FrancophonIA/ELRC3.0 huggingface dataset:
English: AUC: ↓ 24% Cmin: ↓ 66% Cmax: ↔
Danish: Ketoconazol: AUC: ↓ 24 % Cmin: ↓ 66 %
English: Rilpivirine-containing regimen
Danish: Regimer med rilpivirin
English: If you take more Odefsey than you should
Danish: Hvis De har taget for mange Odefsey
English: AUC: ↑ 5% Cmax: ↓ 4%
Danish: Sofosbuvir: AUC: ↑ 5 % Cmax: ↓ 4 %
English: In a study of virologically suppressed patients switching from FTC/RPV/TDF to Odefsey (Study GS-US-366-1216), increases from baseline were observed in fasting values of total cholesterol, direct LDL-cholesterol, HDL-cholesterol, and triglycerides in the Odefsey arm; and no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio were observed in either treatment arm at Week 96.
Danish: 1216), blev der observeret stigninger fra baseline i faste-værdier for total-kolesterol, direkteLDL-kolesterol, HDL-kolesterol og triglycerider i Odefsey-armen.
English: Norelgestromin:
Danish: Osteonekrose
English: This effect was maintained for almost one year.
Danish: Virkningen holdt sig i næsten et år.
English: Sylvant received a marketing authorisation valid throughout the EU on 22 May 2014.
Danish: Sylvant fik en markedsføringstilladelse med gyldighed i hele EU den 22. maj 2014.
English: The recommended dose is 11 mg per kilogram body weight, and the infusion should last around one hour.
Danish: Den anbefalede dosis er 11 mg pr. kg legemsvægt, og infusionen bør vare ca. en time.
English: Sylvant is given every three weeks, until the patient no longer benefits from treatment.
Danish: Sylvant gives hver tredje uge, indtil patienten ikke længere har gavn af behandlingen.
English: The Agency also acknowledged that there is an unmet medical need for these patients.
Danish: Udvalget anerkendte desuden, at der er et udækket medicinsk behov hos disse patienter.
English: Other information about Sylvant
Danish: Andre oplysninger om Sylvant
English: As for all medicines, data on the use of Sylvant are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Sylvant løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Sylvant?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sylvant?
English: Side effects of Sylvant were considered acceptable but further long-term data are to be collected.
Danish: Bivirkningerne af Sylvant blev anset for acceptable, men der bør indsamles flere langsigtede data.
English: The company will ensure that healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.
Danish: Virksomheden skal sørge for, at sundhedspersoner, der forventes at anvende lægemidlet, får udleveret oplysninger om, hvordan de indfører deres patienter i registret.
English: A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Danish: Et monoklonalt antistof er et protein, der er udformet, så det genkender og bindes til en særlig struktur (et antigen) i kroppen.
English: The most serious side effect is anaphylactic reaction (a severe allergic reaction).
Danish: Den alvorligste bivirkning er en svær allergisk reaktion (anafylaksi).
English: Castleman's disease is rare, and Sylvant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 November 2007.
Danish: Castlemans sygdom er sjælden, og Sylvant blev udpeget som "lægemiddel til sjældne sygdomme" den 30. november 2007.
English: Why is Sylvant authorised in the EU?
Danish: Hvorfor blev Sylvant godkendt i EU?
English: The company that markets Sylvant is required to set up a patient registry to provide further data on long-term safety.
Danish: Virksomheden, der markedsfører Sylvant, skal oprette et patientregister, der kan give flere oplysninger om den langsigtede sikkerhed.
English: Further information on Sylvant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Sylvant findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: An overview of Sylvant and why it is authorised in the EU
Danish: En oversigt over Sylvant, og hvorfor det er godkendt i EU
English: The European Medicines Agency decided that Sylvant's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Sylvant opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What is Sylvant and what is it used for?
Danish: Hvad er Sylvant, og hvad anvendes det til?
