natgillin/translations-raw huggingface dataset:
Niveauet af serumferritin (mængden af ferritin i blodet) viser, hvor meget jern der er lagret i kroppen.
The serum ferritin level (the amount of ferritin in the blood) is indicative of the amount of iron stored in the body.
Den gennemsnitlige koncentration af jern i leveren hos Ferriprox- behandlede patienter syntes dog at stige mere end hos patienter behandlet med deferoxamin.
In the initial comparative study, the mean serum ferritin levels were not significantly different in the two treatment groups, but average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.
I undersøgelsen med vekslende behandling, hvor behandlingen kombinerede Ferriprox i fem dage med deferoxamin i to dage, blev ferritinniveauerne reduceret i samme omfang, som når deferoxamin blev taget alene.
In the alternating treatment study, the treatment schedule combining Ferriprox for five days with deferoxamine for two days reduced ferritin levels to the same extent as deferoxamine taken on its own.
Imidlertid var antallet af patienter i undersøgelsen ikke tilstrækkelig stort til at bevise, at en sådan kombineret behandling er lige så effektiv som deferoxamin taget alene.
However, the number of patients in the study was not sufficient to prove that such a schedule is as effective as deferoxamine taken on its own.
De mest almindelige bivirkninger i forbindelse med Ferriprox (set hos flere end 1 ud af 10 patienter) er rødlig/ brun urin (der viser, at der bliver udskilt jern), kvalme, mavesmerte og opkastning.
The most common side effects with Ferriprox (seen in more than 1 patient in 10) are reddish/ brown urine (showing that iron is being excreted), nausea (feeling sick), abdominal (tummy) pain and vomiting.
En ikke almindelig men alvorlig bivirkning er agranulocytose (meget lave niveauer af en type hvide blodlegemer).
An uncommon but serious side effect is agranulocytosis (very low levels of a type of white blood cell).
Ferriprox bør ikke anvendes til patienter, der er overfølsomme (allergiske) over for deferipron eller over for et eller flere af de øvrige indholdsstoffer.
Ferriprox should not be used in people who may be hypersensitive (allergic) to deferiprone or any of the other ingredients.
Ferriprox bør ikke anvendes af personer, som gentagne gange har lidt af neutropeni (lave niveauer af en form for hvide blodlegemer) eller af agranulocytose.
Ferriprox should not be used in people who have had neutropenia (low levels of a type of white blood cell) repeatedly or agranulocytosis.
Ferriprox bør ikke anvendes sammen med lægemidler, der kan forårsage neutropeni eller agranulocytose.
Ferriprox should also not be used with medicines that might cause neutropenia or agranulocytosis.
Ferriprox bør ikke anvendes af gravide eller ammende kvinder.
Ferriprox should not be used in women who are pregnant or breast-feeding.
Udvalget for Humanmedicinske Lægemidler (CHMP) var af den opfattelse, at Ferriproxs fordele er større end risiciene til behandling af jernophobning hos patienter med thalassaemia major, hvor behandlingen med deferoxamin er kontraindiceret eller utilstrækkelig.
The Committee for Medicinal Products for Human Use (CHMP) decided that Ferriprox’ s benefits are greater than its risks for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Ferriprox.
They recommended that Ferriprox be given marketing authorisation.
Ferriprox blev oprindelig godkendt under ‘ særlige omstændigheder ’, fordi der kun var begrænset information tilgængelig på godkendelsestidspunktet, på grund af at sygdommen er sjælden.
Ferriprox was originally authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, limited information was available at the time of approval.
Da ansøgeren havde fremlagt den yderligere anmodede information, blev de ‘ særlige omstændigheder ’ ophævet den 12. april 2002.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 12 April 2002.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ferriprox den 25. august 1999.
The European Commission granted a marketing authorisation valid throughout the European Union for Ferriprox on 25 August 1999.
Markedsføringstilladelsen blev forlænget den 25. august 2004.
The marketing authorisation was renewed on 25 August 2004.
Indehaveren af markedsføringstilladelsen er Apotex Europe B. V.
The marketing authorisation holder is Apotex Europe B. V.
Den fuldstændige EPAR om Ferriprox findes her.
