FrancophonIA/ELRC3.0 huggingface dataset:
English: These adverse reactions are 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 af 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: weeks in combination with other drugs indicated in the disease to be treated.
Danish: uge i kombination med andre lægemidler indiceret til den sygdom, som behandles.
English: • 5% glucose solution or
Danish: • 5 % glukoseopløsning eller
English: The safety and efficacy of ETOPOPHOS and associated names below 18 years of age have not been established.
Danish: Sikkerheden og virkningen af ETOPOPHOS og relaterede navne hos børn under 18 år er ikke klarlagt.
English: Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration.
Danish: Da muligheden for ekstravasation forekommer, anbefales det nøje at overvåge infusionsstedet for mulig infiltration under administration af lægemidlet.
English: Solutions should be prepared under aseptic conditions.
Danish: Opløsninger skal forberedes under aseptiske forhold.
English: Infections and infestations common infection
Danish: Infektioner og parasitære sygdomme almindelig infektion
English: Reversible alopecia, sometimes progressing to total baldness, was observed in up to 44% of patients treated with etoposide phosphate.
Danish: Reversibel alopeci, undertiden progredierende til fuld skaldethed, blev set hos op til 44 % af patienter behandlet med etoposidfosfat.
English: • 0.9 % sodium chloride solution.
Danish: • 0,9 % natriumchloridopløsning.
English: Facial flushing was reported in 2% of patients and skin rashes in 3%.
Danish: Blussen i ansigtet blev rapporteret hos 2 % af patienter og hududslæt hos 3 %.
English: Total doses of 2.4 g/m to 3.5 g/m administered intravenously over three days have resulted in severe mucositis and myelotoxicity.
Danish: Samlede doser på 2,4 g/m til 3,5 g/m administreret intravenøst over tre dage har resulteret i alvorlig mucositis og myelotoksicitet.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om restitution og fortynding af lægemidlet før administration, se pkt.
English: Apnoea with spontaneous resumption of breathing following cessation of infusion have also been reported.
Danish: Apnø med spontan genoptagelse af vejrtrækning efter ophør af infusionen er også blevet rapporteret.
English: Tell your doctor or nurse 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: 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: Given its mechanism of action, etoposide phosphate should be considered a possible carcinogen in humans.
Danish: På grund af dets virkningsmekanisme bør etoposidfosfat betragtes som et muligt karcinogen for mennesker.
English: Both male and female patients who are considering having a child after having treatment with ETOPOPHOS 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 ETOPOPHOS og associerede navne, skal diskutere dette med deres læge eller sygeplejerske.
English: The predominant macromolecular effect of etoposide seems to be the rupture of the double strand by an interaction with DNAtopoisomerase II or by the formation of free radicals.
Danish: Den dominerende makromolekylære virkning af etoposid lader til at være ruptur af dobbeltstrengen ved en interaktion med DNA-topoisomerase II eller ved dannelse af frie radikaler.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}>.
English: ETOPOPHOS and associated names is a white to off-white dry powder.
Danish: ETOPOPHOS og relaterede navne er et hvidt til off-white tørt pulver.
English: • reactions at the site of infusion
Danish: • reaktioner på infusionsstedet
English: The stock solution should be withdrawn under aseptic conditions according to the physician's prescription and transferred to the infusion bottles and/or syringes for the individual patients.
Danish: Stamopløsningen skal udtrækkes under aseptiske forhold ifølge lægens recept og overføres til infusionsflaskerne og/eller sprøjterne til den enkelte patient.
English: There are no or limited amount of data from the use of etoposide phosphate in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af etoposidfosfat til gravide kvinder.
English: Care should be taken to avoid extravasation.
Danish: Der skal udvises forsigtighed for at undgå ekstravasation.
English: Cloudy or discolored solutions must be discarded.
Danish: Grumsede eller misfarvede opløsninger skal bortskaffes.
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 risikoen for fosterskader.
English: • changes in skin colour (pigmentation)
Danish: • ændringer i hudfarven (pigmentering) • forstoppelse
English: Dextran 40 [To be completed nationally]
Danish: Dextran 40 [Skal udfyldes nationalt]
English: The stock solution should be used as soon as possible (see section 6.3).
Danish: Stamopløsningen skal bruges hurtigst muligt (se pkt.
English: Male patients treated with ETOPOPHOS 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 ETOPOPHOS og relaterede navne tilrådes ikke at blive far til et barn under behandlingen og i op til 6 måneder efter behandlingen.
English: Subsequent dosing should be based on patient tolerance and clinical effect.
Danish: Efterfølgende dosering skal baseres på patientens tolerance og den kliniske virkning.
English: Nadirs tend to occur earlier with intravenous administration compared to oral administration.
