natgillin/translations-raw huggingface dataset:
Hvorfor er Kalydeco godkendt i EU? 
Why is Kalydeco authorised in the EU?
Det aktive stof i Kalydeco, ivacaftor, øger aktiviteten af det defekte CFTR-protein. 
The active substance in Kalydeco, ivacaftor, increases the activity of the defective CFTR protein.
Kalydeco indeholder det aktive stof ivacaftor. 
Kalydeco contains the active substance ivacaftor.
Det kan være nødvendigt at justere Kalydeco-dosen, hvis patienten også tager en såkaldt moderat eller stærk CYP3A-hæmmer (f.eks. antibiotika eller svampemidler). 
The doses of Kalydeco may need to be adjusted if the patient is also taking a type of medicine called a ‘moderate or strong CYP3A inhibitor', such as certain antibiotics or medicines for fungal infections.
Kalydeco er et lægemiddel til behandling af cystisk fibrose, der er en arvelig sygdom med svær indvirkning på lungerne, fordøjelsessystemet og andre organer. 
Kalydeco is a medicine used to treat cystic fibrosis, an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Det primære mål for virkning i disse studier var forbedring af patienternes FEV1. 
The main measure of effectiveness in these studies was based on improvements in patients' FEV1.
Hvilke risici er der forbundet med Kalydeco? 
What are the risks associated with Kalydeco?
Studiet viste, at Kalydeco-granulat gav øget legemsvægt og nedsat mængde klorid i sved. 
The study found that Kalydeco granules resulted in increased bodyweight and a decreased amount of chloride contained in sweat.
Patienter med cystisk fibrose har lav legemsvægt, da de har problemer med at fordøje maden, og et højt niveau af klorid i sved, fordi CFTR-proteinet ikke fungerer, som det skal. 
Patients with cystic fibrosis have low bodyweight due to problems with digestion of food and high levels of chloride in sweat due to CFTR not working properly.
Dosis og doseringshyppighed afhænger af, om Kalydeco anvendes alene eller sammen med tezacaftor/ivacaftor. 
The dose and frequency depends on whether Kalydeco is used alone or together with tezacaftor / ivacaftor.
Den fuldstændige liste over bivirkninger og begrænsninger ved Kalydeco fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Kalydeco, see the package leaflet.
Alvorlige bivirkninger omfatter mavesmerter og øget niveau af leverenzymer. 
Serious side effects include abdominal pain and increased liver enzymes.
Kalydeco bør kun ordineres af en læge med erfaring i behandling af cystisk fibrose og bør kun gives til patienter, der har fået konstateret ovennævnte mutationer. 
It should only be prescribed by a doctor with experience in the treatment of cystic fibrosis, and only in patients confirmed to have the mutations mentioned above.
Virkningen blev hovedsageligt bedømt på forbedring af patienternes FEV1. 
The main measure of effectiveness was based on improvement in patients' FEV1.
De to lægemidler anvendes hos patienter, der har arvet F508del-mutationen fra begge forældre og derfor har mutationen i begge kopier af CFTR-genet. 
The two medicines are used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene.
De patienter, der fik Kalydeco og tezacaftor/ivacaftor, havde en gennemsnitlig stigning i FEV1 på 6,5 procentpoint sammenholdt med en stigning på 4,4 procentpoint hos patienter, der fik Kalydeco alene, og et fald på 0,3 procentpoint hos patienter, der fik placebo. 
Patients who took Kalydeco and tezacaftor / ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took Kalydeco alone and a reduction of 0.3 percentage points in patients who took placebo.
To af studierne omfattede 219 patienter med cystisk fibrose, der havde G551D-mutationen. 
Two of the studies involved 219 patients with cystic fibrosis who had the G551D mutation.
Det er påvist, at Kalydeco anvendt alene eller sammen med tezacaftor/ivacaftor forbedrer lungefunktionen hos patienter med specifikke mutationer. 
Kalydeco used on its own or together with tezacaftor / ivacaftor has been shown to improve lung function in patients with specific mutations.
Et yderligere studie undersøgte Kalydeco-granulat hos 34 patienter i alderen 2-5 år, som havde cystisk fibrose forårsaget af G551D- eller S549N-mutation. 
Another study investigated Kalydeco granules in 34 patients aged between 2 and 5 years of age who had cystic fibrosis due to a G551D or S549N mutation.
