FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: You must use effective contraception while you are taking Deferiprone Lipomed.
Danish: Du skal anvende effektiv prævention, mens du tager Deferiprone Lipomed.
English: 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.
Danish: 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.
English: If you take more Deferiprone Lipomed than you should There are no reports of acute overdose with deferiprone.
Danish: Hvis du har taget for meget Deferiprone Lipomed Der foreligger ingen indberetninger om akut overdosering meddeferipron.
English: Monitoring your white blood cell count with Deferiprone Lipomed
Danish: Kontrol af hvide blodcelletal ved behandling med Deferiprone Lipomed
English: INFORMATION IN BRAILLE Deferiprone Lipomed 500 mg
Danish: INFORMATION I BRAILLE-SKRIFT Deferiprone Lipomed 500 mg
English: The risk of agranulocytosis and neutropenia is higher if the baseline absolute neutrophil count (ANC) is less than 1.5 x 109/l.
Danish: Risikoen for agranulocytose og neutropeni er højere, hvis ANC-tallet i udgangspunktet er mindre end 1,5 x 109/l.
English: Do not take Deferiprone Lipomed if you are pregnant or if you are trying to become pregnant.
Danish: Du må ikke tage Deferiprone Lipomed, hvis du er gravid, eller hvis du forsøger at blive gravid.
English: • History of agranulocytosis.
Danish: • Tidligere forekomst af agranulocytose.
English: Please refer to the patient/carer reminder card provided in the folding box.
Danish: Referér venligst til informationskortet til patient/plejer i foldeæsken.
English: Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC02
Danish: Farmakoterapeutisk klassifikation: Jernkelerende stoffer, ATC-kode: V03AC02 Virkningsmekanisme
English: If you forget to take Deferiprone Lipomed
Danish: Hvis du har glemt at tage Deferiprone Lipomed
English: Tablet core: hypromellose, croscarmellose sodium, silica, colloidal anhydrous, microcrystalline cellulose, magnesium stearate
Danish: Tabletkerne: Hypromellose Croscarmellosenatrium Silica, kolloid vandfri Mikrokrystallinsk cellulose Magnesiumstearat
English: The most serious side effect of Deferiprone Lipomed is a very low white blood cell (neutrophil) count.
Danish: Den alvorligste bivirkning ved Deferiprone Lipomed er et meget lavt antal hvide blodlegemer (neutrofiler).
English: Based on the results of this study, no adjustment of the deferiprone dosage regimen is required in patients with impaired renal function.
Danish: Ud fra resultaterne af dette studie er justering af deferipron-dosisregimet ikke nødvendig hos patienter med nyreinsufficiens.
English: The most serious side effect that may occur while taking Deferiprone Lipomed is a very low white blood cell (neutrophil) count.
Danish: De alvorligste bivirkninger, som kan fremkomme, mens du tager Deferiprone Lipomed, er et meget lavt antal hvide blodlegemer (neutrofiler)).
English: 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.
Danish: Deferiprone Lipomed bruges til at behandle jernophobning som følge af hyppige blodtransfusioner hos talassæmi-patienter, hvor nuværende kelationsterapi er kontraindiceret eller utilstrækkelig.
English: Aluminium/PVC-PVDC blisters in cartons of 100 film-coated tablets.
Danish: Aluminium/PVC-PVDC-blistre i æsker med 100 filmovertrukne tabletter 6.6 Regler for destruktion
English: 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.
Danish: Samtidig brug af jernkelerende stoffer frarådes hos patienter, hvis serumferritin falder under 500 μg/l på grund af risikoen for overdreven jernfjernelse.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Lipomed GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Lipomed GmbH
English: 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.
Danish: Ud fra resultaterne af dette studie er der ikke behov for justering af deferipron-dosisregimet hos patienter med let eller moderat leverinsufficiens.
English: Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and 4.9).
Danish: Anvendelse af deferipron bør ophøre, hvis der observeres neurologiske forstyrrelser (se pkt.
English: Please consult with your doctor or pharmacist before taking vitamin C with Deferiprone Lipomed.
Danish: Kontakt din læge eller apoteket, før du tager ascorbinsyre (C-vitamin) sammen med Deferiprone Lipomed.
English: Other medicines and Deferiprone Lipomed
Danish: "Anden medicin og Deferiprone Lipomed")
English: What Deferiprone Lipomed contains The active substance is deferiprone.
Danish: Deferiprone Lipomed indeholder det aktive stof deferipron.
English: Do not take aluminium-based antacids at the same time as taking Deferiprone Lipomed.
Danish: Tag ikke aluminiumbaserede syreneutraliserende midler, samtidig med at du tager Deferiprone Lipomed.
English: 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.
Danish: 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.
