FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Cyltezo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cyltezo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Cyltezo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cyltezo.
English: This means that Cyltezo is highly similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Cyltezo meget nøje svarer til et biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i Den Europæiske Union (EU).
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is calculated according to the child's weight and height.
Danish: Dosis og hyppighed af indsprøjtningerne afhænger af den sygdom, der skal behandles; for børn beregnes dosis efter barnets vægt og højde.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Danish: Ved at bindes til TNF blokerer adalimumab dettes aktivitet, hvorved inflammationen og de øvrige symptomer på sygdommene mindskes.
English: Treatment response was measured as a 20% or more improvement in symptom score, which was seen after 12 and 24 weeks of treatment in 67% and 69% respectively of those given Cyltezo.
Danish: Virkningen af behandlingen (behandlingsresponsen) blev bestemt til en bedring i symptomscore på 20 % eller derover, som kunne ses efter 12-24-ugers behandling hos henholdsvis 67 % og 69 % af dem, der fik Cyltezo.
English: What is Cyltezo and what is it used for?
Danish: Hvad er Cyltezo, og hvad anvendes det til?
English: The reference medicine for Cyltezo is Humira.
Danish: Referencelægemidlet for Cyltezo er Humira.
English: Because Cyltezo is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Cyltezo.
Danish: Da Cyltezo er et biosimilært lægemiddel, behøver de undersøgelser af virkningen og sikkerheden af adalimumab, der er udført for Humira, ikke alle gentages for Cyltezo.
English: Like other medicines of its class, Cyltezo may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Danish: Ligesom andre lægemidler i sin klasse kan Cyltezo påvirke immunsystemets evne til at bekæmpe infektioner og kræft, og der har været nogle tilfælde af alvorlige infektioner og blodkræft hos patienter,
English: Cyltezo is a medicine that acts on the immune system and is used to treat the following conditions:
Danish: Cyltezo er et lægemiddel, der virker på immunsystemet og anvendes til behandling af følgende
English: What are the risks associated with Cyltezo?
Danish: Hvilke risici er der forbundet med Cyltezo?
English: Cyltezo is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Danish: Cyltezo anvendes hos voksne hovedsagelig når sygdommen er svær, moderat svær eller i forværring, eller når patienten ikke kan behandles på anden måde.
English: In addition, a study involving 645 patients with moderate or severe rheumatoid arthritis who were also taking methotrexate confirmed that Cyltezo and Humira have similar effectiveness.
Danish: Endvidere bekræftede en undersøgelse med deltagelse af 645 patienter med moderat eller svær leddegigt, som desuden fik methotrexat, at Cyltezo og Humira har samme virkning.
English: Cyltezo must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the
Danish: Cyltezo må ikke anvendes hos patienter med aktiv tuberkulose, andre svære infektioner eller moderat til svært hjertesvigt (manglende evne af hjertet til at pumpe tilstrækkeligt med blod rundt i kroppen).
English: The company that markets Cyltezo must provide educational packs for doctors who prescribe the medicine.
Danish: Den virksomhed, der markedsfører Cyltezo, skal udlevere uddannelsespakker til læger, som ordinerer lægemidlet.
English: All these data were considered sufficient to conclude that Cyltezo will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Danish: Alle disse oplysninger blev anset for tilstrækkelige til at konkludere, at Cyltezo vil have de samme egenskaber som Humira hvad angår virkningen og sikkerheden ved de godkendte anvendelser.
English: It is not intended to provide practical advice on how to use Cyltezo.
Danish: Det er ikke en praktisk vejledning i, hvordan Cyltezo bør anvendes.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Danish: De hyppigste bivirkninger med adalimumab (der forekommer hos mere end 1 af hver 10 patienter) er infektioner (herunder infektioner i næsen, halsen og bihulerne) reaktioner på injektionsstedet (rødme, kløe, blødning, smerter eller hævelse), hovedpine og muskel- og knoglesmerter.
