natgillin/translations-raw huggingface dataset:
Hvis nyrefunktionen falder i løbet af behandlingen, skal behandlingen med ropeginterferon alfa-2b seponeres. 
If renal function decreases during treatment, ropeginterferon alfa-2b therapy should be discontinued.
Beskrivelse af Besremi 500 mikrogram fyldt pen 
Description Besremi 500 micrograms pre-filled pen
Der er observeret stigende leverenzymniveauer hos patienter, der behandles med ropeginterferon alfa2b. 
Increased liver enzyme levels have been observed in patients treated with ropeginterferon alfa-2b.
Fertile kvinder skal anvende effektiv prævention under behandlingen med ropeginterferon alfa-2b, medmindre andet er diskuteret med lægen. 
Women of childbearing potential/Contraception in females Women of childbearing potential have to use effective contraception during the treatment with ropeginterferon alfa-2b, unless otherwise discussed with the physician.
Beskrivelse af Besremi 250 mikrogram fyldt pen 
Description Besremi 250 micrograms pre-filled pen
Der kræves ingen dosisjustering af ropeginterferon alfa-2b til voksne patienter med let nedsat leverfunktion. 
No ropeginterferon alfa-2b dose adjustment is required for adult patients with mild liver impairment.
Metaboliseringen af ropeginterferon alfa-2b er ikke fuldt klarlagt. 
The metabolism of ropeginterferon alfa-2b is not fully characterised.
Hypertriglyceridæmi, nedsat appetit 
Metabolism and nutrition disorders common hypertriglyceridaemia, decreased appetite
Der er rapporteret om CNS-virkninger, herunder selvmordsforsøg, selvmordstanker, aggression, bipolar lidelse, mani og forvirring i forbindelse med behandling med interferon alfa (se pkt. 
CNS effects including suicide attempt, suicidal ideation, aggression, bipolar disorder, mania and confusion have been reported with interferon alfa (see section 4.4).
Dosen vil blive indstillet af lægen, så den passer specielt til dig og din sygdom. 
The dose will be set individually for you by your doctor for your condition.
Den fyldte pen med 500 mikrogram/0,5 ml har en blå trykknap. 
The 500 micrograms/0.5 mL pre-filled pen has a blue push button.
Leversygdom, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet alkalisk fosfatase i blodet ikke almindelig Hepatotoksicitet, toksisk hepatitis, hepatomegali sjælden 
Hepatobiliary very common gamma-glutamyltransferase increased disorders common liver disorder, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased uncommon hepatotoxicity, hepatitis toxic, hepatomegaly rare hepatic failure#
Den leverer doser på 50 μg, 100 μg, 150 μg, 200 μg, 250 μg, 300 μg, 350 μg, 400 μg, 450 μg og 500 μg. 
250 μg, 300 μg, 350 μg, 400 μg, 450 μg and 500 μg.
Kløe, alopeci, udslæt, erytem, psoriasis, xeroderma, akneiform dermatitis, hyperkeratose, hyperhidrose, tør hud ikke almindelig Lysfølsomhedsreaktion, hudafskalning, negledystrofi ikke kendt 
Skin and subcutaneous tissue disorders common pruritus, alopecia, rash, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, hyperhidrosis, dry skin uncommon photosensitivity reaction, skin exfoliation, nail dystrophy not known skin depigmentation#
Ropeginterferon alfa-2b's farmakokinetiske profil er ikke blevet fastlagt hos overvægtige og undervægtig patienter. 
The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweight patients.
Indlægsseddel: Information til brugeren Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen ropeginterferon alfa-2b Dette lægemiddel er underlagt supplerende overvågning. 
Package leaflet: Information for the user Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b This medicine is subject to additional monitoring.
Hver cylinderampul indeholder 0,5 ml opløsning. 
Each cartridge contains 0.5 mL of solution.
Atrieflimren ikke almindelig Myokardieinfarkt#, atrioventrikulært blok, intrakardiel trombe, aortaklapinsufficiens, kardiovaskulær lidelse sjælden 
Cardiac disorders common atrial fibrillation uncommon myocardial infarction#, atrioventricular block, intracardiac thrombus, aortic valve incompetence, cardiovascular disorder rare cardiomyopathy#, angina pectoris#
Enhver forud eksisterende thyroideasygdom skal behandles og kontrolleres med konventionel behandling (se pkt. 
Before ropeginterferon alfa-2b therapy, any pre-existing thyroid disease needs to be treated and controlled with conventional therapy (see section 4.3).
