FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use if the liquid contains visible particles, is cloudy or is distinctly brown.
Danish: Må ikke anvendes, hvis væsken indeholder synlige partikler, er grumset eller tydeligt brun.
English: Patients randomised to tildrakizumab 100 mg or tildrakizumab 200 mg in Part 1 who were PASI 75 responders at week 28 (reSURFACE1).
Danish: Patienter randomiseret til tildrakizumab 100 mg eller tildrakizumab 200 mg i del 1, og som var PASI 75 respondenter i uge 28 (reSURFACE1) * Ingen imputering for manglende data.
English: Ilumetri is a sterile solution for injection in pre-filled syringe.
Danish: Ilumetri er en steril injektionsvæske, opløsning i fyldt injektionssprøjte.
English: In cynomolgus monkeys, there was negligible secretion of the product into breast milk.
Danish: Der sås en ubetydelig udskillelse af produktet i modermælken hos cynomolgus-aber.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK SIZE 1 PRE-FILLED SYRINGE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - PAKNING MED 1 FYLDT INJEKTIONSSPRØJTE
English: It is unknown whether tildrakizumab is excreted in human milk.
Danish: Det er ukendt om tildrakizumab udskilles i modermælken.
English: Keep the pre-filled syringes in the outer carton in order to protect from light until the time of use.
Danish: Opbevar de fyldte injektionssprøjter i den ydre karton for at beskytte mod lys indtil anvendelsestidspunktet.
English: • Choose an injection site with clear skin and easy access such as abdomen, thighs or upper arm. - DO NOT administer 5 cm around the navel or where the skin is tender, bruised, abnormally red, hardened or affected by psoriasis.
Danish: • Vælg et indstikssted med rask hud og let adgang, såsom maven, lårene eller overarmen.
English: Tildrakizumab is catabolized into component amino acids by general protein degradation processes.
Danish: Tildrakizumab kataboliseres til aminosyrekomponenter gennem almindelige proteinnedbrydningsprocesser.
English: - The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80,
Danish: - Øvrige indholdsstoffer: L-histidin, L-histidinhydrochloridmonohydrat, polysorbat 80, sukrose og vand til injektionsvæsker.
English: Ilumetri is not recommended for use in children and adolescents under 18 years of age.
Danish: Ilumetri anbefales ikke til børn og unge under 18 år, da det endnu ikke er blevet undersøgt i denne patientgruppe.
English: How to use Ilumetri
Danish: Sådan skal du bruge Ilumetri
English: Ilumetri 100 mg solution for injection in pre-filled syringe.
Danish: Ilumetri 100 mg injektionsvæske, opløsning i fyldt injektionssprøjte.
English: If a patient has received live viral or bacterial vaccination it is recommended to wait at least 4 weeks prior to starting treatment with tildrakizumab.
Danish: Det anbefales at vente mindst 4 uger inden start af behandling med tildrakizumab, hvis en patient har fået vacciner med levende vira eller levende bakterier.
English: • Press down the blue plunger until it can go no further.
Danish: • Tryk det blå stempel helt i bund.
English: The pre-filled syringe must not be shaken.
Danish: Den fyldte injektionssprøjte må ikke omrystes.
English: After proper training in subcutaneous injection technique, patients may self-inject Ilumetri if a physician determines that it is appropriate.
Danish: Hvis lægen vurderer, at det er hensigtsmæssigt, kan patienten selv injicere Ilumetri efter grundig oplæring i subkutan injektionsteknik.
English: Ilumetri 100 mg solution for injection in pre-filled syringe tildrakizumab
Danish: Ilumetri 100 mg injektionsvæske, opløsning i fyldt injektionssprøjte tildrakizumab
English: grade improvement from Baseline (%) PASI 90 (%)
Danish: PGA “clear” eller “minimal” med en ≥ 2 grads forbedring i forhold til baseline (%) PASI 90 (%)
English: Injection site pain
Danish: Smerter på injektionsstedet
English: Solution for injection 1 pre-filled syringe
Danish: Injektionsvæske, opløsning 1 fyldt injektionssprøjte
English: What Ilumetri is and what it is used for What you need to know before you use Ilumetri How to use Ilumetri
Danish: Det skal du vide, før du begynder at bruge Ilumetri Sådan skal du bruge Ilumetri Bivirkninger
English: Each pre-filled syringe contains 100 mg of tildrakizumab.
