natgillin/translations-raw huggingface dataset:
Patients treated with Vargatef have an increased risk of venous thromboembolism including pulmonary embolism and deep vein thrombosis.
Pri bolnikih, zdravljenih z zdravilom Vargatef, je povečano tveganje za vensko trombembolijo, vključno s pljučno embolijo in globoko vensko trombozo.
Subsequent complications such as sepsis or febrile neutropenia have been observed.
Opazili so tudi njene posledične zaplete, kot sta sepsa ali febrilna nevtropenija.
+ Odds ratio and p-value were obtained from a logistic regression model adjusted for baseline ECOG Performance Score (0 versus 1).
+ Razmerje obetov in vrednost p sta bila pridobljena iz logističnega regresijskega modela, prilagojenega za izhodiščno stanje zmogljivosti po ECOG (0 ali 1).
In rats, small amounts of radiolabelled nintedanib and/or its metabolites were excreted into the milk (≤ 0.5 % of the administered dose).
Pri podganah so se majhne količine radioaktivno označenega nintedaniba in/ali njegovih presnovkov izločale v mleko (≤ 0,5 % uporabljenega odmerka).
Use caution when treating patients with a higher cardiovascular risk including known coronary artery disease.
Pri zdravljenju bolnikov z večjim srčnožilnim tveganjem, vključno z znano koronarno arterijsko boleznijo, je potrebna previdnost.
No. of patients at risk
Število ogroženih bolnikov
HR (95 % CI)
RO (95-odstotni IZ)
Transaminase, ALKP and bilirubin levels should be investigated before initiation of the combination treatment with Vargatef plus docetaxel.
Ravni transaminaz, ALKP in bilirubina je treba določiti pred uvedbo kombiniranega zdravljenja z zdravilom Vargatef in docetakselom.
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.
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.
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.
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.
Limited safety data available from 9 patients with moderate hepatic impairment (Child Pugh B) are insufficient to characterize this population.
Omejeni podatki o varnosti 9 bolnikov z zmerno jetrno okvaro (Child Pugh B) so nezadostni za opredelitev te populacije.
Nintedanib treatment may be resumed at a reduced dose.
Zdravljenje z nintedanibom lahko nadaljujete z zmanjšanim odmerkom.
In the clinical trial LUME-Lung 1 (see section 5.1), the majority of patients had mild to moderate diarrhoea.
V kliničnem preskušanju LUME-Lung 1 (glejte poglavje 5.1) je imela večina bolnikov blago do zmerno drisko.
After intravenous infusion, a high volume of distribution (Vss: 1050 L, 45.0 % gCV) was observed.
Po intravenskem infundiranju so opazili velik porazdelitveni volumen (Vss : 1.050 l, 45,0 % gCV).
Neutropenia and sepsis
Nevtropenija in sepsa
Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) measurements showed an anti-angiogenic effect of nintedanib in humans.
Merjenje s kontrastno poudarjenim dinamičnim magnetno resonančnim slikanjem (DCE-MRI) je pokazalo antiangiogeni učinek nintedaniba pri ljudeh.
Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways with CYP 3A4 being the predominant enzyme involved.
Le manjši del biotransformacije nintedaniba je potekal po poteh CYP, pri čemer je prevladujoči vpleteni encim CYP 3A4.
Patients should be advised to be cautious when driving or using machines during treatment with Vargatef.
Bolnikom je treba svetovati, naj bodo med vožnjo ali upravljanjem strojev med zdravljenjem z zdravilom Vargatef previdni.
LIST OF EXCIPIENTS Contains soya.
SEZNAM POMOŽNIH SNOVI Vsebuje sojo.
120 x 1 soft capsule
120 x 1 mehka kapsula
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.
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.
Less than 1 % of a single dose of nintedanib is excreted via the kidney (see section 5.2).
Manj kot 1 % enkratnega odmerka nintedaniba se izloči skozi ledvice (glejte poglavje 5.2).
Population PK analyses indicated moderate effects on exposure to nintedanib depending on age, body weight, and race (see below).
Populacijske farmakokinetične analize nakazujejo zmerne učinke na izpostavljenost nintedanibu, ki so odvisni od starosti, telesne mase in rase (glejte spodaj).
Tell your doctor or pharmacist immediately if you become pregnant during treatment with Vargatef.
Zdravniku ali farmacevtu takoj povejte, če boste med zdravljenjem z zdravilom Vargatef zanosili.
In vitro, CYP-dependent metabolism accounted for about 5 % compared to about 25 % ester cleavage.
Delež od CYP odvisne presnove in vitro je približno 5 % v primerjavi s približno 25 % cepitve estra.
