FrancophonIA/ELRC3.0 huggingface dataset:
English: Mechanism: CYP2C19 induction by ritonavir
Danish: Mekanisme: Ritonavirs inducerende virkning på CYP2C19
English: Mechanism: P-gp inhibition by paritaprevir, ritonavir and dasabuvir.
Danish: Mekanisme: Paritaprevir, ritonavir og dasabuvirs hæmning af P-gp.
English: Viekirax without dasabuvir rosuvastatin
Danish: Viekirax uden dasabuvir rosuvastatin
English: Astemizole Terfenadine Mechanism: CYP3A4 inhibition by ritonavir.
Danish: Mekanisme Indvirkninge n på sirolimus skyldes ritonavirs hæmning af CYP3A4
English: If clinically indicated, higher doses of esomeprazole/lansoprazole may be needed.
Danish: Brug højere doser esomeprazol/lansoprazol, hvis det er klinisk indiceret.
English: Mechanism: CYP3A4 inhibition by ritonavir
Danish: Mekanisme: Ritonavirs hæmning af CYP3A4
English: Caution should be used when Viekirax with or without dasabuvir is coadministered with fexofenadine.
Danish: Der bør udvises forsigtighed, når fexofenadin administreres sammen med Viekirax med eller uden dasabuvir
English: ↑ quinidine ↑ ranolazine
Danish: ↑ranolazin
English: OATP1B1 inhibition by paritaprevir.
Danish: Paritaprevirs hæmning af OATP1B/ BCRP.
English: ↑ norbu prenorphine
Danish: ↑ bupre norphin norbuprenor phin
English: Mechanism: CYP3A4/Pgp inhibition by erythromycin, paritaprevir, ritonavir and dasabuvir.
Danish: Mekanisme: Erythromycin ,paritaprevir, ritonavir og dasabuvirs hæmning af CYP3A4/Pgp.
English: PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis
Danish: Klinisk studier hos patienter med kronisk hepatitis C genotype 4-infektion PEARL I - genotype 4, behandlingsnaive eller pegIFN + RBV -erfarne uden cirrose Design:
English: Viekirax and dasabuvir with RBV 12-week arm
Danish: Viekirax og dasabuvir med ribavirin 12-uger-gruppen
English: Viekirax + dasabuvir dolutegravir
Danish: Viekirax + dasabuvir emtricitabin
English: Overall SVR12 Outcome for subjects without SVR12 On-treatment VF Relapse Other * Ombitasvir tablets, paritaprevir tablets and ritonavir capsules administered separately.
Danish: * Ombitasvir-tabletter, paritaprevir-tabletter og ritonavir-kapsler givet separat.
English: Viekirax with weight-based ribavirin for 12 or 16 weeks
Danish: randomiseret, globalt multicenter studie, åben Behandling: Viekirax med ribavirin baseret på vægt i 12 eller 16 uger.
English: Viekirax with dasabuvir
Danish: Viekirax + dasabuvir sofosbuvir
English: Viekirax without dasabuvir omeprazole
Danish: Viekirax uden dasabuvir ketoconazol
English: Colchicine Mechanism: CYP3A4 inhibition by ritonavir.
Danish: Mekanisme: Cobicistats hæmning af CYP3A4.
English: Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir
Danish: Mekanisme: Itraconazols, posaconazols og paritaprevir/
English: Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Danish: Mekanisme: Ritonavirs hæmning af CYP3A4 samt paritaprevir, ombitasvir og dasabuvirs hæmning af UGT.
English: CYP3A4 inhibition by ritonavir.
Danish: Klinisk kommentar ritonavirs hæmning af CYP3A4.
English: Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Danish: Baseline trombocyttal, median (× 109/l) < 90, n (%) ≥ 90, n (%) Samlede analyser af kliniske studier Responsvarighed I alt havde 660 patienter i kliniske fase 2- og fase 3-studier positive HCV-rna-resultater både ved SVR12og SVR24-målingerne.
English: Emtricitabine/ tenofovir
Danish: Emtricitabin/t enofovir
English: ↑ diltiazem, verapamil
Danish: Forventet: ↑ diltiazem, verapamil ↑ paritaprevir
English: Viekirax without
Danish: Viekirax uden emtricitabin
English: There is also a potential risk of autoimmune disease.
Danish: Der er også en potentiel risiko for autoimmun sygdom.
English: This is a summary of the European public assessment report (EPAR) for Strimvelis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Strimvelis.
