FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe liver, kidney or heart damage from a condition called tumour lysis syndrome, caused by harmful amounts of substances from the cancer cells getting into the blood stream, has been seen sometimes when VEPESID is taken along with other drugs used to treat cancer.
Danish: Alvorlig lever-, nyre eller hjertebeskadigelse forbundet med en tilstand kaldet tumorlysesyndrom forårsaget af skadelige mængder af stoffer fra kræftceller, som kommer ud i blodomløbet, er undertiden blevet set, når VEPESID tages sammen med andre lægemidler, som anvendes inden for kræftbehandling.
English: - if you have liver or kidney problems.
Danish: - hvis du har lever- eller nyreproblemer.
English: In clinical studies involving etoposide, episodes of hypertension have been reported.
Danish: I kliniske studier med etoposid er der indberettet episoder med hypertension.
English: • tumour lysis syndrome (complications of substances released from treated cancer cells entering the blood)
Danish: • tumorlysesyndrom (komplikationer forbundet med stoffer frigivet fra behandlede kræftceller, der kommer ud i blodomløbet)
English: Nausea and vomiting are the major gastrointestinal toxicities of etoposide.
Danish: Kvalme og opkastning er de vigtigste gastrointestinale toksiciteter relateret til etoposid.
English: Bacterial infections should be brought under control before treatment with VEPESID and associated names.
Danish: Bakterieinfektioner skal bringes under kontrol inden behandling med VEPESID og associerede navne.
English: The hydroxyacid metabolite [4' dimethyl-epipodophyllic acid-9-(4,6 0-ethylidene-β-Dglucopyranoside)], formed by opening of the lactone ring, is found in the urine of adults and children.
Danish: Oxsyre-metabolitten [4' dimethyl-epipodofylinsyre-9-(4,6 0-ethyliden-β-D-glucopyranosid)], som dannes ved at åbne lactonringen, findes i urinen hos voksne og børn.
English: Etoposide binding ratio correlates directly with serum albumin in cancer patients and normal volunteers (see section 4.4).
Danish: Bindingsforholdet af etoposid korrelerer direkte med serum albumin hos kræftpatienter og normale frivillige deltagere (se pkt.
English: Frequency Adverse Reaction (MedDRA Terms)
Danish: Hyppighed Bivirkning (MedDRA-termer)
English: • infertility
Danish: • infertilitet
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.
Danish: Hvis der forekommer alvorligebivirkninger, skal ldosis af lægemidlet reduceres, eller behandlingenseponeres, og der skal tages passende korrigerende foranstaltninger i henhold til lægens kliniske skøn.
English: No evidence exists for any other differences in etoposide metabolism and excretion after administration of oral capsules as compared to intravenous infusion.
Danish: Der foreligger ikke nogen evidens for andre forskelle i stofskifte og udskillelse af etoposid efter administration af orale kapsler sammenlignet med intravenøs infusion.
English: • infection
Danish: • infektion
English: Capsule content
Danish: Kapselindhold
English: Therefore patients with low serum albumin may be at increased risk for etoposide-associated toxicities.
Danish: Patienter med lavt serum albumin kan derfor have øget risiko for toksiciteter forbundet med etoposid.
English: Severe myelosuppression with resulting infection or haemorrhage may occur.
Danish: Der kan forekomme svær myelosuppression med resulterende infektion eller blødning.
English: Detailed information on this medicinal product is available on the website of [name of MS Agency link].
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside.
English: Within-patient variability in exposure (i.e. between cycles) is larger with oral administration than after intravenous administration.
Danish: Variabiliteten i eksponering for den enkelte patient (dvs. mellem cyklusser) er større med oral administration end efter intravenøs administration.
English: Patients being treated with VEPESID and associated names must be observed for myelosuppression carefully and frequently both during and after therapy.
Danish: Patienter, som behandles med VEPESID og associerede navne, skal observeres nøje og hyppigt for myelosuppression både før og efter behandling.
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%).
Danish: I kliniske forsøg, hvor VEPESID og relaterede navne blev administreret som et enkelt middel, enten oralt eller ved injektion, var de hyppigste bivirkninger af nogen sværhedsgrad leukopeni (60 % til 91 %), trombocytopeni (22 % til 41 %), kvalme og opkastning (31 % til 43 %) og alopeci (8 % til 66 %).
