natgillin/translations-raw huggingface dataset:
Referér venligst til det informationskort til patient/plejer, der følger med denne indlægsseddel.
Please refer to the patient/carer reminder card attached to this leaflet.
Artroser, der strakte sig fra lettere smerter i et eller flere led og op til alvorlig arthritis med effusion og signifikant funktionsnedsættelse er ligeledes blevet rapporteret hos patienter, der har modtaget behandling med deferipron.
Arthropathy events, which ranged from mild pain in one or more joints to severe arthritis with effusion and significant disability, have also been reported in patients treated with deferiprone.
Studie LA37-1111 udførtes for at vurdere virkningen af en enkelt terapeutisk (33 mg/kg) eller supraterapeutisk (50 mg/kg) oral dosis af deferipron på varigheden af hjertets QT-interval hos raske forsøgspersoner.
Study LA37-1111 was conducted to evaluate the effect of single therapeutic (33 mg/kg) and supratherapeutic (50 mg/kg) oral doses of deferiprone on the cardiac QT interval duration in healthy subjects.
De neurologiske forstyrrelser svandt gradvist efter seponering af deferipron.
The neurological disorders progressively regressed after deferiprone discontinuation.
Efter påbegyndelse af Ferriprox-behandling anbefales det, at koncentrationerne af serumferritin eller andre indikatorer for jernophobning i kroppen overvåges hver anden til tredje måned for at vurdere den langsigtede effektivitet af et kelationsregimen til styring af jernophobning i kroppen.
After starting Ferriprox therapy, it is recommended that serum ferritin concentrations, or other indicators of body iron load, be monitored every two to three months to assess the long-term effectiveness of the chelation regimen in controlling the body iron load.
Publicerede data stemmer overens med resultaterne fra Apotex-studiet, der påviste færre hjertesygdomme og/eller forøget overlevelse hos Ferriprox-behandlede patienter end hos dem, der blev behandlet med deferoxamin.
Data from the published literature are consistent with the results from the Apotex studies, demonstrating less heart disease and/or increased survival in Ferriprox-treated patients than in those treated with deferoxamine.
Studie LA12-9907 sammenlignede overlevelse, forekomst af kardial sygdom samt progression af kardial sygdom hos 129 talassæmi-patienter, som blev behandlet i mindst 4 år med Ferriprox (N=54) eller deferoxamin (N=75).
Study LA12-9907 compared survival, incidence of cardiac disease, and progression of cardiac disease in 129 patients with thalassaemia major treated for at least 4 years with Ferriprox (N=54) or deferoxamine (N=75).
Dersom der udvikler sig tegn på infektion samtidigt med neutropenien, skal de aktuelle dyrkninger og diagnostiske procedurer gennemføres, og en egnet behandlingsplan påbegyndes.
Should any evidence of infection develop concurrently with the neutropenia, the appropriate cultures and diagnostic procedures should be performed and an appropriate therapeutic regimen instituted.
Forekomsten af bivirkninger hos 18 børn og 97 voksne behandlet med kombinationsterapi var ikke signifikant forskellig mellem de to aldersgrupper, undtagen i forekomsten af artrose (11,1 % hos børn vs. ingen hos voksne, p=0,02).
The incidences of adverse reactions experienced by 18 children and 97 adults treated with combination therapy were not significantly different between the two age groups except in the incidence of arthropathy (11.1% in children vs. none in adults, p=0.02).
Følg ovenstående retningslinjer og sørg for passende behandling, så som granulocytkolonistimulerende faktor, som indledes samme dag som tilfældet identificeres.
Follow the guidelines above and administer appropriate therapy such as granulocyte colony stimulating factor, beginning the same day that the event is identified; administer daily until the condition resolves.
For at opnå en dosis på ca. 75 mg/kg/dag anvendes det antal tabletter, der foreslås i følgende skemaer til patientens kropsvægt.
To obtain a dose of about 75 mg/kg/day, use the number of tablets suggested in the following tables for the body weight of the patient.
