natgillin/translations-raw huggingface dataset:
AUC: ↓ 42 % Cmin: ↓ 48 % Cmax: ↓ 31 % Induktion af CYP3A 
AUC: ↓ 42% Cmin: ↓ 48% Cmax: ↓ 31%
Cmin: ↑76 % Cmax: ↑ 30 % 
AUC: ↑ 49% Cmin: ↑ 76% Cmax: ↑ 30%
Det skal De vide, før De begynder at tage Odefsey Sådan skal De tage Odefsey Bivirkninger 
What Odefsey is and what it is used for What you need to know before you take Odefsey How to take Odefsey
nedsat leukocyttal1, nedsat hæmoglobin1, nedsat trombocyttal1 
decreased white blood cell count1, decreased haemoglobin1, decreased platelet count1
R(-) metadon: AUC: ↓ 16 % Cmin: ↓ 22 % Cmax: ↓ 14 % 
AUC: ↓ 16% Cmin: ↓ 22% Cmax: ↓ 14%
Ethinylestradiol: AUC: ↔ 
Ethinylestradiol:
Tenofoviralafenamid: AUC: ↑ 32 % Cmax: ↑ 3 % 
AUC: ↑ 32% Cmax: ↑ 3%
AUC: ↔ Cmin: ↑ 26 % 
AUC: ↔ Cmin: ↑ 26% Cmax: ↔
Leversygdom 
Cardiovascular
• mundtørhed 
• tiredness
Cmin: ↑ 10 % 
Cmax: ↑ 21%
5,4 % (95 % CI: 1,5 % til 9,2 %) 
0.4% (95% CI: -3.0% to 3.8%) 5.4% (95% CI: 1.5% to 9.2%)
Mave-tarm-kanalen Meget almindelig: 
Hepatobiliary disorders Very common:
Ketoconazol: AUC: ↓ 24 % Cmin: ↓ 66 % 
AUC: ↓ 24% Cmin: ↓ 66% Cmax: ↔
Regimer med rilpivirin 
Rilpivirine-containing regimen
Hvis De har taget for mange Odefsey 
If you take more Odefsey than you should
1216), blev der observeret stigninger fra baseline i faste-værdier for total-kolesterol, direkteLDL-kolesterol, HDL-kolesterol og triglycerider i Odefsey-armen. 
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.
Osteonekrose 
Norelgestromin:
Virkningen holdt sig i næsten et år. 
This effect was maintained for almost one year.
Sylvant fik en markedsføringstilladelse med gyldighed i hele EU den 22. maj 2014. 
Sylvant received a marketing authorisation valid throughout the EU on 22 May 2014.
Den anbefalede dosis er 11 mg pr. kg legemsvægt, og infusionen bør vare ca. en time. 
The recommended dose is 11 mg per kilogram body weight, and the infusion should last around one hour.
Sylvant gives hver tredje uge, indtil patienten ikke længere har gavn af behandlingen. 
Sylvant is given every three weeks, until the patient no longer benefits from treatment.
Udvalget anerkendte desuden, at der er et udækket medicinsk behov hos disse patienter. 
The Agency also acknowledged that there is an unmet medical need for these patients.
Andre oplysninger om Sylvant 
Other information about Sylvant
Som for alle lægemidler bliver data vedrørende brugen af Sylvant løbende overvåget. 
As for all medicines, data on the use of Sylvant are continuously monitored.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sylvant? 
What measures are being taken to ensure the safe and effective use of Sylvant?
Bivirkningerne af Sylvant blev anset for acceptable, men der bør indsamles flere langsigtede data. 
Side effects of Sylvant were considered acceptable but further long-term data are to be collected.
Virksomheden skal sørge for, at sundhedspersoner, der forventes at anvende lægemidlet, får udleveret oplysninger om, hvordan de indfører deres patienter i registret. 
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.
Et monoklonalt antistof er et protein, der er udformet, så det genkender og bindes til en særlig struktur (et antigen) i kroppen. 
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.
Den alvorligste bivirkning er en svær allergisk reaktion (anafylaksi). 
