FrancophonIA/ELRC3.0 huggingface dataset:
English: Velmetia 50 mg/850 mg film-coated tablets
Danish: Velmetia 50 mg/850 mg filmovertrukne tabletter.
English: EU/1/08/456/001 14 film-coated tablets EU/1/08/456/002 28 film-coated tablets EU/1/08/456/003 56 film-coated tablets EU/1/08/456/019 60 film-coated tablets EU/1/08/456/004 112 film-coated tablets EU/1/08/456/005 168 film-coated tablets EU/1/08/456/020 180 film-coated tablets EU/1/08/456/006 196 film-coated tablets EU/1/08/456/007 50 x 1 film-coated tablets EU/1/08/456/015 196 (2 x 98) film-coated tablets EU/1/08/456/017 168 (2 x 84) film-coated tablets
Danish: EU/1/08/456/001 14 filmovertrukne tabletter EU/1/08/456/002 28 filmovertrukne tabletter EU/1/08/456/003 56 filmovertrukne tabletter EU/1/08/456/019 60 filmovertrukne tabletter EU/1/08/456/004 112 filmovertrukne tabletter EU/1/08/456/005 168 filmovertrukne tabletter EU/1/08/456/020 180 filmovertrukne tabletter EU/1/08/456/006 196 filmovertrukne tabletter EU/1/08/456/007 50 x 1 filmovertrukne tabletter EU/1/08/456/015 196 (2 x 98) filmovertrukne tabletter EU/1/08/456/017 168 (2 x 84) filmovertrukne tabletter
English: The expiry date refers to the last day of the month.
Danish: Brug ikke Velmetia efter den udløbsdato, der står på pakningenefter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: What Velmetia is and what it is used for What you need to know before you take Velmetia How to take Velmetia
Danish: Det skal De vide, før De begynder at tage Velmetia Sådan skal De tage Velmetia Bivirkninger
English: Velmetia 50 mg/1,000 mg film-coated tablets
Danish: Velmetia 50 mg/1.000 mg filmovertrukne tabletter.
English: Velmetia is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Danish: Velmetia er indiceret som supplement til diæt og motion i kombination med et sulfonylurinstof (dvs. tripel kombinationsbehandling) hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin og sulfonylurinstof.
English: Velmetia 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Danish: Velmetia 50 mg/1.000 mg filmovertrukne tabletter sitagliptin/metforminhydrochlorid
English: This is sometimes called insulin-dependent diabetes - if you have or have had an allergic reaction to sitagliptin, metformin, or Velmetia (see section 4) - if you are taking a sulphonylurea or insulin, diabetes medicines, together with Velmetia, as you may experience low blood sugar levels (hypoglycaemia).
Danish: - Hvis De tager anden diabetesmedicin, sulfonylurinstof eller insulin, sammen med Velmetia, da De så kan opleve lavt blodsukker (hypoglykæmi).
English: Velmetia 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
Danish: Velmetia 50 mg/850 mg filmovertrukne tabletter sitagliptin/metforminhydrochlorid
English: Velmetia 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Danish: Velmetia 50 mg/1000 mg tabletter sitagliptin/metforminhydrochlorid
English: Velmetia 50 mg/850 mg tablets sitagliptin/metformin HCl
Danish: Velmetia 50 mg/850 mg tabletter sitagliptin/metforminhydrochlorid
English: Furthermore, the data provided, including some data on reduced bleeding, were considered promising.
Danish: Desuden blev de fremlagte data, herunder data om mindsket blødning, anset for at være lovende.
English: Further information on Ondexxya can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ondexxya.
Danish: Yderligere information om Ondexxya findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/ondexxya.
English: As a result, the excessive bleeding caused by the anticoagulants is reduced.
Danish: Dermed reduceres den overdrevne blødning forårsaget af de antikoagulerende midler.
English: Ondexxya has been given ‘conditional authorisation'.
Danish: Ondexxya har fået en "betinget godkendelse".
English: As for all medicines, data on the use of Ondexxya are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Ondexxya løbende overvåget.
English: These anticoagulants work by blocking factor Xa, a natural protein that helps the blood to clot.
Danish: Disse antikoagulerende midler virker ved at blokere faktor Xa, et naturligt protein, der hjælper blodet til at størkne.
English: Patients treated with Ondexxya, especially those aged over 75 years, may be at a higher risk of thromboembolism.
Danish: Patienter, der behandles med Ondexxya, særligt patienter over 75 år, kan have en højere risiko for tromboemboli.
