FrancophonIA/ELRC3.0 huggingface dataset:
English: Only syringe needles (for example non-metallic) with proven resistance to dilute acid should be used to minimise trace metal impurity levels.
Danish: For at minimere tilstedeværelsen af spormetal urenheder bør der kun anvendes injektionsnåle (for eksempel ikke-metal) med bevist modstandsdygtighed over for fortyndet syre.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Hvis De tager eller for nylig har taget anden medicin, bør De fortælle Deres læge eller apotek herom, også hvis der er tale om ikke-receptpligtig medicin.
English: Adult female 57 kg 15 years 10 years 5 years
Danish: Voksen kvinde 57 kg
English: Yttrium (90Y) chloride
Danish: Yttriumchlorid (90Y)
English: NAME OF THE MEDICINAL PRODUCT YTRACIS Radiopharmaceutical precursor, solution.
Danish: LÆGEMIDLETS NAVN YTRACIS radiofarmaceutisk mærkningsopløsning.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé, pkt.
English: OTHER
Danish: FRANKRIG
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
English: In the rat, following intravenous administration, Yttrium (90Y) chloride is rapidly cleared from the blood.
Danish: Hos rotter udrenses yttriumchlorid (90Y) hurtigt fra blodet efter intravenøs indgivelse.
English: The absorbed dose to the uterus following administration of Yttrium (90Y)-labelled medicinal products is dependent on the specific medicinal product being radiolabelled and is to be specified in the Summary of Product Characteristics/ package leaflet of the medicinal product to be radiolabelled.
Danish: Den absorberede dosis til uterus efter indgivelse af yttrium (90Y)-mærkede lægemidler er afhængig af det specifikke lægemiddel, der radiomærkes, og er specificeret i produktresumeet/indlægssedlen for det lægemiddel, der radiomærkes.
English: YTRACIS is intended for radiolabelling of medicinal products to treat specific diseases, which are subsequently administered by approved route.
Danish: YTRACIS er beregnet til radioaktiv mærkning af medicin, som efterfølgende injiceres via godkendt vej, til behandling af specifikke sygdomme.
English: Information on radiation dosimetry of each different medicinal product following administration of the radiolabelled preparation will be available in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Danish: Information om strålingsdosimetri for hvert lægemiddel efter indgivelse af det radiomærkede præparat er angivet i produktresuméet/indlægssedlen for det specifikke lægemiddel, der skal radiomærkes.
English: Possible side effects following the intravenous administration of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, will be dependent on the specific medicinal product being used.
Danish: Mulige bivirkninger efter intravenøs indgivelse af yttrium (90Y)-mærkede lægemidler klargjort ved radiomærkning med YTRACIS, er afhængig af det specifikke lægemiddel, der anvendes.
English: - The active substance is Yttrium (90Y) chloride.
Danish: YTRACIS indeholder: - Aktivt stof: yttriumchlorid (90Y).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION YTRACIS Yttrium (90Y) chloride
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ YTRACIS, yttriumchlorid (90Y) ANVENDELSESMÅDE Til radiomærkning in vitro.
English: Y) chloride with other medicinal products are known because no studies have investigated this issue.
Danish: Indtagelse af anden medicin: Der kendes ingen vekselvirkninger mellem yttriumchlorid (90Y) og anden medicin, da der ikke er udført undersøgelser om dette emne.
English: PHARMACEUTICAL FORM Radiopharmaceutical precursor, solution.
Danish: LÆGEMIDDELFORM Radiofarmaceutisk mærkningsopløsning.
English: BATCH NUMBER
Danish: FREMSTILLERENS BATCHNUMMER Batchnummer: {XXXXX}
English: If you use more YTRACIS than you should
Danish: Hvis De har brugt for meget YTRACIS
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Such information will be supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Danish: Denne information leveres i produktresumeet/indlægssedlen for det specifikke lægemiddel, der skal radiomærkes.
English: Effects on ability to drive or use machines following treatment by Yttrium (90Y)-labelled medicinal products will be specified in the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Danish: Virkningen på evnen til at føre motorkøretøj eller betjene maskiner efter behandling med yttrium (90Y)-mærkede lægemidler er angivet i produktresuméet/indlægssedlen for det specifikke lægemiddel,
English: BEFORE YOU USE YTRACIS
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT BRUGE YTRACIS
English: For information concerning the use of Yttrium (90Y)-labelled medicinal products in pregnancy and lactation refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.