Danish: Lavpunkter har tendens til at forekomme tidligere med intravenøs administration sammenlignet med oral administration.
English: Hypotension usually responds to cessation of infusion of etoposide phosphate and/or other supportive therapy as appropriate.
Danish: Hypotension reagerer som regel på ophør af infusion af etoposidfosfat og/eller anden understøttende behandling som relevant.
English: The mechanism of action of etoposide phosphate is considered to be the same as that of etoposide.
Danish: Virkningsmekanismen af etoposidfosfat betragtes som værende den samme som for etoposid.
English: Etoposide (as phosphate)
Danish: Etoposid (som fosfat)
English: 6.6 Special precautions for disposal and other handling Procedures for proper handling and disposal of anti-cancer drugs should be followed.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Procedurer for korrekt håndtering og bortskaffelse af kræftlægemidler skal følges.
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.
Danish: I det samme dosisområde tiltager områderne under kurverne plasmakoncentration vs tid (AUC) og værdierne for den maksimale plasmakoncentration (Cmax) lineært i forhold til dosis.
English: As ETOPOPHOS and associated names is given to you by a doctor or nurse, overdose is unlikely.
Danish: Da du sandsynligvis får ETOPOPHOS og relaterede navne af en læge eller sygeplejerske, er en overdosis usandsynlig.
English: ETOPOPHOS and associated names must not be used during pregnancy unless clearly indicated by your doctor.
Danish: ETOPOPHOS og relaterede navnemå ikke anvendes under graviditet, medmindre det tydeligt angives af din læge.
English: Reports of fever and infection were also very common in patients with neutropenia treated with etoposide phosphate.
Danish: Indberetning af feber og infektion var også meget almindelige hos patienter med neutropeni behandlet med etoposidfosfat.
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 dosis af lægemidlet reduceres, eller behandlingenseponeres, og der skal tages passende korrigerende foranstaltninger i henhold til lægens kliniske skøn.
English: If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Danish: Hvis der observeres misfarvning eller partikulært stof, skal den restituerede opløsning bortskaffes.
English: ETOPOPHOS and associated names should not be physically mixed with any other drug.
Danish: ETOPOPHOS og relaterede navne må ikke fysisk blandes med andre lægemidler.
English: In clinical studies in which ETOPOPHOS and associated names was administered as a single agent at a total dose of ≥450 mg/m2 the most frequent adverse reactions of any severity were leucopenia (91%), neutropenia (88%), anaemia (72%) thrombocytopenia (23%), asthenia (39%), nausea and/or vomiting (37%), alopecia (33%) and chills and/or fever (24%).
Danish: I kliniske studier, hvori ETOPOPHOS og relaterede navne blev administreret som monoterapi ved en samlet dosis på ≥ 450 mg/m var de hyppigste bivirkninger af nogen sværhedsgrad leukopeni (91 %), neutropeni (88 %), anæmi (72 %) trombocytopeni (23 %), asteni (39 %), kvalme og/eller opkastning (37 %), alopeci (33 %) og kulderystelser og/eller feber
English: Before use the content of each vial must be reconstituted with 5 ml or 10 ml of:
Danish: Inden brug skal indholdet i hvert hætteglas restitueres med 5 ml eller 10 ml:
English: If clinically significant hypertension occurs in patients receiving etoposide phosphate, appropriate supportive therapy should be initiated.
Danish: Hvis der forekommer klinisk signifikant hypertension hos patienter, som får etoposidfosfat, skal der indledes passende understøttende behandling.
English: Anaphylactic reactions (see section 4.4), manifested by chills, tachycardia, bronchospasm, dyspnoea, diaphoresis, pyrexia, pruritus, hypertension or hypotension, syncope, nausea, and vomiting have been reported to occur in 3% (7 of 245 patients treated with ETOPOPHOS and associated names in 7 clinical studies) of patients treated with ETOPOPHOS and associated names.
Danish: 4.4), der giver sig udtryk ved kulderystelser, takykardi, bronkospasme, dyspnø, diaforese, pyreksi, kløe, hypertension eller hypotension, synkope, kvalme og opkastning er rapporteret at forekomme hos 3 % (7 ud af 245 patienter behandlet med ETOPOPHOS og relaterede navne i 7 kliniske studier) af patienter behandlet med ETOPOPHOS og associerede navne.
English: The role that concentration or rate of infusion plays in the development of anaphylactic reactions is uncertain.
Danish: Det vises ikke, hvilken rolle koncentrationen eller hastigheden af infusionen spiller i udviklingen af anafylaktiske reaktioner.
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 ETOPOPHOS 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 ETOPOPHOS og associerede navne.