The full EPAR for Ferriprox is available here.
EU- nummer EU/ 1/ 99/ 108/ 001 EU/ 1/ 99/ 108/ 002 EU/ 1/ 99/ 108/ 003
EU Number EU/ 1/ 99/ 108/ 001 EU/ 1/ 99/ 108/ 002 EU/ 1/ 99/ 108/ 003
Særnavn Ferriprox Ferriprox Ferriprox
Invented name Ferriprox Ferriprox Ferriprox
Styrke 500 mg 100 mg/ ml 100 mg/ ml
Strength 500 mg 100 mg/ ml 100 mg/ ml
Lægemiddelform Filmovertrukket tablet Oral opløsning Oral opløsning
Pharmaceutical Form Film-coated tablet Oral solution Oral solution
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse
Route of Administration Oral use Oral use Oral use
Emballage Flaske (HDPE) Flaske (PET) Flaske (PET)
Packaging bottle (HDPE) bottle (PET) bottle (PET)
Indhold 100 tabletter 250 ml 500 ml
Content 100 tablets 250 ml 500 ml
Paknings- størrelse 1 flaske 1 flaske 1 flaske
Package size 1 bottle 1 bottle 1 bottle
Hver tablet indeholder 500 mg deferiprone.
Each tablet contains 500 mg deferiprone.
Hvide til off- white, kapselformede, filmovertrukne tabletter påtrykt “ APO ” på den ene halvdel og “ 500 ” på den anden, uden påtryk på bagsiden.
White to off-white, capsule-shaped, film-coated tablets imprinted “ APO” bisect “ 500” on one side, plain on the other.
Ferriprox er indiceret til behandling af jernoverbelastning hos patienter med thalassaemia major, hvor behandlingen med deferoxamine er kontraindiceret eller utilstrækkelig.
Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.
Deferiprone- behandling bør indledes og opretholdes af en læge, der har erfaring i behandling af patienter med thalassaemia.
Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia.
Deferiprone 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.
Dosering pr. kilogram legemsvægt bør beregnes til nærmeste halve tablet.
Dosage per kilogram body weight should be calculated to the nearest half tablet.
4. 4, 4. 8 og 4. 9).
Doses above 100 mg/ kg/ day are not recommended because of the potentially increased risk of adverse reactions; chronic administration of more than 2.5 times the maximum recommended dose has been associated with neurological disorders (see sections 4.4, 4.8, and 4.9).
Der er begrænsede data til rådighed om brugen af deferiprone til børn i alderen fra 6 til 10 år og ingen data om brug af deferiprone 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.
På grund af den alvorlige grad af agranulocytose, der kan forekomme ved anvendelse af deferiprone, er særlig monitorering påkrævet for alle patienter.
Due to the serious nature of agranulocytosis, that can occur with the use of deferiprone, special monitoring is required for all patients.
Der skal udvises forsigtighed, når patientens absolutte neutrofiltal (ANC) er lavt, samt ved behandling af patienter med nyreinsufficiens eller leverdysfunktion (se afsnit 4. 4).
(see section 4.4).
Doseringsskema
2 Dose table
75 mg/ kg/ dag anvendes det antal tabletter, der foreslås i følgende tabel til patientens kropsvægt.
To obtain a dose of about 75 mg/ kg/ day, use the number of tablets suggested in the following table for the body weight of the patient.
gange daglig) 500 750 1000 1250 1500 1750 2000 2250
(mg, three times/ day) 500 750 1000 1250 1500 1750 2000 2250
(tre gange daglig) 1, 0 1, 5 2, 0 2, 5 3, 0 3, 5 4, 0 4, 5
(three times/ day) 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5
Graviditet eller amning (se afsnit 4. 6).
Pregnancy or breast-feeding (see section 4.6).
Da mekanismen for neutropeni fremkaldt af deferiprone ikke er kendt, bør patienterne ikke indtage medicin, der vides at være forbundet med neutropeni, eller medicin, der kan medføre agranulocytose (se afsnit 4. 5).
Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.5).
Neutropeni/ Agranulocytose Deferiprone har vist sig at forårsage neutropeni, herunder agranulocytose.
