FrancophonIA/ELRC3.0 huggingface dataset:
English: If you get any of the above symptoms, seek medical advice immediately.
Danish: Hvis De får et eller flere af ovenstående symptomer, skal De omgående søge lægehjælp.
English: Your doctor may reduce your dose if you have kidney problems.
Danish: Deres læge vil eventuelt nedsætte Deres dosis, hvis De har nyreproblemer.
English: • Reduction in the number of white blood cells and platelets
Danish: • Nedsat antal hvide blodlegemer og blodplader
English: If you are at risk of high potassium levels in your blood, your doctor will monitor this.
Danish: Hvis De har risiko for højt kaliumniveau i blodet, vil lægen overvåge dette.
English: All items for preparation, administration or cleaning, including gloves, as well as liquid waste should be disposed of in accordance with local requirements.
Danish: Alt materiale til forberedelse, administration og rengøring, herunder handsker, samt flydende affald, skal bortskaffes i henhold til lokale retningslinjer.
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Danish: Almindelige (≥1/100 til <1/10) Ikke almindelige (≥1/1.000 til <1/100) Sjældne (≥1/10.000 til <1/1.000)
English: The dose will depend on your height, weight and kidney function.
Danish: Dosis afhænger af Deres højde, vægt og nyrefunktion.
English: This is equivalent to 81% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 81 % af den anbefalede maksimale daglige indtagelse af natrium gennem kosten for en voksen.
English: Cooling procedures such as ice packs should have been removed from the area at least 15 minutes before the Savene administration in order to allow sufficient blood flow.
Danish: Nedkølingsprocedurer, f.eks. med isposer, skal fjernes fra området mindst 15 minutter før administration af Savene for at gøre en tilstrækkelig blodgennemstrømning mulig.
English: Savene will not be used again at the time of your next anthracycline cycle, except if extravasation occurs again.
Danish: Savene skal ikke anvendes i forbindelse med Deres næste antracyklincyklus undtagen i tilfælde, hvor ekstravasation forekommer igen.
English: • Due to an increased thrombotic risk in patients with malignant diseases, the use of anticoagulants treatment is frequent.
Danish: • Grundet en øget trombose-risiko hos patienter med ondartede sygdomme, er anvendelsen af antikoagulantia hyppig.
English: A number of published reports comprising more than 1000 patients have demonstrated a uniform pattern of dose dependent adverse reactions.
Danish: En række publicerede rapporter, som omfatter mere end 1.000 patienter, har vist et ensartet mønster af dosisafhængige bivirkninger.
English: AUCs were dose-proportional.
Danish: AUC er proportionel med dosis.
English: Savene must only be administered intravenously.
Danish: Savene må kun indgives intravenøst.
English: Adverse reactions reported are listed according to the following frequency:
Danish: De rapporterede bivirkninger er opstillet i henhold til de følgende hyppigheder:
English: Use a graduated syringe filled with a needle.
Danish: Anvend en gradueret sprøjte forsynet med en nål.
English: Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Treatment should be given once daily for 3 consecutive days.
Danish: Behandlingen bør indgives en gang dagligt i 3 på hinanden følgende dage.
English: Interactions common to all cytotoxics:
Danish: Interaktioner, som er fælles for alle cytotoksiske midler:
English: Safety and efficacy have not been evaluated in the elderly and the use of dexrazoxane in such patients is not recommended.
Danish: Sikkerhed og effekt er ikke vurderet hos ældre, og brug af dexrazoxan anbefales derfor ikke til sådanne patienter.
English: Cenexi-Laboratoires Thissen SA Rue de la Papyrée 2-4-6 B-1420 Braine-L'Alleud Belgium
Danish: Cenexi-Laboratoires Thissen SA Rue de la Papyrée 2-4-6 B-1420 Braine-L'Alleud Belgien
English: The related razoxane has been demonstrated to be embryotoxic in mice, rats and rabbits and teratogenic in rats and mice.
Danish: Det beslægtede razoxan har vist sig at være embryotoksisk hos mus, rotter og kaniner og teratogent hos rotter og mus.
English: The treatment is considered to have a limited influence on the ability to drive and use machines.
Danish: Behandlingen anses for at have en begrænset indflydelse på evnen til at føre bil eller betjene maskiner.
English: The steady-state volume of distribution of dexrazoxane was 30.5 L ± 11.1 for day 1 and 35.8 L ± 19.7 for day 2.
Danish: Fordelingsvolumenet i steady-state for dexrazoxan var 30,5 l ± 11,1 for dag 1 og 35,8 l ± 19,7 for dag 2.
