natgillin/translations-raw huggingface dataset:
urticaria sjælden eosinofili og systemiske symptomer* som reaktion over for lægemidlet ikke kendt toksisk epidermal nekrolyse*, akut generaliseret eksantematøs pustulose* 
Not known toxic epidermal necrolysis*, acute generalised exanthematous pustulosis*
Samtidig administration af avanafil og REZOLSTA er kontraindiceret (se pkt. 
The combination of avanafil and REZOLSTA is contraindicated (see section 4.3).
REZOLSTA og dolutegravir kan anvendes uden dosisjustering. 
REZOLSTA and dolutegravir can be used without dose adjustments.
Baseret på teoretiske overvejelser kan REZOLSTA muligvis ændre plasmakoncentrationen af warfarin. 
Based on theoretical considerations REZOLSTA may alter warfarin plasma concentrations.
CD4+ celletal gennemsnitlig ændring fra baseline 
CD4+ cell count mean change from baseline
Lever og galdeveje almindelig forhøjede leverenzymer ikke almindelig hepatitis*, cytolytisk hepatitis* 
Uncommon hepatitis*, cytolytic hepatitis*
- clonazepam (til at hindre krampeanfald) - østrogenholdig prævention og hormonerstatningsbehandling. 
- Clonazepam (to prevent seizures).
Behandling med 800/150 mg darunavir/cobicistat under graviditet fører til lav eksponering for darunavir (se pkt. 
Treatment with darunavir/cobicistat 800/150 mg during pregnancy results in low darunavir exposure (see section 5.2), which may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child.
(CYP3A-hæmning og/eller P-gp-hæmning) 
(CYP3A inhibition and/or P-gp inhibition)
Hiv-1 RNA < 50 kopier/ml Hiv-1 RNA gennemsnitlig ændring fra baseline (log10kopier/ml) 
HIV-1 RNA < 50 copies/mL mean HIV-1 RNA log change from baseline (log10 copies/mL) CD4+ cell count mean change from baseline
Almene symptomer og reaktioner på administrationsstedet almindelig 
General disorders and administration site conditions Common fatigue, asthenia
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af digoxin. 
Based on theoretical considerations REZOLSTA is expected to increase digoxin plasma concentrations.
Resultater darunavir/ritonavir 800/100 mg en gang dagligt + OBR N=294 
Outcomes darunvir/ritonavir 800/100 mg once daily + OBR N = 294
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af maraviroc. 
Based on theoretical considerations REZOLSTA is expected to increase maraviroc plasma concentrations.
Udslæt 
urticaria
Et biotilgængelighedsstudie viste, at eksponeringen for darunavir er sammenlignelig mellem REZOLSTA og darunavir/ritonavir 800/100 mg en gang dagligt ved steady state hos ikke-fastende raske forsøgspersoner. 
Darunavir exposure was shown to be comparable in a bioavailability trial between REZOLSTA and darunavir/ritonavir 800/100 mg q.d.
Behandlingserfarne darunavir/ritonavir 800/100 mg en gang dagligt N=294 
Treatment-experienced darunavir/ritonavir 800/100 mg once daily N = 294
Det frarådes at co-administrere REZOLSTA med bosentan. 
Co-administration of REZOLSTA and bosentan is not recommended.
voriconazol må kun tages, når en læge har bedømt brugen af det. - rifabutin (mod bakterieinfektioner). 
Voriconazole should only be taken after medical evaluation.
4.5): - carbamazepin, phenobarbital, phenytoin - rifampicin - lopinavir/ritonavir - perikon (Hypericum perforatum). 
Co-administration with the following medicinal products due to the potential for loss of therapeutic effect (see section 4.5): - carbamazepine, phenobarbital, phenytoin - rifampicin - lopinavir/ritonavir - St John's wort, (Hypericum perforatum).
Baseret på teoretiske overvejelser kan REZOLSTA muligvis ændre plasmakoncentrationen af norethisteron. 
Based on theoretical considerations REZOLSTA may alter norethindrone plasma concentrations.
