natgillin/translations-raw huggingface dataset:
At the start of therapy, the patients bowel pattern and any other symptoms (e.g. fever, cramping pain, nausea, vomiting, dizziness and thirst) should be determined, to allow identification of changes during treatment and to help identify patients at greater risk of diarrhoea.
Na začetku zdravljenja je treba ugotoviti bolnikov ritem odvajanja in morebitne simptome (npr. zvišano telesno temperaturo, krčevite bolečine, navzeo, bruhanje, omotičnost ali žejo): to omogoča odkritje sprememb med zdravljenjem in pomaga prepoznati osebe, ki imajo večje tveganje driske.
There was also an increase in renal infarcts and papillary necrosis in female rats at exposures 7 and 10-fold compared to humans given 1250 mg of lapatinib once daily.
Opazili so tudi več ledvičnih infarktov in papilarne nekroze pri podganjih samicah med izpostavljenostmi, ki so bile 7- in 10-krat tolikšne kot pri človeku med uporabo 1.250 mg lapatiniba enkrat na dan.
It cannot be excluded that lapatinib will affect the pharmacokinetics of substrates of BCRP (e.g. topotecan) and OATP1B1 (e.g. rosuvastatin) (see section 5.2).
Vpliva lapatiniba na farmakokinetiko substratov za BCRP (npr. topotekan) in OATP1B1 (npr. rosuvastatin) ni mogoče izključiti (glejte poglavje 5.2).
b. Pike estimate of the treatment hazard ratio, <1 indicates a lower risk for Tyverb plus capecitabine compared with Trastuzumab plus capecitabine.
b. Pikova ocena razmerja ogroženosti terapije < 1 kaže manjše tveganje s kombinacijo Tyverba in kapecitabina kot s kombinacijo trastuzumaba in kapecitabina.
Patients who carry the HLA alleles DQA1*02:01 and DRB1*07:01 have increased risk of Tyverb-associated hepatotoxicity.
Bolniki-nosilci HLA-alelov DQA1*02:01 in DRB1*07:01 imajo večje tveganje za hepatotoksičnost, povezano z zdravilom Tyverb.
In healthy volunteers receiving ketoconazole, a strong CYP3A4 inhibitor, at 200 mg twice daily for 7 days, systemic exposure to lapatinib (100 mg daily) was increased approximately 3.6-fold, and half-life increased 1.7-fold.
Pri zdravih prostovoljcih, ki so prejemali ketokonazol, močan zaviralec CYP3A4, v odmerku 200 mg dvakrat na dan 7 dni, se je sistemska izpostavljenost lapatinibu (100 mg na dan) povečala za približno 3,6-krat, razpolovni čas pa podaljšal za 1,7-krat.
Tyverb is also supplied in high density polyethylene bottles (HDPE) with a child resistant polypropylene closure containing 70, 84, 105 or 140 film-coated tablets.
Zdravilo Tyverb je na voljo tudi v plastenkah iz polietilena visoke gostote (HDPE) z za otroke varnimi polipropilenskimi zaporkami, ki vsebujejo 70, 84, 105 ali 140 filmsko obloženih tablet.
Tyverb-induced diarrhoea is usually low-grade, with severe diarrhoea of NCI CTCAE grades 3 and 4 occurring in <10% and <1% of patients, respectively.
Driska, ki jo povzroči zdravilo Tyverb, je po navadi nizke stopnje; huda driska stopnje 3 po NCI CTCAE se je pojavila pri < 10 % bolnikov, huda driska stopnje 4 pa pri < 1 % bolnikov.
• quinidine, digoxin - medicines used to treat certain heart problems
• kinidin, digoksin - zdravili za zdravljenje nekaterih težav s srcem,
Table 2 Overall survival data from Study EGF100151 (Tyverb / capecitabine)
Preglednica 2 Podatki o celotnem preživetju iz študije EGF100151 (Tyverb/kapecitabin)
What Tyverb looks like and contents of the pack
Izgled zdravila Tyverb in vsebina pakiranja
Subjects who had not received prior trastuzumab* N
Bolniki, ki predhodno niso prejemali trastuzumaba* N
Lapatinib is predominantly eliminated through metabolism by CYP3A4/5.
