FrancophonIA/ELRC3.0 huggingface dataset:
English: No additional studies were needed as Zoledronic acid Actavis is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Danish: Det var ikke nødvendigt med supplerende undersøgelser, eftersom Zoledronic acid Actavis er et generisk lægemiddel, der indgives ved infusion og indeholder det samme aktive stof som referencelægemidlet Zometa.
English: Zoledronic acid Actavis must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Danish: Zoledronic acid Actavis må kun anvendes af en læge med erfaring i brugen af denne type lægemiddel, som indgives i en vene.
English: Zoledronic acid Actavis can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Danish: Zoledronic acid Actavis kan anvendes til forebyggelse af knoglekomplikationer hos voksne med fremskreden kræft, der påvirker knoglerne.
English: Because Zoledronic acid Actavis is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Zoledronic acid Actavis er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Zoledronic acid Actavis is a medicine that contains the active substance zoledronic acid (4 mg).
Danish: Zoledronic acid Actavis er et lægemiddel, der indeholder det aktive stof zoledronsyre (4 mg).
English: The Committee recommended that Zoledronic acid Actavis be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Zoledronic acid Actavis.
English: The active substance in Zoledronic acid Actavis, zoledronic acid, is a bisphosphonate.
Danish: Det aktive stof i Zoledronic acid Actavis, zoledronsyre, er et bisphosphonat.
English: Zoledronic acid Actavis is a ‘generic medicine'.
Danish: Zoledronic acid Actavis er et "generisk lægemiddel".
English: By preventing the breakdown of bones, Zoledronic acid Actavis also helps to reduce the amount of calcium released into the blood.
Danish: Idet Zoledronic acid Actavis forebygger nedbrydningen af knoglerne, hjælper det samtidig med at reducere den mængde calcium, der afgives til blodet.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Actavis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoledronic acid Actavis?
English: It is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Danish: Det fås som et koncentrat til infusionsvæske, opløsning, (drop i en vene).
English: What are the benefits and risks of Zoledronic acid Actavis?
Danish: Hvilke fordele og risici er der forbundet med Zoledronic acid Actavis?
English: Other information about Zoledronic acid Actavis
Danish: Andre oplysninger om Zoledronic acid Actavis
English: Zoledronic acid Actavis zoledronic acid
Danish: Zoledronic acid Actavis zoledronsyre
English: Zoledronic acid Actavis can also be used to treat the hypercalcaemia caused by tumours.
Danish: Zoledronic acid Actavis kan også anvendes til at behandle forhøjet calciumindhold i blodet, der skyldes svulster (tumorer).
English: Why has Zoledronic acid Actavis been approved?
Danish: Hvorfor blev Zoledronic acid Actavis godkendt?
English: How has Zoledronic acid Actavis been studied?
Danish: Hvordan blev Zoledronic acid Actavis undersøgt?
English: What is Zoledronic acid Actavis?
Danish: Hvad er Zoledronic acid Actavis?
English: What is Zoledronic acid Actavis used for?
Danish: Hvad anvendes Zoledronic acid Actavis til?
English: How is Zoledronic acid Actavis used?
Danish: Hvordan anvendes Zoledronic acid Actavis?
English: How does Zoledronic acid Actavis work?
Danish: Hvordan virker Zoledronic acid Actavis?
English: It is particularly important that you mention any of the following medicines.
Danish: Det er især vigtigt, at du nævner et hvilket som helst af følgende lægemidler.
English: Treatment should be symptomatic and supportive.
Danish: Behandlingen skal være symptomatisk og understøttende.
English: Distribution into testes is relatively low.
Danish: Fordeling til testes er relativt lav.
English: A neutropenia can occur after each administration.
Danish: Neutropeni kan forekomme efter hver administration.
English: Plasma concentrations decrease rapidly during the first two hours and slowly thereafter.
Danish: Plasmakoncentrationen aftager hurtigt i løbet af de første to timer og derefter langsomt.
English: Any duration
Danish: Uanset varighed
English: You may require a blood transfusion.
Danish: Det kan blive nødvendigt med en blodtransfusion
English: Use after other MS-specific treatments
Danish: Anvendelse efter andre MS-specifikke behandlinger
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Hvis det er hensigtsmæssigt, kan produktoplysningerne efterfølgende blive opdateret af medlemsstaternes myndigheder i samarbejde med referencemedlemsstaten, i overensstemmelse med de procedurer, der er fastlagt i kapitel 4, afsnit III i direktiv 2001/83/EF.
