FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Tibolona Aristo and Tibocina outweigh their risks, and the marketing authorisations can be granted in Spain and in the following Member States of the EU: Belgium, Germany and the Netherlands.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved Tibolona Aristo og Tibocina er større end risiciene, og at der kan udstedes markedsføringstilladelser i Spanien og i følgende EU-medlemsstater: Belgien, Tyskland og Nederlandene.
English: Tibolona Aristo and Tibocina are generic medicines based on a ‘reference medicine', Liviella, which is authorised in Germany.
Danish: Tibolona Aristo og Tibocina er generiske lægemidler, der er baseret på et “referencelægemiddel”, Liviella, der er godkendt i Tyskland.
English: Aristo Pharma GmbH submitted Tibolona Aristo and Tibocina to the Spanish medicines regulatory agency for a decentralised procedure.
Danish: Aristo Pharma GmbH søgte Tibolona Aristo og Tibocina godkendt hos den spanske lægemiddelstyrelse ved en decentral procedure.
English: Why were Tibolona Aristo and Tibocina reviewed?
Danish: Hvorfor blev Tibolona Aristo og Tibocina vurderet igen?
English: The grounds for the referral were objections raised by Germany about the data submitted to show that Tibolona Aristo and Tibocina were ‘bioequivalent' to the reference medicine, Liviella.
Danish: Begrundelsen for indbringelsen var betænkelighed ved de indvendinger, der var rejst af Tyskland om den dokumentation, der var indsendt til påvisning af, at Tibolona Aristo og Tibocina var
English: Patients should be monitored for at least one hour after the first infusion for any reactions.
Danish: Patienterne bør overvåges i mindst én time efter den første infusion for alle reaktioner.
English: If a reaction occurs, the infusion should be stopped and patients should receive appropriate treatment.
Danish: Hvis der opstår en reaktion, bør infusionen stoppes, og patienterne bør behandles på passende vis.
English: Overall, the safety profile of Trogarzo was considered to be acceptable.
Danish: Generelt ansås sikkerhedsprofilen af Trogarzo for at være acceptabel.
English: Further information on Trogarzo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/trogarzo.
Danish: Yderligere information om Trogarzo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/trogarzoema.europa.eu/medicines/human/EPAR/trogar zo.
English: Other information about Trogarzo
Danish: Andre oplysninger om Trogarzo
English: As for all medicines, data on the use of Trogarzo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Trogarzo løbende overvåget.
English: In patients with multi-drug resistant HIV, treatment options are limited and there is therefore an unmet medical need in this group.
Danish: Hos patienter med multiresistent hiv er behandlingsmulighederne begrænsede, og der er derfor et udækket medicinsk behov blandt denne gruppe.
English: What measures are being taken to ensure the safe and effective use of Trogarzo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trogarzo?
English: Treatment should be started and monitored by a doctor who is experienced in the treatment of HIV infection.
Danish: Behandlingen bør indledes og følges af en læge med erfaring i behandling af hivinfektion.
English: Side effects reported with Trogarzo are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Trogarzo vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency therefore decided that Trogarzo's 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 Trogarzo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Although the studies submitted were small and did not include a direct comparison with other medicines, the results indicate that adding Trogarzo to other medicines could control the virus in these patients.
Danish: Selv om de forelagte studier var små og ikke omfattede en direkte sammenligning med andre lægemidler, viser resultaterne, at tilføjelse af Trogarzo til andre lægemidler kan medføre en reduktion af virusset hos disse patienter.
English: The most common side effects with Trogarzo (which may affect up to 1 in 10 patients) are rash, diarrhoea, dizziness, headache, nausea (feeling sick), vomiting and tiredness.
Danish: De hyppigste bivirkninger ved Trogarzo (som kan forekomme hos op til 1 ud af 10 patienter) er udslæt, diarré, svimmelhed, hovedpine, kvalme, opkastning og træthed.
English: The company that markets Trogarzo will carry out a study to confirm the benefits of treatment with Trogarzo in patients with multi-drug resistant HIV infection.
Danish: Virksomheden, der markedsfører Trogarzo, vil gennemføre en undersøgelse for at bekræfte fordelene ved behandling med Trogarzo hos patienter med multiresistent hiv-infektion.