English: About 2% of dexrazoxane is protein-bound.
Danish: Cirka 2% af dexrazoxan er proteinbundet.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De bruger dette lægemiddel.
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: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indberette bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: - Anticoagulants (blood thinners) (your blood may need to be monitored more frequently).
Danish: - Antikoagulantia (blodfortyndende midler) (det kan være nødvendigt at analysere Deres blod hyppigere).
English: • Inflammation in the mouth
Danish: • Inflammation i munden
English: The solution must not be mixed with any other medicines.
Danish: Opløsningen må ikke blandes med andre lægemidler.
English: There are no data from the use of dexrazoxane in pregnant women.
Danish: Der er ingen data fra anvendelse af dexrazoxan til gravide kvinder.
English: • Muscle pain, tremor (uncontrolled muscle movement)
Danish: • Muskelsmerter, rysten (ukontrolleret muskelbevægelse)
English: Other possible side effects are listed below:
Danish: Andre bivirkninger er anført nedenfor:
English: The first infusion will be given as soon as possible and within the first six hours after extravasation of an anthracycline medicine.
Danish: Den første infusion gives så hurtigt som muligt og inden for de første seks timer efter ekstravasation af et antracyklinlægemiddel.
English: Use an inactivated vaccine where this exists (poliomyelitis).
Danish: Brug om muligt en inaktiveret vaccine (poliomyelitis).
English: The indicated dose should be administered as an intravenous infusion over 1-2 hours into a large vein of an extremity or area other than the one affected by the extravasation.
Danish: Den indicerede dosis skal indgives som en intravenøs infusion i løbet af 1-2 timer i en stor vene i en ekstremitet eller et andet område end det, der er påvirket af ekstravasationen.
English: Use of gloves and other protective clothing to prevent skin contact is recommended.
Danish: Det anbefales at anvende handsker og beskyttende beklædning for at undgå hudkontakt.
English: 3.2.2 Inject the required volume back into the opened Savene solvent bottle (see point 3.1.5).
Danish: 3.2.2 Injicer det nødvendige volumen i den åbnede flaske med solvens til Savene (se punkt 3.1.5).
English: The systemic clearances were similar between day 1 (9.9 L/h ± 3.1) and day 2 (11.1 L/h ± 4.5), and did not differ from those reported in the literature.
Danish: Den systemiske clearance var omtrent den samme mellem dag 1 (9,9 l/t ± 3,1) og dag 2 (11,1 l/t ± 4,5) og adskilte sig ikke fra de værdier, der er rapporteret i litteraturen.
English: Potassium 98 mg/500 ml or 5.0 mmol/l Sodium 1.61 g/500 ml or 140 mmol/l
Danish: Kalium 98 mg/500 ml eller 5,0 mmol/l Natrium 1,61 g/500 ml eller 140 mmol/l
English: Patients with neutropenia and thrombocytopenia > CTC grade 1 (Common Toxicity Criteria) have not been included in the clinical studies.
Danish: Patienter med neutropeni og trombocytopeni > CTC grad 1 (Common Toxicity Criteria) er ikke inkluderet i de kliniske studier.
English: Marketing Authorisation Holder Clinigen Healthcare B.V.
Danish: Indehaveren af markedsføringstilladelsen Clinigen Healthcare B.V.
English: - Myelosuppressive medicines (decrease production of red, white, or coagulating blood cells).
Danish: - Myelosuppressiv medicin (nedsætter produktionen af røde eller hvide blodceller eller blodplader)
English: It is not known to what extent each of these mechanisms contributes to the preventive effect on tissue destruction following anthracycline extravasation.
Danish: Det vides ikke, i hvilken udstrækning hver af disse mekanismer bidrager til den præventive effekt på vævsskader efter ekstravasation af antracyklin.
English: The first and second doses were 1000 mg/m2 and the third was 500 mg/m2.
Danish: Den første og den anden dosis var 1.000 mg/m2 og den tredje var 500 mg/m2.
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic agents, ATC code: V03AF02
Danish: Farmakoterapeutisk klassifikation: Afgiftningsmidler til antineoplastiske midler, ATC-kode: V03AF02
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 4 hours at 2 to 8 °C.
Danish: Hvis det ikke anvendes med det samme, er opbevaringstider og -forhold før ibrugtagning brugerens ansvar og bør normalt ikke overstige 4 timer ved 2-8 °C.
English: It contains no antibacterial preservative.
Danish: Det indeholder ikke konserveringsmiddel.
English: Dexrazoxane is not recommended in combination with phenytoin.
Danish: Dexrazoxan anbefales ikke i kombination med phenytoin.