Danish: Hver fyldt injektionssprøjte indeholder 100 mg tildrakizumab.
English: • After inserting the needle, let go of the skin gently.
Danish: • Slip forsigtigt huden efter indføring af kanylen.
English: Do not shake or freeze the pre-filled syringe.
Danish: Den fyldte injektionssprøjte må ikke rystes eller nedfryses.
English: Prior to initiating treatment with tildrakizumab, consider completion of all appropriate immunisations according to current immunisation guidelines.
Danish: Det anbefales, at patienterne bringes ajour med alle immuniseringer i henhold til de lokale immuniseringsretningslinjer, inden behandling med tildrakizumab initieres.
English: Tildrakizumab was shown to distribute across the placental barrier.
Danish: Det blev påvist at tildrakizumab passerer placentamembranen.
English: Ilumetri 100 mg injection tildrakizumab SC
Danish: Ilumetri 100 mg injektionsvæske tildrakizumab
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use an effective method of contraception whilst having treatment with Ilumetri and for at least 17 weeks after treatment.
Danish: Du skal anvende sikker prævention, mens du får Ilumetri og i mindst 17 uger efter endt behandling.
English: For instructions on how to inject Ilumetri yourself, see ‘Instructions for use' at the end of this leaflet.
Danish: Se brugsanvisningen sidst i indlægssedlen for instruktioner i selvinjektion af Ilumetri.
English: Frequency category
Danish: Frekvens
English: Renal and Hepatic impairment
Danish: Infektioner og parasitære infestationer
English: Long term responsea,b 200 mg
Danish: Vedligeholdelse af respons i forsøgene reSURFACE 1 og reSURFACE 2 Langsigtet responsa,b 200 mg
English: If you use more Ilumetri than you should
Danish: Hvis du har brugt for meget Ilumetri
English: Pull off the needle cover
Danish: Træk nålehætten af.
English: Gastrointestinal disorders Gastroenteritis
Danish: Gastroenteritis
English: 200 mg 100 mg Etanercep t reSURFACE1
Danish: Uge 28 (3 doser)* 200 mg 100 mg Placebo Etanercept 200 mg 100 mg Etanercept reSURFACE1 Antal patienter PASI 75a (%)
English: The European Commission granted a marketing authorisation valid throughout the European Union for Luminity on 20 September 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Luminity den 20. september 2006.
English: The full EPAR for Luminity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Luminity 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 Luminity.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Luminity.
English: The gas is then cleared through the lungs.
Danish: Gassen elimineres dernæst gennem lungerne.
English: There have been five main studies of Luminity, involving a total of 401 patients.
Danish: Luminity blev undersøgt i fem hovedundersøgelser, hvori der i alt indgik 401 patienter.
English: Other information about Luminity
Danish: Andre oplysninger om Luminity
English: As all five original studies were carried out with a technique known as ‘fundamental' ultrasound imaging, the company also presented the results of some studies to show that the results seen using fundamental imaging could also be obtained when using the imaging techniques known as ‘harmonic' and ‘non linear'.
Danish: Da alle fem oprindelige undersøgelser blev foretaget ved hjælp af en teknik kendt som "grundlæggende" ultralydsbilledteknik, fremlagde firmaet endvidere resultaterne af andre undersøgelser, som viste, at de resultater, der var opnået ved hjælp af "grundlæggende" billedteknikker, også kunne opnås ved hjælp af billedteknikker kendt som "harmoniske" og "ikke-lineære" teknikker.
English: Luminity is for diagnostic use only.
Danish: Luminity er kun til diagnostisk brug.
English: What measures are being taken to ensure the safe and effective use of Luminity?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Luminity?
English: This helps to obtain a better contrast between the area where the gas bubbles are (such as the heart chambers) and the surrounding tissue.