English: In patients who were bleeding, the most common side effects (affecting around 1 in 10 people) were thromboembolism (problems due to clots in blood vessels such as blocked veins, heart attack and stroke) and fever.
Danish: Hos patienter med blødninger var de hyppigste bivirkninger (som forekommer hos omkring 1 ud af 10 personer) tromboemboli (problemer som følge af blodpropper i blodkarrene som f.eks. blokerede vener, hjerteanfald og slagtilfælde) og feber.
English: Ondexxya is given by infusion (drip) into a vein over about 2.5 hours.
Danish: Ondexxya indgives ved infusion (drop) i en vene over ca. 2,5 time.
English: The main measure of effectiveness was the reduction in 'antifactor Xa activity' (a measure of how well natural factor Xa is blocked by an anticoagulant).
Danish: Virkningen blev hovedsageligt målt på reduktionen i "antifaktor Xa-aktivitet" (et mål for, hvor godt naturlig faktor Xa blokeres af et antikoagulerende middel).
English: The Agency therefore decided that Ondexxya's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Ondexxya opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Other information about Ondexxya
Danish: Andre oplysninger om Ondexxya
English: Side effects reported with Ondexxya are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Ondexxya vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: However, the Agency also noted the unmet medical need to stop life-threatening or uncontrolled bleeding caused by factor Xa inhibitors.
Danish: Agenturet bemærkede imidlertid også det uopfyldte medicinske behov for at stoppe livstruende eller ukontrollerede blødninger forårsaget af faktor Xa-hæmmere.
English: The company will also carry out studies to gain more information on the effects and blood levels of Ondexxya and to confirm the dosage recommendations.
Danish: Virksomheden vil også gennemføre studier med henblik på at opnå flere oplysninger om virkningerne og blodets indhold af Ondexxya og for at bekræfte doseringsanbefalingerne.
English: What measures are being taken to ensure the safe and effective use of Ondexxya?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ondexxya?
English: Ondexxya contains the active substance andexanet alfa.
Danish: Ondexxya indeholder det aktive stof andexanet alfa.
English: The European Medicines Agency noted that it has not been established that antifactor Xa activity can be used as a reliable measure for reduced bleeding and that there was not enough evidence on the use of Ondexxya to reverse the effects of edoxaban, another factor Xa inhibitor.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at det ikke er blevet fastslået, at antifaktor Xaaktiviteten kan anvendes som et pålideligt mål for mindsket blødning, og at der ikke var tilstrækkelig dokumentation for brugen af Ondexxya til at bremse virkningen af edoxaban, en anden faktor Xahæmmer.
English: An overview of Ondexxya and why it is authorised in the EU
Danish: En oversigt over Ondexxya, og hvorfor det er godkendt i EU
English: Ondexxya must not be used in patients who are allergic to hamster proteins.
Danish: Ondexxya må ikke gives til patienter, som er allergiske over for hamsterproteiner.
English: Why is Ondexxya authorised in the EU?
Danish: Hvorfor blev Ondexxya godkendt i EU?
English: Based on studies in healthy volunteers, the most common side effects with Ondexxya (which may affect more than 1 in 10 people) are flushing, feeling hot, both of which are related to infusing the medicine, and a short-lived increase in levels of certain proteins indicating blood clotting.
Danish: Baseret på studier med raske frivillige er de hyppigste bivirkninger ved Ondexxya (som kan forekomme hos mere end 1 ud af 10 personer) rødme af huden og varmefornemmelse, som begge er relateret til infusionen af lægemidlet, og en kortvarig stigning i niveauet af visse proteiner, der er tegn på blodets størkning.
English: What is Ondexxya and what is it used for?
Danish: Hvad er Ondexxya, og hvad anvendes det til?
English: Since Ondexxya has been given conditional authorisation, the company that markets Ondexxya will provide evidence from studies in patients with major bleeding to reliably link antifactor X activity with the ability to stop bleeding and to clarify the risk of thromboembolism.
Danish: Da Ondexxya har fået en betinget godkendelse, skal virksomheden, der markedsfører Ondexxya, fremlægge dokumentation fra studier hos patienter med svær blødning for på en pålidelig måde at forbinde antifaktor X-aktivitet med evnen til at standse blødning og klarlægge risikoen for tromboemboli.
English: Ondexxya is a medicine used for stopping life-threatening or uncontrolled bleeding in adults taking the anticoagulant medicines apixaban or rivaroxaban.
Danish: Ondexxya er et lægemiddel, der anvendes til at standse livstruende eller ukontrolleret blødning hos voksne, der tager de antikoagulerende (blodfortyndende) lægemidler apixaban eller rivaroxaban.
