FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Trecondi
Danish: Andre oplysninger om Trecondi
English: Further information on Trecondi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/trecondi.
Danish: Yderligere information om Trecondi findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/trecondi.
English: What measures are being taken to ensure the safe and effective use of Trecondi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trecondi?
English: The dose of Trecondi depends on the condition for which transplantation is needed, whether the patient is an adult or a child and on the patient's weight and height.
Danish: Dosen af Trecondi afhænger af, hvilken sygdom transplantationen skal bruges til, om patienten er en voksen eller et barn, og af patientens vægt og højde.
English: The European Medicines Agency therefore decided that Trecondi's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Trecondi opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Trecondi are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Trecondi vurderes omhyggeligt, og der foretages de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Trecondi, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Trecondi, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects with Trecondi are manageable and comparable to those seen with busulfan.
Danish: Bivirkningerne ved Trecondi er håndterbare og sammenlignelige med dem, der ses ved busulfan.
English: Like busulfan, Trecondi is considered as a conditioning treatment of ‘reduced-intensity': this means that it is less toxic than standard conditioning treatments which are based on chemotherapy with or without radiation.
Danish: I lighed med busulfan betragtes Trecondi som en konditionerende behandling med "reduceret intensitet", dvs. at den er mindre toksisk end almindelige konditionerende behandlinger, som er baseret på kemoterapi med eller uden stråling.
English: An overview of Trecondi and why it is authorised in the EU
Danish: En oversigt over Trecondi, og hvorfor det er godkendt i EU
English: The patient receives Trecondi once a day for 3 days before the transplantation.
Danish: Patienten modtager Trecondi én gang dagligt i 3 dage inden transplantationen.
English: What is Trecondi and what is it used for?
Danish: Hvad er Trecondi, og hvad anvendes det til?
English: Trecondi can therefore kill cells in the patient's bone marrow and make room for the new cells from a donor.
Danish: Trecondi kan derfor dræbe celler i patientens knoglemarv og gøre plads til de nye celler fra en donor.
English: Fludarabine is given once a day for 5 days before transplantation.
Danish: Fludarabin gives en gang dagligt i 5 dage inden transplantationen.
English: In an additional study in 70 children with blood cancers, 99% of children given Trecondi (with fludarabine) were alive 3 months after their transplant.
Danish: I et yderligere studie af 70 børn med blodkræft var 99 % af de børn, der fik Trecondi (med fludarabin), i live 3 måneder efter deres transplantation.
English: Why is Trecondi authorised in the EU?
Danish: Hvorfor blev Trecondi godkendt i EU?
English: It is used as a ‘conditioning' treatment to clear the patient's bone marrow and make room for the transplanted bone marrow cells, which can then produce healthy blood cells.
Danish: Det anvendes som en "konditionerende" (forberedende) behandling for at rense patientens knoglemarv for celler og gøre plads til de transplanterede knoglemarvsceller, som så kan producere sunde blodceller.
English: Haematopoietic stem cell transplantation is rare, and Trecondi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 February 2004.
Danish: Hæmatopoietisk stamcelletransplantation er sjælden, og Trecondi blev udpeget som "lægemiddel til sjældne sygdomme" den 23. februar 2004.
English: The active substance in Trecondi is treosulfan.
Danish: Det aktive stof i Trecondi er treosulfan.
English: Pregnant women must not use Trecondi and live vaccines must not be given to patients receiving Trecondi.
Danish: Gravide kvinder må ikke bruge Trecondi, og patienter, der får Trecondi, må ikke vaccineres med levende vaccine.
English: Trecondi must not be used in patients with an active, uncontrolled infection, with severe heart, lung, liver or kidney problems, and in patients with Fanconi anaemia and other DNA repair disorders.
Danish: Trecondi må ikke anvendes til patienter med en aktiv, ukontrolleret infektion, med svære hjerte-, lunge-, lever- eller nyreproblemer eller til patienter med Fanconi's anæmi og andre DNAreparationssygdomme.
English: What are the risks associated with Trecondi?