English: The concentrate should then be diluted further in the remaining Savene solvent.
Danish: Koncentratet skal herefter fortyndes yderligere med den resterende solvens til Savene.
English: The chelating property is probably also responsible for an increased urinary excretion of iron and zinc and a decreased serum concentration of calcium as described in a few studies.
Danish: De kelerende egenskaber fører sandsynligvis også til øget udskillelse af jern og zink med urinen og til en mindsket serumkoncentration af kalcium, hvilket beskrives i nogle få studier.
English: Due to the rarity of the condition only historical data could be used for comparison (demonstrating surgical rates of 35-50 %, in one country 100% in biopsy proven cases).
Danish: Da sygdommen er sjælden, har det kun været muligt at anvende historiske data til sammenligning (de viste operationsfrekvenser på 35-50 %, i et land 100 % i tilfælde, der er bekræftet ved biopsi).
English: Savene infusion will be given at the same time every day of your treatment.
Danish: Infusionen med Savene vil blive givet på samme tidspunkt hver dag under behandlingen.
English: You will receive your infusion once daily for 3 consecutive days.
Danish: De vil få infusionen en gang dagligt i 3 på hinanden følgende dage.
English: The mean AUC0-24 values for day 1 and day 2 were comparable with each other, and the AUC0-last at day 3 was approximately half that of the first two days, suggesting that the pharmacokinetics of dexrazoxane are dose-dependent.
Danish: Middelværdierne af AUC0-24 for dag 1 og dag 2 var sammenlignelige med hinanden, og AUC0-last på dag 3 var ca. halvt så høj som de første to dage, hvilket tyder på, at farmakokinetikken for dexrazoxan er dosisafhængig.
English: Occasionally an accident occurs and the medicine is infused outside the vein and into the surrounding tissue or leaks from the vein into the surrounding tissue.
Danish: Lejlighedsvis sker der et uheld, og lægemidlet indgives uden for venen og ind i det omgivende væv, eller det lækkes fra venen ind i det omgivende væv.
English: For study purposes, patients with extravasations from a central venous access device (CVAD) were not included in the efficacy evaluation.
Danish: I studieøjemed blev patienter med ekstravasation fra centralt venekateter (CVAD) ikke inkluderet i effektevalueringen.
English: Contains cytotoxics.
Danish: Indeholder cytotoksiske stoffer.
English: If Savene comes into contact with the skin, the affected area should immediately be rinsed thoroughly with water.
Danish: Hvis Savene kommer i kontakt med huden, skylles det udsatte område straks grundigt med vand.
English: The overall ranges and mean of AUC0-24 between days were very similar; it does not appear that there is any significant accumulation of dexrazoxane.
Danish: Den samlede spredning og middelværdi for AUC0-24 mellem dagene var meget ens; der synes ikke at forekomme signifikant akkumulering af dexrazoxan.
English: Women must inform their doctor immediately if they become pregnant (see section 4.3).
Danish: Kvinder skal straks underrette deres læge, hvis de bliver gravide (se pkt.
English: Clear isotonic solution (295 mOsml/l, pH approx. 7.4).
Danish: Klar isotonisk opløsning (295 mOsml/l, pH cirka 7,4).
English: The elimination half-life of the two-ring opened metabolite ADR-925 is not given in literature.
Danish: Eliminationshalveringstiden for metabolitten ADR-925 med to åbne ringe er ikke angivet i litteraturen.
English: Patients treated with anticoagulants should be monitored more frequently as cytotoxic agents may interact with oral anticoagulants.
Danish: Patienter, som behandles med antikoagulantia, skal monitoreres hyppigere, da cytotoksiske stoffer kan påvirke orale antikoagulantia.
English: In-vitro studies on dexrazoxane in human microsomes have shown high stability of dexrazoxane indicating that major metabolism via cytochrome P450 is unlikely.
Danish: In-vitro-studier med dexrazoxan i humane mikrosomer har vist høj stabilitet ved dexrazoxan, hvilket indikerer, at væsentlig metabolisme via cytokrom P450 er usandsynlig.
English: Overall, the most commonly received anthracycline was epirubicin (56 % of the patients).
Danish: Stort set var epirubicin det antracyklin, der blev indgivet mest (56 % af patienterne).
English: 3.2.5 As with all parenteral products, Savene concentrate and infusion solution should be inspected visually for particulate matter and discoloration prior to administration.
Danish: 3.2.5 Som ved alle parentale produkter skal Savene koncentrat og infusionsvæske kontrolleres visuelt for partikler og misfarvning inden administration.
