FrancophonIA/ELRC3.0 huggingface dataset:
English: • a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe (radiation recall dermatitis)
Slovenian: • sončnim opeklinam podoben izpuščaj, ki se lahko pojavi na koži, ki je bila v preteklosti izpostavljena radioterapiji in je lahko hud (dermatitis po obsevanju)
English: - if you are taking phenytoin or any other medicines used to treat epilepsy.
Slovenian: - Če jemljete fenitoin ali katero koli drugo zdravilo za zdravljenje epilepsije.
English: Neither the cumulative risk, nor the predisposing factors related to the development of secondary leukaemia are known.
Slovenian: Niti celotno tveganje niti predispozicijski dejavniki, ki vplivajo na pojav sekundarne levkemije, niso znani.
English: Another characteristic that has been associated with secondary leukaemia in patients who have received epipodophyllotoxins appears to be a short latency period, with average median time to development of leukaemia being approximately 32 months.
Slovenian: Še ena značilnost, povezana s sekundarno levkemijo pri bolnikih, ki so se zdravili z epipodofilotoksini, je kratka latentna doba s povprečnim časom do razvoja levkemije približno 32 mesecev.
English: In vitro plasma protein binding is 97%.
Slovenian: In vitro vezava etopozida na plazemske beljakovine je 97 %.
English: • infection
Slovenian: • okužba
English: Daily doses greater than 200 mg should be divided and given twice per day.
Slovenian: Dnevne odmerke, večje od 200 mg, je treba razdeliti in vzeti v dveh ločenih odmerkih.
English: If etoposide should contact the skin, mucosa or eyes, immediately wash the skin with soap and water and flush the mucosa or eyes with water.
Slovenian: Če pride etopozid v stik s kožo, sluznico ali očmi, je treba kožo takoj umiti z milom in vodo, sluznico ali oči pa izprati z vodo.
English: The nausea and vomiting can usually be controlled by antiemetic therapy.
Slovenian: Navzea in bruhanje se običajno lahko nadzira z antiemetiki.
English: The safety and effectiveness in paediatric patients has not been established.
Slovenian: Varnost in učinkovitost zdravila pri pediatričnih bolnikih nista bili dokazani.
English: Increased within-patient variability in exposure may lead to greater variability in the dose-response relationship, i.e., leading to greater variability in patients' sensitivity to experience treatment-related toxicity from cycle to cycle, and potentially affecting overall efficacy of treatment in some patients.
Slovenian: Povečane razlike v izpostavljenosti pri bolnikih lahko povzročijo večje razlike v povezavi med odmerkom in odzivom, tj. povzročijo večje razlike v občutljivosti bolnikov na pojav z zdravljenjem povezane toksičnosti s cikla v cikel in morda pri nekaterih bolnikih vplivajo na celokupno učinkovitost zdravljenja.
English: Pharmacotherapeutic group: Cytostatics, plant alkaloids and other natural products, podophyllotoxin derivatives, ATC code: L01CB01
Slovenian: Farmakoterapevtska skupina: Citostatiki, rastlinski alkaloidi in druge naravne učinkovine, derivati podofilotoksina, oznaka ATC: L01CB01
English: VEPESID capsules are opaque pink, soft gelatin capsules.
Slovenian: Kapsule VEPESID so neprozorne rožnate mehke želatinaste kapsule.
English: rare dysgeusia, dysphagia
Slovenian: redki disgevzija, disfagija
English: Safety and effectiveness of VEPESID and associated names in paediatric patients has not been systematically studied.
Slovenian: Varnost in učinkovitost zdravila VEPESID in povezana imena pri pediatričnih bolnikih nista bili sistematično preučevani.
English: Given its mechanism of action, etoposide should be considered a possible carcinogen in humans.
Slovenian: Glede na mehanizem delovanja lahko sklepamo, da je etopozid potencialno karcinogen za človeka.
English: Similar toxicities can be expected with oral formulation.
