FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reactions listed in this section fall into the following frequency categories: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: With or without gross residual disease.
Slovenian: Z ali brez preostanka bolezni.
English: Do not stop treatment with MVASI unless you have discussed this with your doctor.
Slovenian: Ne prenehajte zdravljenja z zdravilom MVASI, ne da bi se o tem pogovorili s svojim zdravnikom.
English: There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly diagnosed high-grade glioma.
Slovenian: Na voljo ni dovolj podatkov, da bi določili varnost in učinkovitost bevacizumaba pri otrocih z novo diagnosticiranim gliomom visoke stopnje malignosti.
English: The incidence varied between 10% (4/40) and 20%
Slovenian: Incidenca se je gibala med 10 % (4/40) in 20 % (3/15).
English: p-value (Chi-squared test)
Slovenian: Vrednost p (test hi-kvadrat)
English: Before initiating MVASI, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Slovenian: Pred uvedbo zdravila MVASI je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
English: There are no clinical trial data on the use of bevacizumab in pregnant women.
Slovenian: Iz kliničnih preskušanj ni podatkov o uporabi bevacizumaba pri nosečnicah.
English: It rarely resulted in discontinuation of bevacizumab treatment or hospitalisation.
Slovenian: Redko je prišlo do prekinitve zdravljenja z bevacizumabom ali hospitalizacije.
English: • Bleeding in the eye.
Slovenian: • krvavitev v očesu.
English: After cycle 1, the medicinal product could be delivered as a 1-hour infusion.
Slovenian: Po prvem ciklusu se lahko zdravilo daje kot 1-urna infuzija.
English: Please talk to your doctor since blood clots can lead to heart attack and stroke.
Slovenian: Posvetujte se s svojim zdravnikom, saj lahko krvni strdki privedejo do srčnega napada in kapi.
English: MVASI has not been shown to reduce your ability to drive or to use any tools or machines.
Slovenian: Za zdravilo MVASI se ni izkazalo, da bi zmanjšalo vašo sposobnost za vožnjo ali uporabo orodij oziroma strojev.
English: EU/1/17/1246/002
Slovenian: EU/1/17/1246/001 EU/1/17/1246/002
English: It is important that your doctor knows if you have ever received anthracyclines (for example doxorubicin, a specific type of chemotherapy used to treat some cancers) or had radiotherapy to your chest, or if you have heart disease.
Slovenian: Pomembno je, da vaš zdravnik ve, če ste kdaj prejeli antracikline (na primer doksorubicin, specifično vrsto kemoterapije, ki jo uporabljajo pri zdravljenju nekaterih vrst raka), če so vam obsevali prsni koš ali če imate srčno bolezen.
English: When bevacizumab is injected directly into the eye (unapproved use), the following side effects may occur:
Slovenian: Kadar bevacizumab injiciramo neposredno v oko (neodobrena uporaba), se lahko pojavijo naslednji neželeni učinki:
English: Please discuss this with your doctor if you have metastatic cancer affecting your brain.
Slovenian: Posvetujte se s svojim zdravnikom, če imate rak v metastatski obliki, ki je prizadel vaše možgane.
English: Bevacizumab has no or negligible influence on the ability to drive and use machines.
Slovenian: Bevacizumab nima oziroma ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: • blood clot in the arteries which can lead to a stroke or a heart attack,
Slovenian: • krvni strdki v arterijah, ki lahko vodijo do kapi ali srčnega napada,
English: Key efficacy results for the superiority analysis (ITT population, trial NO16966)
Slovenian: Ključni rezultati učinkovitosti za analizo superiornosti (populacija, ki so jo nameravali zdraviti; preskušanje NO16966)
English: The safety and efficacy of concomitant administration of radiotherapy and bevacizumab has not been established.
Slovenian: Varnost in učinkovitost sočasnega zdravljenja z radioterapijo in bevacizumabom nista bili ugotovljeni.
English: Duration of response Median time (months)
Slovenian: Trajanje odgovora Mediana časa (meseci)
English: For additional information refer below within section “Description of selected serious adverse reactions”.
Slovenian: Za nadaljnje informacije glejte spodnje podpoglavje ”Opis določenih resnih neželenih učinkov”.
English: Patients included in analysis
Slovenian: Število bolnikov, vključenih v analizo delež
English: Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only.
