FrancophonIA/ELRC3.0 huggingface dataset:
English: The second study compared two doses of Adenuric (80 and 120 mg once a day) with allopurinol over one year in 762 patients.
Danish: Den anden undersøgelse sammenlignede to doser af Adenuric (80 og 120 mg en gang dagligt) med allopurinol i en periode på et år hos 762 patienter.
English: What is the risk associated with Adenuric?
Danish: Hvilken risiko er der forbundet med Adenuric?
English: For the treatment of long-term hyperuricaemia, the recommended dose of Adenuric is 80 mg once a day.
Danish: Til behandling af langvarig hyperurikæmi er den anbefalede dosis 80 mg én gang dagligt.
English: The most commonly reported side effects with Adenuric are gout flare-ups, abnormal liver test results, diarrhoea, nausea (feeling sick), headache, rash and oedema (swelling).
Danish: De hyppigst indberettede bivirkninger ved Adenuric er opblussen af urinsyregigtanfald, unormale levertal, diarré, kvalme, hovedpine, udslæt og ødem (hævelse).
English: The CHMP concluded that Adenuric was more effective than allopurinol at lowering blood uric acid levels including in patients undergoing chemotherapy , but that it could carry a greater risk of side effects affecting the heart and blood vessels.
Danish: CHMP konkluderede, at Adenuric var mere effektivt end allopurinol til at reducere niveauet af urinsyre i blodet, men at det kunne medføre en større risiko for bivirkninger, som påvirker hjertet og blodkarrene.
English: Adenuric is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are on chemotherapy and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).
Danish: Adenuric anvendes til behandling og forebyggelse af forhøjede niveauer af urinsyre i blodet hos voksne med blodkræft, som får kemoterapi, og som kan have risiko for tumorlysis-syndrom (en komplikation, der skyldes, at kræftceller nedbrydes og derved bevirker en kraftig stigning i niveauet af urinsyre i blodet, hvilket kan beskadige nyrerne).
English: Why has Adenuric been approved?
Danish: Hvorfor blev Adenuric godkendt?
English: In patients with blood cancer who were undergoing chemotherapy, Adenuric was as effective as allopurinol in controlling blood levels of uric acid: in 98.3 % of patients (170 out of 173) on Adenuric blood levels of uric acid normalised compared with 96 % (166 out of 173) of patients on allopurinol.
Danish: Hos 98,3 % af de patienter (170 ud af173), der fik adenuric, blev urinsyreniveauet i blodet normalt sammenlignet med 96 % (166 ud af 173) af de patienter, der fik allopurinol.
English: What is Adenuric?
Danish: Hvad er Adenuric?
English: What is Adenuric used for?
Danish: Hvad anvendes Adenuric til?
English: The main measure of effectiveness was based on their blood uric acid levels.
Danish: Det vigtigste mål for virkningen var reduktionen af urinsyreniveauet i blodet.
English: How has Adenuric been studied?
Danish: Hvordan blev Adenuric undersøgt?
English: What benefit has Adenuric shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Adenuric?
English: For the treatment of hyperuricaemia and gout, Adenuric has been studied in two main studies involving a total of 1,834 patients.
Danish: Virkningen af Adenuric blev undersøgt i to primære undersøgelser, der samlet omfattede 1 834 patienter med hyperurikæmi og urinsyregigt.
English: How is Adenuric used?
Danish: Hvordan anvendes Adenuric?
English: How does Adenuric work?
Danish: Hvordan virker Adenuric?
English: It is very important for you to keep all of these appointments.
Danish: Det er meget vigtigt, at du overholder alle disse aftaler.
English: Make sure you do the following:
Danish: Husk at gøre følgende:
English: FREQUENCY NOT KNOWN
Danish: HYPPIGHED IKKE KENDT
English: This medicine could seriously harm your baby.
Danish: Dette lægemiddel kan skade dit barn alvorligt.
English: The elimination half-life in most patients is 2 to 3 hours.
Danish: Halveringstiden hos de fleste patienter er 2 til 3 timer.
English: (≥1/100 to <1/10)
Danish: (≥1/100 TIL <1/10)
English: The patient should be advised to limit contact with other individuals in order to reduce the risk of infection.
Danish: Patienten bør rådes til at begrænse kontakten med andre personer for at reducere risikoen for infektion.
English: Limited information is available regarding rechallenge.
Danish: Der er begrænsede informationer tilgængelige vedrørende fornyet behandling.
English: In addition he or she might ask you to undergo liver biopsies.