English: Caution must be exercised in patients with end stage renal disease or severe hepatic dysfunction.
Danish: Der skal udvises forsigtighed hos patienter med nyresygdom i slutstadiet eller svær leverinsufficiens.
English: Interruption of therapy with deferiprone should be considered if serum ferritin falls below 500 µg/l.
Danish: Afbrydelse af behandling med deferipron bør overvejes, hvis serumferritin falder under 500 mikrog./l.
English: 79576 Weil am Rhein Germany
Danish: 79576 Weil am Rhein Tyskland
English: What Deferiprone Lipomed looks like and contents of the pack Deferiprone Lipomed 500 mg film-coated tablets are white to off-white, glossy surface, oval filmcoated tablets.
Danish: Deferiprone Lipomed 500 mg tabletter er hvide til off-white, blanke, ovale filmovertrukne tabletter.
English: Deferiprone Lipomed in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction (see section 4.2).
Danish: 4.4) er indiceret til behandling af talassæmi-patienter, hvor monoterapi med et andet jernkelerende stof er utilstrækkelig eller hvor forebyggelse eller behandling af livstruende konsekvenser af jernophobning kræver hurtig eller intensiv korrektion (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg deferiprone.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 500 mg deferipron.
English: The effect of Deferiprone Lipomed in decreasing the body iron is directly influenced by the dose and the degree of iron overload.
Danish: Hvor effektiv Deferiprone Lipomed er til at reducere kroppens jernophobning påvirkes direkte af doseringen, og hvor stor jernophobningen er.
English: The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils <0.5 x 109/l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4).
Danish: De mest alvorlige bivirkninger, der er rapporteret ved kliniske studier med deferipron, er agranulocytose (neutrofiltal < 0, 5 x 109/l) med en forekomst på 1,1% (0,6 tilfælde pr. 100 patient-årsbehandling) (se pkt.
English: An open-label, non-randomized, parallel group clinical study was conducted to evaluate the effect of impaired renal function on the safety, tolerability, and pharmacokinetics of a single 33 mg/kg oral dose of deferiprone.
Danish: Et åbent, ikke-randomiseret klinisk studie med parallelle grupper blev udført med henblik på at vurdere effekten af leverinsufficiens på sikkerhed, tolerabilitet og farmakokinetik for en enkelt oral dosis på 33 mg/kg deferipron.
English: They recovered from these symptoms after discontinuation of deferiprone.
Danish: Disse symptomer forsvandt, når børnene ophørte med at tage deferipron.
English: Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Danish: Deferiprone Lipomed monoterapi er indiceret til behandling af jernophobning hos talassæmi-patienter, hvor nuværende kelationsterapi er kontraindiceret eller utilstrækkelig.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Deferiprone Lipomed 500 mg filmovertrukne tabletter deferipron Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: Each 500 mg film-coated tablet contains 500 mg deferiprone.
Danish: Hver 500 mg filmovertrukket tablet indeholder 500 mg deferipron.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig.
English: What you need to know before you take Deferiprone Lipomed
Danish: Det skal du vide, før du begynder at tage Deferiprone Lipomed
English: • 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).
Danish: • Da mekanismen for neutropeni fremkaldt af deferipron ikke er kendt, bør patienterne ikke indtage medicin, der vides at være forbundet med neutropeni, eller medicin, der kan medføre agranulocytose (se pkt.
English: Patients should be advised to report immediately to their physician any symptoms indicative of infection such as fever, sore throat or flu-like symptoms.
Danish: Patienterne skal rådes til at henvende sig omgående til deres læge med eventuelle symptomer, der tyder på infektion, såsom feber, ondt i halsen eller influenzalignende symptomer.
English: In post-marketing experience with deferiprone, neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years.
Danish: Hos børn kan endvidere ses følgende bivirkninger Der er efter markedsføring af deferipron rapporteret neurologiske forstyrrelser (såsom tremor, gangforstyrrelser, dobbeltsyn, ufrivillige muskelsammentrækninger, problemer med bevægelseskoordination) er rapporteret hos børn, som igennem flere år frivilligt har fået ordineret mere end 2 gange den maksimalt anbefalede dosis på 100 mg/kg/dag.
English: Do not use Deferiprone Lipomed if you are breast-feeding.
Danish: Brug ikke Deferiprone Lipomed, hvis du ammer.
English: Dose table for Deferiprone Lipomed 500 mg film-coated tablets Body weight (kg)
Danish: Doseringsskema for Deferiprone Lipomed 500 mg filmovertrukne tabletter Kropsvægt (kg)
English: Deferiprone Lipomed 500 mg film-coated tablets deferiprone
Danish: Deferiprone Lipomed 500 mg filmovertrukne tabletter deferipron
English: Important Safety Reminders for Patients Taking Deferiprone Lipomed Prescribing doctor:________________________ Phone no:_______________________________
Danish: Vigtige sikkerhedsinformationer til patienter, der tager Deferiprone Lipomed
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 500 mg deferiprone.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 500 mg deferipron.
