greater than or equal to grade 2 on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Zdravljenje z lapatinibom je treba ukiniti ali prekiniti, če se pri bolniku pojavijo toksični učinki stopnje 2 ali večje po enotnih merilih neželenih dogodkov (NCI CTCAE).
Dosing can be restarted at 1250 mg/ day when the toxicity improves to grade 1 or less.
Ko se znaki toksičnosti izboljšajo na stopnjo 1 ali manjšo, se lahko zdravljenje ponovno uvede v odmerku 1. 250 mg/ dan.
If the toxicity recurs, then lapatinib should be restarted at a lower dose (1000 mg/ day).
Če se toksični učinki ponovijo, je treba zdravljenje ponovno uvesti v nižjem odmerku (1. 000 mg/ dan).
The prescribing information for capecitabine must be consulted for guidance on dose delay and dose reduction recommendations for capecitabine.
Za priporočila glede odložitve zdravljenja s kapecitabinom in zmanjšanje odmerka kapecitabina je treba upoštevati povzetek glavnih značilnosti zdravila za kapecitabin.
Caution is advised in patients with severe renal impairment as there is no experience of lapatinib in this population (see section 5.2),
Pri bolnikih s hudo okvaro ledvic svetujemo previdnost, saj pri tej skupini bolnikov nimamo izkušenj z uporabo lapatiniba (glejte poglavje 5. 2).
Lapatinib should be discontinued if changes in liver function are severe and patients should not be retreated (see section 4.4).
Pri takšnih bolnikih se zdravljenje z lapatinibom ne sme več uvesti (glejte poglavje 4. 4).
Administration of lapatinib 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.
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).
Paediatrics
Otroci
Tyverb is not recommended for use in paediatrics due to insufficient data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila Tyverb pri otrocih ni priporočljiva.
There are limited data of the use of lapatinib in patients aged 65 years and older.
Podatkov o uporabi lapatiniba pri bolnikih, starih 65 let in starejših, je malo.
Please refer to the capecitabine prescribing information for relevant contraindications and safety information when administering lapatinib in combination with capecitabine.
Pri uporabi lapatiniba v kombinaciji s kapecitabinom je glede relevantnih kontraindikacij in podatkov o varnosti treba upoštevati tudi povzetek glavnih značilnosti zdravila za kapecitabin.
3 Lapatinib has been associated with reports of decreases in left ventricular ejection fraction (LVEF) (see section 4.8).
Pri uporabi lapatiniba so poročali o zmanjšanju iztisne frakcije levega prekata (LVEF; “ left ventricular ejection fraction ”) (glejte poglavje 4. 8).
Caution should be taken if lapatinib is to be administered to patients with conditions that could impair left ventricular function.
Pri bolnikih s stanji, ki lahko okvarijo funkcijo levega prekata, je treba lapatinib uporabljati previdno.
LVEF should be evaluated in all patients prior to initiation of treatment with lapatinib to ensure that the patient has a baseline LVEF that is within the institutions normal limits.
Pred začetkom zdravljenja z lapatinibom je treba pri vsakem bolniku ovrednotiti vrednost LVEF in se prepričati, da je izhodiščna vrednost LVEF znotraj normalnih vrednosti.
LVEF should continue to be evaluated during treatment with lapatinib to ensure that LVEF does not decline to an unacceptable level (see section 4.2).
Vrednost LVEF je treba spremljati tudi med zdravljenjem z lapatinibom in tako zagotoviti, da se vrednost ne zmanjša pod sprejemljivo vrednost (glejte poglavje 4. 2).
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).
Patients should be monitored for symptoms of pulmonary toxicity (see section 4.2).
Bolnike je treba nadzirati glede pojava pljučne toksičnosti (glejte poglavje 4. 2).
Hepatotoxicity has occurred with lapatinib use and may in rare cases be fatal.
Pri uporabi lapatiniba so poročali o pojavu hepatotoksičnosti, ki je v redkih primerih lahko usodna.
Liver function (transaminases, bilirubin and alkaline phosphatase) should be monitored before initiation of treatment and monthly thereafter, or as clinically indicated.
Med zdravljenjem je treba te preiskave opravljati enkrat na mesec oziroma v skladu s klinično presojo.
Lapatinib dosing should be discontinued if changes in liver function are severe and patients should not be retreated.
Pri takšnih bolnikih se zdravljenje z lapatinibom ne sme več uvesti.
