natgillin/translations-raw huggingface dataset:
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
Deferiprone Lipomed 500 mg tabletter er hvide til off-white, blanke, ovale filmovertrukne tabletter. 
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.
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. 
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).
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 500 mg deferipron. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg deferiprone.
Hvor effektiv Deferiprone Lipomed er til at reducere kroppens jernophobning påvirkes direkte af doseringen, og hvor stor jernophobningen er. 
The effect of Deferiprone Lipomed in decreasing the body iron is directly influenced by the dose and the degree of iron overload.
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. 
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).
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. 
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.
Disse symptomer forsvandt, når børnene ophørte med at tage deferipron. 
They recovered from these symptoms after discontinuation of deferiprone.
Deferiprone Lipomed monoterapi er indiceret til behandling af jernophobning hos talassæmi-patienter, hvor nuværende kelationsterapi er kontraindiceret eller utilstrækkelig. 
Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Deferiprone Lipomed 500 mg filmovertrukne tabletter deferipron Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger. 
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Hver 500 mg filmovertrukket tablet indeholder 500 mg deferipron. 
Each 500 mg film-coated tablet contains 500 mg deferiprone.
Fortæl det altid til lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Det skal du vide, før du begynder at tage Deferiprone Lipomed 
What you need to know before you take Deferiprone Lipomed
• 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. 
• 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).
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. 
Patients should be advised to report immediately to their physician any symptoms indicative of infection such as fever, sore throat or flu-like symptoms.
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. 
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.
Brug ikke Deferiprone Lipomed, hvis du ammer. 
Do not use Deferiprone Lipomed if you are breast-feeding.
Doseringsskema for Deferiprone Lipomed 500 mg filmovertrukne tabletter Kropsvægt (kg) 
Dose table for Deferiprone Lipomed 500 mg film-coated tablets Body weight (kg)
Deferiprone Lipomed 500 mg filmovertrukne tabletter deferipron 
Deferiprone Lipomed 500 mg film-coated tablets deferiprone
Vigtige sikkerhedsinformationer til patienter, der tager Deferiprone Lipomed 
Important Safety Reminders for Patients Taking Deferiprone Lipomed Prescribing doctor:________________________ Phone no:_______________________________
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 500 mg deferipron. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 500 mg deferiprone.
Tlf.: +49 7621 1693 472 
Phone number: +49 7621 1693 472
: +49 7621 1693 474 E-mail: lipomed@lipomed.com 
Phone number: +49 7621 1693 472 Fax number: +49 7621 1693 474 Electronic mail: lipomed@lipomed.com
Tag ikke Deferiprone Lipomed, hvis du ammer. 
Do not take Deferiprone Lipomed if you are breast-feeding.
: +49 7621 1693 474 lipomed@lipomed.com 
Phone number: +49 7621 1693 472 Fax number: +49 7621 1693 474 lipomed@lipomed.com
LÆGEMIDLETS NAVN Deferiprone Lipomed 500 mg filmovertrukne tabletter 
NAME OF THE MEDICINAL PRODUCT Deferiprone Lipomed 500 mg film-coated tablets
Omgående at kontakte din læge, hvis du får feber, ondt i halsen eller influenzalignende symptomer. 
Contact your doctor immediately if you develop a fever, sore throat or flu-like symptoms.
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Lipomed GmbH 
Name and address of the manufacturer(s) responsible for batch release
− I foldeæsken finder du et informationskort til patient/plejer. 
- 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.
LÆGEMIDLETS NAVN Deferiprone Lipomed 500 mg filmovertrukne tabletter deferipron 
NAME OF THE MEDICINAL PRODUCT Deferiprone Lipomed 500 mg film-coated tablets deferiprone
Sådan skal du tage Deferiprone Lipomed 
How to take Deferiprone Lipomed
Sikkerhed og farmakokinetik for deferipron hos patienter med nyresygdom i slutstadiet er ikke kendt. 
The safety and pharmacokinetics of deferiprone in patients with end stage renal disease is unknown.
Fortæl det straks til din læge, hvis der fremkommer symptomer på infektion, såsom feber, ondt i halsen eller influenzalignende symptomer. 
Report immediately to your doctor any symptoms of infection such as fever, sore throat or flu-like symptoms.
Sikkerheden og farmakokinetikken for deferipron hos patienter med svær leverinsufficiens er ikke kendt. 
The safety and pharmacokinetics of deferiprone in patients with severe hepatic impairment is unknown.
Deferiprone Lipomeds sikkerhed og farmakokinetik hos patienter med nyresygdom i slutstadiet er ikke kendt. 
The safety and pharmacokinetics of Deferiprone Lipomed in patients with end stage renal disease are unknown.
− Spørg lægen eller på apotekspersonalet, hvis der er mere, du vil vide. 
- If you have any further questions, ask your doctor or pharmacist.
− hvis du har haft gentagne episoder med neutropeni (et lavt antal hvide blodlegemer (neutrofiler) 
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)
Opbevares utilgængeligt for børn 
Additional side effects in children
Mikrokrystallinsk cellulose 
Croscarmellose sodium Silica, colloidal anhydrous Microcrystalline cellulose Magnesium stearate
Deferiprone Lipomeds sikkerhed og farmakokinetik hos patienter med svær leverinsufficiens er ikke kendt. 
The safety and pharmacokinetics of Deferiprone Lipomed in patients with severe hepatic impairment are unknown.
Brug af anden medicin sammen med Deferiprone Lipomed Du må ikke tage medicin, der vides at forårsage neutropeni eller agranulocytose (se pkt. 