Danish: Derudover kan han eller hun måske bede dig få taget nogle leverbiopsier.
English: Do not change your daily dose without first talking to your doctor.
Danish: Foretag ikke ændringer i den daglige dosering, uden først at have talt med lægen.
English: FOR WOMEN OF CHILD BEARING AGE
Danish: TIL KVINDER I DEN FØDEDYGTIGE ALDER
English: The amount of Ferriprox that you take will depend on your weight.
Danish: Den mængde Ferriprox, du tager, afhænger af din vægt.
English: Ask your doctor which method is best for you.
Danish: Spørg din læge hvilken metode der er bedst egnet til dig.
English: SYSTEM ORGAN CLASS VERY COMMON
Danish: SYSTEMORGANKLASSE MEGET
English: *number of tablets rounded to nearest half tablet
Danish: *antal tabletter rundet op til den nærmeste halve tablet
English: Less severe episodes of neutropenia were reported in approximately 5% of patients.
Danish: Mindre alvorlige anfald af neutropeni blev rapporteret hos ca. 5% af patienterne.
English: In some patients it may be beneficial to reduce the dose of deferiprone and then scale it back up to the former dose.
Danish: Hos nogle patienter kan det være gavnligt at reducere deferiprondosis og dernæst skalere den tilbage op til den tidligere dosis.
English: There are limited data available on the use of deferiprone in children between 6 and 10 years of age, and no data on deferiprone use in children under 6 years of age.
Danish: Der er begrænsede data til rådighed om brugen af deferipron til børn i alderen fra 6 til 10 år og ingen data om brug af deferipron til børn under 6 år.
English: The neutrophil count should be then monitored more frequently.
Danish: Neutrofiltallet skal derefter kontrolleres hyppigere.
English: Date of latest renewal: 21 September 2009
Danish: Dato for første godkendelse: 25. august 1999 Dato for sidste fornyelse: 21. september 2009
English: Your doctor will also ask you to come in for tests to monitor body iron load.
Danish: Din læge vil også bede dig møde til undersøgelser for at kontrollere din krops jernbelastning.
English: The levels normalised with oral zinc supplementation.
Danish: Niveauerne blev normaliseret med supplerende oral zinktilførsel.
English: 2333 CN Leiden Netherlands
Danish: 2333 CN Leiden Holland
English: Therefore, in the event of neutropenia, rechallenge is not recommended.
Danish: I tilfælde af neutropeni kan fornyet behandling derfor ikke anbefales.
English: There are no adequate data from the use of deferiprone in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af deferipron hos gravide kvinder.
English: In case of overdose, close clinical supervision of the patient is required.
Danish: I tilfælde af en overdosering er tæt lægelig supervision af patienten nødvendig.
English: • To warn women of childbearing age to not become pregnant because deferiprone may seriously harm the unborn baby.
Danish: • For at advare kvinder i den fødedygtige alder om ikke at blive gravide, fordi deferipron kan give alvorlige skader på det ufødte barn.
English: − if you are HIV positive or if your liver or kidney function is severely impaired, your doctor may recommend additional tests.
Danish: − hvis du er HIV-positiv, eller hvis din lever- eller nyrefunktion er kraftigt nedsat, kan din læge anbefale yderligere undersøgelser.
English: Suggested management of cases of neutropenia is outlined below.
Danish: Forslag til behandling af tilfælde af neutropeni er angivet nedenfor.
English: Total daily dose (mg)
Danish: Samlet daglig dosis (mg)
English: Take your first dose in the morning.
Danish: Tag den første dosis om morgenen.
English: No cases of acute overdose have been reported.
Danish: Der er ikke rapporteret om tilfælde af akut overdosering.
English: Dose adjustments should be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of body iron burden).
Danish: Dosisjusteringer bør skræddersys til de enkelte patienters respons og terapeutiske mål (vedligeholdelse eller reduktion af kroppens jernbelastning).
English: • Whenever the risk management system is modified, especially as a result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Discolored urine is a very common effect and is not harmful.
Danish: Misfarvet urin er en meget almindelig bivirkning og er ikke skadelig.
English: Increased Appetite
Danish: Øget appetit
English: The total daily dose should not exceed 100 mg/kg.
Danish: Den totale daglige dosis bør ikke overstige 100 mg/kg.
English: The product information of deferoxamine should be consulted.
Danish: Det anbefales at rådføre sig med produktinformationen for deferoxamin.
English: Even though agranulocytosis only affects 1 to 2 out of 100 users, it is important to monitor your blood on a regular basis.