I et farmakokinetisk studie med raske forsøgspersoner øgedes Cmax for ropeginterferon alfa-2b proportionalt med dosis indenfor et dosisområde på 24 til 270 mikrogram. 
Over a dose range of 24 to 270 micrograms, ropeginterferon alfa-2b Cmax increased proportionally with dose in a pharmacokinetic study with healthy subjects.
Leverenzymer og leverfunktion bør kontrolleres jævnligt hos patienter, som er i langvarig behandling med ropeginterferon alfa-2b. 
Liver enzymes and hepatic function should be regularly controlled in patients with longterm ropeginterferon alfa-2b therapy.
Ropeginterferon alfa-2b's farmakokinetiske profil er ikke blevet fastlagt hos overvægtige og undervægtige patienter. 
The pharmacokinetic profile of ropeginterferon alfa-2b has not been determined in obese and underweighted patients.
Indlægsseddel: Information til brugeren Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen ropeginterferon alfa-2b Dette lægemiddel er underlagt supplerende overvågning. 
Package leaflet: Information for the user Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b This medicine is subject to additional monitoring.
Besremi fyldt pen må kun anvendes til én enkelt patient for at forhindre evt. overførsel af sygdom eller enhver form for kontaminering, selv med udskiftning af kanylen. 
To prevent possible transmission of disease or any kind of contamination, the use of Besremi pre-filled pen should remain strictly for a single patient, even when the needle is changed.
Der er rapporteret om leversvigt hos hepatitis Cinficerede patienter i behandling med andre interferon alfa-lægemidler (se pkt. 
Hepatic failure in hepatitis C virus infected patients was reported with other interferon alfa medicinal products (see section 4.8).
Alle patienter skal overvåges uanset startdosis eller graden af nedsat nyrefunktion. 
Regardless of the starting dose or degree of renal impairment, patients should be monitored.
Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen 1,5 år. 
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen 1.5 years.
• Tag den ydre kanylehætte af kanylen. 
• Remove the outer needle cap from the needle.
Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen 
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen
Ropeginterferon alfa-2b er kontraindiceret hos patienter med dekompenseret levercirrose (se pkt. 
Ropeginterferon alfa-2b is contraindicated in patients with decompensated cirrhosis of the liver (see section 4.3).
Den fyldte pen med 250 mikrogram/0,5 ml har en grå trykknap. 
The 250 micrograms/0.5 mL pre-filled pen has a grey push button.
• Undgå helt at berøre kanylespidsen. 
• Do not touch the needle tip at any time.
Diarré, kvalme, mavesmerter, forstoppelse, abdominal distension, mundtørhed ikke almindelig Gastritis, sygdom i abdominalvæggen, flatulens, hyppig afføring, odynofagi, gingival blødning ikke kendt 
Gastrointestinal disorders common diarrhoea, nausea, abdominal pain, constipation, abdominal distension, dry mouth uncommon gastritis, abdominal wall disorder, flatulence, frequent bowel movements, odynophagia, gingival bleeding not known tooth disorder#, periodontal disease#
Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): - selvmordsforsøg, selvmordstanker - synstab, som kan skyldes blødning i nethinden (nethinden er det lysfølsomme lag i øjet) eller ophobning af fedt i eller under nethinden 
Uncommon side effects (may affect up to 1 in 100 people): - attempted suicide, thoughts about killing yourself - loss of vision which may be caused by bleeding in the retina (the retina is the light-sensitive layer in the eye), or by build-up of fat in or under the retina
Dyspnø ikke almindelig Pneumonitis, hoste, næseblødning, halsirritation meget sjælden Lungeinfiltration# 
Respiratory, thoracic and mediastinal disorders common dyspnoea uncommon pneumonitis, cough, epistaxis, throat irritation very rare lung infiltration#
• Du må ikke injicere i hud, som er irriteret, rødlig, forslået, betændt eller arret på nogen måde. 
• Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
Ropeginterferon alfa-2b er kontraindiceret hos patienter med nyresygdom i slutstadiet (se pkt. 
Ropeginterferon alfa-2b is contraindicated in patients with end stage renal disease (see section 4.3).
Der er rapporteret om leverproblemer hos patienter efter langvarig behandling med ropeginterferon alfa-2b (se pkt. 
Liver disorders have been reported in patients after long-term ropeginterferon alfa-2b therapy (see section 4.8).
De mest almindelige bivirkninger under behandling med ropeginterferon alfa-2b. 
Most common adverse reactions during ropeginterferon alfa-2b treatment.