Amiodaron, bepridil, dronedaron, ivabradin, kinidin, ranolazin til behandling af visse hjertelidelser som f.eks. unormal hjerterytme Carbamazepin, phenobarbital og phenytoin til forebyggelse af krampeanfald Astemizol eller terfenadin til behandling af symptomer på allergi 
Carbamazepine, phenobarbital and phenytoin to prevent seizures Astemizole or terfenadine to treat allergy symptoms
Alle patienter darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=313 
All subjects darunavir/cobicistat 800/150 mg once daily + OBR N = 313
(CYP3A- og/eller P-glykoproteinhæmning) 
(CYP3A and/or P-glycoprotein inhibition)
- amitriptylin, desipramin, imipramin, nortriptylin, paroxetin, sertralin, trazodon (til behandling af depression og angst). 
- Rifabutin (against bacterial infections) - Tadalafil, sildenafil, vardenafil (for erectile dysfunction or high blood pressure in the pulmonary circulation) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety) - Maraviroc (to treat HIV infection) - Colchicine (to treat gout or familial Mediterranean fever).
Behandlingsnaive darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=295 
Treatment-naïve darunavir/cobicistat 800/150 mg once daily + OBR N = 295
Behandlingsnaive darunavir/cobicistat 800/150 mg en gang dagligt N=295 
Treatment-naïve darunavir/cobicistat 800/150 mg once daily N = 295
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af salmeterol. 
Based on theoretical considerations REZOLSTA is expected to increase salmeterol plasma concentrations.
Ved symptomer på alvorlige hudreaktioner skal REZOLSTA straks seponeres. 
REZOLSTA should be discontinued immediately if signs or symptoms of severe skin reactions develop.
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af colchicin. 
Based on theoretical considerations REZOLSTA is expected to increase colchicine plasma concentrations.
Kontakt lægen, hvis du får udslæt. 
Please contact your doctor whenever you develop a rash.
Baseret på teoretiske overvejelser forventes disse antimykobakterielle midler at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat. 
Based on theoretical considerations these antimycobacterials are expected to decrease darunavir and/or cobicistat plasma concentrations.
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af tenofovir. 
Based on theoretical considerations REZOLSTA is expected to increase tenofovir plasma concentrations.
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse PDE-5-hæmmere. 
Based on theoretical considerations REZOLSTA is expected to increase these PDE-5 inhibitor plasma concentrations.
Behandlingserfarne darunavir/cobicistat 800/150 mg en gang dagligt N=18 
Treatment-experienced darunavir/cobicistat 800/150 mg once daily N = 18
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse immunsuppressiva. 
Based on theoretical considerations REZOLSTA is expected to increase these immunosuppressant plasma concentrations.
Det skal du vide, før du begynder at tage REZOLSTA Sådan skal du tage REZOLSTA Bivirkninger 
What REZOLSTA is and what it is used for What you need to know before you take REZOLSTA How to take REZOLSTA
Den rapporterede tid til udbrud er variabel og kan være mange måneder efter behandlingsstart (se pkt. 
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af alfentanil. 
Based on theoretical considerations REZOLSTA is expected to increase alfentanil plasma concentrations.
Behandlingsnaive darunavir/ritonavir 800/100 mg en gang dagligt N=343 
Treatment-naïve darunavir/ritonavir 800/100 mg once daily N = 343
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af alfuzosin. 
Based on theoretical considerations REZOLSTA is expected to increase alfuzosin plasma concentrations.
Baseret på teoretiske overvejelser forventes rifampicin at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat. 
Based on theoretical considerations rifampin is expected to decrease darunavir and/or cobicistat plasma concentrations.
Behandlingserfarne darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=18 
Treatment-experienced darunavir/cobicistat 800/150 mg once daily + OBR N = 18
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af metformin. 
Based on theoretical considerations REZOLSTA is expected to increase metformin plasma concentrations.
Resultater darunavir/ ritonavir 800/100 mg en gang dagligt N=343 
Outcomes darunavir/ ritonavir 800/100 mg once daily N = 343
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse antidepressiva. 
Based on theoretical considerations REZOLSTA is expected to increase these anti-depressant plasma concentrations.
Der henvises til produktresuméet for maraviroc for yderligere oplysninger. 
For further details, consult the maraviroc Summary of Product Characteristics.
