natgillin/translations-raw huggingface dataset:
Som for alle lægemidler bliver data vedrørende brugen af Ferriprox løbende overvåget.
As for all medicines, data on the use of Ferriprox are continuously monitored.
Det er en arvelig sygdom, hvor patienterne ikke er i stand til at danne tilstrækkeligt hæmoglobin, som er det protein i de røde blodlegemer, der transporterer ilt rundt i kroppen.
This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body.
Patienter bør straks underrette deres læge, hvis de har symptomer, der kan skyldes en infektion, såsom feber, ondt i halsen og influenzalignende symptomer.
Patients should tell their doctor immediately if they have symptoms of an infection, such as fever, sore throat and flu-like symptoms.
Lægen kan justere dosen af Ferriprox alt efter, hvor godt patientens jernindhold reguleres, hvilket bør måles hver 2.-3. måned med blodprøver.
The doctor may adjust the dose of Ferriprox according to how well the patient's iron levels are being controlled, which should be measured every 2 to 3 months with blood tests.
Ferritin-niveauet viser, hvor meget jern der er lagret i kroppen.
The blood ferritin level indicates how much iron is being stored in the body.
Der var for få patienter i studiet til at bevise, om en sådan behandling er lige så effektiv som deferoxamin taget alene.
There were too few patients in the study to prove whether such a schedule is as effective as deferoxamine on its own.
De overførte røde blodlegemer bringer jern ind i kroppen.
Transfused red cells bring iron into the body.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ferriprox?
What measures are being taken to ensure the safe and effective use of Ferriprox?
De indberettede bivirkninger ved Ferriprox vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Ferriprox are carefully evaluated and any necessary action taken to protect patients.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Ferriprox opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Ferriprox's benefits are greater than its risks and it can be authorised for use in the EU.
De gennemsnitlige ferritin-niveauer i de to behandlingsgrupper var lig hinanden.
The average blood ferritin levels were similar in the two treatment groups.
Ferriprox fås kun på recept, og behandlingen bør indledes og overvåges af en læge med erfaring i at behandle thalassæmi.
Ferriprox can only be obtained with a prescription and treatment should be started and continued by a doctor who has experience in the treatment of thalassaemia.
Udskillelse af jern på denne måde bidrager til at afhjælpe jernophobningen og forebygge skader på grund af overskud af jern.
Removing iron in this way helps to correct the iron overload and prevent damage from excess iron.
Andre oplysninger om Ferriprox
Other information about Ferriprox
Virksomheden, der markedsfører Ferriprox, skal sørge for, at patienter eller deres omsorgspersoner får udleveret et påmindelseskort med information om vigtigheden af regelmæssige kontroller af neutrofiltal, af at holde øje med symptomer på infektion og af at undgå at blive gravid under behandling med Ferriprox.
The company that markets Ferriprox must supply a reminder card for patients or their carers about the importance of regular tests for neutrophil counts, the need to watch out for symptoms of infection and for women to avoid becoming pregnant during treatment with Ferriprox.
Når patienten tager Ferriprox, bør vedkommendes neutrofiltal kontrolleres regelmæssigt (hver uge i det første år og derefter sjældnere).
When taking Ferriprox, the patient's neutrophil count should be checked regularly (every week in the first year then less frequently).
Hvis patienten får en infektion, bør behandlingen med Ferriprox ophøre midlertidigt, og neutrofiltallet kontrolles oftere.
If the patient gets an infection, treatment with Ferriprox should be temporarily stopped and the neutrophil count checked more often.
Den anbefalede dosis af Ferriprox er 25 mg pr. kg legemsvægt én gang ugentligt.
The usual dose of Ferriprox is 25 mg per kilogram body weight three times a day.
Ferriprox blev undersøgt hos 247 patienter over 6 år med thalassæmi major.
Ferriprox was studied in 247 patients with thalassaemia major, aged over 6 years.
En oversigt over Ferriprox, og hvorfor det er godkendt i EU
An overview of Ferriprox and why it is authorised in the EU
Virkningen blev hovedsageligt bedømt på ændringen af ferritin-niveauet i blodet.
The main measure of effectiveness was the change in the levels of ferritin in the blood.
De hyppigste bivirkninger ved Ferriprox (som kan forekomme hos mere end 1 ud af 10 personer) er rødbrun urin (der viser, at der bliver udskilt jern), kvalme, mavesmerter og opkastninger.
