FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the Committee adopted by majority a positive opinion on 6 March 2013 recommending the granting of a marketing authorisation for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names.
Danish: Den 6. marts 2013 vedtog udvalget derfor en positiv udtalelse og anbefalede udstedelse af markedsføringstilladelse for Florgane, injektionsvæske, 300 mg/ml, til kvæg og svin, og relaterede navne.
English: This application is an extension to add pigs as a target species to the existing 300 mg florfenicol/ml suspension for injection product authorised for use in cattle.
Danish: Ansøgningen vedrører en udvidelse gennem tilføjelse af måldyrearten svin for det eksisterende produkt, florfenicol injektionsvæske, suspension 300 mg/ml, der er godkendt til anvendelse hos kvæg.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Florgane 300 mg/ml suspension for injection for cattle and pigs is positive.
Danish: Efter vurdering af de foreliggende data fandt CVMP, at benefit/risk-forholdet for Florgane, injektionsvæske, suspension, 300 mg/ml, til kvæg og svin, er positivt.
English: Opinion following an Article 33(4)1 referral for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names
Danish: Udtalelse efter en indbringelse i henhold til artikel 33, stk. 41 for Florgane, injektionsvæske, suspension, til kvæg og svin, og relaterede navne
English: It is available as tablets (300 mg/150 mg/300 mg).
Danish: Det leveres som tabletter (300 mg/150 mg/300 mg).
English: This document is a summary of the European Public Assessment Report (EPAR) for Trizivir.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Trizivir.
English: The European Commission granted a marketing authorisation valid throughout the EU for Trizivir on 28 December 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Trizivir den 28. december 2000.
English: The recommended dose of Trizivir is one tablet twice a day.
Danish: Den anbefalede dosis Trizivir er én tablet to gange dagligt.
English: The full EPAR for Trizivir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Trizivir findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Trizivir reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Trizivir mindsker mængden af hiv i blodet og holder den på et lavt niveau.
English: No specific clinical studies have been carried out to assess the safety and effectiveness of the combined tablet.
Danish: Der er ikke udført specifikke, kliniske undersøgelser for at vurdere sikkerheden og virkningen af kombinationstabletten.
English: Patients should have been taking the three active substances separately for at least six to eight weeks before switching to Trizivir.
Danish: Patienter skal have taget disse tre aktive stoffer hver for sig i mindst seks til otte uger, før de skifter til Trizivir.
English: The CHMP noted that the reduction in the number of tablets that patients need to take may help patients stick to their treatment.
Danish: CHMP bemærkede, at det mindre antal tabletter, som patienterne skal tage, kan hjælpe dem med at overholde behandlingen.
English: Other information about Trizivir:
Danish: Andre oplysninger om Trizivir:
English: A risk management plan has been developed to ensure that Trizivir is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ziagen anvendes så sikkert som muligt.
English: Hypersensitivity reactions (allergic reactions) occur in patients taking Trizivir, usually within the first six weeks of treatment, and can be life-threatening.
Danish: Overfølsomhedsreaktioner (allergiske reaktioner) opstår hos ca. 3 % af patienter, der tager Trizivir, normalt inden for de første seks uger af behandlingen, og de kan være livstruende.
English: The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate tablets.
Danish: Virksomheden undersøgte desuden, hvordan den kombinerede tablet blev optaget i kroppen i forhold til de separate tabletter.
English: In patients with high levels of HIV in the blood (above 100,000 copies/ml), the choice of treatment requires special consideration.
Danish: Hos patienter med et højt indhold af hiv i blodet (over 100 000 kopier/ml) vælges behandlingsformen efter nøje overvejelse.
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 Trizivir.
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 anvendelsesbetingelserne for Trizivir.
English: All three active substances have been available in the European Union (EU) for a number of years: abacavir has been authorised as Ziagen since 1999, lamivudine has been authorised as Epivir since 1996, and zidovudine has been available in the EU since the mid-1980s.