Danish: For information om brugen af yttrium (90Y)-mærkede lægemidler i forbindelse med graviditet og amning, se Produktresumé/Indlægsseddel for det lægemiddel, der skal radiomærkes.
English: YTRACIS radiopharmaceutical precursor, solution.
Danish: YTRACIS radiofarmaceutisk mærkningsopløsning.
English: For more information, refer to the package leaflet of the particular medicinal product to be radiolabelled.
Danish: For yderligere information, se indlægsseddel for den medicin, som skal radiomærkes.
English: YTRACIS.
Danish: Akt.
English: Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Danish: Se Produktresumé/Indlægsseddel for det specifikke lægemiddel, der skal radiomærkes.
English: For information on contraindications to particular Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.
Danish: For information om kontraindikationer som gælder specielt for yttrium (90Y)-mærkede radioaktive lægemidler klargjort ved mærkning med YTRACIS, se Produktresumé/Indlægsseddel for det lægemiddel, der skal radiomærkes.
English: For in vitro radiolabelling.
Danish: der skal radiomærkes.
English: The pharmacokinetic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Danish: De farmakokinetiske egenskaber af yttrium (90Y)-mærkede lægemidler, klargjort ved radiomærkning med YTRACIS inden indgivelsen, er afhængig af den type lægemiddel, som skal radiomærkes.
English: - If you have any further questions, ask your doctor or your pharmacist.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaveren af markedsføringstilladelsen og fremstiller CIS bio international
English: Vol.: {Z} ml Act.: {Y} GBq/vial
Danish: : {Y}________GBq/hætteglas Kal.
English: The pharmacodynamic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with YTRACIS, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Danish: De toksikologiske egenskaber af yttrium (90Y)-mærkede lægemidler, klargjort ved radiomærkning med YTRACIS inden indgivelsen, er afhængig af den type lægemiddel, som skal radiomærkes.
English: METHOD OF ADMINISTRATION
Danish: Indgivelsesmåde
English: 91192 GIF-SUR-YVETTE Cedex France
Danish: 91192 GIF-SUR-YVETTE Cedex Frankrig
English: F-91192 GIF-SUR-YVETTE Cedex France
Danish: F-91192 GIF-SUR-YVETTE CEDEX FRANKRIG
English: F-91192 Gif-sur-Yvette Cedex FRANCE
Danish: F-91192 GIF-SUR-YVETTE Cedex Frankrig
English: NAME OF THE MEDICINAL PRODUCT YTRACIS radiopharmaceutical precursor, solution.
Danish: YTRACIS er en radiofarmaceutisk mærkningsopløsning.
English: The radiation dose received by the various organs following administration of a Yttrium (90Y)
Danish: YTRACIS radiofarmaceutisk mærkningsopløsning Yttriumchlorid (90Y)
English: This summary was last updated in 10-2015.
Danish: Dette sammendrag blev sidst ajourført i 10-2015.
English: The patient should avoid eating or drinking for 10 minutes after taking the medicine.
Danish: Patienten bør undgå at spise og drikke i 10 minutter efter at have taget lægemidlet.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sycrest on 1 September 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sycrest den 1. september 2010.
English: Sycrest asenapine
Danish: Sycrest asenapin
English: This dose can be increased to 10 mg twice a day depending on how the patient responds.
Danish: Dosis kan øges til 10 mg to gange dagligt afhængigt af, hvordan patienten responderer på behandlingen.
English: This is a summary of the European public assessment report (EPAR) for Sycrest.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sycrest.
English: Other information about Sycrest:
Danish: Andre oplysninger om Sycrest:
English: The full EPAR for Sycrest can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Sycrest findes på agenturets websted under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Sublingual tablets are tablets that are placed under the tongue, where they dissolve.
Danish: Sublinguale resoribletter er tabletter, der placeres under tungen, hvor de opløses.
English: A risk management plan has been developed to ensure that Sycrest is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Sycrest anvendes så sikkert som muligt.