English: Other information about Strimvelis
Danish: Andre oplysninger om Strimvelis
English: Regarding safety, Strimvelis was relatively well tolerated although data are limited due to the small number of patients studied.
Danish: For så vidt angår sikkerheden, var Strimvelis relativt veltolereret, selv om dataene er begrænsede på grund af det lille antal undersøgte patienter.
English: A risk management plan has been developed to ensure that Strimvelis is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Strimvelis anvendes så sikkert som muligt.
English: All patients were treated with Strimvelis and were still alive 3 years after treatment.
Danish: Alle patienterne blev behandlet med Strimvelis og var stadig i live 3 år efter behandlingen.
English: This type of medicine works by delivering genes into the body.
Danish: Denne type lægemiddel virker ved at indføre gener i kroppen.
English: What is Strimvelis and what is it used for?
Danish: Hvad er Strimvelis, og hvad anvendes det til?
English: As a result, patients lack the ADA enzyme.
Danish: Patienterne mangler således ADA-enzymet.
English: Because Strimvelis is produced using a retrovirus, there could be a potential risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far.
Danish: Da Strimvelis fremstilles ved hjælp af en retrovirus, kan der være en potentiel risiko for kræft som følge af utilsigtede ændringer i det genetiske materiale; der er dog ikke set sådanne tilfælde endnu.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Strimvelis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Strimvelis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The most common side effect with Strimvelis (which may affect up to 1 in 10 people) is pyrexia (fever).
Danish: Den mest almindelige bivirkning ved Strimvelis (som kan forekomme hos op til 1 ud af 10 personer) er feber.
English: The effects are expected to last for the patient's lifetime.
Danish: Virkningen forventes at vare resten af patientens liv.
English: Strimvelis is given as an infusion (drip) into a vein over about 20 minutes.
Danish: Strimvelis gives som en infusion i en blodåre (drop) over ca. 20 minutter.
English: Because the number of patients with ADA-SCID is low, the disease is considered ‘rare', and Strimvelis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 August 2005.
Danish: Da antallet af patienter med ADA-SCID er lavt, betragtes sygdommen som "sjælden", og Strimvelis blev udpeget som "lægemiddel til sjældne sygdomme" den 26. august 2005.
English: What measures are being taken to ensure the safe and effective use of Strimvelis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Strimvelis?
English: Patients are also given an antihistamine injection just before treatment to reduce the risk of allergic reactions.
Danish: Patienterne får også en indsprøjtning med antihistaminer før behandlingen for at nedsætte risikoen for allergiske reaktioner.
English: The company will also maintain a registry of patients treated with Strimvelis and monitor their progress regularly after treatment to study the long-term safety of the medicine.
Danish: Virksomheden vil også føre et register over patienter, der behandles med Strimvelis, og overvåge deres udvikling regelmæssigt efter behandlingen for at undersøge lægemidlets langsigtede sikkerhed.
English: Patients in the study had no appropriate bone marrow donor and alternative treatment had not worked or was not available.
Danish: Patienterne i undersøgelsen havde ingen egnet knoglemarvsdonor, og alternative behandlinger havde enten ikke virket eller var ikke tilgængelige.
English: The full EPAR for Strimvelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Strimvelis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is not intended to provide practical advice on how to use Strimvelis.
Danish: Det er ikke en praktisk vejledning i, hvordan Strimvelis bør anvendes.
English: Why is Strimvelis approved?
Danish: Hvorfor blev Strimvelis godkendt?
English: The dose depends on the bodyweight of the patient.
Danish: Dosen afhænger af patientens legemsvægt.
English: What are the risks associated with Strimvelis?
Danish: Hvilke risici er der forbundet med Strimvelis?
English: Serious side effects with Strimvelis may include effects linked to autoimmunity (when the immune system attacks the body's own cells) such as haemolytic anaemia (low red blood cell counts due to their too rapid breakdown), aplastic anaemia (low blood cell counts due to damaged bone marrow), hepatitis (liver inflammation), thrombocytopenia (low blood platelet count) and Guillain-Barré syndrome (damage to nerves that can result in pain, numbness, muscle weakness and difficulty walking).