Danish: De tre aktive stoffer har alle været tilgængelige i Den Europæiske Union (EU) i en række år.Abacavir har været godkendt under navnet Ziagen siden 1999 og lamivudin under navnet Epivir siden 1996, og zidovudin har kunnet fås i EU siden midten af 1980'erne.
English: Patients will also receive an alert card summarising key safety information on hypersensitivity reactions with this medicine.
Danish: Patienterne vil ligeledes modtage et patientinformationskort med de vigtigste oplysninger om sikkerhed vedrørende overfølsomhedsreaktioner i forbindelse med dette lægemiddel.
English: Trizivir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Trizivir helbreder hverken hivinfektion eller aids, men kan forsinke skaderne på immunsystemet og udviklingen af de infektioner og sygdomme, der er forbundet med aids.
English: The Committee decided that Trizivir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget fandt, at fordelene ved Trizivir opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Overall, since certain other combination treatments could be more effective, the use of Trizivir should only be considered under special circumstances such as co-infection with tuberculosis (as other HIV treatments can interact with the medicines being taken by the patient).
Danish: Da andre kombinationsbehandlinger kan være mere effektive, bør Trizivir generelt kun anvendes under særlige omstændigheder som f.eks. samtidig infektion med tuberkulose (da andre hiv-behandlinger kan interagere med de lægemidler, patienten tager).
English: For more information about treatment with Trizivir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Trizivir, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The risk of hypersensitivity is higher in patients who have the HLA-B (type 5701) gene.
Danish: Risikoen for overfølsomhed er højere hos patienter, der har HLA-B-genet (type 5701).
English: In addition, the company that markets Trizivir provides educational materials for doctors about hypersensitivity reactions with the medicine, including the need to test patients for the HLA-B (type 5701) gene and to remind patients to contact their doctor immediately if they develop symptoms suggestive of hypersensitivity.
Danish: Virksomheden, der markedsfører Ziagen, udleverer desuden informationsmateriale til læger vedrørende overfølsomhedsreaktioner med lægemidlet, herunder at det er nødvendigt at teste patienter for HLA-B (type 5701)-genet og at minde patienterne om, at de skal kontakte deres læge omgående, hvis de udvikler symptomer, der tyder på overfølsomhed.
English: The most common effects with Trizivir (seen in more than 1 patient in 10) are headache and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Trizivir (som ses hos flere end 1 ud af 10 patienter) er hovedpine og kvalme.
English: Before starting treatment with abacavir, all patients should have a test to find out if they have a gene called ‘HLA-B (type 5701)'.
Danish: Inden behandlingen med abacavir indledes, skal alle patienter undersøges for, om de har et bestemt gen kaldet "HLA-B (type 5701)".
English: Because it contains zidovudine, Trizivir must not be used by patients with low neutrophil counts (low levels of a type of white blood cell) or anaemia (low red blood cell counts).
Danish: Da Trizivir indeholder zidovudin, bør det ikke anvendes til patienter med et lavt neutrofiltal (lavt indhold af en type hvide blodlegemer) eller anæmi (lavt antal røde blodlegemer).
English: They all work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Danish: De virker alle ved at blokere reverse transcriptase, et enzym, der produceres af hiv og gør det muligt for virusset at inficere celler og producere flere vira.
English: Patients with this gene are at an increased risk of having an allergic reaction to abacavir so they should not take Trizivir.
Danish: Patienter med dette gen har øget risiko for overfølsomhed over for abacavir og skal derfor ikke have Trizivir.
English: Treatment with Trizivir should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandlingen med Trizivir bør indledes af en læge med erfaring i behandling af hivinfektion.
English: Before prescribing Trizivir, doctors should consider the expected improved ability of the patient to stick to their treatment, the expected effectiveness of the medicine, and the risks associated with the active substances.
Danish: Inden Trizivir ordineres, bør lægen overveje patientens muligheder for bedre at følge behandlingen, lægemidlets forventede virkning samt de risici, der er forbundet med de aktive stoffer.
