FrancophonIA/ELRC3.0 huggingface dataset:
English: This was a randomised phase II trial conducted to compare the efficacy and safety of bevacizumab versus placebo.
Slovenian: To je bilo randomizirano preskušanje 2. faze, v katerem so proučevali učinkovitost in varnost bevacizumaba v primerjavi s placebom.
English: Do not stop treatment with Zirabev unless you have discussed this with your doctor.
Slovenian: Ne prekinite zdravljenja z zdravilom Zirabev, ne da bi se o tem pogovorili z zdravnikom.
English: Trial results show that 94% (277 / 296) of eligible patients went on to receive single agent bevacizumab at cycle 7.
Slovenian: Rezultati preskušanja kažejo, da je 94 % (277/296) primernih bolnikov v 7. ciklu nadaljevalo z zdravljenjem s samim bevacizumabom.
English: The safety and efficacy of concomitant administration of radiotherapy and bevacizumab has not been established.
Slovenian: Varnost in učinkovitost sočasne uporabe obsevalnega zdravljenja in bevacizumaba še nista bili dokazani.
English: The patient characteristics were similar across the trial arms.
Slovenian: V vseh skupinah preskušanja so bile značilnosti bolnikov podobne.
English: If you are considering having children you should discuss this with your doctor before your treatment starts.
Slovenian: Če razmišljate o zanositvi, se posvetujte z zdravnikom, preden začnete z zdravljenjem.
English: The clinical presentation of PRES is often nonspecific, and therefore the diagnosis of PRES requires confirmation by brain imaging, preferably MRI.
Slovenian: Klinična slika PRES je pogosto nespecifična, zato je treba diagnozo PRES potrditi s slikovnimi preiskavami možganov, po možnosti z magnetnoresonančnim slikanjem.
English: The risk of bevacizumab-associated hypertension did not correlate with the patients' baseline characteristics, underlying disease or concomitant therapy.
Slovenian: Tveganje za pojav z bevacizumabom povezane hipertenzije ni bilo povezano z izhodiščnimi značilnostmi bolnikov, osnovno boleznijo ali sočasnim zdravljenjem.
English: The occurrence of those events varied in type and severity, ranging from free air seen on the plain abdominal X-ray, which resolved without treatment, to intestinal perforation with abdominal abscess and fatal outcome.
Slovenian: Pojavljanje teh neželenih učinkov se je razlikovalo glede na vrsto in resnost: od prostega zraka, ki so ga videli na nativnem rentgenogramu trebuha in je izginil brez zdravljenja, do perforacije črevesa z abdominalnimi abscesi in smrtnim izidom.
English: In most clinical trials urine protein levels of ≥ 2 g/24 hrs led to the holding of bevacizumab until recovery to < 2 g/24 hrs.
Slovenian: V večini kliničnih preskušanj so ravni beljakovin v urinu ≥ 2 g/24 ur privedle do prekinitve zdravljenja z bevacizumabom do znižanja na < 2 g/24 ur.
English: Pre-menopausal women (women who have a menstrual cycle) may notice that their periods become irregular or are missed and may experience impaired fertility.
Slovenian: Pri ženskah pred menopavzo (ženske z menstrualnim ciklom) se lahko pojavijo neredne menstruacije ali izostanek menstruacije, opazijo pa lahko tudi zmanjšano plodnost.
English: Both the 5 mg/kg/week and 2.5 mg/kg/week equivalent doses of bevacizumab provided a statistically significant benefit with regards to OS (HR 0.751 in study E3200; HR 0.81 in study ML18147) and PFS (HR 0.518 in study E3200; HR 0.68 in study ML18147).
Slovenian: Oba odmerka bevacizumaba, tj. odmerek, enakovreden 5 mg/kg/teden, in odmerek, enakovreden 2,5 mg/kg/teden, sta zagotovila statistično pomembno korist v smislu OS (HR 0,751 v študiji E3200; HR 0,81 v študiji ML18147) in PFS (HR 0,518 v študiji E3200; HR 0,68 v študiji ML18147).
