FrancophonIA/ELRC3.0 huggingface dataset:
English: Logistic regression revealed a statistically significant association between nintedanib exposure and DCE-MRI response.
Slovenian: Logistična regresija je pokazala statistično značilno povezavo med izpostavljenostjo nintedanibu in odzivom na DCE-MRI.
English: In patients with increased liver parameters, the use of the established stepwise dose reduction scheme was the appropriate measure and discontinuation of treatment was only necessary in 2.2 % of patients.
Slovenian: Kot ustrezen ukrep za bolnike s povečanimi jetrnimi parametri se je izkazalo uveljavljeno stopenjsko zmanjševanje odmerka, zdravljenje pa je bilo treba ukiniti le pri 2,2 % bolnikov.
English: Do not reduce the dose or stop the treatment yourself without consulting your doctor first.
Slovenian: Sami odmerka ne zmanjšujte in ne prenehajte z zdravljenjem, ne da bi se prej posvetovali z zdravnikom!
English: The European Medicines Agency has waived the obligation to submit the results of studies with Vargatef in all subsets of the paediatric population in non-small cell lung cancer (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Vargatef za vse podskupine pediatrične populacije s pljučnim nedrobnoceličnim rakom (za podatek o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: twice daily for 15 days did not prolong the QTcF interval.
Slovenian: 200 mg, dvakrat na dan 15 dni, ne da bi podaljšali interval QTcF.
English: The in vitro protein binding of nintedanib in human plasma was high, with a bound fraction of 97.8 %.
Slovenian: Vezava nintedaniba na beljakovine v plazmi je bila in vitro velika, z vezanim deležem kar 97,8 %.
English: During treatment with Vargatef your doctor will regularly monitor your blood cells and examine you for signs of infection, such as inflammation, fever or tiredness.
Slovenian: Med zdravljenjem z zdravilom Vargatef bo zdravnik redno preverjal število vaših krvnih celic in vas pregledoval za morebitne znake okužb, kot so vnetje, zvišana telesna temperatura ali utrujenost.
English: Events of pancreatitis have been reported in patients taking nintedanib for the treatment of IPF and NSCLC.
Slovenian: O pankreatitisu so poročali pri bolnikih, ki so nintedanib jemali za zdravljenje IPF in NSCLC.
English: Overall Survival (OS)*** Patients, n
Slovenian: Celokupno preživetje (CP)*** Bolniki, n
English: Patients taking concomitant anticoagulation, such as warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, international normalised ratio (INR), and clinical bleeding episodes.
Slovenian: Bolnike, ki sočasno jemljejo antikoagulante, kot sta varfarin ali fenprokoumon, je treba redno spremljati glede sprememb protrombinskega časa, mednarodnega umerjenega razmerja (international normalized ratio - INR) in kliničnih epizod krvavitev.
English: Five point eight percent (5.8 %) of the patients had stable brain metastasis at trial entry and 3.8 % had prior bevacizumab treatment.
Slovenian: Pet celih osem odstotka (5,8 %) bolnikov je imelo ob sprejetju v preskušanje stabilne metastaze v možganih in 3,8 % se jih je pred tem zdravilo z bevacizumabom.
English: Progression free survival (PFS)* - primary analysis Patients, n
Slovenian: Preživetje brez napredovanja (PFS)* - primarna analiza Bolniki, n
English: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90 %).
Slovenian: Nintedanib se pretežno izloča z žolčem/blatom (> 90 %).
English: The terminal half-life of nintedanib was between 10 and 15 h (gCV % approximately 50 %).
Slovenian: Končni razpolovni čas nintedaniba je bil med 10 in 15 urami (gCV % približno 50 %).
English: Patients were randomized (1:1) to receive nintedanib 200 mg orally twice daily in combination with 75 mg/m of intravenous docetaxel every 21 days (n = 655) or placebo orally twice daily in combination with 75 mg/m2 of docetaxel every 21 days (n = 659).
Slovenian: Bolniki so bili randomizirani (1 : 1) na prejemanje nintedaniba po 200 mg peroralno dvakrat na dan v kombinaciji s 75 mg/m docetaksela intravensko vsakih 21 dni (n = 655) ali placeba peroralno dvakrat na dan v kombinaciji s 75 mg/m2 docetaksela vsakih 21 dni (n = 659).