English: The company presented the results of studies with abacavir, lamivudine and zidovudine taken together, which were carried out during the development of Ziagen.
Danish: Virksomheden fremlagde resultaterne af undersøgelser med abacavir, lamivudin og zidovudin taget sammen, som blev gennemført ved udviklingen af Ziagen.
English: What measures are being taken to ensure the safe and effective use of Trizivir?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ziagen?
English: It also noted that the benefit of Trizivir has mainly been shown in patients who have had little or no previous HIV treatment and who do not have advanced disease.
Danish: Det skal også bemærkes, at fordelene ved Trizivir hovedsageligt blev set hos patienter, der tidligere havde fået begrænset eller slet ingen hivbehandling, og hvis sygdom ikke var fremskreden.
English: If patients need to stop taking abacavir, lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing abacavir, lamivudine or zidovudine separately.
Danish: Hvis patienterne har behov for at afbryde behandlingen med abacavir, lamivudin eller zidovudin eller har behov for andre doser på grund af problemer med nyrer, lever eller blod, skal de anvende lægemidler, der indeholder abacavir, lamivudin eller zidovudin hver for sig.
English: Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain (stomach ache), headache, signs of liver damage in the blood, myalgia (muscle pain), dyspnoea (difficulty breathing), cough, lethargy
Danish: Symptomerne omfatter næsten altid feber eller udslæt, men tit også kvalme, opkastninger, diarré, mavesmerter, hovedpine, tegn på leverskader i blodet, myalgi (muskelsmerter), dyspnø (vejrtrækningsproblemer), hoste, letargi (mangel på energi) og utilpashed.
English: Trizivir is used to treat adults who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Trizivir anvendes til behandling af voksne, som er smittet med humant immundefektvirus (hiv), som er et virus, der forårsager erhvervet immundefekt syndrom (aids).
English: What is the risk associated with Trizivir?
Danish: Hvilken risiko er der forbundet med Trizivir?
English: Trizivir abacavir, lamivudine and zidovudine
Danish: Trizivir abacavir, lamivudin og zidovudin
English: In the studies carried out for the development of Ziagen, the combination of the three active substances was shown to be at least as effective as the comparator combinations in keeping viral loads low.
Danish: I de undersøgelser, der blev udført ved udviklingen af Ziagen, viste kombinationen af de tre aktive stoffer sig at være mindst lige så effektiv til at holde virusmængden på et lavt niveau som de kombinationer, de blev sammenlignet med. Kombinationstabletten blev optaget i kroppen på samme måde som de separate tabletter.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Trizivir, 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 Ziagen, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: All three active substances in Trizivir, abacavir, lamivudine, and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Danish: Alle de tre aktive stoffer i Trizivir (abacavir, lamivudin og zidovudin) er nukleoside reverse transkriptasehæmmere (NRTI'er).
English: For the full list of all side effects reported with Trizivir, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Trizivir fremgår af indlægssedlen.
English: Trizivir is a medicine that contains three active substances: abacavir, lamivudine and zidovudine.
Danish: Trizivir er et lægemiddel, der indeholder de tre aktive stoffer abacavir, lamivudin og zidovudin.
English: Why has Trizivir been approved?
Danish: Hvorfor blev Trizivir godkendt?
English: It is used to replace treatment with the three active substances (abacavir, lamivudine and zidovudine) taken separately at doses similar to those in Trizivir.
Danish: Lægemidlet anvendes til at erstatte behandlingen med de tre aktive stoffer (abacavir, lamivudin og zidovudin), der tages særskilt i doser magen til dem i Trizivir.
English: What is Trizivir?
Danish: Hvad er Trizivir?
English: What is Trizivir used for?
Danish: Hvad anvendes Trizivir til?
English: Trizivir must not be used in patients who have kidney failure.
Danish: Kivexa må ikke anvendes til patienter, som er overfølsomme
English: How has Trizivir been studied?
