natgillin/translations-raw huggingface dataset:
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.
Da deferipron binder sig til metalkationer, er der dog mulighed for interaktioner mellem deferipron og trivalente kationafhængige lægemidler, såsom aluminium-baserede antacida.
Since deferiprone binds to metallic cations, the potential exists for interactions between deferiprone and trivalent cation-dependent medicinal products such as aluminium-based antacids.
I betragtning af genotoksicitetsresultaterne kan en carcinogen virkning af deferipron ikke udelukkes (se pkt.
In view of the genotoxicity results, a carcinogenic potential of deferiprone cannot be excluded (see section 5.3).
Hvis du bliver gravid, mens du tager Ferriprox, skal du omgående ophøre med at tage lægemidlet og underrette din læge.
If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.
En positiv sammenhæng mellem MRI T2*-værdier og hjertefunktion (som målt ved venstre ventrikulære uddrivningsfraktion (eller LVEF)) er blevet dokumenteret.
A positive correlation between MRI T2* values and cardiac function (as measured by Left Ventricular Ejection Fraction (LVEF)) has been documented.
Efter en dosis på 25 mg/kg er der detekteret lavere spidskoncentrationer i serum hos patienter, der havde indtaget føde (85 µmol/l) end ved fastende tilstand (126 µmol/l), selv om der ikke var noget fald i mængden af absorberet deferipron, da det blev givet sammen med føde.
Following a dose of 25 mg/kg, lower peak serum concentrations have been detected in patients in the fed state (85 µmol/l) than in the fasting state (126 µmol/l), although there was no decrease in the amount of deferiprone absorbed when it was given with food.
Mediantiden til den første episode med agranulocytose var 190 dage (22 dage-17,6 år) og medianvarigheden var 10 dage i kliniske forsøg.
The median time to onset of the first episode of agranulocytosis was 190 days (ranged 22 days- 17.6 years) and median duration was 10 days in clinical trials.
Dødsfald og livstruende situationer (forårsaget af agranulocytose) er rapporteret med deferipron i kombination med deferoxamin.
Fatalities and life-threatening situations (caused by agranulocytosis) have been reported with deferiprone in combination with deferoxamine.
På samme tidspunkt var LVEF steget fra baseline med 3,07 ± 3,58 absolutte enheder (%) hos Ferriproxgruppen og med 0,32 ± 3,38 absolutte enheder (%) hos deferoxamin-gruppen (forskel mellem grupperne: p=0,003).
At the same time point, LVEF had increased from baseline by 3.07 ± 3.58 absolute units (%) in the Ferriprox group and by 0.32 ± 3.38 absolute units (%) in the deferoxamine group (difference between groups; p=0.003).
Ikke kendt (hyppigheden kan ikke skønnes fra de tilgængelige data): - allergiske reaktioner som f.eks. hududslæt eller nældefeber
Not known (frequency cannot be estimated from the available data): − allergic reactions including skin rash or hives
Fertilitet Der er ikke observeret nogen virkninger på fertilitet eller tidlig fosterudvikling hos dyr (se pkt.
Fertility No effects on fertility or early embryonic development were noted in animals (see section 5.3).
Hvis du har sprunget en dosis over, skal du tage den så snart, du kommer i tanker om det, og så tage den næste dosis til det normalt planlagte tidspunkt.
If you do miss one dose take it as soon as you remember and take your next dose at its regularly scheduled time.
Antal tabletter (tre gange daglig)
Number of tablets (three times/day)
Dosering pr. kilogram legemsvægt bør beregnes til nærmeste 2,5 ml.
Dose per kilogram body weight should be calculated to the nearest 2.5 ml.
Misfarvning af urinen
Discoloration of urine
Der er ikke gennemført prænatale og postnatale reproduktionsstudier på dyr.
No prenatal and postnatal reproductive studies have been conducted in animals.
Ferriprox kan tages med eller uden mad; det kan dog være lettere for dig at huske at tage Ferriprox, hvis du tager det sammen med dine måltider.