Slovenian: Podobne toksičnosti je mogoče pričakovati ob uporabi peroralne oblike zdravila.
English: Etoposide has been shown to be teratogenic in mice and rats (see section 5.3).
Slovenian: Dokazano je, da je etopozid teratogeno pri miših in podganah (glejte poglavje 5.3).
English: In addition, men are advised to seek counselling on sperm preservation before starting treatment.
Slovenian: Priporoča se, da se moški bolniki pred začetkom zdravljenja posvetujejo o shranitvi sperme.
English: - If you are allergic to etoposide or any of the other ingredients of this medicine (listed in section
Slovenian: - Če ste alergični na etopozid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Patients who experience such adverse reactions should be advised to avoid driving or using machines.
Slovenian: Bolniki, pri katerih se pojavijo tovrstni neželeni učinki, ne smejo voziti in upravljati s stroji.
English: If this happens it can cause problems with the liver, kidney, heart or blood, which may result in death if not treated.
Slovenian: To lahko povzroči težave z jetri, ledvicami, srcem ali krvjo, ki imajo lahko smrtne posledice, če jih ne zdravimo.
English: The coefficient of variation is around 30% after oral administration versus 10% after intravenous administration (between-patient variability is similar after intravenous or oral administration, i.e. 30 to 40%).
Slovenian: Koeficient variacije je približno 30 % po peroralnem dajanju v primerjavi z 10 % po intravenskem dajanju (razlike med bolniki so podobne po intravenskem ali peroralnem dajanju, tj. 30 do 40 %).
English: Although minor differences in pharmacokinetic parameters between patients ≤65 years and >65 years of age have been observed, these are not considered clinically significant.
Slovenian: Čeprav so opazili manjše razlike v farmakokinetičnih parametrih med bolniki, starimi 65 let in manj, ter bolniki, starejšimi od 65 let, se ne smatrajo za klinično pomembne.
English: Bacterial infections should be brought under control before treatment with VEPESID and associated names.
Slovenian: Bakterijske okužbe morajo biti pod nadzorom pred pričetkom zdravljenja z zdravilom VEPESID in povezana imena.
English: This course of treatment may then be repeated, depending on the results of blood tests, but this will not be for at least 21 days after the first course of treatment.
Slovenian: Cikel zdravljenja se nato lahko ponovi glede na rezultate krvnih preiskav, vendar ne prej kot 21 dni po zaključku prvega cikla zdravljenja.
English: The available efficacy data for etoposide in the different indications are generally based on studies in which etoposide was used intravenously.
Slovenian: Razpoložljivi podatki o učinkovitosti etopozida za različne indikacije v glavnem temeljijo na študijah, v katerih so etopozid uporabljali intravensko.
English: The exact reason why you have been prescribed VEPESID and associated names capsules is best discussed with your doctor.
Slovenian: O natančnem razlogu, zakaj so vam predpisali kapsule VEPESID in povezana imena, se pogovorite s svojim zdravnikom.
English: At decreased creatinine clearance of 15 to 50 mL/min a dose reduction by 25% is recommended.
Slovenian: Če je očistek kreatinina 15 do 50 ml/min, je priporočljivo zmanjšanje odmerka za 25 %.
English: In vitro, etoposide is highly protein bound (97%) to human plasma proteins.
Slovenian: In vitro se etopozid močno (97 %) veže na humane plazemske beljakovine.
English: - if you are taking any drugs with a similar mechanism of action as VEPESID.
Slovenian: - Če jemljete katera koli zdravila s podobnim načinom delovanja, kot ga ima zdravilo VEPESID.
English: This course of treatment may then be repeated, depending on the results of blood tests, but this will not be for at least 7 days after the first course of treatment.
Slovenian: Cikel zdravljenja se nato lahko ponovi glede na rezultate krvnih preiskav, vendar ne prej kot 7 dni po zaključku prvega cikla zdravljenja.
