FrancophonIA/ELRC3.0 huggingface dataset:
English: In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.7 years (median
Danish: I PPE-populationen blev der ikke set tilfælde af HPV-sygdom (HPV-typer 6/11/16/18-relateret CIN alle grader og kondylomer) gennem 10,7 år (median opfølgning
English: The efficacy of Silgard against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 41.6%
Danish: Effekten af Silgard imod den kombinerede forekomst af HPV 16- eller 18-relateret persisterende infektion, kondylomer, vulva- og vaginallæsioner, alle grader af CIN, AIS og cervixcancere var 41,6
English: Suspension for injection in a pre-filled syringe.
Danish: Injektionsvæske, suspension i fyldt sprøjte.
English: 10 single doses, 0.5 ml pre-filled syringes without needles.
Danish: 10 enkeltdoser på 0,5 ml i fyldte sprøjter uden kanyler.
English: 20 single doses, 0.5 ml pre-filled syringes without needles.
Danish: 20 enkeltdoser på 0,5 ml i fyldte sprøjter uden kanyler.
English: Silgard, suspension for injection in a pre-filled syringe.
Danish: Silgard, injektionsvæske, suspension i fyldt sprøjte.
English: Posology
Danish: Κύπρος
English: 1 dose, 0.5 ml pre-filled syringe with 1 needle.
Danish: 1 dosis på 0,5 ml i fyldt sprøjte med 1 kanyle.
English: In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by
Danish: I kliniske studier blev den beskyttelse, som opnåedes med Silgard, ikke nedsat af præventionsmidler i tabletform (f.eks. p-piller) eller andre svangerskabsforebyggende midler.
English: • Second injection: 2 months after first injection
Danish: Alternativt kan Silgard gives efter et program med 3 doser: - Første injektion: på den valgte dato - Anden injektion: 2 måneder efter første injektion - Tredje injektion: 6 måneder efter første injektion
English: • Third injection: 6 months after first injection The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose.
Danish: Silgard bør gives efter et program med 3 doser: - Første injektion: på den valgte dato - Anden injektion: 2 måneder efter første injektion - Tredje injektion: 6 måneder efter første injektion Den anden dosis bør gives mindst en måned efter den første dosis, og tredje dosis bør gives mindst 3 måneder efter den anden dosis.
English: Silgard, suspension for injection in a pre-filled syringe:
Danish: Silgard, injektionsvæske, suspension i fyldt injektionssprøjte:
English: • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Danish: • effekten af Silgard imod HPV 6-, 11-, 16-, 18-relaterede kondylomer 99,0 % (95 % CI: 96,2;
English: Silgard, suspension for injection - pre-filled syringe without needle, pack of 1, 10, 20
Danish: Silgard, injektionsvæske, suspension- fyldt sprøjte uden kanyle, pakning med 1, 10, 20
English: Therefore appropriate precautions against sexually transmitted disease should continue to be used.
Danish: Derfor skal relevant beskyttelse mod seksuelt
English: 10 single doses, 0.5 ml pre-filled syringes with 1 needle each.
Danish: 10 enkeltdoser på 0,5 ml i fyldte sprøjter med 1 kanyle til hver.
English: 20 single doses, 0.5 ml pre-filled syringes with 1 needle each.
Danish: 20 enkeltdoser på 0,5 ml i fyldte sprøjter med 1 kanyle til hver.
English: 1 dose, 0.5 ml pre-filled syringe without needle.
Danish: 1 dosis på 0,5 ml i fyldt sprøjte uden kanyle.
English: Silgard, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Danish: Silgard, injetionsvæske, suspension- fyldt sprøjte med to kanyler, pakning med 1, 10, 20
English: 1 dose, 0.5 ml pre-filled syringe with 2 needles.
Danish: 1 dosis på 0,5 ml i fyldt sprøjte med 2 kanyler.
English: 20 single doses, 0.5 ml pre-filled syringes with 2 needles each.
Danish: 20 enkeltdoser på 0,5 ml i fyldte sprøjter med 2 kanyler til hver.
English: 10 single doses, 0.5 ml pre-filled syringes with 2 needles each.