English: - If you have liver problems, your doctor will monitor your liver function during treatment.
Danish: - Hvis De har leverproblemer, holder lægen øje med Deres leverfunktion under behandlingen.
English: Concomitant use to assess carefully: Ciclosporin, tacrolimus: Excessive immunosuppression with risk of lymphoproliferative disease.
Danish: Samtidig anvendelse, der bør vurderes nøje: Ciclosporin, tacrolimus: Kraftig immunsuppression med risiko for lymfoproliferativ sygdom.
English: If you are sexually active, you are advised to use effective birth control to prevent pregnancy during and for six months after treatment, whether you are male or female (see section 2 ‘Do not use Savene').
Danish: Hvis De er seksuelt aktiv, rådes De til at anvende effektiv prævention for at forebygge graviditet under og i seks måneder efter behandlingen, hvad enten De er mand eller kvinde (se pkt.
English: Excipients Savene powder: None
Danish: Hjælpestoffer i Savene-pulver: Ingen
English: When tested in five major cytochrome P450 isoenzymes CYP1A, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, none of these were inhibited by dexrazoxane.
Danish: Test af fem vigtige CYP-isoenzymer, CYP1A, CYP2C9, CYP2C19, CYP2D6 og CYP3A4 viste, at ingen af dem blev hæmmet af dexrazoxan.
English: • Reactions at the site of injection (pain at the site, red, swollen or painful skin at the site or hardening of the skin at the site)
Danish: • Reaktioner på infusionsstedet (smerter, rød, hævet eller smertefuld hud eller hærdning af huden på infusionsstedet)
English: It is not known whether dexrazoxane is excreted in human milk.
Danish: Det vides ikke, om dexrazoxan udskilles i human mælk.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Dizziness, tiredness and sudden fainting have been reported in a few patients treated with Savene.
Danish: Svimmelhed, træthed og pludselig bevidstløshed er blevet rapporteret hos nogle få patienter, som blev behandlet med Savene.
English: In both studies dexrazoxane treatment prevented the development of necrosis, allowed cancer treatment to continue as scheduled in the majority of patients (70.4 %), and reduced the occurrence of sequelae (only few and mild long-term sequelae were observed).
Danish: I begge studier forhindrede behandlingen med dexrazoxan udviklingen af nekrose, gjorde det muligt at fortsætte cancerbehandlingen i henhold til planen hos størstedelen af patienterne (70,4 %) og reducerede forekomsten af sequelae (kun få eller lettere langvarige sequelae blev observeret).
English: - If the medicine is not used immediately, it should be kept at a temperature of 2 to 8 °C (in the refrigerator) and no longer than 4 hours.
Danish: - Hvis lægemidlet ikke anvendes straks, skal det opbevares ved en temperatur på 2 til 8° C (på køl) og højst i 4 timer.
English: Note that in these studies dexrazoxane was administered prior to anthracyline administration.
Danish: Bemærk, at dexrazoxan i disse studier blev administreret før administration af antracyklin.
English: Dexrazoxane has two major mechanisms of action:
Danish: Dexrazoxan har to vigtige virkningsmekanismer:
English: Tissue distribution is rapid, with the highest levels of unchanged parent compound and hydrolysed product appearing in liver and kidneys.
Danish: Vævsfordelingen er hurtig med de højeste niveauer af uomdannet lægemiddel og hydrolyseprodukt i lever og nyrer.
English: - If you have kidney problems, your doctor will monitor for signs of changes to your blood cells.
Danish: - Hvis De har nyreproblemer, holder lægen øje med tegn på ændringer i Deres blodceller.
English: In particular, tell your doctor or nurse if you are taking or may take any of the following medicines: - Vaccines: you must not use Savene if you are going to receive yellow fever vaccine and it is not recommended that you use Savene if you are going to receive a vaccine containing live virus particles.
Danish: Fortæl især lægen eller sundhedspersonalet, hvis De tager eller måske tager et eller flere af følgende lægemidler: - Vacciner: De må ikke få Savene, hvis De skal vaccineres mod gul feber, og det anbefales, at De ikke får Savene, hvis De skal vaccineres med en vaccine, der indeholder levende virus.
English: Bibliographical data demonstrate that serum kinetics of dexrazoxane after intravenous administration follow an open two-compartment model independent of schedule and dose.
Danish: Bibliografiske data viser, at dexrazoxans kinetik i serum efter intravenøs administration følger en åben to-kompartment model uafhængigt af doseringsskema og dosis.
English: Inhibition of topoisomerase II.
Danish: Hæmning af topoisomerase II.
