FrancophonIA/ELRC3.0 huggingface dataset:
English: p < 0.001 for comparison between guselkumab and placebo for the major secondary endpoint.
Danish: p < 0,001 for sammenligning mellem guselkumab og placebo for de vigtigste sekundære endepunkter.
English: What you need to know before you use Tremfya 3.
Danish: Det skal du vide, før du begynder at bruge Tremfya Sådan skal du bruge Tremfya Bivirkninger
English: It is supplied as a carton pack containing one single-dose pre-filled pen and as a multipack containing 2 (2 packs of 1) single-dose pre-filled pens.
Danish: Den udleveres i en karton, der indeholder en pen med en enkelt dosis, og i en multipakning, som indeholder 2 (2 pakninger med 1) fyldte penne, der hver indeholder en enkelt dosis.
English: • Back of upper arms (if a caregiver is giving you the injection) Do not inject into skin that is tender, bruised, red, scaly or hard.
Danish: Undlad at injicere i hud, der er øm, forslået, rød, skællende eller hård.
English: Tremfya 100 mg solution for injection in pre-filled pen
Danish: Tremfya 100 mg injektionsvæske, opløsning i fyldt pen
English: Tremfya 100 mg solution for injection in pre-filled syringe.
Danish: Tremfya 100 mg injektionsvæske, opløsning i fyldt injektionssprøjte.
English: Tremfya 100 mg solution for injection in pre-filled pen.
Danish: Tremfya 100 mg injektionsvæske, opløsning i fyldt pen.
English: PRE-FILLED SYRINGE LABEL TEXT (100 mg)
Danish: TEKST PÅ ETIKET TIL FYLDT INJEKTIONSSPRØJTE (100 mg)
English: Release pinch and reposition hand
Danish: Slip huden, og flyt hånden
English: Check with your doctor, nurse or pharmacist if you are not sure.
Danish: - Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: The percentage of patients achieving a PASI 90 response was numerically higher for guselkumab than adalimumab starting at Week 8 with the difference reaching a maximum around Week 20 (VOYAGE 1 and 2) and maintained through Week 48 (VOYAGE 1) (see Figure 1).
Danish: Procentdelen af patienter, som opnåede et PASI 90-respons, var numerisk højere for guselkumab end adalimumab startende i uge 8.
English: Each pre-filled pen contains 100 mg of guselkumab in 1 mL solution.
Danish: Hver fyldt pen indeholder 100 mg guselkumab i 1 ml opløsning.
English: Each pre-filled syringe contains 100 mg of guselkumab in 1 mL.
Danish: Hver fyldt injektionssprøjte indeholder 100 mg guselkumab i 1 ml.
English: DLQI score > 1 at baseline, n Subjects with DLQI 0/1
Danish: DLQI-score > 1 ved baseline, n forsøgspersoner med DLQI 0/1 337 (75,7 %) PSSD-symptom-score, forsøgspersoner med baselinescore > 0
English: Tremfya 100 mg solution for injection in pre-filled syringe
Danish: Tremfya 100 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: Place on skin
Danish: Placer pennen på huden
English: After removing the pre-filled syringe or pre-filled pen from the refrigerator, keep the pre-filled syringe or pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes before injecting Tremfya.
Danish: Når den fyldte injektionssprøjte eller den fyldte pen er taget ud af køleskabet, skal den forblive i den ydre karton, mens den får lov at nå stuetemperatur.
English: Summary of Clinical Responses in VOYAGE 1 and VOYAGE 2 Number of patients (%)
Danish: Tabel 2: Oversigt over klinisk respons i VOYAGE 1 og VOYAGE 2
English: Remove needle cover
Danish: Tag kanylehylsteret af
English: Plunger locks
Danish: Stemplet låser
English: A study shall be conducted to generate robust data on the efficacy of domperidone in the relief of symptoms of nausea and vomiting in children at the recommended doses.
Danish: Der udføres en undersøgelse med henblik på at generere fyldestgørende data om virkningen af domperidon til symptomatisk lindring af kvalme og opkastning hos børn ved de anbefalede doser.
English: The Marketing Authorisation Holders for the rectal formulations that remain authorised shall conduct a pharmacokinetic study to generate data to allow for a comparison between the rectal and oral formulations.
Danish: Indehaverne af markedsføringstilladelse for de rektale formuleringer, der fortsat er godkendt, udfører en farmakokinetisk undersøgelse med henblik på at sammenligne de orale og rektale formuleringer.