The most common side effects with Ferriprox (which may affect more than 1 in 10 people) are redbrown urine (showing that iron is being removed through the urine), nausea (feeling sick), abdominal pain (stomach ache) and vomiting.
Ferriprox indeholder det aktive stof deferipron.
Ferriprox contains the active substance deferiprone.
Hvorfor er Ferriprox godkendt i EU?
Why is Ferriprox authorised in the EU?
Hvis du ønsker mere information om anvendelsen af Ferriprox, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Ferriprox, see the package leaflet or contact your doctor or pharmacist.
Med gentagne transfusioner ophobes jern, fordi kroppen ikke kan fjerne overskydende jern ad naturlig vej.
With repeated transfusions, the iron builds up because the body does not have a natural way of removing excess iron.
Ferriprox (deferipron)
Ferriprox (deferiprone)
Ferriprox anvendes:
Ferriprox is used:
Hvad er Ferriprox, og hvad anvendes det til?
What is Ferriprox and what is it used for?
I et andet studie med deltagelse af 60 patienter, der blev behandlet over 12 måneder, blev en kombination af Ferriprox og deferoxamin (Ferriprox i 5 dage plus deferoxamin i 2 dage hver uge) sammenlignet med deferoxamin alene.
In another study involving 60 patients treated over 12 months, a combination of Ferriprox and deferoxamine (Ferriprox for 5 days plus deferoxamine for 2 days each week) was compared with deferoxamine on its own.
Den fuldstændige liste over begrænsninger og bivirkninger ved Ferriprox fremgår af indlægssedlen.
For the full list of restrictions and side effects of Ferriprox, see the package leaflet.
Ferriprox må ikke anvendes af kvinder, der er gravide eller ammer.
Ferriprox must not be used in women who are pregnant or breastfeeding.
Den gennemsnitlige koncentration af jern i leveren hos Ferriprox-behandlede patienter syntes dog at stige mere end hos patienter behandlet med deferoxamin.
However, the average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.
Det aktive stof i Ferriprox, deferipron, er et "jernchelat".
The active substance in Ferriprox, deferiprone, is an iron chelator.
Ferriprox må heller ikke anvendes sammen med lægemidler, der kan forårsage neutropeni eller agranulocytose.
Ferriprox must also not be used with medicines that might cause neutropenia or agranulocytosis.
I et offentliggjort studie førte Ferriprox sammen med deferoxamin også til større fald i jern i hjertet sammenlignet med patienter, der tager deferoxamin alene.
In a published study, Ferriprox together with deferoxamine also led to greater decreases in iron in the heart compared with patients taking deferoxamine alone.
I hovedstudiet, der omfattede 71 patienter, blev Ferriprox sammenlignet med deferoxamin, et andet jernchelat, over 2 år.
The main study involving 71 patients compared Ferriprox with deferoxamine, another iron chelator, over 2 years.
Ferritin-niveauet i blodet blev reduceret i samme grad hos patienter, der fik kombinationsbehandlingen, som hos patienter, der fik deferoxamin alene.
Blood ferritin levels were reduced to the same extent in patients treated with the combination as with deferoxamine on its own.
Hvilke risici er der forbundet med Ferriprox?
What are the risks associated with Ferriprox?
Ferriprox må ikke anvendes hos personer, der har haft neutropeni eller agranulocytose.
Ferriprox must not be used in people who have had neutropenia repeatedly or agranulocytosis.
Offentliggjorte studier om anvendelsen af Ferriprox sammen med deferoxamin har desuden vist større fald i jernniveauerne , når begge lægemidler blev taget sammen, end når de blev taget hver for sig.
In addition, published studies on Ferriprox together with deferoxamine reported greater reductions in blood ferritin levels when both medicines were used in combination compared with using either medicine on its own.
Hvordan anvendes Ferriprox?
How is Ferriprox used?
I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Ferriprox.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ferriprox have also been included in the summary of product characteristics and the package leaflet.
Lægemidlet anvendes til behandling af jernophobning (overskud af jern i kroppen) hos patienter med thalassæmi major.
Ferriprox is an ‘iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major.
Hvordan virker Ferriprox?
How does Ferriprox work?
Hvilke fordele viser studierne, at der er ved Ferriprox?
What benefits of Ferriprox have been shown in studies?
Det vides ikke på nuværende tidspunkt, hvor godt det virker hos denne aldersgruppe.
It is not yet known how well it works in this age group.
Median PFS var 11,9 måneder.
Median PFS was 11.9 months.
Dette er den maksimale dosis pr. dag.