Danish: Dette bidrager til at opnå en bedre kontrast mellem området, hvor boblerne er (såsom hjertekamre) og det omgivende væv.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Luminity.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Luminity skal anvendes.
English: The most common side effects with Luminity (seen in between 1 and 10 patients in 100) are headache and flushing (reddening of the skin).
Danish: De hyppigste bivirkninger (som ses hos mellem 1 og 10 patienter ud af 100) er hovedpine og rødmen.
English: This ensures that the medicine is shaken in the correct way and for long enough to make up a ‘dispersion' of microspheres of perflutren gas of the right size to get a good quality image.
Danish: Derved sikres det, at lægemidlet rystes på en korrekt måde og længe nok til, at der dannes en "opløsning" af perflutrengasholdige mikrosfærer i den rigtige mængde, så der opnås et billede af god kvalitet.
English: In two of these studies, Luminity was compared with placebo (a dummy treatment).
Danish: I to undersøgelser blev Luminity sammenlignet med placebo (en uvirksom behandling).
English: The way Luminity is given and the dose depend on the technique being used for the echocardiography.
Danish: Den måde Luminity gives på og dosis afhænger af den teknik, der anvendes ved ekkokardiografien.
English: For more information about treatment with Luminity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist
Danish: Hvis du ønsker yderligere oplysninger om behandling med Luminity, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: These studies also looked at left ventricle image enhancement.
Danish: Disse undersøgelser så også på forbedringen af billedet af venstre ventrikel.
English: Luminity is a solution for injection or infusion (drip) into a vein that contains microspheres (tiny bubbles) of perflutren gas as the active substance.
Danish: Luminity er en opløsning til indsprøjtning eller infusion (drop i en vene), der indeholder mikrosfærer (bittesmå bobler) af perflutrengas som aktivt stof.
English: Luminity perflutren-containing lipid microspheres
Danish: Luminity perflutrenholdige lipidmikrosfærer
English: This is then given into a vein either as a ‘bolus' injection (given all at once) or as an infusion after being diluted.
Danish: Det indgives i en åre som en bolusinjektion (givet på én gang) eller som en infusion efter at være blevet opløst.
English: Three studies looked at its ability to enhance the image of the left ventricle, comparing the echocardiography scan before and after administration of Luminity.
Danish: Tre undersøgelser så på dets evne til at forbedre billedet af venstre ventrikel, idet den ekkokardiografiske skanning blev sammenlignet før og efter administration af Luminity.
English: Luminity was effective in enhancing the image of the left ventricle, and it was more effective than placebo in the studies where Luminity and placebo were compared.
Danish: Luminity var effektivt til at forbedre billedet af venstre ventrikel, og det var mere effektivt end placebo i de undersøgelser, hvor det blev sammenlignet med placebo.
English: Luminity should only be given by doctors trained in performing and reading images obtained with contrast echocardiography, in hospitals or clinics where appropriate resuscitation equipment is available in case of heart or lung problems or allergic reactions.
Danish: Luminity må kun administreres af læger, som er uddannet til at udføre og aflæse kontrastekkokardiogrammer, på hospitaler eller klinikker, hvor der er genoplivningsudstyr tilgængeligt i tilfælde af hjerte- eller lungeproblemer eller allergiske reaktioner.
English: The CHMP decided that Luminity's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Luminity opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Luminity.
English: What is the risk associated with Luminity?
Danish: Hvilken risiko er der forbundet med Luminity?
English: During echocardiography, the perflutren microspheres in Luminity reflect ultrasound waves differently from the surrounding tissues.
Danish: Ved ekkokardiografi tilbagekaster perflutrenmikrosfærerne i Luminity ultralyd på en anden måde end det omgivende væv.
English: Before use, Luminity must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare the medicine.
Danish: Inden administration skal Luminity aktiveres i et mekanisk rysteudstyr, som kaldes Vialmix, og som udleveres til læger, der skal anvende lægemidlet.
English: When Luminity is injected, it travels in the veins to the heart.
Danish: Når Luminity indgives transporteres det i årene til hjertet.
English: Luminity is used in adults to obtain a clearer image of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound).