Danish: Hvilke risici er der forbundet med Trecondi?
English: There is also sufficient data to show that Trecondi is effective in adults (but not enough data are available in children) with non-cancerous blood disorders.
Danish: Der er også tilstrækkelige data til at påvise, at Treondi er effektivt til behandling af voksne (børn foreligger der ikke tilstrækkelige data om) med godartede blodsygdomme.
English: Two main studies showed that Trecondi is at least as effective as busulfan, another medicine used to prepare patients for haematopoietic stem cell transplantation.
Danish: To hovedstudier viste, at Trecondi er mindst lige så effektivt som busulfan, som er en anden type lægemiddel, der anvendes til patienter som forberedende behandling inden hæmatopoietisk stamcelletransplantation.
English: In the body, treosulfan is converted into other compounds called epoxides which kill cells, especially cells that develop rapidly such as bone marrow cells, by attaching to their DNA while they are dividing.
Danish: I kroppen omdannes treosulfan til andre stoffer (epoxider), som dræber celler, navnlig celler, der udvikler sig hurtigt, som f.eks. knoglemarvsceller, ved at binde sig til deres
English: Trecondi is given as a two-hour infusion (drip) into a vein.
Danish: Trecondi gives i en vene ved en infusion (drop), der varer 2 timer.
English: The active substance in Trecondi, treosulfan, belongs to a group of medicines called alkylating agents.
Danish: Det aktive stof i Trecondi, treosulfan, er et kræftmiddel, der tilhører en gruppe af lægemidler, som kaldes alkylerende midler.
English: In one of the studies, involving 570 adults with acute myeloid leukaemia (a blood cancer) or myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced), 64% of patients given Trecondi (with fludarabine) had a successful transplant and were alive and disease-free after 2 years, compared with 51% of patients given busulfan (with fludarabine).
Danish: I et af studierne, der omfattede 570 voksne med akut myeloid leukæmi (blodkræft) eller myelodysplastiske syndromer (tilstand, hvor der produceres et stort antal unormale blodlegemer), var transplantationen vellykket hos 64 % af de patienter, der fik Trecondi (med fludarabin), og de var i live og sygdomsfri efter 2 år sammenlignet med 51 % af de patienter, der fik busulfan (med fludarabin).
English: Trecondi is used together with another medicine called fludarabine in adults and children from 1 month of age with blood cancers as well as in adults with other severe disorders requiring a bone marrow transplant.
Danish: Trecondi anvendes sammen med et andet lægemiddel, der hedder fludarabin, til voksne og børn fra 1måneds-alderen med blodkræft samt til voksne med andre alvorlige lidelser, der kræver en knoglemarvstransplantation.
English: Tiredness, febrile neutropenia (low white blood cell counts with fever) and high blood levels of bilirubin (a breakdown product of red blood cells) are also seen in more than 1 in 10 adults, and rash also affects more than 1 in 10 children.
Danish: Træthed, febril neutropeni (lavt antal hvide blodlegemer med feber) og højt indhold af bilirubin (et nedbrydningsprodukt af røde blodlegemer) ses også hos mere end 1 ud af 10 voksne.
English: The medicine can only be obtained with a prescription and use of Trecondi must be supervised by a doctor experienced in conditioning treatment before allogeneic haematopoietic stem cell transplantation.
Danish: Lægemidlet udleveres kun efter recept, og anvendelsen af Trecondi skal overvåges af en læge med erfaring i konditionerende behandling inden allogen hæmatopoietisk stamcelletransplantation.
English: The most common side effects in adults and children with Trecondi (which may affect more than 1 in 10 people) are infections, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), vomiting, diarrhoea and abdominal pain (belly ache).
Danish: De hyppigste bivirkninger hos voksne og børn med Trecondi (som kan forekomme hos mere end 1 ud af 10 patienter) er infektioner, kvalme, betændelse i mundslimhinden, opkastning, diarré og mavesmerter.
English: Trecondi is a medicine given to patients before they have a bone marrow transplant from a donor known as ‘allogeneic haematopoietic stem cell transplantation'.