English: In addition Fms-like tyrosine-protein kinase (Flt)-3, lymphocyte-specific tyrosine-protein kinase (Lck) and proto-oncogene tyrosine-protein kinase Src (Src) are inhibited.
Slovenian: Poleg tega so zavrte še Fms-podobna tirozin-protein kinaza (Flt)-3, limfocit-specifična tirozin-protein kinaza (Lck) in proto-onkogena tirozin-protein kinaza Src (Src).
English: Co-administration of nintedanib with docetaxel (75 mg/m²) did not alter the pharmacokinetics of either medicinal product to a relevant extent.
Slovenian: Sočasno dajanje nintedaniba z docetakselom (75 mg/m²) ni spremenilo farmakokinetike nobenega od zdravil v pomembnem obsegu.
English: Do not stop taking Vargatef without consulting your doctor first.
Slovenian: Zdravila Vargatef ne prenehajte jemati, ne da bi se prej posvetovali z zdravnikom.
English: Supportive care for nausea and vomiting may include medicinal products with anti-emetic properties, e.g. glucocorticoids, anti-histamines or 5-HT3 receptor antagonists and adequate hydration.
Slovenian: Podporna oskrba za slabost in bruhanje lahko vključuje zdravila z antiemetičnimi lastnostmi, npr. glukokortikoide, antihistaminike ali antagoniste receptorja 5-HT3 in ustrezno hidracijo.
English: Information about selected adverse reactions observed from the LUME-Lung 1 trial are described below.
Slovenian: Podatki o izbranih neželenih učinkih, ki so jih opazili v preskušanju LUME-Lung 1, so opisani spodaj.
English: The proportion of adenocarcinoma patients with stage < IIIB/IV at diagnosis was small and balanced across treatment arms (placebo: 54 patients (16.1 %); nintedanib: 50 patients, (15.5 %)).
Slovenian: Delež bolnikov z adenokarcinomom stopnje < IIIB/IV ob diagnozi je bil majhen in uravnotežen v vseh zdravljenih skupinah bolnikov (placebo: 54 bolnikov (16,1 %); nintedanib: 50 bolnikov (15,5 %)).
English: The majority of fatal bleeding events were tumour-associated.
Slovenian: Večina usodnih krvavitev je bila povezanih s tumorjem.
English: Patients with active brain metastasis were excluded from clinical trials and are not recommended for treatment with Vargatef.
Slovenian: Bolnike z aktivnimi metastazami v možganih so iz kliničnih preskušanj izključili, zato zdravljenje z zdravilom Vargatef zanje ni priporočljivo.
English: Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.
Slovenian: Pri bolnikih z znano alergijo na arašidove beljakovine je tveganje za resne reakcije na sojine pripravke povečano.
English: The contribution of renal excretion to the total clearance was low (0.649 % of dose, 26.3 % gCV).
Slovenian: Prispevek ledvičnega izločanja k skupnemu očistku je bil majhen (0,649 % odmerka, 26,3 % gCV).
English: OS analysis and follow-up PFS-analysis performed when 1121 death cases had been observed in the overall ITT population (535 events in adenocarcinoma patients).
Slovenian: Analiza celokupnega preživetja in analiza PFS ob kontrolnem pregledu sta bili izvedeni, ko so poročali o 1121 smrtnih primerih v celotni populaciji ITT (535 dogodkov pri bolnikih z adenokarcinomom).
English: Patients treated with Vargatef have an increased risk of venous thromboembolism including pulmonary embolism and deep vein thrombosis.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Vargatef, je povečano tveganje za vensko trombembolijo, vključno s pljučno embolijo in globoko vensko trombozo.
English: Subsequent complications such as sepsis or febrile neutropenia have been observed.
Slovenian: Opazili so tudi njene posledične zaplete, kot sta sepsa ali febrilna nevtropenija.
English: + Odds ratio and p-value were obtained from a logistic regression model adjusted for baseline ECOG Performance Score (0 versus 1).
Slovenian: + Razmerje obetov in vrednost p sta bila pridobljena iz logističnega regresijskega modela, prilagojenega za izhodiščno stanje zmogljivosti po ECOG (0 ali 1).
