FrancophonIA/ELRC3.0 huggingface dataset:
English: Norditropin is a medicine that contains somatropin, which is a copy of naturally occurring human growth hormone.
Danish: Norditropin er et lægemiddel, der indeholder somatropin, som er en kopi det naturlige menneskelige væksthormon.
English: The new indication was for the use of Norditropin in children with Prader-Willi syndrome, a rare genetic disease that affects children's growth and development.
Danish: Den nye indikation for Norditropin var anvendelse hos børn med Prader-Willis syndrom, der er en sjælden arvelig sygdom, som berører børns vækst og udvikling.
English: The grounds for the referral were the concerns of some Member States that the data on Norditropin submitted in the application were not sufficient to demonstrate its effectiveness in Prader-Willi syndrome.
Danish: Begrundelsen for henvisningen var, at der i visse medlemsstater var betænkelighed ved, at de oplysninger om Norditropin, der var indleveret til støtte for ansøgningen, var utilstrækkelige til at dokumentere dets effektivitet ved Prader-Willis syndrom.
English: It is also used to correct short height in girls who have the genetic disease called Turner syndrome, in children who have long-standing kidney problems, and in children born small for their gestational age and who have not caught up by the age of four.
Danish: Desuden anvendes det til behandling af ringe højde hos piger med den arvelige sygdom Turners syndrom, behandling af børn med langvarige nyreproblemer og behandling af børn, der er født for små i forhold til fødselstidspunktet og ikke har indhentet dette inden 4 års-alderen.
English: Norditropin is used as replacement therapy in children and adults who have a growth hormone deficiency.
Danish: Norditropin anvendes som erstatningsbehandling hos børn og unge med væksthormonmangel.
English: The somatropin in Norditropin is produced by a method known as ‘recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes the organism able to produce it. Norditropin is marketed in the EU Member States under the names Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx and associated names.
Danish: Norditropin markedsføres i EU's medlemsstater under navnene Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx og relaterede navne.
English: The Reference Member State (RMS) for the decentralised procedure for Pantoprazole Olinka application was UK and the Concerned Member States (CMS) were: Germany and Poland.
Danish: Referencemedlemsstaten for den decentraliserede procedure for Pantoprazol Olinka var Det Forenede Kongerige, og de berørte medlemsstater var: Den Tjekkiske Republik, Tyskland, Polen og Den Slovakiske Republik.
English: Other concerns LoOI-Q1: The Applicant was requested to clarify the origin and name of the reference product used in the new bioequivalence study.
Danish: Andre betænkeligheder - listen med uafklarede spørgsmål - Sp. 1: Ansøgeren blev anmodet om at redegøre for oprindelse og navn på det referencelægemidlet, der blev anvendt i den nye bioækvivalensundersøgelse.
English: Gastro-resistant tablet
Danish: Magensaftresistente Tablette
English: Pantoprazole 20 mg Volkspharma Gastroresistant tablets
Danish: Pantoprazole 20 mg Volkspharma
English: Pantoprazole 40 mg Volkspharma Gastroresistant tablets
Danish: Pantoprazole 40 mg Volkspharma
English: How does it work?
Danish: Hvordan fungerer det?
English: Treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandlingen bør indledes af en læge med erfaring i behandling af hiv-infektion.
English: It is only used in patients who have responded well to their current HIV treatment and who do not have an HIV infection that is resistant to treatment or not likely to respond to any of the active substances in the medicine.
Danish: Det anvendes kun til patienter, som har reageret godt på deres nuværende hiv-behandling, og som ikke har en hiv-infektion, der er modstandsdygtig over for behandling eller sandsynligvis ikke vil reagere på nogen af de aktive stoffer i lægemidlet.
English: Patients should take the medicine regularly and avoid missing doses.
Danish: Patienterne skal tage lægemidlet regelmæssigt og undgå at springe doser over.
English: The company also carried out a study that showed that the medicine is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden gennemførte også en undersøgelse, der viste, at lægemidlet er "bioækvivalent" med referencelægemidlet.
English: It does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Lægemidlet helbreder ikke hiv-infektion eller aids, men kan bremse den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: All three active substances block the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Danish: De tre aktivstoffer virker ved at blokere hiv-virussets enzym, revers transkriptase, der gør det muligt for virusset at formere sig i de celler, det har smittet.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Danish: Tenofovir er en nukleosid revers transkriptase-hæmmer.
