natgillin/translations-raw huggingface dataset:
Pain in extremity, back pain administrative site conditions Mucosal inflammation
Bolečina v udih, bolečina v hrbtu
Very common
Vnetje sluznice
Decreased left ventricular ejection fraction Left ventricular ejection fraction (LVEF) decreases have been reported in approximately 1% of patients receiving lapatinib and were asymptomatic in more than 90% of cases.
Zmanjšanje iztisnega deleža levega prekata O zmanjšanju iztisnega deleža levega prekata (LVEF; “ left ventricular ejection fraction ”) so poročali pri približno 1% bolnikov, ki so se zdravili z lapatinibom.
LVEF decreases resolved or improved in more than 60% of cases on discontinuation of treatment with lapatinib.
Po ukinitvi zdravljenja z lapatinibom se je zmanjšanje iztisnega deleža levega prekata popravilo ali izboljšalo pri več kot 60% primerov.
Symptomatic LVEF decreases were observed in approximately 0.1% of patients who received lapatinib monotherapy.
Simptomatsko zmanjšanje iztisnega deleža levega prekata je bilo opaženo pri približno 0, 1% bolnikov, ki so se zdravili samo z lapatinibom.
Observed symptoms included dyspnoea, cardiac failure and palpitations.
Opaženi simptomi so vključevali dispnejo, srčno popuščanje in palpitacije.
All events resolved promptly on discontinuation of lapatinib.
Po ukinitvi lapatiniba so se vsi dogodki hitro izboljšali.
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.
Diarrhoea Diarrhoea occurred in approximately 65% of patients who received lapatinib in combination with capecitabine.
Driska Driska se je pojavila pri približno 65% bolnikov, ki so prejemali lapatinib v kombinaciji s kapecitabinom.
Diarrhoea responds well to proactive management (see section 4.4).
Driska se je dobro odzvala na proaktivno zdravljenje (glejte poglavje 4. 4).
Rash Rash occurred in approximately 28% of patients who received lapatinib in combination with capecitabine.
Izpuščaj Izpuščaj se je pojavil pri približno 28% bolnikov, ki so prejemali lapatinib v kombinaciji s kapecitabinom.
There is no specific antidote for the inhibition of EGFR (ErbB1) and/ or ErbB2 (HER2) tyrosine phosphorylation.
Specifičnega antidota za zaviranje EGFR (ErbB1) in/ ali ErbB2 (HER2) tirozinske fosforilacije ni.
The maximum oral dose of lapatinib that has been administered in clinical trials is 1800 mg once daily.
V kliničnih preskušanjih je bil največji peroralni dnevni odmerek lapatiniba 1. 800 mg enkrat na dan.
There has been a report of one patient who took an overdose of 3000 mg of lapatinib for 10 days and suffered grade 3 diarrhoea and vomiting on day 10.
Pojavila se je driska stopnje 3 in bruhanje na 10. dan.
The symptoms resolved following intravenous hydration and interruption of treatment with lapatinib and letrozole.
Simptomi so minili po intravenskem dovajanju tekočine in prekinitvi zdravljenja z lapatinibom in letrozolom.
7 Pharmacotherapeutic group:
Farmakoterapevtska skupina:
Protein kinase inhibitor, ATC code:
Zaviralci protein- kinaze, oznaka ATC:
This medicinal product has been authorised under a so-called “ conditional approval” scheme.
7 Zdravilo je pridobilo tako imenovano "pogojno dovoljenje za promet".
This means that furrther evidence on this medicinal product is awaited.
To pomeni, da se pričakujejo dodatni dokazi o zdravilu.
Lapatinib a 4-anilinoquinazoline, is an inhibitor of the intracellular tyrosine kinase domains of both EGFR (ErbB1) and of ErbB2 (HER2) receptors (estimated Kiapp 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 ErbB2 (HER2) receptorjev (ocenjeni vrednosti Kiapp 3nM in 13nM) s počasnim sproščanjem s teh receptorjev (razpolovni čas daljši ali enak 300 minutam).