English: After training, patients or their carers may inject Cyltezo if their doctor considers it appropriate.
Danish: Efter opøvning kan patienten eller dennes omsorgsgiver selv foretage indsprøjtningen af Cyltezo, hvis lægen finder det
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Danish: Andre sjældne alvorlige bivirkninger (som kan forekomme hos op til 1 ud af 1 000 personer) er svigtende evne af knoglemarven til at danne blodceller, nervesygdomme, lupus og lupuslignende sygdomme (hvor immunsystemet angriber patientens egne væv, med betændelse og organskader til følge) og den alvorlige hudsygdom Stevens-Johnsons syndrom.
English: For the full list of side effects and restrictions with Cyltezo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Cyltezo fremgår af indlægssedlen.
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Cyltezo is used to treat.
Danish: TNF er en medvirkende årsag til inflammationstilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Cyltezo.
English: Laboratory studies comparing Cyltezo with Humira have shown that the active substance in Cyltezo is highly similar to that in Humira in terms of structure, purity and biological activity.
Danish: Laboratorieundersøgelser, hvor Cyltezo sammenlignes med Humira, har vist, at det aktive stof i Cyltezo i meget høj grad svarer til Humira hvad angår struktur, renhed og biologisk aktivitet.
English: The active substance in Cyltezo, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Danish: Det aktive stof i Cyltezo, adalimumab, er et protein af typen monoklonalt antistof, der er fremstillet således, at det genkender og bindes til et stof i kroppen, der kaldes tumornekrosefaktor (TNF).
English: Therefore, the Agency's view was that, as for Humira, the benefit outweighs the identified risk, and it recommended that Cyltezo be given marketing authorisation.
Danish: Agenturet var derfor af den opfattelse, at fordelene opvejer den identificerede risiko som for Humira, og anbefalede, at Cyltezo godkendes til anvendelse i EU.
English: Cyltezo can only be obtained by prescription.
Danish: Lægemidlet Cyltezo udleveres kun efter recept.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Cyltezo has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Cyltezos og Humiras struktur, renhed og biologiske aktivitet svarer nøje til hinanden, og at de fordeles i kroppen på samme måde.
English: Treatment with Cyltezo must be started and supervised by a doctor who has experience in the treatment of the diseases for which Cyltezo is used.
Danish: Behandling med Cyltezo bør iværksættes og overvåges af en læge med erfaring i behandling af de sygdomme, der behandles med Cyltezo.
English: Cyltezo is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks.
Danish: Cyltezo fås som injektionsvæske, opløsning, i fyldte sprøjter eller penne til indsprøjtning under huden og gives normalt hver anden uge.
English: Doctors treating uveitis should also take advice from doctors who have experience of using Cyltezo.
Danish: Læger, der behandler uveitis, bør søge rådgivning fra læger med erfaring i anvendelse af Cyltezo.
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases
Danish: • polyartikulær juvenil idiopatisk artritis og aktiv enthesitis-relateret artritis (begge er sjældne sygdomme, der medfører inflammation af leddene)
English: For more information about treatment with Cyltezo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cyltezo, kan du læse indlægssedlen (også en del af denne EPAR) eller
English: In addition, a study in rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Danish: Derudover har en undersøgelse ved leddegigt vist, at lægemidlets virkninger svarer til virkningerne af Humira ved denne sygdom.
English: Comparable benefit continued to be seen with longer term
Danish: Ved længere behandling i 48 uger blev der opretholdt en tilsvarende gavnlig virkning.
English: • Crohn's disease (a disease causing inflammation of the gut);
Danish: • Crohns sygdom (en sygdom, der medfører inflammation af tarmen)
English: What benefits of Cyltezo have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cyltezo?