English: Etoposide
Danish: Etoposid
English: Phenylbutazone, sodium salicylate, and aspirin may displace etoposide from plasma protein binding.
Danish: Phenylbutazon, natriumsalicylat og aspirin kan fortrænge etoposid fra plasmaproteinbindingen.
English: As etoposide may decrease male fertility, preservation of sperm may be considered for the purpose of later fatherhood.
Danish: Da etoposid kan reducere fertilitet hos mænd, kan opbevaring af sperma overvejes med henblik på senere faderskab.
English: Women of childbearing potential should use appropriate contraceptive measures to avoid pregnancy during etoposide therapy.
Danish: Kvinder i den fertile alder skal bruge passende kontraception for at undgå graviditet under behandling med etoposid.
English: Infections and infestations not known infection
Danish: Infektioner og parasitære sygdomme ikke kendt infektion
English: • temporary hair loss
Danish: • midlertidigt hårtab
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.
Danish: Hvis du er træt, svimmel, omtåget eller har dårlig mave, må du ikke gøre føre køretøj eller betjene maskiner, før du har diskuteret det med din læge.
English: • serious reactions of the skin and/or mucous membranes which may include painful blisters and fever, including extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
Danish: • alvorlige hudreaktioner og/eller slimhindereaktioner, som kan inkludere smertende blærer og feber, herunder udbredt løsgørelse af huden (StevensJohnsons syndrom og toksisk epidermal nekrolyse)
English: Effect of etoposide on the pharmacokinetics of other drugs
Danish: Virkning af etoposid på farmakokinetikken af andre lægemidler
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
Danish: - testikelkræft - småcellet lungekræft - blodkræft (akut myeloid leukæmi) - tumor i lymfekarsystemet (Hodgkins lymfom, non-Hodgkins lymfom) - kræft i æggestokkene
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: • sleepiness or tiredness
Danish: • søvnighed eller træthed
English: The name of this medicine is VEPESID and associated names.
Danish: Navnet på dette lægemiddel er VEPESID og associerede navne.
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.
Danish: Både fertile mandlige og kvindelige patienter skal bruge sikker kontraception (f.eks. barrieremetoden eller kondomer) under behandlingen og i mindst 6 måneder efter ophør af behandlingen med VEPESID og associerede navne.
English: After either intravenous infusion or oral capsule administration, the Cmax and AUC values exhibit marked intra- and inter-subject variability.
Danish: Efter enten intravenøs infusion eller administration af orale kapsler udviser Cmax- og AUC-værdierne en bemærkelsesværdig variabilitet hos den enkelte forsøgsperson og mellem forsøgspersoner.
English: Concomitant use of yellow fever vaccine or other live vaccines is contraindicated in immunosuppressed patients (see section 4.5).
Danish: Samtidig brug af vaccine mod gul feber eller andre levende vacciner er kontraindiceret hos immunsupprimerede patienter (se pkt.
English: Co-administration of antiepileptic drugs and VEPESID and associated names can lead to decreased seizure control due to pharmacokinetic interactions between the drugs.
Danish: Samtidig administration af antiepileptika og VEPESID og relaterede navne kan medføre reduceret anfaldskontrol som følge af lægemidlernes farmakokinetiske interaktioner.
English: Low serum albumin is associated with increased exposure to etoposide.
Danish: Lavt serum albumin er forbundet med øget eksponering for etoposid.
English: The dose of VEPESID and associated names capsules is based on the recommended intravenous dose taking into account the dose-dependent bioavailability of VEPESID and associated names capsules.
Danish: Dosis af VEPESID og relaterede navne kapsler er baseret på den anbefalede intravenøse dosis, når der tages højde for den dosisafhængige biotilgængelighed af VEPESID og associerede navne kapsler.
English: Cross resistance between anthracyclines and etoposide has been reported in preclinical experiments.
Danish: Krydsresistens mellem antracykliner og etoposid er blevet indberettet i prækliniske eksperimenter.
English: In case of curative intent the intravenous formulation should be used (see section 5.2).
Danish: Når formålet er helbredelse, skal den intravenøse formulering anvendes (se pkt.
English: VEPESID and associated names should not be used during pregnancy unless the clinical condition of the woman requires treatment with etoposide.