English: In rats, small amounts of radiolabelled nintedanib and/or its metabolites were excreted into the milk (≤ 0.5 % of the administered dose).
Slovenian: Pri podganah so se majhne količine radioaktivno označenega nintedaniba in/ali njegovih presnovkov izločale v mleko (≤ 0,5 % uporabljenega odmerka).
English: Use caution when treating patients with a higher cardiovascular risk including known coronary artery disease.
Slovenian: Pri zdravljenju bolnikov z večjim srčnožilnim tveganjem, vključno z znano koronarno arterijsko boleznijo, je potrebna previdnost.
English: No. of patients at risk
Slovenian: Število ogroženih bolnikov
English: HR (95 % CI)
Slovenian: RO (95-odstotni IZ)
English: Transaminase, ALKP and bilirubin levels should be investigated before initiation of the combination treatment with Vargatef plus docetaxel.
Slovenian: Ravni transaminaz, ALKP in bilirubina je treba določiti pred uvedbo kombiniranega zdravljenja z zdravilom Vargatef in docetakselom.
English: The trial included 658 patients (50.1 %) with adenocarcinoma, 555 patients (42.2 %) with squamous cell carcinoma, and 101 patients (7.7 %) with other tumour histologies.
Slovenian: V preskušanje so vključili 658 bolnikov (50,1 %) z adenokarcinomom, 555 bolnikov (42,2 %) s ploščatoceličnim karcinomom in 101 bolnika (7,7 %) s tumorji druge histologije.
English: This population included those adenocarcinoma patients identified at baseline as having progressed and entered the trial less than 9 months since start of their first-line therapy.
Slovenian: Ta populacija zajema vključene bolnike z adenokarcinomom, ki so na izhodišču imeli opredeljeno napredovalo bolezen in so v preskušanje vstopili manj kot 9 mesecev od začetka zdravljenja prve izbire.
English: Limited safety data available from 9 patients with moderate hepatic impairment (Child Pugh B) are insufficient to characterize this population.
Slovenian: Omejeni podatki o varnosti 9 bolnikov z zmerno jetrno okvaro (Child Pugh B) so nezadostni za opredelitev te populacije.
English: Nintedanib treatment may be resumed at a reduced dose.
Slovenian: Zdravljenje z nintedanibom lahko nadaljujete z zmanjšanim odmerkom.
English: In the clinical trial LUME-Lung 1 (see section 5.1), the majority of patients had mild to moderate diarrhoea.
Slovenian: V kliničnem preskušanju LUME-Lung 1 (glejte poglavje 5.1) je imela večina bolnikov blago do zmerno drisko.
English: After intravenous infusion, a high volume of distribution (Vss: 1050 L, 45.0 % gCV) was observed.
Slovenian: Po intravenskem infundiranju so opazili velik porazdelitveni volumen (Vss : 1.050 l, 45,0 % gCV).
English: Neutropenia and sepsis
Slovenian: Nevtropenija in sepsa
English: Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) measurements showed an anti-angiogenic effect of nintedanib in humans.
Slovenian: Merjenje s kontrastno poudarjenim dinamičnim magnetno resonančnim slikanjem (DCE-MRI) je pokazalo antiangiogeni učinek nintedaniba pri ljudeh.
English: Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways with CYP 3A4 being the predominant enzyme involved.
Slovenian: Le manjši del biotransformacije nintedaniba je potekal po poteh CYP, pri čemer je prevladujoči vpleteni encim CYP 3A4.
English: Patients should be advised to be cautious when driving or using machines during treatment with Vargatef.
Slovenian: Bolnikom je treba svetovati, naj bodo med vožnjo ali upravljanjem strojev med zdravljenjem z zdravilom Vargatef previdni.
English: LIST OF EXCIPIENTS Contains soya.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje sojo.
English: 120 x 1 soft capsule
Slovenian: 120 x 1 mehka kapsula
English: In trial 1199.13 (LUME-Lung 1), there was a higher frequency of SAEs in patients treated with nintedanib plus docetaxel with a body weight of less than 50 kg compared to patients with a weight ≥ 50 kg; however the number of patients with a body weight of less than 50 kg was small.