Danish: 10 enkeltdoser på 0,5 ml i fyldte sprøjter med 2 kanyler til hver.
English: Please speak to your doctor for more information.
Danish: Spørg lægen eller apotekspersonalet, hvis der er mere du vil vide.
English: At end of study and in the combined protocols, • the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9 % (95% CI: 91.4,
Danish: • effekten af Silgard imod HPV 6-, 11-, 16-, 18-relateret CIN 1 95,9 % (95 % CI: 91,4; 98,4),
English: Silgard, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Danish: Silgard, injektionsvæske, suspension- fyldt sprøjte med én kanyle, pakning med 1, 10, 20
English: In the Full Analysis Set (FAS) population, the benefit of the vaccine with respect to the overall incidence of EGL was lower, with a reduction of 59.3% (95% CI: 40.0, 72.9), as Silgard does not impact the course of infections or disease that are present at vaccination onset.
Danish: Eftersom Silgard ikke påvirker forløbet af infektioner eller sygdom, som er til stede ved vaccinationens påbegyndelse, var fordelen ved vaccinen for så vidt angår den overordnede forekomst af EGL lavere i fuldt analysesæt (full analysis set FAS)-populationen med en reduktion på 59,3 %
English: Silgard, suspension for injection - single dose vial, pack of 1, 10, 20
Danish: Silgard, injektionsvæske, suspension - hætteglas med én dosis, pakning med 1, 10, 20 stk.
English: In the clinical study in men 16 to 26 years, 98.9%, 99.2%, 98.8%, and 97.4% of individuals who received Silgard became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
Danish: I det kliniske studie af mænd mellem 16 til 26 år blev i alt 98,9 %, 99,2 %, 98,8 % og 97,4 % af de personer, der fik Silgard, anti-HPV 6-, anti
English: PHARMACEUTICAL PARTICULARS
Danish: 5.2 Farmakokinetiske egenskaber
English: Side effects that have been reported during marketed use include:
Danish: Der er set bivirkninger efter markedsføring.
English: The efficacy of Silgard in 16- through 26-year-old women was assessed in 4 placebo-controlled, double-blind, randomised Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Danish: Silgards effekt hos kvinder i alderen fra 16 til 26 år blev vurderet i 4 placebo-kontrollerede, dobbeltblindede, randomiserede kliniske fase II og III studier.
English: The name of the medicine was changed to Trevicta on 26 May 2016.
Danish: Lægemidlets navn blev ændret til Trevicta den 26. maj 2016.
English: This authorisation was based on the authorisation granted to Xeplion in 2011 (‘informed consent').
Danish: Denne tilladelse byggede på den tilladelse, som blev udstedt for Xeplion i 2011 ("informeret samtykke").
English: This is a summary of the European public assessment report (EPAR) for Trevicta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Trevicta.
English: The full EPAR and risk management plan summary for Trevicta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Trevicta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This gives the medicine a long duration of action.
Danish: Dette gør, at virkningen af lægemidlet holder sig længe.
English: Two studies have been conducted with Trevicta given every 3 months.
Danish: Der er udført to undersøgelser med Trevicta, indgivet hver tredje måned.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Paliperidone Janssen on 5 December 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Paliperidone Janssen den 5. december 2014.
English: Other information about Trevicta
Danish: Andre oplysninger om Trevicta
English: A risk management plan has been developed to ensure that Trevicta is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Trevicta anvendes så sikkert som muligt.
English: 1 Previously known as Paliperidone Janssen.
Danish: 1 Tidligere kendt som Paliperidone Janssen.
English: Trevicta is available as a prolonged-release suspension for injection in pre-filled syringes (175 mg, 263 mg, 350 mg and 525 mg).
Danish: Trevicta leveres som depotinjektionsvæske, suspension, i fyldte sprøjter (175 mg, 263 mg, 350 mg og 525 mg).
English: The Committee therefore decided that Trevicta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget afgjorde derfor, at fordelene ved Trevicta overstiger risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Trevicta.
English: Trevicta is given by a healthcare professional.
Danish: Trevicta gives af en sundhedsperson.
English: What measures are being taken to ensure the safe and effective use of Trevicta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trevicta?