English: Clinical trials have shown that transient increases in serum creatinine (ranging between 1.5-1.9 times baseline level), both with and without proteinuria, are associated with the use of bevacizumab.
Slovenian: V kliničnih preskušanjih so dokazali, da so prehodna zvečanja koncentracije kreatinina v serumu (v razponu med 1,5- in 1,9-kratnikom izhodiščne vrednosti), s proteinurijo in brez nje, povezana z uporabo bevacizumaba.
English: The risk of developing connections between the vagina and any parts of the gut can increase if you have persistent, recurrent or metastatic cervical cancer.
Slovenian: Tveganje za nastanek povezav med nožnico in deli črevesja se lahko poveča, če imate dolgotrajni, ponavljajoči se ali metastatski rak materničnega vratu.
English: First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy
Slovenian: Prva linija zdravljenja neploščatoceličnega NSCLC v kombinaciji s kemoterapijo na osnovi platine
English: The primary efficacy parameter of the trial was overall survival, defined as the time from randomisation to death from any cause.
Slovenian: Primarni parameter učinkovitosti v preskušanju je bilo celokupno preživetje, opredeljeno kot čas od randomizacije do smrti iz kateregakoli vzroka.
English: An adverse effect on female fertility can however be expected as repeat dose toxicity studies in animals have shown inhibition of the maturation of ovarian follicles and a decrease/absence of corpora lutea and associated decrease in ovarian and uterus weight as well as a decrease in the number of menstrual cycles.
Slovenian: Pričakovati je škodljiv vpliv na plodnost žensk, saj so študije toksičnosti pri ponavljajočih odmerkih na živalih pokazale zaviranje zorenja ovarijskih foliklov in zmanjšanje/odsotnost rumenega telesca ter s tem povezano zmanjšanje mase jajčnika in maternice ter zmanjšanje števila menstrualnih ciklov.
English: The efficacy data from trials AVF0780g and AVF2192g investigating bevacizumab in combination with 5-FU/FA-chemotherapy are summarised in Table 5.
Slovenian: Povzetek podatkov o učinkovitosti iz preskušanj AVF0780g in AVF2192g, v katerih so proučevali bevacizumab v kombinaciji s kemoterapevtsko shemo 5-FU/FA, je podan v preglednici 5.
English: Toxicity and adverse reactions included arterial hypertension and fatigue as well as CNS ischaemia with acute neurological deficit.
Slovenian: Toksičnosti in neželeni učinki so vključevali arterijsko hipertenzijo in utrujenost ter ishemijo centralnega živčnega sistema z akutnim nevrološkim primanjkljajem.
English: Major or massive pulmonary haemorrhage/haemoptysis has been observed primarily in trials in patients with non-small cell lung cancer (NSCLC).
Slovenian: Večjo ali obsežno krvavitev v pljučih/hemoptizo so opazili predvsem v preskušanjih pri bolnikih z nedrobnoceličnim rakom pljuč (NSCLC - non-small cell lung cancer).
English: Please talk to your doctor since blood clots can lead to heart attack and stroke.
Slovenian: Posvetujte se z zdravnikom, saj krvni strdki lahko povzročijo srčni infarkt in možgansko kap.
English: Non-small cell lung cancer (NSCLC)
Slovenian: Nedrobnocelični rak pljuč (NSCLC - non-small cell lung cancer)
English: The concentrate is a clear to slightly opalescent, colourless to pale brown liquid in a glass vial with a rubber stopper.
Slovenian: Koncentrat je bistra do rahlo motna, brezbarvna do svetlo rjava tekočina v stekleni viali z gumijastim zamaškom.
English: There is no information on the safety profile of bevacizumab in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting bevacizumab treatment, as such patients were excluded from clinical trials.
