natgillin/translations-raw huggingface dataset:
For disse patienter bør der overvejes andre behandlingsmuligheder. 
For these patients other treatment options should be considered.
Cerdelga fik en markedsføringstilladelse med gyldighed i hele EU den 19. januar 2015. 
Cerdelga received a marketing authorisation valid throughout the EU on 19 January 2015.
Patienter, der ikke er testet, eller for hvem resultaterne af testen ikke er klare, bør heller ikke få dette lægemiddel. 
Patients who have not been tested or whom results of the test are not clear should also not take this medicine.
Vedrørende sikkerheden var bivirkningerne hovedsagelig lette og forbigående, men det blev anbefalet nærmere at undersøge lægemidlets langsigtede sikkerhed. 
Regarding safety, side effects were mostly mild and transient, but it was recommended that the longterm safety of the medicine be further investigated.
Før behandlingen påbegyndes, testes patienten for at se, hvor hurtigt kroppen nedbryder lægemidlet. 
Before starting treatment, the patient is tested to see how rapidly their bodies break down the medicine.
Patienter, der nedbryder lægemidlet med normal hastighed, får 1 kapsel to gange dagligt, mens de, der nedbryder lægemidlet langsomt, får 1 kapsel én gang dagligt. 
Patients who break down the medicine at normal speed take 1 capsule twice a day, while those who break down the medicine slowly take 1 capsule once a day.
Cerdelga fås som kapsler (84 mg), der tages gennem munden. 
Cerdelga is available as capsules (84 mg) to be taken by mouth.
Størstedelen af bivirkningerne er lette og forbigående. 
The majority of side effects are mild and short-lived.
Den hyppigste alvorlige bivirkning er besvimelse, som optræder hos 8 ud af hver 1 000 patienter. 
The most common serious side effect is fainting, in 8 out of every 1,000 patients.
Som for alle lægemidler, er data vedrørende brug af Cerdelga løbende overvåget. 
As for all medicines, data on the use of Cerdelga are continuously monitored.
Sygdommen skyldes mangel på et enzym, der nedbryder fedt. 
The disease is caused by the lack of an enzyme for breaking down fat.
Andre oplysninger om Cerdelga 
Other information about Cerdelga
Patienter, der nedbryder dette lægemiddel meget hurtigt (”ultrahurtige metabolisatorer”), bør ikke tage Cerdelga. 
Patients whose bodies break down this medicine very rapidly (‘ultrarapid metabolisers') should not take Cerdelga.
For yderligere oplysninger om brug af Cerdelga, se indlægssedlen, eller kontakt din læge eller dit apotek. 
For more information about using Cerdelga, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Cerdelga opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Cerdelga's benefits are greater than its risks and it can be authorised for use in the EU.
Yderligere information vedrørende Cerdelga findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Further information on Cerdelga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cerdelga indeholder det aktive stof eliglustat. 
Cerdelga contains the active substance eliglustat.
Yderligere oplysninger om udpegelsen til lægemiddel til sjældne sygdomme findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cerdelga? 
What measures are being taken to ensure the safe and effective use of Cerdelga?
Gauchers sygdom er sjælden, og Cerdelga blev udpeget som "lægemiddel til sjældne sygdomme" den 4. december 2007. 
Gaucher disease is rare, and Cerdelga was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 December 2007.
Alle patienter, der overgår fra enzymerstatningsbehandling, bør regelmæssigt overvåges for fremadskriden af sygdommen. 
All patients switching from enzyme replacement should be regularly monitored for disease progression.
Virksomheden skal desuden føre register over de patienter, der behandles med Cerdelga, for at undersøge lægemidlets langsigtede sikkerhed. 
The company will also keep record of patients treated with Cerdelga to look at the long-term safety of the medicine.
Bivirkninger rapporteret for Cerdelga vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Cerdelga are carefully evaluated and any necessary action taken to protect patients.
Et andet studie så på Cerdelga hos 159 patienter, hvis sygdom var velkontrolleret ved enzymerstatningsbehandling. 
Another study looked at Cerdelga in 159 patients whose disease was well controlled by enzyme replacement therapy.