English: ETOPOPHOS and associated names SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
Danish: ETOPOPHOS og relaterede navne MÅ IKKE GIVES VED HURTIG INTRAVENØS INJEKTION.
English: Etoposide phosphate is administered by slow intravenous infusion (usually over a 30 to 60 minute period) (see section 4.4).
Danish: Etoposidfosfat administreres ved langsom intravenøs infusion (som regel i løbet af 30 til 60 minutter) (se pkt.
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 ETOPOPHOS and associated names 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 ETOPOPHOS tages sammen med andre lægemidler, der anvendes inden for kræftbehandling.
English: ETOPOPHOS and associated names 1000 mg is intended to be handled by pharmaceutical staff in central hospital units for the preparation of cytostatics.
Danish: ETOPOPHOS og relaterede navne 1000 mg er beregnet til håndtering af apotekspersonale på centralhospitaler til forberedelse af cytostatika.
English: It is supplied in a glass vial with a butyl rubber stopper and flip-off aluminium seal.
Danish: Det leveres i et hætteglas af glas med en butylgummiprop og et aftageligt aluminiumssegl.
English: ETOPOPHOS and associated names should not be used during pregnancy unless the clinical condition of the woman requires treatment with etoposide.
Danish: ETOPOPHOS og relaterede navne må ikke anvendes under graviditet, medmindre kvindens kliniske tilstand nødvendiggør behandling med etoposid.
English: Patients being treated with ETOPOPHOS and associated names must be observed for myelosuppression carefully and frequently both during and after therapy.
Danish: Patienter, som behandles med ETOPOPHOS og associerede navne, skal observeres nøje og hyppigt for myelosuppression både før og efter behandling.
English: The stopper of the vial should be pierced only once and a sterile transfusion set or any other auxiliary device should be used for withdrawal for the solution.
Danish: Hætteglassets prop må kun gennemstikkes en gang, og der skal anvendes et sterilt transfusionssæt eller andet supplerende udstyr til udtrækning af opløsningen.
English: No dosage adjustment is necessary in elderly patients (age > 65 years old), other than based on renal function.
Danish: Det er ikke nødvendigt at justere dosis hos ældre patienter (alder > 65 år) andet end ud fra nyrefunktion.
English: ETOPOPHOS and associated names should be given only by slow intravenous infusion (usually over a 30 to 60 minute period) since hypotension has been reported as a possible side effect of rapid intravenous injection.
Danish: ETOPOPHOS og relaterede navne må kun gives ved langsom intravenøs infusion (som regel i løbet af 30 til 60 minutter), da hypotension er blevet rapporteret som en mulig bivirkning ved hurtig intravenøs injektion.
English: As etoposide phosphate is converted in vivo to etoposide by phosphorylation, caution should be exercised when administering etoposide phosphate with drugs that are known to inhibit phosphatase activity as such combination may reduce efficacy of etoposide phosphate.
Danish: Efterhånden som etoposidfosfat omdannes til etoposid in vivo ved fosforylering, skal der udvises forsigtighed ved administration af etoposidfosfat sammen med lægemidler, som vides at hæmme fosfataseaktivitet, da en sådan kombination kan reducere virkningen af etoposidfosfat.
English: In all instances where the use of ETOPOPHOS 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 ETOPOPHOS og relaterede navne til kemoterapi, skal lægen evaluere behovet for og nytteværdien af lægemidlet i forhold til risikoen for bivirkninger.
English: The following adverse reactions were reported from ETOPOPHOS and associated names clinical studies and post-marketing experience.
Danish: Følgende bivirkninger blev indberettet fra kliniske studier med ETOPOPHOS og relaterede navne og fra erfaring efter markedsføring.
English: Anaphylactic reactions can occur with the initial dose of etoposide phosphate.
Danish: Anafylaktiske reaktioner kan forekomme med initial dosis af etoposidfosfat.
English: Transient hypotension following rapid intravenous administration has been reported in patients treated with etoposide phosphate and has not been associated with cardiac toxicity or electrocardiographic changes.
Danish: Forbigående hypotension efter hurtig intravenøs administration er indberettet hos patienter behandlet med etoposidfosfat og har ikke været forbundet med hjertetoksicitet eller elektrokardiografiske ændringer.
English: Effect of etoposide phosphate on the pharmacokinetics of other drugs
Danish: Virkning af etoposidfosfat på farmakokinetikken af andre lægemidler
English: Etoposide phosphate is metabolised in vivo into the active substance etoposide by a process of dephosphorylation.
Danish: Etoposidfosfat omsættes in vivo til det aktive stof etoposid ved en defosforyleringsproces.
English: ****Postmarketing complications reported for extravasation included local soft tissue toxicity, swelling, pain, cellulitis, and necrosis including skin necrosis.