English: Two main studies have found Ondexxya effective in healthy volunteers who took either apixaban or rivaroxaban, two anticoagulants that block the effect of factor Xa.
Danish: I to hovedstudier blev det konstateret, at Ondexxya er effektiv hos raske frivillige, der enten fik apixaban eller rivaroxaban, to antikoagulerende midler, der blokerer virkningen af faktor Xa.
English: After treatment with Ondexxya, antifactor Xa activity was reduced on average by 90% in 83 patients taking apixaban and by 78% in 70 patients taking rivaroxaban.
Danish: Efter behandlingen med Ondexxya faldt antifaktor Xa-aktiviteten gennemsnitligt med 90 % hos 83 patienter, der fik apixaban, og med 78 % hos 70 patienter, der fik rivaroxaban.
English: When Ondexxya is given, the anticoagulants attach to andexanet alfa instead, and they are no longer available to block factor Xa.
Danish: Ondexxya får de antikoagulerende midler til at binde sig til andexanet alfa i stedet, så de ikke længere er i stand til at blokere for faktor Xa.
English: For the full list of side effects and restrictions of Ondexxya, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Ondexxya fremgår af indlægssedlen.
English: What are the risks associated with Ondexxya?
Danish: Hvilke risici er der forbundet med Ondexxya?
English: What information is still awaited for Ondexxya?
Danish: Hvilke oplysninger afventes der stadig for Ondexxya?
English: Andexanet alfa, the active substance in Ondexxya, acts as a decoy target for anticoagulants called factor Xa inhibitors such as apixaban and rivaroxaban.
Danish: Det aktive stof i Ondexxya, andexanet alfa, fungerer som attrapmål for antikoagulerende midler kaldet faktor Xa-inhibitorer, såsom apixaban og rivaroxaban.
English: On the basis of studies in healthy volunteers and preliminary data from studies in patients, Ondexxya was found effective for reducing antifactor Xa activity in those taking anticoagulants that block factor Xa (factor Xa inhibitors).
Danish: På grundlag af studier med raske frivillige og foreløbige data fra studier med patienter blev Ondexxya anset for effektivt til at reducere antifaktor Xa-aktiviteten hos dem, der fik antikoagulerende midler, som blokerer faktor Xa (faktor Xa-hæmmere).
English: In the first study, involving people who had taken apixaban, the full dose of Ondexxya reduced antifactor Xa activity by 92% on average in 23 people compared with 33% in 8 people receiving placebo (a dummy treatment).
Danish: I det første studie med personer, der havde fået apixaban, reducerede den fulde dosis Ondexxya antifaktor Xa-aktiviteten med gennemsnitligt 92 % hos 23 personer sammenlignet med 33 % hos 8 personer, der fik placebo (en uvirksom behandling).
English: involving people who had taken rivaroxaban, the full dose of Ondexxya reduced antifactor Xa activity by 97% on average in 26 people, compared with 45% in 13 people receiving placebo.
Danish: I det andet studie med personer, der havde fået rivaroxaban, reducerede den fulde dosis Ondexxya antifaktor Xa-aktiviteten med gennemsnitligt 97 % hos 26 personer sammenlignet med 45 % hos 13 personer, der fik placebo.
English: Ondexxya can only be obtained with a prescription and it must be used in hospital only.
Danish: Lægemidlet udleveres kun efter recept og må kun anvendes på hospitaler.
English: A further ongoing study involved patients taking a factor Xa inhibitor anticoagulant who had major bleeding.
Danish: Endnu et igangværende studie omfattede patienter med svær blødning, der fik en faktor Xa-hæmmer som antikoagulerende middel.
English: How is Ondexxya used?
Danish: Hvordan anvendes Ondexxya?
English: How does Ondexxya work?
Danish: Hvordan virker Ondexxya?
English: Recommendations and precautions to be followed by healthcare professionals for the safe and effective use of Ondexxya 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 Ondexxya.
English: The dose depends on what the last dose of the anticoagulant was and when the patient took it.
Danish: Dosis afhænger af, hvor stor den sidste dosis af det antikoagulerende middel var, og hvornår patienten fik den. For mere information om brug af Ondexxya, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What benefits of Ondexxya have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ondexxya?
English: The MAH should provide adequate and satisfactory data confirming the bioequivalence of their product with the reference product within one year of the European Commission decision.