Kalydeco taget sammen med tezacaftor/ivacaftor blev sammenlignet med placebo. 
Kalydeco, taken with tezacaftor / ivacaftor, was compared with placebo.
I studierne blev Kalydeco sammenlignet med placebo (ikke-aktivt stof). 
In the studies, Kalydeco was compared with placebo (a dummy treatment).
Det fjerde studie omfattede 69 patienter i alderen 6 år og derover med cystisk fibrose, der havde R117H-mutationen. 
The fourth study involved 69 patients aged 6 years and above with cystic fibrosis who had the R117H mutation.
Kalydeco taget sammen med tezacaftor/ivacaftor blev sammenlignet med Kalydeco taget alene og med placebo. 
Kalydeco, taken with tezacaftor / ivacaftor, was compared with Kalydeco taken alone and with placebo.
Hvordan anvendes Kalydeco? 
How is Kalydeco used?
Det tredje studie omfattede 39 patienter over 6 år med cystisk fibrose, der skyldtes flere andre mutationer end G551D. 
The third study involved 39 patients over 6 years of age with cystic fibrosis due to several mutations other than G551D.
Kalydeco anvendes også sammen med et andet lægemiddel mod cystisk fibrose, der indeholder de aktive stoffer tezacaftor og ivacaftor, til behandling af patienter i alderen 12 år og derover med cystisk fibrose, der har den såkaldte F508del-mutation i CFTR-genet. 
Kalydeco is also used together with another cystic fibrosis medicine containing the active substances tezacaftor and ivacaftor to treat patients with cystic fibrosis aged 12 years and above who have a mutation called F508del in the CFTR gene.
Kalydeco anvendes som enkeltstofbehandling hos patienter i alderen 6 måneder og derover med cystisk fibrose, som har en af ni mutationer (forandringer) i genet for proteinet CFTR ("cystic fibrosis transmembrane conductance regulator"). 
Kalydeco is used on its own to treat cystic fibrosis in patients aged 6 months and above who have one of nine mutations (changes) in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR).
Tilsvarende resultater blev opnået hos patienter i alderen 6-11 år, hvor Kalydeco-gruppen oplevede en forbedring, der var 12,5 procentpoint højere end i placebo-gruppen. 
Similar results were seen in patients aged between 6 and 11 years, where Kalydeco treatment led to an improvement of 12.5 percentage points more than with placebo.
Efter 8 ugers behandling oplevede de patienter, der fik Kalydeco, en gennemsnitlig forbedring på 10,7 procentpoint mere end de patienter, der fik placebo. 
After 8 weeks of treatment patients who took Kalydeco had an average improvement of 10.7 percentage points more than those who took placebo.
Efter 24 ugers behandling havde de patienter, der fik disse lægemidler, en gennemsnitlig stigning i FEV1 på 3,4 procentpoint, sammenholdt med et fald på 0,6 procentpoint hos de patienter, der fik placebo. 
After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo.
Ved specifik analyse af en undergruppe af patienter på 18 år og derover sås dog en gennemsnitlig forbedring på ca. 5,0 procentpoint hos patienter, der fik Kalydeco, sammenholdt med placebo. 
However, when analysing the subset of patients aged 18 years and above alone, an average improvement of around 5.0 percentage points was seen in patients who took Kalydeco compared with patients who took placebo.
De anvendes også hos patienter, der har arvet F508del-mutationen fra én forælder og samtidig har én af følgende mutationer i CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, eller 3849+10kbC→T. 
They are also used in patients who have inherited the F508del mutation from one parent and also have one of the following mutations in CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, or 3849+10kbC→T.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Kalydeco. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kalydeco have also been included in the summary of product characteristics and the package leaflet.
Kalydeco anvendes også som enkeltstofbehandling hos patienter i alderen 18 år og derover med cystisk fibrose, som har R117H-mutationen i CFTR-genet. 
Kalydeco is also used on its own to treat patients with cystic fibrosis aged 18 years and above who have the R117H mutation in the CFTR gene.
F508del-mutation fra begge forældre eller F508del-mutation fra én forælder og mutation P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G eller 3849+10kbC→T 
F508del mutation from both parents or F508del mutation from one parent and P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G or 3849+10kbC→T mutations
Hvordan virker Kalydeco? 
How does Kalydeco work?
Hvilke fordele viser studierne, at der er ved Kalydeco? 
What benefits of Kalydeco have been shown in studies?