Danish: Trecondi er et lægemiddel, der gives til patienter, inden de får en knoglemarvstransplantation fra en donor ("allogen hæmatopoietisk stamcelletransplantation").
English: How is Trecondi used?
Danish: Hvordan anvendes Trecondi?
English: What benefits of Trecondi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Trecondi?
English: Trecondi is effective at preparing adults and children with blood cancers for haematopoietic stem cell transplantation.
Danish: Trecondi er effektivt til voksne og børn med blodkræft som forberedende behandling inden hæmatopoietisk stamcelletransplantation.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trecondi have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Trecondi.
English: How does Trecondi work?
Danish: Hvordan virker Trecondi?
English: If these effects are not treated they could be fatal.
Danish: Hvis disse bivirkninger ikke bliver behandlet, kan de være dødelige.
English: The binding is long-lasting.
Danish: Bindingen opretholdes i lang tid.
English: The risk is increased in case of the above-mentioned treatment combinations.
Danish: Risikoen er større i tilfælde af ovennævnte behandlingskombinationer.
English: Teva Gyógyszergyár Zrt.
Danish: Magyarország Teva Gyógyszergyár Zrt.
English: • Alcohol
Danish: • Alkohol
English: The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Danish: Den lille reduktion i AUC forventes ikke at forårsage en reduktion i terapeutisk effekt.
English: The safety data from this study in patients aged 6 to < 18 years appeared generally similar to that observed in adults.
Danish: Sikkerhedsdata fra dette studie hos patienter i alderen 6 til <18 år syntes generelt at svare til dem, der blev observeret hos voksne.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Danish: Patienten bør monitoreres nøje, og behandlingen bør være symptomatisk og understøttende.
English: Insomnia, depression
Danish: Søvnløshed, depression
English: Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Danish: Derfor er det vigtigt at få målt blodtrykket regelmæssigt for at finde ud af, om det ligger i normalområdet.
English: Take it as soon as you remember then carry on as before.
Danish: Tag den så snart du kommer i tanke om det og fortsæt derefter som normalt.
English: Cumulative urinary excretion is <1 % of dose.
Danish: Den kumulative udskillelse i urinen er <1 % af dosis.
English: Absorption of telmisartan is rapid although the amount absorbed varies.
Danish: Absorption af telmisartan sker hurtigt, om end mængden varierer.
English: Its clinical significance and relevance is unknown.
Danish: Den kliniske betydning og relevans er ukendt.
English: The clinical relevance of this observation is not known.
Danish: Den kliniske relevans af denne observation er ikke kendt.
English: If you do not take your tablet on one day, take your normal dose on the next day.
Danish: Hvis du en dag ikke får taget din tablet, skal du blot tage den sædvanlige dosis næste dag.
English: Reduction of cardiovascular morbidity in adults with:
Danish: Reduktion af kardiovaskulær morbiditet hos voksne med:
English: Your doctor may need to change the dose of these other medicines or take other precautions.
Danish: Det kan være nødvendigt at ændre dosis af disse andre typer medicin eller tage andre forholdsregler.
English: Not all pack sizes may be marketed
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: An increase in eosinophils reported in this patient population has not been recorded in adults.
Danish: En stigning i eosinofil-værdier, som blev rapporteret i denne patientpopulation, er ikke blevet registreret hos voksne.
English: • Risk Management Plan (RMP) Not applicable
Danish: • Risikostyringsplan (RMP)
English: There are usually no symptoms of high blood pressure before damage occurs.
Danish: Man har normalt ingen symptomer på forhøjet blodtryk, før en skade sker.
English: The mean absolute bioavailability for telmisartan is about 50 %.
Danish: Den gennemsnitlige, absolutte biotilgængelighed af telmisartan er ca. 50 %.
English: The change was dose dependent.
Danish: Ændringen var dosisafhængig.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: These clinical data do not allow to make conclusions on the efficacy and safety of telmisartan in hypertensive paediatric population.
Danish: Disse kliniske data gør det ikke muligt at drage konklusioner om telmisartans virkning og sikkerhed i den hypertensive pædiatriske population.