English: There is little experience in children and adolescents.
Danish: Der er kun begrænset erfaring hos børn og unge.
English: • if your heart is not working well;
Danish: • - hvis dit hjerte arbejder dårligt.
English: Many of the reported half-life values for the elimination phase are between 10 and 40 hours, but several other authors have reported much longer values of between 7 and 12 days.
Danish: Mange af de rapporterede halveringstider for eliminationsfasen ligger mellem 10 og 40 timer, men flere andre forfattere har rapporteret meget længere værdier på mellem 7 og 12 dage.
English: Novantrone may cause damage to your unborn child.
Danish: Novantrone kan skade dit ufødte barn.
English: If this happens, the infusion must be stopped and restarted in another vein.
Danish: Hvis det sker, skal infusionen standses og genstartes i en anden vene.
English: There are insufficient data that allows for dose adjustment recommendations.
Danish: Der er kun utilstrækkelige data, der ikke muliggør anbefalinger for dosisjustering.
English: In men, no data are available.
Danish: Der foreligger ingen data for mænd.
English: Cases of ECG anomalies have been reported.
Danish: Tilfælde af EKG-anomalier er blevet indberettet.
English: Do not give this medicine to children and adolescents from birth up to age of 18 years as safety and efficacy in children and adolescents have not been established.
Danish: Denne medicin må ikke gives til børn og unge fra fødslen og op til 18 år, da sikkerheden og virkningen hos børn og unge ikke er blevet dokumenteret.
English: Recovery ≤ 21 days
Danish: Restitution ≤ 21 dage
English: Most complete remissions will occur following the initial course of induction therapy.
Danish: De fleste fuldstændige remissioner vil forekomme efter det første induktionsforløb.
English: Time to recovery
Danish: Tid til restitution
English: To date, only isolated cases of severe local reactions (necroses) have been described due to extravasation.
Danish: Indtil nu er der kun beskrevet isolerede tilfælde af svære lokale reaktioner (nekroser) på grund af ekstravasation.
English: A reversible thrombocytopenia can also be observed.
Danish: Reversibel trombocytopeni kan også observeres.
English: Adjustments of the anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation.
Danish: Justering af antikoagulansdosis kan være nødvendig for at opretholde det ønskede antikoagulationsniveau.
English: The individual dose of Novantrone is calculated by your doctor.
Danish: Den individuelle dosis af Novantrone beregnes af lægen.
English: Recovery > 21 days
Danish: Restitution > 21 dage
English: Its presumed mechanism of action in MS is immunosuppression.
Danish: Den formodede virkningsmekanisme ved MS er immunsuppression.
English: The first course was given approximately 6 weeks after the final induction course; the second was generally administered 4 weeks after the first.
Danish: Det første forløb blev givet ca. 6 uger efter det afsluttede induktionsforløb; det andet forløb blev generelt givet 4 uger efter det første.
English: Of the material recovered in urine, 65 % was unchanged active substance.
Danish: Af det genfundne i urinen var 65 % uomdannet aktivt stof.
English: Contraception in men and women
Danish: Prævention hos mænd og kvinder
English: Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above.
Danish: Spørg lægen eller apotekspersonalet, hvis du ikke er sikker på, om din medicin er en af dem, der er anført på listen ovenfor.
English: If you suffer from these side effects, do not drive any vehicles and/or use any machines.
Danish: Hvis du lider af disse bivirkninger, må du ikke føre motorkøretøj og/eller betjene maskiner.
English: Therefore you should avoid becoming pregnant.
Danish: Derfor skal du undgå at blive gravid.
English: In cases of overdosage patients should be monitored closely.
Danish: I tilfælde af overdosering skal patienten overvåges tæt.
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Danish: Dette produktresumé, denne etikettering og indlægsseddel er resultatet af den referralprocedure, som denne kommissionsbeslutning angår.
English: Particular care should be given to assuring full haematological recovery before undertaking consolidation therapy (if this treatment is used) and patients should be monitored closely during this phase.
Danish: Speciel omhu skal udøves for, at sikre fuld hæmatologisk restitution før konsolideringsbehandling startes (hvis denne behandling anvendes), og patienterne skal monitoreres tæt i denne fase.