Der er tale om følgende mutationer: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N og S549R (såkaldt gating-mutationer). 
The mutations are: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N and S549R (also known as gating mutations).
Mutationerne G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R og R117H 
G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H mutations
Hos patienter i alderen 12 år og derover var den gennemsnitlige forbedring af FEV1 efter 24 ugers behandling 10,6 procentpoint højere i Kalydeco-gruppen end i placebo-gruppen. 
After 24 weeks of treatment, patients aged 12 years and older who took Kalydeco had an average improvement in FEV1 of 10.6 percentage points more than those who took placebo.
Fire hovedstudier af patienter med cystisk fibrose, der havde forskellige mutationer, viste, at Kalydeco er effektivt til at forbedre lungefunktionen. 
Kalydeco was shown to be effective at improving lung function in 4 main studies involving patients with cystic fibrosis who had various mutations.
Det er i to hovedstudier af patienter i alderen 12 år og derover med cystisk fibrose, og som havde F508del-mutationen, påvist, at Kalydeco taget sammen med tezacaftor/ivacaftor er effektivt til at forbedre lungefunktionen. 
Kalydeco taken together with tezacaftor / ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above with the the F508del mutation.
Lægemiddelform 
Invented nameStrength Pharmaceutical Form Route of Administration
Brilique 90 mg Filmovertrukket tablet Oral anvendelse enkeltdosisblister (PVC/PVDC/alu) 
Immediate Packaging Pack size blister (PVC/PVDC/alu) 100 x 1 tablet (unit dose)
Information om, hvordan dette gøres, er medtaget i produktinformationen. 
Information on how to do this has been included in the product information.
Yderligere information om LysaKare findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/lysakare. 
Further information on LysaKare can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lysakare.
Andre oplysninger om LysaKare 
Other information about LysaKare
Som for alle lægemidler bliver data vedrørende brugen af LysaKare løbende overvåget. 
As for all medicines, data on the use of LysaKare are continuously monitored.
Bivirkningerne ved LysaKare er sædvanligvis lette eller moderate. 
Side effects with LysaKare are usually mild or moderate.
Hvad er LysaKare, og hvad anvendes det til? 
What is LysaKare and what is it used for?
De hyppigste bivirkninger ved LysaKare (som kan forekomme hos mere end 1 ud af 10 personer) er kvalme og opkastning. 
The most common side effects with LysaKare (which may affect more than 1 in 10 people) are nausea and vomiting.
LysaKare (arginin/lysin) 
LysaKare (arginine / lysine)
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af LysaKare? 
What measures are being taken to ensure the safe and effective use of LysaKare?
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved LysaKare opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency therefore decided that LysaKare's benefits are greater than its risks and it can be authorised for use in the EU.
En oversigt over LysaKare, og hvorfor det er godkendt i EU 
An overview of LysaKare and why it is authorised in the EU
LysaKare må ikke gives til patienter med højt kaliumindhold i blodet, hvis dette ikke er korrigeret før behandling. 
LysaKare must not be given to patients with high levels of potassium in the blood if this has not been corrected before treatment.
LysaKare fås kun på recept og bør kun indgives af en sundhedsperson med erfaring i brug af radioaktive lægemidler. 
LysaKare can only be obtained with a prescription and should only be given by a healthcare professional experienced in the use of radioactive medicines.
Hvorfor er LysaKare godkendt i EU? 
Why is LysaKare authorised in the EU?
De indberettede bivirkninger ved LysaKare vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with LysaKare are carefully evaluated and any necessary action taken to protect patients.
LysaKare bruges hos voksne og indeholder de aktive stoffer arginin og lysin. 
LysaKare is for use in adults and contains the active substances arginine and lysine.
Hvis du ønsker mere information om anvendelsen af LysaKare, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet. 
For more information about using LysaKare, see the package leaflet or contact your doctor or pharmacist.
LysaKare forbindes også med hyperkaliæmi (højt kaliumindhold i blodet), men hyppigheden af denne bivirkning kendes ikke. 
LysaKare is also associated with hyperkalaemia (high blood potassium levels), but the frequency of this side effect is not known.
LysaKare indgives ved infusion (drop) i en vene i løbet af fire timer. 
LysaKare is given by infusion (drip) in to a vein over 4 hours.
Den største risiko ved LysaKare er en farlig stigning i blodets indhold af kalium, men denne bivirkning kan håndteres, hvis den konstateres og behandles korrekt. 