Lapatinib se v glavnem izloča s presnovo s CYP3A4/5.
Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed on one side.
filmsko obložena tableta (tableta) Ovalne, bikonveksne, rumene filmsko obložene tablete, z oznako “GS XJG” na eni strani.
Table 3 Analyses of investigator-assessed progression-free survival and overall survival
Preglednica 3 Analize preživetja brez napredovanja (PFS-progression-free survival) po oceni raziskovalca in analize celotnega preživetja (OS-overall survival)
Don't drink grapefruit juice while you are being treated with Tyverb.
Med zdravljenjem z zdravilom Tyverb ne smete piti soka grenivke.
Pulmonary arterial hypertension**.
Pogostnost neznana pljučna arterijska hipertenzija**
Decreased left ventricular ejection fraction and QT interval prolongation
Zmanjšanje iztisnega deleža levega prekata in podaljšanje intervala QT
Decreased left ventricular ejection fraction (see section 4.2 - dose reduction - cardiac events and section 4.4).
Srčne bolezni Pogosti zmanjšan iztisni delež levega prekata (glejte poglavje 4.2 - Zmanjšanje odmerka - Srčni dogodki in poglavje 4.4)
OUTER CARTON AND BOTTLE LABEL
ŠKATLA IN NALEPKA ZA PLASTENKO
Table 1 Time to progression data from Study EGF100151 (Tyverb / capecitabine)
Preglednica 1 Podatki o času do napredovanja iz študije EGF100151 (Tyverb/kapecitabin)
• If you become pregnant during treatment with Tyverb, tell your doctor.
• Če med zdravljenjem z zdravilom Tyverb zanosite, to povejte svojemu zdravniku.
Serious cutaneous reactions, including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)** Musculoskeletal and connective tissue disorders Very common Pain in extremity*
Pogostnost neznana resne kožne reakcije, vključno s Stevens-Johnsonovim sindromom (SJS) in toksično epidermalno nekrolizo (TEN)** Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti bolečina v okončini* †, bolečina v hrbtu* †, artralgija
Tyverb has been studied in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive (oestrogen receptor [ER] positive and / or progesterone receptor [PgR] positive) advanced or metastatic breast cancer.
Zdravilo Tyverb so raziskali v kombinaciji z letrozolom za zdravljenje postmenopavzalnih žensk z napredovalim ali metastatskim rakom dojke, pozitivnim glede hormonskih receptorjev (pozitivni estrogenski receptorji [ER] in/ali pozitivni progesteronski receptorji [PgR].
Co-administration of lapatinib with intravenously administered docetaxel did not significantly affect the AUC or Cmax of either active substance.
Sočasna uporaba lapatiniba z intravensko uporabljenim docetakselom ni bistveno vplivala na AUC ali Cmax ene ali druge učinkovine.
• wash with a soap-free cleanser
• se umivajte s čistilom brez mila,
Available data suggest that no dose adjustment is necessary in patients with mild to moderate renal impairment.
Razpoložljivi podatki kažejo, da pri bolnikih z blago do zmerno okvaro ledvic odmerka ni treba prilagajati.
Tyverb dosing should be permanently discontinued in patients with diarrhoea which is NCI CTCAE grade 4.
Uporabo zdravila Tyverb je treba za stalno prekiniti pri bolnikih, ki imajo drisko stopnje 4 po NCI CTCAE.
Tyverb dosing should be interrupted in patients with diarrhoea which is NCI CTCAE grade 3 or grade 1 or 2 with complicating features (moderate to severe abdominal cramping, nausea or vomiting greater than or equal to NCI CTCAE grade 2, decreased performance status, fever, sepsis, neutropenia, frank bleeding or dehydration) (see sections 4.4 and 4.8).