English: Savene solvent also contains 1.61 g sodium per 500 ml bottle, equivalent to 81% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Solvenset til Savene indeholder også 1,61 g natrium pr. 500 ml flaske svarende til 81 % af Verdenssundhedsorganisationen WHO's anbefalede maksimale daglige indtagelse på 2 g natrium for en voksen.
English: Infection Neutropenic infection
Danish: Infektion Neutropen infektion
English: The following information is based on two clinical studies, TT01 and TT02, of Savene administered to extravasation patients already receiving cycles of chemotherapeutic agents.
Danish: Følgende oplysninger er baseret på to kliniske studier, TT01 og TT02, med Savene, som blev indgivet til patienter med ekstravasation, som allerede fik cyklusser af kemoterapeutika.
English: A requirement for inclusion in the efficacy part of the study was that the anthracycline extravasation was proven by fluorescence microscopy of one or more biopsies.
Danish: Et inklusionskriterium i effektdelen af studiet var, at ekstravasation af antracyklin blev bekræftet ved fluorescensmikroskopi af en eller flere biopsier.
English: Do not use this medicine after the expiry date which is stated on the carton, powder vial label, and solvent bottle label after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står efter Exp på kartonen og på etiketten på hætteglasset med pulveret og flasken med solvens.
English: Chelation of iron, especially through its ring-opened metabolite thus reducing the irondependent oxidative stress causing anthracycline-induced cardiotoxicity.
Danish: Kelation af jern, især gennem en “åben ring”-metabolit, hvorved det jernafhængige oxidative stress reduceres, så antracyklin-induceret kardiotoksicitet forårsages.
English: • Women of childbearing potential not using contraceptive measures (see section 4.6).
Danish: • Kvinder i den fødedygtige alder som ikke anvender prævention (se pkt.
English: Dexrazoxane has minor influence on the ability to drive and use machines.
Danish: Dexrazoxan påvirker i mindre grad evnen til at føre bil og betjene maskiner.
English: What you need to know before you use Savene
Danish: Det skal De vide, før De begynder at bruge Savene
English: 3.1.4 Allow the vial with the concentrate to stand for 5 minutes at room temperature and check if the solution is homogenous and clear.
Danish: 3.1.4 Lad hætteglasset med koncentratet stå i 5 minutter ved stuetemperatur, og kontrollér, at opløsningen er homogen og klar.
English: Savene should not be administered if you are pregnant.
Danish: De må ikke få Savene, hvis De er gravid.
English: Talk to your doctor or nurse before using Savene: - Savene should only be given to you if you have an extravasation in connection with anthracycline-containing chemotherapy.
Danish: Kontakt lægen eller sundhedspersonalet, før De bruger Savene: - De skal kun have Savene, hvis De har ekstravasation i forbindelse med kemoterapi, som indeholder antracyklin.
English: • Reduction in any of your senses (sight, smell, hearing, touch, taste)
Danish: • Nedsat reaktion på en eller flere sanser (syns-, lugte-, høre-, føle-, smagssans)
English: The Savene solvent contains 98 mg potassium in each 500 ml bottle which may be harmful to people on a low-potassium diet or who have kidney problems.
Danish: Solvens til Savene indeholder 98 mg kalium i hver 500 ml flaske, som kan være skadeligt for personer på diæt med lavt kaliumindhold eller personer med nyreproblemer.
English: Savene solvent also contains 1.61 g sodium (main component of cooking/table salt) in each 500 ml bottle.
Danish: Solvens til Savene indeholder også 1,61 g natrium (hovedkomponent af madlavnings-/bodsalt) i hver 500 ml flaske.
English: Since Savene will be administered to patients undergoing cytotoxic therapy with anthracyclines its cytotoxic potential (especially resulting in reversible haematological toxicity with a nadir occurring on days 11-12) will therefore add to that of the other chemotherapy administered.
Danish: Da Savene indgives til patienter, som gennemgår cytotoksisk behandling med antracykliner, lægges dets cytotoksiske potentiale (især det som fører til reversibel hæmatologisk toksicitet med et nadir, der forekommer på dag 11-12) derfor til det, som findes hos den anden indgivne kemoterapi.
English: • Phenytoin: cytotoxic agents may reduce the absorption of phenytoin leading to an exacerbation of convulsions.
Danish: • Phenytoin: Cytotoksiske stoffer kan nedsætte absorptionen af phenytoin og dermed føre til øget hyppighed af kramper.
English: Previous history of allergy to dexrazoxane should be carefully considered prior to administration (see section 4.3).
Danish: Anamnese med allergi over for dexrazoxan skal overvejes nøje inden administration (se pkt., 4.3).