English: Measured Creatinine Clearance
Slovenian: Izmerjeni očistek kreatinina
English: Both male and female patients who are considering having a child after having treatment with VEPESID and associated names should discuss this with their doctor or nurse.
Slovenian: Bolniki in bolnice, ki razmišljajo o spočetju otroka po zdravljenju z zdravilom VEPESID in povezana imena, naj se o tem posvetujejo z zdravnikom ali medicinsko sestro.
English: Alternative dosage schedule
Slovenian: Alternativni režim odmerjanja
English: In patients with moderate (CrCl =15 to 50 mL/min), or severe (CrCl <15ml/min) renal impairment undergoing haemodialysis, etoposide should be administered at a reduced dose (see section 4.2).
Slovenian: Pri bolnikih z zmerno (CrCl = 15 do 50 ml/min) ali hudo (CrCl < 15 ml/min) okvaro ledvic, ki prejemajo hemodializo, je treba etopozid dajati v zmanjšanem odmerku (glejte poglavje 4.2).
English: In clinical studies in which VEPESID and associated names was administered as a single agent either orally or by injection the most frequent adverse reactions of any severity were leucopenia (60 to 91%), thrombocytopenia (22 to 41%), nausea and/or vomiting (31 to 43%), and alopecia (8 to 66%).
Slovenian: V kliničnih študijah, kjer so bolnikom dajali zdravilo VEPESID in povezana imena v monoterapiji bodisi peroralno ali z injiciranjem, so bili najpogostejši neželeni učinki katere koli resnosti levkopenija (60 do 91 %), trombocitopenija (22 do 41 %), navzea in/ali bruhanje (31 do 43 %) in alopecija (8 do 66 %).
English: • irregular heart beat (arrhythmia), or a heart attack (myocardial infarction)
Slovenian: • nepravilen srčni ritem (aritmija) ali srčna kap (miokardni infarkt)
English: In case of curative intent the intravenous formulation should be used (see section 5.2).
Slovenian: Če je cilj zdravljenja ozdravitev, je treba uporabiti intravensko obliko (glejte poglavje 5.2).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY}
Slovenian: Datum prve odobritve: <{DD. mesec LLLL}> Datum zadnjega podaljšanja: <{DD. mesec LLLL}>
English: VEPESID and associated names must not be used during pregnancy unless clearly indicated by your doctor.
Slovenian: Zdravila VEPESID in povezana imena se med nosečnostjo ne sme uporabljati, razen če vam tako izrecno naroči vaš zdravnik.
English: A decision must be made whether to discontinue breastfeeding or to discontinue VEPESID and associated names, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman (see section 4.3).
Slovenian: Odločiti se je treba med prenehanjem dojenja in prekinitvijo zdravljenja z zdravilom VEPESID in povezana imena, pri čemer je treba upoštevati korist dojenja za otroka in pomembnost zdravljenja za mater (glejte poglavje 4.3).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično.
English: In patients with creatinine clearance less than 15 mL/min and on dialysis further dose reduction is likely to be required as etoposide clearance is further reduced in these patients.
Slovenian: Pri bolnikih z očistkom kreatinina, manjšim od 15 ml/min, ki prejemajo dializo, bo morda potrebno nadaljnje zmanjšanje odmerka, saj je pri teh bolnikih očistek etopozida dodatno zmanjšan.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake Uporabno do/EXP.
English: * Myelosuppression with fatal outcome has been reported **Seizure is occasionally associated with allergic reactions.
Slovenian: **Konvulzije so občasno povezane z alergijskimi reakcijami.
English: In addition, O-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme pathway to produce the corresponding catechol.
Slovenian: Poleg tega z O-dimetilacijo dimetoksifenolnega obroča prek CYP450 3A4 izoencima nastane ustrezen katehol.
English: Metabolic Complications
Slovenian: Metabolični zapleti
English: Handle with caution.
Slovenian: Z zdravilom ravnajte previdno.
