FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Piro exceed the risks for active immunisation of dogs of six months or older against B. canis to reduce the severity of clinical signs associated with acute babesiosis (B. canis) and anaemia as measured by packed cell volume, and recommended that Nobivac Piro be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Nobivac Piro er større end risiciene, når vaccinen anvendes til aktiv immunisering af hunde på seks måneder eller ældre mod B. canis med henblik på at nedsætte sværhedsgraden af kliniske tegn i forbindelse med akut babesiosis (B. canis) og anæmi, bestemt ved volumenprocenten af blodets erythrocytter (hæmatokrit).
English: What is the risk associated with Nobivac Piro?
Danish: Hvilken risiko er der forbundet med Nobivac Piro?
English: Why has Nobivac Piro been approved?
Danish: Hvorfor blev Nobivac Piro godkendt?
English: Other information about Nobivac Piro:
Danish: Andre oplysninger om Nobivac Piro
English: What is Nobivac Piro?
Danish: Hvad er Nobivac Piro?
English: What is Nobivac Piro used for?
Danish: Hvad anvendes Nobivac Piro til?
English: How does Nobivac Piro work?
Danish: Hvordan virker Nobivac Piro?
English: What benefit has Nobivac Piro shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nobivac Piro?
English: This overview was last updated in 06-2018.
Danish: Denne oversigt blev sidst ajourført i 06-2018.
English: For these patients other treatment options should be considered.
Danish: For disse patienter bør der overvejes andre behandlingsmuligheder.
English: Cerdelga received a marketing authorisation valid throughout the EU on 19 January 2015.
Danish: Cerdelga fik en markedsføringstilladelse med gyldighed i hele EU den 19. januar 2015.
English: Patients who have not been tested or whom results of the test are not clear should also not take this medicine.
Danish: Patienter, der ikke er testet, eller for hvem resultaterne af testen ikke er klare, bør heller ikke få dette lægemiddel.
English: Regarding safety, side effects were mostly mild and transient, but it was recommended that the longterm safety of the medicine be further investigated.
Danish: Vedrørende sikkerheden var bivirkningerne hovedsagelig lette og forbigående, men det blev anbefalet nærmere at undersøge lægemidlets langsigtede sikkerhed.
English: Before starting treatment, the patient is tested to see how rapidly their bodies break down the medicine.
Danish: Før behandlingen påbegyndes, testes patienten for at se, hvor hurtigt kroppen nedbryder lægemidlet.
English: 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.
Danish: 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.
English: Cerdelga is available as capsules (84 mg) to be taken by mouth.
Danish: Cerdelga fås som kapsler (84 mg), der tages gennem munden.
English: The majority of side effects are mild and short-lived.
Danish: Størstedelen af bivirkningerne er lette og forbigående.
English: The most common serious side effect is fainting, in 8 out of every 1,000 patients.
Danish: Den hyppigste alvorlige bivirkning er besvimelse, som optræder hos 8 ud af hver 1 000 patienter.
English: As for all medicines, data on the use of Cerdelga are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Cerdelga løbende overvåget.
English: The disease is caused by the lack of an enzyme for breaking down fat.
Danish: Sygdommen skyldes mangel på et enzym, der nedbryder fedt.
English: Other information about Cerdelga
Danish: Andre oplysninger om Cerdelga
English: Patients whose bodies break down this medicine very rapidly (‘ultrarapid metabolisers') should not take Cerdelga.
Danish: Patienter, der nedbryder dette lægemiddel meget hurtigt (”ultrahurtige metabolisatorer”), bør ikke tage Cerdelga.
English: For more information about using Cerdelga, see the package leaflet or contact your doctor or pharmacist.
Danish: For yderligere oplysninger om brug af Cerdelga, se indlægssedlen, eller kontakt din læge eller dit apotek.
English: The European Medicines Agency decided that Cerdelga's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Cerdelga opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Further information on Cerdelga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Cerdelga findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Cerdelga contains the active substance eliglustat.
Danish: Cerdelga indeholder det aktive stof eliglustat.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Yderligere oplysninger om udpegelsen til lægemiddel til sjældne sygdomme findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What measures are being taken to ensure the safe and effective use of Cerdelga?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cerdelga?