Danish: Selvom agranulocytose kun forekommer hos 1 til 2 ud af 100 behandlede, er det vigtigt at overvåge dit blod regelmæssigt.
English: Gastrointestinal effects are more frequent at the beginning of therapy and resolve in most patients within a few weeks without the discontinuation of treatment.
Danish: Gastrointestinale virkninger ses hyppigere i begyndelsen af behandlingen, og hos de fleste patienter ophører de inden for nogle få uger, uden at behandlingen seponeres.
English: The patient's absolute neutrophil count (ANC) should be monitored every week during the first year of therapy.
Danish: Patientens absolutte neutrofiltal (ANC) skal kontrolleres hver uge under det første års behandling.
English: The Patient/Carer reminder card shall contain the following key messages:
Danish: Kortet til patienten/plejeren skal indeholde følgende vigtige budskaber:
English: In the majority of these patients, the increase was asymptomatic and transient, and returned to baseline without discontinuation or decreasing the dose of deferiprone (see section 4.4).
Danish: Hos flertallet af disse patienter var forøgelsen asymptomatisk og forbigående og vendte tilbage til baseline, uden seponering eller dosisnedsættelse af deferipron (se pkt.
English: Take your third dose in the evening.
Danish: Tag den tredje dosis om aftenen.
English: − if you are pregnant or breast-feeding.
Danish: − hvis du er gravid eller ammer.
English: These women should be advised to take contraceptive measures and must be advised to immediately stop taking deferiprone if they become pregnant or plan to become pregnant (see section 4.3).
Danish: Disse kvinder bør rådes til at anvende sikker kontraception og skal informeres om øjeblikkeligt at stoppe med at tage deferipron, hvis de bliver gravide eller planlægger at blive gravide (se pkt.
English: Keizersgracht 311 1016 EE Amsterdam Netherlands
Danish: Keizersgracht 311 1016 EE Amsterdam Holland
English: In these patients careful monitoring of liver histology is recommended.
Danish: Hos disse patienter anbefales omhyggelig overvågning af leverhistologien.
English: Systemic exposure to the inactive 3-O-glucuronide increased with decreasing eGFR.
Danish: Den systemiske eksponering for det inaktive 3-O-glucuronid steg med faldende eGFR.
English: In most cases, the pain disappeared while patients continued taking Ferriprox.
Danish: I de fleste tilfælde forsvandt smerten, selv om patienterne fortsatte med at tage Ferriprox.
English: Your white blood cell count must be checked within 24 hours in order to detect potential agranulocytosis.
Danish: Antallet af hvide blodlegemer skal kontrolleres inden for et døgn for at opdage potentiel agranulocytose.
English: Women of childbearing potential must be advised to avoid pregnancy due to the clastogenic and teratogenic properties of the medicinal product.
Danish: Kvinder i den fødedygtige alder skal rådes til at undgå graviditet pga. de klastogene og teratogene egenskaber af dette lægemiddel.
English: The response to therapy should be assessed periodically, and the occurrence of adverse events closely monitored.
Danish: Respons på behandling bør vurderes jævnligt, og forekomsten af bivirkninger bør overvåges nøje.
English: Carcinogenicity/mutagenicity
Danish: Carcinogenitet/mutagenicitet
English: Cardiac endpoints were assessed by echocardiogram, electrocardiogram, the New York Heart Association classification and death due to cardiac disease.
Danish: Kardiale endpoints blev vurderet ved brug af ekkokardiogram, elektrokardiogram, New York Heart Association-klassificering og dødsfald som følge af kardial sygdom.
English: This metabolite lacks iron-binding capability due to inactivation of the 3-hydroxy group of deferiprone.
Danish: Denne metabolit mangler jernbindingsevne på grund af inaktivering af 3-hydroxy-gruppen i deferipron.
English: Ferriprox was concluded to produce no significant prolongation of the QT interval.
Danish: Det konkluderedes, at ferriprox ikke fremkaldte nogen signifikant forlængelse af QT-intervallet.
English: Do not take this medicine if you are pregnant or if you are trying to become pregnant.
Danish: Du må ikke tage dette lægemiddel, hvis du er gravid, eller hvis du forsøger på at blive gravid.
English: complete, read the card carefully and carry it with you.
Danish: Tag kortet af, udfyld det, læs det omhyggeligt og sørg for at have det på dig.
English: Non-clinical studies have been conducted in animal species including mice, rats, rabbits, dogs and monkeys.
