FrancophonIA/ELRC3.0 huggingface dataset:
English: Kytril solution for injection is indicated in adults for the prevention and treatment of - acute nausea and vomiting associated with chemotherapy and radiotherapy.
Danish: Kytril injektionsvæske er indiceret hos voksne til forebyggelse og behandling af - akut kvalme og opkastning i forbindelse med kemoterapi eller strålebehandling - postoperativ kvalme og opkastning.
English: Each ml solution for injection contains 0.6 mg granisetron (as hydrochloride).
Danish: Hver ml injektionsvæske, opløsning indeholder 0,6 mg granisetron (som hydrochlorid).
English: infusion, diluted in 10-30 ml infusion fluid and administered over 5 minutes prior to the start of chemotherapy.
Danish: En dosis på 10-40 µg/kg legemsvægt (op til 3 mg) fortyndes med 10-30 ml infusionsvæske og administreres som intravenøs infusion over 5 minutter inden påbegyndelse af kemoterapi.
English: WHAT KYTRIL IS AND WHAT IT IS USED FOR Kytril contains a medicine called granisetron.
Danish: Kytril indeholder det aktive stof granisetron.
English: What Kytril looks like and contents of the pack Ampoules - [To be completed nationally]
Danish: 6.5 Emballagetype og pakningsstørrelser Blister - [Udfyldes nationalt]
English: The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be 1 mg.
Danish: Injektionen ind i blodåren vil tage mellem 30 sekunder og 5 minutter, og den sædvanlige dosis er 1 mg. Du vil højst få 3 mg Kytril om dagen.
English: Each ml solution for injection contains 3 mg granisetron (as hydrochloride).
Danish: Hver ml injektionsvæske, opløsning indeholder 3 mg granisetron (som hydrochlorid).
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Kytril til dig personligt.
English: Each ml solution for injection contains 1 mg granisetron (as hydrochloride).
Danish: Hver ml injektionsvæske, opløsning indeholder 1 mg granisetron (som hydrochlorid).
English: However, if you are worried talk to your doctor or nurse.
Danish: Tal med lægen eller sundhedspersonalet, hvis du er bekymret.
English: HOW TO STORE KYTRIL
Danish: Tyskland: Kevatril
English: Although QT-prolongation has been observed with 5-HT3 receptor antagonists (see section 4.4), this effect is of such occurrence and magnitude that it does not bear clinical significance in normal subjects.
Danish: På trods af at QT-forlængelse er blevet observeret med 5-HT3-receptorantagonister (se pkt.
English: Prevention of feeling or being sick
Danish: Forebyggelse af kvalme og opkastning
English: BEFORE YOU TAKE KYTRIL
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE KYTRIL
English: PACKAGE LEAFLET
Danish: Nedsat leverfunktion
English: Paediatrics
Danish: Dosering
English: If you think you have forgotten to take your medicine speak to your doctor or nurse.
Danish: Tal med lægen eller sundhedspersonalet, hvis du tror, at du har glemt at tage din medicin.
English: Therefore, the Committee considered that these effects need to be closely monitored and managed.
Danish: Udvalget fandt derfor, at disse virkninger bør overvåges tæt og kontrolleres.
English: The patient's disease should be confirmed by genetic testing whenever possible.
Danish: Patientens sygdom bør bekræftes ved genetisk testning, hvis dette er muligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lojuxta on 31 July 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Lojuxta den 31. juli 2013.
English: This is a summary of the European public assessment report (EPAR) for Lojuxta.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lojuxta.
English: However, the CHMP noted that the long-term benefit for the heart and circulatory system still needed to be confirmed.
Danish: CHMP bemærkede dog, at den langsigtede fordel for hjertet og kredsløbet stadig manglede at blive bekræftet.
English: It is available as capsules (5, 10, 20, 30, 40 and 60 mg) to be taken by mouth on an empty stomach, at least two hours after the evening meal.
Danish: Det leveres som kapsler (5, 10, 20, 30, 40 og 60 mg), der skal tages gennem munden på tom mave mindst to timer efter aftensmåltidet.
English: Treatment should begin at a dose of 5 mg once per day, and if well tolerated may be steadily increased to a maximum dose of 60 mg per day.