Danish: VEPESID og relaterede navne må ikke anvendes under graviditet medmindre kvindens kliniske tilstand nødvendiggør behandling med etoposid.
English: Live vaccines are contraindicated in immunosuppressed patients (see section 4.3).
Danish: Levende vacciner er kontraindiceret hos immunsupprimerede patienter (se pkt.
English: In all instances where the use of VEPESID and associated names is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions.
Danish: I alle tilfælde, hvor det overvejes at bruge VEPESID og relaterede navne til kemoterapi, skal lægen evaluere behovet for og effekten af lægemidlet i forhold til risikoen for bivirkninger.
English: Unbound fraction of etoposide correlates significantly with bilirubin in cancer patients.
Danish: Den ubundne fraktion af etoposid korrelerer signifikant med bilirubin hos kræftpatienter.
English: • irregular heart beat (arrhythmia), or a heart attack (myocardial infarction)
Danish: • uregelmæssigt hjerteslag (arytmi) eller hjertetilfælde (myokardieinfarkt)
English: - If you are breast-feeding or planning to breast-feed.
Danish: - Hvis du ammer eller planlægger at amme.
English: Testicular atrophy, spermatogenesis arrest, and growth retardation were reported in rats and mice.
Danish: Testesatrofi, ophør af sædudvikling og retarderet vækst blev rapporteret hos rotter og mus.
English: • high blood pressure • sore lips, mouth or throat ulcers
Danish: • højt blodtryk • ømme læber, sår i munden eller halsen
English: Within-patient variability
Danish: Variabilitet for den enkelte patient
English: Follow up doses should be adjusted in case of occurrence of grade 3 or 4 toxicities or if renal creatinine clearance is below 50 ml/min.
Danish: Opfølgende doser skal justeres, hvis der forekommer grad 3 eller 4 toksiciteter, eller hvis renal kreatinin clearance er under 50 ml/min.
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).
Danish: Tidligere eller ledsagende brug af andre lægemidler med myelosupprimerende aktion svarende til etoposids kan forventes at have additive eller samvirkende virkninger (se pkt.
English: Each capsule contains etoposide 50 mg or 100 mg as the active ingredient.
Danish: Hver kapsel indeholder etoposid 50 mg eller 100 mg som det aktive indholdsstof.
English: An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children.
Danish: En omvendt sammenhæng mellem albuminniveauer i plasma og renal clearance af etoposid ses hos børn.
English: Haematological parameters should be measured and dose adjustments in subsequent cycles considered based on haematological toxicity and clinical effect in moderate and severe renal impaired patients.
Danish: Hæmatologiske parametre skal måles og dosisjusteringer i efterfølgende cyklusser overvejes ud fra hæmatologisk toksicitet og klinisk virkning hos patienter med moderat og svært nedsat nyrefunktion.
English: Reinstitution of VEPESID and associated names therapy should be carried out with caution, and with adequate consideration of the further need for the drug and close attention to possible recurrence of toxicity.
Danish: Der skal udvises forsigtighed ved genopstart af behandling med VEPESID og associerede navne, og det fortsatte behov for lægemidlet bør overvejes, idet der udvises passende opmærksomhed over for mulig tilbagevenden af toksicitet.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk.
English: OUTER CARTON AND BOTTLE LABEL TEXT
Danish: TEKST PÅ ETIKETTE PÅ YDREKARTON OG FLASKE
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).
Danish: Hos patienter med moderat (CrCl =15 til 50 ml/min), eller svært (CrCl < 15 ml/min) nedsat nyrefunktion, som er i hæmodialyse, skal der administreres en reduceret dosis (se pkt.
English: rare dysgeusia, dysphagia
Danish: sjælden dysgeusi, dysfagi
English: - if you are taking warfarin (a medicine used to prevent blood clots from forming).
Danish: - hvis du tager warfarin (et lægemiddel som bruges til at forhindre dannelse af blodpropper).
English: In addition the dose should be adjusted in case of occurrence of fever, infections, or at a thrombocyte count below 25,000 cells/mm3, which is not caused by the disease.
Danish: Endvidere skal dosis justeres i tilfælde af feber, infektioner eller et trombocyttal på under 25.000 celler/mm3, som ikke er forårsaget af sygdommen.