Episoder med hypotoni, ustabilitet, manglende evne til at gå og hypertoni med manglende evne til at bevæge lemmerne er rapporteret hos børn efter markedsføringen ved standarddoser af deferipron.
Episodes of hypotonia, instability, inability to walk, and hypertonia with inability of limb movement, have been reported in children in the post-marketing setting with standard doses of deferiprone.
Indhent en komplet blodstælling (CBC) med leukocyttal (WBC) korrigeret for tilstedeværelse af kerneindeholdende erytrocytter, et neutrofiltal og et trombocyttal umiddelbart efter diagnosticering af tilfældet og gentag dernæst daglig.
Obtain a complete blood cell (CBC) count, with a white blood cell (WBC) count, corrected for the presence of nucleated red blood cells, a neutrophil count, and a platelet count immediately upon diagnosing the event and then repeat daily.
Efter randomisering fik 32 patienter deferoxamin (34,9 mg/kg/dag i 5 dage/uge) og Ferriprox (75 mg/kg/dag), og 33 patienter fik deferoxamin monoterapi (43,4 mg/kg/dag i 5 dage/uge).
Following randomization, 32 patients received deferoxamine (34.9 mg/kg/day for 5 days/week) and Ferriprox (75 mg/kg/day) and 33 patients received deferoxamine monotherapy (43.4 mg/kg/day for 5 days/week).
Den er emballeret i flasker à 250 ml eller 500 ml.
It is packaged in bottles of 250 ml or 500 ml.
Hvis du får kvalme eller kaster op, kan det måske hjælpe at indtage Ferriprox sammen med mad.
If you experience nausea or vomiting, it may help to take your Ferriprox with some food.
Neurologiske forstyrrelser er observeret hos børn, som i flere år frivilligt har fået ordineret mere end 2,5 gange den maksimalt anbefalede dosis, men er også observeret ved standarddoser af deferipron.
Neurological disorders have been observed in children treated with more than 2.5 times the maximum recommended dose for several years but have also been observed with standard doses of deferiprone.
Den normale dosis er 25 mg/kg, 3 gange daglig, for en total daglig dosis på 75 mg/kg.
The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg.
Baseret på de rapporterede utilsigtede interaktioner, der kan forekomme mellem deferoxamin og Cvitamin, bør der udvises forsigtighed ved samtidig indgivelse af deferipron og C-vitamin.
Based on the reported adverse interaction that can occur between deferoxamine and vitamin C, caution should be used when administering deferiprone and vitamin C concurrently.
Farmakoterapeutisk klassifikation: Jernkelerende stoffer, ATC-kode: V03AC02
Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC02
ml oral opløsning (tre gange daglig)
ml of oral solution (three times/day)
Forsøgsdeltagerne blev inddelt i 3 grupper ud fra Child-Pugh klassifikationsscoren: raske frivillige, let leverinsufficiens (klasse A: 5-6 point) og moderatleverinsufficiens (klasse B: 7-9 point).
Subjects were categorized into 3 groups based on the Child-Pugh classification score: healthy volunteers, mild hepatic impairment (Class A: 5- 6 points), and moderate hepatic impairment (Class B: 7- 9 points).
Antal af 1000 mg tabletter*
Number of 1000 mg tablets* Morning
− hvis du har haft gentagne episoder med neutropeni (et lavt antal hvide blodlegemer (neutrofiler)).
− if you have a history of repeated episodes of neutropenia (low white blood cell (neutrophil)
Spidskoncentrationer i serum for glukuronidet forekommer 2 til 3 timer efter indgivelse af deferipron.
Peak serum concentrations of the glucuronide occur 2 to 3 hours after administration of deferiprone.
Dosisjusteringer ved anvendelse sammen med andre jernkelerende stoffer Hos patienter, hvor monoterapi er utilstrækkelig, kan Ferriprox anvendes sammen med deferoxamin med en standarddosis (75 mg/kg/dag), men bør ikke overstige 100 mg/kg/dag.