English: Both male patients and female patients of child-bearing age should use an effective contraceptive method (e.g., the barrier method or condoms) during treatment and for at least 6 months after the end of treatment with VEPESID and associated names.
Slovenian: Tako moški kot ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijsko metodo (npr. pregradno metodo ali kondome) med zdravljenjem in še vsaj 6 mesecev po zaključku zdravljenja z zdravilom VEPESID in povezana imena.
English: Total doses of 2.4 g/m2 to 3.5 g/m2 administered intravenously over three days have resulted in severe mucositis and myelotoxicity.
Slovenian: Celokupni odmerki od 2,4 g/m2 do 3,5 g/m2 dani intravensko v treh dneh so povzročili hud mukozitis in mielotoksičnost.
English: • convulsions (seizure)
Slovenian: • konvulzije (krči)
English: No correlation exists between the absolute oral bioavailability of etoposide capsules and non-renal clearance.
Slovenian: Ni povezave med absolutno peroralno biološko uporabnostjo kapsul z etopozidom in ne-ledvičnim očistkom.
English: The main effect of etoposide appears to be at the late S and early G2 portion of the cell cycle in mammalian cells.
Slovenian: Glavni učinek etopozida je njegovo delovanje na pozno S in zgodnjo G2 fazo delitve celice pri celicah sesalcev.
English: This medicine can cause a reduction in the level of some blood cells, which could cause you to suffer from infections, or may mean that your blood doesn't clot as well as it should if you cut yourself.
Slovenian: To zdravilo lahko povzroči znižanje ravni nekaterih krvnih celic, zaradi česar ste lahko bolj dovzetni za okužbe, lahko pa pomeni tudi, da se vaša kri ob urezu ne bo dobro strjevala.
English: In animal studies etoposide was associated with dose-related embryotoxicity and teratogenicity.
Slovenian: V študijah na živalih so etopozid povezovali z od odmerka odvisnima embriotoksičnostjo in teratogenostjo.
English: • high blood pressure • sore lips, mouth or throat ulcers
Slovenian: • visok krvni tlak • boleče ustnice, razjede v ustih ali grlu
English: - if you are taking a medicine called ciclosporin (a drug used to reduce the activity of the immune system).
Slovenian: - Če jemljete zdravilo, ki vsebuje ciklosporin (zdravilo, ki zavira delovanje imunskega sistema).
English: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
English: • breathing problems
Slovenian: • težave z dihanjem
English: If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgment of the physician.
Slovenian: Če se pojavijo resni neželeni učinki, je potrebno zmanjšati odmerek ali prekiniti zdravljenje in po zdravnikovi presoji uvesti korektivne ukrepe.
English: Co-administration of antiepileptic drugs and VEPESID and associated names can lead to decreased seizure control due to pharmacokinetic interactions between the drugs.
Slovenian: Sočasno dajanje antiepileptikov in zdravila VEPESID in povezana imena lahko vodi v zmanjšan nadzor nad konvulzijami zaradi farmakokinetičnih medsebojnih delovanj med zdravili.
English: Effect of etoposide on the pharmacokinetics of other drugs
Slovenian: Učinek etopozida na farmakokinetiko drugih zdravil
English: Etoposide belongs to the group of medicines called cytostatics which are used in the treatment of cancer.
Slovenian: Etopozid spada v skupino zdravil, imenovanih citostatiki, ki jih uporabljamo za zdravljenje raka.
English: As with all medicines used to treat cancer, care must be taken when handling VEPESID and associated names capsules.
Slovenian: Kot pri vseh zdravilih za zdravljenje raka, je pri rokovanju s kapsulami zdravila VEPESID in povezana imena potrebna previdnost.
English: Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiotherapy or chemotherapy (see section 4.4), which may have compromised bone marrow reserve.
Slovenian: Odmerjanje zdravila je treba prilagoditi glede na možne mielosupresivne učinke drugih zdravil, ki se uporabljajo v kombiniranem zdravljenju, ali glede na učinke predhodne radioterapije ali kemoterapije (glejte poglavje 4.4), ki so morda zmanjšali zalogo kostnega mozga.
