FrancophonIA/ELRC3.0 huggingface dataset:
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C and for 8 hours at 25°C.
Slovenian: Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi od 2 do 8 °C in 8 ur pri temperaturi do 25 °C.
English: These data are exploratory and the statistical interaction test was non-significant (lack of evidence for heterogeneity in treatment effect between the RAS wild-type and RAS mutant subgroups).
Slovenian: Ti podatki so eksplorativni in statistični test za interakcijo ni bil značilen (pomanjkanje dokazov o heterogenosti terapevtskega učinka med podskupino z divjim tipom RAS in podskupino z mutantnim RAS).
English: • inflammation inside the nose and upper part of the throat
Slovenian: • vnetje v nosu in zgornjem delu žrela
English: It is important that you read the entire content of this procedure prior to the preparation of infusion solution.
Slovenian: Pomembno je, da pred pripravo raztopine za infundiranje preberete celoten opis tega postopka.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ZALTRAP therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja z zdravilom ZALTRAP, upoštevaje korist dojenja za otroka in korist zdravljenja za žensko.
English: Linear clearance observed in the dose range of 2 to 9 mg/kg is likely due to non saturable biological mechanisms of elimination such as protein catabolism.
Slovenian: Linearni očistek, opažen v razponu odmerkov od 2 do 9 mg/kg, je verjetno posledica nesaturabilnih bioloških mehanizmov odstranjevanja, npr. katabolizma beljakovin.
English: There is no information on the safety of aflibercept given at doses exceeding 7 mg/kg every 2 weeks or 9 mg/kg every 3 weeks.
Slovenian: Informacij o varnosti aflibercepta, uporabljenega v odmerkih, večjih od 7 mg/kg vsaka 2 tedna ali 9 mg/kg vsake 3 tedne, ni.
English: These were comparable between groups, and the difference between groups did not exceed ≥ 2 % incidence for the ZALTRAP/FOLFIRI regimen.
Slovenian: Med skupinama so bili primerljivi in razlika med skupinama ni presegla ≥ 2 % incidence s shemo ZALTRAP/FOLFIRI.
English: Grades ≥3
Slovenian: Stopnje ≥ 3
English: Treatment will continue as long as your doctor thinks the treatment is of benefit to you, and the side effects are acceptable.
Slovenian: Vaše zdravljenje se bo nadaljevalo, dokler zdravnik meni, da vam zdravilo koristi in dokler so neželeni učinki sprejemljivi.
English: Excessive activation of these receptors by VEGF-A can result in pathological neovascularisation and excessive vascular permeability.
Slovenian: Prekomerna aktivacija teh receptorjev z VEGF-A lahko povzroči patološko neovaskularizacijo in prekomerno permeabilnost žil.
English: Women of childbearing potential and fertile males should use effective contraception during and up to a minimum of 6 months after the last dose of treatment.
Slovenian: Ženske v rodni dobi in plodni moški morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še najmanj 6 mesecev po zadnjem odmerku zdravila.
English: Tests may include blood and urine tests, x-ray or other scanning techniques and/or other tests.
Slovenian: Med takšnimi preiskavami so lahko preiskave krvi in urina, rentgensko slikanje ali druge tehnike slikanj in/ali druge preiskave.
English: The infusion should be temporarily suspended until the reaction resolves.
Slovenian: Infundiranje je treba začasno prekiniti, dokler reakcija ne mine.
English: Inform your doctor about your dental treatment and tell your dentist that you are being treated with ZALTRAP.
Slovenian: Obvestite svojega zdravnika o zdravljenju zob in povejte svojemu zobozdravniku, da se zdravite z zdravilom ZALTRAP.
English: • Hypertension that is not adequately controlled with anti-hypertensive therapy or occurrence of hypertensive crisis or hypertensive encephalopathy
Slovenian: • hipertenzije, ki ni ustrezno urejena z antihipertenzivnimi zdravili, pojava hipertenzivne krize ali hipertenzivne encefalopatije
English: There are no data from the use of aflibercept in pregnant women.
Slovenian: Podatkov o uporabi aflibercepta pri nosečnicah ni.
English: • PVC containing DEHP infusion bags or polyolefin infusion bags should be used.
Slovenian: • Uporabiti je treba infuzijske vrečke iz PVC, ki vsebuje DEHP, ali infuzijske vrečke iz poliolefina.
English: Aflibercept increased blood pressure in normotensive rodents.
Slovenian: Aflibercept je zvišal krvni tlak pri normotenzivnih glodalcih.