English: The Marketing Authorisation Holders shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to monitor off-label use.
Danish: Indehaverne af markedsføringstilladelse udfører en undersøgelse af lægemiddelanvendelse med henblik på at vurdere risikominimeringsforanstaltningernes effektivitet og overvåge ikkegodkendt anvendelse.
English: The Marketing Authorisations Holders of products for which a paediatric indication is approved shall submit the protocols of new or ongoing studies to the National Competent Authorities within 4 months of the commission decision for this procedure.
Danish: Indehaverne af markedsføringstilladelse for lægemidler, der er godkendt til en pædiatrisk indikation, indsender protokollerne for nye eller igangværende undersøgelser til de nationale kompetente myndigheder senest fire måneder efter Kommissionens beslutning vedrørende denne procedure.
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaten/medlemsstaterne eller i givet fald i referencemedlemsstaten/-medlemsstaterne sikrer, at indehaveren/indehaverne af markedsføringstilladelse opfylder følgende vilkår:
English: The study shall be conducted in more than one Member State and the protocol shall be submitted to the PRAC within 3 months of the commission decision for this procedure.
Danish: Undersøgelsen udføres i mere end én medlemsstat, og protokollen forelægges PRAC senest tre måneder efter Kommissionens beslutning vedrørende denne procedure.
English: The final study report shall be submitted to the National Competent Authorities within 1 year of the commission decision for this procedure.
Danish: Den endelige rapport for undersøgelsen forelægges de nationale kompetente myndigheder senest ét år efter Kommissionens beslutning vedrørende denne procedure.
English: Within 3 months of the commission decision for this procedure, the MAHs shall submit to the National Competent Authorities a Risk Management Plan containing the key elements described in the PRAC assessment report.
Danish: Senest tre måneder efter Kommissionens beslutning vedrørende denne procedure indsender indehaverne af markedsføringstilladelse en risikohåndteringsplan, som indeholder de hovedelementer, der er beskrevet i PRAC's vurderingsrapport, til de kompetente nationale myndigheder.
English: The final study report shall be submitted to the National Competent Authorities within 36 months of endorsement of the protocol, and updates on progress with recruitment to the study shall be submitted to the National Competent Authorities on a yearly basis.
Danish: Den endelige rapport over undersøgelsen forelægges de nationale kompetente myndigheder senest 36 måneder efter godkendelse af protokollen, og rekrutteringsstatus for undersøgelsen indberettes hvert år til de nationale kompetente myndigheder.
English: Ref. EMEA/CHMP/220307/2006
Danish: EMEA/CHMP/220307/2006
English: Data to support the indication for the treatment of RDS were not sufficient.
Danish: Oplysningerne til støtte for indikationen behandling af RDS er ikke tilstrækkelige.
English: RDS is a life-threatening disease.
Danish: RDS er en livstruende sygdom.
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for SURFAXIN
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for SURFAXIN
English: The effects of SURFAXIN were first tested in experimental models before being studied in humans.
Danish: Virkningerne af SURFAXIN er først testet i forsøgsmodeller, inden de er undersøgt hos mennesker.
English: It contains fat ingredients and a synthetic protein (sinapultide).
Danish: Det indeholder fedtstoffer og et syntetisk protein (sinapultid).
English: It is supplied in a vial containing 8 ml of the medicinal product.
Danish: Det leveres i hætteglas indeholdende 8 ml af lægemidlet.
English: London, 29 June 2006
Danish: London, den 29. juni 2006 Ref.dok.
English: It mainly occurs in premature babies, where the onset of difficulty in breathing is within minutes to a few hours after birth.
Danish: Den optræder hovedsagelig hos for tidligt fødte børn, hos hvem vejrtrækningsbesværet viser sig i løbet af få minutter til få timer efter fødslen.
English: Following CHMP opinion, it usually takes around 2 months for the European Commission to grant an authorisation.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. to måneder om at udstede tilladelsen.
English: SURFAXIN was designated as an ‘orphan medicine' on 29 July 2004.
Danish: SURFAXIN blev udpeget som lægemiddel til sjældne sygdomme den 29. juli 2004.
English: The main concern of the CHMP was related to the way the medicine is made, and in particular to the stability of the medicine.
Danish: CHMPs betænkeligheder vedrørte først og fremmest den måde, lægemidlet fremstilles på, og navnlig lægemidlets holdbarhed.
English: What is SURFAXIN?
Danish: Hvad er SURFAXIN?
English: SURFAXIN is an artificial surfactant expected to compensate for the lack of natural surfactant in babies with RDS.
Danish: SURFAXIN er et kunstigt surfaktant, der forventes at kompensere for det manglende naturlige surfaktant hos spædbørn med RDS.
English: Therefore, at the time of the withdrawal, the Committee's provisional view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor udvalgets opfattelse, at fordelene ikke er tilfredsstillende påvist og ikke opvejer de fundne risici.
English: The presence of synthetic ingredient prevents potential risks associated with animal-derived substance such as potential transmission of infectious agents.
Danish: Ved at anvende et syntetisk indholdsstof undgår man de risici, der kan være forbundet med stoffer af animalsk oprindelse, således mulig overførsel af smitstoffer.
English: The company mainly presented the results of two studies on the prevention of RDS, involving over 1,500 premature neonates in total, where SURFAXIN was compared with other surfactant agents (one which has no protein component and two others which contain animal-derived protein).
Danish: Firmaet har først og fremmest fremlagt resultaterne af to undersøgelser vedrørende forebyggelse af RDS, hvori der indgik over 1 500 for tidligt fødte nyfødte, og hvor SURFAXIN blev sammenlignet med andre overfladeaktive stoffer (af hvilke det ene er uden proteinkomponent, og de to andre indeholder protein af animalsk oprindelse).
English: The CHMP was still questioning whether the design and the results of the studies were sufficient to establish that the product will be at least as effective and safe as other surfactant agents currently used to prevent RDS.
Danish: CHMP fandt det stadig tvivlsomt, om undersøgelserne ved deres tilrettelæggelse og resultater på fyldestgørende måde dokumenterer, at produktet er mindst lige så sikkert og effektivt som andre overfladeaktive stoffer, der i dag anvendes til forebyggelse af RDS.
English: SURFAXIN is a white suspension (i.e. a solution in which active substance is dissolved) to be administered into the lungs via a tube.
Danish: SURFAXIN er en hvid suspension (dvs. en opløsning, hvori det aktive stof er opslæmmet), der indgives i lungerne gennem en sonde.
English: On 7 June 2006, Pharm Research Associates (UK) Limited has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their marketing application for SURFAXIN, for the prevention and treatment of respiratory distress syndrome (RDS) in premature babies.
Danish: Den 7. juni 2006 har Pharm Research Associates (UK) Limited officielt meddelt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for SURFAXIN til forebyggelse og behandling af besværet vejrtrækning (respiratory distress syndrome, RDS) hos for tidligt fødte børn.
English: Effectiveness was measured by looking at frequency of RDS, survival with or without related pulmonary disorder (“bronchopulmonary dysplasia”), at different points in time.
Danish: Virkningen blev målt ved registrering af hyppigheden af RDS og overlevelse med og uden tilknyttet lungesygdom ("bronkopulmonal dysplasi"), til forskellige tidspunkter.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the Company.
Danish: Efter gennemgang af den indledende dokumentation opstiller CHMP en række spørgsmål (på dag 120), der forelægges firmaet.
English: The letter from the Company notifying the EMEA of the withdrawal of SURFAXIN is available here.
Danish: Firmaets brev til EMEA med meddelelsen om tilbagetrækningen for SURFAXIN kan ses her.
English: What was SURFAXIN expected to be used for?
Danish: Hvad forventedes SURFAXIN anvendt til?
English: SURFAXIN was expected to be used for the prevention of RDS in premature neonates of less than 32 weeks of gestational age (babies born 8 weeks or more too early), and, the treatment of RDS in premature neonates of less than 37 weeks of gestational age (babies born 3 weeks or more too early).
Danish: SURFAXIN forventedes anvendt til forebyggelse af RDS hos nyfødte, der er født før 32. svangerskabsuge (dvs. mindst 8 uger for tidligt), og til behandling af RDS hos nyfødte, der er født før 37. svangerskabsuge (dvs. mindst 3 uger for tidligt).
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with SURFAXIN?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med SURFAXIN eller i programmer for anvendelse med særlig udleveringstilladelse?
English: Once the Company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining question(s) (at around day 180) to the Company.
Danish: Når firmaet har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål (omkring dag 180) til firmaet.
English: The active substances of SURFAXIN are sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid.
Danish: De aktive stoffer i SURFAXIN er sinapultid, dipalmitoylphosphatidylcholin, palmitoyloleoylphosphatidylglycerol og palmitinsyre.
English: How is SURFAXIN expected to work?
Danish: Hvordan forventes SURFAXIN at virke?
English: In infants, RDS is caused by a lack of lung surfactant; a complex of protein and fat that is normally present in lungs and helps the air sacs of the lung to inflate with air easily.
Danish: Hos spædbørn skyldes RDS mangel på surfaktant i lungerne; surfaktant er et overfladeaktivt stof, der er sammensat af protein og fedtstof og normalt findes i lungerne, hvor det medvirker til, at lungeblæresækkene let fyldes med luft.
English: The company informed the EMEA that there were no ongoing clinical trials or compassionate use programmes with SURFAXIN at the time of the withdrawal.
Danish: Firmaet har til EMEA oplyst, at der på tilbagetrækningstidspunktet ikke var nogen igangværende kliniske undersøgelser med SURFAXIN eller programmer for anvendelse med særlig udleveringstilladelse.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that SURFAXIN could not be approved for the prevention and treatment of respiratory distress syndrome in premature babies.
Danish: Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af CHMPs spørgsmål var der i CHMP betænkelighed, og udvalgets foreløbige standpunkt var, at SURFAXIN ikke kunne godkendes til forebyggelse og behandling af besværet vejrtrækning (RDS) hos for tidligt fødte børn.
English: Active substances: sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid.
Danish: Aktive stoffer: sinapultid, dipalmitoylphosphatidylcholin, palmitoyloleoylphosphatidylglycerol og palmitinsyre.
English: RDS is a lung disorder that causes increasing difficulty in breathing.
Danish: RDS er en lungesygdom, der medfører besværet vejrtrækning.
English: The likelihood of lack of surfactant is higher in premature neonates.
Danish: For tidligt fødte børn har øget risiko for mangel på surfaktant.
English: The application was at the stage of review of answers to remaining questions, adopted at around day 180, when the Company withdrew it. After the CHMP had assessed the responses from the Company to a list of questions, there were still unresolved outstanding issues.
Danish: Efter at CHMP havde vurderet firmaets besvarelse af en række spørgsmål, tilbagestod der fortsat uafklarede punkter.
English: 0.6 ml (10 mg/ml)
Danish: Fyldt sprøjte (glas) 0,6 ml (10 mg/ml)
English: Strength Pharmaceutical Form
Danish: (Sær)navn Styrke Lægemiddelform Administration Emballage
English: • you are under 18 years.
Danish: • hvis De er under 18 år.
English: This should be checked routinely.
Danish: Dette bør kontrolleres rutinemæssigt.
English: The test will take about 45 minutes.
Danish: Prøven vil vare cirka 45 minutter.
English: Your doctor now wants to find out if the treatment has worked.
Danish: Deres læge ønsker nu at finde ud af, om behandlingen har virket.
English: This is especially important after eradication therapy.
Danish: Dette er især vigtigt efter eradikationsterapi.
English: It is excreted unchanged in the urine.
Danish: Det udskilles uændret i urinen.
English: Do not smoke, eat or drink during this time.
Danish: De må ikke ryge, spise eller drikke i dette tidsrum.
English: How does the test work?
Danish: Hvorledes virker prøven?
English: You must not smoke before or during the test.
Danish: De må ikke ryge før eller under prøven.
English: There are no concerns in relation to the clinical use of the product.
Danish: Der findes ingen betænkeligheder i relation til klinisk anvendelse af produktet.
English: Your doctor will tell you when the results of your test will be available and who to contact for these results.
Danish: Lægen vil fortælle Dem, hvornår resultaterne af prøven vil være til rådighed, og hvem De skal kontakte for at få disse resultater.
English: The endogenous production of urea amounts to 25 - 35 g/day.
Danish: Den endogene produktion af urea er ca. 25 - 35 g per dag.
English: Instruments must be linear over a wide range of CO2 concentrations, typically 1.0 - 6.0%.
Danish: Instrumenterne skal være lineære over et bredt område af CO2-koncentrationer, typisk 1,0 - 6,0 %.
English: Wait 5 minutes
Danish: Vent i fem minutter.
English: This is not supplied within the box.
Danish: Dette medfølger ikke i æsken.
English: • fasting (not taking food) may have medical implications for you
Danish: • hvis det at faste (ikke at indtage føde) kan have helbredsmæssige konsekvenser for Dem.
English: This is important for the proper functioning of the test.
Danish: Dette er vigtigt, for at prøven skal fungere korrekt.
English: A further 3 samples of your breath will then be taken 30 minutes later.
Danish: Yderligere tre prøver af Deres udåndingsluft vil så blive taget 30 minutter senere.
English: The dissolved tablet must be taken immediately.
Danish: Den opløste tablet skal indtages straks.
English: Test is now complete
Danish: Prøven er nu færdig.
English: Therefore, the test must not be used until four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents.
Danish: Derfor må prøven ikke anvendes, før efter fire uger uden systemisk antibakteriel behandling og to uger efter sidste dosis af syresekretionshæmmende midler.
English: You will be asked to drink a "test meal".
Danish: De vil blive bedt om at drikke et "prøvemåltid".
English: Alternatively, any other suitably-validated method may be used, carried out by any objectively qualified laboratory.
Danish: Alternativt kan enhver anden passende valideret metode anvendes, udført af et hvilket som helst objektivt kvalificeret laboratorium.
English: The specificity estimates were all above 90 % with corresponding lower confidence limits ranging from 85 % to 90 %.
Danish: Specificitetsbestemmelserne lå alle over 90 % med tilsvarende konfidensgrænser mellem 85 % og 90 %.
English: Overdose is unlikely to occur in the intended clinical circumstances.
Danish: En overdosis er ikke sandsynlig under de tilsigtede, kliniske forhold.
English: IRMS source parameters and tuning must be optimised daily.
Danish: IRMS-kildeparametrene og indstillingen skal optimeres daglig.
English: Explanation of results:
Danish: Forklaring af resultater:
English: C in the breath will depend on the type of food that you have eaten.
Danish: Mængden af 13C i udåndingsluften vil afhænge af den type mad, De har spist.
English: Suppression of H. pylori might give false negative results.
Danish: Hæmning af H. pylori kan give falske negative resultater.
English: Do not take the test if:
Danish: De må ikke tage prøven:
English: Adults: The tablet is to be dissolved in water and taken 10 minutes after the start of the breath test procedure.
Danish: Voksne: Tabletten skal opløses i vand og tages 10 minutter efter starten af ureaudåndingsprøveproceduren.
English: Ireland enquiries@torbetlaboratories.co.uk
Danish: Irland enquiries@torbetlaboratories.co.uk
English: It is therefore unlikely that the dose of 100 mg urea should cause any adverse effect on pregnancy and lactation.
Danish: Det er derfor usandsynligt, at dosen på 100 mg kunne forårsage skadelig virkning ved graviditet og amning.
English: C and urea are harmless naturally occurring substances which are found in your body.
Danish: 13C og urea er uskadelige, naturligt forekommende stoffer, som findes i kroppen.
English: The test procedure involves the following steps: (A brief form of these instructions is included on the back of the Analysis Request Form)
Danish: Prøveproceduren omfatter følgende punkter: (En kort udgave af denne vejledning findes på bagsiden af Deres formular til rekvisition af analyse)
English: - suffer from any medical condition that you think may affect, or be affected by, the test.
Danish: - hvis De lider af en medicinsk tilstand, som De mener kan påvirke eller blive påvirket af prøven.
English: The cut off point for discriminating between H.pylori negative and positive patients is set to an excess value of 3.5, i.e. <3.5 is negative and 3.5 is positive.
Danish: Skillepunktet mellem H. pylori negative og positive patienter er fastsat til en overskydende værdi på 3,5, dvs. <3,5 er negativ og ≥3,5 er positiv.
English: You should fast for 4 hours before taking the test (See Section 2 Taking Pylobactell with food and drink)
Danish: Faste: De bør faste i fire timer, inden De tager prøven (se sektion 2 "Brug af Pylobactell sammen med mad og drikke")
English: • You have taken antibiotics or medication to treat Helicobacter pylori within the last 28 days
Danish: • hvis De har taget antibiotika eller lægemidler til behandling af Helicobacter pylori inden for de sidste 28 dage.
English: • 2 straws.
Danish: • 2 sugerør.
English: Care should be taken in patients where fasting may have medical implications.
Danish: Der skal udvises forsigtighed hos patienter, hvor faste kan have medicinske konsekvenser.
English: (i) antibiotics in the last 28 days?
Danish: (i) antibiotika inden for de sidste 28 dage?
English: Driving and using machines This test should not affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Denne prøve skulle ikke påvirke Deres evne til at køre bil eller betjene maskiner.
English: Fill to line with water
Danish: Fyld vand i op til stregen