natgillin/translations-raw huggingface dataset:
Den mængde Deferiprone Lipomed, du tager, afhænger af din vægt.
The amount of Deferiprone Lipomed that you take will depend on your weight.
Patientens neutrofiltal skal kontrolleres hver uge.
The patient's neutrophil count should be monitored every week.
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 deferipon 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.
Deferiprone Lipomed kan tages med eller uden mad; det kan dog være lettere for dig at huske at tage, hvis du tager det sammen med dine måltider.
Deferiprone Lipomed can be taken with or without food; however, you may find it easier to remember to take Deferiprone Lipomed if you take it with your meals.
Dato for første godkendelse: 20. september 2018
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2018
Hvis du er HIV-positiv, eller hvis din leverfunktion er kraftigt nedsat, kan din læge anbefale yderligere undersøgelser.
If you are HIV positive or if your liver function is severely impaired, your doctor may recommend additional tests.
I de fleste tilfælde forsvandt smerten, selv om patienterne fortsatte med at tage deferipron.
In most cases, the pain disappeared while patients continued taking deferiprone.
Til kvinder i den fødedygtige aldre
For women of child bearing age
Plasma Zn2+ koncentration Det anbefales at kontrollere plasma Zn2+ koncentrationen og tilføre ekstra i tilfælde af mangel.
Plasma Zn2+ concentration Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
Der er begrænsede informationer tilgængelige vedrørende rechallenge.
Limited information is available regarding re-challenge.
I tilfælde af neutropeni kan rechellange derfor ikke anbefales.
Therefore, in the event of neutropenia, rechallenge is not recommended.
Deferiprone Lipomed er mest effektivt, hvis du ikke springer nogen doser over.
Deferiprone Lipomed will be most effective if you do not miss any doses.
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
Kronisk overdosis og neurologiske forstyrrelser
Chronic overdose and neurological disorders
• Tidligere gentagen forekomst af neutropeni.
• History of recurrent episodes of neutropenia.
Det konkluderedes, at deferipron ikke fremkaldte nogen signifikant forlængelse af QT-intervallet.
Deferiprone was concluded to produce no significant prolongation of the QT interval.
ALMINDELIG (≥1/100 TIL
COMMON (≥1/100 to <1/10)
Informationskortet til patienter/omsorgspersoner skal indeholde følgende vigtige sikkerhedsinformationer (den fuldstændige tekst findes i bilag IIIA i markedsføringstilladelsen)
The Patient/Carer reminder card shall contain the following key messages (full text is included in Annex IIIA of the marketing authorisation):
Denne metabolit mangler jernbindingsevne på grund af inaktivering af 3-hydroxy-gruppen i deferipron.
This metabolite lacks ironbinding capability due to inactivation of the 3-hydroxy group of deferiprone.
Der foreligger kun begrænsede data om den kombinerede brug af deferipron og deferasirox, og der skal udvises forsigtighed, når det overvejes at anvende en sådan kombination.
Limited data are available on the combined use of deferiprone and deferasirox, and caution should be applied when considering the use of such combination.
For at opnå en dosis på ca. 75 mg/kg/dag edet 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.
Der er en meget lille risiko for, at du kan udvikle agranulocytose (meget lavt antal hvide blodceller), mens du tager Deferiprone Lipomed, hvilket kan medføre alvorlig infektion.
There is a small chance that you may develop agranulocytosis (very low white blood cell count) while taking Deferiprone Lipomed, which may lead to a serious infection.
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 to iron in a 3:1 molar ratio.
Denne frekvens bør betragtes i forbindelse med den underliggende forhøjede forekomst af neutropeni hos talassæmi-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.
Deferiprone Lipomed er en jernchelator, dvs. en type medicin, der fjerner overskydende jern fra kroppen.
Deferiprone Lipomed is an iron chelator, a type of medicine that removes excess iron from the body.
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 Deferiprone Lipomed.
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 Deferiprone Lipomed.
Den systemiske eksponering for det inaktive 3-O-glucuronid steg med faldende eGFR.
Systemic exposure to the inactive 3-Oglucuronide increased with decreasing eGFR.
Deferiprone Lipomed er pakket i blisterpakninger.
Deferiprone Lipomed is packaged in blisters.