Jernoxid, sort 
Iron oxide black
4.5) - rifampicin - sekalealkaloider (f.eks. dihydroergotamin, ergometrin, ergotamin, methylergometrin) - cisaprid - dapoxetin - domperidon - naloxegol - lurasidon, pimozid, quetiapin, sertindol (se pkt. 
Co-administration with the following medicinal products due to the potential for serious and/or life-threatening adverse reactions (see section 4.5): - alfuzosin - amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine - astemizole, terfenadine - colchicine, when used in patients with renal and/or hepatic impairment (see section 4.5) - rifampicin - ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) - cisapride - dapoxetine - domperidone - naloxegol - lurasidone, pimozide, quetiapine, sertindole (see section 4.5) - elbasvir/grazoprevir - triazolam, midazolam administered orally (for caution on parenterally administered midazolam,
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse antiarytmika. 
Based on theoretical considerations REZOLSTA is expected to increase these antiarrhythmic plasma concentrations.
Baseret på teoretiske overvejelser forventes disse antiepileptika at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat. 
Based on theoretical considerations these anticonvulsants are expected to decrease darunavir and/or cobicistat plasma concentrations.
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af lumefantrin. 
Based on theoretical considerations REZOLSTA is expected to increase lumefantrine plasma concentrations.
Dokumentationen for virkning af darunavir/ritonavir 800/100 mg en gang dagligt er baseret på 192 ugers-analysen af data hos ART-naive hiv-1-patienter i det randomiserede, kontrollerede, åbne fase III-studie ARTEMIS. 
The evidence of efficacy of darunavir/ritonavir 800/100 mg once daily is based on the analyses of 192 week data from the randomised, controlled, open-label Phase III trial ARTEMIS in antiretroviral treatment-naïve HIV-1 infected patients comparing darunavir/ritonavir 800/100 mg once daily with lopinavir/ritonavir 800/200 mg per day (given as a twice-daily or as a once-daily regimen).
Baseret på teoretiske overvejelser forventes efavirenz at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat. 
Based on theoretical considerations efavirenz is expected to decrease darunavir and/or cobicistat plasma concentrations.
I andet trimester af graviditeten var værdierne for Cmax, AUC24t og Cmin for cobicistat hhv. 50 %, 63 % og 83 % lavere i forhold til post partum. 
During the second trimester of pregnancy, cobicistat Cmax, AUC24h, and Cmin were 50%,
Baseret på teoretiske overvejelser forventes etravirin at nedsætte plasmakoncentrationen af darunavir og/eller cobicistat. 
Based on theoretical considerations etravirine is expected to decrease darunavir and/or cobicistat plasma concentrations.
Din læge skal muligvis kontrollere dit blod. 
Your doctor might want to do some additional tests.
darunavir / ritonavir 800/100 m g en gang dagligt N=343 
darunavir/ ritonavir 800/100 mg once daily N = 343
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse calciumantagonister. 
Based on theoretical considerations REZOLSTA is expected to increase these calcium channel blocker plasma concentrations.
Co-administration af perikon og REZOLSTA er kontraindiceret (se pkt. 
Co-administration of St John's wort and REZOLSTA is contraindicated (see section 4.3).
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af rilpivirin. 
Based on theoretical considerations REZOLSTA is expected to increase rilpivirine plasma concentrations.
(lægemiddel)overfølsomhed ikke almindelig immunrekonstitutionsinflammatorisk syndrom (IRIS) 
Uncommon immune reconstitution inflammatory syndrome
Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af disse antipsykotika. 
Based on theoretical considerations REZOLSTA is expected to increase these anti-neoplastic plasma concentrations.
REZOLSTA og artemether/lumefantrin kan anvendes uden dosisjusteringer. 
REZOLSTA and artemether/lumefantrine can be used without dose adjustments; however, due to the increase in lumefantrine exposure, the combination should be used with caution.
Sekalealkaloider (f.eks. ergotamin, dihydroergotamin, ergometrin og methylergometrin) 
Rifampicin to treat some infections such as tuberculosis Lurasidone, pimozide, quetiapine or sertindole to treat psychiatric conditions Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også rapporteret i forbindelse med immunreaktivering. 
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.8).
Xultophy fik markedsføringstilladelse med gyldighed i hele EU den 18. september 2014. 
Xultophy received a marketing authorisation valid throughout the EU on 18 September 2014.
