FrancophonIA/ELRC3.0 huggingface dataset:
English: The capsules should be taken with a glass of water on an empty stomach.
Danish: Kapslerne skal tages med et glas vand på tom mave.
English: Daily doses greater than 200 mg should be divided and given twice per day.
Danish: Daglige doser på mere end 200 mg bør deles og gives to gange om dagen.
English: * Myelosuppression with fatal outcome has been reported **Seizure is occasionally associated with allergic reactions.
Danish: * Myelosuppression med døden til følge er indberettet **Krampeanfald er lejlighedsvist forbundet med allergiske reaktioner.
English: Effective anti-cancer treatment can destroy cancer cells rapidly in large numbers.
Danish: Effektiv kræftbehandling kan hurtigt destruere et stort antal kræftceller.
English: It is also present in human plasma, presumably as the trans isomer.
Danish: Det findes også i human plasma, antageligt som transisomer.
English: In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours.
Danish: Hos børn udskilles cirka 55 % af dosen i urinen som etoposid i løbet af 24 timer.
English: Appropriate preventive measures should also be considered in patients at risk of this complication of therapy.
Danish: Passende forebyggende foranstaltninger bør desuden overvejes hos patienter, som har risiko for denne behandlingskomplikation.
English: Co-administration of warfarin and etoposide may result in elevated international normalized ratio (INR).
Danish: Samtidig administration af warfarin og etoposid kan resultere i forhøjet international normaliseret ratio (INR).
English: There are no or limited amount of data from the use of etoposide in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af etoposid til gravide kvinder.
English: Handle with caution.
Danish: Skal anvendes med forsigtighed.
English: Patients who experience such adverse reactions should be advised to avoid driving or using machines.
Danish: Patienter, som oplever sådanne bivirkninger, skal tilrådes at undgå at føre motorkøretøjer eller betjene maskiner.
English: - if you have had radiotherapy or chemotherapy recently.
Danish: - hvis du for nylig har fået strålebehandling eller kemoterapi.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Ingen studier er blevet udført af virkningerne på evnen til at føre motorkøretøj og betjene maskiner.
English: This includes appropriate equipment, such as wearing gloves and washing hands with soap and water after handling such products.
Danish: Dette inkluderer brug af passende udstyr, f.eks. at bruge handsker og vaske hænder med sæbe og vand efter håndtering af sådanne produkter.
English: These adverse reactions presented by system organ class and frequency, which is defined by the following categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1, 000, <1/100), rare (≥1/10, 000, <1/1,000), not known (cannot be estimated from the available data).
Danish: Disse bivirkninger er angivet efter systemorganklasse og hyppighed, som defineres ud fra følgende kategorier: Meget almindelig (≥1/10), Almindelig (≥1/100, <1/10), Ikke almindelig (≥1/1.000, <1/100), Sjælden (≥1/10.000, <1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you have reduced liver or kidney function, your doctor may also want you to take regular blood tests to monitor these levels.
Danish: Hvis du har nedsat lever- eller nyrefunktion, er det også muligt, at din læge vil have, at du skal have taget regelmæssige blodprøver for at monitorere disse niveauer.
English: The mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m2.
Danish: De gennemsnitlige fordelingsvolumener ved steady state falder inden for værdiområdet 18 til 29 liter eller 7 til 17 l/m2.
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.
Danish: Lægemidlet kan reducere niveauet af visse blodceller, hvilket kan betyde, at du vil få infektioner, eller at dit blod ikke størkner så godt, som det burde, hvis du skærer dig.
English: Stop taking the medicine and tell your doctor immediately if you get any of the following symptoms: swelling of your tongue or throat, breathing difficulties, fast heartbeat, flushing of the skin or a rash.
Danish: Hold straks op med at tage lægemidlet og fortæl det til din læge, hvis du får nogen af de følgende symptomer: hævelse af tungen eller i halsen, vejrtrækningsbesvær, hurtig puls, rødmen på huden eller et udslæt.
English: If this happens it can cause problems with the liver, kidney, heart or blood, which may result in death if not treated.
Danish: Hvis det sker, kan det forårsage problemer med leveren, nyrerne, hjertet eller blodet, hvilket kan være dødeligt, hvis det ikke behandles.
English: Genetic consultation is recommended if the patient wishes to have children after ending treatment.
Danish: Genetisk rådgivning anbefales, hvis patienten ønsker at få børn efter ophør af behandling.
English: Alternative dosage schedule
Danish: Alternativt doseringsskema
English: Capsules should be taken on an empty stomach.
Danish: Kapsler skal tages på tom mave.
English: In addition, O-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme pathway to produce the corresponding catechol.
Danish: Endvidere finder O-demethylering af dimethoxyphenol-ringen sted gennem CYP450 3A4-isoenzym-pathwayen, så den tilsvarende katekolamin produceres.