English: It is available as sublingual tablets (5 and 10 mg).
Danish: Det fås som sublinguale resoribletter (5 og 10 mg).
English: The recommended starting dose of Sycrest is 5 mg twice a day, one dose in the morning and one in the evening.
Danish: Den normale startdosis af Sycrest er 5 mg to gange dagligt, én dosis om morgenen og én om aftenen.
English: When taken in combination with other medicines, Sycrest should be taken last.
Danish: Når Sycrest tages i kombination med andre lægemidler, bør Sycrest tages til sidst.
English: Sycrest tablets should not be chewed or swallowed.
Danish: Sycrest-resoribletter bør ikke tygges eller sluges.
English: Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.
Danish: Dets nøjagtige virkningsmekanisme kendes ikke, men man ved, at det bindes til flere forskellige receptorer på overfladen af nervecellerne i hjernen.
English: Sycrest was also studied in patients with schizophrenia.
Danish: Sycrest blev også undersøgt hos patienter med skizofreni.
English: What measures are being taken to ensure the safe and effective use of Sycrest?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sycrest?
English: The main measure of effectiveness was the change in the patients' ‘Young mania rating scale' (Y-MRS) score.
Danish: Hovedeffektmålet var ændringen i patienternes "Young Mania Rating Scale" (YMRS)-score.
English: The active substance in Sycrest, asenapine, is an antipsychotic medicine.
Danish: Det aktive stof i Sycrest, asenapin, er et antipsykotisk lægemiddel.
English: Sycrest is a medicine that contains the active substance asenapine.
Danish: Sycrest er et lægemiddel, der indeholder det aktive stof asenapin.
English: The most common side effects with Sycrest (seen in more than 1 patient in 10) are anxiety and somnolence (sleepiness).
Danish: De hyppigste bivirkninger ved Sycrest (som optræder hos flere end 1 ud af 10 patienter) er angst og søvnighed (somnolens).
English: It is thought that Sycrest works by blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Danish: Det menes, at Sycrest virker ved at blokere receptorerne for neurotransmitterne 5-hydroxytrypamin (også kaldet serotonin) og dopamin.
English: The Y-MRS rates the severity of symptoms of manic episodes on a scale from 0 to 60.
Danish: Y-MRS bruges til at vurdere sværhedsgraden af symptomerne på maniske episoder på en skala fra 0 til 60.
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 Sycrest.
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 Sycrest skal anvendes.
English: For more information about treatment with Sycrest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sycrest, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The studies on schizophrenia were not considered to have shown sufficient evidence of the effectiveness in treating this disease.
Danish: Undersøgelserne af skizofreni blev ikke anset for at have dokumenteret virkningen tilstrækkeligt ved behandling af denne sygdom.
English: Since these neurotransmitters are involved in bipolar disorder, Sycrest helps to normalise the activity of the brain, reducing the symptoms of the disease.
Danish: Disse neurotransmittere er aktive ved bipolar lidelse, og Sycrest medvirker derfor til at normalisere hjerneaktiviteten, så symptomerne på sygdommen mindskes.
English: What is the risk associated with Sycrest?
Danish: Hvilken risiko er der forbundet med Sycrest?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sycrest, 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 Sycrest, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Why has Sycrest been approved?
Danish: Hvorfor blev Sycrest godkendt?
English: The CHMP decided that Sycrest's benefits are greater than its risks and recommended that it be given marketing authorisation for the treatment of moderate to severe manic episodes in patients with bipolar disorder.
Danish: CHMP besluttede, at fordelene ved Sycrest opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Sycrest til behandling af moderate til svære maniske episoder hos patienter med bipolar lidelse.
English: In two of these studies, a total of 977 adult patients were given Sycrest, olanzapine (another antipsychotic medicine) or placebo (a dummy treatment) over three weeks.
Danish: I to af disse undersøgelser blev i alt 977 voksne patienter behandlet med Sycrest, olanzapin (et andet antipsykotisk lægemiddel), eller placebo (en virkningsløs behandling) i tre uger.
English: The CHMP, however, did not recommend that the medicine be authorised to treat schizophrenia because of the lack of effectiveness shown in this illness.