Dose adjustments when used with other iron chelators In patients for whom monotherapy is inadequate, Ferriprox may be used with deferoxamine at the standard dose (75 mg/kg/day) but should not exceed 100 mg/kg/day.
For patienter, som ikke har fået afbrudt behandlingen med Ferriprox i løbet af det første år på grund af fald i neutrofiltallet, kan perioden mellem kontrol af det absolutte neutrofiltal efter et års behandling med deferipron forlænges til patientens blodtranfusionsinterval (hver 2.-4. uge).
For patients whose Ferriprox has not been interrupted during the first year of therapy due to any decrease in the neutrophil count, the frequency of ANC monitoring may be extended to the patient's blood transfusion interval (every 2-4 weeks) after one year of deferiprone therapy.
Kliniske studier har vist, at Ferriprox er effektivt til fremme af jernudskillelse, og at en dosis på 25 mg/kg tre gange daglig kan forebygge progression af jernakkumulation vurderet ved serumferritin hos patienter med transfusions-afhængig talassæmi.
Clinical studies have demonstrated that Ferriprox is effective in promoting iron excretion and that a dose of 25 mg/kg three times per day can prevent the progression of iron accumulation as assessed by serum ferritin, in patients with transfusion-dependent thalassaemia.
Denne tilstand, som kaldes svær neutropeni eller agranulocytose, optrådte hos 1 til 2 ud af 100 personer, som tog Ferriprox i kliniske studier.
This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken Ferriprox in clinical studies.
Hos hunner forsinkede en virkning på brunstcyklus tiden til bekræftet parring ved alle testede doser.
In females, an effect on the oestrous cycle delayed time to confirmed mating at all doses tested.
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede): - lavt antal hvide blodlegemer (agranulocytose og neutropeni) - hovedpine - diarré - stigning i leverenzymer - træthed - forøget appetit
Common side effects (may affect up to 1 in 10 people): - low white blood cell count (agranulocytosis and neutropenia) - headache - diarrhoea - increase in liver enzymes - fatigue - increase in appetite
Gule-polyethylenterephthalat (PET) flasker med børnesikret lukke (polypropylen) og et gradueret målebæger (polypropylen).
Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).
Omhyggelig monitorering af hjertetilfælde hos patienter, der fik kombinationsterapi, er berettiget (se pkt.
Careful monitoring of cardiac events in patients on combination therapy is warranted (see section 4.4).
Spørg lægen eller apoteket, hvis du er i tvivl.
Check with your doctor or pharmacist if you are not sure.
Publicerede data om jernbalancestudier hos talassæmi-patienter viser, at brugen af Ferriprox samtidig med deferoxamin (samtidig administration af begge kelerende stoffer på samme dag enten samtidigt eller sekventielt, f.eks. Ferriprox om dagen og deferoxamin om aftenen), fremmer større jernudskillelse end med kun ét af disse lægemidler.
Data from the published literature on iron balance studies in patients with thalassaemia major show that the use of Ferriprox concurrently with deferoxamine (coadministration of both chelators during the same day, either simultaneously or sequentially, e.g., Ferriprox during the day and deferoxamine during the night), promotes greater iron excretion than either drug alone.
Generelt viste færre Ferriprox-behandlede patienter end deferoxamin-behandlede patienter en forværring af den kardiale dysfunktion fra første vurdering til sidste vurdering (4% vs. 20%, p=0,007).
Overall, fewer Ferriprox-treated patients than deferoxamine-treated patients showed a worsening of cardiac dysfunction from first assessment to last assessment (4% vs. 20%, p=0.007).
Kontakt din læge eller apoteket, før du tager ascorbinsyre (C-vitamin) sammen med Ferriprox.
Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.
I tilfælde af jerninduceret hjertesvigt bør Ferriprox med 75-100 mg/kg/dag tilføjes til behandlingen med deferoxamin.
In the case of iron-induced heart failure, Ferriprox at 75-100 mg/kg/day should be added to deferoxamine therapy.