English: Why is Trevicta approved?
Danish: Hvorfor blev Trevicta godkendt?
English: What is Trevicta and what is it used for?
Danish: Hvad er Trevicta, og hvad anvendes det til?
English: By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms of the disease.
Danish: Ved at blokere disse receptorer medvirker paliperidon til at normalisere hjernens aktivitet og mindske symptomerne.
English: It is not intended to provide practical advice on how to use Trevicta.
Danish: Det er ikke en praktisk vejledning i, hvordan Trevicta bør anvendes.
English: In the brain, paliperidone attaches to several different receptors on the surface of nerve cells.
Danish: I hjernen bindes paliperidon til flere forskellige typer receptorer på overfladen af nervecellerne.
English: Trevicta paliperidone
Danish: paliperidon
English: What are the risks associated with Trevicta?
Danish: Hvilke risici er der forbundet med Trevicta?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Trevicta, 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 Trevicta, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that paliperidone injections are effective in treating schizophrenia symptoms.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) bemærkede, at indsprøjtninger af paliperidon er effektivt til behandling af symptomerne på skizofreni.
English: The active substance in this medicine, paliperidone, is an antipsychotic medicine.
Danish: Det aktive stof i dette lægemiddel, paliperidon, er et antipsykotisk lægemiddel.
English: The most common side effects with Trevicta (seen in at least 5 in 100 patients) are insomnia (difficulty sleeping), headache, anxiety, upper respiratory tract infections (such as colds), reactions at the site of injection and increased weight.
Danish: De hyppigste bivirkninger ved Trevicta (som optræder hos mindst 5 ud af 100 patienter) er søvnbesvær (insomni), hovedpine, angst, øvre luftvejsinfektioner (såsom forkølelse), reaktioner på indsprøjtningsstedet og vægtøgning.
English: In the second study (in 305 patients) Trevicta was more effective than placebo (a dummy treatment), with 9% of patients given the medicine suffering a relapse of their condition compared with 29% of those on placebo.
Danish: I den anden undersøgelse (hos 305 patienter) var Trevicta mere effektivt end virkningsløs behandling (placebo), idet tilbagefald af sygdommen forekom hos 9 % af de patienter, der fik lægemidlet, sammenholdt med 29 % af dem, der fik placebo.
English: Trevicta contains the active substance paliperidone.
Danish: Trevicta indeholder det aktive stof paliperidon.
English: It is given every 3 months by slow injection into the upper part of the shoulder (deltoid muscle) or the buttocks.
Danish: Det gives hver tredje måned ved langsom indsprøjtning øverst i skulderen (i deltamusklen) eller i balderne.
English: Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Danish: Paliperidon virker hovedsagelig på receptorerne for neurotransmitterne dopamin og serotonin (5-hydroxytryptamin).
English: The 3-monthly injection is expected to be more convenient to patients and improve their adherence to treatment, and no new safety concerns were raised with this formulation compared with the known safety profile of paliperidone.
Danish: Indsprøjtning hver tredje måned forventes at være mere bekvemt for patienterne og give bedre overholdelse af behandlingen, og der blev med denne formulering ikke rejst nye sikkerhedsproblemer i forhold til sikkerhedsprofilen af paliperidon.
English: The dose of Trevicta is 3.5 times the dose of the monthly injections of paliperidone the patient was previously receiving.
Danish: Dosis af Trevicta er 3,5 gange dosis ved de månedlige indsprøjtninger af paliperidon, som patienten tidligere fik.
English: The symptoms of schizophrenia include disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Danish: Symptomerne ved skizofreni er bl.a. tanke- og taleforstyrrelser, sansebedrag (hallucinationer), mistænksomhed og vrangforestillinger.
English: Because paliperidone for use by monthly injections has already been authorised in the EU as Xeplion, the company also used data from Xeplion to support the use of Trevicta.
Danish: Da paliperidon til indsprøjtning én gang om måneden allerede har været godkendt i EU under navnet Xeplion, brugte virksomheden nogle af oplysningerne fra Xeplion som dokumentation for anvendelsen af Trevicta.