This is the maximum dose per day.
Dette er kendt som en hypertensiv krise.
This is known as a hypertensive crisis.
Tag Votrient på omtrent samme tidspunkt hver dag.
Take Votrient at about the same time each day.
Følgende begreber er blevet kombineret:
The following terms have been combined:
Tilstande, som du skal holde øje med
Conditions you need to look out for
Dato for første markedsføringstilladelse: 14. juni 2010 Dato for seneste fornyelse: 8. januar 2018
Date of first authorisation: 14 June 2010 Date of latest renewal: 08 January 2018
Undergruppeanalyser af PFS blev udført for 20 demografiske og prognostiske faktorer.
Subgroup analyses of PFS were performed for 20 demographic and prognostic factors.
Behandlingen genoptages, når såret er helet tilstrækkeligt.
Your treatment will be restarted when the wound has adequately healed.
Votrient anbefales ikke til personer under 18 år.
Votrient is not recommended for people aged under 18.
Risikoen for disse problemer kan være højere for personer, som allerede har hjerteproblemer eller som tager andre lægemidler.
The risks of these problems may be higher for people with an existing heart problem, or who are taking other medicines.
Lægen vil informere dig om resultaterne af dine blodprøver
Your doctor will inform you of the results of the blood tests
Efter måned 4 fortsættes med periodiske undersøgelser.
Periodic testing should then continue after month 4.
Én forsøgsperson kom sig ikke, og follow-up data for de sidste 5 forsøgspersoner var ikke tilgængelige.
One subject did not recover and follow-up data were not available for the other 5 subjects.
- Fortæl det til lægen, hvis du er gravid eller planlægger at blive gravid.
- Tell your doctor if you are pregnant or planning to get pregnant.
09400 Aranda De Duero, Burgos Spanien
09400 Aranda De Duero, Burgos Spain
Lægen vil afgøre, om Votrient er egnet til dig.
Your doctor will decide whether Votrient is suitable for you.
- nefazodon (bruges til behandling af depression).
- nefazodone (used to treat depression).
Kombination med anden systemisk anti-cancer-terapi
Combination with other systemic anti-cancer therapies
Det kan være nødvendigt at foretage nogle ekstra undersøgelser for at kontrollere, om dit hjerte og din lever fungerer, som de skal.
You may need extra tests to check that your heart and liver are working properly.
Tabletterne skal synkes hele med vand, én ad gangen.
Swallow the tablets whole with water, one after the other.
Risikofaktorer
Risk factors
Hyppighed (alle grader)
Frequency (all grades)
Fortæl det til lægen, hvis du bemærker usædvanlige ændringer i dine hjerteslag, f.eks. at hjertet slår for hurtigt eller for langsomt.
Tell your doctor if you notice any unusual changes in your heart beat, such as beating too fast or too slow.
Det virker ved at forhindre aktiviteten af proteiner, der er involveret i kræftcellers udvikling og evne til at sprede sig.
It works by preventing the activity of proteins that are involved in the growth and spread of cancer cells.
Med den nuværende kliniske erfaring er der ikke set forskelle i respons mellem ældre og yngre patienter, men det kan ikke udelukkes, at nogle ældre patienter har en større følsomhed.
Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly patients cannot be ruled out.
- simvastatin og muligvis også andre statiner (bruges til behandling af forhøjet kolesteroltal).
- simvastatin and possibly other statins (used to treat high cholesterol levels).
Brug af Votrient sammen med mad og drikke
Votrient with food and drink
Samlede effektresultater er vist i tabel 5.
Overall efficacy results are summarised in Table 5.
95 % konfidensintervallet inkluderede en hazard ratio på 1 for alle undergrupperne.
The 95% confidence intervals for all subgroups include a hazard ratio of 1.
Kategorierne er tildelt på basis af absolutte hyppigheder fra data fra de kliniske studier.
Categories have been assigned based on absolute frequencies in the clinical trial data.
Hvis du skal opereres
If you are going to have an operation
Stop med at tage Votrient og søg straks lægehjælp, hvis du udvikler hypertensiv krise.
Stop taking Votrient and seek medical help immediately if you develop hypertensive crisis.
Titandioxid (E 171)
Titanium dioxide (E171)
Undersøgelser h
Investigations h
Lægemidler, der øger gastrisk pH
Medicinal products that raise gastric pH
Behandling med Votrient må kun indledes af en læge med erfaring i administration af lægemidler til behandling af cancer.