English: Repeat prior dose
Danish: Gentag tidligere dosis
English: There are very limited data on the use of mitoxantrone in pregnant women.
Danish: Der er meget begrænsede data fra anvendelse af mitoxantron til gravide kvinder.
English: Your doctor will decide precisely which subsequent dosage you need.
Danish: Lægen vil afgøre, præcist hvilken efterfølgende dosis du skal have.
English: In each individual case the benefit of treatment must be weighed up against the possible risk to the foetus.
Danish: I hvert enkelt tilfælde skal fordelen ved behandling vejes op mod den mulige risiko for fosteret.
English: Differences in the estimates may be due to the availability of data at late times after doses, weighing of the data and assay sensitivity.
Danish: Forskelle i estimaterne kan skyldes tilgængelighed af data på sene tidspunkter efter dosering, vægtning af data og analysefølsomhed.
English: Cardiac function for cancer patients should be carefully monitored during treatment.
Danish: Cancerpatienters kardiale funktion skal monitoreres nøje under behandlingen.
English: You should avoid becoming pregnant.
Danish: Du skal undgå at blive gravid.
English: LVEF evaluation is recommended at regular intervals and/or if signs or symptoms of congestive heart failure develop.
Danish: LVEF-vurdering anbefales med regelmæssige intervaller, og/eller hvis der opstår tegn eller symptomer på kongestivt hjertesvigt.
English: If used alone for recurrence (return of the cancer)
Danish: Hvis det bruges alene ved tilbagefald (kræften er kommet tilbage):
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA <Not applicable>
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA Ikke relevant.
English: No effects were observed on pup development or fertility in the two generation study in rats.
Danish: Der blev ikke observeret indvirkning på afkommets udvikling og fertilitet i to-generationsstudiet hos rotter.
English: Safety and efficacy have not been established.
Danish: Sikkerhed og virkning er ikke klarlagt.
English: Extravasation*
Danish: Ekstravasation*
English: It must always be administered as an intravenous infusion (in a vein) and must always be diluted before.
Danish: Det skal altid gives som en intravenøs infusion (i en vene) og skal altid fortyndes først.
English: Phlebitis has also been reported at the site of infusion.
Danish: Der er også blevet indberettet flebitis på infusionsstedet.
English: Infection (including fatal outcome)
Danish: Infektion (herunder med dødelig udgang)
English: • if you already use other medicines that affect your heart;
Danish: • - hvis du bruger anden medicin, der påvirker hjertet.
English: In human studies, only 10 % and 18 % of the dose were recovered in urine and faeces respectively as either active substance or metabolite during the 5-day period following administration of the medicinal product.
Danish: I humane studier blev kun 10 % og 18 % af dosen genfundet i henholdsvis urin og fæces som enten aktivt stof eller metabolit i løbet af 5-dages-perioden efter indgivelse af lægemidlet.
English: Its therapeutic efficacy has been reported in numerous malignancies.
Danish: Der er rapporteret terapeutisk virkning ved talrige maligniteter.
English: You are more prone to these side effects if you take higher doses of Novantrone or:
Danish: Du har større risiko for disse bivirkninger, hvis du bruger høje doser af Novantrone, eller:
English: Also the time course over which the cumulative dose was given ranged from 3 to 24 months.
Danish: Tidsintervallet, som den kumulative dosis blev givet over, spændte fra 3 til 24 måneder.
English: Infections and Infestations Very common
Danish: Infektioner og infestationer Meget almindelig
English: Withhold until recovery, then repeat prior dose.
Danish: Udskyd dosering indtil restitution, gentag derefter tidligere dosis.
English: The tubing should be inserted preferably into a large vein.
Danish: Kanylen skal fortrinsvis indsættes i en stor vene.
English: The table below is based on safety data derived from clinical trials and spontaneous reporting in oncological indications and from clinical trials, post authorisation safety studies and spontaneous reporting for patients treated for multiple sclerosis.
Danish: Tabellen nedenfor er baseret på sikkerhedsdata fra kliniske forsøg og spontane indberetninger ved onkologiske indikationer og fra kliniske forsøg, sikkerhedsstudier efter godkendelse og spontane indberetninger fra patienter behandlet for dissemineret sklerose.
English: Non-metastatic breast cancer
Danish: Ikke-metastatisk brystcancer
English: This is in general a transient neutropenia with the lowest count of leucocytes at day 10 after the infusion and recovered around day 20.