Danish: CHMP anbefalede imidlertid, at lægemidlet ikke godkendes til behandling af skizofreni, på grund af manglende dokumentation for virkning med hensyn til behandling af denne sygdom.
English: The studies included short- and long-term studies in patients receiving Sycrest, other medicines for schizophrenia (olanzapine, risperidone or haloperidol) or placebo.
Danish: Undersøgelserne omfattede kortvarige og langvarige undersøgelser hos patienter, der blev behandlet med Sycrest eller andre lægemidler for skizofreni (olanzapin, risperidon eller haloperidol) eller fik placebo.
English: What is Sycrest?
Danish: Hvad er Sycrest?
English: Sycrest was effective at treating manic episodes in patients with bipolar disorder.
Danish: Sycrest var effektivt til behandling af maniske episoder hos patienter med bipolar lidelse.
English: Four main studies looked at the use of Sycrest for manic episodes in bipolar disorder.
Danish: Fire hovedundersøgelser så nærmere på anvendelsen af Sycrest til behandling af maniske episoder ved bipolar lidelse.
English: In the first long-term study, a reduction in Y-MRS score of 12.9 was seen in patients taking Sycrest compared with 16.2 in patients taking olanzapine.
Danish: Den første langvarige undersøgelse viste en reduktion i Y-MRS-scoren på 12,9 point hos patienter, der tog Sycrest, sammenlignet med 16,2 point hos patienter, der tog olanzapin.
English: In the second long-term study, the reductions in Y-MRS score were 10.3 and 7.9 for Sycrest and placebo, respectively, after three weeks and 12.7 and 9.3 after 12 weeks.
Danish: Den anden langvarige undersøgelse viste en reduktion af Y-MRS-scoren på 10,3 og 7,9 point for henholdsvis Sycrest og placebo efter tre uger og 12,7 og 9,3 point efter 12 uger.
English: Sycrest is used to treat moderate to severe manic episodes (extremely high mood) in adults (aged 18 years or over) with bipolar disorder, a mental illness in which patients have periods of abnormally high mood alternating with periods of normal or depressed mood.
Danish: Sycrest anvendes til behandling af moderate til svære maniske episoder (ekstremt højt humør) hos voksne (18 år eller derover) med bipolar affektiv sindslidelse.
English: What is Sycrest used for?
Danish: Hvad anvendes Sycrest til?
English: What benefit has Sycrest shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Sycrest?
English: How has Sycrest been studied?
Danish: Hvordan blev Sycrest undersøgt?
English: The reductions for the second shortterm study were 10.8 and 12.6 points for Sycrest and olanzapine, respectively, and 5.5 for placebo.
Danish: Den anden kortvarige undersøgelse viste en reduktion på 10,8 og 12,6 point for henholdsvis Sycrest og olanzapin og 5,5 point for placebo.
English: In the first shortterm study, the reductions in Y-MRS score after three weeks were 11.5 and 14.6 points for Sycrest and olanzapine, respectively, compared with 7.8 points for placebo.
Danish: Den første kortvarige undersøgelse viste en reduktion af Y-MRS-scoren på 11,5 og 14,6 point efter tre uger for henholdsvis Sycrest og olanzapin sammenlignet med 7,8 point for placebo.
English: How is Sycrest used?
Danish: Hvordan anvendes Sycrest?
English: The other two studies lasted longer: one compared Sycrest with olanzapine over nine weeks in patients who had come from the short-term studies; and the other was a 12-week ‘add on' study, in which 326 patients who were already being treated with another medicine (lithium or valproic acid) were also given either Sycrest or placebo.
Danish: Den anden undersøgelse var en 12-ugers tillægsundersøgelse, hvor 326 patienter, som allerede fik behandling med et andet lægemiddel (lithium eller valproinsyre), også blev behandlet med enten Sycrest eller placebo.
English: How does Sycrest work?
Danish: Hvordan virker Sycrest?
English: - You do not take the medicine every day.
Danish: - Du skal ikke tage medicinen hver dag.
English: You may need medical treatment.
Danish: Det kan være nødvendigt med lægebehandling.
English: OS was not statistically significantly different between the two treatment groups.
Danish: Der var ikke statistisk signifikant forskel på OS mellem de to behandlingsgrupper.