English: For more information about using Trogarzo, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Trogarzo, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: An overview of Trogarzo and why it is authorised in the EU
Danish: En oversigt over Trogarzo, og hvorfor det er godkendt i EU
English: Why is Trogarzo authorised in the EU?
Danish: Hvorfor er Trogarzo godkendt i EU?
English: Trogarzo does not cure HIV-1 infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Trogarzo helbreder ikke hiv-1-infektion eller aids, men kan udsætte den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: What is Trogarzo and what is it used for?
Danish: Hvad er Trogarzo, og hvad anvendes det til?
English: T cells are the main target of the HIV virus, which it uses as a host to reproduce.
Danish: Tceller er det primære mål for hiv-virusset, som bruger dem til at reproducere sig.
English: What are the risks associated with Trogarzo?
Danish: Hvilke risici er der forbundet med Trogarzo?
English: The active substance in Trogarzo, ibalizumab, is a monoclonal antibody (a type of protein) designed to attach to CD4, a receptor (target) found on the surface of immune cells called T cells.
Danish: Det aktive stof i Trogarzo, ibalizumab, er et monoklonalt antistof (en type protein), der er udviklet til at binde sig til CD4, en receptor (target), der findes på overfladen af immunceller kaldet T-celler.
English: Treatment is started with a single infusion of 2,000 mg followed by 800 mg every 2 weeks; if treatment is interrupted, it should be restarted in the same way.
Danish: Behandlingen indledes med én infusion a 2.000 mg efterfulgt af 800 mg hver 2. uge.
English: Similar effects were seen in a second main study with 113 adults, where 44% of patients who had maintenance doses of Trogarzo added to standard treatment had undetectable HIV levels after 25 weeks.
Danish: Lignende resultater sås i et andet hovedstudie, der omfattede 113 voksne, hvor der hos 44 % af de patienter, der fik vedligeholdelsesdoser af Trogarzo i tillæg til en standardbehandling, ikke kunne påvises hiv-virus efter 25 uger.
English: Trogarzo is given with other HIV medicines when none of the standard combinations work to control the infection because the virus is resistant to them (multi-drug resistant HIV).
Danish: Trogarzo gives sammen med andre hiv-lægemidler, når ingen af standardkombinationerne er effektive til at bekæmpe infektionen, fordi virusset er resistent over for dem (multiresistent hiv).
English: Trogarzo is a medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Trogarzo er et lægemiddel, der anvendes til at behandle voksne, som er smittet med humant immundefektvirus type 1 (hiv-1), et virus, som forårsager erhvervet immundefektsyndrom (aids).
English: For the full list of side effects and restrictions with Trogarzo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Trogarzo fremgår af indlægssedlen.
English: In a main study that included 40 adults with multi-drug resistant HIV whose HIV treatment was failing, levels of HIV virus in the blood were undetectable (fewer than 50 copies/ml) in 43% of patients after 25 weeks of combining standard treatment with Trogarzo.
Danish: I et hovedstudie, der omfattede 40 voksne med multiresistent hiv, hvis hiv-behandling ikke var effektiv, kunne der ikke påvises hiv-virus i blodet (færre end 50 kopier/ml) hos 43 % af patienterne efter 25 ugers kombination af standardbehandling med Trogarzo.
English: By attaching to CD4, ibalizumab prevents the virus from entering the T-cells and reproducing, thereby slowing down the spread of infection.
Danish: Ved at binde sig til CD4 forhindrer ibalizumab virusset i at trænge ind i T-cellerne og reproducere sig selv.
English: Trogarzo is available as a solution for infusion (drip) into a vein.
Danish: Trogarzo findes som væske til infusion (drop) i en vene.
English: Trogarzo taken with other HIV medicines was shown to be effective at reducing viral load (blood levels of HIV virus) in patients with multi-drug resistant HIV, that is, where standard HIV combination treatments have failed to suppress levels of HIV in the blood sufficiently.
Danish: Trogarzo i kombination med andre hiv-lægemidler har vist sig effektivt til at reducere virusbelastningen (hiv-koncentrationen i blodet) hos patienter med multiresistent hiv, dvs. i tilfælde, hvor hiv-kombinationsbehandlinger ikke i tilstrækkelig grad har formået at undertrykke hivkoncentrationen i blodet.
English: What benefits of Trogarzo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Trogarzo?
English: How is Trogarzo used?
Danish: Hvordan anvendes Trogarzo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trogarzo have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Trogarzo.