Data fra den poolede sikkerhedsdatabase fra kliniske studier (1343 patientårs eksponering for Ferriprox-monoterapi og 244 patientårs eksponering for Ferriprox og deferoxamin) viste statistisk signifikante (p<0,05) forskelle i forekomsten af bivirkninger baseret på systemorganklassen “Hjerte", "Knogler, led, muskler og bindevæv” samt "Nyrer og urinveje".
Data from the pooled safety database from clinical trials (1343 patient-years exposure to Ferriprox monotherapy and 244 patient-years exposure to Ferriprox and deferoxamine) showed statistically significant (p<0.05) differences in the incidence of adverse reactions based on System Organ Class for “Cardiac disorders", "Musculoskeletal and connective tissue disorders” and "Renal and urinary disorders".
Ledsmerte og hævelse spændende fra let smerte i et eller flere led til alvorlig funktionsnedsættelse.
Events of joint pain and swelling ranged from mild pain in one or more joints to severe disability.
Dosis (mg, tre gange daglig)
Dose (mg, three times/day)
Abdominalsmerter Opkastning
Abdominal Pain Vomiting
Du må ikke tage Ferriprox, hvis du er gravid, eller hvis du forsøger at blive gravid.
Do not take Ferriprox if you are pregnant or if you are trying to become pregnant.
Den højere forekomst af bivirkninger i systemorganklassen “Hjerte", rapporteret under kombinationsterapi end monoterapi, skyldtes muligvis den højere forekomst af allerede eksisterende hjertesygdomme hos patienter, som fik kombinationsterapi.
The higher rate of “Cardiac disorders" reported during combination therapy than monotherapy was possibly due to the higher incidence of pre-existing cardiac disorders in patients who received combination therapy.
Tag den anden dosis midt på dagen.
Take your second dose midday.
- Graviditet (se pkt.
- Pregnancy (see section 4.6).
Hydroxypropylcellulose
Hydroxypropyl cellulose
Afbrydelse af behandling med deferipron bør overvejes, hvis serumferritin falder under 500 µg/l.
Interruption of therapy with deferiprone should be considered if serum ferritin falls below 500 µg/l.
Hvis behandling ikke kan undgås, skal amningen stoppes (se pkt.
If treatment is unavoidable, breast-feeding must be stopped (see section 4.3).
Den maksimale forskel mellem middelværdierne (beregnet ved mindste kvadraters metode) ved den terapeutiske dosis og placebo var 3,01 ms (95% ensidet øvre konfidensgrænse (UCL): 5,01 ms), og mellem middelværdierne (beregnet ved mindste kvadraters metode) ved den supraterapeutiske dosis og placebo var 5,23 ms (95% ensidet UCL: 7,19 ms).
The maximum difference between the LS means of the therapeutic dose and placebo was 3.01 ms (95% one-sided UCL: 5.01 ms), and between the LS means of the supratherapeutic dose and placebo was 5.23 ms (95% one-sided UCL: 7.19 ms).
Agranulocytose og neutropeni forsvinder normalt, når behandlingen med Ferriprox seponeres, men der har været rapporter om tilfælde af agranulocytose med dødelig udgang.
Agranulocytosis and neutropenia usually resolve upon discontinuation of Ferriprox, but fatal cases of agranulocytosis have been reported.
Nyre- og leverfunktion bør overvåges hos disse patientpopulationer, mens de er i behandling med deferipron.
Renal and hepatic function should be monitored in these patient populations during deferiprone therapy.
Den alvorligste bivirkning rapporteret i kliniske studier med deferipron var agranulocytose, defineret som et absolut neutrofiltal på mindre end 0,5 x 109/l, som opstod hos ca. 1% af patienterne.
The most serious adverse reaction reported in clinical trials with deferiprone was agranulocytosis, defined as an absolute neutrophil count less than 0.5 x 109/l, which occurred in approximately 1% of patients.
Studierne LA16-0102, LA-01 og LA08-9701 sammenlignede Ferriprox' virkning med deferoxamins virkning til styring af serumferritin hos transfusionsafhængige talassæmi-patienter.