Danish: Hvordan blev Trizivir undersøgt?
English: How is Trizivir used?
Danish: Hvordan anvendes Trizivir?
English: What benefit has Trizivir shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Trizivir?
English: How does Trizivir work?
Danish: Hvordan virker Trizivir?
English: Repeatability was 97%.
Danish: Repeterbarheden var 97 %.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1337/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1337/001
English: Package leaflet: Information for the patient/user
Danish: Indlægsseddel: Information til patienten/brugeren
English: To ensure that the test results are reliable, you need to follow the rules below:
Danish: For at sikre, at testresultatet er pålideligt, skal du følge nedenstående regler:
English: No specific recommendations after overdose are given.
Danish: Der er ingen specifikke anbefalinger ved overdosering.
English: For oral use after reconstitution.
Danish: Til oral anvendelse efter rekonstitution.
English: Transfer the measured amount to a drinking glass.
Danish: Overfør den beregnede mængde til et drikkeglas.
English: Read all of this leaflet carefully before you take this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du tager dette lægemiddel, da den indeholder vigtige oplysninger.
English: It is a test that helps your doctor to diagnose this condition.
Danish: Det er en test, der hjælper lægen med at diagnosticere denne tilstand.
English: It is unknown whether this may affect QTc.
Danish: Det vides ikke, om dette kan have indvirkning på QTc.
English: • Physical exercise - avoid strenuous physical activity 24 hours before the test.
Danish: • Fysisk aktivitet - undgå hård fysisk aktivitet 24 timer før testen.
English: Data on both tests were available for 140 subjects;
Danish: Data fra begge test var tilgængelige for 140 forsøgspersoner:
English: It is unknown whether such potential interactions may also affect QTc (see above).
Danish: Det vides ikke, om sådanne potentielle interaktioner også kan påvirke QTc (se ovenfor).
English: Store in the original package, in order to protect from light and moisture.
Danish: Opbevares i den originale yderpakning for at beskytte mod lys og fugt.
English: No studies to assess carcinogenicity and effects on reproduction and development have been conducted.
Danish: Der er ikke udført studier til undersøgelse af karcinogenicitet og indvirkning på reproduktion og udvikling.
English: You have to drink the complete test dose within 30 seconds.
Danish: Du skal drikke hele test-dosen inden for 30 sekunder.
English: The shelf life of a sachet is 4 years.
Danish: Holdbarhedstiden for et brev er 4 år.
English: Long-term use
Danish: Længerevarende brug
English: Growth hormone secretion normally decreases with age.
Danish: Udskillelsen af væksthormon falder normalt med alderen.
English: These side effects are mostly mild, do not last long, and usually go away quickly without treatment.
Danish: Disse bivirkninger er typisk lette, varer ikke lang tid og går normalt hurtigt væk uden behandling.
English: The suspension must be prepared and administered by a healthcare professional.
Danish: Suspensionen skal klargøres og administreres af en sundhedsperson.
English: This is not a treatment for patients who do not have enough growth hormone.
Danish: Det er ikke en behandling til patienter, der ikke har tilstrækkeligt væksthormon.
English: Medicinal products with a potential to induce torsades de pointes
Danish: Lægemidler med potentiale til at inducere torsades de pointes
English: It is used when your doctor thinks that you may not have enough growth hormone (adult growth hormone deficiency).
Danish: Det anvendes, når lægen mener, at du måske ikke har nok væksthormon (væksthormonmangel hos voksne).
English: • Fasting - you must not eat for at least 8 hours before the test, and during the test.
Danish: • Faste - du må ikke spise i mindst 8 timer før testen og under testen.
English: Interpretation of macimorelin test results
Danish: Fortolkning af macimorelin-testens resultater
English: Results
Danish: Resultater
English: You need to stop such treatment at least 1 month before the test.
Danish: En sådan behandling skal være ophørt senest 1 måned før testen
English: The dose is calculated based on the patient´s body weight.