Zdravilo Tyverb je treba nehati uporabljati pri bolnikih z drisko stopnje 3 po NCI CTCAE ali z drisko stopnje 1 ali 2 in zapletajočimi dejavniki (zmernimi do hudimi krči v trebuhu, navzeo ali bruhanjem stopnje 2 ali več po NCI CTCAE, zmanjšanim stanjem zmogljivosti, zvišano telesno temperaturo, sepso, nevtropenijo, manifestno krvavitvijo ali dehidracijo) (glejte poglavji 4.4 in 4.8).
How to take Tyverb
Kako jemati zdravilo Tyverb
• in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1).
• v kombinaciji s trastuzumabom za bolnike z metastatsko boleznijo, negativno glede hormonskih receptorjev, ki je napredovala med predhodnim/i zdravljenjem/zdravljenji s trastuzumabom v kombinaciji s kemoterapijo (glejte poglavje 5.1).
Tyverb is for oral use.
Način uporabe Zdravilo Tyverb je za peroralno uporabo.
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 preko ledvic ne izloča v pomembnejšem obsegu in se v veliki meri veže na plazemske proteine, zato je malo verjetno, da bi se lapatinib pri hemodializi hitreje izločil iz telesa.
Symptomatic LVEF decreases were observed in approximately 0.3% of patients who received lapatinib monotherapy or in combination with other anti-cancer medicinal products.
Simptomatsko zmanjšanje iztisnega deleža levega prekata je bilo opaženo pri približno 0,3 % bolnikov, ki so se zdravili lapatinibom v monoterapiji ali v kombinaciji z drugimi zdravili proti raku.
What Tyverb contains
Kaj vsebuje zdravilo Tyverb
Co-administration of Tyverb with orally administered midazolam resulted in an approximate 45% increase in the AUC of midazolam.
Sočasna uporaba zdravila Tyverb s peroralnim midazolamom je povečala AUC midazolama za približno 45 %.
Multipacks contain 140 (2 packs of 70) film-coated tablets.
Pakiranje vsebuje 140 (2 pakiranji po 70) filmsko obloženih tablet.
Tyverb is prescribed in combination with capecitabine, for patients who have had treatment for advanced or metastatic breast cancer before.
Zdravilo Tyverb predpisujejo v kombinaciji s kapecitabinom za bolnike, ki so se že zdravili zaradi napredovalega ali metastatskega raka dojke.
Diarrhoea occurred in approximately 65 % of patients who received lapatinib in combination with capecitabine, in 64 % of patients who received lapatinib in combination with letrozole and in 62 % of patients who received lapatinib in combination with trastuzumab.
Driska se je pojavila pri približno 65 % bolnikov, ki so prejemali lapatinib v kombinaciji s kapecitabinom, pri 64 % bolnikov, ki so prejemali lapatinib v kombinaciji z letrozolom in pri 62 % bolnikov, ki so prejemali lapatinib v kombinaciji s trastuzumabom.
Number of subjects who died Median overall survival, weeks Hazard Ratio (95% CI) p value
Število oseb s smrtnim izidom Mediana vrednost celotnega preživetja, tedni Razmerje tveganj (95 % interval zaupanja) p vrednost
Number of TTP events 121 Median TTP, weeks Hazard Ratio (95% CI) p value
Število TTP dogodkov 121 Mediana vrednost TTP, tedni Razmerje tveganj 0,72 (95 % interval zaupanja) p vrednost
• ritonavir, saquinavir - medicines used to treat HIV
• ritonavir, sakvinavir - zdravili za zdravljenje okužbe z virusom HIV,
This was followed by three doses of lapatinib 2000 mg administered in the same way.
Nato so bolniki na isti način prejeli tri odmerke 2.000 mg lapatiniba.
Co-administration of lapatinib with intravenous paclitaxel increased the exposure of paclitaxel by 23%, due to lapatinib inhibition of CYP2C8 and/or Pgp.
Sočasna uporaba lapatiniba in intravenskega paklitaksela je zaradi zavrtja CYP2C8 in/ali Pgp z lapatinibom povečala izpostavljenost paklitakselu za 23 %.
• repaglinide - a medicine used to treat diabetes
• repaglinid - zdravilo za zdravljenje sladkorne bolezni,
Lapatinib inhibits the transport proteins BCRP and OATP1B1 in vitro.
