FrancophonIA/ELRC3.0 huggingface dataset:
English: In subjects with mild, moderate and severe hepatic impairment (Child-Pugh Class A, B, and C, respectively), mean AUC of total obeticholic acid, the sum of obeticholic acid and its two active conjugates, increased by 1.13-, 4- and 17-fold, respectively, compared to subjects with normal hepatic function following single-dose administration of 10 mg obeticholic acid.
Danish: Efter administration af en enkelt dosis på 10 mg obeticholsyre steg middel-AUC for totalobeticholsyre (summen af obeticholsyre og dets to aktive konjugater) henholdsvis 1,13, 4 og 17 gange hos forsøgspersoner med let, moderat og svært nedsat leverfunktion (Child-Pugh klasse A, B og C) sammenlignet med forsøgspersoner med normal leverfunktion.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION OCALIVA 5 mg film-coated tablets Each film-coated tablet contains 5 mg of obeticholic acid.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING OCALIVA 5 mg filmovertrukne tabletter 1 filmovertrukket tablet indeholder 5 mg obeticholsyre.
English: The starting dose and dosage titration by PBC patient population is shown in Table 1.
Danish: PBC (primær biliær cholangitis) -patientpopulation er vist i tabel 1.
English: For Non-Cirrhotic or Child-Pugh Class A patients:
Danish: Hos patienter, der ikke har cirrose, eller som har Child-Pugh A:
English: How to take OCALIVA
Danish: Sådan skal du tage OCALIVA
English: What OCALIVA looks like and contents of the pack - OCALIVA 5 mg is a yellow, round film-coated tablet with ‘INT' on one side and ‘5' on the other side of the film-coated tablet.
Danish: Udseende og pakningsstørrelser - OCALIVA 5 mg er en gul rund filmovertrukket tablet, mærket med “INT” på den ene side og
English: e Response rates were calculated based on the observed case analysis (i.e., [n=observed responder]/[N=Intention to Treat (ITT) population]); percentage of patients with Month 12 values are 86%, 91% and 96% for the OCALIVA 10 mg, OCALIVA titration and placebo arms, respectively.
Danish: Procentdelen af patienter med værdier for måned 12 er henholdsvis 86 %, 91 % og 96 % for OCALIVA 10 mg-, OCALIVA-titrerings- og placeboarmen.
English: Thyroid function abnormality
Danish: Abnorm thyroideafunktion
English: Starting Dosage
Danish: Startdosis
English: Due date
Danish: Forfaldsdato
English: Based on animal studies and intended pharmacology, obeticholic acid is not expected to interfere with breast-feeding or the growth or development of a breast-fed child. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from obeticholic acid therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman (see section 5.3).
Danish: Det skal besluttes, om amning skal ophøre eller behandling med obeticholsyre seponeres/undlades, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen (se pkt.
English: • fever
Danish: Feber
English: What OCALIVA is and what it is used for What you need to know before you take OCALIVA How to take OCALIVA
Danish: Det skal du vide, før du begynder at tage OCALIVA Sådan skal du tage OCALIVA Bivirkninger
English: OCALIVA 10 mg film-coated tablets
Danish: OCALIVA 10 mg filmovertrukket tablet
English: Pharmacotherapeutic group: Bile and liver therapy, Bile acid preparations.
Danish: Farmakoterapeutisk klassifikation: Galde- og leverterapi, galdesyrer og derivater, ATC-kode: A05AA04
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 5 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE 5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 10 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE 10 mg
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE 10 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKE 10 mg
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med OCALIVA Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE 5 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKE 5 mg
English: NAME OF THE MEDICINAL PRODUCT OCALIVA 5 mg film-coated tablets OCALIVA 10 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN OCALIVA 5 mg filmovertrukne tabletter OCALIVA 10 mg filmovertrukne tabletter
English: For patients taking bile acid binding resins, obeticholic acid should be administered at least 4-6 hours before or 4-6 hours after taking a bile acid binding resin, or at as great an interval as possible (see section 4.5).
Danish: Patienter, som tager galdesyrebindende resiner, skal tage OCALIVA mindst 4-6 timer før eller 46 timer efter at have taget det galdesyrebindende resin (eller med så langt et tidsinterval som muligt) (se pkt.
English: • stomach pain
Danish: • Mavesmerter
English: When concomitant bile acid binding resins are administered, obeticholic acid should be taken at least 4-6 hours before or 4-6 hours after taking a bile acid binding resin, or at as great an interval as possible.
Danish: Ved samtidig administration af galdesyrebindende resiner skal obeticholsyre tages mindst 4-6 timer før eller 46 timer efter administration af det galdesyrebindende resin (eller med så langt et tidsinterval som muligt).