Slovenian: Podatkov o varnostnem profilu bevacizumaba pri bolnikih s prirojeno hemoragično diatezo, pridobljeno koagulopatijo ali pri bolnikih, ki prejemajo poln odmerek antikoagulantov za zdravljenje trombembolije pred začetkom zdravljenja z bevacizumabom, ni, saj so takšne bolnike izključili iz kliničnih preskušanj.
English: No incompatibilities between Zirabev and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Slovenian: Med zdravilom Zirabev in vrečkami iz polivinilklorida ali poliolefina ali infuzijskimi seti niso opazili nobenih inkompatibilnosti.
English: Eight hundred and twenty-nine patients were randomised (292 FOLFOX-4, 293 bevacizumab + FOLFOX-4 and 244 bevacizumab monotherapy).
Slovenian: Randomizirali so 829 bolnikov (292 na shemo FOLFOX-4, 293 na bevacizumab + shema FOLFOX-4 in 244 na monoterapijo z bevacizumabom).
English: A doctor or nurse will give you this diluted Zirabev solution by intravenous infusion (a drip into your vein).
Slovenian: Zdravnik ali medicinska sestra vam bosta razredčeno raztopino zdravila Zirabev dala z intravensko infuzijo (kapalna infuzija v veno).
English: 878 patients were randomised to the two arms.
Slovenian: V 2 skupini so skupno randomizirali 878 bolnikov.
English: MAHA is a haemolytic disorder which can present with red cell fragmentation, anaemia, and thrombocytopenia.
Slovenian: MAHA je hemolitična motnja, ki se lahko kaže s fragmentacijo rdečih krvnih celic, anemijo in trombocitopenijo.
English: ● if you develop severe high blood pressure requiring treatment with blood pressure medicines,
Slovenian: ● če se vam pojavi zelo visok krvni tlak, ki ga je treba zdraviti z zdravili proti povišanemu krvnemu tlaku,
English: Table 12 Efficacy results for trial BO17704
Slovenian: Preglednica 12 Rezultati učinkovitosti v preskušanju BO17704
English: While the incidence of CHF was, in both arms, above that previously observed for doxorubicin therapy, the rate was higher in the R-CHOP plus bevacizumab arm.
Slovenian: Medtem ko je bila pojavnost KSP v obeh skupinah večja od tiste, ki so jo predhodno opazili pri zdravljenju z doksorubicinom, je bil delež večji v skupini, ki je prejemala R-CHOP in bevacizumab.
English: The clinical benefit, as measured by overall survival, was seen in all pre-specified patient subgroups, including those defined by age, sex, performance status, location of primary tumour, number of organs involved and duration of metastatic disease.
Slovenian: Klinično korist, ki so jo izmerili s celokupnim preživetjem, so opazili pri vseh vnaprej določenih podskupinah bolnikov, vključno s podskupinami, ki so jih osnovali glede na starost, spol, splošno stanje zmogljivosti, lokalizacijo primarnega tumorja, število prizadetih organov in trajanje metastatske bolezni.
English: • reduction in the number of white cells in the blood, and cells that help the blood clot,
Slovenian: • zmanjšanje števila belih krvnih celic in celic, ki pomagajo pri strjevanju krvi,
English: You must not breast-feed your baby during treatment with Zirabev and for at least 6 months after the last dose of Zirabev, as this medicine may interfere with the growth and development of your baby.
Slovenian: Med zdravljenjem z zdravilom Zirabev in še najmanj 6 mesecev po zadnjem odmerku zdravila Zirabev ne smete dojiti, saj lahko to zdravilo vpliva na rast in razvoj vašega otroka.
English: In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of post-operative bleeding or wound healing complications observed in patients who underwent major surgery 28-60 days prior to starting bevacizumab.
Slovenian: V kliničnih preskušanjih pri bolnikih z metastatskem karcinomom debelega črevesa in danke niso opazili povečanega tveganja za pooperativno krvavitev ali zaplete pri celjenju ran pri bolnikih, ki so imeli 28-60 dni pred začetkom zdravljenja z bevacizumabom večji kirurški poseg.
English: Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja, vključno z malformacijami (glejte poglavje 5.3).
