FrancophonIA/ELRC3.0 huggingface dataset:
English: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink.
Danish: Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med grøn, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 3” på kapslens underdel med sort blæk.
English: ° anaemia (reduced levels of red blood cells)
Danish: ° anæmi (lavt antal røde blodlegemer) ° højt antal af en type hvide blodlegemer ° lavt indhold af skjoldbruskkirtel-hormon (thyroideastimulerende hormon, TSH) i blodet
English: Reagila 3 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Danish: Reagila 3 mg hårde kapsler: prægelatiniseret (majs-) stivelse, magnesiumstearat, Allura red AC (E129), Brilliant blue FCF (E133), titandioxid (E171), gul jernoxid (E172), gelatine, sort blæk
English: Hepatobiliary disorders
Danish: Dysfagi
English: Reagila 4.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink.
Danish: Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med grøn, uigennemsigtig overdel og grøn, uigennemsigtig underdel, præget med “GR 4.5” på kapslens underdel med hvidt blæk.
English: Reagila 1.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink.
Danish: Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med hvid, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 1.5” på kapslens underdel med sort blæk.
English: Reagila 6 mg hard capsules ‘Size 3' (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink.
Danish: Hård gelatinekapsel i str. 3 (ca. 15,9 mm lang) med lilla, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 6” på kapslens underdel med sort blæk.
English: Odefsey contains three active substances.
Danish: Odefsey indeholder tre aktive stoffer.
English: The full EPAR for Odefsey can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Odefsey findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Odefsey.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Odefsey.
English: This means that the effects of these components in Odefsey should be similar to their effects in other medicines.
Danish: Dette betyder, at virkningerne af disse komponenter i Odefsey bør ligne virkningerne hos andre lægemidler.
English: Other information about Odefsey
Danish: Andre oplysninger om Odefsey
English: The CHMP therefore decided that Odefsey's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP konkluderede derfor, at fordelene ved Odefsey opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that Odefsey is an alternative treatment option to Eviplera with similar effectiveness.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Odefsey er en alternativ behandlingsform til Eviplera med lignende effektivitet.
English: What measures are being taken to ensure the safe and effective use of Odefsey?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Odefsey?
English: Odefsey does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Odefsey helbreder ikke hiv-1-infektion eller aids, men kan sinke den skade på immunsystemet og udviklingen af de infektioner og sygdomme, der er forbundet med aids.
English: Odefsey must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Odefsey:
Danish: Odefsey må ikke anvendes sammen med følgende lægemidler, da disse kan mindske blodets indhold af rilpivirin, så virkningen af Odefsey mindskes:
English: By blocking this enzyme, Odefsey reduces the amount of HIV-1 in the blood and keeps it at a low level.
Danish: Ved at blokere dette enzym, mindsker Odefsey hiv-1mængden i blodet og holder den nede.
English: • dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) except when used as a single dose treatment;
Danish: • dexamethason (et kortikosteroid til behandling af betændelse og hæmning af immunsystemet), undtagen hvis det anvendes som engangsbehandling
English: Odefsey is an antiviral medicine used to treat adults and adolescents (aged over 12 years and weighing at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Odefsey er et antiviralt lægemiddel, der anvendes til behandling af voksne og unge (over 12 år med en vægt på mindst 35 kg), der er smittet med humant immundefektvirus type 1 (hiv-1), et virus der forårsager erhvervet immundefektsyndrom (aids).
English: It is not intended to provide practical advice on how to use Odefsey.
Danish: Det er ikke en praktisk vejledning i, hvordan Odefsey bør anvendes.
English: Why is Odefsey approved?
Danish: Hvorfor blev Odefsey godkendt?
English: All three active substances block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected.
Danish: De tre aktivstoffer virker ved at blokere virussets enzym, revers transkriptase, der gør det muligt for hiv-1 at formere sig i de celler, det har smittet.
English: What is Odefsey and what is it used for?
Danish: Hvad er Odefsey, og hvad anvendes det til?
English: To support the use of tenofovir alafenamide, the company provided data from studies showing that combination medicines containing tenofovir alafenamide are as effective in reducing the amount of HIV-1 in the blood as those containing tenofovir disoproxil.
