natgillin/translations-raw huggingface dataset:
Hyperurikæmi kan medføre, at der dannes og opbygges uratkrystaller i leddene og nyrerne. 
Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys.
Derfor anbefales det, at patienter tager andre lægemidler for at forebygge urinsyregigtanfald i mindst de første seks måneder af behandlingen med Adenuric. 
Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first six months of treatment with Adenuric.
Til behandling og forebyggelse af hyperurikæmi hos patienter, der gennemgår kemoterapi, er den anbefalede dosis 120 mg én gang dagligt. 
For the prevention and treatment of hyperuricaemia in patients undergoing chemotherapy, the recommended dose is 120 mg once a day.
Adenuric anvendes til patienter, som allerede har symptomer på opbygning af krystaller, herunder arthrose (smerter og inflammation i leddene) eller tophi (”sten”, større aflejringer af uratkrystaller, som kan medføre led- og knogleskader). 
Adenuric is used in patients who already have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones', larger deposits of urate crystals that can cause joint and bone damage).
Adenuric var mere effektivt end allopurinol og placebo til at behandle hyperurikæmi ved at nedsætte niveauet af urinsyre i blodet. 
Adenuric was more effective than allopurinol and placebo in treating hyperuricaemia by reducing blood uric acid levels.
Adenuric anvendes til behandling af voksne med langvarig hyperurikæmi (et højt indhold af urinsyre eller ”urat” i blodet). 
Adenuric is used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Det aktive stof i Adenuric, febuxostat, reducerer dannelsen af urinsyre. 
The active substance in Adenuric, febuxostat, reduces the formation of uric acid.
Den første undersøgelse, som omfattede 1 072 patienter, sammenlignede tre doser Adenuric (80, 120 og 240 mg en gang dagligt) med placebo (en virkningsløs behandling) og med allopurinol (et andet lægemiddel til behandling af hyperurikæmi). 
The first study, carried out in 1,072 patients, compared three doses of Adenuric (80, 120 and 240 mg once a day) with placebo (a dummy treatment) and allopurinol (another medicine used to treat hyperuricaemia).
I den første undersøgelse havde 48 % af patienterne, som modtog 80 mg Adenuric en gang dagligt (126 ud af 262), og 65 % af de patienter, som modtog 120 mg en gang dagligt (175 ud af 269), et urinsyreniveau under 6 mg/dl i de sidste tre målinger. 
In the first study, 48% of the patients taking 80 mg Adenuric once a day (126 out of 262) and 65% of the patients taking 120 mg once a day (175 out of 269) had levels of uric acid below 6 mg/dl in the final three measurements.
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. 
The second study compared two doses of Adenuric (80 and 120 mg once a day) with allopurinol over one year in 762 patients.
Hvilken risiko er der forbundet med Adenuric? 
What is the risk associated with Adenuric?
Til behandling af langvarig hyperurikæmi er den anbefalede dosis 80 mg én gang dagligt. 
For the treatment of long-term hyperuricaemia, the recommended dose of Adenuric is 80 mg once a day.
De hyppigst indberettede bivirkninger ved Adenuric er opblussen af urinsyregigtanfald, unormale levertal, diarré, kvalme, hovedpine, udslæt og ødem (hævelse). 
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).
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. 
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.
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). 
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).
Hvorfor blev Adenuric godkendt? 
Why has Adenuric been approved?
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. 
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.
Hvad er Adenuric? 
What is Adenuric?
Hvad anvendes Adenuric til? 
What is Adenuric used for?
Det vigtigste mål for virkningen var reduktionen af urinsyreniveauet i blodet. 
The main measure of effectiveness was based on their blood uric acid levels.
Hvordan blev Adenuric undersøgt? 
How has Adenuric been studied?
Hvilken fordel viser undersøgelserne, at der er ved Adenuric? 
What benefit has Adenuric shown during the studies?
Virkningen af Adenuric blev undersøgt i to primære undersøgelser, der samlet omfattede 1 834 patienter med hyperurikæmi og urinsyregigt. 
For the treatment of hyperuricaemia and gout, Adenuric has been studied in two main studies involving a total of 1,834 patients.
Hvordan anvendes Adenuric? 
How is Adenuric used?
Hvordan virker Adenuric? 
How does Adenuric work?
Det er meget vigtigt, at du overholder alle disse aftaler. 
It is very important for you to keep all of these appointments.
Husk at gøre følgende: 
Make sure you do the following:
HYPPIGHED IKKE KENDT 
FREQUENCY NOT KNOWN
Dette lægemiddel kan skade dit barn alvorligt. 
This medicine could seriously harm your baby.