Danish: Neutropeni er generelt forbigående med den laveste leukocyttælling på dag 10 efter infusion og restitution omkring dag 20.
English: Distribution to tissues is extensive: steady-state volume of distribution exceeds 1,000 L/m2.
Danish: Fordeling til væv er ekstensiv: fordelingsvolumen ved steady state overstiger 1000 l/m2.
English: Your doctor will decide exactly what dosage you need.
Danish: Lægen vil afgøre, præcist hvilken dosis du skal have.
English: This medicinal product is authorised in the Member States of the EEA under the following names: [See Annex I - To be completed nationally]
Danish: Dette lægemiddel er godkendt i medlemsstaterne af EØS under følgende navne: [Se bilag I - udfyldes nationalt]
English: You should also tell your doctor if you are already taking Novantrone and you are prescribed a new medicine that you have not already taken at the same time as Novantrone.
Danish: Du skal også fortælle det til lægen, hvis du allerede bruger Novantrone, og du har fået ordineret et nyt lægemiddel, som du ikke tidligere har taget samtidigt med Novantrone.
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable>
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Ikke relevant.
English: In patients administered 15-90 mg/m2, there is a linear relationship between dose and the area under the concentration curve (AUC).
Danish: Hos patienter, der får 15-90 mg/m2, er der et lineært forhold mellem dosis og arealet under tid-koncentration-kurven (AUC).
English: For patients being treated for cancer:
Danish: For patienter i behandling for kræft:
English: ** The casual relationship to mitoxantrone administration is uncertain.
Danish: ** Den kausale sammenhæng med administration af mitoxantron er usikker.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også bivirkninger, der ikke er nævnt her.
English: It has a cytocidal effect on both proliferating and non-proliferating cultured human cells, suggesting lack of cell cycle phase specificity and activity against rapidly proliferating and slow-growing neoplasms.
Danish: Det har en cytocid virkning på både prolifererende og ikke-prolifererende dyrkede humane celler, hvilket antyder mangel på cellecyklusfase-specificitet og aktivitet mod hurtigt prolifererende og langsomtvoksende neoplasmer.
English: If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
Danish: Hvis du bruger et eller flere af disse, vil lægen måske ordinere en anden medicin til dig.
English: These medicines should be used with care or may need to be avoided during your treatment with Novantrone.
Danish: Disse lægemidler skal bruges med forsigtighed eller skal måske undgås under behandling med Novantrone.
English: The active substance was carcinogenic in experimental animals at doses below the proposed clinical dose.
Danish: Det aktive stof var karcinogent hos forsøgsdyr ved doser under den anbefalede kliniske dosis.
English: Accidental overdoses have been reported.
Danish: Utilsigtet overdosering er blevet indberettet.
English: Oedema Extravasation* Dysgeusia
Danish: Ekstravasation* Dysgeusi
English: Treatment with mitoxantrone 12 to 14 mg/m² was effective in the treatment of various cancers.
Danish: Behandling med mitoxantron 12-14 mg/m2 var effektiv i behandlingen af forskellige cancertyper.
English: Haematological parameters should be regularly monitored (see section 4.4).
Danish: Hæmatologiske parametre skal monitoreres regelmæssigt (se pkt.
English: If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage.
Danish: Såvidt muligt undgås vener over led eller i ekstremiteter med kompromitteret vene- eller lymfedrænage.
English: 4.7 Effects on ability to drive and use machines Mitoxantrone has minor influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Mitoxantron påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: The medicine also suppresses the immune system and is used because of this effect to treat a specific form of multiple sclerosis when there are no alternative treatment options.
Danish: Lægemidlet undertrykker også immunsystemet og bruges på grund af denne virkning til at behandle en speciel form for dissemineret sklerose, når der ikke er andre behandlingsmuligheder.
English: If you become pregnant during the treatment with Novantrone, you must tell your doctor immediately and stop treatment with Novantrone.
Danish: Hvis du bliver gravid under behandlingen med Novantrone, skal du straks fortælle det til lægen og standse behandlingen med Novantrone.
English: Patients should be informed about risks, symptoms and signs of acute leukaemia and prompted to seek medical attendance if any such symptoms should occur even after the five year period has passed.