Lapatinib retained significant activity against breast cancer cell lines selected for long-term growth in trastuzumab-containing medium in vitro.
Lapatinib je ohranil pomembno delovanje proti celičnim linijam raka dojke, selekcioniranim za dolgotrajno rast v mediju s trastuzumabom in vitro.
The efficacy and safety of lapatinib in combination with capecitabine in breast cancer patients with good performance status was evaluated in a randomized, phase III trial.
Učinkovitost in varnost lapatiniba v kombinaciji s kapecitabinom pri bolnikih z rakom dojke z dobro telesno zmogljivostjo so vrednotili z randomiziranim preskušanjem III. faze.
Patients eligible for enrolment had ErbB2 (HER2)-over-expressing, locally advanced or metastatic breast cancer, progressing after prior treatment that included taxanes, anthracyclines and trastuzumab.
Bolniki, ki so bili primerni za vključitev, so imeli čezmerno ekspresijo ErbB2 (HER2), lokalno napredovali ali metastatski rak dojke, ki je napredoval po predhodnem zdravljenju, ki je vključevalo taksane, antracikline in trastuzumab.
LVEF was evaluated in all patients (using echocardiogram or MUGA) prior to initiation of treatment with lapatinib to ensure baseline LVEF was within the institutions normal limits.
Pred začetkom zdravljenja z lapatinibom je bila pri vseh bolnikih ovrednotena vrednost LVEF (ehokardiografsko ali s preiskavo MUGA) in izhodiščna vrednost LVEF v mejah normalne vrednosti.
In clinical trials LVEF was monitored at approximately eight week intervals during treatment with lapatinib to ensure it did not decline to below the institutions lower limit of normal.
V kliničnih preskušanjih so vrednost LVEF nadzirali v približno osemtedenskih intervalih med zdravljenjem z lapatinibom, da so zagotovili, da se vrednost ni zmanjšala pod spodnjo mejo normalne vrednosti.
The majority of LVEF decreases (greater than 60%) were observed during the first nine weeks of treatment, however limited data was available for long term exposure.
Večina primerov zmanjšanja vrednosti LVEF (večje od 60%) je bilo opaženih med prvimi devetimi tedni zdravljenja, podatkov za dolgotrajno izpostavljenost je malo.
Patients were randomized to receive either lapatinib 1250 mg once daily (continuously) plus capecitabine (2000 mg/ m2/ day on days 1-14 every 21 days), or to receive capecitabine alone (2500 mg/ m2/ day on days 1-14 every 21 days).
Bolniki so bili randomizirani tako, da so prejemali bodisi lapatinib v odmerku 1. 250 mg enkrat na dan (neprekinjeno) in kapecitabin (2. 000 mg/ m2/ dan na 1. - 14. dan 21- dnevnega ciklusa) ali pa samo kapecitabin (2. 500 mg/ m2/ dan na 1. - 14. dan 21- dnevnega ciklusa).
The primary endpoint was time to progression (TTP).
Primarni opazovani dogodek je bil čas do progresije (TTP, “ time to progression ”).
The study was halted based on the results of a pre-specified interim analysis that showed an improvement in TTP for patients receiving lapatinib plus capecitabine.
Študija je bila prekinjena na osnovi rezultatov vnaprej določene začasne analize, ki je pokazala izboljšanje časa do progresije pri bolnikih, ki so prejemali lapatinib in kapecitabin.
Investigator analysis on data at the stop of enrolment is presented in the following table.
Analiza podakov, ki so jo naredili raziskovalci, je predstavljena v naslednji tabeli.
capecitabine (2,000 mg/ m2/ day) Number of TTP events
Ocena raziskovalcev Kapecitabin (2. 500 mg/ m2/ dan Lapatinib (1. 250 mg/ dan) + kapecitabin (2. 000 mg/ m2/ dan) Število TTP dogodkov
Median TTP, weeks Hazard Ratio
Mediana vrednost TTP, tedni
0.72
18, 3
18.3
0, 72
(95% CI) p value
(95% interval zaupanja) p vrednost
The independent assessment of the data also demonstrated that lapatinib when given in combination with capecitabine significantly increased time to progression (Hazard Ratio 0.57 [95% Cl 0.43, 0.77] p=0.0001) compared to capecitabine alone.