Danish: De nationale kompetente myndigheder skal koordineret af referencemedlemsstaten sikre, at følgende betingelser opfyldes af indehaveren af markedsføringstilladelsen: Indehaveren af markedsføringstilladelsen forelægger fyldestgørende og tilfredsstillende data, der bekræfter lægemidlets bioækvivalens med referencelægemidlet, inden for et år efter EuropaKommissionens afgørelse.
English: The following procedure shows how you do this.
Danish: Nedenstående procedure viser, hvordan du gør dette.
English: The majority of these reactions were mild or moderate.
Danish: Hovedparten af disse reaktioner var lette eller moderate.
English: In other cases, seek help as soon as possible
Danish: I andre tilfælde skal der søges hjælp hurtigst muligt.
English: Never use more than one injection in the same day.
Danish: Tag aldrig mere end en injektion på den samme dag.
English: Date of first authorisation: 30 August 2012 Date of latest renewal: 23 June 2017
Danish: Dato for første markedsføringstilladelse: 30. august 2012 Dato for seneste fornyelse: 23. juni 2017
English: Active or suspected malignancy.
Danish: Aktiv eller mistænkt malign sygdom.
English: This assessment should be conducted more frequently within the first months of treatment.
Danish: Denne vurdering bør foretages oftere inden for de første måneder af behandlingen.
English: Paediatric population (≥1 year)
Danish: Pædiatrisk population (≥1 år)
English: 3.6 Check for air bubbles.
Danish: 3.6 Tjek for luftbobler.
English: This is because there is no experience with Revestive in this age group.
Danish: Dette skyldes, at der ikke er nogen erfaring med Revestive hos denne aldersgruppe.
English: Treatment should be stopped if no overall improvement of the patient condition is achieved.
Danish: Behandlingen bør stoppes, hvis der ikke opnås en generel forbedring af patientens tilstand.
English: The clinical studies conducted could neither exclude nor confirm such an increased risk.
Danish: De gennemførte kliniske studier kunne hverken af- eller bekræfte en sådan øget risiko.
English: If any powder remains, repeat steps 2.5 and 2.6.
Danish: Hvis der er pulver tilbage, skal trin 2.5 og 2.6 gentages.
English: These changes were neither associated with any changes in other laboratory parameters nor with any reported clinical symptoms.
Danish: Disse ændringer var hverken relateret til ændringer i andre laboratorieparametre eller til andre rapporterede kliniske symptomer.
English: Long-term safety data are not yet available for this paediatric population.
Danish: Langtidssikkerhedsdata er endnu ikke tilgængelige for den pædiatriske population.
English: These observations were not confirmed in clinical studies of more than one year duration.
Danish: Disse observationer blev ikke bekræftet i kliniske studier, der forløb over længere tid end et år.
English: Subsequent colonoscopies are recommended at a minimum of five year intervals.
Danish: Efterfølgende koloskopier anbefales som minimum med fem års intervaller.
English: In general, fluid overload can be prevented by appropriate and timely assessment of parenteral nutrition needs.
Danish: Generelt kan væskeophobning forebygges ved passende og rettidig vurdering af behov for parenteral ernæring.
English: There are no data from the use of Revestive in pregnant women.
Danish: Der er ingen data fra anvendelse af Revestive til gravide kvinder.
English: If a polyp is found, adherence to current polyp follow-up guidelines is recommended.
Danish: Hvis der konstateres en polyp anbefales det at overholde de gældende retningslinjer for polypopfølgning.
English: A risk to the breast-fed newborn/infant cannot be excluded.
Danish: En risiko for ammede nyfødte/spædbørn kan ikke udelukkes.
English: Interim data for the NIS should be provided every second year.
Danish: Interimdata fra dette NIS skal fremsendes hvert 2. år.
English: Specifically, clearance decreases with increasing age from 1 year old to adults.
Danish: Specifikt falder clearance med stigende alder fra 1 år til voksenalderen.
English: It is recommended that your doctor performs these examinations once a year during the first 2 years after starting treatment, and then at a minimum of five-year intervals.
Danish: Det anbefales, at din læge udfører disse undersøgelser en gang om året de første 2 år efter behandlingsstart og derefter minimum hvert 5. år.
English: A small amount of bleeding may occur.
Danish: Der kan forekomme let blødning.
English: The powder is white and the solvent is clear and colourless.
Danish: Pulveret er hvidt, og solvensen er klar og farveløs.
English: There was no reduction in PN/IV infusion days per week in the SOC arm.
Danish: Der var ingen reduktion i PN/i.v.-infusionsdage pr. uge i SOC-armen.
English: Clinical assessment by the physician should consider individual treatment objectives and patient preferences.