En oversigt over Cerdelga og hvorfor det er godkendt i EU 
An overview of Cerdelga and why it is authorised in the EU
I dette studie forblev sygdommen stabil hos 85 % af de patienter, der skiftede til Cerdelga i et år, og hos 94 % af dem, der fortsatte med enzymerstatningsbehandling. 
In this study, the disease remained stable in 85% of patients who switched to Cerdelga for a year and in 94% of patients who continued with enzyme replacement therapy.
Cerdelga må ikke tages af visse patienter med leverproblemer eller af dem, der får visse lægemidler, som kan berøre kroppens evne til at nedbryde lægemidlet. 
Cerdelga must not be taken by some patients with liver problems or those taking certain medicines that can interfere with the ability of the body to break down the medicine.
Hvorfor er Cerdelga godkendt i EU? 
Why is Cerdelga authorised in the EU?
Hvad er Cerdelga, og hvad anvendes det til? 
What is Cerdelga and what is it used for?
Det aktive stof i Cerdelga, eliglustat, virker ved at blokere et enzym, der medvirker i produktionen af fedtstoffet glucosylceramid. 
The active substance in Cerdelga, eliglustat, works by blocking the action of an enzyme involved in the production of the glucosylceramide fat.
I et studie med 40 tidligere ubehandlede patienter med Gauchers sygdom type 1 havde de patienter, der fik Cerdelga, efter 9 måneders behandling fået reduceret størrelsen af milten med 28 %, sammenholdt med en stigning på 2 % hos dem, der fik virkningsløs behandling (placebo). 
In a study of 40 previously untreated patients with type-1 Gaucher disease, patients taking Cerdelga had a 28% reduction in spleen size, compared with a 2% increase in those taking placebo (a dummy treatment) after 9 months of treatment.
Studier viser, at Cerdelga er effektivt til at behandle sygdommen, herunder at mindske størrelsen af en forstørret milt eller lever. 
Studies show that Cerdelga is effective at treating the disease, including reducing the size of enlarged spleens and livers.
Den hyppigste bivirkning, som optræder med Cerdelga, er halsbrand (dyspepsi) hos ca. 6 ud af hver 100 patienter. 
The most common side effect seen with Cerdelga is dyspepsia (heartburn) in approximately 6 out of 100 patients.
Hos de patienter, der fik Cerdelga, var der desuden bedring i andre sygdomstegn såsom reduktion i størrelsen af leveren og stigning i hæmoglobin (det protein i de røde blodlegemer, der transporterer ilt i kroppen). 
Patients who took Cerdelga also showed an improvement of other signs of the disease such as a reduction in liver size and increased levels of haemoglobin (the protein in red blood cells that carries oxygen).
Et mindretal på ca. 15 % af de patienter, der skiftede fra enzymerstatning til Cerdelga, fik dog ikke optimal virkning efter et års behandling. 
However, a minority of patients (about 15%) who were switched from enzyme replacement to Cerdelga, did not respond optimally after treatment for one year.
Cerdelga udleveres kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af Gauchers sygdom. 
Cerdelga can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of Gaucher disease.
Gauchers sygdom er en genetisk sygdom, der medfører ophobning af fedtstoffet glucosylceramid (eller glucocerebrosid) i kroppen, typisk i leveren, milten og knoglerne. 
Gaucher disease is a genetic condition, in which a fat called glucosylceramide (or glucocerebroside) builds up in the body, typically in the liver, spleen and bone.
Hvilke risici er der forbundet med Cerdelga? 
What are the risks associated with Cerdelga?
Den virksomhed, der markedsfører Cerdelga, skal udlevere oplysningsmateriale til læger og patienter for at sikre, at kun patienter med Gauchers sygdom type 1 behandles med Cerdelga, og at Cerdelga ikke anvendes sammen med andre lægemidler, der væsentligt kan påvirke dets koncentration i blodet. 
The company that markets Cerdelga will provide doctors and patients with educational materials to ensure that only patients with type-1 Gaucher disease are treated with Cerdelga and that Cerdelga is not used in some patients with liver problems and together with other medicines which can significantly alter its blood levels.
Cerdelga er et lægemiddel til langvarig behandling af Gauchers sygdom type 1 hos voksne. 
Cerdelga is a medicine used for the long-term treatment of type-1 Gaucher disease in adults.