Based on the high inter-individual variability of exposure observed in the clinical LUME-Lung-1 trial these effects are not considered clinically relevant.
Na podlagi velike variabilnosti izpostavljenosti med posamezniki, ki so jo opazili v kliničnem preskušanju LUME-Lung-1, našteti učinki ne veljajo za klinično pomembne.
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.
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.
In patients on chronic low dose therapy with low molecular weight heparins or acetylsalicylic acid, no increased frequency of bleeding was observed.
Pri bolnikih s stalnim zdravljenjem z majhnjimi odmerki nizkomolekularnih heparinov ali acetilsalicilno kislino niso opazili večje pogostnosti krvavitev.
Black ink:
Črnilo:
Diarrhoea ≥ grade 3 despite anti-diarrhoeal treatment
Navzea ≥ 3. stopnje kljub zdravljenju z antiemetiki
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).
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).
If you take more Vargatef than you should Contact your doctor or pharmacist immediately.
Če ste vzeli večji odmerek zdravila Vargatef, kot bi smeli Takoj se posvetujte z zdravnikom ali farmacevtom.
However, no thorough QT-trial of nintedanib administered in combination with docetaxel was conducted.
Vendar temeljitih preskušanj QT z nintedanibom v kombinaciji z docetakselom niso izvajali.
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.
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.
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.
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.
What you need to know before you take Vargatef
Kaj morate vedeti, preden boste vzeli zdravilo Vargatef
The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses.
Posameznih dnevnih priporočenih odmerkov nintedaniba ni dovoljeno povečati, zato da bi nadomestili pozabljene odmerke.
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.
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.
Based on preclinical investigations there is no evidence for impairment of male fertility (see section 5.3).
Na podlagi predkliničnih preiskav ni znakov za vpliv na plodnost pri moških (glejte poglavje 5.3).
However, the frequency of patients with gastrointestinal perforation was low.
Vendar je bila pogostnost bolnikov s predrtjem prebavil majhna.
Do not take Vargatef on the same day as your chemotherapy treatment with docetaxel.
Zdravila Vargatef ne vzemite istega dne, ko prejmete kemoterapijo z docetakselom.
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).
Ne jemljite zdravila Vargatef - če ste alergični na nintedanib, arašide ali sojo, ali na katerokoli sestavino tega zdravila (navedeno v poglavju 6).
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.
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.
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).
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).
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.
Korelacije odziva na DCE-MRI z naknadnimi klinično značilno zmanjšanimi velikostmi ciljnih lezij niso ugotovili, vendar je bil tovrsten odziv povezan s stabilizacijo bolezni.
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.
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.
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.
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.
The rates of sepsis (1.3 %) and febrile neutropenia (7.5 %) were increased under treatment with nintedanib as compared to the placebo arm.
Deleža sepse (1,3 %) in febrilne nevtropenije (7,5 %) sta bila pri zdravljenju z nintedanibom povečana v primerjavi s skupino s placebom.
Dose reduction
Zmanjševanje odmerka
Diarrhoea occurred in 43.4 % (≥ grade 3: 6.3 %) of adenocarcinoma patients in the nintedanib arm.
Driska se je pojavila pri 43,4 % (≥ 3. stopnje: 6,3 %) bolnikov z adenokarcinomom v skupini z nintedanibom.
Therefore, it is not recommended to treat these patients with Vargatef.
Zato zdravljenje teh bolnikov z zdravilom Vargatef ni priporočljivo.
Vargatef contains soya The capsules contain soya lecithin.
Zdravilo Vargatef vsebuje sojo Kapsule vsebujejo sojin lecitin.
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.
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.
Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B; see section 5.2).
Izpostavljenost se je povečala pri bolnikih z jetrno okvaro (Child Pugh A, Child Pugh B; glejte poglavje 5.2).
Blood counts should be monitored during therapy, in particular during the combination treatment with docetaxel.
Med zdravljenjem je treba spremljati krvno sliko, zlasti med kombiniranim zdravljenjem z docetakselom.
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).
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).
Patients with a recent history of myocardial infarction or stroke were excluded from this trial.
Bolniki z miokardnim infarktom ali možgansko kapjo v nedavni anamnezi so bili iz tega preskušanja izključeni.
No adjustment of the initial dosing is required on the basis of a patient's age (see section 5.2).
Začetnega odmerka ni treba prilagajati bolnikovi starosti (glejte poglavje 5.2).
Treatment with Vargatef should therefore only be initiated or - in case of perioperative interruption - resumed based on clinical judgement of adequate wound healing.
Zdravilo Vargatef je zato dovoljeno uvesti (ali v primeru perioperativne prekinitve, nadaljevati njegovo jemanje) le na podlagi klinične ocene ustreznega celjenja ran.