Ferriprox can be taken with or without food; however, you may find it easier to remember to take Ferriprox if you take it with your meals.
Øgede niveauer af serumleverenzymer er blevet rapporteret hos nogle patienter, der tager deferipron.
Increased levels of serum liver enzymes have been reported in some patients taking deferiprone.
Doserne af Ferriprox i disse studier lå mellem 50 og 100 mg/kg/dag og doserne af deferoxamin mellem 40 og 60 mg/kg/dag.
Doses of Ferriprox in those studies ranged from 50 to 100 mg/kg/day and doses of deferoxamine from 40 to 60 mg/kg/day.
Ved kliniske studier 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.
− Lægen har ordineret dette lægemiddel til dig personligt.
− This medicine has been prescribed for you only.
500 ml oral opløsning
500 ml oral solution
I tilfælde af agranulocytose (ANC < 0,5x109/l):
For agranulocytosis (ANC < 0.5x109/l):
Der var ingen signifikant forskel i procentdelen af patienter med kardial dysfunktion ved første vurdering (13% for Ferriprox vs. 16% for deferoxamin).
There was no significant difference in percentage of patients with cardiac dysfunction at first assessment (13% for Ferriprox vs. 16% for deferoxamine).
Din læge vil bede dig om at få taget en blodprøve for at undersøge for neutropeni (kontrollere antallet af hvide blodlegemer) regelmæssigt, så ofte som hver uge, mens du behandles med Ferriprox.
To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) performed regularly, as frequently as every week, while you are being treated with Ferriprox.
Der var en forbedring i kardial T2* på mere end 3 ms hos patienter behandlet med Ferriprox sammenlignet med en forandring på ca. 1 ms hos patienter behandlet med deferoxamin.
There was an improvement in cardiac T2* of more than 3 ms in patients treated with Ferriprox compared with a change of about 1 ms in patients treated with deferoxamine.
Patienterne skal informeres om, at deres urin kan udvise en rødlig/brunlig misfarvning på grund af udskillelsen af jerndeferipronkompleks.
Patients should be informed that their urine may show a reddish/brown discoloration due to the excretion of the iron-deferiprone complex.
Sikkerheden ved samtidig anvendelse af deferipron og C-vitamin er ikke blevet formelt undersøgt.
The safety of concurrent use of deferiprone and vitamin C has not been formally studied.
Vurdering af antallet af reaktioner pr. 100 patientårs eksponering viste, at kun forekomsten af diarré var signifikant højere hos børn (11,1) end hos voksne (2,0, p=0,01).
Evaluation of rate of reactions per 100 patient-years of exposure showed that only the rate of diarrhoea was significantly higher in children (11.1) than in adults (2.0, p=0.01).
Få foretaget en blodprøve hver uge i det første år, du er i behandling med Ferriprox, og derefter så ofte, som din læge anbefaler.
Have your blood monitored on a weekly basis for the first one year of treatment with Ferriprox and as regularly as your doctor recommends thereafter.
De øvrige indholdsstoffer er: renset vand; hydroxyethylcellulose; glycerol (E422); koncentreret saltsyre (til pH-regulering); kunstig kirsebærsmag; pebermynteolie; Sunset Yellow (E110); sucralose (E955).
The other ingredients are: purified water; hydroxyethylcellulose; glycerol (E422); hydrochloric acid, concentrated (for pH adjustment); artificial cherry flavour; peppermint oil; Sunset Yellow (E110); sucralose (E955).
Ordinerende læger mindes om, at brugen af doser over 100 mg/kg/dag frarådes.
Prescribers are reminded that the use of doses above 100 mg/kg/day are not recommended.
Der sås ingen signifikant effekt af nyreinsufficiensen på den systemiske eksponering for deferipron.
No significant effect of renal impairment was seen on systemic exposure to deferiprone.
Lave plasmazinkniveauer er blevet forbundet med deferipron hos et mindre antal patienter.
Low plasma zinc levels have been associated with deferiprone in a minority of patients.