English: The European Medicines Agency has waived the obligation to conduct studies with ZALTRAP in all subsets of the paediatric population in adenocarcinoma of the colon and rectum (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za izvedbo študij z zdravilom ZALTRAP za vse skupine pediatrične populacije pri adenokarcinomu kolona in rektuma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Vascular endothelial growth factor A and B (VEGF-A, VEGF-B), and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as potent mitogenic, chemotactic, and vascular permeability factors for endothelial cells.
Slovenian: Žilna endotelijska rastna faktorja A in B (VEGF-A,-B VEGF) ter placentni rastni faktor (PlGF) spadajo v družino angiogenih faktorjev VEGF, ki lahko delujejo kot močni mitogeni, kemotaktični in žilni permeabilnostni faktorji za endotelijske celice.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden začnete dobivati zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: There is no relevant use of ZALTRAP in the paediatric population for the indication of metastatic colorectal cancer.
Slovenian: Zdravilo ZALTRAP v pediatrični populaciji nima relevantne uporabe pri indikaciji metastatskega kolorektalnega raka.
English: Your doctor may need to treat the allergic reaction or stop your treatment with ZALTRAP.
Slovenian: Zdravnik bo morda moral zdraviti alergijsko reakcijo ali prekiniti vaše zdravljenje z zdravilom ZALTRAP.
English: VEGF-A acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells.
Slovenian: VEGF-A deluje preko dveh receptorskih tirozin-kinaz, VEGFR-1 in VEGFR-2, ki sta prisotni na površini endotelijskih celic.
English: Distribution The volume of distribution of free aflibercept at steady-state is approximately 8 litres.
Slovenian: Porazdelitev Volumen porazdelitve prostega aflibercepta v stanju dinamičnega ravnovesja je približno 8 litrov.
English: Your doctor will temporarily stop the treatment before and after surgery.
Slovenian: Zdravnik bo pred operacijo in po njej začasno prekinil vaše zdravljenje.
English: • Based on the required dose for the patient, withdraw the necessary volume of ZALTRAP concentrate from the vial.
Slovenian: • Glede na odmerek, ki ga potrebuje bolnik, izvlecite iz viale potrebno količino koncentrata zdravila ZALTRAP.
English: Reproductive and developmental toxicology
Slovenian: Reprodukcijska in razvojna toksikologija
English: This may include swelling of the feet or whole body and may be related to kidney disease.
Slovenian: Povezano je lahko z oteklostjo stopal ali vsega telesa in je lahko v zvezi z boleznijo ledvic.
English: Your doctor may need to treat you with other medicines and/or fluids given intravenously.
Slovenian: Zdravnik vas bo morda moral zdraviti z drugimi zdravili in/ali intravenskim dajanjem tekočine.
English: However, results from a repeat dose toxicity study suggest there is a potential for aflibercept to impair reproductive function and fertility.
Slovenian: Toda rezultati študije toksičnosti ponavljajočih se odmerkov kažejo, da aflibercept lahko okvari reproduktivno funkcijo in plodnost.
English: PlGF is also linked to pathological neovascularisation and recruitment of inflammatory cells into tumours.
Slovenian: PlGF je povezan tudi s patološko neovaskularizacijo in novačenjem vnetnih celic v tumorjih.
English: • Posterior reversible encephalopathy syndrome (PRES) (also known as reversible posterior leukoencephalopathy syndrome (RPLS))
Slovenian: • sindroma posteriorne reverzibilne encefalopatije (PRES - posterior reversible encephalopathy syndrome), znanega tudi kot sindrom reverzibilne posteriorne levkoencefalopatije (RPLS
English: Baseline and periodic evaluations of left ventricular function should be considered while the patient is receiving Zaltrap.
Slovenian: Treba je razmisliti o izhodiščni in nato periodičnih ocenah funkcije levega prekata, medtem ko bolnik prejema zdravilo Zaltrap.
English: • you have ever had any allergies - serious allergic reactions can happen during treatment with ZALTRAP (see section 4).
Slovenian: • če ste kdaj imeli kakšne alergije - med zdravljenjem z zdravilom ZALTRAP se lahko pojavijo resne alergijske reakcije (glejte poglavje 4).
English: As with other large proteins, both free and bound aflibercept, are expected to be cleared, more slowly, by other biological mechanisms, such as proteolytic catabolism.
Slovenian: Tako kot za druge velike beljakovine je mogoče pričakovati, da se tako prosti kot vezani aflibercept odstranita počasneje tudi z drugimi biološkimi mehanizmi, npr. s proteolitičnim katabolizmom.