Danish: Patienterne skal informeres om risici, symptomer og tegn på akut leukæmi samt informeres om at søge læge, hvis et eller flere af disse symptomer skulle forekomme, også efter at 5-års perioden er forløbet.
English: In comparative oncology trials, the overall cumulative probability rate of moderate or severe decreases in LVEF at this dose was 13%.
Danish: I komparative onkologiforsøg var den totale kumulative sandsynlighedsrate for moderate eller svære fald i LVEF ved denne dosis 13 %.
English: Pharmacotherapeutic group: Antineoplastic agents, Anthracyclines and related substances ATC-Code: L01DB07
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske præparater, antracykliner og beslægtede stoffer ATC-kode: L01DB07
English: A cumulative dose of 72 mg/m² is still effective and associated with less cardiotoxicity than higher cumulative doses.
Danish: En kumulativ dosis på 72 mg/m² er stadig effektiv og forbundet med mindre kardiotoksicitet end højere kumulerede doser.
English: Your doctor may need to adjust your treatment or stop Novantrone temporarily or permanently.
Danish: Lægen skal måske regulere behandlingen eller standse behandlingen med Novantrone midlertidigt eller permanent.
English: For this reason, patients should be monitored for evidence of cardiac toxicity and questioned about symptoms of heart failure prior to the initiation of and during treatment.
Danish: Derfor bør patienterne overvåges for tegn på kardial toksicitet og udspørges om symptomer på hjertesvigt før behandlingsstart og under behandlingen.
English: Haematological support and antimicrobial therapy may be required during prolonged periods of severe myelosuppression.
Danish: Hæmatologisk støtte og antimikrobiel terapi kan være nødvendig i langvarige perioder med svær myelosuppression.
English: Neoplasms benign and malignant (including cysts and polyps) Uncommon
Danish: Benigne og maligne neoplasmer (herunder cyster og polypper) Ikke almindelig
English: The remaining 35 % was composed of monocarboxylic and dicarboxylic acid derivatives and their glucuronide conjugates.
Danish: De resterende 35 % bestod af monocarboxyl- og dicarboxylsyrederivater og deres glukuronidkonjugater.
English: Your doctor will carry out blood tests more often, in which he will in particular monitor the number of white blood cells (neutrophilic leucocytes) in the blood:
Danish: Lægen vil oftere tage blodprøver, hvor han specielt overvåger antallet af hvide blodlegemer (neutrofile leukocytter) i blodet, hvis
English: Levels of uric acid, electrolytes and urea should be monitored.
Danish: Urinsyre-, elektrolyt- og urea-niveauer skal monitoreres.
English: Before you start Novantrone and during treatment, your doctor will do a blood test to count the number of your blood cells.
Danish: Før du starter med Novantrone og under behandlingen, vil lægen tage en blodprøve for at tælle antallet af blodceller.
English: There does not seem to be relevant differences in pharmacokinetics of mitoxantrone between elderly and young adult patients.
Danish: Der synes ikke at være relevante forskelle i mitoxantrons farmakokinetik hos ældre og unge voksne patienter.
English: In the absence of sufficient efficacy data in the adjuvant treatment of breast cancer and accounting for the increased risk of leukaemia, mitoxantrone should only be used for metastatic breast cancer.
Danish: I fravær af tilstrækkelige virkningsdata ved adjuvansbehandling af brystcancer og til at redegøre for den øgede risiko for leukæmi må mitoxantron kun anvendes ved metastatisk brystcancer.
English: Mitoxantrone should be used with caution.
Danish: Mitoxantron skal anvendes med forsigtighed.
English: Mitoxantrone is 78 % bound to plasma proteins.
Danish: Mitoxantron er 78 % bundet til plasmaproteiner.
English: Amongst the 80 enrolled patients the median values for the lowest white blood cell count and platelet count were 400/μl (WHO grade 4), and 9.500/μl (WHO grade 4),
Danish: Blandt de 80 indrullerede patienter var medianværdierne for laveste leukocyt- og trombocyttal henholdsvis 400/μl (WHO-grad 4) og 9,500/μl (WHO-grad 4).
English: Mitoxantrone is considered a potential human teratogen because of its mechanism of action and the developmental effects demonstrated by related agents.
Danish: Mitoxantron betragtes som et potentielt humant teratogen på grund af dets virkningsmekanisme og de virkninger på udviklingen, der er påvist ved beslægtede præparater.