English: The full EPAR can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Danish: Både nukleoside og nukleotide revers transkriptase-hæmmere betegnes som NRTI'er.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan er et antiviralt lægemiddel til behandling af voksne, som er smittet med humant immundefektvirus-1 (hiv-1), et virus, der medfører erhvervet immundefektsyndrom (aids).
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved de aktive stoffer i den godkendte anvendelse med referencelægemidlet, Atripla, og det er ikke nødvendigt at gentage disse med Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan keeps the amount of HIV in the blood at a low level.
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan holder mængden af hiv i blodet på et lavt niveau.
English: Because Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Danish: Lægemidlet indeholder tre aktive stoffer: efavirenz, som er en såkaldt non-nukleosid revers transkriptase-hæmmer (NNRTI), emtricitabin, som er en nukleosid revers transkriptase-hæmmer, og tenofovirdisoproxil, som er et "prodrug" (forstadium) til tenofovir, dvs. det omdannes til det aktive stof tenofovir i kroppen.
English: The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one.
Danish: Den virksomhed, der markedsfører lægemidlet, skal sikre, at alle læger, som forventes at ordinere lægemidlet, får udleveret informationsmateriale om den øgede risiko for nyresygdom, der er forbundet med lægemidler, som indeholder tenofovirdisoproxil, herunder Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan efavirenz / emtricitabine / tenofovir disoproxil
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan efavirenz/emtricitabin/tenofovirdisoproxil
English: What is Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan and what is it used for?
Danish: Hvad er Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, og hvad anvendes det til?
English: For practical information about using Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Danish: Andre oplysninger om Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
English: For more information about treatment with this medicine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Content Package size
Danish: Påfyldningsvolumen
English: Inactivated poliomyelitis virus (IPV): type 1
Danish: inaktiveret poliovirus (IPV): type 1
English: Recombinant hepatitis B surface antigen, S (HBsAg)
Danish: rekombinant hepatitis B overflade-antigen (HBsAg)
English: EU Number Invented name Strength Pharmaceutical formRoute of administration Packaging
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage
English: Haemophilus influenzae polysaccharide type b conjugated to tetanus protein (PRP-T)
Danish: Haemophilus influenzae type b polysackarid konjugeret til tetanustoksoid (PRP-T)
English: 1 Monodose preparation of 0.5 ml contains: Purified diptheria toxoid, adsorbed (PDT)
Danish: Enkeltdosispræparat a 0,5 ml indeholder: renset difteritoksoid, adsorberet (PDT)
English: Purified filamentous haemagglutinin adsorbed (FHA)
Danish: renset pertussis filamentøst haemagglutinin, adsorberet (FHA)
English: Purified pertussis toxoid, adsorbed (PTxd)
Danish: renset pertussistoksoid, adsorberet (PTxd)
English: Purified tetanus toxoid, adsorbed (PTT)
Danish: renset tetanustoksoid, adsorberet (PTT)
English: 10 syringes without attached needle with 2 separate needles
Danish: 10 injektionssprøjter uden fastsiddende nål med 2 separate nåle
English: 10 syringes without attached needle with 1 separate needle
Danish: 10 injektionssprøjter uden fastsiddende nål med 1 separat nål
English: 1 syringe without attached needle with 2 separate needles
Danish: 1 injektionssprøjte uden fastsiddende nål med 2 separate nåle
English: 1 syringe without attached needle
Danish: 1 injektionssprøjte uden fastsiddende nål
English: 1 syringe without attached needle with 1 separate needle
Danish: 1 injektionssprøjte uden fastsiddende nål med 1 separat nål
English: 1 syringe with attached needle
Danish: 1 injektionssprøjte med fastsiddende nål
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ruconest on 28 October 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ruconest den 28. oktober 2010.
English: This is a summary of the European public assessment report (EPAR) for Ruconest.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ruconest.
English: The main measure of effectiveness was how long it took for the symptoms to start to improve.
Danish: Det primære effektmål var, hvor lang tid der gik, før symptomerne begyndte at blive bedre.
English: The full EPAR for Ruconest can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ruconest findes på agenturets websted under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Improvement was measured by the patients rating the severity of their symptoms on a scale from 0 to 100.
Danish: Forbedringen blev målt ved, at patienterne vurderede deres symptomers sværhedsgrad på en skala fra 0 til 100.