English: ● It is possible that Zirabev may cause bleeding in and around your brain.
Slovenian: ● Možno je, da zdravilo Zirabev povzroča krvavitve v možganih in okoli možganov.
English: Patients were treated until disease progression.
Slovenian: Bolnike so zdravili do napredovanja bolezni.
English: If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive and use machines until symptoms abate.
Slovenian: Bolnikom, pri katerih se pojavijo simptomi, ki vplivajo na vid ali koncentracijo oziroma sposobnost odzivanja, je treba svetovati, naj ne vozijo in upravljajo strojev, dokler simptomi ne izzvenijo.
English: Marketing Authorisation Holder Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Slovenian: Imetnik dovoljenja za promet z zdravilom Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija
English: Therapy should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed.
Slovenian: Zdravljenja ne smemo začeti, če je od večjega kirurškega posega minilo manj kot 28 dni oziroma dokler se kirurška rana popolnoma ne zaceli.
English: Once the vial has been opened, the dilution must be performed immediately.
Slovenian: Po odprtju viale je treba zdravilo takoj razredčiti.
English: The primary outcome measure was overall survival defined as the time from randomisation until death from any cause.
Slovenian: Primarno merilo izida je bilo celokupno preživetje, opredeljeno kot čas od randomizacije do smrti iz kateregakoli vzroka.
English: Patients and percentage of patients with best overall response of confirmed CR or PR; percentage calculated on patients with measurable disease at baseline 95% CI for one sample binomial using Pearson-Clopper method Approximate 95% CI for difference of two rates using Hauck-Anderson method log-rank test (stratified) Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis
Slovenian: ocene po Kaplan-Meierjevi metodi bolnice in odstotek bolnic z najboljšim celokupnim odzivom s potrjenim CR ali PR; odstotek so izračunali pri bolnicah z merljivo boleznijo ob izhodišču 95 % IZ za binomsko porazdelitev z enim vzorcem z uporabo Pearson-Clopperjeve metode približno 95 % IZ za razliko med dvema stopnjama z uporabo Hauck-Andersonove metode log-rank test (stratificiran) primarno analizo so opravili s podatki, ki so jih zajeli do 12. decembra 2012, in velja za končno analizo nadaljnjo analizo so opravili s podatki, ki so jih zajeli do 7. marca 2014 p-vrednost je navedena samo v opisne namene
English: Very rare Frequency not known
Slovenian: Zelo redki Neznana pogostnost
English: In this trial, there were two primary objectives: to show that XELOX was non-inferior to FOLFOX-4 and to show that bevacizumab in combination with FOLFOX-4 or XELOX chemotherapy was superior to chemotherapy alone.
Slovenian: V tem preskušanju sta bila 2 primarna cilja: pokazati, da je shema XELOX neinferiorna shemi FOLFOX-4 in da je bevacizumab v kombinaciji s kemoterapevtsko shemo FOLFOX-4 ali XELOX superioren zdravljenju samo s kemoterapijo.
English: Patients with thromboembolic reactions ≤ Grade 3 need to be closely monitored (NCI-CTCAE v.3).
Slovenian: Bolnike s trombemboličnimi dogodki stopnje ≤ 3 je treba skrbno spremljati (NCI-CTCAE v.3).
English: What you need to know before you use Zirabev
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Zirabev
English: a Interferon alfa-2a 9 MIU 3x/week b Bevacizumab 10 mg/kg q 2 wk
Slovenian: Interferon alfa-2a 9 mio i.e. 3-krat/teden Bevacizumab 10 mg/kg vsaka 2 tedna
English: An exploratory multivariate Cox regression model using backward selection indicated that the following baseline prognostic factors were strongly associated with survival independent of treatment: gender, white blood cell count, platelets, body weight loss in the 6 months prior to trial entry, number of metastatic sites, sum of longest diameter of target lesions, Motzer score.