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;
Danish: • svedkirtelbetændelse (hidradenitis suppurativa) (acne inversa), en varig hudsygdom, der forårsager knuder, pusansamlinger (abscesser) og ar i huden
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Danish: • aksial spondyloarthritis (betændelse i rygsøjlen, der forårsager rygsmerter), herunder Bekhterevs sygdom (ankyloserende spondylitis) og sygdom uden røntgenforandringer men med tydelige tegn
English: Cyltezo contains the active substance adalimumab and is a ‘biosimilar medicine'.
Danish: Cyltezo er et lægemiddel, der indeholder det aktive stof adalimumab.
English: For practical information about using Cyltezo, patients should read the package leaflet or contact their
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cyltezo, kan du læse indlægssedlen eller
English: For detailed information on the use of Cyltezo in all conditions, including when it can be used in children, see the summary of product characteristics.
Danish: Nærmere oplysninger om anvendelsen af Cyltezo til de forskellige sygdomme, herunder hvornår det kan anvendes til børn, fremgår af
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cyltezo have also been included in the summary of product characteristics and the
Danish: 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 Cyltezo.
English: Studies have also shown that giving Cyltezo produces similar levels of the active substance in the body to giving Humira.
Danish: Undersøgelser viser desuden, at behandling med Cyltezo frembringer samme mængde aktivt stof i
English: • rheumatoid arthritis (a disease causing inflammation of the joints);
Danish: • leddegigt (reumatoid arthritis), en sygdom, der medfører inflammation i leddene
English: An alert card will also be
Danish: Patienterne skal desuden have udleveret et patientkort.
English: • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Danish: • betændelse i øjets årehinde (ikke-infektiøs uveitis).
English: • plaque psoriasis (a disease causing red, scaly patches on the skin);
Danish: • plaque-psoriasis (en sygdom, der giver røde, skællende hudområder) • psoriasisgigt (en sygdom, der giver røde, skællende hudområder og betændelsesreaktion
English: The following definitions applies for resistance categories used:
Danish: Følgende definitioner gælder for de anvendte resistenskategorier:
English: Data on longer treatment duration is very limited.
Danish: Data vedrørende længere behandlingsvarighed er meget begrænset.
English: First 2 weeks:
Danish: De første 2 uger:
English: A final evaluation was conducted at Week 120.
Danish: Den endelige evaluering fandt sted i uge 120.
English: Date of first authorisation: 5 March 2014 Date of latest renewal: 11 January 2019
Danish: Dato for første markedsføringstilladelse: 5. marts 2014 Dato for seneste fornyelse: 11. januar 2019
English: Clinical monitoring should be considered.
Danish: Klinisk monitorering bør overvejes.
English: You may need to keep taking your other medicines for tuberculosis for longer than 6 months.
Danish: Du skal måske fortsætte med at tage de andre lægemidler mod tuberkulose længere end 6 måneder.
English: Discontinued but converted
Danish: Udgået, men konverteret
English: This is because it has not been studied in this age group.
Danish: Det skyldes, at medicinen ikke er undersøgt hos denne aldersgruppe.
English: The most common cause of death as reported by the investigator was tuberculosis (9 patients).
Danish: Den almindeligste dødsårsag i henhold til investigators indberetninger var tuberkulose (9 patienter).
English: * Patients who died during the trial or discontinued the trial were considered as non-responders.
Danish: * Patienter der døde under studiet, eller som afbrød studiet, ansås som nonrespondere.
English: you may take SIRTURO on Monday, Wednesday and Friday every week from week 3
Danish: SIRTURO mandag, onsdag og fredag hver uge fra og med den 3. uge.
English: All of these toxicities except effects on MPS were monitored clinically.
Danish: Alle disse toksiciteter undtagen virkninger på MPS blev monitoreret klinisk.
English: The causes of death in the remaining patients varied.
Danish: Der var varierende dødsårsager for de resterende patienter.
English: This medicine may pose a risk to the environment.
Danish: Dette lægemiddel kan udgøre en risiko for miljøet.
English: S = susceptible R = resistant
Danish: S = følsom R=resistent
English: Consideration should be given to WHO guidelines when selecting the appropriate combination regimen.