Of note, pre-planned analyses according to histology showed statistically significant difference in OS between treatment arms in the adenocarcinoma population only (Table 4).
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).
Vargatef capsules must be taken orally, preferably with food, swallowed whole with water, and must not be chewed or crushed.
Način uporabe Kapsule zdravila Vargatef je treba zaužiti cele z vodo, najbolje s hrano; ne sme se jih žvečiti ali drobiti.
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).
Med zdravljenjem je pomembno spremljati bolnikovo krvno sliko, zlasti med kombiniranim zdravljenjem z docetakselom (glejte poglavje 4.4).
Sepsis and febrile neutropenia have been reported as subsequent complications of neutropenia.
O sepsi in febrilni nevtropeniji so poročali kot o zapletu, ki je sledil nevtropeniji.
Overall survival analysis in the overall population did not reach statistical significance (HR 0.94; 95 % CI: 0.83 - 1.05).
Analiza celokupnega preživetja v celotni populaciji bolnikov ni dosegla statistične pomembnosti (RO: 0,94; 95 % IZ: 0,83; 1,05).
The efficacy and safety of Vargatef was investigated in 1314 adult patients with locally advanced, metastatic or recurrent NSCLC after one prior line of chemotherapy.
Učinkovitost in varnost zdravila Vargatef so proučevali pri 1.314 odraslih bolnikih z lokalno napredovalim, metastatskim ali ponovljenim NSCLC po eni predhodni kemoterapiji.
Table 3 summarizes the frequencies of adverse drug reactions that were reported in the pivotal trial LUME-Lung 1 for patients with NSCLC of adenocarcinoma tumour histology (n = 320) or from the post-marketing period.
Preglednica 3 prikazuje povzetek pogostnosti neželenih učinkov, o katerih so poročali v ključnem preskušanju LUME-Lung 1 za bolnike z NSCLC s histologijo adenokarcinoma (n = 320) ali iz obdobja trženja.
Myocardial infarction (see section 4.4)
Srčne bolezni miokardni infarkt (glejte poglavje 4.4)
The values should be monitored as clinically indicated or periodically during treatment, i.e. in the combination phase with docetaxel at the beginning of each treatment cycle and monthly in case Vargatef is continued as monotherapy after discontinuation of docetaxel.
Vrednosti je treba med zdravljenjem spremljati, kot je klinično indicirano ali periodično, to je v obdobju dajanja v kombinaciji z docetakselom na začetku vsakega terapevtskega cikla in nato mesečno, če bolniki jemanje zdravila Vargatef po ukinitvi docetaksela nadaljujejo kot monoterapijo.
In case your doctor has stopped your chemotherapy with docetaxel you should continue to take Vargatef twice daily.
Če vas je zdravnik prenehal zdraviti s kemoterapijo z docetakselom, morate nadaljevati jemanje zdravila Vargatef 2-krat na dan.
This medicine is used in combination with another cancer medicine (docetaxel) to treat a cancer of the lung called non-small cell lung cancer (NSCLC).
To zdravilo se uporablja v kombinaciji z drugim zdravilom za zdravljenje raka (docetaksel), ki se uporablja za zdravljenje vrste pljučnega raka imenovanega nedrobnocelični pljučni rak (non-small cell lung cancer - NSCLC).
Your doctor may reduce your recommended dose to 300 mg per day (two capsules of 150 mg).
Zdravnik lahko vaš priporočeni odmerek zmanjša na 300 mg na dan (dve kapsuli po 150 mg).
- if you have high blood pressure - if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall
- če imate visok krvni tlak; - če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Preobčutljivost za nintedanib, arašide ali sojo ali katero koli pomožno snov, navedeno v poglavju 6.1.
Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation and survival of endothelial as well as perivascular cells (pericytes and vascular smooth muscle cells).
Nintedanib se kompetitivno veže na vezavno mesto adenozin trifosfata (ATP) teh receptorjev in zavira znotrajcelično signaliziranje, ki je odločilno za proliferacijo in preživetje endotelijskih in perivaskularnih celic (periciti in žilne gladkomišične celice).
Tumour angiogenesis is an essential feature contributing to tumour growth, progression and metastasis formation and is predominantly triggered by the release of pro-angiogenic factors secreted by the tumour cell (i.e. VEGF and bFGF) to attract host endothelial as well as perivascular cells to facilitate oxygen and nutrient supply through the host vascular system.
Angiogeneza tumorja je bistvena lastnost, ki prispeva k njegovi rasti, napredovanju in nastajanju metastaz, in jo pretežno sproža sproščanje proangiogenskih dejavnikov, ki jih izločajo tumorske celice (VEGF in bFGF), ki privlačijo gostiteljske endotelijske in perivaskularne celice in tako olajšajo oskrbo s kisikom in hranili prek gostiteljskega žilnega sistema.