English: A patient should not be given more than two injections within any 24-hour period.
Danish: En patient bør ikke få mere end to injektioner i løbet af 24 timer.
English: Other information about Ruconest
Danish: Andre oplysninger om Ruconest
English: One injection is usually enough to treat an attack, but a second injection may be given if the patient does not improve enough after the first one.
Danish: Én injektion er som regel nok til at behandle et anfald, men der kan gives endnu en injektion, hvis patienten ikke viser tilstrækkelig bedring efter den første injektion.
English: What measures are being taken to ensure the safe and effective use of Ruconest?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ruconest?
English: In this case the powder that comes with the solvent should be used.
Danish: I sådanne tilfælde skal det pulver, der følger med solvensen, bruges.
English: Patients may be able to inject the medicine themselves after they have been properly trained.
Danish: Patienter kan selv injicere lægemidlet, når de er blevet behørigt instrueret heri.
English: Patients receiving placebo started to improve after four hours in one study and after over eight hours in the other.
Danish: Patienter, der fik placebo, oplevede en forbedring efter 4 timer i den ene undersøgelse og efter mere end 8 timer i den anden undersøgelse.
English: What is Ruconest and what is it used for?
Danish: Hvad er Ruconest, og hvad anvendes det til?
English: When an attack occurred, the patients were given Ruconest or placebo (a dummy treatment).
Danish: Når anfaldene indtraf, fik patienterne Ruconest eller placebo (en uvirksom behandling).
English: The most common side effect with Ruconest (seen in between 1 and 10 patients in 100) is headache.
Danish: Den mest almindelige bivirkning ved Ruconest (som optræder hos mellem 1 og 10 ud af 100 patienter) er hovedpine.
English: Patients receiving Ruconest at doses of 50 units/kg and 100 units/kg started to improve after one and two hours.
Danish: Patienter, der fik Ruconest i doser på 50 enheder/kg og 100 enheder/kg, oplevede en forbedring efter henholdsvis 1 og 2 timer.
English: Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema.
Danish: Patienter med lave niveauer af dette protein har en overdrevent stor aktivitet i disse to systemer, hvilket fører til symptomerne på angioødem.
English: Why is Ruconest approved?
Danish: Hvorfor blev Ruconest godkendt?
English: Ruconest contains the active substance conestat alfa.
Danish: Ruconest indeholder det aktive stof conestat alfa.
English: When it is given during an angioedema attack, conestat alfa stops this excessive activity, helping to relieve the patient's symptoms.
Danish: Når det gives under et angioødemanfald, standser conestat alfa denne overdrevne aktivitet, hvilket er med til at lindre patientens symptomer.
English: Ruconest is available as a powder (with or without solvent) that is made up into a solution for injection.
Danish: Ruconest fås som et pulver (med eller uden solvens), der blandes til en injektionsvæske.
English: It is given by slow injection into a vein lasting around five minutes.
Danish: Det gives som en langsom intravenøs injektion over ca. 5 minutter.
English: The CHMP decided that Ruconest's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Ruconest er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain.
Danish: Hos patienter med angioødem kan der opstå hævelser overalt i kroppen, såsom i ansigt, ekstremiteter eller rundt om tarmen, hvilket giver ubehag og smerter.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ruconest.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Ruconest skal anvendes.
English: For more information about treatment with Ruconest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ruconest, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Ruconest was more effective than placebo at improving the symptoms of patients having an attack of angioedema.
Danish: Ruconest var mere effektivt end placebo til at forbedre symptomerne hos patienter, der fik angioødemanfald.
English: Ruconest must not be used in patients with known or suspected allergy to rabbits.
Danish: Det må ikke anvendes til patienter med kendt eller formodet allergi over for kaniner.
English: The company will also provide prescribers with an alert card for their patients.
Danish: Virksomheden vil ligeledes give de ordinerende læger et patientinformationskort.
English: The C1 esterase inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation.
Danish: C1-esterasehæmmerproteinet er nødvendigt for at kontrollere "kontakt- og komplementsystemerne", som er samlinger af proteiner i blodet, der bekæmper infektioner og forårsager betændelse.
English: Ruconest can only be obtained with a prescription and treatment should be started under the supervision of a doctor with experience in diagnosing and treating hereditary angioedema.
Danish: Ruconest udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i diagnosticering og behandling af hereditært angioødem.