Slovenian: S pomočjo raziskovalnega multivariantnega Coxovega regresijskega modela s postopnim izključevanjem so ugotovili, da so naslednji izhodiščni prognostični dejavniki močno povezani s preživetjem, neodvisno od zdravljenja: spol, število belih krvnih celic, število trombocitov, zmanjšanje telesne mase v 6 mesecih pred vključitvijo v preskušanje, število metastatskih mest, vsota najdaljših premerov tarčnih lezij, rezultat po Motzerju.
English: Observed effects included decreases in maternal and foetal body weights, an increased number of foetal resorptions and an increased incidence of specific gross and skeletal foetal malformations.
Slovenian: Opazili so zmanjšanje telesne mase tako matere kot ploda, povečanje števila resorbiranih plodov ter povečano pojavnost določenih hujših in skeletnih nepravilnosti ploda.
English: Patients with NSCLC of known squamous cell histology or mixed cell type with predominant squamous cell histology were excluded from subsequent phase III trials, while patients with unknown tumour histology were included.
Slovenian: Bolnike z NSCLC z znano ploščatocelično histologijo ali mešanim celičnim tipom s prevladujočo ploščatocelično histologijo so izključili iz nadaljnjih preskušanj 3. faze, vključili pa so bolnike z neznano histologijo tumorja.
English: For further information please refer to Table 3 ‘Adverse reactions reported in post-marketing setting.'
Slovenian: Za nadaljnje informacije glejte preglednico 3 ''Neželeni učinki, o katerih so poročali v obdobju trženja''.
English: The addition of bevacizumab to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see Table 4).
Slovenian: Dodajanje bevacizumaba shemi IFL je statistično pomembno podaljšalo celokupno preživetje, preživetje brez napredovanja bolezni in celokupni odziv na zdravljenje (glejte preglednico 4).
English: The primary efficacy variable of the trial was overall survival.
Slovenian: Primarna spremenljivka učinkovitosti v preskušanju je bilo celokupno preživetje.
English: Detailed information about these post-marketing reactions are provided in Table 3.
Slovenian: Natančnejši podatki o teh neželenih učinkih iz obdobja trženja so navedeni v preglednici 3.
English: The pharmacokinetic results show that the clearance and volume of distribution of bevacizumab were comparable between paediatric and young adult patients when normalised by body weight, with exposure trending lower as body weight decreased.
Slovenian: Farmakokinetični rezultati kažejo, da sta bila po normalizaciji glede na telesno maso očistek in volumen porazdelitve bevacizumaba med pediatričnimi in mlajšimi odraslimi bolniki primerljiva, pri čemer se je izpostavljenost zmanjševala z manjšanjem telesne mase.
English: Across clinical trials, the following Grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patients treated with bevacizumab with at least a 2% difference compared to the corresponding control groups: hyperglycaemia, decreased haemoglobin, hypokalaemia, hyponatraemia, decreased white blood cell count, increased international normalised ratio (INR).
Slovenian: V kliničnih preskušanjih so se naslednje laboratorijske nepravilnosti stopnje 3 in 4 (NCI-CTCAE v.3) pri bolnikih, ki so se zdravili z bevacizumabom, pojavile z najmanj 2 % razliko v primerjavi z ustreznimi kontrolnimi skupinami: hiperglikemija, zmanjšanje vrednosti hemoglobina, hipokaliemija, hiponatriemija, zmanjšanje števila belih krvnih celic, povečano internacionalno normalizirano razmerje (INR - international normalised ratio).
English: When used for patients with kidney cancer, it will be administered with another type of medicine called interferon.
Slovenian: Kadar ga uporabljamo pri bolnikih z rakom ledvic, ga dajemo skupaj z drugo vrsto zdravila, ki se imenuje interferon.
English: ● Zirabev can increase the incidence of high blood pressure.
Slovenian: ● Zdravilo Zirabev lahko poveča pojavnost visokega krvnega tlaka.
English: The primary endpoint of this trial was progression free survival (PFS), based on trial investigators' assessment of disease progression.