Danish: Lægens kliniske vurdering bør indeholde individuelle mål for behandlingen og patientpræferencer.
English: The absolute bioavailability of subcutaneous teduglutide is high (88%).
Danish: Den absolutte biotilgængelighed af subkutan teduglutid er høj (88 %).
English: Final study report
Danish: Endelig studierapport
English: Allow the area to air-dry.
Danish: Lad området lufttørre.
English: Do not touch the top of the vial.
Danish: Rør ikke ved toppen af hætteglasset.
English: These studies included 101 patients in the following age groups: 5 patients 1-2 years, 56 patients 2 to <6 years, 32 patients 6 to <12 years, 7 patients 12 to <17 years, and 1 patient 17 to <18 years.
Danish: Disse studier omfattede 101 patienter i følgende aldersgrupper: 5 patienter 1-2 år, 56 patienter 2 til <6 år, 32 patienter 6 til <12 år, 7 patienter 12 til <17 år og 1 patient 17 til <18 år.
English: Children below 1 year of age
Danish: Børn under 1 år
English: In the event of an overdose, the patient should be carefully monitored by the medical professional.
Danish: I tilfælde af overdosering bør patienten overvåges nøje af sundhedspersonalet.
English: This means that it is essentially ‘sodium-free'.
Danish: Det betyder, at det i det væsentlige er natriumfrit.
English: Important information about some of the ingredients in Revestive
Danish: Vigtig information om nogle af indholdsstofferne i Revestive
English: Treatment should not be initiated until it is reasonable to assume that a patient is stable following a period of intestinal adaptation.
Danish: Behandlingen bør ikke påbegyndes, før det er rimeligt at antage, at patienten er stabil efter en periode, hvor tarmen har adapteret sig.
English: Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Danish: Frekvenserne er defineret som meget almindelig (1/10); almindelig (1/100 til <1/10); ikke almindelig (1/1.000 til 1/100); sjælden (1/10.000 til 1/1.000); meget sjælden (1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Despite the limited sample size, which did not allow meaningful statistical comparisons, clinically meaningful, numerical reductions in the requirement for parenteral support were observed across all age groups.
Danish: På trods af den begrænsede prøve størrelse, som ikke tillod meningsfulde statistiske sammenligninger, blev der hos alle aldersgrupper observeret klinisk meningsfulde, numeriske reduktioner i behovet for parenteral støtte.
English: If a neoplasia is detected, it should be removed.
Danish: Hvis der konstateres neoplasi, bør det fjernes.
English: Revestive should not be administered intravenously or intramuscularly.
Danish: Revestive må ikke administreres intravenøst eller intramuskulært.
English: Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after one year of treatment, every 5 years thereafter while on continuous treatment with Revestive, and if they have new or unexplained gastrointestinal bleeding.
Danish: Koloskopi/sigmoidoskopi anbefales til alle børn og unge efter et års behandling, hvert 5. år derefter, mens de er i kontinuerlig behandling med Revestive, og hvis de får ny eller uforklarlig gastrointestinal blødning.
English: 4.4 Pull back the plunger slightly.
Danish: 4.4 Træk stemplet lidt tilbage.
English: Teduglutide is an analogue of GLP-2.
Danish: Teduglutid er en GLP-2-analog.
English: Now you are ready to dissolve the powder with the solvent.
Danish: Nu er du klar til at opløse pulveret i solvensen.
English: With the other hand, hold the syringe as you would with a pencil.
Danish: Hold sprøjten med den anden hånd, som du ville holde en blyant.
English: Since teduglutide is a peptide it is likely that it follows the principal mechanism for peptide metabolism.
Danish: Eftersom teduglutid er et peptid, er det sandsynligt, at det følger den primære mekanisme for peptidmetabolisering.
English: You will find detailed instructions for injections at the end of this leaflet.
Danish: Du vil finde detaljeret instruktion omkring injicering sidst i denne indlægsseddel.
English: Reduction in parenteral nutrition volume
Danish: Reduktion i parenteralt ernæringsvolumen
English: You can still use the medicine that is already in the syringe.
Danish: Du kan stadig bruge medicinen, der er i sprøjten.
English: Paediatric population See also general precautions for adults under this section.
Danish: Pædiatrisk population Se også de generelle forsigtighedsregler for voksne ovenfor.
English: Let the vial rest for approximately 30 seconds.
Danish: Lad hætteglasset hvile i ca. 30 sekunder.
English: This container must be puncture proof (top and sides).
Danish: Beholderen skal være punkteringssikker (i top og sider).