It is recommended to take the capsule with food, i.e. during or immediately before or after a meal.
Kapsule je priporočljivo jemati s hrano, torej med obrokom, tik pred njim ali takoj po njem.
In a post-hoc analysis in adenocarcinoma patients having progressed and entered the trial ≥ 9 months since start of their first-line therapy the difference did not reach statistical significance (HR for OS: 0.89, 95 % CI 0.66 - 1.19).
V post-hoc analizi pri bolnikih z napredovalim adenokarcinomom, ki so v preskušanje vstopili ≥ 9 mesecev od začetka zdravljenja v prvi liniji, razlika ni dosegla statistične pomembnosti (RO za CP: 0,89, 95 % IZ 0,66-1,19).
Nintedanib is a triple angiokinase inhibitor blocking vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and ß) and fibroblast growth factor receptors (FGFR 1-3) kinase activity.
Nintedanib je trojni zaviralec angiokinaze, ki zavira aktivnost kinaze receptorjev žilnega endotelijskega rastnega faktorja (vascular endothelial growth factor receptors - VEGFR 1-3), receptorje rastnega faktorja iz trombocitov (platelet-derived growth factor receptors - PDGFR α in ß) in receptorjev rastnega faktorja fibroblastov (fibroblast growth factor receptors - FGFR 1-3).
Exposure to nintedanib was not influenced by gender (body weight corrected), mild and moderate renal impairment (estimated by creatinine clearance), liver metastases, ECOG performance score, alcohol consumption, and P-gp genotype.
Na izpostavljenost nintedanibu niso vplivali spol (prilagojen za telesno maso), blaga ali zmerna ledvična okvara (ocenjeno z očistkom kreatinina), metastaze v jetrih, rezultat zmogljivosti po ECOG, pitje alkohola in genotip P-gp.
However, based on the mechanism of action patients treated with Vargatef may have an increased risk of gastrointestinal perforations.
Vendar zaradi mehanizma delovanja pri bolnikih, zdravljenih z zdravilom Vargatef, lahko obstaja povečano tveganje za predrtje prebavil.
Pregnancy testing should be conducted at least prior to treatment with Vargatef.
Testiranje nosečnosti je treba opraviti že pred zdravljenjem z zdravilom Vargatef.
Febrile neutropenia and sepsis (common, may affect up to 1 in 10 people) Treatment with Vargatef may lead to a reduced number of a type of your white blood cells (neutropenia) which are important for the body´s reaction against bacterial or fungal infections.
febrilna nevtropenija in sepsa (pogosti, pojavita se lahko pri največ 1 od 10 bolnikov) Zdravljenje z zdravilom Vargatef lahko zmanjša število vrste belih krvnih celic (nevtropenija), ki so pomembne za odziv telesa proti bakterijskim ali glivičnim okužbam.
If necessary, your doctor may further reduce your daily dose to 200 mg per day (two capsules of 100 mg).
Če je potrebno, vam lahko zdravnik vaš dnevni odmerek znova zmanjša na 200 mg na dan (dve kapsuli po 100 mg).
Vargatef 100 mg soft capsules EU/1/14/954/001
Vargatef 100 mg mehke kapsule EU/1/14/954/001
Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.
Zdravilo Vargatef je indicirano v kombinaciji z docetakselom za zdravljenje odraslih bolnikov z lokalno napredovalim, metastatskim ali lokalno ponovljivim nedrobnoceličnim pljučnim rakom (non-small cell lung cancer - NSCLC) s histologijo adenokarcinoma po kemoterapiji prve izbire.
Particular caution should be exercised when treating patients with previous abdominal surgery or a recent history of a hollow organ perforation.
Posebno pozornost zahteva zdravljenje bolnikov, ki so imeli predhodno abdominalno operacijo ali imajo v nedavni anamnezi predrtje votlega organa.
Based on population pharmacokinetic (PK) analyses, no a priori dose adjustments of Vargatef are necessary (see section 5.2).
Na podlagi populacijskih farmakokinetičnih (FK) analiz odmerka zdravila Vargatef ni treba vnaprej prilagajati (glejte poglavje 5.2).
The HR for these patients for PFS and OS was 1.24 (95 % CI: 0.68, 2.28) and 1.09 (95 % CI: 0.70, 1.70), respectively.
RO za te bolnike za PFS je bil 1,24 (95 % IZ: 0,68, 2,28), za celokupno preživetje pa 1,09 (95 % IZ: 0,70, 1,70).