Dette medfører symptomer som lavt antal røde blodlegemer (anæmi) træthed, blå mærker, forstørret milt og lever samt knoglesmerter og -brud. 
This causes symptoms such as anaemia (low red blood cell counts), tiredness, easy bruising, an enlarged spleen and liver, and bone pain and fractures.
Hvordan anvendes Cerdelga? 
How is Cerdelga used?
Den fuldstændige liste over indberettede bivirkninger med Cerdelga fremgår af indlægssedlen. 
For the full list of side effects reported for Cerdelga, see the package leaflet.
Hvilke fordele viser studierne, at der er ved Cerdelga? 
What benefits of Cerdelga have been shown in studies?
Studier viser, at Cerdelga er effektivt til at give bedring i sygdomssymptomerne hos de fleste tidligere ubehandlede patienter med Gauchers sygdom type 1. 
Studies show that Cerdelga is effective in improving the symptoms of the disease for a majority of previously untreated patients with type-1 Gaucher disease and in keeping the disease stable in most patients previously treated by enzyme replacement.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Cerdelga. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cerdelga have also been included in the summary of product characteristics and the package leaflet.
Hvordan virker Cerdelga? 
How does Cerdelga work?
Ophobningen at dette fedtstof i organer som milt, lever og knogler er ansvarlig for symptomerne på Gauchers sygdom type 1. 
Because the build-up of this fat in organs like the spleen, liver and bones is responsible for the symptoms of type-1 Gaucher disease, reducing its production helps prevent its build-up, and thereby helps the affected organs to function better.
Alle sundhedspersoner, der forventes at ordinere Cerdelga, skal have udleveret en ordineringsvejledning. 
All patients who are prescribed Cerdelga will be provided with a patient alert card. All healthcare professionals who are expected to prescribe Cerdelga will be provided with a prescriber guide.
Ikke kendt*** 
Not known***
(<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
(<1/10,000), not known (cannot be estimated from the available data).
Voncento kan bruges i alle aldersgrupper. 
Voncento can be used for all age groups.
Dato for første markedsføringstilladelse: 12 august 2013 Dato for seneste fornyelse: 26 april 2018 
Date of first authorisation: 12 August 2013 Date of latest renewal: 26 April 2018
1 ikke-sterilt plaster 
1 non-sterile plaster
Der foreligger ingen data om fertilitet. 
There are no data on fertility available.
• Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis. 
• Do not take a double dose to make up for a forgotten dose.
• du opdager, at lægemidlet er holdt op med at virke korrekt (blødning stoppes ikke). 
• you notice that the medicine stops working properly (bleeding is not stopped).
Dette kan gøres enten ved at lade hætteglassene stå i stuetemperatur i en times tid eller ved at holde dem i hænderne i nogle få minutter. 
This can be done either by leaving the vials at room temperature for about an hour, or by holding them in your hands for a few minutes.
Ud fra et mikrobiologisk synspunkt skal præparatet bruges med det samme. 
From a microbiological point of view, the product should be used immediately.
*** Observeret i forbindelse med overvågning efter markedsførelsen, ikke observeret under kliniske forsøg. 
*** Observed during postmarketing surveillance, not observed in clinical trials.
Lad blodet flyde tilbage til enden af røret. 
Let blood flow back to the end of the tube.
• Tag straks den næste dosis, og fortsæt dernæst med regelmæssige mellemrum som anbefalet af lægen. 
• Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.
Da Voncento indeholder både FVIII og VWF, er det vigtigt at vide, hvilken faktor du har mest brug for. 
As Voncento contains both FVIII and VWF, it is important to know which factor you most need.
Der er indberettet fem tilfælde af overdosering fra kliniske studier. 
Five cases of overdose have been reported from clinical trials.
Ældre Dosisjustering er ikke nødvendig hos ældre. 
Elderly No dose adjustment is necessary for the older people.
Ikke almindelig (PTPs)** Meget almindelig (PUPs)** 
Uncommon (PTPs)** Very common (PUPs)**
Almindelig Meget almindelig 
Common Very common
Injektions-/infusionshastigheden må ikke overstige 6 ml/minut. 
The injection/infusion rate should not exceed 6 ml per minute.