Danish: Behandlingen skal begynde med en dosis på 5 mg én gang dagligt; tåles denne dosis godt, sættes den op til højst 60 mg dagligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Lojuxta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Lojuxta er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This is because it has not been possible to obtain complete information about Lojuxta to date due to the rarity of the disease.
Danish: Det betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om Lojuxta, fordi sygdommen er sjælden.
English: Lojuxta has been authorised under ‘exceptional circumstances'.
Danish: Lojuxta er godkendt under "særlige omstændigheder".
English: Patients should avoid drinking grapefruit juice while taking Lojuxta.
Danish: Patienterne bør undgå at drikke grapefrugtjuice, mens de får Lojuxta.
English: Lojuxta was not compared with any other treatment.
Danish: Lojuxta blev ikke sammenlignet med nogen anden behandling.
English: Lojuxta must not be used in women who are pregnant.
Danish: Lojuxta må ikke anvendes hos gravide kvinder.
English: The study will also provide data on pregnancies in women taking the medicine, and on healthcare professionals' compliance with the recommendations to screen and monitor patients before and during treatment.
Danish: Undersøgelsen skal desuden give oplysninger om graviditeter hos kvinder, der tager lægemidlet, og om lægernes overholdelse af anbefalingerne om at screene og overvåge patienterne før og under behandlingen.
English: A risk management plan has been developed to ensure that Lojuxta is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Lojuxta anvendes så risikofrit som muligt.
English: Lojuxta lomitapide
Danish: Lojuxta lomitapid
English: Patients taking certain other medicines may also need to take a reduced dose or take Lojuxta and their other medication at different times.
Danish: Patienter, der får visse andre lægemidler, skal muligvis også have en lavere dosis eller tage Lojuxta og de andre lægemidler på forskellige tidspunkter.
English: The most common side effects are problems with the gut, which may affect as many as 9 out of 10 people: diarrhoea and nausea (feeling sick) were each seen in around 7 out of 10 people, dyspepsia (heartburn) and vomiting were each seen in more than 3 out of 10 people, while pain, discomfort and bloating of the abdomen (belly), constipation and flatulence were each seen in at least 2 out of 10 people.
Danish: De hyppigste bivirkninger er problemer med tarmen, som kan forekomme hos op til ni ud af ti patienter: diarré og kvalme sås hos ca. syv ud af ti patienter, dydpepsi (halsbrand) og opkastning sås begge hos mere end tre ud af ti patienter, mens smerter, ubehag og oppustethed i maven, forstoppelse og flatulens (luft i maven) alle forekom hos mindst 2 ud af 10 patienter.
English: On average, the patients' LDL cholesterol levels were reduced by 40%.
Danish: Patienternes indhold af LDLkolesterol faldt i gennemsnit med 40 %.
English: Treatment should be started and monitored by a doctor experienced in treating conditions involving high levels of fats in the blood.
Danish: Behandlingen skal indledes og overvåges af en læge med erfaring i behandling af sygdomme med højt fedtindhold i blodet.
English: Lojuxta is a medicine that contains the active substance lomitapide.
Danish: Lojuxta er et lægemiddel, der indeholder det aktive stof lomitapid.
English: What measures are being taken to ensure the safe and effective use of Lojuxta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lojuxta?
English: It must also not be used by patients with moderately or severely reduced liver function or with unexplained, abnormal liver test results, or by patients with significant or long-term bowel problems.
Danish: Det må heller ikke anvendes hos patienter med middelsvært eller svært nedsat leverfunktion, med abnorme leverprøver af ukendt årsag eller med betydelige eller langvarige tarmproblemer.
English: Other information about Lojuxta
Danish: Andre oplysninger om Lojuxta
English: Lojuxta must not be used together with over 40 mg per day of simvastatin (another medicine used to lower blood cholesterol levels) or with certain other medicines that affect the way lomitapide is broken down in the body.
Danish: Lojuxta må ikke anvendes sammen med mere end 40 mg simvastatin dagligt (et andet kolesterolsænkende lægemiddel) eller med visse andre lægemidler, der griber ind i nedbrydningen af lomitapid i kroppen.
English: Patients with moderately or severely reduced liver function must not take Lojuxta.