Slovenian: Primarni opazovani dogodek v tem preskušanju je bilo preživetje brez napredovanja bolezni (PFSprogression-free survival) na podlagi napredovanja bolezni, kot so ga ocenili raziskovalci v preskušanju.
English: This has mainly been seen in combination with platinum- or taxane-based therapies in the treatment of NSCLC, mBC, and in combination with paclitaxel and topotecan in persistent, recurrent, or metastatic cervical cancer.
Slovenian: To so večinoma opazili v kombinaciji z zdravljenjem na osnovi platine ali taksanov pri bolnikih z NSCLC, mBC in v kombinaciji s paklitakselom in topotekanom pri bolnicah z dolgotrajnim, ponavljajočim se ali metastatskim rakom materničnega vratu.
English: The addition of bevacizumab to fluoropyrimidine-based chemotherapy resulted in a statistically significant prolongation of survival in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen (ITT = 819) (see Table 9).
Slovenian: Dodajanje bevacizumaba kemoterapiji na osnovi fluoropirimidina je statistično pomembno podaljšalo preživetje pri bolnikih z mCRC, pri katerih je bolezen napredovala po prvi liniji zdravljenja po shemi, ki je vključevala bevacizumab (ITT = 819) (glejte preglednico 9).
English: An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
Slovenian: Vmesna analiza je pokazala, da se je čas do napredovanja bolezni pomembno podaljšal v skupini, ki je prejemala odmerek 10 mg/kg, v primerjavi s skupino, ki je prejemala placebo (razmerje ogroženosti 2,55; p < 0,001).
English: Bevacizumab use has been associated with serious cases of fistulae including reactions resulting in death.
Slovenian: Uporaba bevacizumaba je povezana z resnimi primeri fistul, vključno s takšnimi, ki so se končali s smrtjo.
English: The primary endpoint was duration of survival.
Slovenian: Primarni opazovani dogodek je bilo trajanje preživetja.
English: In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving bevacizumab.
Slovenian: V kliničnih preskušanjih so o proteinuriji poročali pri 0,7 % do 54,7 % bolnikov, ki so prejemali bevacizumab.
English: There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurological disorder.
Slovenian: Pri bolnikih, ki so se zdravili z bevacizumabom, so redko poročali o pojavu znakov in simptomov, značilnih za PRES, redko nevrološko motnjo.
English: Depending on the dose prescribed for you, some or all of the contents of the Zirabev vial will be diluted with sodium chloride solution before use.
Slovenian: Odvisno od odmerka, ki vam ga je predpisal zdravnik, je treba del ali vso vsebino viale z zdravilom Zirabev pred uporabo razredčiti z raztopino natrijevega klorida.
English: When events were noted as both all grade and grade 3-5 adverse drug reactions in clinical trials, the highest frequency observed in patients has been reported.
Slovenian: Kadar so bili neželeni učinki v kliničnih preskušanjih vseh stopenj in stopnje 3-5, so poročali o največji pogostnosti, ki so jo opazili pri bolnikih.
English: Tumour-associated haemorrhage was also seen rarely in other tumour types and locations, including cases of central nervous system (CNS) bleeding in patients with CNS metastases (see section 4.4).
Slovenian: S tumorjem povezano krvavitev so redkeje opazili pri bolnikih z drugimi vrstami in lokalizacijami tumorjev, vključno s primeri krvavitve v centralnem živčnem sistemu (CŽS) pri bolnikih z metastazami v CŽS (glejte poglavje 4.4).
English: In the majority of the occasions the necessary amount of Zirabev can be diluted with 0.9% sodium chloride solution for injection to a total volume of 100 mL.
Slovenian: V večini primerov lahko potrebno količino zdravila Zirabev razredčimo z 0,9-odstotno raztopino natrijevega klorida za injiciranje do končnega volumna 100 ml.
English: ● if you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
Slovenian: ● če ste alergični na produkte ovarijskih celic kitajskega hrčka (CHO - Chinese hamster ovary) ali druga rekombinantna humana ali humanizirana protitelesa.