Studierne LA16-0102, LA-01 og LA08-9701 sammenlignede deferiprons' virkning med deferoxamins virkning til styring af serumferritin hos transfusionsafhængige talassæmi-patienter.
Studies LA16-0102, LA-01 and LA08-9701 compared the efficacy of deferiprone with that of deferoxamine in controlling serum ferritin in transfusion-dependent thalassaemia patients.
Deferipron udviste ikke nogen direkte mutagene egenskaber; men det udviste klastogene egenskaber ved in vitro-analyser og in vivo hos dyr.
Deferiprone did not show direct mutagenic properties; however, it did display clastogenic characteristics in in vitro assays and in vivo in animals.
Tabletovertræk: Hypromellose, macrogol 6000, titandioxid.
Coating: hypromellose, macrogol 6000, titanium dioxide
Doserne af deferipron i disse studier lå mellem 50 og 100 mg/kg/dag og doserne af deferoxamin mellem 40 og 60 mg/kg/dag.
Doses of deferiprone in those studies ranged from 50 to 100 mg/kg/day and doses of deferoxamine from 40 to 60 mg/kg/day.
Hvis Deferiprone Lipomed tages under graviditet, kan det skade det ufødte barn alvorligt.
If taken during pregnancy, Deferiprone Lipomed may seriously harm the unborn baby.
At få taget en blodprøve hver uge.
Have your blood monitored on a weekly basis.
• for at advare kvinder i den fødedygtige om ikke at blive gravide, da deferipron kan skade det udfødte barn alvorligt.
• To warn women of childbearing age to not become pregnant because deferiprone may seriously harm the unborn baby
Hvis du bliver gravid, mens du tager Deferiprone Lipomed, skal du omgående ophøre med at tage lægemidlet og underrette din læge.
If you become pregnant while taking Deferiprone Lipomed, stop taking the medicine immediately and tell your doctor.
Indehaveren af markedsføringstilladelsen skal i at alle de medlemsstater, hvor Deferiprone Lipomed markedsføres, sikre, at alle patienter/omsorgspersoner, der forventes at anvende Deferiprone Lipomed, modtager et informationskort sammen med den ydre emballage
The MAH shall ensure that in each Member State where Deferiprone Lipomed is marketed, all patients/carers who are expected to use Deferiprone Lipomed are provided with the Patient/Carer reminder card as a part of the outer packaging.
Deferipron 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).
Deferiprone 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).
Hvis du får kvalme eller kaster op, kan det måske hjælpe at indtage Deferiprone Lipomed sammen med mad.
If you experience nausea or vomiting, it may help to take your Deferiprone Lipomed with some food.
Deferipron har vist sig at forårsage neutropeni, herunder agranulocytose.
Deferiprone has been shown to cause neutropenia, including agranulocytosis.
Efter en dosis på 25 mg/kg er der detekteret lavere spidskoncentrationer i serum hos patienter, der havde indtaget føde (85 mikromol/l) end ved fastende tilstand (126 mikromol/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.
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet og er således stort set natriumfrit.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet and that is to say essentially ‘sodium-free'.
Hvis patienten udvikler en infektion under behandlingen med deferipron, 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.
En pakke indeholder 100 filmovertrukne tabletter.
One pack contains 100 film-coated tablets.
I tilfælde af alvorlig neutropeni eller agranulocytose:
In the event of severe neutropenia or agranulocytosis:
Ved kliniske studier har ugentlig monitorering af neutrofiltallet vist sig effektivt til identifikation af tilfælde af neutropeni og agranulocytose, og disse episoder forsvandt, når behandlingen blev seponeret.
In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis and those episodes resolved once therapy was withdrawn.
Lipomed GmbH Hegenheimer Strasse 2 79576 Weil am Rhein Tyskland
Lipomed GmbH Hegenheimer Strasse 2 79576 Weil am Rhein GERMANY
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 is not recommended.
Uanset graden af nyreinsufficiens blev størstedelen af deferipron-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 deferiprone was excreted in the urine over the first 24 hours as deferiprone 3-O-glucuronide.
I tilfælde af agranulocytose er rechallenge kontraindiceret.
In the event of agranulocytosis, re-challenge is contraindicated.
Dosisjusteringer ved anvendelse sammen med andre jernkelerende stoffer Hos patienter, hvor monoterapi er utilstrækkelig, kan Deferiprone Lipomed 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, Deferiprone Lipomed may be used with deferoxamine at the standard dose (75 mg/kg/day) but should not exceed 100 mg/kg/day.