Caution is warranted if lapatinib is prescribed to patients with moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Pri predpisovanju lapatiniba bolnikom z zmerno ali s hudo okvaro jeter je potrebna previdnost (glejte poglavji 4. 2 in 5. 2).
Caution is advised if lapatinib is prescribed to patients with severe renal impairment (see sections 4.2 and 5.2).
Pri predpisovanju lapatiniba bolnikom s hudo okvaro ledvic svetujemo previdnost (glejte poglavji 4. 2 in 5. 2).
Diarrhoea, including severe diarrhoea, has been reported with lapatinib treatment (see section 4.8).
Pri zdravljenju z lapatinibom so poročali o pojavu driske, vključno s hudo drisko (glejte poglavje 4. 8).
Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, and interruption or discontinuation of lapatinib therapy (see section 4.2 – dose delay and dose reduction – other toxicities).
V hudih primerih driske bo morda potrebno peroralno ali intravensko dajanje elektrolitov in tekočin ter prekinitev ali ukinitev zdravljenja z lapatinibom (glejte poglavje 4. 2 – Odložitev zdravljenja in zmanjšanje odmerka – Drugi toksični učinki).
Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to lapatinib (see section 4.5).
Zaradi tveganja za manjšo izpostavljenost lapatinibu se je treba izogibati sočasnemu zdravljenju z induktorji CYP3A4 (glejte poglavje 4. 5).
Concomitant treatment with strong inhibitors of CYP3A4 should be avoided due to risk of increased exposure to lapatinib (see section 4.5).
Zaradi tveganja za večjo izpostavljenost lapatinibu se je treba izogibati sočasnemu zdravljenju z močnimi zaviralci CYP3A4 (glejte poglavje 4. 5).
Grapefruit juice should be avoided during treatment with lapatinib (see section 4.5).
Med zdravljenjem z lapatinibom bolnik ne sme uživati soka grenivke (glejte poglavje 4. 5).
Coadministration of lapatinib with medicinal product with narrow therapeutic windows that are substrates of CYP3A4 or CYP2C8 should be avoided (see section 4.5).
Sočasni uporabi lapatiniba skupaj z zdravili z ozkim terapevtskim oknom, ki so substrati za CYP3A4 ali CYP2C8, se je treba izogibati (glejte poglavje 4. 5).
Concomitant treatment with substances that increase gastric pH should be avoided, as lapatinib solubility and absorption may decrease (see section 4.5).
Sočasnemu zdravljenju z učinkovinami, ki zvišujejo pH vrednost želodčnega soka se je treba izogibati, saj se lahko zmanjšata topnost in absorpcija lapatiniba (glejte poglavje 4. 5).
Lapatinib is predominantly metabolised by CYP3A (see section 5.2).
Lapatinib se v glavnem presnavlja s CYP3A (glejte poglavje 5. 2).
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.
Coadministration of lapatinib with strong inhibitors of CYP3A4 (e. g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone) should be avoided.
Sočasni uporabi lapatiniba in močnih zaviralcev CYP3A4 (npr. ritonavir, sakvinavir, telitromicin, ketokonazol, itrakonazol, vorikonazol, posakonazol,
Coadministration of lapatinib with moderate inhibitors of CYP3A4 should proceed with caution and clinical adverse reactions should be carefully monitored.
Skrbno je treba nadzirati morebiten pojav kliničnih neželenih učinkov.
4 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%.
Pri zdravih prostovoljcih, ki so prejemali karbamazepin, induktor CYP3A4, v odmerku 100 mg dvakrat na dan 3 dni in 200 mg dvakrat na dan 17 dni, se je sistemska izpostavljenost lapatinibu zmanjšala za približno 72%.
Coadministration of lapatinib with known inducers of CYP3A4 (e. g. rifampicin, rifabutin, carbamazepine, phenytoin or Hypericum perforatum [St John’ s wort]) should be avoided.
Sočasni uporabi lapatiniba in znanih induktorjev CYP3A4 (npr. rifampicin, rifabutin, karbamazepin, fenitoin ali Hypericum perforatum [šentjanževka]) se je treba izogibati.
Inhibitors (ketoconazole, itraconazole, quinidine, verapamil, cyclosporine, erythromycin) and inducers (rifampin, St John’ s Wort) of these proteins may alter the exposure and/ or distribution of lapatinib (see section 5.2).