Lapatinib in vitro zavira transportne proteine BCRP in OATP1B1.
Tyverb should be discontinued in patients who experience pulmonary symptoms which are NCI CTCAE grade 3 or greater (see section 4.4).
Zdravljenje z zdravilom Tyverb je treba prekiniti pri bolnikih, ki imajo pljučne simptome stopnje 3 ali večje po NCI CTCAE (glejte poglavje 4.4).
tyverb 250 mg [folding box only]
tyverb 250 mg [samo škatla]
• cough, shortness of breath
• kašelj, kratka sapa,
Lapatinib AUC values were approximately 3- and 4-fold higher (Cmax approximately 2.5 and 3-fold higher) when administered with a low fat (5% fat [500 calories]) or with a high fat (50% fat [1,000 calories]) meal, respectively, as compared with administration in the fasted state.
Vrednosti AUC lapatiniba so bile približno 3-krat večje pri uporabi skupaj z obrokom z majhno vsebnostjo maščob (5 % maščobe [500 kalorij]) (Cmax približno 2,5-krat večja), pri uporabi skupaj z obrokom, bogatim z maščobami (50 % maščobe [1.000 kalorij]), pa 4-krat večja (Cmax približno 3-krat večja) v primerjavi z uporabo na tešče.
• medicines that decrease stomach acidity - used to treat stomach ulcers or indigestion
• zdravila, ki znižujejo kislost želodčnega soka (uporabljamo jih pri zdravljenju želodčne razjede ali prebavnih težav).
Tyverb 1500 mg / day + Letrozole 2.5 mg /day N=111
Tyverb 1500 mg/dan + letrozol 2,5 mg/dan N = 111
15.4 wks (8.4, 16.9)
15,4 tedna (8,4; 16,9)
Caution is warranted if Tyverb is prescribed to patients with moderate or severe hepatic impairment and to patients with severe renal impairment (see sections 4.2 and 5.2).
Pri predpisovanju zdravila Tyverb bolnikom z zmerno ali hudo okvaro jeter in bolnikom s hudo okvaro ledvic je potrebna previdnost (glejte poglavji 4.2 in 5.2).
Co-administration of lapatinib with orally administered digoxin resulted in an approximate 80% increase in the AUC of digoxin.
Sočasna uporaba lapatiniba in peroralnega digoksina je povečala AUC digoksina za približno 80 %.
Tyverb 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 zdravilom Tyverb 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 Criteria Adverse Event”) ali če se vrednost LVEF zmanjša pod sprejemljivo spodnjo mejo normalne vrednosti (glejte poglavje 4.4).
Nail disorders including paronychia.
Pogosti bolezni nohtov, vključno s paronihijo
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).
• rash, dry skin, itching
• izpuščaj, suha koža, srbenje.
Co-administration of Tyverb with strong inhibitors of CYP3A4 (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone) should be avoided.
Sočasni uporabi zdravila Tyverb in močnih zaviralcev CYP3A4 (npr. ritonavir, sakvinavir, telitromicin, ketokonazol, itrakonazol, vorikonazol, posakonazol, nefazodon) se je treba izogibati.
†, arthralgia General disorders and administration site conditions Very common Fatigue, mucosal inflammation*, asthenia * These adverse reactions were observed when lapatinib was administered in combination with capecitabine.
Splošne težave in spremembe na mestu aplikacije Zelo pogosti utrujenost, vnetje sluznice*, astenija * Te neželene učinke so ugotovili, če je bil lapatinib uporabljen v kombinaciji s kapecitabinom.
In rabbits, lapatinib was associated with maternal toxicity at 60 and 120 mg/kg/day (8% and 23% of the expected human clinical exposure, respectively) and abortions at 120 mg/kg/day.
Pri kuncih je bil lapatinib pri odmerkih 60 in 120 mg/kg/dan (8-odstotna oziroma 23-odstotna izpostavljenost človeka pri klinični uporabi) povezan s toksičnimi učinki za mater in abortusi pri odmerku 120 mg/kg/dan.
Serious skin reactions have been seen with Tyverb.