Halveringstiden hos de fleste patienter er 2 til 3 timer. 
The elimination half-life in most patients is 2 to 3 hours.
(≥1/100 TIL <1/10) 
(≥1/100 to <1/10)
Patienten bør rådes til at begrænse kontakten med andre personer for at reducere risikoen for infektion. 
The patient should be advised to limit contact with other individuals in order to reduce the risk of infection.
Der er begrænsede informationer tilgængelige vedrørende fornyet behandling. 
Limited information is available regarding rechallenge.
Derudover kan han eller hun måske bede dig få taget nogle leverbiopsier. 
In addition he or she might ask you to undergo liver biopsies.
Foretag ikke ændringer i den daglige dosering, uden først at have talt med lægen. 
Do not change your daily dose without first talking to your doctor.
TIL KVINDER I DEN FØDEDYGTIGE ALDER 
FOR WOMEN OF CHILD BEARING AGE
Den mængde Ferriprox, du tager, afhænger af din vægt. 
The amount of Ferriprox that you take will depend on your weight.
Spørg din læge hvilken metode der er bedst egnet til dig. 
Ask your doctor which method is best for you.
SYSTEMORGANKLASSE MEGET 
SYSTEM ORGAN CLASS VERY COMMON
*antal tabletter rundet op til den nærmeste halve tablet 
*number of tablets rounded to nearest half tablet
Mindre alvorlige anfald af neutropeni blev rapporteret hos ca. 5% af patienterne. 
Less severe episodes of neutropenia were reported in approximately 5% of patients.
Hos nogle patienter kan det være gavnligt at reducere deferiprondosis og dernæst skalere den tilbage op til den tidligere dosis. 
In some patients it may be beneficial to reduce the dose of deferiprone and then scale it back up to the former dose.
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. 
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.
Neutrofiltallet skal derefter kontrolleres hyppigere. 
The neutrophil count should be then monitored more frequently.
Dato for første godkendelse: 25. august 1999 Dato for sidste fornyelse: 21. september 2009 
Date of latest renewal: 21 September 2009
Din læge vil også bede dig møde til undersøgelser for at kontrollere din krops jernbelastning. 
Your doctor will also ask you to come in for tests to monitor body iron load.
Niveauerne blev normaliseret med supplerende oral zinktilførsel. 
The levels normalised with oral zinc supplementation.
2333 CN Leiden Holland 
2333 CN Leiden Netherlands
I tilfælde af neutropeni kan fornyet behandling derfor ikke anbefales. 
Therefore, in the event of neutropenia, rechallenge is not recommended.
Der foreligger ikke tilstrækkelige data om brugen af deferipron hos gravide kvinder. 
There are no adequate data from the use of deferiprone in pregnant women.
I tilfælde af en overdosering er tæt lægelig supervision af patienten nødvendig. 
In case of overdose, close clinical supervision of the patient is required.
• For at advare kvinder i den fødedygtige alder om ikke at blive gravide, fordi deferipron kan give alvorlige skader på det ufødte barn. 
• To warn women of childbearing age to not become pregnant because deferiprone may seriously harm the unborn baby.
− hvis du er HIV-positiv, eller hvis din lever- eller nyrefunktion er kraftigt nedsat, kan din læge anbefale yderligere undersøgelser. 
− if you are HIV positive or if your liver or kidney function is severely impaired, your doctor may recommend additional tests.
Forslag til behandling af tilfælde af neutropeni er angivet nedenfor. 
Suggested management of cases of neutropenia is outlined below.
Samlet daglig dosis (mg) 
Total daily dose (mg)
Tag den første dosis om morgenen. 
Take your first dose in the morning.
Der er ikke rapporteret om tilfælde af akut overdosering. 
No cases of acute overdose have been reported.
Dosisjusteringer bør skræddersys til de enkelte patienters respons og terapeutiske mål (vedligeholdelse eller reduktion af kroppens jernbelastning). 
Dose adjustments should be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of body iron burden).
• 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. 
• 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.
Misfarvet urin er en meget almindelig bivirkning og er ikke skadelig. 
Discolored urine is a very common effect and is not harmful.
Øget appetit 
Increased Appetite
Den totale daglige dosis bør ikke overstige 100 mg/kg. 
The total daily dose should not exceed 100 mg/kg.
Det anbefales at rådføre sig med produktinformationen for deferoxamin. 
The product information of deferoxamine should be consulted.
Selvom agranulocytose kun forekommer hos 1 til 2 ud af 100 behandlede, er det vigtigt at overvåge dit blod regelmæssigt. 