English: Although the study was too small for a meaningful assessment of the pharmacokinetics of children under 12 years of age, the results are generally consistent with the findings in adults and confirm the non-linearity of telmisartan, particularly for Cmax.
Danish: Selvom studiet var for lille til en meningsfuld vurdering af farmakokinetikken hos børn under 12 år, er resultaterne generelt i overensstemmelse med resultaterne hos voksne og bekræfter non-lineariteten af telmisartan, især for Cmax.
English: There is limited information available with regard to overdose in humans.
Danish: Der er begrænsede erfaringer med overdosering hos mennesker.
English: • Amifostine (a protective medicine during radiotherapy for cancer treatment)
Danish: • Amifostin (en beskyttende medicin under strålebehandling mod kræft)
English: Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics, or antidepressants.
Danish: Endvidere kan ortostatisk hypotension blive forværret af alkohol, barbiturater, narkotika eller antidepressiva.
English: Try to take the tablet at the same time each day.
Danish: Det er mest hensigtsmæssigt at tage tabletten på samme tidspunkt hver dag.
English: Non-steroidal anti-inflammatory medicinal products
Danish: Non-steroide antiinflammatoriske lægemidler
English: The observed increased occurrence rate of sepsis associated with the use of telmisartan may be either a chance finding or related to a mechanism not currently known.
Danish: Den observerede øgede forekomst af sepsis forbundet med brugen af telmisartan kan enten være en tilfældighed eller relateret til en mekanisme, som på nuværende tidspunkt ikke er kendt.
English: Other possible side effects of telmisartan:
Danish: Andre mulige bivirkninger ved telmisartan:
English: Some people feel dizzy or tired when taking Telmisartan Teva.
Danish: Nogle vil føle sig svimle eller blive trætte, når de tager Telmisartan Teva.
English: • Other medicines used to treat high blood pressure
Danish: • Anden medicin, der anvendes til behandling af forhøjet blodtryk
English: There is no linear relationship between doses and plasma levels.
Danish: Der er ingen lineær sammenhæng mellem dosis og plasmaniveauer.
English: Push the tablet through the exposed foil
Danish: Tryk tabletten gennem folien
English: • type 2 diabetes mellitus with documented target organ damage
Danish: • type 2-diabetes med dokumenteret organpåvirkning.
English: No pharmacological activity has been shown for the conjugate.
Danish: Der er ikke set farmakologisk aktivitet for konjugatet.
English: There are no adequate data from the use of Telmisartan Teva in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af Telmisartan Teva hos gravide kvinder.
English: Treatment of essential hypertension
Danish: Behandling af essentiel hypertension
English: Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Danish: 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: After oral (and intravenous) administration, telmisartan is nearly exclusively excreted with the faeces, mainly as unchanged compound.
Danish: Efter oral (og intravenøs) administration blev telmisartan udskilt næsten udelukkende i fæces og hovedsagelig som uforandret stof.
English: Adverse reactions have been ranked under headings of frequency using the following convention:
Danish: Bivirkningerne er opdelt efter hyppighed ud fra følgende konvention:
English: Hypoglycaemia (in diabetic patients)
Danish: Hypoglykæmi (hos diabetes patienter)
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet beskrevet i markedsføringstilladelsen, Modul 1.8.1, er på plads og fungerer, før og mens produktet markedsføres.
English: Corticosteroïds (systemic route) Reduction of the antihypertensive effect.
Danish: Kortikosteroider (systemisk administration) Reducerer den antihypertensive virkning.
English: East Sussex, BN22 9AG United Kingdom
Danish: East Sussex, BN22 9AG Storbritannien
English: • Barbiturates (strong sleeping tablets)
Danish: • Barbiturater (stærke sovepiller)
English: Cmax and to a lesser extent AUC increase disproportionately at doses above 40 mg.
Danish: Cmaks og i mindre grad AUC stiger disproportionalt ved doser over 40 mg.
English: Do not take a double dose to make up for forgotten individual doses.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Activated charcoal may be useful in the treatment of overdosage.