Zaviralci (ketokonazol, itrakonazol, kinidin, verapamil, ciklosporin, eritromicin) in induktorji (rifampin, šentjanževka) teh proteinov lahko spremenijo izpostavljenost in/ ali porazdelitev lapatiniba (glejte poglavje 5. 2).
Lapatinib inhibits CYP3A4 and CYP2C8 in vitro at clinically relevant concentrations.
Lapatinib in vitro pri klinično pomembnih koncentracijah zavira CYP3A4 in CYP2C8.
Coadministration of lapatinib with medicines with narrow therapeutic windows that are substrates of CYP3A4 (e. g. cisapride, pimozide and quinidine) or CYP2C8 (e. g. repaglinide) should be avoided (see sections 4.4 and 5.2).
Sočasni uporabi lapatiniba z zdravili z ozkim terapevtskim oknom, ki so substrati za CYP3A4 (npr. cisaprid, pimozid in kinidin) ali CYP2C8 (npr. repaglinid), se je treba izogibati (glejte poglavji 4. 4 in 5. 2).
If lapatinib is administered in combination with paclitaxel (175 mg/ m2 every three weeks), severe neutropenia may coincide with diarrhoea.
Če se lapatinib uporablja v kombinaciji s paklitakselom (175 mg/ m2 vsake tri tedne), se lahko sočasno z drisko pojavi huda nevtropenija.
This warrants monitoring and early treatment of diarrhoea.
Potreben je nadzor in zgodnje zdravljenje driske.
Lapatinib inhibits the transport proteins Pgp, BCRP and OATP1B1 in vitro.
Lapatinib in vitro zavira transportne proteine Pgp, BCRP in OATP1B1.
It cannot be excluded that lapatinib will affect the pharmacokinetics of substrates of Pgp (e. g. digoxin), BCRP (e. g. topotecan) and OATP1B1 (e. g. rosuvastatin) (see section 5.2).
Vpliva lapatiniba na farmakokinetiko substratov za Pgp (npr. digoksin), BCRP (npr. topotekan) in OATP1B1 (npr. rosuvastatin) ni mogoče izključiti (glejte poglavje 5. 2).
Concomitant administration of lapatinib with capecitabine or trastuzumab did not meaningfully alter the pharmacokinetics of these agents (or the metabolites of capecitabine) or lapatinib.
Pri sočasni uporabi lapatiniba in kapecitabina ali trastuzumaba se farmakokinetika teh zdravil (ali presnovkov kapecitabina) ali lapatiniba ni pomembneje spremenila.
The bioavailability of lapatinib is increased up to about 4 times by food, depending on e. g. the fat content in the meal (see sections 4.2 and 5.2).
Biološka uporabnost lapatiniba se je pri uporabi skupaj s hrano povečala približno do 4- krat, odvisno od npr. vsebnosti maščob v obroku (glejte poglavji 4. 2 in 5. 2).
Grapefruit juice may inhibit CYP3A4 in the gut wall and increase the bioavailability of lapatinib and should therefore be avoided during treatment with lapatinib.
Sok grenivke lahko zavre CYP3A4 v črevesni steni in poveča biološko uporabnost lapatiniba, zato se mu je med zdravljenjem z lapatinibom treba izogibati.
There are no adequate data from the use of lapatinib in pregnant women.
Ni zadostnih podatkov o uporabi lapatiniba pri nosečnicah.
Lapatinib should not be used during pregnancy unless clearly necessary.
Lapatiniba ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Women of childbearing potential should be advised to use adequate contraception and avoid becoming pregnant while receiving treatment with lapatinib.
Ženskam v rodni dobi je treba svetovati, da naj za preprečitev nosečnosti med zdravljenjem z lapatinibom uporabljajo ustrezno kontracepcijsko metodo.
The safe use of lapatinib during lactation has not been established.
Varnost uporabe lapatiniba med dojenjem ni bila dokazana.
Breast feeding must be discontinued in women who are receiving therapy with lapatinib.
Med zdravljenjem z lapatinibom mora ženska prenehati z dojenjem.
The clinical status of
Pri presojanju sposobnosti bolnika za
5 the patient and the adverse event profile of lapatinib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
5 opravila, ki zahtevajo presojo in motorične ter kognitivne sposobnosti, je treba upoštevati tako klinično stanje kot profil neželenih učinkov lapatiniba.