Danish: Patienter med moderat eller svært nedsat leverfunktion må ikke tage Lojuxta.
English: The Committee also noted that Lojuxta had side effects in the gut in most patients, which caused some patients to stop treatment, and that it led to increased liver enzyme levels whose long-term consequences are not known.
Danish: Udvalget konstaterede også, at Lojuxta medførte bivirkninger i tarmen hos de fleste patienter, og at dette fik nogle af patienterne til at stoppe med behandlingen, og at det medførte forhøjede leverenzymer, som man ikke kender de langsigtede følger af.
English: What is Lojuxta and what is it used for?
Danish: Hvad er Lojuxta, og hvad anvendes det til?
English: The benefits of Lojuxta in reducing blood cholesterol were assessed in a main study involving 29 patients with homozygous familial hypercholesterolaemia.
Danish: Fordelene ved Lojuxta til nedsættelse af blodets kolesterolindhold blev vurderet i én hovedundersøgelse med deltagelse af 29 patienter med homozygot familiær hyperkolesterolæmi.
English: Microsomal triglyceride transfer protein is involved in assembling fatty substances such as cholesterol and triglyceride into larger particles called lipoproteins, which are then released into the blood stream.
Danish: Mikrosomalt triglyceridtransportprotein medvirker til at samle fedtstoffer såsom kolesterol og triglycerider til større partikler, der kaldes lipoproteiner, som derefter frigives til blodbanen.
English: The most serious side effect seen in some patients treated with Lojuxta is abnormally raised liver enzyme levels.
Danish: De alvorligste bivirkninger, der ses hos nogle patienter ved behandling med Lojuxta, er unormalt forhøjede leverenzymer.
English: It is not intended to provide practical advice on how to use Lojuxta.
Danish: Det er ikke en praktisk vejledning i, hvordan Lojuxta bør anvendes.
English: It is used together with a low fat diet and other medicines to reduce the level of fats in the blood.
Danish: Det anvendes sammen med fedtfattig diæt og andre lægemidler til nedsættelse af fedtindholdet i blodet.
English: It is used to treat adult patients with homozygous familial hypercholesterolaemia, an inherited disease causing high blood levels of cholesterol (a type of fat).
Danish: Det anvendes til behandling af voksne patienter med homozygot familiær hyperkolesterolæmi, en arvelig sygdom, der medfører højt indhold i blodet af kolesterol (et fedtstof).
English: All patients were given Lojuxta together with other medicines for reducing the level of fats in the blood.
Danish: Alle patienterne fik Lojuxta sammen med andre lægemidler til nedsættelse af fedtindholdet i blodet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lojuxta, 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 Lojuxta, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Since Lojuxta has been approved under exceptional circumstances, the company that markets the medicine is carrying out a long-term study in patients taking Lojuxta to provide further data on its safety and effectiveness, including its side effects on the liver, stomach, gut, and cardiovascular system.
Danish: Da Lojuxta blev godkendt under særlige omstændigheder, udfører den virksomhed, der markedsfører lægemidlet, en langsigtet undersøgelse af dets sikkerhed og virkning, herunder dets virkninger på leveren, maven, tarmen og hjerte-karsystemet.
English: Why is Lojuxta approved?
Danish: Hvorfor blev Lojuxta godkendt?
English: The CHMP considered that the medicine's effect in reducing LDL cholesterol levels was a benefit for patients with homozygous familial hypercholesterolaemia, who have an unmet medical need.
Danish: CHMP fandt, at lægemidlets virkning i form af nedsættelse af indholdet af LDL-kolesterol var en fordel for patienter med homozygot familiær hyperkolesterolæmi, som har et uopfyldt behandlingsbehov.
English: The main measure of effectiveness was the change in the patients' blood levels of ‘low density lipoprotein' (LDL) cholesterol, commonly known as ‘bad cholesterol', after 26 weeks of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringen i blodets indhold af lavdensitetslipoprotein-kolesterol (LDLkolesterol), også kaldet "dårligt kolesterol", efter 26-ugers behandling.
English: What are the risks associated with Lojuxta?
Danish: Hvilke risici er der forbundet med Lojuxta?
English: For the full list of side effects, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger fremgår af indlægssedlen.