English: The roles of both administration schedules and cumulative doses of etoposide have been suggested, but have not been clearly defined.
Danish: Det er antydet, at både administrationsskemaer og kumulative doser af etoposid spiller en rolle, men disse roller er ikke blevet klart defineret.
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.
Danish: Både mandlige og kvindelige patienter, som overvejer at få børn efter behandling med VEPESID og associerede navne, skal diskutere dette med deres læge eller sygeplejerske.
English: The available efficacy data for etoposide in the different indications are generally based on studies in which etoposide was used intravenously.
Danish: De tilgængelige effektdata vedrørende etoposid i de forskellige indikationer er generelt baseret på studier, hvori etoposid blev brugt intravenøst.
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.
Danish: Af denne grund er det afgørende, at fordelene ved oral administration nøje afvejes mod ulemperne af større variabilitet i eksponering hos den enkelte patient efter oral administration.
English: - if you are taking phenytoin or any other medicines used to treat epilepsy.
Danish: - hvis du tager phenytoin eller andre lægemidler, som anvendes til at behandle epilepsi.
English: OTHER Cytotoxic.
Danish: ANDET Cytotoksisk.
English: Although minor differences in pharmacokinetic parameters between genders have been observed, these are not considered clinically significant.
Danish: Omend der er blevet observeret mindre forskelle i farmakokinetiske parametre mellem kønnene, betragtes disse ikke som klinisk signifikante.
English: • a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe (radiation recall dermatitis)
Danish: • et udslæt, der ligner solskoldning, kan forekomme på hud, som tidligere er blevet eksponeret for stråleterapi, og det kan være alvorligt (radiation recall dermatitis)
English: Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported.
Danish: Restitution af knoglemarv er som regel fuldstændig efter 20 dage, når der ikke er indberettet nogen kumulativ toksicitet.
English: On intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution half-life of about 1.5 hours and terminal elimination half-life ranging from 4 to 11 hours.
Danish: Ved intravenøs administration kan dispositionen af etoposid bedst beskrives som en bifasisk proces med en halveringstid i fordelingsfasen på 1,5 timer og en eliminationshalveringstid for den terminale fase på mellem 4 og 11 timer.
English: VEPESID capsules are opaque pink, soft gelatin capsules.
Danish: VEPESID kapsler er uigennemsigtigt lyserøde, bløde gelatinekapsler.
English: The main effect of etoposide appears to be at the late S and early G2 portion of the cell cycle in mammalian cells.
Danish: Hovedvirkningen af etoposid forekommer at være den sene S og tidlige G2 del af cellecyklussen i pattedyrsceller.
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.
Danish: Øget variabilitet i eksponering for den enkelte patient kan medføre større variabilitet i dosisreaktion, dvs. medføre større variabilitet i patienters følsomhed med hensyn til at opleve behandlingsrelateret toksicitet fra cyklus til cyklus, hvilket potentielt kan påvirke den overordnede behandlingseffekt hos nogle patienter.
English: - If you have recently been given a live vaccine, including Yellow fever vaccine.
Danish: - hvis du for nylig har fået en levende vaccine, herunder vaccine mod gul feber.
English: In vitro, etoposide is highly protein bound (97%) to human plasma proteins.
Danish: In vitro er etoposid i høj grad proteinbundet (97 %) til plasmaproteiner hos mennesker.
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.
Danish: Samlede doser på 2,4 g/m2 til 3,5 g/m2 administreret intravenøst over tre dage har resulteret i alvorlig mucositis og myelotoksicitet.
English: Small cell lung cancer
Danish: Småcellet lungekræft
English: There is increased risk of fatal systemic vaccinal disease with the use of yellow fever vaccine.
Danish: Der er øget risiko for letal systemisk vaccinationssygdom ved anvendelse af vaccine mod gul feber.
English: You should avoid touching the capsules by wearing gloves and wash your hands with soap and water after handling the medicine.
Danish: Du skal undgå at røre kapslerne ved at bruge handsker og vaske dine hænder med sæbe og vand efter håndtering af lægemidlet.
English: Pharmacotherapeutic group: Cytostatics, plant alkaloids and other natural products, podophyllotoxin derivatives, ATC code: L01CB01
Danish: Farmakoterapeutisk klassifikation: Cytostatika, plantealkaloider og andre naturlige produkter, podophyllotoksin-derivater, ATC-kode: L01CB01
English: Recurrent or refractory testicular cancer
Danish: Recidiverende eller refraktær testikelkræft
English: VEPESID and associated names must not be used during pregnancy unless clearly indicated by your doctor.
Danish: VEPESID og relaterede navne må ikke anvendes under graviditet, medmindre det tydeligt angives af din læge.