• for at øge patientens bevidshed om vigtigheden af regelmæssig monitorering af neutrofiltallet under behandling med Deferiprone Lipomed
• To increase patient awareness of the importance of regular monitoring of the neutrophil count during treatment with Deferiprone Lipomed
Hvid til off-white, blank, oval, filmovertrukket tablet.
White to off-white, glossy surface, oval film-coated tablet.
Deferiprone Lipomed indeholder natrium
Deferiprone Lipomed contains sodium
Tal med din læge eller apotektet, inden du begynder at tage Deferiprone Lipomed.
Talk to your doctor or pharmacist before taking Deferiprone Lipomed.
Efter påbegyndelse af Deferiprone Lipomed -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 Deferiprone Lipomed 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.
Abdominalsmerter Opkastning
Abdominal pain Vomiting
Den observerede forekomst af den mindre alvorlige form for neutropeni (neutrofiltal < 1, 5 x 109//l) er 4,9% (2,5 tilfælde pr. 100 patient-år).
The observed incidence of the less severe form of neutropenia (neutrophils <1.5 x 109/l) is 4.9% (2.5 cases per 100 patient-years).
• for at øge patientens bevidsthed om betydningen af ethvert symtom på infektion, under behandling med Deferiprone Lipomed
• To increase patient awareness of the significance of any symptoms of infection while taking Deferiprone Lipomed
Data fra den poolede sikkerhedsdatabase fra kliniske studier (1343 patientårs eksponering for deferipron monoterapi og 244 patientårs eksponering for deferipron 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 deferiprone monotherapy and 244 patient-years exposure to deferiprone 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”.
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 other immunocompromised patients.
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.
Forsøgsdeltagerne blev inddelt i 3 grupper ud fra Child-Pughklassifikationsscoren: raske frivillige, let leverinsufficiens (klasse A: 5-6 point) og moderat leverinsufficiens (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).
Publicerede data om jernbalancestudier hos talassæmi-patienter viser, at brugen af deferipron samtidig med deferoxamin (samtidig administration af begge kelerende stoffer på samme dag enten samtidigt eller sekventielt, f.eks. deferipron 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 deferiprone concurrently with deferoxamine (co-administration of both chelators during the same day, either simultaneously or sequentially, e.g., deferiprone during the day and deferoxamine during the night), promotes greater iron excretion than either drug alone.
Kliniske studier har vist, at deferipron 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 deferiprone 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.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterpakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Denne tilstand, som kaldes svær neutropeni eller agranulocytose, optrådte hos 1 til 2 ud af 100 personer, som tog deferiproni kliniske studier.
This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken deferiprone in clinical studies.
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.
INFORMATIONSKORT TIL PATIENT/OMSORGSPERSON ((Forside))
PATIENT/CARER REMINDER CARD ((Front Cover))
De bivirkninger, der hyppigst er blevet rapporteret i løbet af behandling med deferipron i kliniske studier var kvalme, opkastning, mavesmerte og kromaturi, som blev rapporteret hos mere end 10% af patienterne.
The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, vomiting, abdominal pain, and chromaturia, which were reported in more than 10% of patients.
Du skal anvende effektiv prævention, mens du tager Deferiprone Lipomed.
You must use effective contraception while you are taking Deferiprone Lipomed.
Sikkerhedsprofilen for kombinationsterapi (med deferipron og deferoxamin), der er observeret i kliniske studier, erfaring efter markedsføring og publicerede date, stemmer overens med den sikkerhedsprofil, som er karakteristisk for monoterapi.
The safety profile of combination therapy (deferiprone and deferoxamine) observed in clinical trials, post-marketing experience or published literature was consistent with that characterized for monotherapy.
Hvis du har taget for meget Deferiprone Lipomed Der foreligger ingen indberetninger om akut overdosering meddeferipron.
If you take more Deferiprone Lipomed than you should There are no reports of acute overdose with deferiprone.
Kontrol af hvide blodcelletal ved behandling med Deferiprone Lipomed
Monitoring your white blood cell count with Deferiprone Lipomed
INFORMATION I BRAILLE-SKRIFT Deferiprone Lipomed 500 mg
INFORMATION IN BRAILLE Deferiprone Lipomed 500 mg
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 1.5 x 109/l.