Anbrudsdato: 
Opened date:
Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen 3 år. 
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen 3 years.
Positiv antithyroideaantistof, forhøjet niveau af thyreoideastimulerende hormon i blodet, forhøjet legemstemperatur, positiv antinukleært antistof, forhøjet laktatdehydrogenase i blodet ikke almindelig Forhøjet trombocyttal, forhøjet urinsyre i blodet, positiv Coombs test, vægttab #Rapporteret som bivirkninger under behandling med andre interferon alfa-lægemidler. 
Investigations common antithyroid antibody positive, blood thyroid stimulating hormone increased, body temperature increased, antinuclear antibody positive, blood lactate dehydrogenase increased uncommon platelet count increased, blood uric acid increased,
- tørre øjne - skade på kapillærerne (meget små blodkar) i kroppen - åndedrætsbesvær - diarré, kvalme, mavesmerter eller ubehag i maven, forstoppelse, mundtørhed - leversygdom, stigning i visse leverenzymer (ses i blodprøver) - kløe, hårtab, udslæt, hudrødme, psoriasis, tør og skællende hud, akne, fortykkelse af det ydre lag af huden, øget svedtendens - en sygdom, som kaldes Sjögrens syndrom, hvor kroppens immunsystem angriber de kirtler, som producerer væske (såsom tåre- og spytkirtler), leddegigt, smerter i arme og ben, knoglesmerter, 
- diarrhoea, nausea, abdominal pain or stomach discomfort, constipation, dry mouth - liver disorder, increase in certain liver enzymes (shown in blood tests) - itching, hair loss, rash, redness of skin, psoriasis, dry and scaly skin, acne, thickening of the outer layer of the skin, increased sweating - a disorder called Sjogren's syndrome where the body's immune system attacks glands that produce fluid (such as the tear and saliva glands), arthritis, pain in arms and legs, bone pain, painful sudden tightening of a muscle - fever, weakness, chills, general health problems, irritation or redness at the site of injection - in blood tests: antibodies which are produced by the body´s immune system, increase of an enzyme called lactate dehydrogenase
Der skal ligeledes udvises forsigtighed med CYP2D6-substrater (f.eks. vortioxetin, 
Likewise, caution is recommended with CYP2D6 substrates (e.g. vortioxetine, risperidone) combined with ropeginterferon alfa-2b.
112 måneders behandling i PROUD-PV-studiet og 12 måneders behandling i forlængelsesstudiet). 
112-month treatment duration in the PROUD-PV Study and 12-month treatment duration in the extension study 212-month treatment duration in the PROUD-PV Study and 24-month treatment duration in the extension study
Undgå at injicere i et område, hvor huden er irriteret, rød, forslået, inficeret eller arret. 
Do not inject into an area where the skin is irritated, reddened, bruised, infected or scarred.
Ropeginterferon alfa-2bbehandlingsarmen 
Ropeginterferon alfa-2b treatment arm
4.2) resulterer i en forlængelse af den tid, det tager at nå den individuelle optimale dosis sammenlignet med hydroxycarbamid. 
The recommended posology for the titration phase of ropeginterferon alfa-2b (see section 4.2) results in a prolonged time to reach the individual optimal dose compared to hydroxycarbamide.
Mikroangiopati ikke almindelig Raynauds fænomen, hypertension, hæmatom, rødme 
Raynaud's phenomenon, hypertension, haematoma, flushing
Patienter ned 24 måneders behandling med ropeginterferon alfa 2b1 
Patients with 24 months of ropeginterferon alfa-2b treatment1
I brugsanvisningen finder du yderligere oplysninger om, hvordan du klargør og injicerer Besremi. 
Details on how to prepare and inject Besremi are given in the Instructions for Use.
Denne indlægsseddel blev senest ændret Andre informationskilder 
This leaflet was last revised in .
Undgå at injicere i et område på kroppen, hvor huden er irriteret, rødlig, forslået, betændt eller arret. 
It should not be injected into an area of the body where the skin is irritated, reddened, bruised, infected or scarred.
Du må ikke injicere i hud, som er irriteret, rødlig, forslået, betændt eller arret på nogen måde. 
Do not inject into skin that is irritated, reddened, bruised, infected or scarred in any way.
Mest almindelige bivirkninger 
Most common adverse reactions
Hvis en patient under behandling med ropeginterferon alfa-2b udvikler symptomer, der kan tyde på nedsat thyroideafunktion, bør TSH-værdierne fastlægges. 