The most serious side effect is anaphylactic reaction (a severe allergic reaction).
Castlemans sygdom er sjælden, og Sylvant blev udpeget som "lægemiddel til sjældne sygdomme" den 30. november 2007. 
Castleman's disease is rare, and Sylvant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 November 2007.
Hvorfor blev Sylvant godkendt i EU? 
Why is Sylvant authorised in the EU?
Virksomheden, der markedsfører Sylvant, skal oprette et patientregister, der kan give flere oplysninger om den langsigtede sikkerhed. 
The company that markets Sylvant is required to set up a patient registry to provide further data on long-term safety.
Yderligere information om Sylvant findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Further information on Sylvant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
En oversigt over Sylvant, og hvorfor det er godkendt i EU 
An overview of Sylvant and why it is authorised in the EU
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Sylvant opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Sylvant's benefits are greater than its risks and it can be authorised for use in the EU.
Hvad er Sylvant, og hvad anvendes det til? 
What is Sylvant and what is it used for?
Indberettede bivirkninger ved Sylvant vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Sylvant are carefully evaluated and any necessary action taken to protect patients.
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. 
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.
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. 
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.
Hvilke risici er der forbundet med Sylvant? 
What are the risks associated with Sylvant?
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. 
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.
For mere information om brug af Sylvant se indlægssedlen, eller kontakt lægen eller apotekspersonalet. 
For more information about using Sylvant, see the summary of product characteristics or contact a doctor or pharmacist.
Med multicentrisk menes, at sygdommen omfatter flere lymfeknuder foruden andre organer i kroppen. 
Multicentric means that the disease affects several lymph nodes as well as other organs in the body.
Sylvant udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af uddannet sundhedspersonale under tilstrækkeligt lægeligt opsyn. 
Sylvant can only be obtained with a prescription and treatment should be given by qualified healthcare professionals and under appropriate medical supervision.
Det gives gennem et drop (ved infusion) i en vene. 
It is given by infusion (drip) into a vein.
Det aktive stof i Sylvant, siltuximab, er et monoklonalt antistof. 
The active substance in Sylvant, siltuximab, is a monoclonal antibody.
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. 
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.
Sylvant er undersøgt i ét hovedstudie med 79 voksne, som havde multicentrisk Castlemans sygdom, men ikke hiv- eller HHV-8-infektion. 
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.
Siltuximab er udformet, så det bindes til kroppens protein interleukin 6 (IL-6). 
Siltuximab has been designed to attach to a protein in the body called interleukin 6 (IL-6).
Sylvant anvendes til behandling af multicentrisk Castlemans sygdom hos voksne, der ikke er smittet med humant immundefektvirus (hiv) eller humant herpesvirus-8 (HHV-8). 
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).
Sylvant indeholder det aktive stof siltuximab. 
Sylvant contains the active substance siltuximab.
Symptomerne kan være træthed, natlige svedudbrud, feber, prikken og stikken som følge af nervebeskadigelse (perifer neuropati) og forstørret lever og milt. 
Symptoms can include tiredness, sweating at night, fever, peripheral neuropathy (pins and needles due to nerve damage) and swelling of liver and spleen.
Den fuldstændige liste over bivirkninger og begrænsninger ved Sylvant fremgår af indlægssedlen. 
For the full list of side effects and restrictions of Sylvant, see the package leaflet.
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. 
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.
Når siltuximab bindes til IL-6, blokerer det dets aktivitet og standser den abnorme cellevækst, så lymfeknuderne bliver mindre, og sygdomssymptomerne aftager. 
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.
Hvordan anvendes Sylvant? 
How is Sylvant used?
Hvordan virker Sylvant? 
How does Sylvant work?
Hvilke fordele viser studierne, at der er ved Sylvant? 
What benefits of Sylvant have been shown in studies?
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. 
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.
Castlemans sygdom er en sygdom i lymfesystemet, dvs. det netværk af kar, der transporterer væske fra vævene gennem lymfeknuderne til blodbanen. 
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.
Patienter med Castlemans sygdom producerer for meget IL-6. 
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.