English: What is the risk associated with Ruconest?
Danish: Hvilke risici er der forbundet med Ruconest?
English: The company that markets Ruconest will ensure that healthcare professionals who are expected to prescribe Ruconest are provided with an educational pack containing information on the proper use of the medicine and warnings about the risk of allergy.
Danish: Den virksomhed, der fremstiller Ruconest, vil sikre, at sundhedspersonale, som forventes at ordinere Ruconest, modtager undervisningsmateriale med information om den korrekte brug af lægemidlet og advarsler om risikoen for allergi.
English: Ruconest is a medicine used to treat attacks of hereditary angioedema in adults and adolescents.
Danish: Ruconest er et lægemiddel, der anvendes til behandling af anfald af hereditært angioødem hos voksne og unge.
English: Ruconest was studied in two main studies involving a total of 70 adults and adolescents with hereditary angioedema caused by low levels of C1 esterase inhibitor protein.
Danish: Ruconest blev undersøgt i to hovedundersøgelser, der omfattede i alt 70 voksne og unge med hereditært angioødem som følge af lave niveauer af C1-esterasehæmmerprotein.
English: The active substance in Ruconest, conestat alfa, is a copy of the C1 esterase inhibitor protein and wor ks in the same way as the natural human protein.
Danish: Det aktive stof i Ruconest, conestat alfa, er en kopi af C1esterasehæmmerproteinet og virker på samme måde som det naturlige menneskelige protein.
English: How is Ruconest used?
Danish: Hvordan anvendes Ruconest?
English: Ruconest is used in patients with hereditary angioedema that is linked to naturally low levels of a protein called ‘C1 esterase inhibitor'.
Danish: Ruconest anvendes til patienter med hereditært angioødem, som skyldes naturligt lave niveauer af et protein, der kaldes "C1esterasehæmmer".
English: For the full list of all side effects reported with Ruconest, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Ruconest fremgår af indlægssedlen.
English: What benefits of Ruconest have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ruconest?
English: How does Ruconest work?
Danish: Hvordan virker Ruconest?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ruconest have also been included in the summary of product characteristics and the package leaflet.
Danish: 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 Ruconest.
English: This mechanism takes place at high concentrations.
Danish: Denne mekanisme optræder ved høje koncentrationer.
English: Referral procedures on the basis of Article 35 of Directive 2001/82/EC require a clearly formulated question referred to the Committee.
Danish: Henvisningsprocedurer på grundlag af artikel 35 i direktiv 2001/82/EC kræver et klart formuleret spørgsmål til udvalget.
English: The Committee concluded that most of the current broad indications would not be supported by data.
Danish: Udvalget konkluderede, at størstedelen af de nuværende brede indikationer ikke kan dokumenteres af dataene.
English: Estonia Interchemie werken "De Adelaar" Eesti AS
Danish: Estland Interchemie werken "De Adelaar" Eesti AS
English: The CVMP notes that pursuant to Article 36 of the Directive, its obligation is to consider the matter concerned and issue a reasoned opinion within the appropriate time limit.
Danish: CVMP bemærker, at udvalget i henhold til artikel 36 i direktivet er forpligtet til at behandle sagen og afgive en begrundet udtalelse inden for en rimelig frist.
English: The interpretation of the EU legislation and consideration of compliance with the legal provisions of Article 6(3) of the Directive are not within the remit of the Committee and therefore these issues are not addressed in the assessment of the referral procedure.
Danish: Fortolkningen af EU-lovgivningen og hensynet til overensstemmelsen med lovbestemmelserne i direktivets artikel 6, stk. 3 ligger uden for udvalgets arbejdsområde, hvorfor disse punkter ikke er omfattet af vurderingen ved indbringelsesproceduren.
English: Member State EU/EEA
Danish: Medlem sstat EU/EØS
English: There are insufficient data available to support the currently approved indications.
Danish: Der er ikke tilstrækkelige data til dokumentation af de nuværende godkendte indikationer.
English: The scope of referral procedures is limited to evaluation of quality, safety and efficacy of veterinary medicinal products.
Danish: Området for henvisningsprocedurer er begrænset til vurdering af veterinærlægemidlers kvalitet, sikkerhed og virkning.
English: Croatia PROPHARMA VET d.o.o.
Danish: Kroatien PROPHARMA VET d.o.o.
English: 24010 León Spain
Danish: 24010 León Spanien