English: What information is still awaited for Lojuxta?
Danish: Hvilke oplysninger afventes der stadig for Lojuxta?
English: Lojuxta can only be obtained with a prescription.
Danish: Lojuxta udleveres kun efter recept.
English: It will also contain educational materials to be given to patients, including a brochure and an alert card.
Danish: Materialet skal derudover indeholde oplysningsmateriale bestående af en brochure og et advarselskort, der skal udleveres til patienterne.
English: For practical information about using Lojuxta, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Lojuxta, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The active substance in Lojuxta, lomitapide, blocks the action of a substance in the body called ‘microsomal triglyceride transfer protein', which is present in the cells of the liver and the gut.
Danish: Det aktive stof i Lojuxta, lomitapid, virker ved at blokere enzymer af typen mikrosomalt triglyceridtransportprotein, som findes i cellerne i leveren og tarmen.
English: Patients on kidney dialysis may need to take a reduced dose.
Danish: Patienter i nyredialyse skal muligvis have en lavere dosis.
English: How is Lojuxta used?
Danish: Hvordan anvendes Lojuxta?
English: The full EPAR for Lojuxta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Lojuxta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Hvis du ønsker yderligere oplysninger om behandling med Lojuxta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
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 Lojuxta skal anvendes.
English: By blocking this protein, Lojuxta decreases the level of fats released into the blood, thereby helping to reduce the level of cholesterol in hypercholesterolaemia.
Danish: Lojuxta blokerer dette enzym og nedsætter derved kolesterolindholdet ved hyperkolesterolæmi.
English: How does Lojuxta work?
Danish: Hvordan virker Lojuxta ?
English: What benefits of Lojuxta have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Lojuxta?
English: In addition, the company that markets Lojuxta will provide educational materials to all doctors expected to prescribe Lojuxta, containing information on how to select suitable patients as well as key safety information, including side effects, interactions with other medicines and use in women who could potentially have children.
Danish: Materialet skal indeholde oplysninger om hvordan de udvælger egnede patienter, og vigtige sikkerhedsoplysninger om bivirkninger, vekselvirkninger med andre lægemidler og anvendelse hos kvinder i den fødedygtige alder.
English: EU/2/09/102/001 GRIPOVAC 3 strains of inactivated
Danish: EU/2/09/102/001 GRIPOVAC 3 stammer af
English: EU Number Invented Name
Danish: EU-nummer Særnavn Styrke
English: Content Package size
Danish: Indhold Pakningsstørrelse
English: * Strains of inactivated Influenza A virus/swine/ Bakum/IDT1769/2003 (H3N2)
Danish: * Stammer af inaktiveret Influenza A virus/svin: Bakum/IDT1769/2003 (H3N2) ≥ 10,53 log2 GMNU1 1GMNU = Geometrisk gennemsnit af neutraliserende enheder induceret i marsvin efter to gange immunisering med 0,5 ml af denne vaccine
English: Suspension for injection
Danish: Injektionsvæsk
English: Strength
Danish: Svin
English: This is a summary of the European public assessment report (EPAR) for Natpar.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Natpar.
English: Other information about Natpar
Danish: Andre oplysninger om Natpar
English: The proportion of patients taking placebo (a dummy treatment) who achieved the same was 2.5% (1 out of 40 patients).
Danish: Den andel af de patienter, der fik virkningsløs medicin (placebo) og opnåede samme resultat, var 2,5 % (1 ud af 40 patienter).
English: The maximum daily dose is 100 micrograms.
Danish: Den maksimale daglige dosis er 100 µg.
English: Why is Natpar approved?
Danish: Hvorfor blev Natpar godkendt?
English: What measures are being taken to ensure the safe and effective use of Natpar?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Natpar?
English: What is Natpar and what is it used for?
Danish: Hvad er Natpar, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Natpar.
Danish: Det er ikke en praktisk vejledning i, hvordan Natpar bør anvendes.
English: What are the risks associated with Natpar?
Danish: Hvilke risici er der forbundet med Natpar?
English: Because the number of patients with hypoparathyroidism is low, the disease is considered ‘rare', and Natpar was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2013.