English: Gaucher disease is rare, and Cerdelga was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 December 2007.
Danish: Gauchers sygdom er sjælden, og Cerdelga blev udpeget som "lægemiddel til sjældne sygdomme" den 4. december 2007.
English: All patients switching from enzyme replacement should be regularly monitored for disease progression.
Danish: Alle patienter, der overgår fra enzymerstatningsbehandling, bør regelmæssigt overvåges for fremadskriden af sygdommen.
English: The company will also keep record of patients treated with Cerdelga to look at the long-term safety of the medicine.
Danish: Virksomheden skal desuden føre register over de patienter, der behandles med Cerdelga, for at undersøge lægemidlets langsigtede sikkerhed.
English: Side effects reported with Cerdelga are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Cerdelga vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Another study looked at Cerdelga in 159 patients whose disease was well controlled by enzyme replacement therapy.
Danish: Et andet studie så på Cerdelga hos 159 patienter, hvis sygdom var velkontrolleret ved enzymerstatningsbehandling.
English: An overview of Cerdelga and why it is authorised in the EU
Danish: En oversigt over Cerdelga og hvorfor det er godkendt i EU
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Why is Cerdelga authorised in the EU?
Danish: Hvorfor er Cerdelga godkendt i EU?
English: What is Cerdelga and what is it used for?
Danish: Hvad er Cerdelga, og hvad anvendes det til?
English: The active substance in Cerdelga, eliglustat, works by blocking the action of an enzyme involved in the production of the glucosylceramide fat.
Danish: Det aktive stof i Cerdelga, eliglustat, virker ved at blokere et enzym, der medvirker i produktionen af fedtstoffet glucosylceramid.
English: 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.
Danish: 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).
English: Studies show that Cerdelga is effective at treating the disease, including reducing the size of enlarged spleens and livers.
Danish: Studier viser, at Cerdelga er effektivt til at behandle sygdommen, herunder at mindske størrelsen af en forstørret milt eller lever.
English: The most common side effect seen with Cerdelga is dyspepsia (heartburn) in approximately 6 out of 100 patients.
Danish: Den hyppigste bivirkning, som optræder med Cerdelga, er halsbrand (dyspepsi) hos ca. 6 ud af hver 100 patienter.
English: 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).
Danish: 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).
English: However, a minority of patients (about 15%) who were switched from enzyme replacement to Cerdelga, did not respond optimally after treatment for one year.
Danish: Et mindretal på ca. 15 % af de patienter, der skiftede fra enzymerstatning til Cerdelga, fik dog ikke optimal virkning efter et års behandling.
English: 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.
Danish: Cerdelga udleveres kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af Gauchers sygdom.
English: 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.
Danish: Gauchers sygdom er en genetisk sygdom, der medfører ophobning af fedtstoffet glucosylceramid (eller glucocerebrosid) i kroppen, typisk i leveren, milten og knoglerne.
English: What are the risks associated with Cerdelga?
Danish: Hvilke risici er der forbundet med Cerdelga?
English: 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.
Danish: 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.
English: Cerdelga is a medicine used for the long-term treatment of type-1 Gaucher disease in adults.
Danish: Cerdelga er et lægemiddel til langvarig behandling af Gauchers sygdom type 1 hos voksne.
English: This causes symptoms such as anaemia (low red blood cell counts), tiredness, easy bruising, an enlarged spleen and liver, and bone pain and fractures.
Danish: Dette medfører symptomer som lavt antal røde blodlegemer (anæmi) træthed, blå mærker, forstørret milt og lever samt knoglesmerter og -brud.
English: How is Cerdelga used?
Danish: Hvordan anvendes Cerdelga?
English: For the full list of side effects reported for Cerdelga, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Cerdelga fremgår af indlægssedlen.
English: What benefits of Cerdelga have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Cerdelga?
English: 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.
Danish: Studier viser, at Cerdelga er effektivt til at give bedring i sygdomssymptomerne hos de fleste tidligere ubehandlede patienter med Gauchers sygdom type 1.