Studies LA16-0102, LA-01 and LA08-9701 compared the efficacy of Ferriprox with that of deferoxamine in controlling serum ferritin in transfusion-dependent thalassaemia patients.
Anvendelse af deferipron bør ophøre, hvis der observeres neurologiske forstyrrelser (se pkt.
Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and
Nyligt diagnosticeret kardial dysfunktion opstod hos 13 (20,6%) deferoxamin-behandlede patienter og hos 2 (4,3%) Ferriprox-behandlede patienter, som var fri for hjertesygdomme ved første vurdering (p=0,013).
Newly diagnosed cardiac dysfunction occurred in 13 (20.6%) deferoxamine-treated patients and in 2 (4.3%) Ferriprox-treated patients who were cardiac disease-free at the first assessment (p=0.013).
Samtidig brug af jernkelerende stoffer frarådes hos patienter, hvis serumferritin falder under 500 µg/l på grund af risikoen for overdreven jernfjernelse.
Concurrent use of iron chelators is not recommended in patients whose serum ferritin falls below 500 µg/l due to the risk of excessive iron removal.
En total daglig dosis på over 100 mg/kg kropsvægt kan ikke anbefales, da der muligvis er en øget risiko for bivirkninger (se pkt.
A total daily dose above 100 mg/kg body weight is not recommended because of the potentially increased risk of adverse reactions (see sections 4.4, 4.8, and 4.9).
Der blev ikke observeret nogen virkninger på fertilitet eller tidlig fosterudvikling hos ikke-jernbelastede han- og hunrotter, som fik deferipron oralt i doser på op til 75 mg/kg 2 gange daglig i 28 dage (hanner) eller 2 uger (hunner) før parring og til aflivning (hanner) eller under tidlig drægtighed (hunner).
No effects on fertility or early embryonic development were noted in non-iron-loaded male and female rats that received deferiprone orally at doses of up to 75 mg/kg twice daily for 28 days (males) or 2 weeks (females) prior to mating and until termination (males) or through early gestation (females).
Ændringen fra ugentlig kontrol af det absolutte neutrofiltal til tidspunktet for transfusionsbesøgene efter 12 måneders behandling med Ferriprox skal tilpasses den enkelte patient efter lægens vurdering af patientens forståelse for de nødvendige risikominimeringsforanstaltninger under behandlingen (se pkt.
The change from weekly ANC monitoring to at the time of transfusion visits after 12 months of Ferriprox therapy, should be considered on an individual patient basis, according to the physician's assessment of the patient's understanding of the risk minimization measures required during therapy (see section 4.4 below).
KONTROL AF HVIDE BLODCELLETAL VED BEHANDLING MED FERRIPROX
MONITORING YOUR WHITE BLOOD CELL COUNT WITH FERRIPROX
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 250 ml oral opløsning
PHARMACEUTICAL FORM AND CONTENTS 250 ml oral solution
61 patienter med jernophobning i hjertet, som tidligere blev behandlet med deferoxamin, blev randomiseret til at fortsætte med deferoxamin (gennemsnitlig dosis på 43 mg/kg/dag; N=31) eller skifte til Ferriprox (gennemsnitlig dosis på 92 mg/kg/dag N=29).
Sixty-one patients with cardiac iron overload, previously treated with deferoxamine, were randomized to continue deferoxamine (average dose 43 mg/kg/day; N=31) or to switch to Ferriprox (average dose 92 mg/kg/day N=29).
Hver pakning indeholder en flaske med 250 ml eller 500 ml oral opløsning.
Each pack contains one bottle of 250 ml or 500 ml oral solution.
Det hyppigste fund hos ikke jernbelastede dyr i doser på 100 mg/kg/dag og derover var hæmatologiske virkninger, såsom hypocellularitet i knoglemarven og nedsat antal hvide og røde blodlegemer og/eller trombocytter i perifert blod.