English: - if you are being treated with cisplatin (a medicine used to treat cancer).
Danish: - hvis du behandles med cisplatin (et lægemiddel som bruges til at behandle kræft).
English: Women of childbearing potential should be advised to avoid becoming pregnant.
Danish: Fertile kvinder skal tilrådes at undgå graviditet.
English: Effects of other drugs on the pharmacokinetics of etoposide
Danish: Virkninger af andre lægemidler på farmakokinetikken af etoposid
English: [To be completed nationally]
Danish: [Skal udfyldes nationalt]
English: The effect of renal disease on plasma etoposide clearance is not known in children.
Danish: Nyresygdoms indvirkning på clearance af etoposid fra plasma kendes ikke for børn.
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).
Danish: Det skal besluttes, om amning skal ophøre eller behandling med VEPESID og relaterede navne skal seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen (se pkt.
English: In adult cancer patients with liver dysfunction, total body clearance of etoposide is not reduced.
Danish: Hos voksne kræftpatienter med leverfunktionssvigt er den totale clearance af etoposid fra kroppen ikke reduceret.
English: Acute fatal reactions associated with bronchospasm have been reported with etoposide.
Danish: Akutte letale reaktioner relateret til bronkospasme er indberettet med etoposid.
English: Historically, preclinical species have been more sensitive compared to humans towards cytotoxic agents.
Danish: Dyrearterne i prækliniske studier har historisk været mere følsomme over for cytotoksiske stoffer end mennesker.
English: The following adverse reactions were reported from VEPESID and associated names clinical studies and post-marketing experience.
Danish: Følgende bivirkninger blev indberettet fra kliniske studier med VEPESID og relaterede navneog fra erfaringer opnået efter markedsføringen.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Skal udfyldes nationalt] {Navn og adresse} <{tlf.}> <{fax}> <{e-mail}>
English: There is no evidence of a hepatic first-pass effect for etoposide.
Danish: Der er intet tegn på en “fist-pass” virkning i leveren for etoposid.
English: Anaphylactic reactions manifested by chills, fever, tachycardia, bronchospasm, dyspnoea, and hypotension which can be fatal can occur with the initial dose of etoposide.
Danish: Anafylaktiske reaktioner, der giver sig udtryk ved kulderystelser, feber, takykardi, bronkospasme, dyspnø og hypotension som kan væreletal, kan forekomme med den første dosis etoposid.
English: Neutropenia and thrombocytopenia
Danish: Neutropeni eller trombocytopeni
English: VEPESID and associated names capsules should only be administered and monitored under the supervision of a qualified physician experienced in the use of anti-neoplastic medicinal products (see section 4.4).
Danish: Kapsler af VEPESID og relaterede navne må kun administreres og monitoreres under opsyn af en kvalificeret læge med erfaring i brugen af antineoplastiske lægemidler (se punkt 4.4).
English: Reports than 50,000 platelets/mm of fever and infection were also very common in patients with neutropenia treated with etoposide.
Danish: Rapporter om feber og infektion var også meget almindelige hos patienter med neutropeni behandlet med etoposid.
English: Etoposide is mutagenic in mammalian cells.
Danish: Etoposid er mutagen i pattedyrsceller.
English: VEPESID and associated names is used in the treatment of certain types of cancers in adults:
Danish: VEPESID og relaterede navnebruges i behandlingen af visse typer kræft hos voksne:
English: Glycerol (85 per cent) (E422) Gelatin (E441)
Danish: Glycerol (85 procent) (E422)
English: This abnormality has also been seen in patients developing secondary leukaemia after being treated with chemotherapy regimens not containing epipodophyllotoxins and in leukaemia occurring de novo.
Danish: Denne abnormitet er også blevet set hos patienter, som udvikler sekundær leukæmi efter behandling med kemoterapiregimener, som ikke indeholder epipodophyllotoksiner såvel som ved nydiagnosticeret leukæmi.
English: The following haematological parameters should be measured at the start of therapy and prior to each subsequent dose of VEPESID and associated names: platelet count, haemoglobin, white blood cell count and differential.
Danish: Følgende hæmatologiske parametre skal måles ved start af behandling og før hver efterfølgende dosis af VEPESID og associerede navne: trombocyttal, hæmoglobin, leukocyttal og differentialtælling.