Med uporabo zdravila Tyverb so opažali resne kožne reakcije.
Co-administration of Tyverb with known inducers of CYP3A4 (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or Hypericum perforatum [St John's Wort]) should be avoided.
Sočasni uporabi zdravila Tyverb in znanih induktorjev CYP3A4 (npr. rifampicin, rifabutin, karbamazepin, fenitoin ali Hypericum perforatum [šentjanževka]) se je treba izogibati.
Tyverb is also available in multipacks containing 140 tablets that comprise 2 packs, each containing 70 tablets.
Zdravilo Tyverb je na voljo tudi v pakiranju po več enot, ki vsebuje 140 tablet in sestoji iz 2 škatel.
In patients with HER2-overexpressing MBC, investigator-determined progression-free survival (PFS) was significantly greater with letrozole plus Tyverb compared with letrozole plus placebo.
Pri bolnicah z metastatskim rakom dojke s čezmerno ekspresijo HER2 je bilo preživetje brez napredovanja po raziskovalčevi oceni statistično značilno večje s kombinacijo letrozola in zdravila Tyverb kot s kombinacijo letrozola in placeba.
It is not known whether Tyverb passes into breast-milk.
Ni znano, če se zdravilo Tyverb izloča z materinim mlekom.
Administration of lapatinib in patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 4.4).
Pri bolnikih z okvaro jeter je treba lapatinib uporabljati previdno (glejte poglavji 4.2 in 4.4).
If you suffer from diarrhoea while taking Tyverb:
Če se vam med jemanjem zdravila Tyverb pojavi driska:
Tell your doctor if you have any heart problems before you take Tyverb.
Pred začetkom jemanja zdravila Tyverb svojemu zdravniku povejte, če imate kakršne koli težave s srcem.
Gastrointestinal disorders Very common Diarrhoea, which may lead to dehydration (see section 4.2 - dose delay and dose reduction - other toxicities and section 4.4), nausea, vomiting, dyspepsia*, stomatitis*, constipation*, abdominal pain*.
Bolezni prebavil Zelo pogosti driska, ki lahko povzroči dehidracijo (glejte poglavje 4.2 - Odložitev zdravljenja in zmanjšanje odmerka - Drugi toksični učinki in poglavje 4.4), navzea, bruhanje, dispepsija*, stomatitis*, zaprtost*, bolečine v trebuhu*
Lapatinib inhibits CYP3A (Ki 0.6 to 2.3 µg/ml) and CYP2C8 (0.3 µg/ml) in vitro at clinically relevant concentrations.
Lapatinib in vitro pri klinično pomembnih koncentracijah zavira CYP3A (Ki 0,6 do 2,3 µg/ml) in CYP2C8 (0,3 µg/ml).
• nefazodone - a medicine used to treat depression
• nefazodon - zdravilo za zdravljenje depresije,
Please refer to the full prescribing information of the co-administered aromatase inhibitor for dosing details.
Za podrobnosti o odmerjanju sočasno uporabljenega zaviralca aromataze glejte celotno informacijo za njegovo predpisovanje.
Rash occurred in approximately 28 % of patients who received lapatinib in combination with capecitabine, in 45 % of patients who received lapatinib in combination with letrozole and in 23 % of patients who received lapatinib in combination with trastuzumab.
Izpuščaj se je pojavil pri približno 28 % bolnikov, ki so prejemali lapatinib v kombinaciji s kapecitabinom, pri 45 % bolnikov, ki so prejemali lapatinib v kombinaciji z letrozolom in pri 23 % bolnikov, ki so prejemali lapatinib v kombinaciji s trastuzumabom.
• phenytoin, carbamazepine - medicines used to treat seizures
• fenitoin, karbamazepin - zdravili za zdravljenje epileptičnih napadov,
Tyverb / aromatase inhibitor combination posology Each pack of Tyverb contains 84 film-coated tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 12 tablets each.
Odmerjanje kombinacije zdravila Tyverb/zaviralec aromataze Ena škatla zdravila Tyverba vsebuje 84 filmsko obloženih tablet v pretisnih omotih (poliamid/aluminij/polivinilklorid/aluminij).