English: Phone number: +49 7621 1693 472
Danish: Tlf.: +49 7621 1693 472
English: Phone number: +49 7621 1693 472 Fax number: +49 7621 1693 474 Electronic mail: lipomed@lipomed.com
Danish: : +49 7621 1693 474 E-mail: lipomed@lipomed.com
English: Do not take Deferiprone Lipomed if you are breast-feeding.
Danish: Tag ikke Deferiprone Lipomed, hvis du ammer.
English: Phone number: +49 7621 1693 472 Fax number: +49 7621 1693 474 lipomed@lipomed.com
Danish: : +49 7621 1693 474 lipomed@lipomed.com
English: NAME OF THE MEDICINAL PRODUCT Deferiprone Lipomed 500 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Deferiprone Lipomed 500 mg filmovertrukne tabletter
English: Contact your doctor immediately if you develop a fever, sore throat or flu-like symptoms.
Danish: Omgående at kontakte din læge, hvis du får feber, ondt i halsen eller influenzalignende symptomer.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Lipomed GmbH
English: - Provided in the folding box, you will find a patient/carer reminder card. You should complete and read the card carefully and carry it with you.
Danish: − I foldeæsken finder du et informationskort til patient/plejer.
English: NAME OF THE MEDICINAL PRODUCT Deferiprone Lipomed 500 mg film-coated tablets deferiprone
Danish: LÆGEMIDLETS NAVN Deferiprone Lipomed 500 mg filmovertrukne tabletter deferipron
English: How to take Deferiprone Lipomed
Danish: Sådan skal du tage Deferiprone Lipomed
English: The safety and pharmacokinetics of deferiprone in patients with end stage renal disease is unknown.
Danish: Sikkerhed og farmakokinetik for deferipron hos patienter med nyresygdom i slutstadiet er ikke kendt.
English: Report immediately to your doctor any symptoms of infection such as fever, sore throat or flu-like symptoms.
Danish: Fortæl det straks til din læge, hvis der fremkommer symptomer på infektion, såsom feber, ondt i halsen eller influenzalignende symptomer.
English: The safety and pharmacokinetics of deferiprone in patients with severe hepatic impairment is unknown.
Danish: Sikkerheden og farmakokinetikken for deferipron hos patienter med svær leverinsufficiens er ikke kendt.
English: The safety and pharmacokinetics of Deferiprone Lipomed in patients with end stage renal disease are unknown.
Danish: Deferiprone Lipomeds sikkerhed og farmakokinetik hos patienter med nyresygdom i slutstadiet er ikke kendt.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: − Spørg lægen eller på apotekspersonalet, hvis der er mere, du vil vide.
English: Do not take Deferiprone Lipomed: - if you are allergic to deferiprone or any of the other ingredients of this medicine (listed in section 6); - if you have a history of repeated episodes of neutropenia (low white blood cell (neutrophil)
Danish: − hvis du har haft gentagne episoder med neutropeni (et lavt antal hvide blodlegemer (neutrofiler)
English: Additional side effects in children
Danish: Opbevares utilgængeligt for børn
English: Croscarmellose sodium Silica, colloidal anhydrous Microcrystalline cellulose Magnesium stearate
Danish: Mikrokrystallinsk cellulose
English: The safety and pharmacokinetics of Deferiprone Lipomed in patients with severe hepatic impairment are unknown.
Danish: Deferiprone Lipomeds sikkerhed og farmakokinetik hos patienter med svær leverinsufficiens er ikke kendt.
English: Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Deferiprone Lipomed”).
Danish: Brug af anden medicin sammen med Deferiprone Lipomed Du må ikke tage medicin, der vides at forårsage neutropeni eller agranulocytose (se pkt.
English: • you have cancer
Danish: • du har kræft
English: • do not eat anything
Danish: • spis ikke noget
English: • you are a smoker (as this may increase the risk of dental problems)
Danish: • du er ryger (da dette kan øge risikoen for tandproblemer)
English: You can drink water but no other drinks
Danish: Du må drikke vand, men ingen andre drikkevarer
English: • If you can't stand or sit upright for at least one hour (60 minutes) at a time.
Danish: • hvis du ikke kan stå eller sidde oprejst i mindst én time (60 minutter) ad gangen.
English: • If your kidneys are not functioning normally.
Danish: • hvis dine nyrer ikke fungerer normalt.