English: Side effects reported with Sylvant are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Sylvant vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: During the first 12 months of treatment the patient should have a blood test before each dose of Sylvant, and every nine weeks afterwards; treatment may need to be delayed in patients whose blood tests are abnormal or who have certain side effects.
Danish: I de første 12 måneder af behandlingen skal patienten have taget blodprøver før hver dosis af Sylvant, derefter hver 9. uge; ved abnorme blodprøver eller ved visse bivirkninger kan det nødvendigt at udsætte behandlingen.
English: The Agency concluded that Sylvant has shown beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman's disease, and that this positive effect seems to be maintained over time.
Danish: Agenturet konkluderede, at Sylvant er påvist at have gavnlig virkning i form af mindskelse af svulsternes størrelse og symptomerne hos patienter med multicentrisk Castlemans sygdom, og at denne positive virkning ser ud til at vedvare.
English: What are the risks associated with Sylvant?
Danish: Hvilke risici er der forbundet med Sylvant?
English: The effect of the medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients who responded to treatment for at least 18 weeks, as shown by a 50% reduction (‘partial response') or complete disappearance (‘complete response') of tumours and symptoms of the disease.
Danish: Virkningen aflægemidlet blev sammenlignet med en uvirksom behandling (placebo), og det vigtigste mål for virkningen var den andel af patienterne, der reagerede på behandlingen i mindst 18 uger, som det fremgik af en reduktion på 50 % ("delvis respons") eller fuldstændig forsvinden ('komplet respons') af svulster og sygdomssymptomer.
English: For more information about using Sylvant, see the summary of product characteristics or contact a doctor or pharmacist.
Danish: For mere information om brug af Sylvant se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Multicentric means that the disease affects several lymph nodes as well as other organs in the body.
Danish: Med multicentrisk menes, at sygdommen omfatter flere lymfeknuder foruden andre organer i kroppen.
English: Sylvant can only be obtained with a prescription and treatment should be given by qualified healthcare professionals and under appropriate medical supervision.
Danish: Sylvant udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af uddannet sundhedspersonale under tilstrækkeligt lægeligt opsyn.
English: It is given by infusion (drip) into a vein.
Danish: Det gives gennem et drop (ved infusion) i en vene.
English: The active substance in Sylvant, siltuximab, is a monoclonal antibody.
Danish: Det aktive stof i Sylvant, siltuximab, er et monoklonalt antistof.
English: The most common side effects with Sylvant (which may affect more than 1 in 5 people) are infections (including upper respiratory tract infections such as those of the throat and nose), itching, rash, joint pain and diarrhoea.
Danish: De hyppigste bivirkninger ved Sylvant (som optræder hos mere end 1 ud af 5 patienter) er infektioner (herunder infektioner i øvre luftveje som næse og svælg), kløe, udslæt, ledsmerter og diarré.
English: Sylvant has been investigated in one main study involving 79 adults with multicentric Castleman's disease who did not have HIV or HHV-8 infection.
Danish: Sylvant er undersøgt i ét hovedstudie med 79 voksne, som havde multicentrisk Castlemans sygdom, men ikke hiv- eller HHV-8-infektion.
English: Siltuximab has been designed to attach to a protein in the body called interleukin 6 (IL-6).
Danish: Siltuximab er udformet, så det bindes til kroppens protein interleukin 6 (IL-6).
English: Sylvant is a medicine that is used to treat multicentric Castleman's disease in adults who are not infected with human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8).
Danish: Sylvant anvendes til behandling af multicentrisk Castlemans sygdom hos voksne, der ikke er smittet med humant immundefektvirus (hiv) eller humant herpesvirus-8 (HHV-8).
English: Sylvant contains the active substance siltuximab.
Danish: Sylvant indeholder det aktive stof siltuximab.
English: Symptoms can include tiredness, sweating at night, fever, peripheral neuropathy (pins and needles due to nerve damage) and swelling of liver and spleen.