Danish: Luminity anvendes hos voksne til at give et klarere billede af hjertekamrene, navnlig af venstre hjertekammer (ventrikel) ved ekkokardiografi (en diagnostisk undersøgelse, som ved hjælp af ultralyd giver et billede af hjertet).
English: The last two studies were set up primarily to look at the ability of Luminity to improve the accuracy of the measurement of the ejection fraction (the percentage of the blood volume that is pumped out of the heart in one beat).
Danish: De sidste to undersøgelser gik hovedsagelig ud på at se Luminitys evne til at forbedre målenøjagtigheden af uddrivningsfraktionen (den del af blodmængden, som pumpes ud af hjertet ved et hjerteslag).
English: For full details, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
English: For the full list of all side effects and restrictions with Luminity, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Luminity fremgår af indlægssedlen.
English: Luminity is used in patients with suspected or confirmed coronary artery disease (obstruction of the blood vessels supplying the heart muscle), when the image obtained without a contrast agent is not good enough.
Danish: Luminity anvendes til patienter, hvor der er mistanke om eller er stillet diagnosen kranspulsåresygdom (tillukning af de blodkar, der forsyner hjertemusklen), og hvor det billede, der er opnået uden kontraststof, ikke er godt nok.
English: It is a contrast agent (a medicine that helps obtain better images of organs and tissues during a scan).
Danish: Det er et kontraststof (et lægemiddel, der medvirker til at synliggøre organer og væv kroppens indre opbygning ved scanning).
English: Why has Luminity been approved?
Danish: Hvorfor blev Luminity godkendt?
English: How has Luminity been studied?
Danish: Hvordan blev Luminity undersøgt?
English: What is Luminity?
Danish: Hvad er Luminity?
English: What benefit has Luminity shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Luminity?
English: What is Luminity used for?
Danish: Hvad anvendes Luminity til?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Luminity have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Luminity.
English: How is Luminity used?
Danish: Hvordan anvendes Luminity?
English: How does Luminity work?
Danish: Hvordan virker Luminity?
English: 2 carton pack.
Danish: 2 karton pakning.
English: 40 mg/0.8 ml
Danish: Pakningsstørrelse mg/0,8ml
English: Each carton contains: 1 vial + 1 syringe + 1 needle + 1 sterile adapter + 2 alcohol pads
Danish: hætteglas injektionssp røjte +1 kanyle 1 steril adapter + 2 alkoholservi etter
English: Immediate Packaging
Danish: Styrke Lægemiddelform Administration Emballage
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MF (EU)nummer
English: 2 pre-filled syringes + 2
Danish: 2 fyldte injektionssprø jter med beskyttelses hætte + 2 alkoholserviet ter
English: 1 pre-filled syringe with needle guard
Danish: 1 fyldt injektionssp røjte med beskyttelse shætte +
English: alcohol pads
Danish: Hætteglas (glas)
English: This summary was last updated in 04-2011.
Danish: Dette sammendrag blev sidst ajourført i 04-2011.
English: Similar results were seen in the other two studies of
Danish: Tilsvarende resultater forekom i de andre to undersøgelser af tidligere
English: They should also receive antibiotics and antiviral medicines during and after
Danish: De skal desuden have antibiotika og antivirale midler under og
English: This is called ‘dose escalation'.
Danish: Dette kaldes ‘dosiseskalering'.
English: The full EPAR for MabCampath can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for MabCampath findes på agenturets websted: : ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports..
English: The European Commission granted a marketing authorisation valid throughout the European Union for MabCampath on 6 July 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for MabCampath den 6. juli 2001.
English: The marketing authorisation holder is Genzyme Europa BV.
Danish: Indehaveren af markedsføringstilladelsen er Genzyme Europa BV.
English: It contains the active substance alemtuzumab (10 mg/ml or 30 mg/ml).
Danish: Det indeholder det aktive stof alemtuzumab 10 mg/ml eller 30 mg/ml.
English: Patients should be given steroids, an antihistamine and a painkiller before the first dose and before any increase in dose.
Danish: Patienterne skal have steroider, et antihistamin og et smertestillende middel inden den første dosis og inden enhver stigning i dosis.