English: ZALTRAP has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo ZALTRAP nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Infection (1)
Slovenian: okužba (1)
English: Hypersensitivity to aflibercept or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na aflibercept ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Aflibercept is expected to degrade to small peptides and individual amino acids.
Slovenian: Pričakovati je, da se aflibercept razgradi v majhne peptide in posamezne aminokisline.
English: There was no margin of exposure to patients in relation to these effects.
Slovenian: Glede teh učinkov ni bilo nobene meje izpostavljenosti v razmerju do bolnikov.
English: Stratified log-rank test p-value
Slovenian: Vrednost p za stratificirani log-rang test
English: • The active substance is aflibercept.
Slovenian: • Zdravilna učinkovina je aflibercept.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi 5.
English: In the event of hypertension on aflibercept treatment, blood pressure should be controlled with appropriate anti-hypertensive therapy and blood pressure should be monitored regularly.
Slovenian: V primeru hipertenzije med zdravljenjem z afliberceptom je treba krvni tlak urediti z ustreznim antihipertenzivnim zdravljenjem in krvni tlak redno kontrolirati.
English: Gender was the most significant covariate for explaining the interindividual variability of free aflibercept clearance and volume with a 15.5 % higher clearance and a 20.6 % higher volume of distribution in males than in females.
Slovenian: Spol je bil najpomembnejša sospremenljivka za pojasnitev interindividualne variabilnosti očistka prostega aflibercepta in volumna porazdelitve: očistek je bil pri moških 15,5 % večji kot pri ženskah, volumen pa 20,6 % večji kot pri ženskah.
English: • difficulty when breathing
Slovenian: • težko dihanje
English: Caution should be exercised when handling ZALTRAP, taking into account the use of containment devices, personal protective equipment (e.g. gloves), and preparation procedures.
Slovenian: Pri ravnanju z zdravilom ZALTRAP je potrebna previdnost; uporabiti je treba naprave za prestrezanje, osebno zaščitno opremo (npr. rokavice) in upoštevati je treba postopke priprave.
English: Most findings were considered to be related to the pharmacological activity of aflibercept.
Slovenian: Večina izsledkov velja za povezano s farmakološko aktivnostjo aflibercepta.
English: • polyvinyl chloride (PVC) containing bis(2-ethylhexyl) phthalate (DEHP)
Slovenian: • polivinilklorida (PVC), ki vsebuje bis(2-etilheksil)ftalat (DEHP)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur pri temperaturi od 2 do 8 °C, razen če je bilo razredčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
English: Patients were treated until disease progression or unacceptable toxicity.
Slovenian: Bolniki so bili zdravljeni do napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
English: Talk to your doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Slovenian: Takoj se posvetujte z zdravnikom, če opazite katerega od naslednjih resnih neželenih učinkovmorda boste potrebovali nujno zdravniško pomoč:
English: This is because it is not known if the medicine passes into breast milk.
Slovenian: Ne ve se namreč, ali to zdravilo prehaja v mleko.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku ( 2 - 8 °C).
English: More than one vial could be needed for the preparation of the infusion solution.
Slovenian: Za pripravo raztopine za infundiranje je lahko potrebna več kot ena viala.
English: Aflibercept, also known as VEGF TRAP in the scientific literature, is a recombinant fusion protein consisting of VEGF-binding portions from the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of the human IgG1.
Slovenian: Aflibercept, v znanstveni literaturi znan tudi kot VEGF TRAP, je rekombinantna fuzijska beljakovina, sestavljena iz VEGF-vežočih delov zunajceličnih območij humanih receptorjev VEGF 1 in 2, vezanih na Fc-del človeškega IgG1.
English: For these reasons, comparison of the incidence of antibodies to ZALTRAP with the incidence of antibodies to other products may be misleading.
Slovenian: Primerjava incidence protiteles proti zdravilu ZALTRAP z incidenco protiteles proti drugim zdravilom je zato lahko zavajajoča.
English: At doses greater than 2 mg/kg, free aflibercept clearance was approximately 1.0L/day with a terminal half-life of 6 days.
Slovenian: Ob odmerkih, večjih od 2 mg/kg, je bil očistek prostega aflibercepta približno 1,0 l/dan in s terminalnim razpolovnim časom 6 dni.
English: Free aflibercept is primarily cleared by binding to endogenous VEGF to form a stable, inactive complex.
Slovenian: Prosti aflibercept se v prvi vrsti odstrani z vezavo na endogeni VEGF, s čimer nastane stabilen, neaktiven kompleks.