English: - if you are taking any anthracyclines (a group of medicines used to treat cancer).
Danish: - hvis du tager nogen antracykliner (en gruppe af lægemidler, der anvendes til at behandle kræft).
English: An 11q23 chromosome abnormality has been observed in some cases of secondary leukaemia in patients who have received epipodophyllotoxins.
Danish: Der er i visse tilfælde af sekundær leukæmi blevet observeret en abnormitet i kromosomet 11q23 hos patienter, som har fået epipodophyllotoksiner.
English: The occurrence of acute leukaemia, which can occur with or without myelodysplastic syndrome, has been described in patients that were treated with etoposide containing chemotherapeutic regimens.
Danish: Forekomsten af akut leukæmi, med eller uden myelodysplastisk syndrom, er blevet beskrevet hos patienter, som blev behandlet med etoposid-holdige kemoterapeutiske midler.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg etoposide
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 50 mg etoposid
English: • breathing problems
Danish: • vejrtrækningsproblemer
English: Since etoposide and its metabolites are not dialyzable, it can be administered pre- and post-haemodialysis (see section 4.9).
Danish: Da etoposid og dets metabolitter ikke kan dialyseres, kan det administreres inden og efter hæmodialyse (se pkt.
English: Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m2 and, like the terminal elimination half-life, are independent of dose over a range 100 to 600 mg/m2.
Danish: Værdier for total clearance fra kroppen rækker fra 33 til 48 ml/min eller 16 til 36 ml/m2 og er ligesom eliminationshalveringstiden for den terminale fase uafhængige af dosen i et dosisområde på 100 til 600 mg/m2.
English: Nadirs tend to occur earlier with intravenous administration compared to oral
Danish: Lavpunkter har tendens til at forekomme tidligere med intravenøs administration sammenlignet med oral administration.
English: Respiratory, thoracic and mediastinal disorders rare interstitial pneumonitis, pulmonary fibrosis
Danish: Luftveje, thorax og mediastinum sjælden interstitiel pneumoni, lungefibrose
English: Prior use of cisplatin may also result in a decrease of etoposide total body clearance in children.
Danish: Tidligere brug af cisplatin kan også resultere i en reduktion i total clearance af etoposid fra kroppen hos børn.
English: Women of childbearing potential have to use effective contraception during and up to 6 months after treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under og i op til 6 måneder efter behandlingen.
English: An alternative dosage schedule for VEPESID and associated names capsules is 50 mg/m2/day for 2 to 3 weeks, with courses repeated after a one week rest period or upon recovery from myelosuppression.
Danish: Et alternativt doseringsskema for kapsler af VEPESID og relaterede navneer 50 mg/m2/dag i 2 til 3 uger med gentagelse af behandlingsserier efter en uges pause eller efter restituering efter myelosuppression.
English: Secondary leukaemia
Danish: Sekundær leukæmi
English: - The other ingredients are: citric acid, anhydrous (E330), glycerol (85 per cent) (E422), macrogol 400 (E1521) and water.
Danish: - Øvrige indholdsstoffer: citronsyre, vandfri (E330), glycerol (85 procent) (E422), macrogol 400 (E1521) og vand.
English: Subsequent dosing in moderate and severe renal impairment should be based on patient tolerance and clinical effect (see section 4.4).
Danish: Efterfølgende dosering ved moderat til svært nedsat nyrefunktion skal være baseret på patientens tolerance og den kliniske virkning (se pkt.
English: • tingling or numbness in hands and feet Rare side effects (affecting between 1 in 1,000 and 1 in 10,000 people)
Danish: • prikken eller følelsesløshed i hænder og fødder Sjældne bivirkninger (påvirker mellem 1 ud af 1.000 og 1 ud af 10.000 personer)
English: Etoposide has been shown to cause metaphasearrest in chick fibroblasts.
Danish: Etoposid er blevet påvist at forårsage metafasestop i fibroblaster hos kyllinger.
English: Reproductive system and breast disorders not known infertility
Danish: Det reproduktive system og mammae ikke kendt infertilitet
English: INFORMATION IN BRAILLE [To be completed nationally]
Danish: INFORMATION I BRAILLESKRIFT [Skal udfyldes nationalt]