Slovenian: V preskušanju 1199.13 (LUME-Lung 1) je bila pri bolnikih, ki so se zdravili z nintedanibom in docetakselom, pogostnost resnih neželenih učinkov večja med bolniki s telesno maso do 50 kg, v primerjavi z bolniki, ki so tehtali ≥ 50 kg; vendar pa je bilo bolnikov, lažjih od 50 kg, malo.
English: Less than 1 % of a single dose of nintedanib is excreted via the kidney (see section 5.2).
Slovenian: Manj kot 1 % enkratnega odmerka nintedaniba se izloči skozi ledvice (glejte poglavje 5.2).
English: Population PK analyses indicated moderate effects on exposure to nintedanib depending on age, body weight, and race (see below).
Slovenian: Populacijske farmakokinetične analize nakazujejo zmerne učinke na izpostavljenost nintedanibu, ki so odvisni od starosti, telesne mase in rase (glejte spodaj).
English: Tell your doctor or pharmacist immediately if you become pregnant during treatment with Vargatef.
Slovenian: Zdravniku ali farmacevtu takoj povejte, če boste med zdravljenjem z zdravilom Vargatef zanosili.
English: In vitro, CYP-dependent metabolism accounted for about 5 % compared to about 25 % ester cleavage.
Slovenian: Delež od CYP odvisne presnove in vitro je približno 5 % v primerjavi s približno 25 % cepitve estra.
English: Based on the high inter-individual variability of exposure observed in the clinical LUME-Lung-1 trial these effects are not considered clinically relevant.
Slovenian: Na podlagi velike variabilnosti izpostavljenosti med posamezniki, ki so jo opazili v kliničnem preskušanju LUME-Lung-1, našteti učinki ne veljajo za klinično pomembne.
English: In case of further persistence of the adverse reaction(s), i.e. if a patient does not tolerate 100 mg twice daily, treatment with Vargatef should be permanently discontinued.
Slovenian: Kadar neželeni učinek/ učinki ne izginejo, tj. če bolnik ne prenaša odmerka po 100 mg dvakrat na dan, je treba zdravljenje z zdravilom Vargatef trajno ukiniti.
English: In patients on chronic low dose therapy with low molecular weight heparins or acetylsalicylic acid, no increased frequency of bleeding was observed.
Slovenian: Pri bolnikih s stalnim zdravljenjem z majhnjimi odmerki nizkomolekularnih heparinov ali acetilsalicilno kislino niso opazili večje pogostnosti krvavitev.
English: Black ink:
Slovenian: Črnilo:
English: Diarrhoea ≥ grade 3 despite anti-diarrhoeal treatment
Slovenian: Navzea ≥ 3. stopnje kljub zdravljenju z antiemetiki
English: The population mean exposure to nintedanib was 33 - 50 % higher in Chinese, Taiwanese, and Indian patients and 16 % higher in Japanese patients while it was 16 - 22 % lower in Koreans compared to Caucasians (body weight corrected).
Slovenian: Populacijska srednja izpostavljenost nintedanibu je bila od 33 % do 50 % večja pri Kitajcih, Tajvancih in Indijcih ter 16 % večja pri Japoncih, medtem ko je pri Korejcih od 16 % do 22 % manjša v primerjavi z belci (popravljena glede na telesno maso).
English: If you take more Vargatef than you should Contact your doctor or pharmacist immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Vargatef, kot bi smeli Takoj se posvetujte z zdravnikom ali farmacevtom.
English: However, no thorough QT-trial of nintedanib administered in combination with docetaxel was conducted.
Slovenian: Vendar temeljitih preskušanj QT z nintedanibom v kombinaciji z docetakselom niso izvajali.
English: A pre-specified evaluation was performed in the population of adenocarcinoma patients considered to have entered the trial with a particularly poor treatment prognosis, namely, patients who progressed during or shortly after first-line therapy prior to trial entry.
Slovenian: Izvedli so vnaprej opredeljeno analizo populacije bolnikov z adenokarcinomom, ki so imeli ob vstopu v preskušanje izjemno slabo prognozo zdravljenja, in sicer pri tistih, pri katerih se je napredovanje bolezni pojavilo med zdravljenjem prve izbire ali kmalu zatem, torej pred vstopom v preskušanje.