Danish: Aktivt kul kan ofte med fordel anvendes ved behandlingen af overdosis.
English: Your doctor will normally advise you to stop taking Telmisartan Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Teva.
Danish: Normalt vil din læge anbefale dig at stoppe med at tage Telmisartan Teva, før du bliver gravid eller så snart du ved, du er gravid og anbefale en anden type medicin i stedet for Telmisartan Teva.
English: Hypertension Treatment of essential hypertension in adults.
Danish: Hypertension Behandling af essentiel hypertension hos voksne.
English: There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Danish: Der var ingen tegn på mutagenicitet og relevant klasteogen aktivitet ved in vitro-forsøg og ingen tegn på karcinogenicitet i rotter og mus.
English: • Lithium containing medicines to treat some types of depression.
Danish: • Medicin, som indeholder lithium til behandling af depression.
English: Put the tablet in your mouth and swallow with water or a suitable liquid
Danish: Put tabletten i munden og synk med vand eller anden egnet væske
English: The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Danish: Det tilsyneladende fordelingsvolumen, (Vdss), ved “steady state” er ca. 500 l.
English: The occurrence of hyperkalaemia depends on associated risk factors.
Danish: Forekomsten af hyperkaliæmi er relateret til risikofaktorer.
English: The event may be a chance finding or related to a mechanism currently not known (see also section
Danish: Observationen kan være en tilfældighed eller relateret til en mekanisme, som på nuværende tidspunkt ikke er kendt (se pkt.
English: Pharmacokinetic objectives included the determination of the steady-state of telmisartan in children and adolescents, and investigation of age-related differences.
Danish: De farmakokinetiske parametre omfattede bestemmelse af telmisartan-steady-state hos børn og unge og undersøgelse af aldersrelaterede forskelle.
English: The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC), increase disproportionately with dose.
Danish: Den maksimale plasmakoncentration (Cmaks) og, i mindre grad, arealet under plasmakoncentrationtidskurven (AUC) stiger disproportionalt med dosis.
English: Telmisartan Teva contains sorbitol.
Danish: Telmisartan Teva indeholder sorbitol.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på æsken og blisteren efter ”EXP”.
English: The incidence of adverse reactions was not dose related and showed no correlation with gender, age or race of the patients.
Danish: Hyppigheden af bivirkninger var ikke dosisrelateret, og der var ingen korrelation med patienternes køn, alder eller race.
English: Táncsics Mihály út 82 Hungary (Headquarters: 4042 Debrecen, Pallagi út 13)
Danish: Táncsics Mihály út 82 Ungarn (Hovedsæde: 4042 Debrecen, Pallagi út 13)
English: Táncsics Mihály út 82 Hungary
Danish: Táncsics Mihály út 82 Ungarn
English: Elderly patients No dose adjustment is necessary for elderly patients.
Danish: Ældre patienter Dosisjustering er ikke nødvendig hos ældre patienter.
English: Cardiovascular prevention
Danish: Kardiovaskulær forebyggelse
English: The mean duration of follow up was 4 years and 8 months.
Danish: Behandlingsperioden var i gennemsnit 4 år og 8 måneder.
English: There is no evidence of clinically relevant accumulation of telmisartan taken at the recommended dose.
Danish: Der er ingen tegn på klinisk relevant akkumulering af telmisartan ved anbefalet dosering.
English: Sepsis including fatal outcome1
Danish: Sepsis inklusive sepsis med fatalt udfald1
English: Plasma concentrations were higher in females than in males, without relevant influence on efficacy.
Danish: Plasmakoncentrationen er højere hos kvinder end hos mænd uden relevant indvirkning på effekt.
English: Therefore it is not expected to potentiate bradykinin-mediated adverse effects.
Danish: Derfor forventes det ikke, at bradykinin-medierede bivirkninger potenseres.
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Danish: I farmakokinetiske forsøg med patienter med nedsat leverfunktion var der en forøgelse af den absolutte biotilgængelighed på op til næsten 100 %.