The main risk with LysaKare is a dangerous rise of blood potassium levels but this side effect can be managed if recognised and treated appropriately.
Hvilke risici er der forbundet med LysaKare? 
What are the risks associated with LysaKare?
Da brugen af arginin og lysin til at beskytte nyrerne under denne type kræftbehandling er veletableret, fremlagde virksomheden data fra faglitteraturen. 
Because the use of arginine and lysine to protect the kidneys during this type of cancer treatment is well established, the company presented data from the scientific literature.
Det radioaktive lægemiddel udskilles derfor gennem urinen, og nyrerne udsættes for mindre stråling. 
As a result, the radioactive medicine leaves the body in the urine and the kidneys are exposed to less radiation.
Da LysaKare kan give kvalme og opkastning, får patienterne medicin til at forebygge kvalme og opkastning, inden de modtager LysaKare. 
Because LysaKare can cause nausea (feeling sick) and vomiting, patients will be given medicines to prevent nausea and vomiting before receiving LysaKare.
LysaKare (arginin/lysin) EMA/314645/2019 
LysaKare (arginine / lysine) EMA/378037/2019
Den fuldstændige liste over bivirkninger og begrænsninger ved LysaKare fremgår af indlægssedlen. 
For the full list of side effects and restrictions with LysaKare, see the package leaflet.
Infusionen med LysaKare indledes 30 minutter, før patienten får lutetium (177Lu) oxodotreotid (også ved infusion). 
Infusion with LysaKare is started 30 minutes before the patient is given lutetium (177Lu) oxodotreotide (also by infusion).
LysaKare er et lægemiddel, der anvendes til at beskytte nyrerne mod strålingsskader under kræftbehandling med et radioaktivt lægemiddel, der kaldes lutetium (177Lu) oxodotreotid. 
LysaKare is a medicine used to protect the kidneys from radiation damage during cancer treatment with a radioactive medicine called lutetium (177Lu) oxodotreotide.
Hvordan anvendes LysaKare? 
How is LysaKare used?
I et andet offentliggjort studie med deltagelse af 229 patienter viste målinger af kreatinin-clearance (en indikator for nyrefunktion) ingen nyreskade 14 måneder efter behandling med arginin og lysin samtidigt med lutetium (177Lu) oxodotreotid. 
In another published study involving 229 patients, measurement of creatinine clearance (an indication of how well the kidneys are working) did not show kidney damage 14 months after patients were treated with arginine and lysine at the same time as lutetium (177Lu) oxodotreotide.
Stråling fra lutetium (177Lu) oxodotreotid kan forvolde skade, når lægemidlet passerer gennem nyrens tubuli. 
Radiation from lutetium (177Lu) oxodotreotide can cause damage when the medicine passes through tubules in the kidney.
Hvilke fordele viser studierne, at der er ved LysaKare? 
What benefits of LysaKare have been shown in studies?
De aktive stoffer i LysaKare, arginin og lysin, hindrer lutetium (177Lu) oxodotreotids passage gennem disse nyretubuli. 
The active substances in LysaKare, arginine and lysine, interfere with the passage of lutetium (177Lu) oxodotreotide through these kidney tubules.
Brugen af arginin og lysin under behandling med lutetium (177Lu) oxodotreotid har vist sig at reducere nyreskader og at gøre det muligt for patienter at modtage en virksom dosis af radioaktiv behandling for deres kræftlidelse. 
The use of arginine and lysine during treatment with lutetium (177Lu) oxodotreotide has been shown to reduce kidney damage and allow patients to be given an effective dose of radioactive treatment for their cancer.
Hvordan virker LysaKare? 
How does LysaKare work?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af LysaKare. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of LysaKare have been included in the summary of product characteristics and the package leaflet.
kræftpatienter behandlet med lutetium (177Lu) oxodotreotid, som viste, at arginin og lysin var effektive til at forebygge nyreskade. 
These included data from over 1,200 cancer patients treated with lutetium (177Lu) oxodotreotide, which showed that arginine and lysine were effective at preventing kidney damage.
Indhold Pakningsstørrelse 
Content (concentration) Package size
Intravenøs brug Hætteglas 
Intravenous use Vial (glass)
Pulver til infusionsvæske, opløsning 
50 mg Powder for solution for infusion
ASAS delvis remission BASDAI 
ASAS partial remission BASDAI
Resultater fra den samlede UC-II studiespopulation er vist i tabel 22. 