Danish: Symptomerne kan være træthed, natlige svedudbrud, feber, prikken og stikken som følge af nervebeskadigelse (perifer neuropati) og forstørret lever og milt.
English: For the full list of side effects and restrictions of Sylvant, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Sylvant fremgår af indlægssedlen.
English: Sylvant was more effective than placebo in reducing tumour size and disease symptoms: 17 out of 53 patients who received Sylvant showed a partial response and one showed a complete response, compared with none of the 26 patients who received placebo.
Danish: Sylvant var mere effektivt end placebo til at få svulster og sygdomssymptomer til at svinde: 17 ud af 53 patienter, som fik Sylvant, udviste delvis respons, og én udviste komplet respons.
English: By attaching to IL-6, siltuximab blocks its activity and stops abnormal cell growth, thus reducing the size of the lymph nodes and the symptoms of the disease.
Danish: Når siltuximab bindes til IL-6, blokerer det dets aktivitet og standser den abnorme cellevækst, så lymfeknuderne bliver mindre, og sygdomssymptomerne aftager.
English: How is Sylvant used?
Danish: Hvordan anvendes Sylvant?
English: How does Sylvant work?
Danish: Hvordan virker Sylvant?
English: What benefits of Sylvant have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Sylvant?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sylvant have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Sylvant.
English: Castleman's disease is a disorder of the lymphatic system (a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream) in which cells in lymph nodes start growing abnormally, causing benign tumours.
Danish: Castlemans sygdom er en sygdom i lymfesystemet, dvs. det netværk af kar, der transporterer væske fra vævene gennem lymfeknuderne til blodbanen.
English: Patients with Castleman's disease produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in the lymph nodes.
Danish: Patienter med Castlemans sygdom producerer for meget IL-6.
English: The child should then be given water or milk to swallow the granules.
Danish: Derefter skal barnet have vand eller mælk for at sluge granulatet.
English: The dose is chosen to be lowest possible that controls the child's symptoms.
Danish: Den valgte dosis er den lavest mulige til kontrol af barnets symptomer.
English: The full EPAR for Alkindi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Alkindi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Alkindi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Alkindi.
English: The capsules are opened and the granules are placed in the child's mouth.
Danish: Kapslerne åbnes, og granulatet puttes i barnets mund.
English: The company also carried out studies to show that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden gennemførte også undersøgelser, der viste, at lægemidlet er "bioækvivalent" med referencelægemidlet.
English: Other information about Alkindi
Danish: Andre oplysninger om Alkindi
English: As for every medicine, the company provided studies on the quality of Alkindi.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Alkindi.
English: The granules can also be sprinkled on a spoonful of soft food and given to the child immediately.
Danish: Granulatet kan også drysses på en skefuld blød mad, der gives til barnet med det samme.
English: This means that it is similar to a ‘reference medicine' containing the same active substance (in this case Hydrocortisone Tablets Auden Mckenzie), but Alkindi is available in a different form (granules instead of tablets) and has been developed for children only.
Danish: Det betyder, at det svarer til et "referencelægemiddel", som indeholder det samme aktive stof (i dette tilfælde Auden Mckenzie (hydrocortison-tabletter)), men Alkindi fås i en anden form (granulat i stedet for tabletter) og er kun beregnet til børn.
English: The European Medicines Agency concluded that the benefits of Alkindi are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Alkindi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Why is Alkindi approved?
Danish: Hvorfor blev Alkindi godkendt?
English: A lack of the hormone causes several symptoms, including weight loss, muscle weakness, tiredness and low blood pressure.
Danish: Mangel på hormonet giver mange symptomer, herunder vægttab, muskelsvaghed, træthed og lavt blodtryk.
English: What is Alkindi and what is it used for?
Danish: Hvad er Alkindi, og hvad anvendes det til?
English: Alkindi produces similar levels of hydrocortisone in the blood to a reference medicine already authorised in the EU.
Danish: Alkindi giver de samme niveauer af hydrocortison i blodet som et referencelægemiddel, der allerede er godkendt i EU.