Patienten skal holdes under observation for eventuelle umiddelbare reaktioner. 
The patient should be observed for any immediate reaction.
Denne virkning indtræffer umiddelbart og skyldes i væsentlig grad proteinets polymeriseringsgrad. 
This effect occurs immediately and is known to depend to a large extent on the level of polymerisation of the protein.
Der er ikke udført reproduktionsstudier hos dyr med Voncento. 
Animal reproduction studies have not been conducted with Voncento.
Voncento kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, Voncento can cause side effects, although not everybody gets them.
Hvis det sker, kan din eller dit barns medicin stoppe med at virke korrekt, og du eller dit barn kan opleve vedvarende blødning. 
If this happens your or your child's medicines may stop working properly and you or your child may experience persistent bleeding.
• Ændret smagssans (dysgeusi) 
• Taste alteration (dysgeusia)
• Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, 
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
Kontakt straks lægen hvis: • du får symptomer på en allergisk reaktion 
Please contact your doctor immediately if: • you notice symptoms of allergic reactions
Din læge bør oplyse dig om de tidlige tegn på overfølsomhedsreaktioner. 
Your doctor should inform you of the early signs of hypersensitivity reactions.
Disse inhibitorer stopper behandlingen i at arbejde korrekt, især ved høje niveauer, og du eller dit barn vil blive overvåget nøje for udvikling af disse inhibitorer. 
These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors.
Overfølsomhed (allergiske reaktioner) 
Hypersensitivity (allergic reactions)
Se punkt 2 ”Voncento indeholder natrium”. 
See section 2 “Voncento contains sodium”.
Hyppighed evalueres i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til < 1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden 
Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
• Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og æsken efter EXP. 
• Do not use this medicine after the expiry date, which is stated on the label and carton.
Følg de retningslinjer, som du får af din læge. 
Follow the directions given to you by your doctor.
• Det rekonstituerede lægemiddel skal anvendes med det samme. 
• The reconstituted product should preferably be used immediately.
• hvis du er allergisk over for VWF eller FVIII eller et af de øvrige indholdsstoffer (angivet i punkt 6). 
• If you are allergic to VWF or FVIII or any of the other ingredients of this medicine (listed in section 6).
** fremstillet af plasma fra humane donorer ***VWF-aktivitet bestemmes ved hjælp af WHO-standarden for VWF. 
** produced from plasma of human donors ***The VWF activity is determined using the WHO Standard for VWF.
I så fald skal den allerede fortyndede opløsning af Voncento dog ikke fortyndes yderligere. 
However, in these cases the initially reconstituted solution of Voncento should not be diluted any further.
- VWF forhaler korrektion af den associerede FVIII-mangel. 
- VWF produces delayed correction of the associated FVIII deficiency.
FVIII/VWF-komplekset består af to molekyler (FVIII og VWF) med forskellige fysiologiske funktioner. 
The FVIII/VWF complex consists of two molecules (FVIII and VWF) with different physiological functions.
• hvor alvorlig sygdommen er 
• the severity of your disease
Efter rekonstitution er kemisk og fysisk stabilitet efter anbrud dokumenteret i 8 timer ved stuetemperatur (under 25 °C). 
After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at room temperature (below 25 °C).
6-12 år 
6-12 years
Hvis du holder op med at bruge Voncento Hold ikke op med at bruge Voncento uden først at konsultere din læge. 
If you stop using Voncento Do not stop using Voncento without consulting your doctor.
Den rette dosis beregnes ud fra følgende formel: 
The required dose is determined using the following formula:
Hvor meget VWF og FVIII du skal have samt behandlingens varighed afhænger af: 
The amount of VWF and FVIII you need to take and the duration of treatment depend on:
Voncento indeholder natrium 
Voncento contains sodium
Din læge skal sætte dig i behandling for at forebygge trombose. 
Your doctor should give you treatment to prevent thrombosis.
Generelt bør alle patienter i behandling med koagulationsfaktor VIII-produkter overvåges omhyggeligt for udvikling af inhibitorer ved passende kliniske observationer og laboratorietests. 
In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Bivirkninger hos børn og unge forventes at være de samme som hos voksne. 
Side effects in children and adolescents are expected to be the same as in adults.