Danish: ****Komplikationer efter markedsføring indberettet i forbindelse med ekstravasation inkluderede lokal bløddelstoksicitet, hævelse, smerter, flegmone, og nekrose, herunder hudnekrose.
English: Bacterial infections should be brought under control before treatment with ETOPOPHOS and associated names.
Danish: Bakterieinfektioner skal bringes under kontrol inden behandling med ETOPOPHOS og associerede navne.
English: ETOPOPHOS and associated names solutions must be prepared under aseptic conditions.
Danish: Opløsninger af ETOPOPHOS og relaterede navneskal forberedes under aseptiske forhold.
English: In clinical studies involving etoposide phosphate, episodes of hypertension have been reported.
Danish: I kliniske studier med etoposidfosfat er der indberettet episoder med hypertension.
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 initiale dosis overvejes ud fra på den målte kreatinin clearance.
English: The name of this medicine is ETOPOPHOS and associated names.
Danish: Navnet på dette lægemiddel er ETOPOPHOS og associerede navne.
English: Co-administration of antiepileptic drugs and ETOPOPHOS and associated names can lead to decreased seizure control due to pharmacokinetic interactions between the drugs.
Danish: Samtidig administration af antiepileptika og ETOPOPHOS og relaterede navne kan medføre reduceret anfaldskontrol som følge af lægemidlernes farmakokinetiske interaktioner.
English: ETOPOPHOS and associated names is for single use only.
Danish: ETOPOPHOS og relaterede navne er kun til engangsbrug.
English: Vascular disorders common hypertension, transient systolic hypotension following rapid intravenous administration uncommon haemorrhage
Danish: Vaskulære sygdomme almindelig hypertension, forbigående systolisk hypotension efter hurtig intravenøs administration ikke almindelig blødning
English: Physicians should be aware of the possible occurrence of an anaphylactic reaction with ETOPOPHOS and associated names, manifested by chills, pyrexia, tachycardia, bronchospasm, dyspnoea and hypotension, which can be fatal.
Danish: Læger skal være opmærksomme på muligheden for en anafylaktisk reaktion med ETOPOPHOS og associerede navne, som giver sig udtryk ved kulderystelser, pyreksi, takykardi, bronkospasme, dyspnø og hypotension, som kan være dødelige.
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 (see section 4.4).
Danish: Hos patienter i dialyse med kreatinin clearance under 15 ml/min vil yderligere dosisreduktion sandsynligvis være nødvendig, da clearance af etoposid er yderligere reduceret hos disse patienter (se pkt.
English: Nausea and vomiting are the major gastrointestinal toxicities of etoposide phosphate.
Danish: Kvalme og opkastning er de vigtigste gastrointestinale toksiciteter relateret til etoposidfosfat.
English: Reinstitution of ETOPOPHOS 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 ETOPOPHOS og associerede navne, og det fortsatte behov for lægemidlet bør overvejes, idet der udvises nøje opmærksomhed over for mulig tilbagevenden af toksicitet.
English: Leucopenia and severe leucopenia (less than 1,000 cells/mm3) were observed in 91% and 17%, respectively, for etoposide phosphate.
Danish: Leukopeni og svær leukopeni (under 1.000 celler/mm3) blev observeret hos hhv. 91 % og 17 % for
English: Anaphylactic reactions have been reported to occur during or immediately after intravenous administration of etoposide phosphate.
Danish: Anafylaktiske reaktioner er indberettet under eller umiddelbart efter intravenøs administration af etoposidfosfat.
English: Etoposide phosphate may cause adverse reactions that affect the ability to drive or use machines such as fatigue, somnolence, nausea, vomiting, cortical blindness, hypersensitivity reactions with hypotension.
Danish: Etoposidfosfat kan forårsage bivirkninger, som påvirker evnen til at føre motorkøretøj og betjene maskiner, såsom træthed, somnolens, kvalme, opkastning, kortikal blindhed, overfølsomhedsreaktioner med hypotension.
English: • sore lips, mouth or throat ulcers
Danish: • ømme læber, sår i munden eller halsen
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 raske forsøgspersoner (se pkt.
English: Talk to your doctor, pharmacist or nurse before receiving ETOPOPHOS and associated names
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du får ETOPOPHOS og associerede navne.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: ETOPOPHOS and associated names 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: ETOPOPHOS 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: - If you are breast-feeding or planning to breast-feed.
Danish: - Hvis du ammer eller planlægger at amme
English: General disorders and administration site conditions very common asthenia, malaise common extravasation****, phlebitis rare pyrexia
Danish: Almene symptomer og reaktioner på administrationsstedet meget almindelig asteni, utilpashed almindelig ekstravasation****, phlebitis sjælden pyreksi