Danish: Da antallet af patienter med hypoparatyroidisme er lavt, betragtes sygdommen som "sjælden", og Natpar blev udpeget som "lægemiddel til sjældne sygdomme" den 18. december 2013.
English: Regarding safety, the risk of calcium levels becoming too high or too low is considered important and further data are needed to better understand the consequences of wide fluctuations in blood calcium level after the medicine is given once a day.
Danish: Hvad angår sikkerheden, anses risikoen for forhøjet eller nedsat calciumindhold for vigtig, og der behøves yderligere data for at give bedre indsigt i følgerne af store svingninger i blodets calciumindhold, når lægemidlet gives én gang om dagen.
English: What information is still awaited for Natpar?
Danish: Hvilke oplysninger afventes der stadig for Natpar?
English: The full EPAR for Natpar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Natpar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Therefore, Natpar should only be used in patients who are not adequately controlled with standard treatments alone, who do not have other treatment options.
Danish: Natpar bør derfor kun bruges hos patienter, der ikke er tilfredsstillende reguleret med sædvanlige behandlinger alene, og som ikke har andre behandlingsmuligheder.
English: As a result, patients have low levels of calcium which can cause problems in bones, muscles, heart, kidneys and other parts of the body.
Danish: Som følge heraf har patienterne for lavt indhold af calcium, hvilket kan medføre problemer i knogler, muskler, hjerte, nyrer og andre dele af kroppen.
English: In a main 24-week study involving 124 patients, 54.8% (46 out of 84) of the patients who received Natpar achieved and maintained acceptable blood calcium levels while reducing their doses of calcium and vitamin D supplements by at least 50%.
Danish: I en 24-ugers hovedundersøgelse med 124 patienter opnåede 54,8 % (46 ud af 84) af de patienter, der fik Natpar, et vedvarende acceptabelt indhold af calcium i blodet, og de kunne nedsætte deres tilskud af calcium- og vitamin D med mindst 50 %.
English: Patients can inject Natpar themselves once they have been trained.
Danish: Patienten kan godt selv indsprøjte Natpar efter forudgående oplæring.
English: The usual recommended starting dose is 50 micrograms once a day.
Danish: Startdosis er normalt 50 µg én gang dagligt.
English: The company that markets Natpar will set-up a registry and collect long-term data on patients treated with Natpar, including its effects on bones, kidneys and patients' quality of life.
Danish: Virksomheden, der markedsfører Natpar, skal oprette et register og indsamle langsigtede data om patienter, der behandles med Natpar, herunder dets virkning på knoglerne, nyrerne og patienternes livskvalitet.
English: Because of the limited data available, Natpar has been given ‘conditional approval'.
Danish: Natpar har fået en "betinget godkendelse".
English: Natpar parathyroid hormone
Danish: Natpar parathyroideahormon
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Natpar 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 om Natpar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The most common side effects with Natpar (which may affect more than 1 in 10 people) are too high or too low blood calcium levels, which can lead to headache, diarrhoea, vomiting, paraesthesia (unusual sensations like pins and needles), hypoaesthesia (reduced sense of touch) and high calcium levels in the urine.
Danish: De hyppigste bivirkninger ved Natpar (som optræder hos mere end 1 ud af 10 personer) er for højt eller for lavt calciumindhold i blodet, som kan medføre hovedpine, diarré, opkastning, usædvanlige sanseindtryk som stikken og prikken (paræstesi), nedsat følesans (hypæstesi), og for højt calciumindhold i urinen.
English: Natpar is available as a powder and a liquid that are mixed together to make a solution for injection.
Danish: Natpar fås som et pulver og en væske, der blandes sammen til en injektionsvæske.
English: While the main study showed that Natpar helps control blood calcium levels while reducing the need for calcium and vitamin D supplements, the study was of short duration and there was no evidence of improvements in patients' quality of life or reductions in long-term problems such as kidney impairment.
Danish: Hovedundersøgelsen viste, at Natpar medvirker til at regulere blodets indhold af calcium og nedsætter behovet for tilskud af calcium og vitamin D, men undersøgelsen var kortvarig, og der var ingen tegn på bedring i patienternes livskvalitet eller mindskelse af langvarige problemer såsom nedsat nyrefunktion.