Neutropenia/ Agranulocytosis Deferiprone has been shown to cause neutropenia, including agranulocytosis.
Patientens neutrofiltal skal kontrolleres hver uge.
The patient ’ s neutrophil count should be monitored every week.
Ved kliniske forsøg har ugentlig monitorering af neutrofiltallet vist sig effektivt til identifikation af tilfælde af neutropeni og agranulocytose.
In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis.
Hvis patienten udvikler en infektion under behandlingen med deferiprone, skal behandlingen seponeres, og neutrofiltallet skal kontrolleres hyppigere.
If the patient develops an infection while on deferiprone, therapy should be interrupted and the neutrophil count monitored more frequently.
Det anbefales, at en sådan behandlingsprotokol er på plads, før der indledes patientbehandling med deferiprone.
It is recommended that such a management protocol be in place prior to initiating any patient on deferiprone treatment.
Behandling med deferiprone bør ikke indledes, hvis patienten har neutropeni.
Treatment with deferiprone should not be initiated if the patient is neutropenic.
Risikoen for agranulocytose og neutropeni er højere, hvis ANC- tallet i udgangspunktet er mindre end 1, 5 x 109/ l.
The risk of agranulocytosis and neutropenia is higher, if the baseline absolute neutrophil count (ANC) is less than 1.5x109/ l.
Giv patienten bedsked på omgående at ophøre med indtagelsen af deferiprone 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.
Indhent en fuldblodstælling (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.
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
3 I tilfælde af alvorlig neutropeni eller agranulocytose:
In the event of severe neutropenia or agranulocytosis:
Indgiv dette daglig, indtil tilstanden er afhjulpet.
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.
I tilfælde af neutropeni kan fornyet behandling derfor ikkeanbefales.
Therefore, in the event of neutropenia, rechallenge is not recommended.
I tilfælde af agranulocytose er fornyet behandlig kontraindiceret.
In the event of agranulocytosis, a rechallenge is contraindicated.
Carcinogenitet/ mutagenicitet/ fertilitetspåvirkning I betragtning af genotoksicitetsresultaterne kan en carcinogen virkning af deferiprone ikke udelukkes (se afsnit 5. 3).
Carcinogenicity/ mutagenicity/ effects on fertility In view of the genotoxicity results, a carcinogenic potential of deferiprone cannot be excluded (see section 5.3).
Der er ikke rapporteret om dyreforsøg til vurdering af de mulige virkninger af deferiprone på fertiliteten.
No animal studies to evaluate the potential effects of deferiprone on fertility have been reported.
Serumferritinkoncentration/ plasma Zn2+ koncentration For at vurdere langtidsvirkningen af keleringskuren til kontrol af kroppens jernbelastning, anbefales det at kontrollere serumferritinkoncentrationer eller andre indikatorer på jernbelastning af kroppen, hver anden eller tredje måned.
Serum ferritin concentration/ plasma Zn2+ concentration 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.
Det bør overvejes at seponere behandlingen med deferiprone, dersom serumferritinmålingerne falder til under 500 μg/ l.
Interruption of therapy with deferiprone should be considered if serum ferritin measurements fall below 500 μ g/ l.
HIV- positive eller på anden vis immunudsatte patienter Der findes ingen tilgængelige data om anvendelse af deferiprone på patienter, som er HIV- positive eller på anden vis har et defekt immunforsvar.
HIV positive or other immune compromised patients No data are available on the use of deferiprone in HIV positive or in other immune compromised patients.
Eftersom deferiprone kan forbindes med neutropeni og agranulocytose, bør behandling af patienter med svækket immunforsvar ikke indledes, medmindre de mulige fordele overstiger de mulige risici.
Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immune compromised patients should not be initiated unless potential benefits outweigh potential risks.
Nyre - eller leverinsufficiens og leverfibrose Der foreligger ingen tilgængelige informationer om anvendelsen af deferiprone hos patienter med nedsat nyre - eller leverfunktion.
Renal or hepatic impairment and liver fibrosis There are no data available on the use of deferiprone in patients with renal or hepatic impairment.