English: What measures are being taken to ensure the safe and effective use of Alkindi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Alkindi?
English: Alkindi is a ‘hybrid medicine'.
Danish: Alkindi er et "hybridt lægemiddel".
English: Alkindi hydrocortisone
Danish: Alkindi hydrocortison
English: No side effects were reported in studies with Alkindi, but some side effects have been reported with other hydrocortisone medicines.
Danish: Der er ikke rapporteret om bivirkninger i undersøgelser af Alkindi, men nogle bivirkninger er blevet indberettet ved brug af andre hydrocortisonholdige lægemidler.
English: These include changes in behaviour, nausea, inflammation in the lining of the stomach and changes in blood potassium levels and excess acid in the blood.
Danish: Disse omfatter adfærdsændringer, kvalme, mavekatar, ændringer i blodets kaliumniveau og forhøjet syreindhold i blodet.
English: It is not intended to provide practical advice on how to use Alkindi.
Danish: Det er ikke en praktisk vejledning i, hvordan Alkindi bør anvendes.
English: Studies on the benefits and risks of the active substance have already been carried out with the reference medicine and do not need to be repeated for Alkindi.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof for referencelægemidlet, og det er ikke nødvendigt at gentage disse for Alkindi.
English: Alkindi is available as capsules containing granules.
Danish: Alkindi fås som kapsler, der indeholder granulat.
English: What are the risks associated with Alkindi?
Danish: Hvilke risici er der forbundet med Alkindi?
English: Hydrocortisone replaces the natural cortisol that is missing in children whose adrenal glands do not produce enough of the hormone, thereby helping to relieve their symptoms.
Danish: Hydrocortison erstatter det naturlige kortisol, der mangler hos børn, hvis binyrer ikke producerer nok af hormonet, og på den måde kan deres symptomer afhjælpes.
English: It must also not be used in children with difficulty swallowing or in premature babies who haven't started feeding by mouth.
Danish: Alkindi må heller ikke gives til børn, der har svært ved at synke, eller til for tidligt fødte, der endnu ikke tager føde gennem munden.
English: Alkindi contains the active substance hydrocortisone.
Danish: Alkindi indeholder det aktive stof hydrocortison.
English: For more information about treatment with Alkindi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Alkindi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For the full list of side effects see the package leaflet.
Danish: Den fuldstændige liste over bivirkningerne fremgår af indlægssedlen.
English: Alkindi is a medicine for children (from birth to up to 18 years of age) whose adrenal glands cannot make enough of a hormone called cortisol.
Danish: Alkindi er et lægemiddel til børn (0-18 år), hvis binyrer ikke kan producere nok af hormonet kortisol.
English: Alkindi must not be used in patients with hypersensitivity (allergy) to the active substance or to any of the ingredients of Alkindi.
Danish: Alkindi må ikke gives til patienter, der er overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne.
English: The active substance in Alkindi, hydrocortisone, is the same as cortisol, the main steroid hormone released by the body's adrenal gland.
Danish: Det aktive stof i Alkindi, hydrocortison, svarer til kortisol, som er det vigtigste steroidhormon, der dannes i binyrerne.
English: For practical information about using Alkindi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Alkindi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Alkindi used?
Danish: Hvordan anvendes Alkindi?
English: Alkindi is also available in a form suitable for children and it is easier to give a precise dose with Alkindi than with other treatments which require crushing tablets and weighing up the right dose.
Danish: Det er lettere at give en nøjagtig dosis af Alkindi end af andre lægemidler, der kræver knusning af tabletter og vejning af den rette dosis.
English: Cortisol is needed to control many body processes (including inflammation and the control of sugar and mineral levels) and is sometimes referred to as the ‘stress hormone' because it helps the body respond to stress.
Danish: Kortisol er nødvendigt til kontrol af mange kropsprocesser (herunder kontrol af betændelse og kontrol af sukker- og mineralniveauer).