Even though agranulocytosis only affects 1 to 2 out of 100 users, it is important to monitor your blood on a regular basis.
Gastrointestinale virkninger ses hyppigere i begyndelsen af behandlingen, og hos de fleste patienter ophører de inden for nogle få uger, uden at behandlingen seponeres. 
Gastrointestinal effects are more frequent at the beginning of therapy and resolve in most patients within a few weeks without the discontinuation of treatment.
Patientens absolutte neutrofiltal (ANC) skal kontrolleres hver uge under det første års behandling. 
The patient's absolute neutrophil count (ANC) should be monitored every week during the first year of therapy.
Kortet til patienten/plejeren skal indeholde følgende vigtige budskaber: 
The Patient/Carer reminder card shall contain the following key messages:
Hos flertallet af disse patienter var forøgelsen asymptomatisk og forbigående og vendte tilbage til baseline, uden seponering eller dosisnedsættelse af deferipron (se pkt. 
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).
Tag den tredje dosis om aftenen. 
Take your third dose in the evening.
− hvis du er gravid eller ammer. 
− if you are pregnant or breast-feeding.
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. 
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).
Keizersgracht 311 1016 EE Amsterdam Holland 
Keizersgracht 311 1016 EE Amsterdam Netherlands
Hos disse patienter anbefales omhyggelig overvågning af leverhistologien. 
In these patients careful monitoring of liver histology is recommended.
Den systemiske eksponering for det inaktive 3-O-glucuronid steg med faldende eGFR. 
Systemic exposure to the inactive 3-O-glucuronide increased with decreasing eGFR.
I de fleste tilfælde forsvandt smerten, selv om patienterne fortsatte med at tage Ferriprox. 
In most cases, the pain disappeared while patients continued taking Ferriprox.
Antallet af hvide blodlegemer skal kontrolleres inden for et døgn for at opdage potentiel agranulocytose. 
Your white blood cell count must be checked within 24 hours in order to detect potential agranulocytosis.
Kvinder i den fødedygtige alder skal rådes til at undgå graviditet pga. de klastogene og teratogene egenskaber af dette lægemiddel. 
Women of childbearing potential must be advised to avoid pregnancy due to the clastogenic and teratogenic properties of the medicinal product.
Respons på behandling bør vurderes jævnligt, og forekomsten af bivirkninger bør overvåges nøje. 
The response to therapy should be assessed periodically, and the occurrence of adverse events closely monitored.
Carcinogenitet/mutagenicitet 
Carcinogenicity/mutagenicity
Kardiale endpoints blev vurderet ved brug af ekkokardiogram, elektrokardiogram, New York Heart Association-klassificering og dødsfald som følge af kardial sygdom. 
Cardiac endpoints were assessed by echocardiogram, electrocardiogram, the New York Heart Association classification and death due to cardiac disease.
Denne metabolit mangler jernbindingsevne på grund af inaktivering af 3-hydroxy-gruppen i deferipron. 
This metabolite lacks iron-binding capability due to inactivation of the 3-hydroxy group of deferiprone.
Det konkluderedes, at ferriprox ikke fremkaldte nogen signifikant forlængelse af QT-intervallet. 
Ferriprox was concluded to produce no significant prolongation of the QT interval.
Du må ikke tage dette lægemiddel, hvis du er gravid, eller hvis du forsøger på at blive gravid. 
Do not take this medicine if you are pregnant or if you are trying to become pregnant.
Tag kortet af, udfyld det, læs det omhyggeligt og sørg for at have det på dig. 
complete, read the card carefully and carry it with you.
Der er udført prækliniske studier på dyrearter såsom mus, rotter, kaniner og hunde samt aber. 
Non-clinical studies have been conducted in animal species including mice, rats, rabbits, dogs and monkeys.
Behandling med deferipron bør ikke indledes, hvis patienten har neutropeni. 
Treatment with deferiprone should not be initiated if the patient is neutropenic.
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. 
Limited data are available on the combined use of Ferriprox and deferasirox, and caution should be applied when considering the use of such combination.
En stigning i MRI T2* på behandling indikerer, at jern fjernes fra hjertet. 
An increase in MRI T2* on treatment indicates that iron is being removed from the heart.
((Inderside 1)) 
((Inside 1))
• For at øge patientens bevidsthed om vigtigheden af jævnlig kontrol af neutrofiltallet under behandling med deferipron 
• To increase patient awareness of the importance of regular monitoring of the neutrophil count during treatment with deferiprone
Nogle patienter fik progression af fibrosen, forbundet med en øgning af jernophobningen eller hepatitis C. 
Some patients experienced progression of fibrosis associated with an increase in iron overload or hepatitis C.