Slovenian: Analizo po spremljanju so opravili s podatki, zajetimi do 7. marca 2014; vse vrednosti p so napisane samo za deskriptivne namene.
English: • The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
Slovenian: • tveganje za pojav krvnih strdkov v arterijah (tip krvne žile) je lahko povečano, če ste starejši od 65 let, imate sladkorno bolezen ali če ste v preteklosti že imeli krvne strdke v arterijah.
English: The median age of patients was 61.0 (range: 25-84) years.
Slovenian: Mediana starosti bolnic je bila 61,0 let (razpon: 25 do 84 let).
English: These clinically significant reactions have therefore been included in table 2 within the column entitled “Frequency not known”.
Slovenian: Te klinično pomembne neželene učinke so zato v preglednici 2 razvrstili v kolono »Neznana pogostnost«.
English: • It is possible that MVASI can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
Slovenian: • možno je, da lahko zdravilo MVASI povzroči preobčutljivost in/ali reakcije, povezane z infundiranjem (reakcije, povezane z injiciranjem zdravila).
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba lastniško ime in številko serije uporabljenega zdravila jasno zabeležiti (navesti) v bolnikovo kartoteko.
English: • A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with MVASI treatment.
Slovenian: • redek neželen učinek, povezan z živci, imenovan sindrom posteriorne reverzibilne encefalopatije (PRES), povezujejo z zdravljenjem z zdravilom MVASI.
English: The incidence of adverse events, including grade ≥ 3 adverse events and serious adverse events, was similar between the two treatment arms.
Slovenian: Incidenca neželenih učinkov, vključno z neželenimi učinki stopnje ≥ 3 in resnimi neželenimi učinki, je bila pri obeh zdravljenih skupinah podobna.
English: In most cases hypertension was controlled adequately using standard antihypertensive treatment appropriate for the individual situation of the affected patient.
Slovenian: V večini primerov je bila hipertenzija ustrezno uravnana s standardnimi antihipertenzivnimi zdravili, ki so bila primerna za posameznega bolnika v dani situaciji.
English: Other medicines and MVASI
Slovenian: Druga zdravila in zdravilo MVASI
English: If you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery, you should not receive this medicine.
Slovenian: Če boste operirani, če je od večje operacije minilo manj kot 28 dni, ali če se vaša rana po operaciji še ni zacelila, tega zdravila ne smete prejeti.
English: Combinations of MVASI with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Slovenian: Kombinacija zdravila MVASI z drugim zdravilom, imenovanim sunitinib malat (predpisanem za zdravljenje raka ledvic in prebavil), lahko povzroči hude neželene učinke.
English: Exploratory analysis; OS updated analysis at clinical cut-off on 28 October 2015, approx. 45% patient had died and OS is therefore considered immature.
Slovenian: Eksplorativna analiza; analiza celokupnega preživetja, posodobljena s kliničnimi podatki, zajetimi do 28. oktobra 2015; približno 45 % bolnikov je umrlo in zato oceno celokupnega preživetja ocenjujemo kot nezrelo.
English: In the chemotherapy arms, the FOLFOX-4 regimen used the same doses and schedule as shown in table 6 for trial NO16966.
Slovenian: V skupini, ki je prejemala kemoterapijo, so pri zdravljenju po shemi FOLFOX-4 uporabljali enake odmerke in sheme, kot je prikazano v preglednici 6 za preskušanje NO16966.
English: The median age was 60.0 years in the CP arm and 59.0 years in the CPB arm.
Slovenian: Mediana starost je bila 60,0 let v skupini CP in 59,0 let v skupini CPB.
English: Overall survival - Follow-up analysis7 Median (months)1
Slovenian: Celokupno preživetje - analiza po spremljanju7 Mediana (meseci)1
English: What MVASI is and what it is used for
Slovenian: Kaj je zdravilo MVASI in za kaj ga uporabljamo
English: MVASI is not approved for use in patients under the age of 18 years.
Slovenian: Zdravilo MVASI ni odobreno za uporabo pri bolnikih, mlajših od 18 let.
English: Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 mL of red blood) should not be treated with bevacizumab.
Slovenian: Bolnike, ki so nedavno imeli krvavitev v pljučih/hemoptizo (> 2,5 ml rdeče krvi), z bevacizumabom ne smemo zdraviti.