English: • thyroid hormone irregularity
Danish: • Risikostyringsplan (RMP)
English: Oropharyngeal pain
Danish: Galdesyrebindende resiner
English: OCALIVA 5 mg film-coated tablets Yellow, 8 mm round tablet debossed with ‘INT' on one side and ‘5' on the other side.
Danish: Gul 8,0 mm rund tablet, præget med ‘INT' på den ene side og ‘5' på den anden side.
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer): Unormalt niveau af skjoldbruskkirtelhormon Svimmelhed
English: OCALIVA 5 mg film-coated tablets: Each film-coated tablet contains 5 mg of obeticholic acid.
Danish: OCALIVA 5 mg filmovertrukne tabletter: 1 filmovertrukket tablet indeholder 5 mg obeticholsyre.
English: Hepatic impairment
Danish: Orofaryngeale smerter
English: NAME OF THE MEDICINAL PRODUCT OCALIVA 5 mg film-coated tablets obeticholic acid
Danish: LÆGEMIDLETS NAVN OCALIVA 5 mg filmovertrukne tabletter Obeticholsyre
English: NAME OF THE MEDICINAL PRODUCT OCALIVA 10 mg film-coated tablets obeticholic acid
Danish: LÆGEMIDLETS NAVN OCALIVA 10 mg filmovertrukne tabletter Obeticholsyre
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 5 mg of obeticholic acid.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 filmovertrukket tablet indeholder 5 mg obeticholsyre.
English: OCALIVA 5 mg film-coated tablets OCALIVA 10 mg film-coated tablets obeticholic acid
Danish: OCALIVA 5 mg filmovertrukne tabletter OCALIVA 10 mg filmovertrukne tabletter
English: OCALIVA 10 mg film-coated tablets: Each film-coated tablet contains 10 mg of obeticholic acid.
Danish: OCALIVA 10 mg filmovertrukne tabletter: 1 filmovertrukket tablet indeholder 10 mg obeticholsyre.
English: OCALIVA 10 mg film-coated tablets Each film-coated tablet contains 10 mg of obeticholic acid.
Danish: OCALIVA 10 mg filmovertrukne tabletter 1 filmovertrukket tablet indeholder 10 mg obeticholsyre.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg of obeticholic acid.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 filmovertrukket tablet indeholder 10 mg obeticholsyre.
English: (8%) in the OCALIVA 10 mg arm, 5 patients (7%) in the OCALIVA titration arm, and 5 patients (7%) in the placebo arm. c Patients were randomized (1:1:1) to receive OCALIVA 10 mg once daily for the entire 12 months of the trial,
Danish: OCALIVA 10 mg-armen, 5 patienter (7 %) i OCALIVA-titreringsarmen og 5 patienter (7 %) i placeboarmen.
English: Constipation
Danish: Dosistitrering
English: These findings were maintained at 48 weeks.
Danish: Disse resultater blev fastholdt efter 48 uger.
English: Intelence received a marketing authorisation valid throughout the EU on 28 August 2008.
Danish: Intelence fik en markedsføringstilladelse med gyldighed i hele EU den 28. august 2008.
English: Other information about Intelence
Danish: Andre oplysninger om Intelence
English: Intelence (etravirine)
Danish: Intelence (etravirin)
English: Further information on Intelence can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Intelence findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients who cannot swallow can disperse the tablets in a glass of water and then drink the solution immediately.
Danish: Patienter, der ikke kan synke, kan opløse tabletterne i et glas vand og derefter drikke opløsningen med det samme.
English: As for all medicines, data on the use of Intelence are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Intelence løbende overvåget.
English: It contains the active substance etravirine.
Danish: Det indeholder det aktive stof etravirin.
English: Intelence is available as tablets (25, 100 and 200 mg) to be swallowed whole with a glass of water.
Danish: Intelence fås som tabletter (25, 100 og 200 mg), der skal synkes hele med et glas vand.
English: What measures are being taken to ensure the safe and effective use of Intelence?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Intelence?
English: An overview of Intelence and why it is authorised in the EU
Danish: En oversigt over Intelence, og hvorfor det er godkendt i EU
English: The European Medicines Agency therefore decided that its benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Intelence opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The active substance in Intelence, etravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Danish: Det aktive stof i Intelence, etravirin, er en non-nukleosid revers transkriptasehæmmer (NNRTI).
English: What is Intelence and what is it used for?
Danish: Hvad er Intelence, og hvad anvendes det til?
English: Side effects reported with Intelence are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Intelence vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: For further information about using Intelence, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Intelence, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Why is Intelence authorised in the EU?
Danish: Hvorfor blev Intelence godkendt i EU?
English: The most common side effects with Intelence (which may affect more than 1 in 10 people) are rash, diarrhoea, nausea (feeling sick) and headache.