Neodvisna ocena podatkov je tudi pokazala, da je lapatinib pri uporabi v kombinaciji s kapecitabinom pomembno podaljšal čas do progresije (razmerje tveganj 0, 57 [95% interval zaupanja 0, 43; 0, 77] p=0, 0001) v primerjavi s kapecitabinom samim.
8 Results of an updated analysis of the overall survival data to 28 September 2007 are presented in the table below.
8 Rezultati dopolnjene analize podatkov o celotnem preživetju do 28. septembra 2007 so prikazani v spodnji tabeli.
capecitabine (2,000 mg/ m2/ day) Number of subjects who died
Kapecitabin (2. 500 mg/ m2/ dan Lapatinib (1. 250 mg/ dan) + kapecitabin (2. 000 mg/ m2/ dan) Število oseb s smrtnim izidom
Hazard Ratio
Razmerje tveganj
(95% CI) p value
(95% interval zaupanja)
(0.71, 1.12) 0.3
(0, 71; 1, 12)
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.
The absolute bioavailability following oral administration of lapatinib is unknown, but it is incomplete and variable (approximately 70% coefficient of variation in AUC).
Absolutna biološka uporabnost lapatiniba po peroralni uporabi ni znana, vendar pa je nepopolna in variabilna (približno 70% koeficient variacije vrednosti AUC).
Serum concentrations appear after a median lag time of 0.25 hours (range 0 to 1.5 hours).
Serumske koncentracije se pojavijo po srednjem času prilagajanja 0, 25 ure (razpon 0 do 1, 5 ure).
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.
Pri dnevnem odmerku 1. 250 mg so geometrijske srednje vrednosti v stanju dinamičnega ravnovesja (koeficient variacije) Cmax 2, 43 (76%) µg/ ml, vrednosti AUC pa 36, 2 (79%) µg* ur/ ml.
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.
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).
Lapatinib is highly bound (greater than 99%) to albumin and alpha-1 acid glycoprotein.
Lapatinib se v velikem obsegu (več kot 99%) veže na albumin in alfa- 1 kisli glikoprotein.
In vitro studies indicate that lapatinib is a substrate for the transporters BCRP (ABCG1) and p-glycoprotein (ABCB1).
In vitro študije kažejo, da je lapatinib substrat za prenašalce BCRP (ABCG1) in p- glikoprotein (ABCB1).
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.
The clinical significance of these effects on the pharmacokinetics of other medicinal products or the pharmacological activity of other anti-cancer agents is not known.
Klinični pomen teh učinkov na farmakokinetiko drugih zdravil ali farmakološko aktivnost drugih protitumorskih učinkovin ni znan.
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.
Nobeden od teh ne predstavlja več kot 14% odmerka v blatu ali 10% plazemske koncentracije lapatiniba.
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).
Lapatinib did not significantly inhibit the following enzymes in human liver microsomes:
Lapatinib ni pomembneje zaviral naslednjih encimov v humanih jetrnih mikrosomih:
CYP1A2, CYP2C9, CYP2C19, and CYP2D6 or UGT enzymes (in vitro IC50 values were greater than or equal to 6.9 µg/ ml).
CYP1A2, CYP2C9, CYP2C19 in CYP2D6 ali UGT encimov (in vitro IC50 vrednosti so bile večje ali enake 6, 9 µg/ ml).
Lapatinib is predominantly eliminated through metabolism by CYP3A4/ 5.
Lapatinib se v glavnem izloča s presnovo s CYP3A4/ 5.
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%).
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).
9 Lapatinib pharmacokinetics have not been specifically studied in patients with renal impairment or in patients undergoing haemodialysis.