English: Women of childbearing potential/Contraception in males and females
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder
English: No correlation exists between the absolute oral bioavailability of etoposide capsules and non-renal clearance.
Danish: Der er ingen korrelation mellem den absolutte orale biotilgængelighed af kapsler med etoposid og ikke-renal clearance.
English: Etoposide is excreted in human milk.
Danish: Etoposid udskilles i human mælk.
English: Etoposide and its metabolites are not dialyzable.
Danish: Etoposid og dets metabolitter kan ikke dialyseres.
English: The safety and efficacy of VEPESID and associated names in children below 18 years of age have not been established.
Danish: Sikkerheden og virkningen af VEPESID og relaterede navne hos børn under 18 år er ikke klarlagt.
English: Etoposide belongs to the group of medicines called cytostatics which are used in the treatment of cancer.
Danish: Etoposid tilhører en gruppe lægemidler kaldet cytostatika, som bruges inden for kræftbehandling.
English: Patients with impaired hepatic function should regularly have their hepatic function monitored due to the risk of accumulation.
Danish: Patienter med nedsat leverfunktion skal regelmæssigt have deres leverfunktion monitoreret på grund af risikoen for akkumulering.
English: The safety and effectiveness in paediatric patients has not been established.
Danish: Sikkerheden og virkningen hos pædiatriske patienter er ikke blevet klarlagt.
English: • temporary blindness
Danish: • midlertidig blindhed
English: Dose of Etoposide
Danish: Dosis af etoposid
English: Fatal myelosuppression has been reported following etoposide administration.
Danish: Fatal myelosuppression er indberettet efter administration af etoposid.
English: - If you are allergic to etoposide or any of the other ingredients of this medicine (listed in section
Danish: - hvis du er allergisk over for etoposid eller et af de øvrige indholdsstoffer i lægemidlet (angivet i pkt.
English: Glucuronide and/or sulfate conjugates of etoposide are also excreted in human urine.
Danish: Glucuronid og/eller sulfatkonjugater af etoposid udskilles ligeledes i urinen hos mennesker.
English: If clinically significant hypertension occurs in patients receiving etoposide, appropriate supportive therapy should be initiated.
Danish: Hvis der forekommer klinisk signifikant hypertension hos patienter, som får etoposid, skal der indledes passende understøttende behandling.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.> 18.
English: Close monitoring of patients is needed to detect early signs of tumour lysis syndrome, especially in patients with risk factors such as bulky treatmentsensitive tumours, and renal insufficiency.
Danish: Nøje monitorering af patienter er nødvendigt for at detektere tidlige tegn på tumorlysesyndrom, særligt hos patienter med risikofaktorer, såsom store behandlingsfølsomme tumorer og nyreinsufficiens.
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.
Danish: Omend der er blevet observeret mindre forskelle i farmakokinetiske parametre mellem patienter på ≤ 65 år og > 65 år betragtes disse ikke som klinisk signifikante.
English: In general etoposide can cause fetal harm when administered to pregnant women.
Danish: Etoposid kan generelt forårsage fosterskader ved administration til gravide kvinder.
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%).
Danish: Variationskoefficienten er cirka 30 % efter oral administration sammenlignet med 10 % efter intravenøs administration (variabiliteten mellem patienter er tilsvarende efter intravenøs og oral administration, dvs. 30 % til 40 %).
English: Male patients treated with VEPESID and associated names are advised not to father a child during treatment and for up to 6 months after treatment.
Danish: Mandlige patienter behandlet med VEPESID og relaterede navne tilrådes ikke at blive far til et barn under behandlingen og i op til 6 måneder efter behandlingen.
English: - if you have recently been given any live vaccines.
Danish: - hvis du for nylig har fået en levende vaccine.
English: Anaemia, leucopenia, and thrombocytopenia were observed in rats and mice, while dogs had mild reversible deterioration of liver and kidney functions.
Danish: Anæmi, leukopeni og trombocytopeni blev observeret hos rotter og mus, mens hunde havde mild reversibel forværring af lever- og nyrefunktioner.
English: As with all medicines used to treat cancer, care must be taken when handling VEPESID and associated names capsules.
Danish: Som med alle lægemidler, der bruges til at behandle kræft, skal der udvises forsigtighed ved håndtering af kapsler af VEPESID og associerede navne.
English: In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance.
Danish: Hos patienter med nedsat nyrefunktion skal følgende ændringer af initial dosis overvejes ud fra på den målte kreatinin clearance.
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.
Danish: Hvis lægemidlet anvendes under graviditet, eller hvis patienten bliver gravid, mens hun får lægemidlet, skal patienten informeres om muligheden for fosterskader.
English: - if you are taking any drugs with a similar mechanism of action as VEPESID.
Danish: - hvis du tager nogen lægemidler med en virkningsmekaniske svarende til VEPESID.