English: If radiotherapy or chemotherapy has been given prior to starting etoposide treatment, an adequate interval should be allowed to enable the bone marrow to recover.
Slovenian: Če je bolnik pred pričetkom zdravljenja z etopozidom prejemal radioterapijo ali kemoterapijo, je potreben ustrezen časovni zamik terapije, ki omogoči okrevanje kostnega mozga.
English: However, if you feel tired, sick to your stomach, dizzy or light-headed you should not do so until you have discussed it with your doctor.
Slovenian: Če ste zaradi jemanja zdravila utrujeni, vam je slabo, ste omotični ali vrtoglavi, ne smete voziti in upravljati s stroji, dokler se o tem ne posvetujete z zdravnikom.
English: If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be informed of the potential hazard to the fetus.
Slovenian: Če se zdravilo uporablja med nosečnostjo ali če bolnica zanosi med zdravljenjem, jo je treba opozoriti na možne škodljive učinke za plod.
English: Granulocyte and platelet nadirs tend to occur about 10 to 14 days after administration of etoposide depending on the way of administration and treatment scheme.
Slovenian: Najnižje vrednosti granulocitov in trombocitov se navadno pojavijo približno 10 - 14 dni po prejetju etopozida in so odvisne od načina dajanja in sheme zdravljenja.
English: Blood tests will be taken at the start of your treatment, and before each dose you take, to make sure that this isn't happening.
Slovenian: Ob začetku vašega zdravljenja in pred vsakim odmerkom, ki ga boste vzeli, bodo opravili krvne preiskave, da se bodo prepričali, da ne prihaja do teh neželenih učinkov.
English: For oral use.
Slovenian: Za peroralno uporabo
English: You should avoid touching the capsules by wearing gloves and wash your hands with soap and water after handling the medicine.
Slovenian: Dotikanju kapsul se morate izogniti, tako da uporabljate rokavice in si po rokovanju z zdravilom umijete roke z milom in vodo.
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Študij o vplivu na sposobnost vožnje in upravljanja s stroji z zdravilom Vepesid niso izvedli.
English: No dosage adjustment is necessary in elderly patients (age > 65 years old), other than based on renal function (see section 5.2).
Slovenian: Pri starejših bolnikih (starost > 65 let) prilagajanje odmerka ni potrebno, razen zmanjšanja na osnovi delovanja ledvic (glejte poglavje 5.2).
English: What VEPESID and associated names is and what it is used for What you need to know before you take VEPESID and associated names How to take VEPESID and associated names Possible side effects
Slovenian: Kaj je zdravilo VEPESID in povezana imena in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo VEPESID in povezana imena Kako jemati zdravilo VEPESID in povezana imena Možni neželeni učinki
English: The effect of renal disease on plasma etoposide clearance is not known in children.
Slovenian: Učinek ledvičnih obolenj na očistek etopozida pri otrocih ni znan.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
English: VEPESID and associated names should not be used during pregnancy unless the clinical condition of the woman requires treatment with etoposide.
Slovenian: Zdravila VEPESID in povezana imena se med nosečnostjo ne sme uporabljati, razen kadar klinično stanje nosečnice zahteva zdravljenje z etopozidom.
English: The oral bioavailability is variable but averages 76% at the 100 mg oral dose and 48% at the 400 mg oral dose.
Slovenian: Peroralna biološka uporabnost variira, vendar je povprečna 76 % za 100 mg peroralni odmerek in 48 % za 400 mg peroralni odmerek.
English: Prior or concurrent use of other drugs with similar myelosuppressant action as etoposide may be expected to have additive or synergetic effects (see section 4.4).
Slovenian: Pri predhodni ali sočasni uporabi drugih zdravil s podobnim mielosupresivnim delovanjem kot etopozid, lahko pričakujemo aditiven ali sinergističen učinek (glejte poglavje 4.4).