Danish: Der er udført prækliniske studier på dyrearter såsom mus, rotter, kaniner og hunde samt aber.
English: Treatment with deferiprone should not be initiated if the patient is neutropenic.
Danish: Behandling med deferipron bør ikke indledes, hvis patienten har neutropeni.
English: Limited data are available on the combined use of Ferriprox and deferasirox, and caution should be applied when considering the use of such combination.
Danish: Der foreligger kun begrænsede data om den kombinerede brug af Ferriprox og deferasirox, og der skal udvises forsigtighed, når det overvejes at anvende en sådan kombination.
English: An increase in MRI T2* on treatment indicates that iron is being removed from the heart.
Danish: En stigning i MRI T2* på behandling indikerer, at jern fjernes fra hjertet.
English: ((Inside 1))
Danish: ((Inderside 1))
English: • To increase patient awareness of the importance of regular monitoring of the neutrophil count during treatment with deferiprone
Danish: • For at øge patientens bevidsthed om vigtigheden af jævnlig kontrol af neutrofiltallet under behandling med deferipron
English: Some patients experienced progression of fibrosis associated with an increase in iron overload or hepatitis C.
Danish: Nogle patienter fik progression af fibrosen, forbundet med en øgning af jernophobningen eller hepatitis C.
English: However, chelation therapy may not necessarily protect against iron-induced organ damage.
Danish: Kelationsterapi beskytter dog ikke nødvendigvis mod jerninduceret organskade.
English: Data from pooled clinical studies in patients with systemic iron overload show that 63% of the episodes of agranulocytosis occurred within the first six months of treatment, 74% within the first year and 26% after one year of therapy.
Danish: Data fra poolede kliniske studier med patienter med systemisk jernophobning viser, at 63 % af episoderne med agranulocytose forekom inden for de første seks måneders behandling, 74 % inden for det første år og 26 % efter et års behandling.
English: Ferriprox is an iron chelator, a type of medicine that removes excess iron from the body.
Danish: Ferriprox er en jernchelator, dvs. en type medicin, der fjerner overskydende jern fra kroppen.
English: Adverse reaction frequencies: Very common (≥1/10), Common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
Danish: Bivirkningshyppighed: Meget almindelig (≥1/10), Almindelig (≥1/100 til <1/10), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Name and address of the manufacturers responsible for batch release Eurofins PROXY Laboratories B.V.
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse Eurofins PROXY Laboratories B.V.
English: A low white blood cell count can be associated with a serious and potentially life-threatening infection.
Danish: Et lavt antal hvide blodlegemer kan være forbundet med en alvorlig og måske livstruende infektion.
English: It is recommended that such a management protocol be in place prior to initiating any patient on deferiprone treatment.
Danish: Det anbefales, at en sådan behandlingsprotokol er på plads, før der indledes patientbehandling med deferipron.
English: If you have accidentally taken more than the prescribed dose, you should contact your doctor.
Danish: Hvis du ved en fejltagelse har indtaget mere end den anbefalede dosis, skal du kontakte din læge.
English: In the event of agranulocytosis, rechallenge is contraindicated.
Danish: I tilfælde af agranulocytose er fornyet behandling kontraindiceret.
English: If you miss more than one dose do not take a double dose to make up for forgotten individual doses, just continue with your normal schedule.
Danish: Hvis du springer mere end én dosis over, må du ikke tage en dobbeltdosis som erstatning for glemte enkeltdoser, du skal blot fortsætte efter den normale behandlingsplan.
English: If taken during pregnancy, Ferriprox may seriously harm the unborn baby.
Danish: Hvis Ferriprox tages under graviditet, kan det skade det ufødte barn alvorligt.
English: Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia.
Danish: Deferipron-behandling bør indledes og opretholdes af en læge, der har erfaring i behandling af patienter med talassæmi.
English: Instruct the patient to immediately discontinue deferiprone and all other medicinal products with a potential to cause neutropenia.
Danish: Giv patienten besked på omgående at ophøre med indtagelsen af deferipron og alle øvrige lægemidler, som muligvis kan forårsage neutropeni.
English: Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract.
Danish: Deferipron absorberes hurtigt fra den øverste del af gastrointestinalkanalen.
English: • To increase patient awareness of the significance of any symptoms of infection while taking deferiprone
Danish: • For at øge patientens bevidsthed om betydningen af eventuelle symptomer på infektion, mens denne tager deferipron
English: Ferriprox will be most effective if you do not miss any doses.
Danish: Ferriprox er mest effektivt, hvis du ikke springer nogen doser over.