Systemisk eksponering for deferipron og dets metabolit deferipron 3-O-glucuronid blev vurderet med PK-parametrene Cmax og AUC.
Systemic exposure to deferiprone and to its metabolite deferiprone 3-O-glucuronide was assessed by the PK parameters Cmax and AUC.
Dosering pr. kilogram legemsvægt bør beregnes til nærmeste halve tablet.
Dose per kilogram body weight should be calculated to the nearest half tablet.
Eftersom deferipron 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 immunocompromised patients should not be initiated unless potential benefits outweigh potential risks.
Der er ikke gennemført carcinogenitetsstudier med deferipron på dyr.
No carcinogenicity studies in animals have been conducted with deferiprone.
Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelse:
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
I tilfælde af neutropeni (ANC < 1,5x109/l og > 0,5x109/l):
For neutropenia events (ANC < 1.5x109/l and > 0.5x109/l):
Det kan derfor ikke anbefales, at indtage aluminium-baserede antacida og deferipron samtidigt.
Therefore, it is not recommended to concomitantly ingest aluminium-based antacids and deferiprone.
Deferiprons genotoksiske potentiale blev evalueret i en række in vitro- og in vivo-studier.
The genotoxic potential of deferiprone was evaluated in a set of in vitro and in vivo tests.
Ferriprox og deferoxamin var ækvivalente med hensyn til at fremme en nettostabilisering eller reduktion af kroppens jernophobning, til trods for den kontinuerlige jernindgivelse via transfusion hos disse patienter (ingen forskel i andelen af patienter med en negativ tendens i serumferritin mellem de to behandlingsgrupper ved regressionsanalyse; p >0,05).
Ferriprox and deferoxamine were equivalent in promoting a net stabilization or reduction of body iron load, despite the continuous transfusional iron administration in those patients (no difference in proportion of patients with a negative trend in serum ferritin between the two treatment groups by regression analysis; p >0.05).
Indgivelsesmåde Til oral anvendelse.
Method of administration For oral use.
Deferipron var teratogent og embryotoksisk ved reproduktionsstudier hos ikke-jernbelastede drægtige rotter og kaniner i doser så lave som 25 mg/kg/dag.
Deferiprone was teratogenic and embryotoxic in reproductive studies in non-iron-loaded pregnant rats and rabbits at doses at least as low as 25 mg/kg/day.
Neurologiske forstyrrelser
Neurological disorders
Uanset graden af nyreinsufficiens blev størstedelen af Ferriprox-dosen udskilt i urinen som deferipron 3-O-glucuronid over de første 24 timer.
Regardless of the degree of renal impairment, the majority of the dose of Ferriprox was excreted in the urine over the first 24 hours as deferiprone 3-O-glucuronide.
HIV-positive eller på anden vis immunudsatte patienter Der findes ingen tilgængelige data om anvendelse af deferipron på patienter, som er HIV-positive eller på anden vis har et defekt immunforsvar.
HIV positive or other immunocompromised patients No data are available on the use of deferiprone in HIV positive or in other immunocompromised patients.
- Tidligere forekomst af agranulocytose.
- History of agranulocytosis.
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 ANC is less than 1.5x109/l.
INFORMATIONSKORT TIL PATIENT/PLEJER ((Forside))
PATIENT/CARER REMINDER CARD ((Front Cover))
Sørg for beskyttende isolation og indlæg patienten på sygehus, hvis det er klinisk indiceret.
Provide protective isolation and if clinically indicated, admit patient to the hospital.
Deferipron metaboliseres primært til et glukuronidkonjugat.
Deferiprone is metabolised predominantly to a glucuronide conjugate.
Tilfælde af diarré, som oftest lette og forbigående, er blevet rapporteret hos patienter, der er behandlet med deferipron.
Episodes of diarrhoea, mostly mild and transient, have been reported in patients treated with deferiprone.
Hvis der forekommer vedvarende forøgelse af serumalanin-aminotransferase (ALAT), bør det overvejes at seponere behandlingen med deferipron.
If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.