9 Pri bolnikih z okvaro ledvic in bolnikih, ki se zdravijo s hemodializo, farmakokinetike lapatiniba niso posebej preučevali.
The pharmacokinetics of lapatinib were examined in subjects with moderate (n = 8) or severe (n = 4) hepatic impairment (Child-Pugh scores of 7-9, or greater than 9, respectively) and in 8 healthy control subjects.
Farmakokinetiko lapatiniba so raziskovali pri osebah z zmerno (n = 8) ali hudo (n = 4) okvaro jeter (ocena po Child- Pugh- u 7- 9 oziroma večja od 9) in 8 zdravih kontrolnih osebah.
Systemic exposure (AUC) to lapatinib after a single oral 100 mg dose increased approximately 56% and 85% in subjects with moderate and severe hepatic impairment, respectively.
Sistemska izpostavljenost (AUC) lapatinibu po enkratnem peroralnem odmerku 100 mg lapatiniba se je pri osebah z zmerno okvaro jeter povečala za približno 56%, pri osebah s hudo okvaro jeter pa za 85%.
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).
Lapatinib was studied in pregnant rats and rabbits given oral doses of 30, 60, and 120 mg/ kg/ day.
Lapatinib so raziskovali pri brejih podganah in kunčicah, ki so ga prejemale peroralno v odmerkih 30, 60 in 120 mg/ kg/ dan.
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).
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.
At ≥ 60 mg/ kg/ day there were decreased foetal body weights, and minor skeletal variations.
Pri odmerkih ≥ 60 mg/ kg/ dan so poročali o zmanjšani telesni masi plodov in manjših skeletnih odstopanjih.
In the rat pre- and 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.
The highest no- effect dose for this study was 20 mg/ kg/ day.
Največji odmerek brez učinka v tej študiji je bil 20 mg/ kg/ dan.
There were no effects on male or female rat gonadal function, mating, or fertility at doses up to 120 mg/ kg/ day (females) and up to 180 mg/ kg/ day (males) (8 and 3 times the expected human clinical exposure, respectively).
Pri odmerkih do 120 mg/ kg/ dan (samice) in do 180 mg/ kg/ dan (samci) (8- kratna oziroma 3- kratna pričakovana izpostavljenost človeka pri klinični uporabi) niso opazili vpliva na delovanje moških ali ženskih spolnih žlez, na parjenje ali na plodnost.
Tablet core Microcrystalline cellulose Povidone (K30) Sodium starch glycolate (Type A) Magnesium stearate
Jedro tablete mikrokristalna celuloza povidon (K30) natrijev karboksimetilškrob (vrsta A) magnezijev stearat
Tablet coating Hypromellose Titanium dioxide (E171) Macrogol 400 Polysorbate 80 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)
Each pack of Tyverb contains 70 tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 10 tablets each.
En pretisni omot vsebuje 10 tablet.
Multipacks contain 140 film-coated tablets consisting of 2 x 70 tablet packs in a large outer carton.
Pakiranje po več enot vsebuje 140 filmsko obloženih tablet, in sicer 2 x 70 tablet, pakiranih v večjo škatlo.
11 ANNEX II
11 {DD/ MM/ LLLL}
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
12 A.
12 DODATEK II
Glaxo Operations UK Limited Priory Street Ware Hertfordshire SG12 0DG United Kingdom
Glaxo Operations UK Limited Priory Street Ware Hertfordshire SG12 0DG Velika Britanija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3, predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo na trgu.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4a of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt upravljanja tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 4a načrta za obvladovanje tveganja (RMP – "Risk Management Plan"), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki bi lahko vplivale na trenutne varnostne specifikacije zdravila, načrt farmakovigilance ali na dejavnost za zmanjševanje tveganja.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
v 60 dneh, potem ko je dosežen pomemben mejnik (pri farmakovigilanci ali dejavnostih za zmanjševanje tveganja).
13 C.
•
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
na zahtevo Evropske agencije za zdravila (EMEA).
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame.
POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
The results of which shall be taken into account in the risk benefit balance during the assessment of the application for a renewal.
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji program študij, katerih rezultate je treba upoštevati pri oceni razmerja med koristjo in tveganjem pri podaljšanju dovoljenja za promet z zdravilom.
To perform and submit an updated analysis of survival data for study EGF100151.
Izvesti in predložiti dopolnjeno analizo podatkov o preživetju za študijo EGF100151.
A data cut-off date of August 2008 will be applied, with the results of the analysis to be submitted by December 2008.
Rezultati analize bodo predloženi decembra 2008.
To conduct a Phase III randomised, controlled clinical study to evaluate the incidence of brain metastases as the site of relapse with a lapatinib-containing therapy compared with an appropriate, trastuzumab-containing control arm.
Izvesti randomizirano, nadzorovano klinično študijo III. faze, ki bo ovrednotila pojavnost metastaz v možganih, kot mesto ponovitve pri zdravljenju z lapatinibom v primerjavi z ustrezno kontrolno skupino, zdravljeno s trastuzumabom.
The study protocol will be finalised and submitted to the EMEA by July 2008.
Protokol študije bo dokončno pripravljen in predložen Evropski agenciji za zdravila do julija 2008.
The final study report for the trial will by submitted by May 2013.
Končno poročilo o preskušanju bo predloženo maja 2013.
15 A. LABELLING
15 DODATEK III
OUTER CARTON (14 DAY, SINGLE PACK)
17 PODATKI NA ZUNANJI OVOJNINI
Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom
Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, Velika Britanija
OUTER CARTON (28-DAY, MULTIPACK)
ŠKATLA (PAKIRANJE PO VEČ ENOT ZA 28- DNEVNO ZDRAVLJENJE)
140 film-coated tablets Multipack comprising 2 packs, each containing 70 film-coated tablets
Ena škatla vsebuje 70 filmsko obloženih tablet.
OUTER CARTON (14 DAY PACK, PART OF 28 DAY MULTIPACK)
ŠKATLA (PAKIRANJE ZA 14- DNEVNO ZDRAVLJENJE, SESTAVNI DEL PAKIRANJA PO VEČ ENOT ZA 28- DNEVNO ZDRAVLJENJE)
Component of the multipack, not to be sold separately
V prometu ne sme biti kot samostojna enota.
Tyverb 250 mg film-coated tablets Lapatinib
Tyverb 250 mg filmsko obložene tablete lapatinib
Don’ t pass it on to others.
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
their symptoms seem the same as yours.
škodovalo, čeprav imajo znake bolezni, podobne vašim.
What Tyverb is and what it is used for 2.
Kaj je zdravilo Tyverb in za kaj ga uporabljamo 2.
Before you take Tyverb 3.
Kaj morate vedeti, preden boste vzeli zdravilo Tyverb 3.
How to take Tyverb 4.
Kako jemati zdravilo Tyverb 4.
How to store Tyverb 6.
Shranjevanje zdravila Tyverb 6.
WHAT TYVERB IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TYVERB IN ZA KAJ GA UPORABLJAMO
Tyverb is used to treat certain types of breast cancer.
Zdravilo Tyverb uporabljamo za zdravljenje nekaterih vrst raka dojke.
While taking Tyverb you will also take another medicine containing the active substance capecitabine to treat cancer.
Med jemanjem zdravila Tyverb boste za zdravljenje raka jemali še eno zdravilo z zdravilno učinkovino kapecitabin.
Information about capecitabine, is described the capecitabine patient information leaflet.
Podatki o uporabi kapecitabina so na voljo v navodilu za uporabo kapecitabina.
Ask your doctor to give you information about capecitabine.
O uporabi kapecitabina se posvetujte s svojim zdravnikom.
BEFORE YOU TAKE TYVERB
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO TYVERB
- if you are allergic (hypersensitive) to lapatinib or any of the other ingredients of Tyverb.
- če ste alergični na (preobčutljivi za) lapatinib ali katerokoli sestavino zdravila Tyverb.