Patients who develop symptoms indicative of a thyroid dysfunction during ropeginterferon alfa-2b therapy, should evaluate their thyroid stimulating hormone (TSH) levels.
Besremi 250 mikrog/0,5 ml injektion ropeginterferon alfa-2b s.c. 
Besremi 250 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen Den fyldte pen er fremstillet af hvid polypropylen med en blå trykknap og styrken "500 mikrog/0.5 
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen The pre-filled pen is made of white polypropylene, with a blue push button and the strength “500 mcg/0.5 mL” highlighted in blue on the label.
Patienter ned 36 måneders behandling med ropeginterferon alfa 2b2 
Patients with 36 months of ropeginterferon alfa-2b treatment2
Pyreksi, reaktion på injektionsstedet, asteni, kuldegysninger, generel forringelse af fysisk helbred, erytem på injektionsstedet ikke almindelig Smerte på injektionsstedet, kløe på injektionsstedet, følsomhed over for vejrforandringer ikke kendt 
General disorders and administration site conditions very common influenza like illness, fatigue common pyrexia, injection site reaction, asthenia, chills, general physical health deterioration, injection site erythema uncommon injection site pain, injection site pruritus, sensitivity to weather change not known:
Besremi 500 mikrog/0,5 ml injektion ropeginterferon alfa-2b s.c. 
Besremi 500 mcg/0.5 mL injection ropeginterferon alfa-2b SC
Der er rapporteret om ét tilfælde af uforsætlig overdosering med ropeginterferon alfa-2b under det kliniske studieprogram. 
During the clinical study program, one accidental case of overdose has been reported with ropeginterferon alfa-2b.
Hvis du har brugt for meget Besremi 
If you use more Besremi than you should
Benzylalkohol Polysorbat 80 
Sodium chloride Sodium acetate, anhydrous Acetic acid, glacial Benzyl alcohol Polysorbate 80
Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen Hver fyldt pen med 0,5 ml opløsning indeholder 500 mikrogram ropeginterferon alfa-2b målt på proteinbasis, svarende til 1.000 mikrogram/ml. 
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1,000 micrograms/mL.
Hver fyldt pen med 0,5 ml opløsning indeholder 500 mikrogram ropeginterferon alfa-2b målt på proteinbasis, svarende til 1.000 mikrogram/ml. 
Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1,000 micrograms/mL.
Øjentørhed ikke almindelig Nethindehæmoragi#, nethindeekssudater#, synssvækkelse, nedsat synsskarphed, uklart syn, ubehag i øjnene, eksem på øjenlåg sjælden 
Eye disorders common dry eye uncommon retinal haemorrhage#, retinal exudates#, visual impairment, visual acuity reduced, vision blurred, ocular discomfort, eczema eyelids rare retinopathy#, optic neuropathy#, retinal artery occlusion#, retinal vein occlusion#,
Hver fyldt pen med 0,5 ml opløsning indeholder 250 mikrogram ropeginterferon alfa-2b målt på proteinbasis, svarende til 500 mikrogram/ml. 
Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL.
Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen Hver fyldt pen med 0,5 ml opløsning indeholder 250 mikrogram ropeginterferon alfa-2b målt på proteinbasis, svarende til 500 mikrogram/ml. 
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL.
Kardiomyopati#, angina pectoris# meget sjælden Myokardieiskæmi# 
very rare myocardial ischemia#
Nethindeløsning# 
not known retinal detachment#
(kaldet blodplader) - led- eller muskelsmerter - influenzalignende symptomer, træthedsfornemmelse - i blodprøver: stigning i et enzym kaldet gammaglutamyltransferase 
Very common side effects (may affect more than 1 in 10 people): - decrease in the number of a type of white blood cells (called leucocytes) and in blood clotting cells (called platelets) - joint or muscle pain - flu-like symptoms, feeling tired - in blood tests: increase of an enzyme called gamma-glutamyltransferase
Det tyder på, at pegyleret interferon alfa-2a ikke har nogen virkning på den metaboliske aktivitet af cytochrom P450 (CYP) 3A4, 2C9, 2C19 og 2D6- isozymerne in vivo . 
Administration of 180 micrograms of pegylated interferon alfa-2a once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that pegylated interferon alfa-2a has no effect on in vivo metabolic activity of cytochrome P450 (CYP) 3A4, 2C9, 2C19 and 2D6 isozymes.