Kelationsterapi beskytter dog ikke nødvendigvis mod jerninduceret organskade. 
However, chelation therapy may not necessarily protect against iron-induced organ damage.
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. 
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.
Ferriprox er en jernchelator, dvs. en type medicin, der fjerner overskydende jern fra kroppen. 
Ferriprox is an iron chelator, a type of medicine that removes excess iron from the body.
Bivirkningshyppighed: Meget almindelig (≥1/10), Almindelig (≥1/100 til <1/10), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
Adverse reaction frequencies: Very common (≥1/10), Common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse Eurofins PROXY Laboratories B.V. 
Name and address of the manufacturers responsible for batch release Eurofins PROXY Laboratories B.V.
Et lavt antal hvide blodlegemer kan være forbundet med en alvorlig og måske livstruende infektion. 
A low white blood cell count can be associated with a serious and potentially life-threatening infection.
Det anbefales, at en sådan behandlingsprotokol er på plads, før der indledes patientbehandling med deferipron. 
It is recommended that such a management protocol be in place prior to initiating any patient on deferiprone treatment.
Hvis du ved en fejltagelse har indtaget mere end den anbefalede dosis, skal du kontakte din læge. 
If you have accidentally taken more than the prescribed dose, you should contact your doctor.
I tilfælde af agranulocytose er fornyet behandling kontraindiceret. 
In the event of agranulocytosis, rechallenge is contraindicated.
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. 
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.
Hvis Ferriprox tages under graviditet, kan det skade det ufødte barn alvorligt. 
If taken during pregnancy, Ferriprox may seriously harm the unborn baby.
Deferipron-behandling bør indledes og opretholdes af en læge, der har erfaring i behandling af patienter med talassæmi. 
Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia.
Giv patienten besked på omgående at ophøre med indtagelsen af deferipron og alle øvrige lægemidler, som muligvis kan forårsage neutropeni. 
Instruct the patient to immediately discontinue deferiprone and all other medicinal products with a potential to cause neutropenia.
Deferipron absorberes hurtigt fra den øverste del af gastrointestinalkanalen. 
Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract.
• For at øge patientens bevidsthed om betydningen af eventuelle symptomer på infektion, mens denne tager deferipron 
• To increase patient awareness of the significance of any symptoms of infection while taking deferiprone
Ferriprox er mest effektivt, hvis du ikke springer nogen doser over. 
Ferriprox will be most effective if you do not miss any doses.
Deferipron må ikke anvendes af ammende mødre. 
Deferiprone must not be used by breast-feeding mothers.
((Bagside)) 
((Back Cover))
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. 
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.
((Inderside 2)) 
((Inside 2))
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. 
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.
Lettere artroser er generelt forbigående. 
Mild arthropathies are generally transient.
Der foreligger ingen indberetninger om akut overdosering med Ferriprox. 
There are no reports of acute overdose with Ferriprox.
Der er rapporteret en variabel mængde udskillelse via fæces. 
A variable amount of elimination via the faeces has been reported.
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. 
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.
Det aktive stof er deferipron (3-hydroxy-1,2-dimetylpyridin-4-et), en bidentat ligand, som binder sig til jern i molarforholdet 3:1. 
The active substance is deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a bidentate ligand which binds iron in a 3:1 molar ratio.
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. 
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.
Vigtige sikkerhedsinformationer for patienter, der tager Ferriprox (deferipron) Ordinerende læge:____________________ 
Important Safety Reminders for Patients taking Ferriprox (deferiprone) Prescribing doctor: _________________ Phone No: ________________________
Hold glasset tæt tillukket for at beskytte indholdet mod fugt. 
Keep the bottle tightly closed in order to protect from moisture.
Det vides ikke, om deferipron udskilles i modermælk. 
It is not known whether deferiprone is excreted in human milk.
Deferipron viste ikke direkte mutagene egenskaber, men det viste klastogene egenskaber i in vitro-analyser og hos dyr. 
Deferiprone did not show direct mutagenic properties; however, it did display clastogenic characteristics in in vitro assays and in animals.
Plasma Zn2+ koncentration Det anbefales at kontrollere plasma Zn2+ koncentrationen og tilføre ekstra i tilfælde af mangel. 
Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
Der blev observeret dødsfald i 8,3 % af de rapporterede episoder med agranulocytose fra kliniske forsøg og efter markedsføring. 
A fatal outcome was observed in 8.3% of the reported episodes of agranulocytosis from clinical trials and post-marketing experience.
- Tidligere gentagen forekomst af neutropeni. 
- History of recurrent episodes of neutropenia.