Danish: De alvorlige bivirkninger, der kan forekomme ved Strimvelis, er autoimmune sygdomme (når immunforsvaret angriber kroppens egne celler) som f.eks. hæmolytisk anæmi (lavt antal røde blodlegemer, fordi de nedbrydes for hurtigt), aplastisk anæmi (lavt antal blodlegemer på grund af beskadiget knoglemarv), leverbetændelse, trombocytopeni (lavt antal blodplader) og Guillain-Barrésyndrom (nerveskade, der kan medføre smerter, følelsesløshed, muskelsvaghed og gangbesvær).
English: It must not be used in patients who have tested positive for human immunodeficiency virus (HIV, the virus that causes AIDS) or some other infections, or in patients who have previously had gene therapy treatment.
Danish: Lægemidlet må ikke bruges hos patienter, der er testet positive for human immundefektvirus (hiv, der er den virus, der forårsager aids) eller for andre infektioner, eller hos patienter, der tidligere har fået genterapi.
English: For the full list of restrictions and side effects reported with Strimvelis, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og indberettede bivirkninger ved Strimvelis fremgår af indlægssedlen.
English: Because ADA is essential for maintaining healthy lymphocytes (white blood cells that fight off infections), the immune system of patients with ADA-SCID does not work properly and without effective treatment they rarely survive more than 2 years.
Danish: Da ADA er nødvendigt for at fastholde raske lymfocytter (de hvide blodlegemer, der bekæmper infektioner), fungerer immunforsvaret hos patienter med ADA-SCID ikke normalt, og uden en effektiv behandling overlever de sjældent mere end 2 år.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Strimvelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Strimvelis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In addition, the company that makes Strimvelis will provide educational materials for patients and healthcare professionals with information on the medicine, and patients will have to sign a consent form before treatment is started.
Danish: Derudover skal den virksomhed, der fremstiller Strimvelis, udarbejde undervisningsmateriale til patienter og sundhedspersonale med oplysninger om lægemidlet, og patienterne skal underskrive en samtykkeerklæring, før behandlingen starter.
English: Strimvelis is a type of advanced therapy medicine called a ‘gene therapy product'.
Danish: Strimvelis er et lægemiddel til avanceret terapi, som kaldes et "genterapiprodukt".
English: These lymphocytes improve the patient's ability to fight infection, and so overcome the symptoms of the condition related to the immune system.
Danish: Disse lymfocytter forbedrer patientens evne til at bekæmpe infektioner og på den måde bekæmpe de symptomer på lidelsen, der er relateret til immunforsvaret.
English: Results from the main study show that Strimvelis is effective at improving survival of ADA-SCID patients.
Danish: Resultaterne fra hovedundersøgelsen viser, at Strimvelis effektivt forbedrer overlevelsen blandt ADASCID-patienter.
English: To prepare Strimvelis, two samples of the patient's bone marrow are collected, one to make Strimvelis and one that is kept as a back-up in case Strimvelis cannot be given or does not work.
Danish: Til forberedelse af Strimvelis skal der anvendes to prøver af patientens knoglemarv: én til at fremstille Strimvelis og én som backup, hvis Strimvelis ikke kan gives eller ikke virker.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Strimvelis, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Strimvelis, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Strimvelis can only be obtained with a prescription and treatment should only be given in a specialist transplant centre by a doctor who has experience in the treatment of ADA-SCID and the use of this type of medicine.
Danish: Strimvelis udleveres kun efter recept, og behandlingen bør kun gives på et specialiseret transplantationscenter af en læge med erfaring i behandling af patienter med ADA-SCID og brugen af denne type lægemiddel.
English: The rate of severe infections declined after treatment and continued to decline with longer-term follow-up beyond 3 years.
Danish: Frekvensen af alvorlige infektioner faldt efter behandlingen, og en opfølgende langtidskontrol viste, at faldet fortsatte ud over de 3 år.
English: Strimvelis contains cells derived from the patient's own bone marrow.
Danish: Strimvelis indeholder celler, der er udvundet af patientens egen knoglemarv.
English: Once given back to the patient into a vein, Strimvelis is transported in the bloodstream to the bone marrow where the CD34+ cells start to grow and make normal lymphocytes that can produce ADA.
Danish: Når patienten får infusionen med Strimvelis i en vene, transporteres lægemidlet via blodbanen til knoglemarven, hvor CD34+-cellerne begynder at vokse og lave normale lymfocytter, der kan producere ADA.
English: For more information about treatment with Strimvelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Strimvelis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Strimvelis is used in patients with ADA-SCID who cannot be treated by a bone-marrow transplant because they do not have a suitable, matched, related donor.