English: Deferiprone must not be used by breast-feeding mothers.
Danish: Deferipron må ikke anvendes af ammende mødre.
English: ((Back Cover))
Danish: ((Bagside))
English: In thalassaemia patients there is an association between liver fibrosis and iron overload and/or hepatitis C. Special care must be taken to ensure that iron chelation in patients with hepatitis C is optimal.
Danish: Hos talassæmi-patienter er der en forbindelse mellem leverfibrose og jernophobning og/eller hepatitis C. Der skal udvises særlig forsigtighed for at sikre, at jernkeleringen hos patienter med hepatitis C er optimal.
English: ((Inside 2))
Danish: ((Inderside 2))
English: There is a small chance that you may develop agranulocytosis (very low white blood cell count) while taking Ferriprox, which may lead to a serious infection.
Danish: Der er en meget lille risiko for, at du kan udvikle agranulocytose (meget lavt antal hvide blodlegemer), mens du tager Ferriprox, hvilket kan medføre alvorlig infektion.
English: Mild arthropathies are generally transient.
Danish: Lettere artroser er generelt forbigående.
English: There are no reports of acute overdose with Ferriprox.
Danish: Der foreligger ingen indberetninger om akut overdosering med Ferriprox.
English: A variable amount of elimination via the faeces has been reported.
Danish: Der er rapporteret en variabel mængde udskillelse via fæces.
English: It is recommended that following recovery from neutropenia, weekly CBC, WBC, neutrophil and platelet counts continue to be obtained for three consecutive weeks, to ensure that the patient recovers fully.
Danish: Det anbefales, at der efter restituering efter neutropeni fortsat indhentes ugentlige CBC, WBC, neutrofil- og trombocyttal i tre på hinanden følgende uger for at sikre, at patienten er helt restitueret.
English: The active substance is deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a bidentate ligand which binds iron in a 3:1 molar ratio.
Danish: Det aktive stof er deferipron (3-hydroxy-1,2-dimetylpyridin-4-et), en bidentat ligand, som binder sig til jern i molarforholdet 3:1.
English: Because white blood cells help to fight infection, a low neutrophil count may place you at risk of developing a serious and potentially life-threatening infection.
Danish: Da hvide blodlegemer hjælper med at bekæmpe infektioner, vil et lavt antal neutrofiler udsætte dig for en risiko for at udvikle en alvorlig eller evt. livstruende infektion.
English: Important Safety Reminders for Patients taking Ferriprox (deferiprone) Prescribing doctor: _________________ Phone No: ________________________
Danish: Vigtige sikkerhedsinformationer for patienter, der tager Ferriprox (deferipron) Ordinerende læge:____________________
English: Keep the bottle tightly closed in order to protect from moisture.
Danish: Hold glasset tæt tillukket for at beskytte indholdet mod fugt.
English: It is not known whether deferiprone is excreted in human milk.
Danish: Det vides ikke, om deferipron udskilles i modermælk.
English: Deferiprone did not show direct mutagenic properties; however, it did display clastogenic characteristics in in vitro assays and in animals.
Danish: Deferipron viste ikke direkte mutagene egenskaber, men det viste klastogene egenskaber i in vitro-analyser og hos dyr.
English: Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
Danish: Plasma Zn2+ koncentration Det anbefales at kontrollere plasma Zn2+ koncentrationen og tilføre ekstra i tilfælde af mangel.
English: A fatal outcome was observed in 8.3% of the reported episodes of agranulocytosis from clinical trials and post-marketing experience.
Danish: Der blev observeret dødsfald i 8,3 % af de rapporterede episoder med agranulocytose fra kliniske forsøg og efter markedsføring.
English: - History of recurrent episodes of neutropenia.
Danish: - Tidligere gentagen forekomst af neutropeni.
English: Since deferiprone binds to metallic cations, the potential exists for interactions between deferiprone and trivalent cation-dependent medicinal products such as aluminium-based antacids.
Danish: Da deferipron binder sig til metalkationer, er der dog mulighed for interaktioner mellem deferipron og trivalente kationafhængige lægemidler, såsom aluminium-baserede antacida.
English: In view of the genotoxicity results, a carcinogenic potential of deferiprone cannot be excluded (see section 5.3).
Danish: I betragtning af genotoksicitetsresultaterne kan en carcinogen virkning af deferipron ikke udelukkes (se pkt.
English: If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.
Danish: Hvis du bliver gravid, mens du tager Ferriprox, skal du omgående ophøre med at tage lægemidlet og underrette din læge.