Xultophy gives én gang dagligt, fortrinsvis på samme tidspunkt hver dag. 
Xultophy is given once a day, preferably at the same time each day.
Yderligere information om Xultophy findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.. 
Further information on Xultophy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Som for alle lægemidler bliver data vedrørende brugen af Xultophy løbende overvåget. 
As for all medicines, data on the use of Xultophy are continuously monitored.
I den gruppe, der fortsatte med at få GLP-1agonisten, faldt det fra 7,7 % til 7,4 %. 
In the group that kept on receiving the GLP-1 agonist, it fell from 7.7% to 7.4%.
Andre oplysninger om Xultophy 
Other information about Xultophy
Der bør skiftes injektionssted for hver injektion for at undgå hudforandringer (såsom fortykkelse), der kan få lægemidlet til at virke dårligere end forventet. 
The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the medicine work less well than expected.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xultophy? 
What measures are being taken to ensure the safe and effective use of Xultophy?
Patienterne i undersøgelsen fortsatte enten med deres igangværende behandling eller fik Xultophy i stedet for GLP-1agonisten. 
Patients in the study either continued with their current treatment or received Xultophy instead of the GLP-1 agonist.
Bivirkninger for fordøjelsessystemet forekom hos op til 1 ud af 10 patienter og omfattede kvalme, diarré, opkastning, forstoppelse, fordøjelsesbesvær (dyspepsi), mavekatar (gastritis), mavesmerter, luft i maven (flatulens), tilbageløb af maveindholdet op mod munden (gastroøsofagealt reflukssygdom) og oppustet mave. 
Side effects on the digestive system occurred in up to 1 in 10 patients and included nausea (feeling sick), diarrhoea, vomiting, constipation, dyspepsia (indigestion), gastritis (inflammation of the stomach), abdominal pain (stomach ache), flatulence (wind), gastroesophageal reflux disease (passage of stomach acid back up towards the mouth), and distension (swelling) of the belly.
Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Xultophy opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Xultophy's benefits are greater than its risks and it can be authorised for use in the EU.
I den gruppe, som fik insulin degludec, faldt det fra 8,8 % til 8,0 %. 
In the group using insulin degludec it fell from 8.8% to 8.0%.
Oversigt over Xultophy, og hvorfor det er godkendt i EU 
An overview of Xultophy and why it is authorised in the EU
Insulin degludec er kun en anelse forskelligt fra det menneskelige insulin, idet det optages langsommere og jævnt af kroppen efter en indsprøjtning og virker i lang tid. 
Insulin degludec is slightly different from human insulin as it is absorbed more slowly and regularly by the body after an injection and it works for a long time.
Xultophy er et lægemiddel, der anvendes til behandling af type 2-sukkersyge. 
Xultophy is a medicine that is used for the treatment of type 2 diabetes.
De bivirkninger, der blev indberettet for Xultophy, vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Xultophy are carefully evaluated and any necessary action taken to protect patients.
Hvis du ønsker flere oplysninger om anvendelsen af Xultophy, kan du læse indlægssedlen eller kontakte lægen eller apoteket. 
For more information about using Xultophy, see the package leaflet or contact your doctor or pharmacist.
Én daglig indsprøjtning af Xultophy er påvist at have gavnlig virkning på reguleringen af blodsukkeret i tre hovedundersøgelser med 2 514 patienter med type 2-sukkersyge. 
Once-daily injection of Xultophy has been shown to be of benefit in controlling blood glucose in three main studies involving 2,514 patients with type 2 diabetes.
Xultophy (insulin degludec / liraglutid) 
Xultophy (insulin degludec / liraglutide)
Størstedelen af de patienter, der blev behandlet med Xultophy i disse undersøgelser, opnåede kontrol af blodsukkeret (et HbA1c på under 7,0 %), og mange nåede et HbA1c på under 6,5 %. 
The majority of patients treated with Xultophy in these studies achieved control of their blood glucose (HbA1c below 7.0%) and many achieved HbA1c below 6.5%.
Patienterne kan give sig selv indsprøjtningerne med Xultophy, hvis de er behørigt instrueret heri. 
Patients can inject themselves with Xultophy if they have been trained appropriately.
Hvad er Xultophy, og hvad anvendes det til? 