English: Do not change the dose without talking to your doctor.
Danish: Du må ikke ændre din dosis uden at tale med din læge.
English: - Swallow the capsules whole with a glass of water.
Danish: - Kapslerne skal synkes hele sammen med et glas vand.
English: Complete response Near complete response Partial response
Danish: Fuldstændigt respons Næsten fuldstændigt respons
English: The remainders are metabolites.
Danish: Resten er metabolitter.
English: Number of patients at risk
Danish: Antal patienter i risiko
English: These could be signs of a low level of red blood cells.
Danish: Det kan være tegn på et lavt antal røde blodlegemer.
English: The educational programme is aimed to address the risk of medication error.
Danish: Uddannelsesprogrammet har til formål at adressere risikoen for medicineringsfejl.
English: Therefore, starting dose adjustments are not necessary.
Danish: Justeringer af startdosis er derfor ikke nødvendigt.
English: Your doctor will monitor your condition to see if the treatment is working.
Danish: Din læge vil holde øje med din tilstand, for at se om behandlingen virker.
English: Your doctor will discuss with you which is the best method for you to use.
Danish: Din læge vil drøfte med dig, hvilken metode der passer bedst til dig.
English: The days of the cycle are numbered on the blister.
Danish: Dagene i cyklus er nummererede på blisterpakningen.
English: Some side effects could be serious
Danish: Nogle bivirkninger kan være alvorlige.
English: 1 Hazard ratio obtained from stratified Cox model
Danish: 1 Hazard ratio opnået fra stratificeret Cox model
English: The patient information pack should contain:
Danish: Patient-informationspakken bør indeholde:
English: Tell your doctor about all the doses that you have missed during any 21-day cycle of treatment.
Danish: Fortæl din læge om alle de doser, du har glemt i løbet af den 21 dage lange behandlingscyklus.
English: The median OS was 17.5 months.
Danish: Median OS var 17,5 måneder.
English: - After Week 3 you start a new cycle again as shown in Tables 1 and 2 below.
Danish: - Efter uge 3 begynder du på en ny cyklus igen, som vist i tabel 1 og 2 nedenfor.
English: phenobarbital or phenytoin).
Danish: phenobarbital eller phenytoin).
English: - The medicine can be taken with or without food.
Danish: - Medicinen kan tages sammen med mad eller uden mad.
English: This includes patients:
Danish: Det omfatter patienter med:
English: The dose should not be reduced below 10 mg and the same treatment schedule (3-week treatment cycle) should be kept.
Danish: Dosis bør ikke nedsættes til under 10 mg, og den samme behandlingsplan (3-ugers behandlingscyklus) bør bibeholdes.
English: Overall response [95% CI]
Danish: Overordnet respons [95 % CI]
English: Neutropenia may require temporary or permanent dose reduction.
Danish: Neutropeni kan kræve midlertidig eller permanent dosisreduktion.
English: These patients had a median of 3 prior therapies.
Danish: Disse patienter havde en median på 3 tidligere behandlinger.
English: Patients should be treated initially for eight cycles.
Danish: Patienter bør til at begynde med behandles i otte cyklusser.
English: In the event of QT prolongation during treatment:
Danish: I tilfælde af QT-forlængelse under behandlingen:
English: - Do not take Farydak in Week 3.
Danish: - Du skal ikke tage Farydak i den tredje uge.
English: If you feel dizzy while taking this medicine, do not drive a vehicle or use any tools or machines.
Danish: Hvis du føler dig svimmel, mens du tager denne medicin, må du ikke køre bil, bruge værktøj eller betjene maskiner.
English: • uncontrolled shaking of the body
Danish: • ukontrollerede rystelser i kroppen
English: - Farydak is taken over 21 days (2 weeks on and 1 week off) - this is called a treatment cycle.
Danish: - Farydak tages over 21 dage (2 uger med og 1 uge uden) - det kaldes en behandlingscyklus.
English: o A table describing the treatment regimen for each day of the cycle with space for the patient to note what medication they took.
Danish: o En tabel, der beskriver behandlingsregimet for hver dag af cyklus med plads til at patienterne kan notere, hvilken medicin de tog.