English: • blood clot in very small blood vessels (also called ‘thrombotic microangiopathy').
Slovenian: • krvni strdki v zelo majhnih žilah (to imenujemo tudi "trombotična mikroangiopatija").
English: ZALTRAP will be given to you by a doctor or a nurse that is experienced in the use of ‘chemotherapy'.
Slovenian: Zdravilo ZALTRAP vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje s »kemopterapijo«.
English: Information about storage and the time to use ZALTRAP, after it has been diluted and is ready to use, is described in the ‘Practical information for healthcare professionals on preparation and handling of ZALTRAP 25 mg / ml concentrate for solution for infusion' at the end of this leaflet.
Slovenian: Informacije o shranjevanju in času uporabe zdravila ZALTRAP po njegovem redčenju in ko je pripravljeno za uporabo najdete pod naslovom "Praktične informacije za zdravstveno osebje o pripravi in ravnanju z zdravilom ZALTRAP 25 mg/ml koncentrat za raztopino za infundiranje" na koncu tega navodila.
English: Other medicines and ZALTRAP
Slovenian: Druga zdravila in zdravilo ZALTRAP
English: Patients with Grade 3 DVT should be treated with anticoagulation as clinically indicated, and aflibercept therapy should be continued.
Slovenian: Bolnike z GVT 3. stopnje je treba zdraviti z antikoagulansi, kot je klinično indicirano, zdravljenje z afliberceptom pa je treba nadaljevati.
English: No specific studies with aflibercept have been conducted in animals to evaluate the effect on fertility.
Slovenian: Pri živalih niso izvedli specifičnih študij z afliberceptom za oceno vpliva na plodnost.
English: Careful monitoring is recommended in order to rapidly detect and treat signs and symptoms of diarrhoea and dehydration and to minimize potential risk (see section 4.8).
Slovenian: Priporočljivo je skrbno nadziranje, da bi hitro odkrili in zdravili znake in simptome driske in dehidracije in da bi tako čim bolj zmanjšali možno tveganje (glejte poglavje 4.8).
English: Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15 % of the total molecular mass, resulting in a total molecular weight of 115 kDa.
Slovenian: Aflibercept je dimeren glikoprotein z beljakovinsko molekulsko maso 97 kilodaltonov (kDa) in vsebuje glikozilate, ki pomenijo dodatnih 15 % celotne molekulske mase, tako da je skupna molekulska masa 115 kDa.
English: 19.8 (16.4 to 23.2)
Slovenian: 19,8 (16,4 do 23,2)
English: No dose adjustment is required for aflibercept (see sections 4.2, 4.8 and 5.2).
Slovenian: Odmerka aflibercepta ni treba prilagoditi (glejte poglavja 4.2. 4.8 in 5.2).
English: ZALTRAP should be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Slovenian: Zdravilo ZALTRAP je treba dajati pod nadzorom zdravnika, ki ima izkušnje z uporabo antineoplastičnih zdravil.
English: VTE include deep venous thrombosis and pulmonary embolism.
Slovenian: VTE vključujejo globoko vensko trombozo in pljučno embolijo.
English: In the few patients with severe renal impairment, drug exposure was similar to that observed in patients with normal renal function.
Slovenian: Pri maloštevilnih bolnikih s hudo okvaro ledvic je bila izpostavljenost zdravilu podobna kot pri bolnikih z normalnim delovanjem ledvic.
English: Treatment with anti-diarrhoeal medicinal products and rehydration can be used as needed.
Slovenian: Uporabiti je mogoče antidiaroike in rehidracijo, kot je potrebno.
English: Administration of aflibercept to mice bearing xenotransplant or allotransplant tumours inhibited the growth of various cancer types.
Slovenian: Uporaba aflibercepta pri miših, ki so imele ksenotransplantate ali alotransplantate tumorjev, je zavrla rast različnih vrst raka.
English: Observed effects included decreases in maternal body weights, an increased number of foetal resorptions, and an increased incidence of external, visceral, and skeletal foetal malformations.
Slovenian: Med opaženimi učinki so bili zmanjšanje materine telesne mase, večje število resorpcij ploda ter večja incidenca zunanjih, visceralnih in skeletnih malformacij pri plodu.
English: Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medicinal products, and underlying disease.
Slovenian: Poleg tega lahko na opaženo incidenco pozitivnih protiteles v preskusu vpliva več dejavnikov, med drugim ravnanje z vzorcem, čas odvzema vzorca, sočasno uporabljana zdravila in osnovna bolezen.