Danish: De hyppigste bivirkninger ved Intelence (der kan forekomme hos mere end 1 ud af 10 personer) er udslæt, diarré, kvalme og hovedpine.
English: In two main studies in a total of 1,203 adults, the average viral load was 70,000 copies/ml at the start of treatment.
Danish: I to hovedstudier med i alt 1 203 voksne var den gennemsnitlige virusbelastning 70 000 kopier/ml ved behandlingsstart.
English: Intelence must not be used together with elbasvir/grazoprevir, a medicine to treat hepatitis C infection.
Danish: Intelence må ikke anvendes sammen med elbasvir/grazoprevir, der er medicin til behandling af hepatitis C-infektion.
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Danish: Det blokerer aktiviteten af revers transkriptase, et enzym, der produceres af hiv, og som gør det muligt for hiv-infektionen at inficere celler i kroppen og producere mere virus.
English: What are the risks associated with Intelence?
Danish: Hvilke risici er der forbundet med Intelence?
English: Intelence does not cure HIV infection or AIDS, but it may delay damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Intelence helbreder ikke hiv-infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: Intelence is a medicine for treating human immunodeficiency virus type 1 (HIV-1) in adults and children from 6 years of age.
Danish: Intelence er et lægemiddel til behandling af humant immundefektvirus type 1 (hiv-1) hos voksne og børn i alderen 6 år og opefter.
English: Intelence (etravirine) EMA/440123/2019
Danish: Intelence (etravirin) EMA/514667/2018
English: In adults, the recommended dose of Intelence is 200 mg twice a day after a meal while in children the dose depends on body weight and ranges from 100 mg twice a day to 200 mg twice a day.
Danish: Den anbefalede dosis Intelence til voksne er 200 mg to gange dagligt efter et måltid, mens dosen til børn er 100-200 mg to gange dagligt afhængigt af deres legemsvægt.
English: In a main study of 101 children aged between 6 and 17 years, about half of them had undetectable levels of HIV after 24 weeks of taking Intelence in combination with other medicines, and the proportion of children with undetectable levels of HIV increased slightly after 48 weeks.
Danish: I et hovedstudie med 101 børn i alderen 6-17 år havde omkring halvdelen ikke-detekterbare niveauer af hiv efter 24 ugers behandling med Intelence i tillæg til andre lægemidler, og andelen af børn med ikke-detekterbare hiv-niveauer steg en smule efter 48 uger.
English: Intelence is effective at reducing viral load to undetectable levels in both adults and children and its side effects are considered manageable.
Danish: Intelence er effektivt til at reducere virusbelastningen til ikke-detekterbare niveauer hos både voksne og børn, og bivirkningerne vurderes at være håndterbare.
English: Intelence is only used in patients who have been treated for their HIV infection before and it must be used together with other HIV medicines that include a ‘boosted protease inhibitor'.
Danish: Intelence anvendes kun til patienter, der tidligere er blevet behandlet for hiv-infektion, og det skal anvendes sammen med andre hiv-lægemidler, der omfatter en "boostet proteasehæmmer".
English: Studies have shown that Intelence, in combination with other medicines, is effective at reducing the level of HIV in the blood (viral load) to undetectable levels (below 50 copies/ml) in many patients with HIV-1 infection.
Danish: Studier har vist, at Intelence i kombination med andre lægemidler reducerer niveauet af hiv i blodet (virusbelastningen) til ikke-detekterbare niveauer (under 50 kopier/ml) hos mange patienter med hiv1-infektion.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.
Danish: Lægemidlet udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af hiv-infektion.
English: After 24 weeks, 59% of the patients taking Intelence together with other HIV medicines had undetectable levels of HIV, compared with 41% of those taking placebo (a dummy treatment) plus the other HIV medicines.
Danish: Efter 24 uger havde 59 % af de patienter, der fik Intelence sammen med andre hivmidler, ikke-detekterbare hiv-niveauer, sammenholdt med 41 % af dem, der fik placebo (ikke-aktivt stof) i tillæg til de andre hiv-midler.
English: For the full list of side effects and restrictions with Intelence, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Intelence fremgår af indlægssedlen.
English: How is Intelence used?
Danish: Hvordan anvendes Intelence?
English: What benefits of Intelence have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Intelence?
English: By blocking this enzyme, Intelence, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Ved at blokere dette enzym reducerer Intelence koncentrationen af hiv i blodet og holder den på et lavt niveau, når det tages i kombination med andre hiv-midler.
English: How does Intelence work?
Danish: Hvordan virker Intelence?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intelence have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Intelence.