Safety of lapatinib has been evaluated as monotherapy or in combination with other chemotherapies for various cancers including patients who received lapatinib in combination with capecitabine (see section 5.1).
Varnost lapatiniba so vrednotili tako pri samostojnem zdravljenju kot pri uporabi v kombinaciji z drugimi kemoterapevtiki pri različnih vrstah raka, vključno z bolniki, ki so prejemali lapatinib skupaj s kapecitabinom (glejte poglavje 5. 1).
The most common adverse reactions (> 25%) during therapy with lapatinib plus capecitabine were gastrointestinal (diarrhoea, nausea, and vomiting) or dermatologic (palmar-plantar erythrodysesthesia [PPE] and rash).
Najpogostejši neželeni učinki (> 25%) med zdravljenjem z lapatinibom in kapecitabinom so bili gastrointestinalni (driska, navzea in bruhanje) ali dermatološki (palmarno- plantarna eritrodisestezija [PPE] in izpuščaj).
The incidence of PPE was similar in both 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.
Diarrhoea was the most common adverse reaction resulting in discontinuation of treatment and this had a similar incidence in both treatment groups (lapatinib plus capecitabine:
Pojavnost driske je bila podobna v obeh skupinah (lapatinib v kombinaciji s kapecitabinom:
Very common ((≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100), Rare (≥ 1/ 10,000 to < 1/ 1,000) and Very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Pogostnost je navedena v skladu z naslednjim dogovorom: zelo pogosti ((≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The following adverse reactions have been reported to be associated with lapatinib:
V povezavi z uporabo lapatiniba so poročali o naslednjih neželenih učinkih:
Decreased left ventricular ejection fraction (see section 4.2 - dose reduction – cardiac events and section 4.4)
Zmanjšanje iztisnega deleža levega prekata (glejte poglavje 4. 2 – Zmanjšanje odmerka – Srčni dogodki in poglavje 4. 4)
Respiratory, thoracic and mediastinal disorders Uncommon
Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni Bolezni prebavil
Interstitial lung disease/ pneumonitis
Intersticijska pljučna bolezen/ pnevmonitis
Gastrointestinal disorders Very common
Zelo pogosti
Diarrhoea, which may lead to dehydration (see section 4.2 - dose delay and dose reduction – other toxicities and section 4.4).
Driska, ki lahko povzroči dehidracijo (glejte poglavje 4. 2 - Odložitev zdravljenja in zmanjšanje odmerka – Drugi toksični učinki in poglavje 4. 4).
Rash (including dermatitis acneiform) (see section 4.2 - dose delay and dose reduction – other toxicities)
Izpuščaj (vključno z akneiformnim dermatitisom) (glejte poglavje 4. 2 - Odložitev zdravljenja in zmanjšanje odmerka – Drugi toksični učinki)
Hepatobiliary disorders Common
Bolezni jeter, žolčnika in žolčevodov Pogosti
Hyperbilirubinaemia, hepatotoxicity
Hiperbilirubinemija, hepatotoksičnost
The following additional adverse reactions have been reported to be associated with lapatinib in combination with capecitabine with a frequency difference of greater than 5% compared to capecitabine alone.
učinkih, katerih razlika v pogostnosti je bila večja od 5% v primerjavi z uporabo kapecitabina samega.
Gastrointestinal disorders Very common Skin and subcutaneous Very common
Bolezni prebavil Zelo pogosti
Dyspepsia tissue disorders Dry skin
Bolezni kože in podkožja Zelo pogosti
6 In addition, the following adverse reactions were reported to be associated with lapatinib in combination with capecitabine but were seen at a similar frequency in the capecitabine alone arm.
6 V povezavi z uporabo lapatiniba v kombinaciji s kapecitabinom so poročali tudi o naslednjih neželenih učinkih, vendar pa je bila njihova pogostnost podobna pogostnosti v skupini, ki je prejemala samo kapecitabin.
Nervous system disorders Common
Bolezni živčevja Pogosti Bolezni prebavil
Gastrointestinal disorders Very common Skin and subcutaneous Very common
Bolezni kože in podkožja Zelo pogosti
Stomatitis, constipation, abdominal pain tissue disorders Palmar-plantar erythrodysaesthesia
Palmarno- plantarna eritrodisestezija
Musculoskeletal and connective tissue disorders Very common General disorders and Very common Psychiatric disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva Zelo pogosti