English: 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.
Danish: 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.
English: How does Cerdelga work?
Danish: Hvordan virker Cerdelga?
English: 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.
Danish: Ophobningen at dette fedtstof i organer som milt, lever og knogler er ansvarlig for symptomerne på Gauchers sygdom type 1.
English: 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.
Danish: Alle sundhedspersoner, der forventes at ordinere Cerdelga, skal have udleveret en ordineringsvejledning.
English: Not known***
Danish: Ikke kendt***
English: (<1/10,000), not known (cannot be estimated from the available data).
Danish: (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Voncento can be used for all age groups.
Danish: Voncento kan bruges i alle aldersgrupper.
English: Date of first authorisation: 12 August 2013 Date of latest renewal: 26 April 2018
Danish: Dato for første markedsføringstilladelse: 12 august 2013 Dato for seneste fornyelse: 26 april 2018
English: 1 non-sterile plaster
Danish: 1 ikke-sterilt plaster
English: There are no data on fertility available.
Danish: Der foreligger ingen data om fertilitet.
English: • Do not take a double dose to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: • you notice that the medicine stops working properly (bleeding is not stopped).
Danish: • du opdager, at lægemidlet er holdt op med at virke korrekt (blødning stoppes ikke).
English: 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.
Danish: 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.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal præparatet bruges med det samme.
English: *** Observed during postmarketing surveillance, not observed in clinical trials.
Danish: *** Observeret i forbindelse med overvågning efter markedsførelsen, ikke observeret under kliniske forsøg.
English: Let blood flow back to the end of the tube.
Danish: Lad blodet flyde tilbage til enden af røret.
English: • Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.
Danish: • Tag straks den næste dosis, og fortsæt dernæst med regelmæssige mellemrum som anbefalet af lægen.
English: As Voncento contains both FVIII and VWF, it is important to know which factor you most need.
Danish: Da Voncento indeholder både FVIII og VWF, er det vigtigt at vide, hvilken faktor du har mest brug for.
English: Five cases of overdose have been reported from clinical trials.
Danish: Der er indberettet fem tilfælde af overdosering fra kliniske studier.
English: Elderly No dose adjustment is necessary for the older people.
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre.
English: Uncommon (PTPs)** Very common (PUPs)**
Danish: Ikke almindelig (PTPs)** Meget almindelig (PUPs)**
English: Common Very common
Danish: Almindelig Meget almindelig
English: The injection/infusion rate should not exceed 6 ml per minute.
Danish: Injektions-/infusionshastigheden må ikke overstige 6 ml/minut.
English: The patient should be observed for any immediate reaction.
Danish: Patienten skal holdes under observation for eventuelle umiddelbare reaktioner.
English: This effect occurs immediately and is known to depend to a large extent on the level of polymerisation of the protein.
Danish: Denne virkning indtræffer umiddelbart og skyldes i væsentlig grad proteinets polymeriseringsgrad.
English: Animal reproduction studies have not been conducted with Voncento.
Danish: Der er ikke udført reproduktionsstudier hos dyr med Voncento.
English: Like all medicines, Voncento can cause side effects, although not everybody gets them.
Danish: Voncento kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: If this happens your or your child's medicines may stop working properly and you or your child may experience persistent bleeding.
Danish: Hvis det sker, kan din eller dit barns medicin stoppe med at virke korrekt, og du eller dit barn kan opleve vedvarende blødning.
English: • Taste alteration (dysgeusia)
Danish: • Ændret smagssans (dysgeusi)
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
Danish: • Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid,
English: Please contact your doctor immediately if: • you notice symptoms of allergic reactions
Danish: Kontakt straks lægen hvis: • du får symptomer på en allergisk reaktion
English: Your doctor should inform you of the early signs of hypersensitivity reactions.
Danish: Din læge bør oplyse dig om de tidlige tegn på overfølsomhedsreaktioner.
English: 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.
Danish: 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.
English: Hypersensitivity (allergic reactions)
Danish: Overfølsomhed (allergiske reaktioner)
English: See section 2 “Voncento contains sodium”.