Sjögrens syndrom, artritis, smerte i ekstremitet, muskuloskeletale smerter, knoglesmerter, muskelspasmer ikke almindelig Muskelsvækkelse, nakkesmerter, lyskesmerter Nyrer og urinveje ikke almindelig Hæmoragisk cystitis, dysuri, imperiøs vandladningstrang, urinretention 
Sjogren's syndrome, arthritis, pain in extremity, musculoskeletal pain, bone pain, muscle spasms uncommon muscular weakness, neck pain, groin pain
Besremi 500 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen ropeginterferon alfa-2b 
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b
- hvis du har diabetes eller højt blodtryk. 
- if you have diabetes or high blood pressure − your doctor may ask you to have an eye examination.
Øjne almindelig 
very rare blindness#
Besremi 250 mikrogram/0,5 ml injektionsvæske, opløsning i fyldt pen ropeginterferon alfa-2b 
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen ropeginterferon alfa-2b
• Brug tommelfingeren og pegefingeren til at knibe huden sammen. 
• Raise a fold of skin between the thumb and forefinger.
Virkning og anvendelse 2. 
What Besremi is and what it is used for 2.
Trombocytopeni Artralgi Træthed 
Gastrointestinal disorders
Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer): - idiopatisk eller trombotisk trombocytopenisk purpura (øget tendens til blå mærker, blødning, 
Very rare side effects (may affect up to 1 in 10,000 people): - idiopathic or thrombotic thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) - myocardial ischemia (reduced blood flow to your heart muscle)
Ropeginterferon alfa-2b menes at have samme eliminationsvej. 
The same elimination route is considered for ropeginterferon alfa-2b.
Psykiske forstyrrelser almindelig 
Hepatic impairment
Artralgi, myalgi almindelig 
Musculoskeletal and connective tissue disorders very common arthralgia, myalgia common
Luftveje, thorax og mediastinum almindelig 
Vascular disorders common microangiopathy uncommon
Denne oversigt blev sidst ajourført i 02-2019. 
This overview was last updated in 02-2019.
Det anvendes til behandling af følgende sygdomme: 
It is used to treat the following diseases:
Simponi fik en markedsføringstilladelse med gyldighed i hele EU den 1. oktober 2009. 
Simponi received a marketing authorisation valid throughout the EU on 1 October 2009.
Dette blev bedømt efter seks uger i det første studie og efter 54 uger i det andet studie. 
This was assessed after 6 weeks in the first study and after 54 weeks in the second study.
Andre oplysninger om Simponi 
Other information about Simponi
Yderligere information om Simponi findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/simponi. 
Further information on Simponi can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/simponi.
Det kan anvendes alene eller i kombination med methotrexat 
It can be used alone or in combination with methotrexate;
Som for alle lægemidler bliver data vedrørende brug af Simponi løbende overvåget. 
As for all medicines, data on the use of Simponi is continuously monitored.
Ved at blokere TNF- mindsker golimumab betændelsen og andre symptomer på disse sygdomme. 
By blocking TNF-α, golimumab reduces the inflammation and other symptoms of these diseases.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Simponi? 
What measures are being taken to ensure the safe and effective use of Simponi?
Simponi er et antiinflammatorisk lægemiddel. 
Simponi is an anti-inflammatory medicine.
Dette studie viste også, at de patienter, der fik Simponi, oplevede større forbedringer med hensyn til at udføre dagligdagshandlinger (såsom at klæde sig på, spise og gå) efter 24 uger. 
This study also showed that patients who received Simponi had greater improvements in carrying out everyday tasks (such as dressing, eating and walking) after 24 weeks.
En oversigt over Simponi, og hvorfor det er godkendt i EU 
An overview of Simponi and why it is authorised in the EU
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Simponi opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Simponi's benefits are greater than its risks and that it can be authorised for use in the EU.
For mere information om brug af Simponi, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Simponi, see the package leaflet or contact your doctor or pharmacist.
Et monoklonalt antistof er et antistof (en type protein), der er opbygget, så det genkender og binder sig til en bestemt struktur (kaldet et antigen), som findes i kroppen. 
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Hvorfor blev Simponi godkendt i EU? 
Why is Simponi authorised in the EU?
Som følge af øget infektionsrisiko skal patienter, der får Simponi, overvåges nøje for infektioner, herunder tuberkulose, under behandlingen og i op til fem måneder efter behandlingen. 
Due to an increased risk of infection, patients taking Simponi must be monitored closely for infections, including tuberculosis, during and for up to 5 months after treatment.
Hvad er Simponi, og hvad anvendes det til? 
What is Simponi and what is it used for?