Danish: WHO's retningslinjer skal tages i betragtning ved valg af et egnet kombinationsregime.
English: The clinical relevance is unknown.
Danish: Den kliniske relevans kendes ikke.
English: Patients infected with human immunodeficiency virus (HIV)
Danish: Patienter inficeret med human immundefekt virus (hiv)
English: • Annual updates on study progress in the frame of annual renewal submissions
Danish: • Årlige opdateringer om studiets fremdrift indenfor rammerne af den årlige redegørelse ved fornyelse
English: It is used in adults aged 18 years and over.
Danish: Det anvendes til voksne over 18 år.
English: Culture Conversion Status, n (%)
Danish: Status for dyrkningskonvertering, n (%)
English: The food is important to get the right levels of medicine in your body.
Danish: Maden har betydning for, at den rette mængde medicin optages i kroppen.
English: This increase is likely due to ritonavir.
Danish: En sådan øgning skyldes formentlig ritonavir.
English: Medicine (name of the active substance)
Danish: Medicin (navn på det aktive stof)
English: 188 tablets
Danish: 188 tabletter
English: Table 1: Culture conversion Status
Danish: Tabel 1: Status for dyrkningskonvertering
English: From week 3 to week 24:
Danish: Fra 3. til 24. uge:
English: • increase the chance that the bacteria will become resistant to the medicine.
Danish: • øger det risikoen for, at bakterierne bliver resistente over for medicinen.
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14, stk. 7, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: After treatment cessation, all indications of toxicity exhibited at least partial recovery to good recovery.
Danish: Efter behandlingens ophør udviste alle indikationer af toksicitet tegn på i det mindste delvis bedring til god bedring.
English: If you forget to take SIRTURO During the first 2 weeks
Danish: Hvis du har glemt at tage SIRTURO I løbet af de første 2 uger
English: This can be seen in a blood test;
Danish: Det vil fremgå af en blodprøve
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan berøre flere end 1 ud af 10 personer):
English: This means your disease may not be treatable by SIRTURO or other medicines in the future.
Danish: Det betyder, at din sygdom fremover måske ikke kan behandles med SIRTURO eller andre lægemidler.
English: SIRTURO is a type of antibiotic.
Danish: SIRTURO er en type antibiotika.
English: The observed imbalance in deaths between the two treatment groups is unexplained.
Danish: Den observerede skæve fordeling af dødsfaldene i de to behandlingsgrupper er ikke afklaret.
English: • make your treatment ineffective and your tuberculosis could get worse, and;
Danish: • vil din behandling måske ikke virke, og tuberkulosen kan blive forværret
English: • you are allergic to bedaquiline or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for bedaquilin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Hypromellose Polysorbate 20
Danish: Hypromellose Polysorbat 20
English: • aching or tender muscles, not caused by exercise
Danish: • smertende eller ømme muskler, der ikke skyldes motion
English: 24 tablets
Danish: 24 tabletter
English: The plasma protein binding of bedaquiline is > 99.9% in all species tested, including human.
Danish: Bedaquilins plasmaproteinbinding er > 99,9 % hos alle de undersøgte arter inklusive mennesker.
English: Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Danish: Hyppighedskategorierne defineres således: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til
English: There are no data to support a lowered bedaquiline dose in such circumstances.
Danish: Der er ingen data, der understøtter en nedsat bedaquilindosis under sådanne omstændigheder.
English: • Final analysis - Clinical Study Report 4Q 2023
Danish: • Endelig analyseklinisk studierapport 4. kvartal 2023
English: All but one patients who died of tuberculosis had not converted or had relapsed.
Danish: Alle patienter, der døde af tuberkulose, med undtagelse af én havde ikke konverteret eller havde recidiveret.
English: Tell your doctor right away if you faint.
Danish: Fortæl det straks til lægen, hvis du bliver svimmel.