English: It is for adult patients whose NSCLC is of a certain type (“adenocarcinoma”) and who had already received one treatment with another medicine to treat this cancer but whose tumour started to grow again.
Slovenian: Namenjeno je odraslim bolnikom, ki imajo določeno vrsto nedrobnoceličnega pljučnega raka (adenokarcinom) in so se predhodno že zdravili z drugim zdravilom proti raku, a je začel tumor ponovno rasti.
English: What you need to know before you take Vargatef
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vargatef
English: The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses.
Slovenian: Posameznih dnevnih priporočenih odmerkov nintedaniba ni dovoljeno povečati, zato da bi nadomestili pozabljene odmerke.
English: Women of childbearing potential being treated with Vargatef should be advised to avoid becoming pregnant while receiving this treatment and to use adequate contraception during and at least 3 months after the last dose of Vargatef.
Slovenian: Ženskam v rodni dobi, ki se zdravijo z zdravilom Vargatef, je treba svetovati, naj med zdravljenjem s tem zdravilom ne zanosijo in naj uporabljajo ustrezno kontracepcijo med njegovim jemanjem in še vsaj 3 mesece po zadnjem odmerku.
English: Based on preclinical investigations there is no evidence for impairment of male fertility (see section 5.3).
Slovenian: Na podlagi predkliničnih preiskav ni znakov za vpliv na plodnost pri moških (glejte poglavje 5.3).
English: However, the frequency of patients with gastrointestinal perforation was low.
Slovenian: Vendar je bila pogostnost bolnikov s predrtjem prebavil majhna.
English: Do not take Vargatef on the same day as your chemotherapy treatment with docetaxel.
Slovenian: Zdravila Vargatef ne vzemite istega dne, ko prejmete kemoterapijo z docetakselom.
English: Do not take Vargatef - if you are allergic to nintedanib, to peanut or soya, or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Vargatef - če ste alergični na nintedanib, arašide ali sojo, ali na katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: A study of male fertility and early embryonic development to implantation in rats did not reveal effects on the male reproductive tract and male fertility.
Slovenian: Študija vpliva na sposobnost razmnoževanja pri samcih in zgodnjega razvoja zarodka do implantacije pri podganah ni razkrila učinkov na reproduktivni sistem niti na sposobnost razmnoževanja pri samcih.
English: As initial measure for the management of adverse reactions (see Tables 1 and 2) treatment with nintedanib should be temporarily interrupted until the specific adverse reaction has resolved to levels that allow continuation of therapy (to grade 1 or baseline).
Slovenian: Začetni ukrep za obravnavo neželenih učinkov (glejte Preglednico 1 in 2) je začasna prekinitev zdravljenja z nintedanibom, dokler specifični neželeni učinek ne bo izzvenel do ravni, ki omogoča nadaljevanje zdravljenja (do 1. stopnje ali izhodiščnega stanja).
English: No correlation of the DCE-MRI response and subsequent clinically significant reduction in target lesion size was found, but DCE-MRI response was associated with disease stabilization.
Slovenian: Korelacije odziva na DCE-MRI z naknadnimi klinično značilno zmanjšanimi velikostmi ciljnih lezij niso ugotovili, vendar je bil tovrsten odziv povezan s stabilizacijo bolezni.
English: As several other tyrosine kinase inhibitors are known to exert an effect on QT, caution should be exercised when administering nintedanib in patients who may develop QTc prolongation.
Slovenian: Znano je, da nekateri drugi zaviralci tirozin kinaze vplivajo na interval QT, zato je pri dajanju nintedaniba bolnikom, pri katerih lahko pride do podaljšanja intervala QTc, potrebna previdnost.
English: Diarrhoea (very common, may affect more than 1 in 10 people) Diarrhoea may lead to a loss of fluid and important salts (electrolytes, such as sodium or potassium) in your body.
Slovenian: driska (zelo pogosta, pojavi se lahko pri več kot 1 od 10 bolnikov) Driska lahko povzroči izgubo tekočine in pomembnih soli (elektrolitov, kot sta natrij in kalij) v telesu.