English: However, the increase in the primary endpoint of overall survival by 2 months was not significant (HR = 0.91).
Slovenian: Vendar pa povečanje primarnega končnega cilja - celokupnega preživetja - za 2 meseca ni bilo signifikantno (razmerje ogroženosti = 0,91).
English: The secondary endpoint of overall survival was not mature.
Slovenian: Sekundarni cilj študije, celokupno preživetje, ni bilo zrelo.
English: Bevacizumab clearance was approximately 30% faster in patients with low levels of serum albumin and 7% faster in subjects with higher tumour burden when compared with a typical patient with median values of albumin and tumour burden.
Slovenian: Očistek bevacizumaba je bil približno 30 % hitrejši pri bolnikih z nizkimi vrednostmi serumskega albumina in 7 % hitrejši pri bolnikih z visokim tumorskim bremenom v primerjavi s tipičnim bolnikom s srednjimi vrednostmi albumina in tumorskega bremena.
English: Objective response rate**
Slovenian: Objektivni odgovor**
English: * Primary analysis was performed with a data cut-off date of 14 November 2011.
Slovenian: * Primarna analiza je bila pripravljena s podatki, zajetimi do 14. novembra 2011.
English: log-rank test (stratified).
Slovenian: Test log-rang (stratificirani).
English: The addition of bevacizumab to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Slovenian: Dodatek bevacizumaba k zdravljenju po shemi FOLFOX-4 je statistično značilno podaljšal preživetje.
English: MVASI therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Slovenian: Zdravljenje z zdravilom MVASI je treba pri bolnikih, pri katerih se razvije nekrotizirajoči fasciits, nemudoma prekiniti in takoj začeti z ustreznim zdravljenjem.
English: Investigator assessment*
Slovenian: Ocena raziskovalca*
English: Additional endpoints included objective response, duration of response, overall survival and safety.
Slovenian: Ostali cilji so vključevali objektiven odgovor, trajanje odgovora, celokupno preživetje in varnost.
English: MVASI may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Slovenian: Zdravilo MVASI lahko poškoduje nerojenega otroka, ker lahko zaustavi tvorbo novih krvnih žil.
English: Pulmonary embolism,
Slovenian: pljučna embolija,
English: • if you have problems with wound healing following surgery,
Slovenian: • če imate težave s celjenjem ran po operaciji,
English: • MVASI may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
Slovenian: • zdravilo MVASI lahko povzroči okužbe in zmanjša število vaših nevtrofilcev (vrsta krvnih celic, ki so pomembne za zaščito pred bakterijami).
English: In an exploratory analysis, the extent of bevacizumab benefit on overall survival was less pronounced in the subgroup of patients who did not have adenocarcinoma histology.
Slovenian: V eksplorativni analizi so ugotovili, da je bila korist bevacizumaba glede celokupnega preživetja manj izražena v podskupini bolnikov, ki ni imela adenokarcinoma.
English: If you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor.
Slovenian: Če imate stanje, ki povzroča trebušno vnetje (npr. divertikulitis, želodčno razjedo, s kemoterapijo povezan kolitis), se o tem pogovorite s svojim zdravnikom.
English: • feeling weak and having no energy,
Slovenian: • občutek šibkosti in pomanjkanja energije,
English: Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, see section 6.6.
Slovenian: Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 6.6.
English: There is evidence suggesting that all grade (US National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Slovenian: Obstajajo dokazi, da je proteinurija vseh stopenj (US National Cancer InstituteCommon Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) lahko povezana z odmerkom.
English: The incidence of these reactions in some clinical trials of bevacizumab is common (up to 5% in bevacizumab-treated patients).
Slovenian: Incidenca teh reakcij pri nekaterih kliničnih preskušanjih bevacizumaba je pogosta (do 5 % pri bolnikih, zdravljenih z bevacizumabom).
English: • decreased number of red cells in the blood,
Slovenian: • zmanjšano število rdečih krvnih celic,
English: 5-Fluorouracil
Slovenian: 5-fluorouracil i.v.
English: The dose of MVASI needed depends on your body weight and the kind of cancer to be treated.
Slovenian: Potrebni odmerek zdravila MVASI je odvisen od telesne mase in vrste raka, ki ga zdravimo.