English: • For the next hour (60 minutes) after you've taken your tablet
Danish: • I løbet af den følgende time (60 minutter) efter at du har indtaget tabletten
English: • after you first get up for the day, and
Danish: • efter at du er stået op om morgenen, og
English: Never take two Bonviva tablets within the same week.
Danish: Tag aldrig to Bonviva tabletter inden for den samme uge.
English: Choose one day of the month that will be easy to remember:
Danish: Vælg en månedsdato, der er let at huske:
English: • before you have anything to eat or drink (on an empty stomach)
Danish: • før du har fået noget at spise eller drikke (dvs. på tom mave)
English: • you don't receive routine dental care or have not had a dental check up for a long time
Danish: • du ikke får regelmæssig tandpleje eller ikke har været til tandeftersyn i lang tid
English: • Swallow your tablet with a full glass of water (at least 180 ml).
Danish: • Synk tabletten med et helt glas vand (mindst 180 ml).
English: • Choose one day of the month that will be easy to remember.
Danish: • Vælg en månedsdato, så det er let at huske.
English: Bonviva is less effective if it's taken with food.
Danish: Bonviva er mindre effektivt, når det indtages sammen med mad.
English: • you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
Danish: • du tidligere har været behandlet med et bisphosphonat (anvendes i behandling eller forebyggelse af knoglelidelser)
English: Children and adolescents Do not give Bonviva to children or adolescents below 18 years.
Danish: Børn og unge Giv ikke Bonviva til børn og unge under 18 år.
English: Bonviva It's important to keep taking Bonviva every month.
Danish: Bonviva Det er vigtigt at tage Bonviva hver måned.
English: • do not drink anything (except water if you need it)
Danish: • drik ikke noget (undtagen vand, hvis du har brug for det) • indtag ikke anden medicin
English: • you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
Danish: • du tager medicin kaldet kortikosterioder (såsom prednisolon eller dexamethason)
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: If you develop these symptoms, stop taking Bonviva and tell your doctor straight away (see section 3).
Danish: Hvis du udvikler disse symptomer, skal du stoppe med at tage Bonviva og straks kontakte din læge (se punkt 3).
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Bonviva on an individual patient basis, particularly after 5 or more years of use.
Danish: Behovet for fortsat behandling skal revurderes regelmæssigt, baseret på fordele og mulige risici af Bonviva for den enkelte patient, især efter anvendelse i 5 år eller mere.
English: • do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus
Danish: • lig ikke ned: Hvis du ikke er oprejst (stående eller siddende), kan noget af medicinen løbe tilbage i spiserøret
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EC og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: You can choose either the same date (such as the 1st of each month) or the same day (such as the first Sunday of each month) to take your Bonviva tablet.
Danish: Du kan vælge enten den samme dato (som f.eks. den 1. i hver måned) eller den samme dag (som f.eks. den første søndag i hver måned) til indtagelsen af din Bonviva tablet.
English: Do not make yourself vomit, and do not lie down - this could cause Bonviva to irritate your oesophagus.
Danish: Fremkald ikke opkastning, og læg dig ikke ned - dette kan medføre, at Bonviva irriterer spiserøret.
English: • or the same day (such as the first Sunday of each month).
Danish: • eller den samme dag (som f.eks. den første søndag i hver måned).
English: In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Danish: For at reducere risikoen for at udvikle knoglenekrose i kæben, er der nogle forholdsregler, du bør tage
English: It's important to keep taking Bonviva every month, as long as your doctor prescribes it for you.
Danish: Det er vigtigt, at du anvender Bonviva hver måned, så længe lægen ordinerer det.
English: They are designed to help your Bonviva tablet reach your stomach quickly, so it's less likely to cause irritation.
Danish: De er lavet med henblik på, at Bonviva tabletten hurtigt når frem til maven, så der er mindst mulig sandsynlighed for at forårsage irritation.
English: • Swallow your tablet whole, do not chew it, crush it or let it dissolve in your mouth.
Danish: • Synk tabletten hel - lad være med at tygge den, knuse den eller opløse den i munden.
English: Bonviva with food and drink:
Danish: Brug af Bonviva sammen med mad og drikke
English: Bonviva belongs to a group of medicines called bisphosphonates.
Danish: Bonviva tilhører en medicingruppe, som kaldes bisphosphonater.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2004
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 23. februar 2004 Dato for seneste fornyelse: 18. december 2013
English: • After you've waited for an hour, you can have your first food and drink of the day.
Danish: • Efter du har ventet én time, kan du indtage dagens første måltid eller drikkevarer.
English: Do not take Bonviva with food.
Danish: Indtag ikke Bonviva sammen med mad.
English: • Take your Bonviva tablet at least 6 hours after you last had anything to eat or drink except water.
Danish: • Indtag Bonviva tabletten mindst 6 timer efter, at du sidst har spist eller drukket, bortset fra vand.