English: It is not known whether bedaquiline or its metabolites are excreted in human milk.
Danish: Det er ukendt, om bedaquilin eller dets metabolitter udskilles i human mælk.
English: • you have liver disease or you drink alcohol on a regular basis;
Danish: • hvis du har fået at vide, at du har en leversygdom, eller hvis du regelmæssigt drikker alkohol
English: These reports should aid the physician in selecting a combination of antibacterial medicinal products for treatment.
Danish: Disse rapporter kan hjælpe lægen til at udvælge en kombination af antibakterielle lægemidler til behandlingen.
English: Do not take SIRTURO if this applies to you.
Danish: Tag ikke SIRTURO, hvis dette gælder for dig.
English: The safety and efficacy of SIRTURO in children aged < 18 years have not yet been established.
Danish: SIRTURO's sikkerhed og virkning hos børn i alderen < 18 år er endnu ikke klarlagt.
English: Each tablet contains 145 mg of lactose (as monohydrate).
Danish: Hver tablet indeholder 145 mg lactose (som monohydrat).
English: SIRTURO tablets should be swallowed whole with water.
Danish: SIRTURO tabletter bør synkes hele med vand.
English: Main demographics were as follows: 63.1% were males, median age 34 years, 35% were Black, and 15% were HIV positive.
Danish: Hoveddemografien var som følger: 63,1 % var mænd, medianalderen var 34 år, 35 % var sorte, og 15 % var hiv-positive.
English: Animal toxicology studies have been conducted with bedaquiline administration up to 3 months in mice, up to 6 months in rats, and up to 9 months in dogs.
Danish: Der er udført dyrestudier af toksikologi med administration af bedaquilin i op til 3 måneder i mus, op til 6 måneder i rotter og op til 9 måneder i hunde.
English: Maximum plasma concentrations (Cmax) are typically achieved at about 5 hours post-dose.
Danish: Maksimal plasmakoncentration (Cmax) indtræffer sædvanligvis ca. 5 timer efter indgift af dosis.
English: Antibiotics are medicines that kill bacteria that cause disease.
Danish: Antibiotika er lægemidler, der dræber sygdomsfremkaldende bakterier.
English: In the SIRTURO treatment group, the majority of these increases occurred throughout the 24 weeks of treatment and were reversible.
Danish: I SIRTURO-gruppen opstod de fleste af disse stigninger under de 24 ugers behandling, og de var reversible.
English: • extra-pulmonary tuberculosis (e.g. central nervous system, bone)
Danish: • ekstrapulmonal tuberkulose (f.eks. i centralnervesystemet, knogler)
English: One of the ten deaths in the SIRTURO group (due to alcohol poisoning) occurred during the 24 week treatment period.
Danish: Det ene af de ti dødsfald i SIRTURO-gruppen (pga. alkoholforgiftning) indtraf i løbet af 24-ugers behandlingsperioden.
English: Most of the observed changes occurred after prolonged daily dosing and subsequent increases in plasma and tissue concentrations of the active substance.
Danish: De fleste af de observerede ændringer indtraf efter længerevarende daglig indgift efterfulgt af stigninger i plasma- og vævskoncentrationer af det aktive stof.
English: This is called multi-drug resistant pulmonary tuberculosis.
Danish: Det kaldes for multiresistent lungetuberkulose.
English: This long terminal elimination phase likely reflects slow release of bedaquiline and M2 from peripheral tissues.
Danish: Den lange terminale eliminationsfase reflekterer sandsynligvis den langsomme frigivelse af bedaquilin og M2 fra perifere væv.
English: Normal spermatogenesis and a normal amount of spermatozoa in the epidydimides were noted in these animals.
Danish: Der sås normal spermatogenese og en normal mængde spermatozoer i bitestiklerne hos disse dyr.
English: The elimination of bedaquiline has not been fully characterised in vivo.
Danish: Bedaquilins elimination er ikke karakteriseret fuldstændigt in vivo.