Da deferiprone nedbrydes i leveren skal der ligeledes udvises forsigtighed hos patienter med leverinsufficiens.
Similarly, as deferiprone is metabolised in the liver, caution must be exercised in patients with hepatic dysfunction.
Nyre - og leverfunktion bør overvåges hos denne patientpopulation, mens de er i behandling med deferiprone.
Renal and hepatic function should be monitored in this patient population during deferiprone therapy.
Hvis der forekommer vedvarende forøgelse af serumalanin- aminotransferase (ALT), bør det overvejes at seponere behandlingen med deferiprone.
If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
Hos thalassaemia- patienter er der en forbindelse mellem leverfibrose og jern- overbelastning og/ eller hepatitis C.
In thalassaemia patients there is an association between liver fibrosis and iron overload and/ or hepatitis C.
Der skal udvises særlig forsigtighed for at sikre, at jernkeleringen hos patienter med hepatitis C er optimal.
Special care must be taken to ensure that iron chelation in patients with hepatitis C is optimal.
Misfarvning af urinen Patienterne skal informeres om, at deres urin kan udvise en rødlig/ brunlig misfarvning på grund af udskillelsen af jerndeferipronekompleks.
Discoloration of urine Patients should be informed that their urine may show a reddish/ brown discoloration due to the excretion of the iron-deferiprone complex.
Kronisk overdosering og neurologiske forstyrrelser Der er observeret neurologiske forstyrrelser hos børn, som i flere år frivilligt har fået ordineret 2, 5 til 3 gange den maksimalt anbefalede dosis.
Chronic overdose and neurological disorders Neurological disorders have been observed in children treated with 2.5 to 3 times the recommended dose for several years.
4. 2, 4. 8 og 4. 9).
Prescribers are reminded that the use of doses above 100 mg/ kg/ day are not recommended (see sections 4.2, 4.8 and 4.9).
4. 5 Interaktion med andre lægemidler og andre former for interaktion
4 4.5 Interaction with other medicinal products and other forms of interaction
Der er ikke rapporteret om interaktioner mellem deferiprone og andre lægemidler.
Interactions between deferiprone and other medicinal products have not been reported.
Eftersom deferiprone binder sig til metalkationer, er der dog mulighed for interaktioner mellem deferiprone og trivalente kationafhængige lægemidler, såsom aluminium- baserede antacida.
However, since deferiprone binds to metallic cations, the potential exists for interactions between deferiprone and trivalent cation-dependent medicinal products such as aluminium-based antacids.
Det kan derfor ikke anbefales, at indtage aluminium- baserede antacida og deferiprone samtidigt.
Therefore, it is not recommended to concomitantly ingest aluminium-based antacids and deferiprone.
4 Sikkerheden ved samtidig anvendelse af deferiprone og C- vitamin er ikke blevet formelt undersøgt. Baseret på de rapporterede utilsigtede interaktioner, der kan forekomme mellem deferoxamin og C- vitamin, bør der udvises forsigtighed ved samtidig indgivelse af deferiprone 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.
Da mekanismen for neutropeni fremkaldt af deferiprone ikke er kendt, bør patienterne ikke indtage medicin, der vides at være forbundet med neutropeni, eller medicin, der kan medføre agranulocytose (se afsnit 4. 3).
Due to the unknown mechanism of deferiprone induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.3).
Graviditet Der foreligger ikke tilstrækkelige data om brugen af deferiprone hos gravide kvinder.
Pregnancy There are no adequate data from the use of deferiprone in pregnant women.
Dyreforsøg har vist reproduktionstoksicitet (se afsnit 5. 3).
Studies in animals have shown reproductive toxicity (see section 5.3).
Kvinder i den fødedygtige alder skal frarådes graviditet på grund af lægemidlets clastogene og teratogene egenskaber.
Women of childbearing potential must be advised to avoid pregnancy due to the clastogenic and teratogenic properties of the medicinal product.
Disse kvinder skal rådes til at anvende prævention samt til omgående at ophøre med anvendelsen af deferiprone, hvis de bliver gravide eller har planer om at blive gravide (se afsnit 4. 3).
These women should be counselled 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).
Amning Det vides ikke, om deferiprone udskilles i human modermælk.