Danish: Strimvelis anvendes hos patienter med ADA-SCID, der ikke kan behandles med en knoglemarvstransplantation, fordi det ikke har været muligt at finde en egnet, matchende beslægtet stamcelledonor.
English: ADA-SCID is a rare inherited condition in which there is a change (mutation) in the gene needed to make an enzyme called adenosine deaminase (ADA).
Danish: ADA-SCID er en sjælden, arvelig sygdom, hvor der sker en ændring (mutation) i det gen, der er nødvendigt for at lave det såkaldte adenosindeaminase-enzym (ADA).
English: Then, CD34+ cells (cells that can make lymphocytes) are extracted from the bone marrow cells.
Danish: Derefter udvindes CD34+cellerne (de celler, som kan lave lymfocytter) fra knoglemarvscellerne.
English: However, measures are in place to monitor such events once the medicine is in use by using a registry of patients to study their long-term progress.
Danish: Der er imidlertid truffet foranstaltninger for at overvåge sådanne tilfælde ved hjælp af et register over behandlede patienter, således at der kan holdes øje med deres udvikling over tid.
English: Strimvelis can only be used to treat the same patient whose bone marrow was used to make the medicine.
Danish: Strimvelis må kun gives til den patient, hvis knoglemarv er anvendt til at fremstille lægemidlet.
English: Strimvelis is a medicine used to treat severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID).
Danish: Strimvelis er et lægemiddel, der anvendes til at behandle svær kombineret immundefekt (SCID) forårsaget af adenosindeaminase-mangel (ADA-SCID).
English: Before Strimvelis is given, patients receive conditioning (preparatory) treatment with another medicine, busulfan, to get rid of their abnormal bone marrow cells.
Danish: Før administrationen af Strimvelis får patienten forberedende behandling med et andet lægemiddel, busulfan, der skal fjerne de unormale knoglemarvsceller.
English: Some of the cells (called CD34+ cells) have been genetically modified to contain a working gene for ADA.
Danish: Nogle af cellerne (de såkaldte CD34+-celler) er blevet genetisk modificeret, så de indeholder et gen, der producerer ADA.
English: What benefits of Strimvelis have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Strimvelis?
English: Strimvelis provides the opportunity of a cure that improves the working of the immune system for patients with ADA-SCID, which is a life-threatening condition.
Danish: Strimvelis er en kur, som kan forbedre immunforsvarets funktion hos patienter med ADA-SCID, der er en livstruende sygdom.
English: A working gene for ADA is inserted into the CD34+ cells using a type of virus called a retrovirus, which has been altered genetically so that it can carry the ADA gene into cells and does not cause viral disease in humans.
Danish: Genet, der producerer ADA, sættes ind i CD34+-cellerne ved hjælp af en type virus (et såkaldt retrovirus), der er blevet genetisk modificeret, så det kan transportere ADA-genet ind i cellerne uden at medføre viral sygdom hos mennesker.
English: Strimvelis must not be used in patients who have leukaemia (cancer of white blood cells) or myelodysplasia (a type of bone marrow disorder) or have had these conditions in the past.
Danish: Patienter, der lider af leukæmi (kræft i de hvide blodlegemer) eller myelodysplasi (en knoglemarvslidelse), eller som tidligere har lidt af disse sygdomme, må ikke behandles med Strimvelis.
English: For practical information about using Strimvelis, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Strimvelis, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The benefits of Strimvelis have been shown in one main study involving 12 patients from 6 months to around 6 years old with ADA-SCID.
Danish: En hovedundersøgelse med 12 patienter i alderen 6 måneder til ca. 6 år med ADA-SCID har vist fordelene ved Strimvelis.
English: How is Strimvelis used?
Danish: Hvordan anvendes Strimvelis?
English: Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence
Danish: +-beriget cellefraktion indeholdende CD34 +-celler transduceret med retroviral vektor, som koder for den humane adenosindeaminase (ADA)cDNA-sekvens
English: To make Strimvelis, a sample of the patient's bone marrow is collected.
Danish: For at fremstille Strimvelis udtages der en prøve af patientens knoglemarv.
English: How does Strimvelis work?
Danish: Hvordan virker Strimvelis?
English: OTHER Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Danish: ANDET Mandag Tirsdag Onsdag Torsdag Fredag Lørdag Søndag
English: *Compared to historical data.
Danish: *Sammenlignet med historiske data.