Danish: For at understøtte anvendelsen af tenofoviralafenamid har virksomheden fremlagt data fra undersøgelser, der viser at kombinationslægemidler indeholdende tenofoviralafenamid er lige så effektive til at reducere mængden af hiv-1 i blodet som dem, der indeholder tenofovirdisoproxil.
English: For more information about treatment with Odefsey, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Odefsey, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In terms of safety, tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil and may lead to reduced side effects in the kidneys and bones.
Danish: Hvad angår sikkerheden er tenofoviralafenamid effektiv ved en lavere dosis en tenofovirdisoproxil og kan føre til reducerede bivirkninger i nyrer og knogler.
English: What are the risks associated with Odefsey?
Danish: Hvilke risici er der forbundet med Odefsey?
English: It is only used in patients where the virus has not developed resistance to a class of HIV medicines called nonnucleoside reverse transcriptase inhibitors, tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Danish: Det anvendes kun til patienter, hvis virus ikke har udviklet resistens over for visse hiv-lægemidler kaldet non-nukleoside reverse transkriptasehæmmere (NNRTI), tenofovir eller emtricitabin, og hvis indhold af hiv i blodet højst er 100 000 hiv-1 RNA-kopier/ml.
English: In addition, to support its application, the company performed a ‘bioequivalence' study comparing Odefsey with two other HIV medicines: Edurant (rilpivirine) and Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide).
Danish: I tillæg hertil, for at understøtte ansøgningen, har virksomheden udført en bioækvivalensundersøgelse, hvor Odefsey blev sammenlignet med to andre hiv-lægemidler: Edurant (rilpivirin) og Genvoya (elvitegravir, cobicistat, emtricitabin og tenofoviralafenamid).
English: • rifabutin, rifampicin, rifapentine (antibiotics);
Danish: • rifabutin, rifampicin og rifapentin (antibiotika)
English: Very common side effects with rilpivirine also include increased cholesterol levels (total cholesterol and LDL-cholesterol), insomnia (difficulty sleeping) and increased liver and pancreas enzymes.
Danish: Almindelige bivirkninger ved rilpivirin kan også omfatte øget kolesterolniveau (samlet kolesterol og LDL-kolesterol), søvnløshed (søvnbesvær) og øget enzymniveau i lever og pankreas.
English: Odefsey is available as tablets, each containing 200 mg emtricitabine, 25 mg rilpivirine, and 25 mg tenofovir alafenamide.
Danish: Odefsey fås som tabletter med et indhold af 200 mg emtricitabin, 25 mg rilpivirin og 25 mg tenofoviralafenamid.
English: The most common side effects seen with the active substance rilpivirine and with the combination of emtricitabine and tenofovir alafenamide (which may affect more than 1 in 10 people) are headache, dizziness and nausea (feeling sick).
Danish: Meget almindelige bivirkninger ved aktivstoffet rilpivirin og kombinationen af emtricitabin og tenofoviralafenamid (som kan forekomme hos mere end én ud af 10 personer) er hovedpine, svimmelhed og kvalme (opkastning).
English: This study showed that Odefsey produces the same levels of rilpivirine in the body as Edurant, and the same levels of emtricitabine and tenofovir alafenamide as Genvoya.
Danish: Dette forsøg viste, at Odefsey producerer de samme niveauer af rilpivirin i kroppen som Edurant, og de samme niveauer af emtricitabin og tenofoviralafenamid som Genvoya.
English: Rilpivirine is an antiviral agent called non-nucleoside reverse transcriptase inhibitor.
Danish: Rilpivirin er et antiviralt middel, der også kaldes en nonnukleosid revers transkriptasehæmmer.
English: For practical information about using Odefsey, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Odefsey, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Odefsey emtricitabine / rilpivirine / tenofovir alafenamide
Danish: Odefsey emtricitabin/rilpivirin/tenofoviralafenamid
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Odefsey have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Odefsey.
English: Odefsey contains the active substances emtricitabine, rilpivirine and tenofovir alafenamide.
Danish: Odefsey indeholder de aktive stoffer emtricitabin, rilpivirin og tenofoviralafenamid.