Derefter skal barnet have vand eller mælk for at sluge granulatet. 
The child should then be given water or milk to swallow the granules.
Den valgte dosis er den lavest mulige til kontrol af barnets symptomer. 
The dose is chosen to be lowest possible that controls the child's symptoms.
Den fuldstændige EPAR for Alkindi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Alkindi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Alkindi. 
This is a summary of the European public assessment report (EPAR) for Alkindi.
Kapslerne åbnes, og granulatet puttes i barnets mund. 
The capsules are opened and the granules are placed in the child's mouth.
Virksomheden gennemførte også undersøgelser, der viste, at lægemidlet er "bioækvivalent" med referencelægemidlet. 
The company also carried out studies to show that it is ‘bioequivalent' to the reference medicine.
Andre oplysninger om Alkindi 
Other information about Alkindi
Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Alkindi. 
As for every medicine, the company provided studies on the quality of Alkindi.
Granulatet kan også drysses på en skefuld blød mad, der gives til barnet med det samme. 
The granules can also be sprinkled on a spoonful of soft food and given to the child immediately.
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. 
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.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Alkindi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
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.
Hvorfor blev Alkindi godkendt? 
Why is Alkindi approved?
Mangel på hormonet giver mange symptomer, herunder vægttab, muskelsvaghed, træthed og lavt blodtryk. 
A lack of the hormone causes several symptoms, including weight loss, muscle weakness, tiredness and low blood pressure.
Hvad er Alkindi, og hvad anvendes det til? 
What is Alkindi and what is it used for?
Alkindi giver de samme niveauer af hydrocortison i blodet som et referencelægemiddel, der allerede er godkendt i EU. 
Alkindi produces similar levels of hydrocortisone in the blood to a reference medicine already authorised in the EU.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Alkindi? 
What measures are being taken to ensure the safe and effective use of Alkindi?
Alkindi er et "hybridt lægemiddel". 
Alkindi is a ‘hybrid medicine'.
Alkindi hydrocortison 
Alkindi hydrocortisone
Der er ikke rapporteret om bivirkninger i undersøgelser af Alkindi, men nogle bivirkninger er blevet indberettet ved brug af andre hydrocortisonholdige lægemidler. 
No side effects were reported in studies with Alkindi, but some side effects have been reported with other hydrocortisone medicines.
Disse omfatter adfærdsændringer, kvalme, mavekatar, ændringer i blodets kaliumniveau og forhøjet syreindhold i blodet. 
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.
Det er ikke en praktisk vejledning i, hvordan Alkindi bør anvendes. 
It is not intended to provide practical advice on how to use Alkindi.
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. 
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.
Alkindi fås som kapsler, der indeholder granulat. 
Alkindi is available as capsules containing granules.
Hvilke risici er der forbundet med Alkindi? 
What are the risks associated with Alkindi?
Hydrocortison erstatter det naturlige kortisol, der mangler hos børn, hvis binyrer ikke producerer nok af hormonet, og på den måde kan deres symptomer afhjælpes. 
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.
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. 
It must also not be used in children with difficulty swallowing or in premature babies who haven't started feeding by mouth.
Alkindi indeholder det aktive stof hydrocortison. 
Alkindi contains the active substance hydrocortisone.
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. 
For more information about treatment with Alkindi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Den fuldstændige liste over bivirkningerne fremgår af indlægssedlen. 
For the full list of side effects see the package leaflet.
Alkindi er et lægemiddel til børn (0-18 år), hvis binyrer ikke kan producere nok af hormonet kortisol. 
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.
Alkindi må ikke gives til patienter, der er overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne. 
Alkindi must not be used in patients with hypersensitivity (allergy) to the active substance or to any of the ingredients of Alkindi.
Det aktive stof i Alkindi, hydrocortison, svarer til kortisol, som er det vigtigste steroidhormon, der dannes i binyrerne. 
The active substance in Alkindi, hydrocortisone, is the same as cortisol, the main steroid hormone released by the body's adrenal gland.
Hvis du ønsker praktisk vejledning om anvendelsen af Alkindi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Alkindi, patients should read the package leaflet or contact their doctor or pharmacist.