English: Metabolic acidosis and cases of serious hepatic toxicity have been reported in patients receiving higher than recommended intravenous doses of etoposide.
Danish: Metabolisk acidose og tilfælde af alvorlig levertoksicitet er indberettet hos patienter, som får højere end anbefalede intravenøse doser af etoposid.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister strip 50mg and 100mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister strip 50 mg og 100 mg
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.
Danish: Denne behandlingsserie kan derefter gentages afhængig af resultaterne af dine blodprøver, men dette vil først være mindst 7 dage efter den første behandlingsserie.
English: No dosage adjustment is necessary in elderly patients (age > 65 years old), other than based on renal function (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos ældre patienter (alder > 65 år), undtagen når det gælder nyrefunktionen (se pkt.
English: Safety and effectiveness of VEPESID and associated names in paediatric patients has not been systematically studied.
Danish: Sikkerheden og virkningen af VEPESID og relaterede navne hos pædiatriske patienter er ikke blevet systematisk undersøgt.
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.
Danish: Hvis der er givet stråleterapi eller kemoterapi inden start af behandling med etoposid, skal der gå tilstrækkelig lang tid til at muliggøre restitution af knoglemarven.
English: - The active substance is etoposide.
Danish: - Aktivt stof: etoposid.
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.
Danish: Denne behandlingsserie kan derefter gentages afhængig af resultaterne af dine blodprøver, men dette vil først være mindst 21 dage efter den første behandlingsserie.
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.
Danish: Hos patienter med kreatinin clearance under 15 ml/min, som er i dialyse, vil yderligere dosisreduktion sandsynligvis være nødvendig, da clearance af etoposid er yderligere reduceret hos disse patienter.
English: The oral bioavailability is variable but averages 76% at the 100 mg oral dose and 48% at the 400 mg oral dose.
Danish: Den orale biotilgængelighed varierer, men er i gennemsnit 76 % ved den orale dosis på 100 mg og 48 % ved den orale dosis på 400 mg.
English: In animal studies etoposide was associated with dose-related embryotoxicity and teratogenicity.
Danish: Etoposid var i dyreforsøg forbundet med dosisrelateret embryotoksicitet og teratogenicitet.
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.
Danish: Det lader til, at et andet karaktertræk forbundet med sekundær leukæmi hos patienter, som har fået epipodophyllotoksiner, er en kort latenstid med en gennemsnitlig mediantid til udvikling af leukæmi på cirka 32 timer.
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.
Danish: Lavpunkter for granulocytter og trombocytter forekommer som regel omkring 10 til 14 dage efter administration af etoposid afhængig af administrationsvejen og behandlingsplanen.
English: Gastrointestinal Toxicity
Danish: Gastrointestinal toksicitet
English: - if you are taking a medicine called ciclosporin (a drug used to reduce the activity of the immune system).
Danish: - hvis du tager en medicin kaldet ciclosporin (et lægemiddel som anvendes til at reducere immunsystemets aktivitet).
English: Etoposide has been shown to be teratogenic in mice and rats (see section 5.3).
Danish: Etoposid er blevet påvist at være teratogen hos mus og rotter (se pkt.
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).
Danish: I et studie af indvirkningen af andre behandlingsmidler på in vitro binding af 14C etoposid til humane serum proteiner, fortrængte kun phenylbutazon, natriumsalicylat og aspirin proteinbundet etoposid ved koncentrationer generelt set in vivo (se pkt.
English: Patients with impaired renal function receiving etoposide have exhibited reduced total body clearance, increased AUC and higher steady state volume of distribution (see section 4.2).
Danish: Patienter med nedsat nyrefunktion, som får etoposid, har udvist reduceret total clearance fra kroppen, øget AUC og et højere fordelingsvolumen i steady state (se pkt.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Danish: 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Very common side effects (affecting more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan påvirke mere end 1 ud af 10 personer)
English: High dose ciclosporin, resulting in plasma concentrations above 2000 ng/mL, administered with oral etoposide has led to an 80% increase in etoposide exposure (AUC) with a 38% decrease in total body clearance of etoposide compared to etoposide alone.
Danish: Høj-dosis ciclosporin, resulterende i plasmakoncentrationer over 2000 ng/ml, som administreres sammen med oral etoposid, har medført en stigning i eksponering for etoposid (AUC) på 80 % med et fald i kroppens totale clearance af etoposid på 38 % sammenlignet med etoposid alene.
English: Measured Creatinine Clearance
Danish: Målt kreatinin clearance
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.
Danish: Hvis etoposid kommer i kontakt med hud, slimhinder eller øjne, skal huden straks vaskes med sæbe og vand, og slimhinder eller øjne skylles med vand.
English: The nausea and vomiting can usually be controlled by antiemetic therapy.
Danish: Kvalme og opkastning kan som regel kontrolleres af antiemetika.