English: The rates of sepsis (1.3 %) and febrile neutropenia (7.5 %) were increased under treatment with nintedanib as compared to the placebo arm.
Slovenian: Deleža sepse (1,3 %) in febrilne nevtropenije (7,5 %) sta bila pri zdravljenju z nintedanibom povečana v primerjavi s skupino s placebom.
English: Dose reduction
Slovenian: Zmanjševanje odmerka
English: Diarrhoea occurred in 43.4 % (≥ grade 3: 6.3 %) of adenocarcinoma patients in the nintedanib arm.
Slovenian: Driska se je pojavila pri 43,4 % (≥ 3. stopnje: 6,3 %) bolnikov z adenokarcinomom v skupini z nintedanibom.
English: Therefore, it is not recommended to treat these patients with Vargatef.
Slovenian: Zato zdravljenje teh bolnikov z zdravilom Vargatef ni priporočljivo.
English: Vargatef contains soya The capsules contain soya lecithin.
Slovenian: Zdravilo Vargatef vsebuje sojo Kapsule vsebujejo sojin lecitin.
English: In repeat dose toxicology studies in rats, adverse effects (e.g. thickening of epiphyseal plates, lesions of the incisors) were mostly related to the mechanism of action (i.e. VEGFR-2 inhibition) of nintedanib.
Slovenian: V študijah toksičnosti po ponavljajočih se odmerkih pri podga nah so bili neželeni učinki (npr. odebelitev epifiznih ploščic, lezije sekalcev) večinoma povezani z mehanizmom delovanja (z zaviranjem VEGFR-2) nintedaniba.
English: Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B; see section 5.2).
Slovenian: Izpostavljenost se je povečala pri bolnikih z jetrno okvaro (Child Pugh A, Child Pugh B; glejte poglavje 5.2).
English: Blood counts should be monitored during therapy, in particular during the combination treatment with docetaxel.
Slovenian: Med zdravljenjem je treba spremljati krvno sliko, zlasti med kombiniranim zdravljenjem z docetakselom.
English: In the pivotal trial 1199.13, 85 patients (12.9 % of the patients with adenocarcinoma histology) were ≥ 70 years of age (median age: 72 years, range: 70 - 80 years) (see section 5.1).
Slovenian: V ključnem preskušanju 1199.13 je bilo 85 bolnikov (12,9 % je imelo histologijo adenokarcinoma) starih ≥ 70 let (mediana starost: 72 let, razpon: 70 do 80 let) (glejte poglavje 5.1).
English: Patients with a recent history of myocardial infarction or stroke were excluded from this trial.
Slovenian: Bolniki z miokardnim infarktom ali možgansko kapjo v nedavni anamnezi so bili iz tega preskušanja izključeni.
English: No adjustment of the initial dosing is required on the basis of a patient's age (see section 5.2).
Slovenian: Začetnega odmerka ni treba prilagajati bolnikovi starosti (glejte poglavje 5.2).
English: Treatment with Vargatef should therefore only be initiated or - in case of perioperative interruption - resumed based on clinical judgement of adequate wound healing.
Slovenian: Zdravilo Vargatef je zato dovoljeno uvesti (ali v primeru perioperativne prekinitve, nadaljevati njegovo jemanje) le na podlagi klinične ocene ustreznega celjenja ran.
English: Of note, pre-planned analyses according to histology showed statistically significant difference in OS between treatment arms in the adenocarcinoma population only (Table 4).
Slovenian: Omembe vredno je, da so predhodno načrtovane analize glede na histologijo pokazale statistično značilno razliko v celokupnem preživetju zdravljenih skupin samo v populaciji bolnikov z adenokarcinomom (Preglednica 4).
English: Vargatef capsules must be taken orally, preferably with food, swallowed whole with water, and must not be chewed or crushed.
Slovenian: Način uporabe Kapsule zdravila Vargatef je treba zaužiti cele z vodo, najbolje s hrano; ne sme se jih žvečiti ali drobiti.
English: It is important that the patient's blood counts are monitored during therapy, in particular during the combination treatment with docetaxel (see section 4.4).
Slovenian: Med zdravljenjem je pomembno spremljati bolnikovo krvno sliko, zlasti med kombiniranim zdravljenjem z docetakselom (glejte poglavje 4.4).