English: If you forget to take VEPESID and associated names If you miss or forget to take a dose of this medicine, DO NOT WORRY - just take the next dose when it is due.
Slovenian: Če ste pozabili vzeti odmerek tega zdravila, NE SKRBITE - vzemite naslednji odmerek, ko je čas zanj.
English: Etoposide binding ratio correlates directly with serum albumin in cancer patients and normal volunteers (see section 4.4).
Slovenian: Obseg vezave etopozida je direktno povezan z nivojem serumskih albuminov pri rakavih bolnikih in zdravih prostovoljcih (glejte poglavje 4.4).
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}> [To be completed nationally]
Slovenian: <{MM/LLLL}> <{DD/MM/LLLL}> <{DD. mesec LLLL}>
English: There is no evidence of a hepatic first-pass effect for etoposide.
Slovenian: Ni dokazov, da bi pri etopozidu prišlo do učinka prvega prehoda.
English: If you take more VEPESID and associated names than you should If you take too many capsules go to your nearest hospital emergency department or tell your doctor immediately.
Slovenian: Če ste vzeli preveč kapsul naenkrat, takoj obiščite oddelek za nujno pomoč v najbližji bolnišnici ali obvestite svojega zdravnika.
English: Over the same dose range, the areas under the plasma concentration vs. time curves (AUC) and the maximum plasma concentration (Cmax) values increase linearly with dose.
Slovenian: Pri enakem odmernem intervalu pa površina pod koncentracijsko krivuljo (AUC) in maksimalna plazemska koncentracija (Cmax) linearno naraščata v odvisnosti od odmerka.
English: In a study of the effects of other therapeutic agents on in vitro binding of 14C etoposide to human serum proteins, only phenylbutazone, sodium salicylate, and aspirin displaced protein-bound etoposide at concentrations generally achieved in vivo (see section 4.5).
Slovenian: V preskušanju učinkov drugih učinkovin na in vitro vezavo 14C-etopozida na humane serumske beljakovine, so le fenilbutazon, natrijev salicilat in acetilsalicilna kislina v koncentracijah, ki se navadno dosežejo in vivo, izpodrinili etopozid s humanih serumskih beljakovin (glejte poglavje 4.5).
English: For this reason, it is critical that the advantages of the oral administration route are carefully weighed against the disadvantages of larger within-patient variability in exposure after oral administration.
Slovenian: Zato je ključnega pomena, da zdravnik pretehta prednosti peroralnega dajanja in slabosti večjih razlik v izpostavljenosti pri bolnikih, do katerih prihaja po peroralnem dajanju.
English: - if you are taking phenylbutazone, sodium salicylate, or aspirin.
Slovenian: - Če jemljete fenilbutazon, natrijev salicilat ali acetilsalicilno kislino.
English: Within-patient variability in exposure (i.e. between cycles) is larger with oral administration than after intravenous administration (see section 4.4 and 5.2).
Slovenian: Razlike v izpostavljenosti med bolniki (tj. med cikli) so pri peroralnem dajanju večje kot pri intravenskem dajanju (glejte poglavji 4.4 in 5.2).
English: testicular cancer small cell lung cancer cancer of the blood (acute myeloid leukaemia) tumour in the lymphatic system (Hodgkin's lymphoma, non-Hodgkin's lymphoma) ovarian cancer
Slovenian: - krvni rak (akutna mieloična levkemija) - tumor v limfnem sistemu (Hodgkinov limfom, ne-Hodgkinov limfom)
English: Chronic toxicity
Slovenian: Kronična toksičnost
English: Etoposide and its metabolites are not dialyzable.
Slovenian: Etopozid in njegovi presnovki se ne dializirajo.
English: Total body clearance and the terminal elimination half-life are independent of dose over a range 100 to 600 mg/m2.
Slovenian: Celotni telesni očistek etopozida in končni razpolovni čas izločanja sta neodvisna od odmerka v razponu od 100 do 600 mg/m2.