Lactation It is not known whether deferiprone is excreted in human milk.
Der er ikke gennemført nogen prænatale og postnatale reproduktionsundersøgelser på dyr.
No prenatal and postnatal reproductive studies have been conducted in animals.
Deferiprone må ikke anvendes af ammende mødre.
Deferiprone must not be used by breast-feeding mothers.
Amning skal stoppes hvis behandlingen ikke kan undværes.
If treatment is unavoidable, breast feeding must be stopped.
Der er ikke udført nogen undersøgelser af virkninger på evnen til at føre motorkøretøj og betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
100 patient- års - behandling) (se afsnit 4. 4).
The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils < 0.5x109/ l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4).
100 patient- år).
The observed incidence of the less severe form of neutropenia (neutrophils < 1.5x109/ l) is 4.9% (2.5 cases per 100 patient-years).
Denne frekvens bør betragtes i forbindelse med den underliggende forhøjede forekomst af neutropeni hos thalassaemia- patienter, specielt hos patienter med hypersplenisme.
This rate should be considered in the context of the underlying elevated incidence of neutropenia in thalassaemia patients, particularly in those with hypersplenism.
Tilfælde af diarré, som oftest lette og forbigående, er blevet rapporteret hos patienter, der er behandlet med deferiprone.
Episodes of diarrhoea, mostly mild and transient, have been reported in patients treated with deferiprone.
Hos nogle patienter kan det være gavnligt at reducere deferipronedosis 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.
Arthropatier, 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 deferiprone.
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.
Lettere arthropatier er generelt forbigående.
Mild arthropathies are generally transient.
Der er rapporteret om øgede niveauer af serumleverenzymer hos patienter der tager deferiprone.
Increased levels of serum liver enzymes have been reported in patients taking deferiprone.
Hos flertallet af disse patienter var forøgelsen asymptomatisk og forbigående og vendte tilbage til baseline, uden seponering eller dosisnedsættelse af deferiprone (se afsnit 4. 4).
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).
Nogle patienter fik progression af fibrosen, forbundet med en øgning af jernoverskuddet eller hepatitis C.
Some patients experienced progression of fibrosis associated with an increase in iron overload or hepatitis C.
Lave plasmazinkniveauer er blevet forbundet med deferiprone hos et mindre antal patienter.
5 Low plasma zinc levels have been associated with deferiprone, in a minority of patients.
5 Der er observeret neurologiske forstyrrelser (såsom cerebellare symptomer, diplopi, lateral nystagmus, nedsat psykomotorisk tempo, håndbevægelser og aksial hypotoni) hos børn, som igennem flere år frivilligt har fået ordineret mere end 2, 5 gang den maksimalt anbefalede dosis på 100 mg/ kg/ dagligt.
Neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/ kg/ day for several years.
4. 2, 4. 4 og 4. 9).
The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.2, 4.4 and 4.9).
Bivirkningshyppighed:
Adverse reaction frequencies:
Meget almindelig (≥1/ 10), Almindelig (≥1/ 100 til, < 1/ 10), Ikke almindelig (≥1/ 1. 000 til, < 1/ 100).
Very common (≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100).
SYSTEMORGANKLASSE
SYSTEM ORGAN CLASS Investigations Blood and lymphatic system disorders Nervous system disorders
MEGET ALMINDELIG (≥1/ 10)
VERY COMMON (≥ 1/ 10)
ALMINDELIG (≥1/ 100 TIL, < 1/ 10)
COMMON (≥ 1/ 100 to < 1/ 10) Increased liver enzymes Neutropenia Agranulocytosis Headache
IKKE ALMINDELIG (≥1/ 1. 000 TIL, < 1/ 100)
UNCOMMON (≥ 1/ 1,000 to < 1/ 100)
Undersøgelser
Gastrointestinal disorders
Forhøjede leverenzymer
Nausea Abdominal Pain Vomiting
Blod og lymfesystem
Diarrhoea
Neutropeni Agranulocytose
Renal and urinary disorders
Nervesystemet
Chromaturia
Kvalme Abdominalsmerter Opkastning
Musculoskeletal and connective tissue disorders