Lapatinib inhibits ErbB-driven tumour cell growth in vitro and in various animal models.
Lapatinib in vitro ter na različnih živalskih modelih zavira z ErbB povzročeno rast tumorskih celic.
Very common Hot flush Respiratory, thoracic and mediastinal disorders Very common Epistaxis
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti epistaksa †, kašelj
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 zaviralec znotrajceličnih tirozin-kinaznih domen EGFR (ErbB1) in HER2(ErbB2) receptorjev (ocenjeni vrednosti Ki app
Take special care with Tyverb
Bodite posebno pozorni pri uporabi zdravila Tyverb
There were no teratogenic effects; however, minor anomalies (left-sided umbilical artery, cervical rib and precocious ossification) occurred in rats at ≥60 mg/kg/day (4 times the expected human clinical exposure).
Teratogenih učinkov niso opazili, vendar pa so pri podganah pri odmerkih ≥ 60 mg/kg/dan (4-kratna pričakovana izpostavljenost človeka pri klinični uporabi) poročali o manjših anomalijah (levostranska pozicija umbilikalne arterije, vratno rebro in prezgodnja osifikacija).
Patients were randomised to letrozole 2.5 mg once daily plus Tyverb 1500 mg once daily or letrozole with placebo.
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.
Very common Headache
Pogosti glavobol*
Trastuzumab (loading dose of 8mg/kg followed by 6mg/kg q3 weekly infusions)
Trastuzumab (polnilni odmerek 8 mg/kg, nato 6 mg/kg v infuzijah na 3 tedne )
Asymptomatic and symptomatic cases of overdose have been reported in patients being treated with Tyverb.
Pri bolnikih, ki so se zdravili z zdravilom Tyverb, so poročali o asimptomatskih in simptomatskih primerih prevelikega odmerjanja.
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).
Less than 2% of the administered oral dose (as lapatinib and metabolites) excreted in urine.
Po peroralni uporabi se z urinom izloči manj kot 2 % odmerka (v obliki lapatiniba in presnovkov).
OUTER CARTON (14 DAY, SINGLE PACK)
ŠKATLA (ENOJNO PAKIRANJE ZA 14-DNEVNO ZDRAVLJENJE)
• if you have any kidney problems
• če imate kakršne koli težave z ledvicami,
70 film-coated tablets 84 film-coated tablets
filmsko obložena tableta 70 filmsko obloženih tablet 84 filmsko obloženih tablet
• collapse or blackout.
• kolaps ali izgubo zavesti.
Adverse reactions should be carefully monitored if Tyverb is co-administered with irinotecan, and a reduction in the dose of irinotecan should be considered.
Ob sočasni uporabi zdravila Tyverb z irinotekanom je treba natančno kontrolirati neželene učinke in morebiti zmanjšati odmerek irinotekana.
Rash was generally low grade and did not result in discontinuation of treatment with lapatinib.
Izpuščaj je bil običajno blažji in zdravljenja z lapatinibom ni bilo treba prekiniti.
• unusual hair loss or thinning
• neobičajno izpadanje ali redčenje las.
Each pack of Tyverb contains 70 or 84 tablets in aluminium foil blisters of 10 or 12 tablets each.
Ena škatla zdravila Tyverb vsebuje 70 ali 84 tablet v pretisnih omotih iz aluminijske folije.
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.
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.
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.
Zdravljenje z zdravilom Tyverb je treba ukiniti ali prekiniti, če se pri bolniku pojavijo toksični učinki stopnje 2 ali večje po NCI CTCAE.
Number (%) with event Kaplan-Meier estimate, months a
KaplanMeierjeva ocena, meseci a
• cisapride - a medicine used to treat certain digestive system problems
• cisaprid - zdravilo za zdravljenje nekaterih prebavnih težav,
In rats, growth retardation was observed in pups which were exposed to lapatinib via breast milk.
Pri podganjih mladičih, ki so bili med dojenjem izpostavljeni lapatinibu, so poročali o zaostanku v rasti.
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.
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.