English: This is a summary of the European public assessment report (EPAR) for MabCampath.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for MabCampath.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 04 July 2008.
Danish: Da virksomheden havde fremlagt de yderligere oplysninger, som man havde anmodet om, blev de ”særlige omstændigheder”
English: MabCampath must not be used in patients:
Danish: MabCampath må ikke anvendes hos patienter:
English: After this, the recommended dose is 30 mg three times a week (every other day) for a maximum of 12 weeks.
Danish: Herefter er den anbefalede dosis 30 mg pr. dag, som gives tre gange om ugen (hver anden dag) i op til højst 12 uger.
English: MabCampath has been looked at in four main studies involving a total of 446 patients with CLL.
Danish: MabCampath blev undersøgt i fire hovedundersøgelser af i alt 446 patienter med CLL.
English: MabCampath is given as an infusion lasting about two hours.
Danish: MabCampath gives som en infusion, der varer ca. to timer.
English: MabCampath was originally authorised under ‘exceptional circumstances', because, for scientific reasons, it had not been possible to obtain complete information on the medicine.
Danish: MabCampath blev oprindeligt godkendt under ”særlige omstændigheder”, da det af faglige årsager ikke har været muligt at indhente fyldestgørende oplysninger om lægemidlet.
English: • who have an active infection that has spread throughout the body; • with HIV infection;
Danish: • som har en aktiv infektion, der har bredt sig til hele kroppen
English: One study included 297 patients who had not received treatment before.
Danish: En af undersøgelserne omfattede 297 patienter, som ikke havde fået nogen behandling før.
English: During the first week of treatment, MabCampath should be given in increasing doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3, as long as each dose is well tolerated.
Danish: I den første uge af behandlingen gives MabCampath i stigende doser: 3 mg på dag 1, 10 mg på dag 2 og 30 mg på dag 3, så længe hver dosis tåles godt.
English: In patients who had not received treatment before, MabCampath was more effective than chlorambucil.
Danish: Hos patienter, der ikke havde modtaget behandling før, var MabCampath mere effektivt end chlorambucil.
English: In these studies, MabCampath was not compared with any other treatment.
Danish: I disse undersøgelser blev MabCampath ikke sammenlignet med andre former for behandling.
English: The main measure of effectiveness was how long it took until the disease got worse or the patient died.
Danish: Behandlingens virkning blev hovedsagelig bedømt i forhold til, hvor lang tid, der gik inden sygdommen blev værre eller patienten
English: In the patients receiving MabCampath, it took an average of 14.6 months for the disease to get worse or for the patient to die, compared with 11.7 months in those taking chlorambucil.
Danish: Hos patienter, der fik MabCampath, tog det i gennemsnit 14,6 måneder længere, inden sygdommen blev værre, eller inden patienten døde sammenlignet med 11,7 måneder hos dem, der fik
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for MabCampath.
English: 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 certain cells in the body.
Danish: Et monoklonalt antistof er et antistof (en type protein), som er udviklet til at kunne genkende og binde sig til en særlig struktur (kaldet et antigen), som findes i visse celler i kroppen.
English: In the study of patients who had been treated with fludarabine before, 33% responded partially or completely to treatment with MabCampath.
Danish: I hovedundersøgelsen af patienter, som var blevet behandlet før, reagerede 33 % helt eller delvist på behandling med MabCampath.
English: What is the risk associated with MabCampath?
Danish: Hvilken risiko er der forbundet med MabCampath?
English: MabCampath treatment should be supervised by a doctor experienced in the use of cancer treatments.
Danish: Behandlingen med MabCampath bør overvåges af en læge med erfaring i brug af lægemidler mod kræft.
English: The most frequent serious adverse reactions are low counts of blood cells, infusion reactions, and infections or immunosuppression (reduced activity of the immune system).
Danish: De hyppigste bivirkningerer nedsat antal hvide blodlegemer, infusionsreaktioner og infektioner eller immunosuppression (nedsat aktivitet i immunsystemet.
English: In CLL, too many lymphocytes are produced.
Danish: Ved CLL producerer organismen for mange lymfocytter.