English: 1 Article 35 of Directive 2001/82/EC
Danish: 1 Artikel 35 i direktiv 2001/82/EF
English: The final opinion was converted into a Decision by the European Commission on 10 June 2010.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 10. juni
English: The referral procedure started on 16 April 2009.
Danish: Indbringelsesproceduren blev indledt den 16. april 2009.
English: The rapporteur and co-rapporteur appointed were: Prof. Christian Friis and Dr Karolina Törneke, respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis prof. Christian Friis og dr. Karolina Törneke.
English: Written explanations were provided by the applicants/marketing authorisation holders on 15 July 2009 and 13 January 2010.
Danish: Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 15. juli 2009 og den 13. januar 2010.
English: Colistin sulfate is a polypeptide antibiotic belonging to the polymyxins group of antibiotics.
Danish: Colistinsulfat er et polypeptidantibiotikum, der tilhører antibiotika af polymyxingruppen.
English: Due to concerns that the differences in posology and withdrawal periods established across the European Union for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species may present a potential serious risk to public and animal health, the United Kingdom referred the matter to the Agency on 1 April 2009, under Article 35 of Directive 2001/82/EC.
Danish: Som følge af betænkeligheder ved, om forskelle i dosering og tilbageholdelsestider i Den Europæiske Union for veterinærlægemidler, der indeholder colistin 2 000 000 IE pr. ml, og som er beregnet til administration i drikkevandet til fødevareproducerende arter, kan udgøre en potentiel alvorlig risiko for <0} folkesundheden og dyrs sundhed, indbragte Det Forenede Kongerige sagen for agenturet den 1. april 2009 i henhold til artikel 35 i direktiv 2001/82/EF.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP, adopted, on 10 February 2010, an opinion recommending variations of the marketing authorisations for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species in order to amend the summary of the product characteristics (SPC), labelling and package leaflet to harmonise the posology and withdrawal periods (where applicable) for the concerned products.
Danish: På grundlag af rapportørernes vurdering af de foreliggende oplysninger vedtog CVMP den 10. februar 2010 en udtalelse, hvori det anbefalede en ændring af markedsføringstilladelserne for veterinærlægemidler, der indeholder colistin 2 000 000 IE pr. ml, og som er beregnet til administration i drikkevandet til fødevareproducerende arter, samt ændringer i produktresumé, etikettering og indlægsseddel med henblik på harmonisering af dosering og tilbageholdelsestider (hvor relevant) for de pågældende lægemidler.
English: Veterinary medicinal formulations containing colistin sulfate at 2 000 000 IU per ml and intended for administration via drinking water to calves, pigs, lambs and poultry are used for the treatment of infections of the gastrointestinal tract caused by Escherichia coli and Salmonella spp susceptible to colistin.
Danish: Veterinærlægemidler, der indeholder colistin 2 000 000 IE pr. ml, og som er beregnet til administration i drikkevandet til kalve, grise, lam og fjerkræ, anvendes til behandling af infektioner i mavetarmkanalen forårsaget af Escherichia coli og Salmonella spp., som er følsomme over for colistin.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in the Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II.
English: referral for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 351 om veterinærlægemidler, der indeholder colistin 2 000 000 IE pr. ml, og som er beregnet til administration i drikkevandet til fødevareproducerende arter
English: This summary was last updated in 09-2014.
Danish: Dette sammendrag blev sidst ajourført i 09-2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Noxafil on 25 October 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Noxafil den 25. oktober 2005.
English: The full EPAR for Noxafil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Noxafil findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This document is a summary of the European public assessment report (EPAR) for Noxafil.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Noxafil.
English: Noxafil posaconazole
Danish: Noxafil posaconazol
English: A risk management plan has been developed to ensure that Noxafil is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Noxafil anvendes så sikkert som muligt.
English: After 14 days of treatment, both medicines had been successful in curing or improving about 92% of patients.
Danish: Efter 14 dages behandling var der for begge lægemidler opnået helbredelse eller bedring hos ca. 92 % af patienterne.
English: Without ergosterol, the fungus dies or is prevented from spreading.
Danish: Uden ergosterol dør svampen eller forhindres i at sprede sig.
English: The studies looked at the number of patients who developed an invasive fungal infection.
Danish: I undersøgelserne så man nærmere på antallet af patienter, der udviklede en invasiv svampeinfektion.
English: Other information about Noxafil
Danish: Andre oplysninger om Noxafil
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 Noxafil.
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 Noxafil skal anvendes.
English: Noxafil must not be used in patients who are taking any of the following medicines:
Danish: Noxafil må ikke anvendes til patienter, der får et eller flere af følgende lægemidler:
English: What measures are being taken to ensure the safe and effective use of Noxafil?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Noxafil?
English: For more information about treatment with Noxafil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Noxafil, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.