English: It is unknown whether aflibercept is excreted in human milk.
Slovenian: Ni znano, ali se aflibercept pri človeku izloča v materino mleko.
English: Patients with a dipstick of ≥ 2+ for protein or a UPCR > 1 or a protein/creatinine ratio (PCR)> 100 mg/mmol should undergo a 24-hour urine collection.
Slovenian: Bolniki z vrednostjo proteinov na urinskem testnem traku ≥2+ ali UPCR >1 ali razmerjem protein/kreatinin (PCR) >100 mg/mmol morajo opraviti 24-urno zbiranje urina.
English: You should take your temperature often during treatment with this medicine.
Slovenian: Med zdravljenjem s tem zdravilom si morate pogosto izmeriti telesno temperaturo.
English: Race No effect of race was identified in the population analysis.
Slovenian: Rasa Populacijska analiza ni pokazala vpliva rase.
English: If your white blood cells are low, your doctor may need to delay your treatment.
Slovenian: Če imate majhno število belih krvnih celic, bo zdravnik morda moral odložiti vaše zdravljenje.
English: 3.9 (3.02 to 4.30)
Slovenian: 3,9 (3,02 do 4,30)
English: Irinotecan dose should be reduced by 15-20 %.
Slovenian: Odmerek irinotekana je treba zmanjšati za 15 do 20 %.
English: • drop in the number of white blood cells (leucopenia)
Slovenian: • zmanjšanje števila belih krvnih celic (levkopenija)
English: Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with ZALTRAP.
Slovenian: Tako kot pri vseh terapevtskih beljakovinah tudi pri zdravilu ZALTRAP obstaja možnost imunogenosti.
English: Increased AST (2) Increased ALT (2)
Slovenian: Pogosti zvišanje AST (2) zvišanje ALT (2)
English: Exploratory biomarker analyses were undertaken in the VELOUR trial including analyses of RAS mutational status in 482 of 1,226 patients (n = 240 aflibercept; 242 placebo).
Slovenian: V preskušanju VELOUR so izvedli eksplorativne analize bioloških označevalcev, vključno z analizami mutacijskega stanja RAS, pri 482 od 1226 bolnikov (n = 240 aflibercept, 242 placebo).
English: • you experience signs of a blood clot (see section 4).
Slovenian: • če se vam pojavijo znaki krvnega strdka (glejte poglavje 4).
English: It is recommended to monitor blood pressure every two weeks, including before each administration or as clinically indicated during treatment with aflibercept.
Slovenian: Krvni tlak je priporočljivo kontrolirati na dva tedna, vključno pred vsako uporabo zdravila, ali kot je klinično indicirano med zdravljenjem z afliberceptom.
English: If hypertension cannot be adequately controlled, treatment with aflibercept should not be initiated.
Slovenian: Če hipertenzije ni mogoče ustrezno urediti, se zdravljenja z afliberceptom ne sme začeti.
English: Most aflibercept-related findings were noted from the lowest dose tested corresponding to plasma exposures close to those in patients at the therapeutic dose.
Slovenian: Večino z afliberceptom povezanih izsledkov so ugotovili pri najmanjšem testiranem odmerku, ki ustreza plazemski izpostavljenosti, blizu tisti pri bolnikih med uporabo terapevtskega odmerka.
English: The pharmacokinetic properties described below have to a large extent been derived from a population pharmacokinetic analysis with data from 1,507 patients with various types of advanced malignancies.
Slovenian: Spodaj opisane farmakokinetične lastnosti v veliki meri izvirajo iz populacijske farmakokinetične analize podatkov 1507 bolnikov z različnimi vrstami napredovalih malignomov.
English: Aflibercept should be permanently discontinued if hypertension cannot be adequately managed with appropriate anti-hypertensive therapy or aflibercept dose reduction, or if hypertensive crisis or hypertensive encephalopathy occurs (see section 4.2).
Slovenian: Zdravljenje z afliberceptom je treba za stalno končati, če hipertenzije ni mogoče ustrezno obvladati z ustreznim antihipertenzivnim zdravljenjem ali zmanjšanjem odmerka aflibercepta, ali če se pojavita hipertenzivna kriza ali hipertenzivna encefalopatija (glejte poglavje 4.2).
English: Do not re-enter the vial after the initial puncture.
Slovenian: Po prvem prebadanju v vialo ne posegajte več.
English: Aflibercept should be suspended for at least 4 weeks prior to elective surgery.
Slovenian: Uporabo zdravila aflibercept je treba prekiniti vsaj 4 tedne pred elektivno operacijo.