English: • omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole (medicines for reducing stomach acid);
Danish: • omeprazol, esomeprazol, dexlansoprazol, lansoprazol, pantoprazol, rabeprazol (lægemidler mod for meget mavesyre)
English: Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors.
Danish: Tenofovir og emtricitabin er beslægtede virusmidler af typen reverse transkriptasehæmmere.
English: What benefits of Odefsey have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Odefsey?
English: How does Odefsey work?
Danish: Hvordan virker Odefsey?
English: How is Odefsey used?
Danish: Hvordan anvendes Odefsey?
English: • St John's wort (a herbal preparation used for depression and anxiety).
Danish: • perikum (et naturlægemiddel til behandling af depression og angst).
English: The combination of active substances in Odefsey (emtricitabine, rilpivirine and tenofovir) is already approved in the EU as Eviplera to treat HIV-1 infection, although in Eviplera tenofovir is present as tenofovir disoproxil whereas in Odefsey it is present as tenofovir alafenamide.
Danish: Kombinationen af aktive stoffer i Odefsey (emtricitabin, rilpivirin og tenofovir) er allerede godkendt i EU som Eviplera til behandling af hiv-1-infektion.
English: 100 g 1 bottle
Danish: 50g 10 flasker
English: In total 692 patients were enrolled.
Danish: Der deltog i alt 692 patienter.
English: Safety was comparable between the groups.
Danish: Sikkerheden kunne sammenlignes i de to grupper.
English: Relief of symptoms is obtained rapidly.
Danish: Lettelse af symptomerne opnås hurtigt.
English: Individual adjustment of dosage should be considered.
Danish: Individuel justering af dosis bør overvejes.
English: All three have a very limited potential for drug interactions at the CYP level (Unge and Andersson 1997).
Danish: Alle tre har et meget begrænset potentiale for lægemiddelinteraktion på CYP-niveau (Unge og Andersson 1997).
English: The bibliographic data submitted provide evidence to support the indications:
Danish: De fremlagte bibliografiske data giver dokumentation til underbyggelse af indikationerne:
English: Rare (0.01-0.1%) Very Rare
Danish: Sjældne (0,01-0,1%)
English: Overall rate of healing according to Sakitas classification was 95%.
Danish: Den samlede helingsrate var i følge Sakitas's klassifikation 95 %.
English: Therefore, the use of lansoprazole during pregnancy is not recommended.
Danish: Brugen af lansoprazol under graviditet anbefales derfor ikke.
English: The limited data as regards lansoprazole support this.
Danish: De begrænsede data for lansoprazol understøtter dette.
English: If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
Danish: Hvis symptomerne ikke er lettet inden for 4 uger med en daglig dosis på 30 mg, anbefales yderligere undersøgelser.
English: Endoscopy was also performed at week 8.
Danish: Der blev også foretaget endoskopi i uge 8.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: Dyreundersøgelser indikerer ingen direkte skadelige virkninger med hensyn til graviditet, embryonal/føtal udvikling, barsel eller postnatal udvikling.
English: Reflux oesophagitis may not present as ulceration and/or visual damage, therefore in certain cases endoscopy alone may not be sufficient.
Danish: Reflux øsofagitis fremstår måske ikke som ulceration og/elle visuel beskadigelse, hvorfor i visse tilfælde endoskopi alene ikke er tilstrækkelig.
English: At 4 weeks, the corresponding healing rates were 30%, 47% and 57%.
Danish: Efter 4 uger var de tilsvarende helingsrater 30 %, 47 % og 57 %.
English: The primary endpoint was recurrence of symptomatic and complicated ulcers during the 8 weeks.
Danish: Det primære slutpunkt var recidiverende symptomatiske og komplicerede ulcera i løbet af de 8 uger.
English: The effects of overdose of lansoprazole in humans are not known (although the acute toxicity is likely to be low) and, consequently, instructions for treatment cannot be given.
Danish: Overdosering Virkningerne ved overdosering med lansoprazol hos mennesker er ikke kendte (selvom den akutte toksicitet sandsynligvis er lav) og vejledninger for behandling kan derfor ikke gives.