Danish: Se punkt 2 ”Voncento indeholder natrium”.
English: 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
Danish: 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
English: • Do not use this medicine after the expiry date, which is stated on the label and carton.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og æsken efter EXP.
English: Follow the directions given to you by your doctor.
Danish: Følg de retningslinjer, som du får af din læge.
English: • The reconstituted product should preferably be used immediately.
Danish: • Det rekonstituerede lægemiddel skal anvendes med det samme.
English: • If you are allergic to VWF or FVIII or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for VWF eller FVIII eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: ** produced from plasma of human donors ***The VWF activity is determined using the WHO Standard for VWF.
Danish: ** fremstillet af plasma fra humane donorer ***VWF-aktivitet bestemmes ved hjælp af WHO-standarden for VWF.
English: However, in these cases the initially reconstituted solution of Voncento should not be diluted any further.
Danish: I så fald skal den allerede fortyndede opløsning af Voncento dog ikke fortyndes yderligere.
English: - VWF produces delayed correction of the associated FVIII deficiency.
Danish: - VWF forhaler korrektion af den associerede FVIII-mangel.
English: The FVIII/VWF complex consists of two molecules (FVIII and VWF) with different physiological functions.
Danish: FVIII/VWF-komplekset består af to molekyler (FVIII og VWF) med forskellige fysiologiske funktioner.
English: • the severity of your disease
Danish: • hvor alvorlig sygdommen er
English: After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at room temperature (below 25 °C).
Danish: Efter rekonstitution er kemisk og fysisk stabilitet efter anbrud dokumenteret i 8 timer ved stuetemperatur (under 25 °C).
English: 6-12 years
Danish: 6-12 år
English: If you stop using Voncento Do not stop using Voncento without consulting your doctor.
Danish: Hvis du holder op med at bruge Voncento Hold ikke op med at bruge Voncento uden først at konsultere din læge.
English: The required dose is determined using the following formula:
Danish: Den rette dosis beregnes ud fra følgende formel:
English: The amount of VWF and FVIII you need to take and the duration of treatment depend on:
Danish: Hvor meget VWF og FVIII du skal have samt behandlingens varighed afhænger af:
English: Voncento contains sodium
Danish: Voncento indeholder natrium
English: Your doctor should give you treatment to prevent thrombosis.
Danish: Din læge skal sætte dig i behandling for at forebygge trombose.
English: 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.
Danish: Generelt bør alle patienter i behandling med koagulationsfaktor VIII-produkter overvåges omhyggeligt for udvikling af inhibitorer ved passende kliniske observationer og laboratorietests.
English: Side effects in children and adolescents are expected to be the same as in adults.
Danish: Bivirkninger hos børn og unge forventes at være de samme som hos voksne.
English: Lack of either factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed.
Danish: Mangel på en af disse faktorer betyder, at blodet ikke koagulerer så hurtigt, som det bør, og derved øges tendensen til blødninger.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Danish: Dosis baseret på legemsvægt kan kræve justering hos undervægtige eller overvægtige patienter.
English: DO NOT expose the vials to direct heat.
Danish: Udsæt ikke hætteglassene for direkte varme.
English: In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Danish: Hos patienter med eksisterende kardiovaskulære risikofaktorer kan substitutionsterapi med FVIII øge den kardiovaskulære risiko.
English: Name and address of the manufacturer(s) of the biological active substances
Danish: Navn og adresse på fremstilleren (fremstillerne) af de biologisk aktive stoffer
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Danish: Forholdsreglerne kan være af begrænset værdi mod uindkapslede virus såsom parvovirus B19.
English: Voncento contains approximately 128.2 mmol/l (2.95 mg/ml) of sodium.
Danish: Voncento indeholder ca. 128,2 mmol/l (2,95 mg/ml) natrium.
English: Furthermore patients may develop inhibitors to FVIII and VWF.
Danish: Endvidere kan patienterne udvikle inhibitorer over for FVIII og VWF.
English: This is equivalent to 0.74 % of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 0,74 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: Minor surgery including tooth extraction
Danish: Mindre kirurgiske indgreb inklusive tandudtrækning