Votrient treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
Tilfælde af alvorlige infektioner (med eller uden neutropeni), i nogle tilfælde med letal udgang, er rapporteret.
Cases of serious infections (with or without neutropenia), in some cases with fatal outcome, have been reported.
Demografiske karakteristika var ens for begge behandlingsarme.
Demographic characteristics were similar between the treatment arms.
Ikke kendt Ikke kendt Ikke kendt
Not known Not known Not known
Eksponeringen ved en dosis på 200 mg er markant reduceret, men stærkt variabel hos disse patienter med værdier, der anses for at være utilstrækkelige til at opnå en relevant klinisk effekt.
Exposure at a 200 mg dose is markedly reduced, though highly variable, in these patients, with values considered insufficient to obtain a clinically relevant effect.
- hvis du har haft hjertesvigt eller et hjertetilfælde.
- if you have had heart failure or a heart attack.
Symptomerne inkluderer åndenød eller hoste, der ikke går væk.
Symptoms include shortness of breath or cough that will not go away.
Der blev ikke observeret nogen statistisk forskel mellem behandlingsgrupperne i forbindelse med vurderingen af livskvaliteten (Global Quality of Life), vurderet ved hjælp af EORTC QLQ-C30 og EuroQoL EQ-5D.
No statistical differences were observed between treatment groups for Global Quality of Life using EORTC QLQ-C30 and EuroQoL EQ-5D.
* - behandlingsnaiv og cytokin-behandlet population.
* - treatment-naïve and cytokine pre-treated populations
Bivirkninger (herunder alvorlige bivirkninger under den relevante frekvenskategori)
Possible side effects (including possible serious side effects under the relevant frequency category).
Almindelig Infektioner (med eller uden neutropeni)†
Infections (with or without neutropenia)†
- Lad være med at føre motorkøretøjer eller betjene maskiner, hvis du føler dig svimmel, træt eller svag, eller hvis dit energiniveau er lavt.
- Avoid driving or using machines if you feel dizzy, tired or weak, or if your energy levels are low.
Pazopanib er til oral anvendelse.
Pazopanib is for oral use.
Højt blodtryk og Votrient
High blood pressure and Votrient
Patienter skal undgå at føre motorkøretøj eller betjene maskiner, hvis de føler sig svimle, trætte eller svage.
Patients should avoid driving or using machines if they feel dizzy, tired or weak.
I sub-gruppen af cytokin-behandlede patienter, havde størstedelen (75 %) fået interferon-baseret behandling.
In the cytokine pre-treated subgroup, the majority (75%) had received interferon-based treatment.
I sådanne tilfælde skal der være særlig opmærksomhed på bivirkninger, og yderligere dosisreduktion skal overvejes, hvis der observeres potentielt lægemiddelrelaterede bivirkninger.
In such cases there should be close attention to adverse drug reaction, and further dose reduction may be considered if possible drug-related adverse events are observed.
99 % af patienterne (243/246), der var indskrevet i STS fase III-studiet, inklusive de 15 forsøgspersoner, fik antracyklin.
99% of patients (243/246) enrolled in the STS Phase III study, including the 15 subjects, received anthracycline.
Votrient bør ikke anvendes, hvis du er gravid.
Votrient is not recommended if you are pregnant.
- Hvis du bliver gravid under behandlingen med Votrient, skal du fortælle det til lægen.
- If you do become pregnant during treatment with Votrient, tell your doctor.
Lægen kan nedsætte din dosis, hvis du får bivirkninger.
Your doctor may need to reduce your dose if you get side effects.
Votrient kan øge dit blodtryk.
Votrient can raise your blood pressure.
Pazopanibs sikkerhed og virkning hos børn i alderen 2 til 18 år er endnu ikke klarlagt.
The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established.
Fortæl det til lægen, hvis du oplever ændringer ved dit syn.
Tell your doctor if you notice any change in your vision.
Votrients virkning under graviditet kendes ikke.
The effect of Votrient during pregnancy is not known.
Graviditet/kontraception hos mænd og kvinder
Pregnancy/ Contraception in males and females
Tabel 2 Behandlingsrelaterede bivirkninger rapporteret i RCC-studier (n = 1149) eller i perioden efter markedsføring
Table 2 Treatment-related adverse reactions reported in RCC studies (n = 1149) or during post-marketing period
Alle patienter havde en clear celle-histologi eller en overvejende clear celle-histologi.
All patients had clear cell histology or predominantly clear cell histology.