Hvordan anvendes Alkindi? 
How is Alkindi used?
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. 
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.
Kortisol er nødvendigt til kontrol af mange kropsprocesser (herunder kontrol af betændelse og kontrol af sukker- og mineralniveauer). 
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.
Hvilke fordele viser undersøgelserne, at der er ved Alkindi? 
What benefits of Alkindi have been shown in studies?
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. 
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.
Hvordan virker Alkindi? 
How does Alkindi work?
den 9. august 2002. 
on 9 August 2002.
Markedsføringstilladelsen er efterfølgende blevet fornyet. 
The Marketing Authorisation was subsequently renewed.
Dette sammendrag blev sidst ajourført i 07-2007. 
This summary was last updated in July 2007.
Undersøgelserne blev udført i overensstemmelse med kravene i de relevante monografier i Den Europæiske Farmakopé. 
The studies were performed according to the requirements of the appropriate European Pharmacopoeia monographs.
Derfor anbefales det ikke at anvende andre vacciner end disse inden for 14 dage efter vaccination med lægemidlet. 
It is therefore recommended that no other vaccine than these should be administered within 14 days after vaccination with the product.
Beskyttelsen indtræder efter 2 uger og varer op til 9 uger. 
The onset of protection is from 2 weeks onwards and the protection extends to 9 weeks.
Vaccinen er endvidere effektiv mod Marek's sygdom. 
The vaccine is also effective against Marek's disease.
Beskyttelsen indtræder efter 4 dage. 
The onset of protection is from 4 days onwards.
Lægemidlets sikkerhed er blevet påvist i adskillige laboratorie- og feltundersøgelser med specifikke patogenfrie kyllinger og andre kyllinger. 
The safety of the product has been demonstrated in several laboratory and field trials in specific pathogen-free and other chickens.
Benefit/risk-forholdet fremgår af afsnit 6 af denne EPAR. 
The benefit-risk balance may be found in module 6 of this EPAR.
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. 
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.
Sikkerheden for ikke-modtagelige fuglearter (fasaner, ænder, agerhøns, vagtler og duer) og for pattedyrearter (mus og marsvin) er ligeledes blevet påvist. 
The safety for non-susceptible bird species (pheasants, ducks, partridges, quails and pigeons) and for mammalian species (mice and guinea-pigs) was also demonstrated.
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. 
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.
Da lægemidlet opbevares i en beholder i flydende kvælstof, gives der særlige anvisninger for rekonstitution af vaccinen i afsnittet om produktinformation i denne EPAR. 
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.
Kun raske fugle bør vaccineres, og produktet bør ikke anvendes til æglæggende fugle og avlsfugle. 
Only healthy birds should be vaccinated and the product should not be used in birds in lay and breeding birds.
Som for enhver levende herpesvirus fra kalkuner (HVT) er produktet udskilt fra vaccinerede fugle og kan spredes til kalkuner. 
As for any turkey Herpesvirus (HVT) live vaccine, the product is excreted from vaccinated birds and may spread to turkeys.
Mens vaccinen næppe vil påvirke fertiliteten hos hanerne, er der ikke desto mindre indført en advarsel i produktresumeet. 
Whilst the vaccine is unlikely to affect male fertility, a warning has nevertheless been included in the SPC.
Den leveres som frossen suspension, der skal rekonstitueres med et fortyndingsmiddel og injiceres i kyllinger og i æg med kyllingefostre. 
It is presented as a frozen suspension to be reconstituted with diluent and injected into chickens and into eggs where chicks are developing.
Lægemidlet synes ikke at forstyrre antistoffer, der kommer fra moderfuglen, og produktet kan gives sikkert til daggamle kyllinger og til æg med kyllingefostre, uden at det tilsyneladende medfører noget sikkerhedsproblem eller undertrykkende virkning på immunforsvaret. 
The product appears to show no interference with antibodies derived from the mother bird and can be safely administered to day-old chickens and chicks in the egg without presenting any apparent safety problem or inducing an immunosuppressive effect.