English: Trevicta must not be given to people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.
Danish: Trevicta må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for paliperidon eller andre af indholdsstofferne eller over for risperidon.
English: Prolonged-release means that the active substance, paliperidone, is released slowly over a few months after being injected.
Danish: At det er et depotpræparat, betyder, at det aktive stof, paliperidon, frigives langsomt i løbet af flere måneder efter injektionen.
English: In Trevicta as in Xeplion, paliperidone has been attached to a fatty acid that allows it to be released slowly after being injected.
Danish: Både i Trevicta og i Xeplion er paliperidon koblet til en fedtsyre, hvilket gør, at det frigives langsomt efter at være injiceret.
English: For the full list of all side effects reported with Trevicta, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Trevicta fremgår af indlægssedlen.
English: For more information about treatment with Trevicta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Trevicta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Trevicta, which is given by injection every 3 months, is more effective than placebo and as effective as paliperidone monthly injection in preventing relapses of schizophrenia.
Danish: Trevicta, givet ved indsprøjtning hver 3. måned, er mere effektivt end placebo og lige så effektivt som paliperidon, givet ved indsprøjtning en gang om måneden, til at forhindre tilbagefald af skizofreni.
English: In one of them (involving 1,016 patients) Trevicta was as effective as paliperidone monthly injections in preventing relapses of schizophrenia.
Danish: I den ene (med 1 016 patienter) var Trevicta lige så effektivt som en indsprøjtning af paliperidon én gang om måneden til at forhindre tilbagefald af skizofreni.
English: It has also been authorised as Xeplion since 2011 for use by monthly injections for the maintenance treatment of schizophrenia.
Danish: Det har desuden siden 2011 været godkendt under navnet Xeplion til brug ved indsprøjtning én gang om måneden til vedligeholdelsesbehandling af skizofreni.
English: Paliperidone has been authorised in the European Union (EU) as Invega since 2007 for use by mouth to treat schizophrenia.
Danish: Paliperidon har siden 2007 under navnet Invega været godkendt i EU til indgift gennem munden til behandling af skizofreni.
English: For more information on the use of Trevicta, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Trevicta fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: For practical information about using Trevicta, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Trevicta, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', substances that nerve cells use to communicate with neighbouring cells.
Danish: Derved afbrydes de signaler, som hjernecellerne sender til naboceller ved hjælp af signalstoffer (neurotransmittere).
English: What benefits of Trevicta have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Trevicta?
English: How is Trevicta used?
Danish: Hvordan anvendes Trevicta?
English: Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Danish: Risperidon er et andet antipsykotisk middel, der var været anvendt til behandling af skizofreni siden 1990'erne.
English: Trevicta is an antipsychotic medicine used for the maintenance treatment of schizophrenia in adults whose disease has been stable on treatment with once-monthly injections of paliperidone.
Danish: Det anvendes til vedligeholdelsesbehandling af skizofreni hos voksne, hos hvem sygdommen i forvejen har været stabil ved behandling med indsprøjtning af paliperidon én gang om måneden.
English: How does Trevicta work?
Danish: Hvordan virker Trevicta?
English: Results will be provided on a yearly basis.
Danish: Resultaterne vil blive leveret på årsbasis.
English: Overall survival (OS) was the key secondary endpoint.
Danish: Samlet overlevelse (OS) var det vigtigste sekundære endepunkt.
English: Probability of survival (%)
Danish: Sandsynlighed for overlevelse (%)
English: Do not take more than this dose.
Danish: Du må ikke tage mere end denne dosis.
English: AND/OR
Danish: OG/ELLER
English: Component of a multipack, cannot be sold separately.
Danish: Del af multipakning, kan ikke sælges separat.
English: In the overall population, 72.7 % of the patients were male.
Danish: I den samlede population var 72,7 % af patienterne mænd.
English: Data from black individuals was very limited but in the same range as for Caucasians.
Danish: Data fra sorte individer var meget begrænsede, men i samme størrelsesorden som for kaukasiere.
English: No. of patients at risk
Danish: Antal patienter i risiko
English: This medicine has not been studied in children or adolescents and is therefore not to be taken by children and adolescents below the age of 18 years.