English: What you need to know before you use MVASI
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo MVASI
English: Your doctor should advise you about using contraception during treatment with MVASI and for at least 6 months after the last dose of MVASI.
Slovenian: Vaš zdravnik vam bo svetoval uporabo primerne kontracepcije med zdravljenjem z zdravilom MVASI in še najmanj 6 mesecev po njegovem zadnjem odmerku.
English: Information on foetal malformations observed in the post-marketing setting are provided in sections 4.6 and 4.8.
Slovenian: Podatki o malformacijah ploda, ki so jih opazili v obdobju po prihodu zdravila na trg, so vključeni v poglavji 4.6 ter 4.8.
English: • infection, and in particular infection in the blood or bladder,
Slovenian: • okužbo, še posebej krvi ali mehurja,
English: These were most commonly NCI-CTCAE v.3 grade 1 epistaxis that lasted less than 5 minutes, resolved without medical intervention and did not require any changes in the bevacizumab treatment regimen.
Slovenian: Večinoma je šlo za epistakse stopnje 1 po lestvici NCI-CTCAE v.3, ki so trajale manj kot 5 minut, so prenehale brez zdravniške pomoči in niso zahtevale sprememb sheme zdravljenja z bevacizumabom.
English: • If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Slovenian: • če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
English: • high blood pressure.
Slovenian: • visok krvni tlak.
English: • MVASI increases the risk of having protein in your urine especially if you already have high blood pressure.
Slovenian: • zdravilo MVASI poveča tveganje za pojav beljakovin v seču, še posebej, če že imate visok krvni tlak.
English: Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all bevacizumab-treated patients.
Slovenian: Smrtni izidi so bili zabeleženi v približno tretjini resnih primerov perforacij prebavil; to pomeni od 0,2 do 1 % vseh bolnikov, zdravljenih z bevacizumabom.
English: • sores in the mouth and the tube from the mouth to the stomach, which may be painful and cause difficulty swallowing,
Slovenian: • vnetje v ustih in cevi med usti in želodcem, ki je lahko boleče in povzroča težave pri požiranju,
English: • changes in speech,
Slovenian: • motnje v govoru,
English: Intravitreal use
Slovenian: Intravitrealna uporaba
English: Final overall survival analysis performed when 46.7% of the patients had died with data cut-off date of 31 March 2013.
Slovenian: Končno celokupno analizo so opravili, ko je 46,7 % bolnic umrlo (s podatki zbranimi do 31. marca 2013).
English: Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells.
Slovenian: Bevacizumab se veže na vaskularni endotelijski rastni faktor (VEGF - vascular endothelial growth factor), ki je ključni dejavnik vaskulogeneze in angiogeneze, in s tem zavira vezavo VEGF na njegova receptorja Flt-1 (VEGFR-1) in KDR (VEGFR-2) na površini endotelijskih celic.
English: • if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with MVASI (bevacizumab), in particular when you are also receiving or have received an injection of bisphosphonate into your blood.
Slovenian: • pred invazivnimi posegi v zobozdravstvu in oralni kirurgiji povejte svojemu zobozdravniku, da se zdravite z zdravilom MVASI (bevacizumabom), še posebej, če prejemate ali ste prejemali injekcije difosfonata v kri.
English: It is recommended that the treatment with MVASI in addition to erlotinib is continued until disease progression.
Slovenian: Priporočamo, da se zdravljenje z zdravilom MVASI kot dodatek erlotinibu nadaljuje do napredovanja bolezni.
English: • MVASI may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Slovenian: • zdravilo MVASI lahko poveča tveganje za razvoj neobičajne povezave ali prehoda med dvema organoma ali žilami.
English: Leucovorin on day 1 and 2
Slovenian: 2 h levkovorin 1. in 2. dan
English: A high proportion of patients (approximately 62%) went on to receive a variety of non-protocol specified anti-cancer therapies, which may have impacted the analysis of overall survival.
Slovenian: Velik del bolnikov (približno 62 %) je prejemal različna zdravila za zdravljenje novotvorb, ki niso bila določena v protokolu študije, kar je lahko vplivalo na analizo celokupnega preživetja.
English: • lesions in the gums with an exposed jaw bone that does not heal and may be associated with pain and inflammation of the surrounding tissue (see the paragraphs below the list of side effects for further recommendations),
Slovenian: • lezije v dlesnih z izpostavljeno čeljustnico, ki se ne pozdravijo in so lahko povezane z bolečino in vnetjem okoliških tkiv (za nadaljnja priporočila glejte spodaj),
English: Stopping your treatment with MVASI may stop the effect on tumour growth.