For de patienter, der responderede på behandlingen, var mediantiden til respons 11,9 uger, og medianvarigheden af respons var 58,7 uger bedømt ved en uafhængig gennemgang (VEG105192).
For patients who responded to treatment, the median time to response was 11.9 weeks and the median duration of response was 58.7 weeks as per independent review (VEG105192).
Tal med lægen, hvis du mener, at dette gælder for dig.
Check with your doctor if you think this applies to you.
Hypertensiv krise (pludselig og alvorlig blodtryksstigning) Votrient kan til tider forårsage en pludselig og alvorlig blodtryksstigning.
Hypertensive crisis (sudden and severe rise in blood pressure) Votrient can on occasion cause a sudden and severe rise in blood pressure.
Brug af VEGF-hæmmere hos patienter med eller uden hypertension kan fremme dannelse af aneurismer og/eller arterielle dissektioner.
The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysm and/or artery dissections.
Baseret på den gnaverspecifikke patogenese og mekanisme for disse fund anses de ikke for at repræsentere en øget karcinogen risiko hos patienter, der tager pazopanib.
Based on the rodent-specific pathogenesis and mechanism for these findings, they are not considered to represent an increased carcinogenic risk for patients taking pazopanib.
Du må ikke tage Votrient sammen med mad.
Don't take Votrient with food.
Det primære mål med dette studie var at evaluere og sammenligne PFS hos patienter behandlet med pazopanib i forhold til patienter behandlet med sunitinib.
The primary objective of this study was to evaluate and compare PFS in patients treated with pazopanib to those treated with sunitinib.
- hvis du har en leversygdom.
- if you have liver disease.
Ikke alle pakningsstørrelser eller tabletstyrker er nødvendigvis markedsført i dit land.
Not all pack sizes or tablet strengths may be available in your country.
Binding af pazopanib til humant plasmaprotein in vivo var over 99 %, og der var ingen koncentrationsafhængighed i intervallet 10-100 g/ml.
Binding of pazopanib to human plasma protein in vivo was greater than 99% with no concentration dependence over the range of 10-100 g/ml.
Tabel 3 Behandlingsrelaterede bivirkninger rapporteret i STS-studier (n = 382)
Table 3 Treatment-related adverse reactions reported in STS studies (n=382)
Pazopanibs fire hovedmetabolitter bidrager kun til 6 % af eksponeringen i plasma.
The four principle pazopanib metabolites account for only 6% of the exposure in plasma.
Dosis af pazopanib må ikke overskride 800 mg.
The dose of pazopanib should not exceed 800 mg.
Størstedelen af patienterne havde enten gunstige (39 %) eller intermediære (54 %) MSKCC- (Memorial Sloan Kettering Cancer Centre)/Motzer-prognostiske faktorer.
The majority of patients had either favourable (39%) or intermediate (54%), MSKCC (Memorial Sloan Kettering Cancer Centre) / Motzer prognostic factors.
Anbefalinger for samtidig administration af PPI´er og H2-receptorantagonister er baseret på fysiologiske overvejelser.
The recommendations for how PPIs and H2-receptor antagonists are co-administered are based on physiological considerations.
Der foreligger begrænsede data om brugen af pazopanib til patienter på 65 år og derover.
There are limited data on the use of pazopanib in patients aged 65 years and older.
De filmovertrukne tabletter skal tages hele med vand og må ikke deles eller knuses (se pkt.
The film-coated tablets should be taken whole with water and not broken or crushed (see section 5.2).
Resultater tyder på, at mindre end 4 % af en oralt administreret dosis af pazopanib udskilles i urinen som pazopanib og metabolitter.
Results indicate that less than 4% of an orally administered pazopanib dose is excreted in the urine as pazopanib and metabolites.
AUC (0-24) (µg x time/ml)
AUC (0-24) (µg x hr/ml)
Median (uger)
Median (weeks)
Extremadura, 3, 09400 Aranda De Duero, Burgos, Spanien Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Storbritannien
Extremadura, 3, 09400 Aranda De Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Herudover bør samtidig administration af pazopanib og andre statiner ske med forsigtighed, da data er utilstrækkelige til at kunne afgøre påvirkningen af ALAT-niveauet.
In addition, concomitant use of pazopanib and other statins should be undertaken with caution as there are insufficient data available to assess their impact on ALT levels.
Der er observeret tilfælde af hyperglykæmi ved samtidig behandling med ketoconazol.
Cases of hyperglycaemia have been observed during concomitant treatment with ketoconazole.