The most common findings in non-iron-loaded animals at doses of 100 mg/kg/day and above were hematologic effects such as bone marrow hypocellularity, and decreased WBC, RBC and/or platelet counts in peripheral blood.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Anvendes inden/EXP.
Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. After first opening use within 35 days.
− de alvorligste bivirkninger, som kan fremkomme, mens du tager Ferriprox, er et meget lavt antal hvide blodlegemer (neutrofiler)).
− the most serious side effect that may occur while taking Ferriprox is a very low white blood cell (neutrophil) count.
Deferipron seponeres omgående, hvis patienten får en infektion.
Immediately interrupt deferiprone if the patient experience infection.
Du skal benytte effektive præventionsmidler, mens du tager Ferriprox.
You must use effective contraception while you are taking Ferriprox.
Myokardial MRI T2*-værdier på mindre end 20 ms indikerer jernophobning i hjertet.
Myocardial MRI T2* values of less than 20 ms represent iron overload in the heart.
Deferipron-3-O-glucuronids AUC var 10 % lavere og Cmax 20 % lavere hos forsøgsdeltagere med let eller moderat leverinsufficiens sammenlignet med raske frivillige.
Deferiprone-3-O-glucuronide AUC was decreased by 10% and Cmax by 20% in mildly and moderately impaired subjects compared with healthy volunteers.
75% til 90% af den indtagne dosis rapporteres som værende genfundet i urinen i løbet af de første 24 timer i form af frit deferipron, glucuronidmetabolitten og jerndeferipronkompleks.
In humans, deferiprone is eliminated mainly via the kidneys; 75% to 90% of the ingested dose is reported as being recovered in the urine in the first 24 hours, in the form of free deferiprone, the glucuronide metabolite and the iron-deferiprone complex.
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 behandlede): - mavesmerter - kvalme - opkastning - rødbrun misfarvning af urinen
Very common side effects (may affect more than 1 in 10 people): - abdominal pain - nausea - vomiting - reddish/brown discoloration of urine
For at opnå en dosis på ca. 75 mg/kg/dag anvendes den mængde oral opløsning, der foreslås i følgende skema for patientens legemsvægt.
To obtain a dose of about 75 mg/kg/day, use the volume of oral solution suggested in the following table for the body weight of the patient.
Disse symptomer forsvandt, når børnene ophørte med at tage Ferriprox.
The children recovered from these symptoms after Ferriprox discontinuation.
Ferriprox oral opløsning indeholder Sunset yellow (E110) Sunset yellow (E110) er et farvestof, som kan forårsage allergiske reaktioner.
Ferriprox oral solution contains Sunset Yellow (E110) Sunset Yellow (E110) is a colouring agent which may cause allergic reactions.
− hvis du har haft agranulocytose (et meget lavt antal hvide blodlegemer (neutrofiler)).
− if you have a history of agranulocytosis (very low white blood cell (neutrophil) count).
Deferipron indgives som regel oralt med 25 mg/kg legemsvægt tre gange dagligt for en total daglig dosis på 75 mg/kg legemsvægt.
Deferiprone is usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight.
Ved første vurdering oplevede ingen af patienterne med kardial dysfunktion, som blev behandlet med deferipron, sammenlignet med fire (33%) behandlet med deferoxamin en forværring af deres kardiale status (p=0,245).
Of patients with cardiac dysfunction at first assessment, none treated with deferiprone compared with four (33%) treated with deferoxamine had worsening of their cardiac status (p=0.245).
Den alvorligste bivirkning ved Ferriprox er et meget lavt antal hvide blodlegemer (neutrofiler).
The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count.
Hvis De ønsker yderligere oplysninger om Ferriprox, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Ud fra resultaterne af dette studie er justering af Ferriprox-dosisregimet ikke nødvendig hos patienter med nyreinsufficiens.
Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with impaired renal function.
I studiets 12-måneders-forløb var Ferriprox superior til deferoxamin mht. reduktion af kardial jernophobning.
Over the 12-month duration of the study, Ferriprox was superior to deferoxamine in decreasing cardiac iron load.