English: It is therefore very important that you (or your partner) do not become pregnant during this treatment.
Danish: Derfor er det meget vigtigt, at du (eller din partner) ikke bliver gravid under behandlingen.
English: Ribavirin can harm your unborn baby.
Danish: Ribavirin kan skade dit ufødte barn.
English: None of these effects have been observed in humans.
Danish: Ingen af disse påvirkninger er observeret hos mennesker.
English: Black/African American Other
Danish: Sort/Afroamerikansk Andet
English: Effect of food on oral absorption
Danish: Virkning af fødeindtagelse på oral absorption
English: Category/ Substitution, n (%)
Danish: Kategori/ Substitution, n (%)
English: No antagonism of antiviral activity was observed.
Danish: Der blev ikke observeret antagonisme af antiviral aktivitet.
English: Caution is advised.
Danish: Forsigtighed anbefales.
English: Genotype-specific activity
Danish: Genotype-specifik aktivitet
English: The absolute bioavailability of the tablet formulation is 67%.
Danish: Tabletformuleringens absolutte biotilgængelighed er 67%.
English: Age (years): median (range) Race:
Danish: Alder (år): median (interval) Race:
English: The most common of these side effects are listed below.
Danish: De mest almindelige af disse bivirkninger er beskrevet nedenfor.
English: All 4 patients achieved SVR12.
Danish: Alle 4 patienter nåede SVR12.
English: Then take the next dose at your usual time.
Danish: Tag herefter den næste dosis på det sædvanlige tidspunkt.
English: Keep the tablet blister with you so that you can easily describe what you have taken.
Danish: Du bør have blisterpakningen på dig, så du nemt kan fortælle, hvad du har taget.
English: The lowest dose of digoxin should be initially prescribed.
Danish: Den laveste dosis af digoxin bør indledningsvis ordineres.
English: The table is not all-inclusive.
Danish: Tabellen er ikke altomfattende.
English: NNRTI-based Other
Danish: NNRTI-baseret Andet
English: 4.24 l/h.
Danish: 4,24 l/time.
English: Loc. Fontana del Ceraso 03012 Anagni (FR) Italy
Danish: Loc. Fontana del Ceraso 03012 Anagni (FR) Italien
English: **GS-331007 is the major circulating metabolite of the prodrug sofosbuvir.
Danish: **GS-331007 er den væsentligste cirkulerende metabolit af prodruget sofosbuvir.
English: The duration of your treatment with Daklinza will be either 12 or 24 weeks.
Danish: Varigheden af behandlingen med Daklinza er enten 12 eller 24 uger.
English: Do not chew or crush the tablet as it has a very unpleasant taste.
Danish: Du må ikke tygge eller knuse tabletten, da den har en meget ubehagelig smag.
English: It is important that you continue to take Daklinza during the whole treatment period.
Danish: Det er vigtigt, at du fortsætter med at tage Daklinza gennem hele behandlingsperioden.
English: Patients should be instructed to swallow the tablet whole.
Danish: Patienten skal instrueres i at sluge tabletten hel.
English: Other oral contraceptives have not been studied.
Danish: Andre orale svangerskabsforebyggende midler er ikke undersøgt.
English: No metabolites circulated at levels more than 5% of the parent concentration.
Danish: Ingen metabolitter cirkulerede ved niveauer på mere end 5% af den oprindelige koncentration.
English: Laboratory Value/Clinical Criteria
Danish: Laboratorieværdi/kliniske kriterier
English: *results are dose-normalised to 60 mg dose.
Danish: *resultater er dosisnormaliseret til 60 mg dosis.
English: Titanium dioxide (E171) Macrogol 400
Danish: Titandioxid (E171) Macrogol 400
English: This lowers the amount of hepatitis C virus in your body and removes the virus from your blood over a period of time.
Danish: På den måde nedsættes mængden af hepatitis C-virus i kroppen, og viruset fjernes fra blodet efter et stykke tid.
English: Steady state was achieved after 4 days of once-daily administration.
Danish: Steady state blev nået efter 4 dage med administration en gang dagligt.
English: The film-coated tablet should not be chewed or crushed due the unpleasant taste of the active substance.
Danish: Den filmovertrukne tablet må ikke tygges eller knuses på grund af det aktive stofs ubehagelige smag.
English: Otherwise the medicine may not work against the hepatitis C virus.
Danish: Ellers virker medicinen muligvis ikke mod hepatitis C-viruset.