Danish: Dette lægemiddel er ikke undersøgt hos børn og unge og må derfor ikke tages af børn og unge under 18 år.
English: This medicine can interact with certain other medicines.
Danish: Dette lægemiddel kan vekselvirke med visse andre lægemidler.
English: Safety data for Black and African American patients are limited.
Danish: Der foreligger begrænsede sikkerhedsdata for sorte og afroamerikanske patienter.
English: The following side effects were observed under treatment with this medicine:
Danish: Følgende bivirkninger er observeret under behandling med dette lægemiddel:
English: Submission of final study report of the single-arm study: Q4 2020
Danish: Indsendelse af afsluttet studie rapport for enkelt-arm studie: Q4 2020
English: Number of Deaths or Progressions, n (%) Median PFS [months]
Danish: Antal dødsfald eller progressioner, n (%) Median PFS [måneder]
English: A risk to the breast-fed child cannot be excluded.
Danish: En risiko for det ammende barn kan ikke udelukkes.
English: The majority of these events were reported for patients in the IPF indication.
Danish: Størstedelen af disse hændelser blev rapporteret for patienter med IPF-indikationen.
English: You should not drive or use machines if you feel sick.
Danish: Du bør ikke føre motorkøretøj eller betjene maskiner, hvis du har det dårligt.
English: Therefore close monitoring is recommended in patients weighing < 50 kg.
Danish: Derfor anbefales tæt kontrol af patienter der vejer < 50 kg.
English: These changes are known from other VEGFR-2 inhibitors and can be considered class effects.
Danish: Disse forandringer kendes fra andre VEGFR-2hæmmere og kan anses for at være klasseeffekter.
English: Based on this information your doctor may carry out some blood tests, for example to check your liver function and to determine how fast your blood can clot.
Danish: Ud fra disse oplysninger tager din læge måske nogle blodprøver, f.eks. for at kontrollere din leverfunktion og for at måle, hvor hurtigt dit blod størkner.
English: DCE-MRI effects were seen 24 - 48 h after the first intake of the medicinal product and were preserved or even increased after continuous treatment over several weeks.
Danish: DCE-MRI-virkninger sås 24-48 timer efter den første indtagelse af lægemidlet og blev opretholdt eller sågar øget efter kontinuerlig behandling over flere uger.
English: PK-efficacy analyses were not performed for clinical endpoints.
Danish: PK-effektanalyser blev ikke udført for kliniske endepunkter.
English: Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken.
Danish: Brug ikke lægemidlet, hvis du bemærker, at blisteren, som indeholder kapslerne, er åbnet, eller at en kapsel er i stykker.
English: The overall recovery was considered complete (above 90 %) within 4 days after dosing.
Danish: Den samlede genfinding ansås for at være fuldstændig (over 90 %) inden for 4 dage efter dosering.
English: The recommended maximum daily dose of 400 mg should not be exceeded.
Danish: Den anbefalede højeste daglige dosis på 400 mg må ikke overskrides.
English: However, such patients should be closely monitored for signs and symptoms of cerebral bleeding.
Danish: Sådanne patienter skal dog kontrolleres tæt for tegn og symptomer på cerebral blødning.
English: Your doctor will decide when to resume your treatment with this medicine
Danish: Din læge afgør, hvornår din behandling med dette lægemiddel skal genoptages.
English: Do not reduce the dose or stop the treatment yourself without consulting your doctor first.
Danish: Du må ikke selv nedsætte dosis eller stoppe behandlingen uden først at tale med din læge.
English: If you do not take this medicine as prescribed by your doctor, this cancer treatment may not work properly.
Danish: Hvis du ikke tager dette lægemiddel efter lægens anvisninger, kan det være, at denne kræftbehandling ikke virker efter hensigten.
English: The major CYP-dependent metabolite could not be detected in plasma in the human ADME study.
Danish: Den vigtigste CYP-afhængige metabolit kunne ikke måles i plasma i ADME-studiet på mennesker.
English: Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects.
Danish: Du må ikke tage dette lægemiddel under graviditeten, da det kan skade det ufødte barn og forårsage misdannelser.