English: What benefits of Alkindi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Alkindi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alkindi have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Alkindi.
English: How does Alkindi work?
Danish: Hvordan virker Alkindi?
English: on 9 August 2002.
Danish: den 9. august 2002.
English: The Marketing Authorisation was subsequently renewed.
Danish: Markedsføringstilladelsen er efterfølgende blevet fornyet.
English: This summary was last updated in July 2007.
Danish: Dette sammendrag blev sidst ajourført i 07-2007.
English: The studies were performed according to the requirements of the appropriate European Pharmacopoeia monographs.
Danish: Undersøgelserne blev udført i overensstemmelse med kravene i de relevante monografier i Den Europæiske Farmakopé.
English: It is therefore recommended that no other vaccine than these should be administered within 14 days after vaccination with the product.
Danish: Derfor anbefales det ikke at anvende andre vacciner end disse inden for 14 dage efter vaccination med lægemidlet.
English: The onset of protection is from 2 weeks onwards and the protection extends to 9 weeks.
Danish: Beskyttelsen indtræder efter 2 uger og varer op til 9 uger.
English: The vaccine is also effective against Marek's disease.
Danish: Vaccinen er endvidere effektiv mod Marek's sygdom.
English: The onset of protection is from 4 days onwards.
Danish: Beskyttelsen indtræder efter 4 dage.
English: The safety of the product has been demonstrated in several laboratory and field trials in specific pathogen-free and other chickens.
Danish: Lægemidlets sikkerhed er blevet påvist i adskillige laboratorie- og feltundersøgelser med specifikke patogenfrie kyllinger og andre kyllinger.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Danish: Benefit/risk-forholdet fremgår af afsnit 6 af denne EPAR.
English: Studies have shown that the strain appears safe for turkeys, however precautionary measures should be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Danish: Undersøgelser har vist, at stammen synes sikker for kalkuner, men der skal tages sikkerhedsforanstaltninger med henblik på at undgå direkte eller indirekte kontakt mellem vaccinerede kyllinger og kalkuner.
English: The safety for non-susceptible bird species (pheasants, ducks, partridges, quails and pigeons) and for mammalian species (mice and guinea-pigs) was also demonstrated.
Danish: Sikkerheden for ikke-modtagelige fuglearter (fasaner, ænder, agerhøns, vagtler og duer) og for pattedyrearter (mus og marsvin) er ligeledes blevet påvist.
English: No information is available on the safety and efficacy from the concurrent use with any other vaccine, except Merial attenuated vaccines against Marek's disease, Newcastle disease and Infectious bronchitis.
Danish: Der er ingen information tilgængelig om sikkerhed og effekt ved samtidig anvendelse med nogen anden vaccine, undtagen Merial's svækkede vacciner imod Marek's sygdom, Newcastle sygdom og infektiøs bronkitis.
English: As the product is stored in a tank under liquid nitrogen, particular instructions for reconstitution of the vaccine are provided in the product information module of the EPAR.
Danish: Da lægemidlet opbevares i en beholder i flydende kvælstof, gives der særlige anvisninger for rekonstitution af vaccinen i afsnittet om produktinformation i denne EPAR.
English: Only healthy birds should be vaccinated and the product should not be used in birds in lay and breeding birds.
Danish: Kun raske fugle bør vaccineres, og produktet bør ikke anvendes til æglæggende fugle og avlsfugle.
English: As for any turkey Herpesvirus (HVT) live vaccine, the product is excreted from vaccinated birds and may spread to turkeys.
Danish: Som for enhver levende herpesvirus fra kalkuner (HVT) er produktet udskilt fra vaccinerede fugle og kan spredes til kalkuner.
English: Whilst the vaccine is unlikely to affect male fertility, a warning has nevertheless been included in the SPC.
Danish: Mens vaccinen næppe vil påvirke fertiliteten hos hanerne, er der ikke desto mindre indført en advarsel i produktresumeet.