Danish: Dosen beregnes ud fra patientens legemsvægt.
English: There are no data for the use of macimorelin in pregnant women.
Danish: Der er ingen data om anvendelse af macimorelin hos gravide kvinder.
English: Step 5 Have the patient drink the entire content of the drinking glass within 30 seconds.
Danish: Trin 5 Bed patienten om at drikke hele glassets indhold inden for 30 sekunder.
English: During the test, the patient needs to stay fasted until the end of the blood sampling.
Danish: Under testen skal patienten være fastende indtil efter blodprøvetagningen.
English: No drug-drug interaction studies have been performed in humans.
Danish: Der er ikke udført lægemiddelinteraktionsstudier hos mennesker.
English: • type 2 diabetes (pioglitazone)
Danish: • type 2-diabetes (pioglitazon)
English: Potential for false negative test results in recent onset hypothalamic disease
Danish: Potentiale for falsk negative testresultater ved nyligt opstået hypothalamus sygdom
English: If you are a woman able to have children, you must use effective contraceptive methods to ensure you are not pregnant at the time of the test.
Danish: Hvis du er en kvinde, der kan blive gravid, skal du bruge sikker prævention for at sikre, at du ikke er gravid på tidspunktet for testen.
English: Repeatability was tested in a subset of 34 subjects who underwent two MAC tests.
Danish: Repeterbarheden blev testet i en undergruppe på 34 forsøgspersoner, der gennemgik to MAC-test.
English: MedDRA organ class
Danish: MedDRA systemorganklasse
English: If either of these conditions is not met, the growth hormone stimulation test must be re-scheduled for a new test day.
Danish: Hvis en af disse betingelser ikke er opfyldt, skal væksthormonstimulationstesten udskydes til en anden dag.
English: Only limited pharmacokinetic data are available in the elderly.
Danish: Der foreligger kun begrænsede data om farmakokinetikken hos ældre.
English: Pharmacotherapeutic group: Diagnostic agents, Tests for pituitary function, ATC code: V04CD06
Danish: Farmakoterapeutisk klassifikation: Diagnostica, tests for hypofysefunktion, ATC-kode: V04CD06
English: It is unknown whether macimorelin or its metabolites are excreted in human milk.
Danish: Det vides ikke, om macimorelin eller dets metabolitter udskilles i human mælk.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Medicinal products affecting growth hormone release
Danish: Lægemidler, der påvirker frigivelsen af væksthormon
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before this medicine is given to you.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller sundhedspersonalet til råds, før du får dette lægemiddel.
English: Stir the suspension gently for 2 minutes (a small amount of undissolved particles will remain giving a slightly turbid suspension).
Danish: Omrør forsigtigt suspensionen i 2 minutter (en lille mængde uopløste partikler vil være tilbage, hvilket giver en lidt uklar suspension).
English: One hundred and fifty-seven (157) subjects underwent at least one of the two tests in this study, 59% were male, 41% female and 86% of white origin.
Danish: 157 forsøgspersoner gennemgik mindst én af de to test i dette studie; 59 % var mænd, 41 % var kvinder, og 86 % var af hvid oprindelse.
English: The mechanism for the observed QTcF prolongation is unknown.
Danish: Mekanismen bag den observerede QTcF-forlængelse er ikke kendt.
English: • cystic fibrosis (lumacaftor)
Danish: • cystisk fibrose (lumacaftor)
English: Preclinical data from safety pharmacology, repeated dose toxicity and genotoxicity studies reveal no specific hazard for humans.
Danish: Prækliniske data fra studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet viser ingen særlige risici for mennesker.
English: PC: {number} SN: {number} NN: {number}
Danish: SN: {nummer}
English: Agreement between the result of the first test and the second test was observed in 31 cases (91.2%).
Danish: Overensstemmelse mellem resultatet af den første test og den anden test blev observeret i 31 tilfælde