English: Instructions for Use and Handling
Danish: Eventuelle instruktioner vedrørende anvendelse og håndtering
English: The following interactions between lansoprazole and certain antibiotics used in eradication therapy have been found so far:
Danish: De følgende interaktioner mellem lansopranzol og visse antibiotika anvendt til udryddelsesbehandling er blevet fundet indtil nu:
English: For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should be considered.
Danish: For risikopatienter eller med ulcera, der er vanskelige at hele, bør et længere behandlingsforløb og/eller en højere dosis overvejes.
English: Lansoprazol HEXAL 15 mg, 30 mg, gastro-resistant capsules, hard were referred for arbitration according to Article 29 of Council Directive 2001/83/EC, as amended, following concerns raised by Germany during a Mutual Recognition Procedure with Finland acting as Reference Member state.
Danish: Lansoprazol HEXAL 15 mg, 30 mg, gastro-resistente kapsler, hårde, blev indbragt til voldgiftsafgørelse i henhold til artikel 29 i Rådets direktiv 2001/83/EF, med senere ændringer, efter at Tyskland havde givet udtryk for betænkeligheder under en procedure om gensidig anerkendelse med Finland som referencemedlemsstat.
English: 2, 7, 10, 14, 15, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 and 250 capsules
Danish: 2, 7, 10, 14, 15, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 og 250 kapsler
English: Senses taste disturbances and visual disturbances.
Danish: Sanser smagsforstyrrelser og synsforstyrrelser.
English: Special Warning and Precautions for Use The diagnosis of gastroduodenal ulcers and reflux oesophagitis should be confirmed by endoscopy or other appropriate diagnostic means.
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Diagnosen af gastroduodenale ulcera og reflux øsofagitis bør bekræftes ved endoskopi eller andre passende diagnostiske metoder.
English: Three published papers on the clinical evidence for prevention of NSAID related ulcers are submitted.
Danish: Der er fremlagt 3 offentliggjorte dokumenter om den kliniske dokumentation for forebyggelse af NSAIDrelaterede ulcera.
English: If lansoprazole, in combination with antibiotics, is used for eradication therapy of H.-pylori, then also instructions for the use of these antibiotics should be followed.
Danish: Hvis lansoprazol, i kombination med antibiotika, anvendes til udryddelsesbehandling af H. pylori, bør brugsanvisningerne for disse antibiotika også følges.
English: Compared with placebo, lansoprazole only reduced the need for antacids in one of the studies but significant difference with regard to symptoms was not shown.
Danish: forhold til placebo reducerer lansoprazol kun behovet for antacider i en af undersøgelserne, men der blev ikke påvist væsentlige forskelle med hensyn til symptomerne.
English: For duodenal ulcers (n=46), the healing rates were between 81%-93% at week 8 in the 3 treatment groups.
Danish: For duodenal ulcera (n=46) var helingsraterne mellem 81 % - 93 % efter uge 8 i den 3. behandlingsgruppe.
English: A poor metaboliser would have more marked effects than an extensive metaboliser.
Danish: En dårlig metabolisator ville have mere udprægede vikninger end en omfattende metabolisator.
English: Primary endpoint was the recurrence of ulcer complications.
Danish: Det primære endepunkt var recidiverende ulcerkomplikationer.
English: Patients in the lansoprazole groups had significantly less abdominal pain compared with patients in the misoprostol group.
Danish: Patienter i lansoprazol-gruppen havde betydeligt færre abdominale smerter i forhold til patienter i misoprostol-gruppen.
English: Therefore, the benefit-risk profile of Lansoprazol HEXAL 15 mg, 30 mg in the proposed indications can be considered favourable.
Danish: Benefit-risk profilen af Lansoprazol HEXAL 15 mg, 30 mg til de ansøgte indikationer kan derfor anses for gunstig.
English: The SPC of the reference product in Germany does not contain the indications related to the concomitant use of NSAIDs and the treatment and prevention of gastric and duodenal ulceration caused by these compounds.
Danish: Produktresuméet for referenceproduktet i Tyskland indeholder ikke indikationerne for samtidig anvendelse af NSAID'er samt behandling og forebyggelse af gastrisk og duodenal ulceration forårsaget af disse præparater.