Results from the overall UC-II study population are shown in table 22.
Dobbelt-blind respons ved uge 12 
Double-Blind Response at week
Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data): 
Not known (frequency cannot be estimated from available data):
SOLYMBIC kan også anvendes alene. 
SOLYMBIC can also be given alone.
Beslutningen om at stoppe med at bruge SOLYMBIC skal diskuteres med din læge. 
The decision to stop using SOLYMBIC should be discussed with your doctor.
Efter administration af 24 mg/m 
Following the administration of 24 mg/m
SOLYMBIC virker ved at reducere denne inflammation. 
SOLYMBIC works by reducing this inflammation.
Hvis der er behov for en anden dosis, bør der bruges andre adalimumabprodukter, som giver mulighed for dette. 
If an alternate dose is required, other adalimumab products offering such an option should be used.
Patienter, som opfylder protokol-specifikke kriterier for tab af respons eller ingen forbedring, var forpligtet til at udgå af studierne og blev optalt som non-respondere 
Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders
Det er et lægemiddel, der reducerer disse sygdommes inflammatoriske proces. 
It is a medicine that decreases the inflammation process of these diseases.
Lægen vil fortælle dig den korrekte dosis. 
Your child's doctor will tell you the correct dose to use.
Første signifikante respons blev observeret ved uge 2 og blev opretholdt frem til uge 24 (Tabel 8). 
Significant response was first observed at week 2 and maintained through 24 weeks (table 8).
≥30 % reduktion af hudsmerter b 
≥30% Reduction in Skin Pain b
Det vides ikke, om SOLYMBIC passerer over i mælk. 
It is not known whether SOLYMBIC passes into breast milk.
TNF-antagonister, så som SOLYMBIC påvirker immunsystemet og brugen af dem kan påvirke kroppens forsvar mod infektion og cancer. 
TNF-antagonists, such as SOLYMBIC affect the immune system and their use may affect the body's defence against infection and cancer.
Bivirkninger kan forekomme op til 4 måneder efter den sidste SOLYMBIC injektion. 
Side effects may occur at least up to 4 months after the last SOLYMBIC injection.
Tag ikke SOLYMBIC: 
Do not use SOLYMBIC:
• lupus-lignende syndrom. 
• lupus-like syndrome.
PGA: Clear/minimal b a 
PGA: Clear/minimal c a
SOLYMBIC i kombination med methotrexat er indiceret til: 
SOLYMBIC in combination with methotrexate, is indicated for:
2-sidet p-værdi fra log rank test. c NE = ikke estimerbar. 
2-sided P value from log rank test. c NE = not estimable.
ASDAS inaktiv sygdom hs-CRP 
ASDAS Inactive Disease hs-CRP
SOLYMBIC er et biosimilært lægemiddel. 
SOLYMBIC is a biosimilar medicinal product.
Opbevar patientkortet på dig. 
Keep this Patient Alert Card with you.
Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data): • leversvigt. 
Not known (frequency cannot be estimated from available data): • liver failure.
Du skal fortsætte med at injicere SOLYMBIC så længe, din læge har fortalt dig. 
You should continue to inject SOLYMBIC for as long as your doctor has told you.
Det vides ikke, om adalimumab udskilles i humanmælk eller absorberes systemisk efter indgift. 
It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion.
Lægen vil teste dig for HBV. SOLYMBIC kan forårsage reaktivering af HBV hos mennesker, der bærer denne virus. 
Your doctor should test you for HBV. SOLYMBIC can cause reactivation of HBV in people who carry this virus.
Du og din læge bør være særligt opmærksomme på tegn på infektion mens du er i behandling med SOLYMBIC. 
You and your doctor should pay special attention to signs of infection while you are being treated with SOLYMBIC.
● Brug ikke den fyldte pen, hvis: 
● Do not use the pre-filled pen if:
Rater for vedligeholdelse af remission- og respons er vist i Tabel 18. 
Maintenance of remission and response rates are presented in table 18.
4.3, 4.4 og 4.8 ** inklusive åben-label forlængelsesstudie inklusive spontane rapporter 
* further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies 1) including spontaneous reporting data
Administration af SOLYMBIC kan ikke anbefales under graviditet. 
Administration of SOLYMBIC is not recommended during pregnancy.