Du må ikke tage Deferiprone Lipomed, hvis du er gravid, eller hvis du forsøger at blive gravid.
Do not take Deferiprone Lipomed if you are pregnant or if you are trying to become pregnant.
• Tidligere forekomst af agranulocytose.
• History of agranulocytosis.
Referér venligst til informationskortet til patient/plejer i foldeæsken.
Please refer to the patient/carer reminder card provided in the folding box.
Farmakoterapeutisk klassifikation: Jernkelerende stoffer, ATC-kode: V03AC02 Virkningsmekanisme
Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC02
Hvis du har glemt at tage Deferiprone Lipomed
If you forget to take Deferiprone Lipomed
Tabletkerne: Hypromellose Croscarmellosenatrium Silica, kolloid vandfri Mikrokrystallinsk cellulose Magnesiumstearat
Tablet core: hypromellose, croscarmellose sodium, silica, colloidal anhydrous, microcrystalline cellulose, magnesium stearate
Den alvorligste bivirkning ved Deferiprone Lipomed er et meget lavt antal hvide blodlegemer (neutrofiler).
The most serious side effect of Deferiprone Lipomed is a very low white blood cell (neutrophil) count.
Ud fra resultaterne af dette studie er justering af deferipron-dosisregimet ikke nødvendig hos patienter med nyreinsufficiens.
Based on the results of this study, no adjustment of the deferiprone dosage regimen is required in patients with impaired renal function.
De alvorligste bivirkninger, som kan fremkomme, mens du tager Deferiprone Lipomed, er et meget lavt antal hvide blodlegemer (neutrofiler)).
The most serious side effect that may occur while taking Deferiprone Lipomed is a very low white blood cell (neutrophil) count.
Deferiprone Lipomed bruges til at behandle jernophobning som følge af hyppige blodtransfusioner hos talassæmi-patienter, hvor nuværende kelationsterapi er kontraindiceret eller utilstrækkelig.
Deferiprone Lipomed is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Aluminium/PVC-PVDC-blistre i æsker med 100 filmovertrukne tabletter 6.6 Regler for destruktion
Aluminium/PVC-PVDC blisters in cartons of 100 film-coated tablets.
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.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Lipomed GmbH
NAME OF THE MARKETING AUTHORISATION HOLDER Lipomed GmbH
Ud fra resultaterne af dette studie er der ikke behov for justering af deferipron-dosisregimet hos patienter med let eller moderat leverinsufficiens.
Based on the results of this study, no adjustment of the deferiprone dosage regimen is required in patients with mildly or moderately impaired hepatic function.
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 4.9).
Kontakt din læge eller apoteket, før du tager ascorbinsyre (C-vitamin) sammen med Deferiprone Lipomed.
Please consult with your doctor or pharmacist before taking vitamin C with Deferiprone Lipomed.
"Anden medicin og Deferiprone Lipomed")
Other medicines and Deferiprone Lipomed
Deferiprone Lipomed indeholder det aktive stof deferipron.
What Deferiprone Lipomed contains The active substance is deferiprone.
Tag ikke aluminiumbaserede syreneutraliserende midler, samtidig med at du tager Deferiprone Lipomed.
Do not take aluminium-based antacids at the same time as taking Deferiprone Lipomed.
Forekomsten af bivirkninger i systemorganklassen "Knogler, led, muskler og bindevæv" og "Nyrer og urinveje" var lavere under kombinationsterapi end monoterapi, hvorimod forekomsten af bivirkninger i systemorganklassen "Hjerte" var højere under kombinationsterapi end monoterapi.
The incidences of “Musculoskeletal and connective tissue disorders” and “Renal and urinary disorders” were lower during combination therapy than monotherapy, whereas the incidence of “Cardiac disorders” was higher during combination therapy than monotherapy.
Der skal udvises forsigtighed hos patienter med nyresygdom i slutstadiet eller svær leverinsufficiens.
Caution must be exercised in patients with end stage renal disease or severe hepatic dysfunction.
Afbrydelse af behandling med deferipron bør overvejes, hvis serumferritin falder under 500 mikrog./l.
Interruption of therapy with deferiprone should be considered if serum ferritin falls below 500 µg/l.
79576 Weil am Rhein Tyskland
79576 Weil am Rhein Germany