What is Xultophy and what is it used for?
Det gives som en indsprøjtning under huden i låret, overarmen eller maveskindet. 
It is given as an injection under the skin of the thigh, the upper arm or the abdomen (belly).
Hvorfor er Xultophy godkendt? 
Why is Xultophy approved?
Den hyppigste bivirkning ved Xultophy (som optræder hos mere end 1 ud af 10 patienter) er hypoglykæmi (lavt blodsukker). 
The most common side effect with Xultophy (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Den virksomhed, der markedsfører Xultophy, skal udlevere oplysningsmateriale til sundhedspersoner og patienter med instruktioner i sikker anvendelse af lægemidlet, for at nedsætte risikoen for fejlbehandling. 
The company that markets Xultophy will provide educational materials for healthcare professionals, explaining how to use the medicine safely, so as to reduce the risk of medication errors.
Det virker på samme måde som inkretiner (hormoner, der produceres i tarmen) ved at få bugspytkirtlen til at afgive mere insulin som reaktion på fødeindtagelse. 
It acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food.
Tilføjelse af dette lægemiddel til andre sukkersygelægemidler giver bedre kontrol af blodsukkeret, og det er værdifuldt at råde over en ekstra behandlingsmulighed for at kunne tilpasse behandlingen til den enkelte patient. 
Adding this medicine to other diabetes medicines offers better control of blood glucose and having an alternative treatment option is valuable in individualising treatment.
Hvilke risici er der forbundet med Xultophy? 
What are the risks associated with Xultophy?
Ved type 2-sukkersyge producerer kroppen enten ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet effektivt. 
Type 2 diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose, or the body is unable to use insulin effectively.
Det ene aktive stof i Xultophy, insulin degludec, er et erstatningsinsulin, der virker på samme måde som naturligt produceret insulin, og som får glukose til at trænge ind i cellerne fra blodet. 
One of the active substances in Xultophy, insulin degludec, is a replacement insulin that acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Det andet aktive stof i Xultophy, liraglutid, tilhører en gruppe sukkersygelægemidler, der er kendt som GLP-1-agonister. 
The other active substance in Xultophy, liraglutide, belongs to the class of diabetes medicines known as GLP-1 agonists.
Den fuldstændige liste over bivirkninger og begrænsninger ved Xultophy fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Xultophy, see the package leaflet.
Behandling med Xultophy og metformin blev sammenlignet med behandling med insulin degludec og metformin. 
Treatment with Xultophy and metformin was compared with treatment using insulin degludec and metformin.
Det gennemsnitlige indhold af HbA1c var i begyndelsen 8,3 %, men faldt til 6,4 % efter 26 ugers behandling med Xultophy, sammenlignet med henholdsvis 6,9 % og 7,0 % med insulin degludec og liraglutid. 
The average HbA1c level, which was 8.3% at the start, fell to 6.4% after 26 weeks of treatment with Xultophy, compared with 6.9% and 7.0% respectively with insulin degludec and liraglutide.
De aktive stoffer i Xultophy er insulin degludec og liraglutid. 
The active substances in Xultophy are insulin degludec and liraglutide.
• Den tredje undersøgelse omfattede 438 patienter, hvis blodsukker ikke var tilfredsstillende reguleret med en kombination af en GLP-1-agonist (liraglutid eller exenatid) og metformin med eller uden andre sukkersygelægemidler indtaget gennem munden. 
• The third study involved 438 patients whose blood glucose was not adequately controlled by a combination of a GLP-1 agonist (liraglutide or exenatide) and metformin with or without other diabetes medicines taken by mouth.
• Den første undersøgelse omfattede 1 663 patienter, hvis sukkersyge ikke var tilfredsstillende reguleret med sukkersygelægemidlerne metformin eller metformin og pioglitazon indtaget gennem munden. 
• The first study involved 1,663 patients whose diabetes was not adequately controlled with the diabetes medicines metformin or metformin and pioglitazone taken by mouth.
I alle undersøgelserne blev virkningen hovedsagelig bedømt på ændringen i blodets indhold af stoffet glykosyleret hæmoglobin (HbA1c) efter 6 måneders behandling. 
In all studies, the main measure of effectiveness was the change after 6 months of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.