Mangel på en af disse faktorer betyder, at blodet ikke koagulerer så hurtigt, som det bør, og derved øges tendensen til blødninger. 
Lack of either factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed.
Dosis baseret på legemsvægt kan kræve justering hos undervægtige eller overvægtige patienter. 
Dose based on bodyweight may require adjustment in underweight or overweight patients.
Udsæt ikke hætteglassene for direkte varme. 
DO NOT expose the vials to direct heat.
Hos patienter med eksisterende kardiovaskulære risikofaktorer kan substitutionsterapi med FVIII øge den kardiovaskulære risiko. 
In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Navn og adresse på fremstilleren (fremstillerne) af de biologisk aktive stoffer 
Name and address of the manufacturer(s) of the biological active substances
Forholdsreglerne kan være af begrænset værdi mod uindkapslede virus såsom parvovirus B19. 
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Voncento indeholder ca. 128,2 mmol/l (2,95 mg/ml) natrium. 
Voncento contains approximately 128.2 mmol/l (2.95 mg/ml) of sodium.
Endvidere kan patienterne udvikle inhibitorer over for FVIII og VWF. 
Furthermore patients may develop inhibitors to FVIII and VWF.
Dette svarer til 0,74 % af den anbefalede maximale daglige indtagelse af natrium for en voksen. 
This is equivalent to 0.74 % of the recommended maximum daily dietary intake of sodium for an adult.
Mindre kirurgiske indgreb inklusive tandudtrækning 
Minor surgery including tooth extraction
Profylakse af venøs tromboemboli bør iværksættes i henhold til gældende rekommandationer. 
Prophylaxis against venous thromboembolism should be instituted, according to the current recommendations.
Træk luft ind i en tom, steril sprøjte. 
Draw air into an empty, sterile syringe.
Der er ingen erfaring med behandling af gravide kvinder eller kvinder, der ammer. 
Experience in the treatment of pregnant or breast-feeding women is not available.
Det noteres at den årlige blødningsrate (ABR) ikke kan sammenlignes i forskellige kliniske studier eller mellem forskellige faktorkoncentrater. 
Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Dette svarer til 1,48 % af den anbefalede maximale daglige indtagelse af natrium for en voksen. 
This is equivalent to 1.48% of the recommended maximum daily dietary intake of sodium for an adult.
Prækliniske studier med administration af gentagne doser (kronisk toksicitet, karcinogenicitet og mutagenicitet) kan ikke umiddelbart udføres i konventionelle dyremodeller pga. udvikling af antistoffer efter administration af heterologt humant protein. 
Preclinical studies with repeated dose applications (chronic toxicity, carcinogenicity and mutagenicity) cannot be reasonably performed in conventional animal models due to the development of antibodies following the application of heterologous human proteins.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Tabellen nedenfor er opstillet efter MedDRAs systemorganklasser. 
The table presented below is according to the MedDRA system organ classification.
På grund af sjælden forekomst af hæmofili A hos kvinder foreligger der ingen data fra behandling under graviditet og amning. 
Based on the rare occurrence of haemophilia A in women, experience regarding the treatment during pregnancy and breastfeeding is not available.
Din læge vil måske anbefale, at du overvejer vaccination mod hepatitis A og B, hvis du regelmæssigt eller gentagne gange får lægemidler udvundet af humant plasma såsom Voncento. 
Your doctor may recommend that you consider being vaccinated against hepatitis A and B if you regularly/repeatedly receive human plasma-derived medicines such as Voncento.
Patienter i risikogruppen bør derfor monitoreres for tidlige tegn på trombose. 
Therefore, patients at risk must be monitored for early signs of thrombosis.
• Udvikling af inhibitorer (antistoffer) er en kendt komplikation, som kan opstå under behandling med alle faktor VIII-lægemidler. 
• The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines.
• Voncento må ikke blandes med andre lægemidler, fortyndingsmidler eller solvenser end dem, der omtales i punkt 6. 
• Voncento must not be mixed with other medicines, diluents or solvents except those mentioned in section 6.
* FVIII-aktiviteten (IE) bestemmes ved hjælp af den Europæiske Farmakopés kromogene assay. 
* The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay.