FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment is started with a dose of 20 mg per kilogram bodyweight given once by slow infusion over 30 minutes.
Danish: Behandlingen indledes med en dosis på 20 mg per kg legemsvægt, administreret en gang ved langsom infusion over 30 minutter.
English: Apnoea in premature babies is due to the baby's breathing centres in the brain not being fully developed.
Danish: Apnø hos for tidligt fødte spædbørn skyldes, at barnets vejrtrækningscenter i hjernen ikke er fuldt udviklet.
English: Peyona caffeine citrate
Danish: Peyona koffeincitrat
English: What measures are being taken to ensure the safe and effective use of Peyona?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Peyona?
English: Apnoea in newborns is the cessation of breathing for more than 20 seconds.
Danish: Apnø hos nyfødte er ophør af vejrtrækning i mere end 20 sekunder.
English: When judged necessary, the doctor may monitor the level of caffeine in the baby's blood and adjust the dose accordingly.
Danish: Når det anses for at være nødvendigt, kan lægen overvåge koncentrationerne af koffein i barnets blod og tilpasse dosis herefter.
English: The main measure of effectiveness in this review was the number of patients who did not have ‘treatment failure'.
Danish: Det primære effektmål ved denne gennemgang var antallet af patienter, hvor der ikke kunne iagttages manglende terapeutisk effekt.
English: The active substance in Peyona, caffeine citrate, is a stimulant of the nervous system.
Danish: Det aktive stof i Peyona, koffeincitrat, stimulerer nervesystemet.
English: For more information about treatment with Peyona, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Peyona, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Caffeine citrate is an ‘antagonist' of adenosine, a substance that blocks the activity of some parts of the brain, including the part responsible for controlling breathing.
Danish: Koffeincitrat er en »antagonist« af adenosin, et stof, der blokerer aktiviteten i nogle dele af hjernen, herunder den del, der er ansvarlig for kontrol af vejrtrækningen.
English: A baby was considered to be in treatment failure if there was no halving of the number of apnoea episodes, if the baby required a machine to assist in breathing or if the baby did not survive.
Danish: Behandlingen blev anset for at have manglende terapeutisk effekt på et spædbarn, hvis der ikke skete en halvering af antallet af apnøepisoder, hvis spædbarnet havde behov for en maskine til at hjælpe med vejrtrækningen, eller hvis spædbarnet ikke overlevede.
English: The card will contain information on how Peyona should be administered, including doses, the monitoring of plasma caffeine levels and the side effects that may occur during treatment.
Danish: Kortet skal give oplysninger om, hvordan Peyona skal administreres, herunder doser, overvågning af koffeinniveauer i plasma og de bivirkninger, der kan opstå under behandlingen.
English: Because caffeine citrate has been used in premature babies for a long time, the company presented information from the scientific literature.
Danish: Da koffeincitrat er blevet anvendt til for tidligt fødte spædbørn i lang tid, fremlagde virksomheden oplysninger fra faglitteraturen.
English: Because the number of patients with primary apnoea of premature newborns is low, the disease is considered ‘rare', and Peyona was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 February 2003.
Danish: Da antallet af patienter med primær apnø hos for tidligt fødte spædbørn er lavt, betragtes sygdommen som »sjælden«, og Peyona blev udpeget som »lægemiddel til sjældne sygdomme« den 17. februar
English: The main measure of effectiveness was based on the reduction by at least a half in the daily number of apnoea episodes over ten days.
Danish: Det primære effektmål var baseret på mindst en halvering af det daglige antal apnøepisoder over 10 dage.
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 Peyona.
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 Peyona skal anvendes.
English: The full EPAR for Peyona can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Peyona findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Peyona is a solution for infusion (drip) into a vein that contains the active substance caffeine citrate (20 mg/ml).
Danish: Peyona er en infusionsvæske, opløsning, (drop i en vene), som indeholder det aktive stof koffeincitrat (20 mg/ml).
English: The doctor will stop treatment with Peyona when the baby has five to seven consecutive days without apnoea attacks.
Danish: Lægen afbryder behandlingen med Peyona, når barnet ikke har haft apnøanfald i 5-7 dage.
English: After 24 hours, a ‘maintenance dose' of 5 mg per kg bodyweight may be given everyday
Danish: Efter 24 timer kan der administreres en vedligeholdelsesdosis på 5 mg per
English: What is the risk associated with Peyona?
Danish: Hvilken risiko er der forbundet med Peyona?
English: The summary of opinion of the Committee for Orphan Medicinal Products for Peyona can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Peyona findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The CHMP decided that Peyona's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Peyona opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Peyona.
English: In the large published study, 46% of babies given placebo (431 out of 932) died or had neurological disabilities compared with 40% of babies given caffeine citrate (377 out of 937).
Danish: I den store publicerede undersøgelse døde 46 % af de børn, der fik placebo (431 ud af 932), eller de havde neurologiske lidelser, sammenlignet med 40 % af de spædbørn, som fik koffeincitrat (377 ud af
English: Caffeine citrate works in apnoea by blocking the receptors that adenosine normally attaches to.
Danish: Ved apnø virker koffeincitrat ved at blokere de receptorer, som adenosin normalt binder sig til.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Peyona, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Peyona, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: In addition, more babies who were given caffeine citrate had at least eight days with no apnoea: 22% of babies given caffeine citrate compared with none of babies who were given placebo.
Danish: Desuden havde flere spædbørn, som fik koffeincitrat, mindst 8 dage uden apnø: 22 % af de spædbørn, der fik koffeincitrat sammenlignet med ingen af de spædbørn, der fik placebo.
English: In addition, the company that makes Peyona will agree with Member States on a card that will be displayed in intensive care units where the medicine will be used.
Danish: Virksomheden, som fremstiller Peyona, skal desuden indgå aftale med medlemsstaterne om et kort, der skal opsættes på de intensivafdelinger, hvor lægemidlet vil blive anvendt.
English: In six out of ten days caffeine citrate was more effective than placebo in reducing the number of apnoea episodes by at least a half.
Danish: I 6 ud af 10 dage var koffeincitrat mere effektivt end placebo til at reducere antallet af episoder med apnø med mindst halvdelen.
English: The most common side effects with caffeine citrate (seen in between 1 and 10 patients in 100) are hyperglycaemia (high blood glucose levels), tachycardia (rapid heartbeat) and phlebitis (inflammation of a vein) and inflammation at the site of infusion.
Danish: De hyppigste bivirkninger ved koffeincitrat (som optræder hos mellem 1 og 10 patienter ud af 100) er højt blodglukoseniveau (hyperglykæmi), forøget hjertefrekvens (takykardi), betændelse i en vene (flebitis) og betændelse ved injektionsstedet.
English: Why has Peyona been approved?
Danish: Hvorfor blev Peyona godkendt?
English: What is Peyona?
Danish: Hvad er Peyona?
English: Treatment with the medicine should only take place in an intensive care unit for newborns that is well equipped for monitoring the baby.
Danish: Behandling skal foregå i en neonatal intensivafdeling, som er veludstyret til monitorering af spædbarnet.
English: Caffeine citrate was more effective than placebo at treating apnoea in premature babies.
Danish: Koffeincitrat var mere effektivt end placebo til behandling af apnø hos for tidligt fødte spædbørn.
English: Treatment with Peyona should only be started under the supervision of a doctor experienced in treating newborn babies requiring intensive care.
Danish: Behandling med Peyona bør kun indledes under opsyn af en læge med erfaring i neonatal intensiv behandling.
English: In a published review of five studies, caffeine and theophylline (another stimulant) were compared with placebo in 192 premature babies with apnoea.
Danish: I en publiceret gennemgang af 5 undersøgelser blev koffein og theophyllin (et andet stimulerende middel) sammenlignet med placebo hos 192 for tidligt fødte spædbørn med apnø.
English: by slow infusion over 10 minutes or by mouth using a nasogastric tube (a tube through the nose to the stomach).
Danish: kg legemsvægt hver dag, administreret ved langsom infusion over 10 minutter eller ved oral administration gennem en nasogastrisk sonde (et rør gennem næsen ned til maven).
English: In a published study involving 85 premature babies who had had several episodes of apnoea, caffeine citrate was compared with placebo (a dummy treatment).
Danish: I en publiceret undersøgelse, som omfattede 85 for tidligt fødte spædbørn med adskillige apnøepisoder, blev koffeincitrat sammenlignet med placebo (en virkningsløs behandling).
English: What is Peyona used for?
Danish: Hvad anvendes Peyona til?
English: For the full list of all side effects and restrictions with caffeine citrate, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved koffeincitrat fremgår af indlægssedlen.
English: Peyona is used to treat primary apnoea in premature newborns.
Danish: Peyona anvendes til behandling af primær apnø hos for tidligt fødte spædbørn.
English: In the review of five studies, fewer babies treated with caffeine or theophylline had treatment failure compared with placebo.
Danish: I gennemgangen af 5 undersøgelser kunne der iagttages manglende terapeutisk effekt hos færre spædbørn, der blev behandlet med koffein og theophyllin, i sammenligning med placebo.
English: How has Peyona been studied?
Danish: Hvordan blev Peyona undersøgt?
English: What benefit has Peyona shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Peyona?
English: How is Peyona used?
Danish: Hvordan anvendes Peyona?
English: How does Peyona work?
Danish: Hvordan virker Peyona?
English: A large published study compared caffeine citrate with placebo in treating 2,006 premature babies with apnoea.
Danish: I en stor publiceret undersøgelse omfattende 2 006 for tidligt fødte spædbørn med apnø blev koffeincitrat sammenlignet med placebo.
English: Median Time to Event (Days)
Danish: Mediantid til event (dage)
English: • If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.
Danish: • Hvis der forekommer kontraindikationer til et af af lægemidlerne i kombinationsregimet, bør det pågældende lægemiddel ikke anvendes.
English: Instead, continue your regular dosing schedule and check with your doctor.
Danish: I stedet skal du fortsætte med din regelmæssige dosisplan og tale med din læge.
English: Severe and/or Life-threatening (grade 3-4) or considered medically relevant
Danish: Alvorlige og/eller livstruende (grad 3-4) eller vurderet som klinisk relevant
English: • Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual.
Danish: • Kvalme: hvis du mister appetitten, og hvis du spiser meget mindre hver dag, end du plejer.
English: It may harm them,
Danish: Afskalning af huden,
English: Other side effects are:
Danish: Andre bivirkninger er:
English: Treatment should not be restarted until the patient is rehydrated and any precipitating causes have been corrected or controlled.
Danish: Behandlingen bør ikke genoptages, før patienten er rehydreret, og udløsende årsager er korrigeret eller kontrolleret.
English: • specific changes in the electrocardiogram (QT prolongation)
Danish: • specifikke forandringer i elektrokardiogram (QT-forlængelse)
English: • Vomiting: if you vomit more than once in a 24-hour time period.
Danish: • Opkastning: hvis du kaster op mere end én gang i løbet af 24 timer.
English: Dose adjustment for next cycle/dose (% of starting dose)
Danish: Dosisjustering for næste serie/dosis (% af begyndelsesdosis)
English: • Fever: if you have a temperature of 38°C or greater.
Danish: • Feber: hvis din temperatur stiger til 38 °C eller derover.
English: The following are the recommended dose modifications for toxicity:
Danish: De anbefalede dosismodifikationer for toksicitet er følgende:
English: Median overall survival ITT
Danish: Median samlet overlevelse ITT
English: Permanent discontinuation should be considered based on clinical assessment of the onset, duration and severity of the observed toxicities.
Danish: Permanent seponering bør overvejes på baggrund af en klinisk vurdering af debut, varighed og sværhedsgrad af de observerede toksiciteter.
English: • blurred or double vision
Danish: • sløret syn eller dobbeltsyn
English: Elderly patients (see section 4.2)
Danish: Ældre patienter (se pkt 4.2)
English: oral use
Danish: oral anvendelse
English: intravenous bolus injection immediately after leucovorin
Danish: Intravenøs bolusinjekion umiddelbart efter leucovorin
English: Capecitabine Teva may be used either alone or in combination with other medicines.
Danish: Capecitabine Teva kan anvendes enten alene eller i kombination med andre lægemidler.
English: DPD deficiency: DPD deficiency is a rare condition present at birth that is not usually associated with health problems unless you receive certain medicines.
Danish: DPD-mangel: DPD-mangel er en sjælden, medfødt tilstand, der almindeligvis ikke er forbundet med helbredsproblemer, medmindre man får bestemte lægemidler.
English: If caught early, these side effects usually improve within 2 to 3 days after treatment discontinuation.
Danish: Hvis disse bivirkninger opdages hurtigt, vil de normalt bedres i løbet af 2 til 3 dage efter, at behandlingen er stoppet.
English: • Infection: if you experience signs of infection caused by bacteria or virus, or other organisms.
Danish: • Infektion: hvis du oplever tegn på infektion forårsaget af bakterier eller virus eller andre
English: 820 Patients were randomised to receive either sequential treatment (n=410) or combination treatment (n=410).
Danish: 820 patienter blev randomiseret til at få enten sekventiel behandling (n=410) eller kombinationsbehandling (n=410).
English: Not applicable *According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
Danish: Ikke relevant * I følge National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) eller Common Terminology Criteria for Adverse Events (CTCAE) fra Cancer Therapy Evaluation Program, US National Cancer Institute, version 4.0.
English: Merckle GmbH Ludwig Merckle Str. 3 89143 Blaubeuren Germany
Danish: Merckle GmbH Ludwig Merckle Str. 3 89143 Blaubeuren Tyskland
English: If these side effects continue, however, contact your doctor immediately.
Danish: Hvis bivirkningerne alligevel fortsætter, skal du straks kontakte lægen.
English: Central or peripheral nervous system disease
Danish: Centrale eller perifere nervesystem
English: A reduction of the starting dose in these patients may be considered to avoid serious toxicity.
Danish: Det kan overvejes at reducere start-dosis hos disse patienter, for at undgå alvorlig toksicitet.
English: Careful monitoring of patients ≥60 years of age is advisable.
Danish: Omhyggelig monitorering af patienter ≥ 60 år tilrådes.
English: The median follow up at the time of the analysis was 6.9 years.
Danish: Den mediane tid for follow-up på analysetidspunktet var 6,9 år.
English: • cold sores or other herpes infections
Danish: • forkølelsessår eller andre herpesinfektioner
English: This will help reduce the likelihood that the side effect continues or becomes severe.
Danish: Dermed nedsættes sandsynligheden for, at bivirkningen fortsætter eller forværres.
English: Dose per administration (mg)
Danish: Dosis pr. administration (mg)
English: Other side-effects seen in this setting are the following:
Danish: Andre bivirkninger, der ses i denne forbindelse, er følgende:
English: Capecitabine can induce the occurrence of diarrhoea, which has been observed in up to 50% of patients.
Danish: 4.4) Capecetabin kan inducere forekomsten af diarré, hvilket er observeret hos op til 50 % af patienterne.
English: • eye inflammation causing eye pain and possibly eyesight problems
Danish: • inflammation i øjet, der medfører smerter i øjet og muligvis problemer med synet
English: Tinnitus, Hypoacusis
Danish: Tinnitus, hypoakusis
English: SPECIAL STORAGE CONDITIONS Store below 30 °C.
Danish: Opbevares ved temperaturer under 30 °C.
English: Capecitabine Teva tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Danish: Capecitabine Teva-tabletter tages normalt i 14 dage efterfulgt af 7 dages pause (hvor der ikke tages tabletter).
English: • inflammation of the skin causing red scaly patches due to an immune system illness
Danish: • inflammation i huden, der medfører røde skællende pletter på grund af en sygdom i immunsystemet.
English: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien
Danish: Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien
English: STOP taking Capecitabine Teva immediately and contact your doctor if any of these symptoms occur:
Danish: STOP øjeblikkeligt med at tage Capecitabine Teva og kontakt lægen, hvis du får nogle af følgende symptomer:
English: Pharmacotherapeutic group: antineoplastic agents, antimetabolites, ATC code: L01BC06
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, antimetabolitter, ATC kode: L01BC06
English: • difficulty in urination, blood or protein in the urine
Danish: • vandladningsbesvær, blod eller protein i urinen
English: Diabetes mellitus or electrolyte disturbances
Danish: Diabetes mellitus eller elektrolytforstyrrelser
English: Your doctor may instruct you to decrease the dose and/or temporarily discontinue treatment with Capecitabine Teva.
Danish: Lægen vil måske bede dig om at sætte dosis ned og/eller midlertidigt afbryde behandlingen med Capecitabine Teva.
English: It is therefore possible that Capecitabine Teva could affect your ability to drive a car or operate machines.
Danish: Det er derfor muligt, at Capecitabine Teva kan påvirke din evne til at køre bil og betjene maskiner.
English: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. filmovertrukket tablet, dvs. det er i det væsentlige natrium-frit.
English: Most adverse reactions are reversible and do not require permanent discontinuation of therapy, although doses may need to be withheld or reduced.
Danish: De fleste bivirkninger er reversible og kræver ikke seponering af behandlingen, selvom nogle doser måske skal springes over eller reduceres.
English: • Chest pain: if you experience pain localised to the centre of the chest, especially if it occurs during exercise.
Danish: • Brystsmerter: hvis du får smerter i midten af brystet, specielt hvis det sker under anstrengelse.
English: • bruising or reaction at the injection site (caused by medicines given by injection at the same time)
Danish: • blå mærker eller reaktion ved indstiksstedet (som skyldes lægemidler, der injiceres samtidig)
English: • In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity
Danish: • Patienter med kendt fuldstændig mangel på dihydropyrimidindehydrogenase (DPD) aktivitet (se pkt.
English: Since metabolism of R-warfarin was not affected, these results indicate that capecitabine down-regulates isozyme 2C9, but has no effect on isozymes 1A2 and 3A4.
Danish: Da R-warfarins metabolisme ikke var påvirket, tyder disse resultater på, at capecitabin nedregulerer isoenzym 2C9, men ikke har effekt på isoenzymerne 1A2 og 3A4.
English: The inclusion of bevacizumab in a combination regimen has no effect on the starting dose of capecitabine.
Danish: Inklusionen af bevacizumab i et kombinationsregime har ingen effekt på initialdosis af capecitabin.
English: Dehydration should be prevented or corrected at the onset.
Danish: Dehydrering bør forebygges eller korrigeres, så snart den forekommer.
English: The following factors were prespecified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomization, gender, CEA levels at baseline, lymph nodes at baseline, and country.
Danish: Følgende faktorer var præspecificerede i den statistiske analyseplan for inklusion i modellen: Alder, tid fra operation til randomisering, køn, CEA-værdier ved baseline, lymfeknuder ved baseline samt land.
English: Body surface area (m2)
Danish: Legemsoverfladeareal (m2)
English: • History of severe and unexpected reactions to fluoropyrimidine therapy,
Danish: • Tidligere alvorlige og uventede reaktioner på behandling med fluorpyrimidin,
English: Progression-free Survival after 6 months ITT
Danish: Progressionsfri overlevelse efter 6 måneder ITT konfidensinterval
English: • jaundice (yellowing of skin and eyes)
Danish: • gulsot (gulfarvning af hud og øjne)
English: Finally, β-ureido-propionase cleaves FUPA to α-fluoro-β-alanine
Danish: Endeligt spalter β-ureido-propionase FUPA til α-fluoro-β-alanin (FBAL),
English: Date of latest renewal: 09 January 2017
Danish: Dato for første markedsføringstilladelse: 20. April 2012 Dato for seneste fornyelse: 9. Januar 2017
English: Toxic leukoencephalopa thy (very rare)
Danish: Toksisk leukoencefalopati (meget sjælden)
English: • ringing or buzzing in the ears (tinnitus), loss of hearing
Danish: • ringen eller summen for ørerne (tinnitus), tab af høreevne
English: Although sensitivity analyses show that differences in regimen schedules and timing of tumor assessments impact the ontreatment PFS analysis, a full explanation for this result has not been found.
Danish: Selvom sensitivitetsanalyser viser, at forskelle i behandlingsskemaer og tidspunkt for tumorvurdering påvirker analysen for progressionsfri overlevelse on-treatment, er der ikke fundet en fyldestgørende forklaring på dette fund.
English: Some of these side effects are more common when capecitabine is used with other medicines for the treatment of cancer.
Danish: Nogle af disse bivirkninger er mere almindelige, når capecitabin bruges sammen med andre lægemidler til behandling af kræft.