English: The bibliographic data submitted by the applicant show that in patients who continue to receive NSAID medication, lansoprazole is more effective in healing gastric ulcers than H2-receptor antagonist and the healing rates are acceptable although somewhat lower than reported for omeprazole.
Danish: De bibliografiske oplysninger fremlagt af ansøgeren viser, at lansoprazol hos patienter, der fortsætter med at få NSAID, er mere virksomt til at hele gastriske ulcera end H2-receptor- antagonisten, og helingsraterne er acceptable, selv om de er lidt lavere end dem, der er indberettet for omeprazol.
English: Elderly: Due to delayed elimination of lansoprazole in the elderly it may be necessary to administer the treatment in doses of 15-30 mg adjusted to individual requirements.
Danish: Grundet forsinket elimination af lansoprazol hos de ældre, kan det være nødvendigt at indgive behandlingen i doser på 15 til 30 mg, justeret efter individuelle kra.
English: • Treatment of duodenal and gastric ulcer confirmed by endoscopy or radiography.
Danish: • Behandling af duodenalt og gatrisk ulcus bekræftet ved endoskopi eller røntgen.
English: [See Annex I - to be completed nationally]
Danish: [Se Bilag I - udfyldes nationalt]
English: It may not be excluded that lanzoprazole may affect transport via this protein giving rise to increased plasma concentrations of P-gp substrates such as digoxin.
Danish: Det kan ikke udelukkes, at lansoprazol kan påvirke tranport via dette protein givende anledning til øgede plasmakoncentrationer af P-gp substrater såsom digoxin.
English: Antacid use was significantly less among patients in the lansoprazole groups compared with patients in the misoprostol and placebo groups.
Danish: Anvendelsen af antacid var betydeligt mindre blandt patienter i lansoprazogruppen end blandt patienter i misoprostol- og placebo-grupperne.
English: There is scarce data concerning healing rates for duodenal ulcers but duodenal ulcers are known in general to heal better than gastric ulcers following acid suppression.
Danish: Der er kun sparsomme oplysninger om helingsraterne for duodenale ulcera, men duodenale ulcera er kendt for i almindelighed at hele bedre end gastriske ulcera efter syrehæmning.
English: Increase bioaivalability and half-life of lansoprazole by 30 % each; increased plasma levels of a clarithromycin metabolite by 30 %
Danish: Øger biotilgængeligheden og halveringstiden for lansoprazol med 30 % hver; øgede plasmaniveauer af en clarithromycinmetabolit med 30 %
English: hair loss, erythema multiforme, stevens
Danish: petechia, purpura, hårtab, erythema multiforme, Stevens
English: Benign NSAID-associated gastric and duodenal ulcers:
Danish: Benigne NSAID-relaterede gastriske og duodenale ulcera:
English: Several clinical trials as well as extensive clinical experience has not indicated that there exist interactions when lansoprazole is given together with NSAIDs.
Danish: Adskillige kliniske undersøgelser og omfattende kliniske erfaringer har ikke indikeret, at der eksisterer interaktioner, når lansoprazol administreres samtidig med NSAID.
English: The cumulative incidence of symptomatic and complicated GD ulcers at week 8 was 4.5% in the lansoprazole group and 42.9% in the no treatment group (P=0.0025).
Danish: Den kumulative incidens af symptomatiske og komlicerede ulcera i uge 8 var 4,5 % i lansoprazol gruppen og 42,9 % i gruppen, der ingen behandling modtog (P=0.0025).
English: The lack of formal interaction studies with NSAIDs has to be adequately reflected in the SPC.
Danish: Manglen på formelle interaktionsundersøgelser med NSAID skal afspejles fuldt ud i produktbeskrivelsen.
English: In patients receiving NSAIDs with H. pylori infection gastric ulcer healing with an antisecretory agent was significantly enhanced (70% vs 61%, P<0.05).
Danish: Hos patienter med H. pylori-infektion, som fik NSAID'er, fremmede det sekretionshæmmende middel helingen af gastrisk ulcus væsentligt (70 % vs 61 %, P<0.05).
English: Interaction with NSAIDs has not been suggested.
Danish: Interaktion med NSAID'er ikke blevet antydet.