Do not take medicines known to cause neutropenia or agranulocytosis (see “Do not take Deferiprone Lipomed”).
• du har kræft 
• you have cancer
• spis ikke noget 
• do not eat anything
• du er ryger (da dette kan øge risikoen for tandproblemer) 
• you are a smoker (as this may increase the risk of dental problems)
Du må drikke vand, men ingen andre drikkevarer 
You can drink water but no other drinks
• hvis du ikke kan stå eller sidde oprejst i mindst én time (60 minutter) ad gangen. 
• If you can't stand or sit upright for at least one hour (60 minutes) at a time.
• hvis dine nyrer ikke fungerer normalt. 
• If your kidneys are not functioning normally.
• I løbet af den følgende time (60 minutter) efter at du har indtaget tabletten 
• For the next hour (60 minutes) after you've taken your tablet
• efter at du er stået op om morgenen, og 
• after you first get up for the day, and
Tag aldrig to Bonviva tabletter inden for den samme uge. 
Never take two Bonviva tablets within the same week.
Vælg en månedsdato, der er let at huske: 
Choose one day of the month that will be easy to remember:
• før du har fået noget at spise eller drikke (dvs. på tom mave) 
• before you have anything to eat or drink (on an empty stomach)
• du ikke får regelmæssig tandpleje eller ikke har været til tandeftersyn i lang tid 
• you don't receive routine dental care or have not had a dental check up for a long time
• Synk tabletten med et helt glas vand (mindst 180 ml). 
• Swallow your tablet with a full glass of water (at least 180 ml).
• Vælg en månedsdato, så det er let at huske. 
• Choose one day of the month that will be easy to remember.
Bonviva er mindre effektivt, når det indtages sammen med mad. 
Bonviva is less effective if it's taken with food.
• du tidligere har været behandlet med et bisphosphonat (anvendes i behandling eller forebyggelse af knoglelidelser) 
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
Børn og unge Giv ikke Bonviva til børn og unge under 18 år. 
Children and adolescents Do not give Bonviva to children or adolescents below 18 years.
Bonviva Det er vigtigt at tage Bonviva hver måned. 
Bonviva It's important to keep taking Bonviva every month.
• drik ikke noget (undtagen vand, hvis du har brug for det) • indtag ikke anden medicin 
• do not drink anything (except water if you need it)
• du tager medicin kaldet kortikosterioder (såsom prednisolon eller dexamethason) 
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• 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. 
• 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.
Hvis du udvikler disse symptomer, skal du stoppe med at tage Bonviva og straks kontakte din læge (se punkt 3). 
If you develop these symptoms, stop taking Bonviva and tell your doctor straight away (see section 3).
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. 
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.
• lig ikke ned: Hvis du ikke er oprejst (stående eller siddende), kan noget af medicinen løbe tilbage i spiserøret 
• do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus
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. 
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.
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. 
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.
Fremkald ikke opkastning, og læg dig ikke ned - dette kan medføre, at Bonviva irriterer spiserøret. 
Do not make yourself vomit, and do not lie down - this could cause Bonviva to irritate your oesophagus.
• eller den samme dag (som f.eks. den første søndag i hver måned). 
• or the same day (such as the first Sunday of each month).
For at reducere risikoen for at udvikle knoglenekrose i kæben, er der nogle forholdsregler, du bør tage 
In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Det er vigtigt, at du anvender Bonviva hver måned, så længe lægen ordinerer det. 
It's important to keep taking Bonviva every month, as long as your doctor prescribes it for you.
De er lavet med henblik på, at Bonviva tabletten hurtigt når frem til maven, så der er mindst mulig sandsynlighed for at forårsage irritation. 
They are designed to help your Bonviva tablet reach your stomach quickly, so it's less likely to cause irritation.
• Synk tabletten hel - lad være med at tygge den, knuse den eller opløse den i munden. 
• Swallow your tablet whole, do not chew it, crush it or let it dissolve in your mouth.
Brug af Bonviva sammen med mad og drikke 
Bonviva with food and drink:
Bonviva tilhører en medicingruppe, som kaldes bisphosphonater. 
Bonviva belongs to a group of medicines called bisphosphonates.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 23. februar 2004 Dato for seneste fornyelse: 18. december 2013 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2004
• Efter du har ventet én time, kan du indtage dagens første måltid eller drikkevarer. 
• After you've waited for an hour, you can have your first food and drink of the day.
Indtag ikke Bonviva sammen med mad. 
Do not take Bonviva with food.
• Indtag Bonviva tabletten mindst 6 timer efter, at du sidst har spist eller drukket, bortset fra vand. 
• Take your Bonviva tablet at least 6 hours after you last had anything to eat or drink except water.
- Patienten må ikke tygge eller sutte på tabletterne på grund af risiko for orofaryngeal ulceration. 
- Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration
En tandundersøgelse med forebyggende tandlægearbejde samt en individuel risikovurdering, anbefales før behandling med Bonviva hos patienter med samtidige risikofaktorer. 
A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Bonviva in patients with concomitant risk factors.
Hvis en dosis af Bonviva glemmes 
If a dose of Bonviva is missed
• du har problemer med din mund og tænder, såsom dårlig tandsundhed, tandkødssygdomme eller en planlagt tandudtrækning 
• you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
• enten den samme dato (som f.eks. den 1. i hver måned) 
• either the same date (such as the 1st of each month)
INFORMATION I BRAILLESKRIFT Bonviva 150 mg 
INFORMATION IN BRAILLE Bonviva 150 mg