Slovenian: Prenehanje zdravljenja z zdravilom MVASI lahko ustavi učinek na rast tumorja.
English: Patients with untreated CNS metastases were routinely excluded from clinical trials with bevacizumab, based on imaging procedures or signs and symptoms.
Slovenian: Bolniki z nezdravljenimi zasevki v osrednjem živčevju so bili rutinsko izključeni iz kliničnih preskušanj z bevacizumabom, glede na postopke slikanj ali znake in simptome.
English: You must not breast-feed your baby during treatment with MVASI and for at least 6 months after the last dose of MVASI, as this medicine may interfere with the growth and development of your baby.
Slovenian: Med zdravljenjem z zdravilom MVASI in še najmanj 6 mesecev po njegovem zadnjem odmerku otroka ne smete dojiti, ker lahko to zdravilo vpliva na rast in razvoj vašega otroka.
English: Objective response rate (%) in patients with measurable disease
Slovenian: Objektivni odgovor (%) pri bolnikih z merljivo boleznijo n Odgovor
English: After correcting for body weight, male patients had a higher bevacizumab clearance (+ 17%) than females.
Slovenian: Po prilagoditvi glede na telesno maso so imeli bolniki višji očistek bevacizumaba (+ 17 %) kot bolnice.
English: These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); decreased haemoglobin (found in red blood cells, which carry oxygen), which may be severe.
Slovenian: To vključuje zmanjšanje števila belih krvnih celic v krvi, še posebno nevtrofilcev (vrsta belih krvnih celic, ki pomaga varovati pred okužbami), prisotnost beljakovin v seču, zmanjšanje ravni kalija, natrija ali fosforja (mineral) v krvi, zvišan sladkor v krvi, zvečanje alkalne fosfataze (encim), zvečanje kreatinina v serumu (beljakovina, ki jo merijo v preiskavah krvi, da ocenijo, kako dobro delujejo vaše ledvice), zmanjšanje hemoglobina (nahaja se v rdečih krvnih celicah, ki prenašajo kisik), ki je lahko hudo.
English: The administration of MVASI should be temporarily discontinued
Slovenian: Dajanje zdravila MVASI je treba začasno opustiti
English: In one clinical trial, the incidence of hypertension of grade ≥ 3 was two fold higher in patients aged > 65 years than in the younger age group (< 65 years).
Slovenian: V enem kliničnem preskušanju je bila incidenca hipertenzije stopnje ≥ 3 dvakrat višja pri bolnikih, starih nad 65 let, v primerjavi s skupino, ki je vključevala mlajše bolnike (< 65 let).
English: In both studies, bevacizumab exposure trended lower as body weight decreased.
Slovenian: V obeh študijah se je izpostavljenost bevacizumabu z manjšanjem telesne mase zmanjševala.
English: • bleeding from the lower part of the large bowel,
Slovenian: • krvavitev iz spodnjega dela debelega črevesa,
English: Patients with central nervous system metastases, including previously-treated or resected brain lesions, were excluded.
Slovenian: Bolniki z metastazami v osrednjem živčevju, vključno s predhodno zdravljenimi ali odstranjenimi lezijami v možganih, niso bili vključeni.
English: For further information please refer to table 3 “Adverse reactions reported in post-marketing setting”.
Slovenian: Za nadaljnje informacije, prosimo, glejte preglednico 3 ”Neželeni učinki, o katerih so poročali po prihodu zdravila na trg”.
English: • a hole in the stomach or intestines,
Slovenian: • luknja v želodcu ali črevesju,
English: Efficacy results from study BO17707 (ICON7) Progression-free survival
Slovenian: Rezultati učinkovitosti iz študije BO17707 (ICON7) Preživetje brez napredovanja bolezni
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + bevacizumab) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression-free survival was 8.8 months.
Slovenian: Med 110 bolniki, randomiziranimi v skupino 3 (5-FU/FA + bevacizumab), je bila mediana celokupnega preživetja pred ukinitvijo te skupine 18,3 meseca, mediana preživetja brez napredovanja bolezni pa 8,8 meseca.