English: How does Trogarzo work?
Danish: Hvordan virker Trogarzo?
English: Date of latest renewal: 2 July 2009.
Danish: Dato for seneste fornyelse: 2. juli 2009.
English: Other special considerations are discussed below.
Danish: Andre særlige forhold nævnes nedenfor.
English: Every 6 to 8 weeks depending on your disease
Danish: Hver 6. til 8. uge afhængig af din sygdom
English: PASI 75 response**
Danish: PASI 75 respons**
English: Adults (≥ 18 years)
Danish: Voksne (≥ 18 år)
English: The median CDAI score was 180.
Danish: Median CDAI scoren var 180.
English: Radiographic changes were assessed in IMPACT 2.
Danish: Radiografiske ændringer blev vurderet i IMPACT2.
English: • Your doctor will want to closely monitor your heart.
Danish: • Din læge vil nøje overvåge dit hjerte.
English: These children must be 6 years of age or older.
Danish: Børnene skal være 6 år eller ældre.
English: For more information see section on vaccination.
Danish: For mere information, se afsnit om vaccination.
English: The information above also applies to children and adolescents.
Danish: Ovenstående oplysninger gælder også for børn og unge.
English: • The table below shows how often you will usually have this medicine after your first dose.
Danish: • Tabellen nedenfor viser, hvor ofte du sædvanligvis vil få denne medicin efter din første dosis.
English: Date of first authorisation: 13 August 1999.
Danish: Dato for første markedsføringstilladelse: 13. august 1999.
English: Some of these reactions may be serious or life-threatening.
Danish: Nogle af disse reaktioner kan være alvorlige eller livstruende.
English: Some of these patients have been under 50 years of age.
Danish: Nogle af disse patienter var under 50 år gamle.
English: There was no difference between groups in the number of late responders thereafter.
Danish: Der var herefter ingen forskel mellem grupperne i antallet af sene responderende.
English: * ITT-analysis where subjects with missing data were included as non-responders.
Danish: * ITT-analyser med emner med manglende data blev inkluderet som ikke-responderende.
English: Allow the reconstituted solution to stand for 5 minutes.
Danish: Lad det rekonstituerede koncentrat stå i 5 minutter.
English: The available clinical experience is limited.
Danish: Den eksisterende kliniske erfaring er begrænset.
English: Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period.
Danish: Da eliminationen af infliximab kan tage op til 6 måneder, bør monitorering fortsættes i denne periode.
English: Switching between biological DMARDS
Danish: Skift mellem biologiske DMARDS
English: Nearly 50% of reported deaths have been associated with infection.
Danish: Næsten 50 % af rapporterede dødsfald var forbundet med infektion.
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Danish: Da du får denne medicin af din læge eller sygeplejerske, er det usandsynligt, at du vil få for meget.
English: • Reduce the signs and symptoms of your disease
Danish: • Reducere tegn og symptomer på din sygdom
English: EXP EXP, if not refrigerated ___________________
Danish: EXP EXP, hvis ikke opbevaret i køleskab ___________________
English: Combined data from ACT 1 & 2
Danish: Kombinerede resultater fra ACT 1 & 2.
English: The median duration of response was 12 weeks.
Danish: Median varigheden af respons var 12 uger.
English: Approximately 50% of patients were in functional Class III.
Danish: Omkring 50 % af patienterne var i funktionsklasse III.
English: No case of overdose has been reported.
Danish: Der har ikke været rapporteret noget tilfælde af overdosering.
English: Approximately half the cases were lymphomas.
Danish: Omtrent halvdelen af tilfældene var lymfomer.
English: In this situation, Remicade should be re-initiated as a single dose followed by the maintenance dose recommendations described above.
Danish: I denne situation bør Remicade initieres igen som en enkelt dosis efterfulgt af vedligeholdelsesdoser som anbefalet ovenfor.
English: These medicines may cause side effects.
Danish: Disse lægemidler kan give bivirkninger.
English: No further clinically relevant accumulation was observed.
Danish: Ingen yderligere klinisk relevant akkumulering blev observeret.
English: Fistula Response (%) Complete fistula response (%)
Danish: Fistula Respons (%) Komplet fistula respons (%)
English: List of allergies:
Danish: Liste over allergier:
English: If adequate response is achieved, patients should be continued on the selected dose or dose frequency.
Danish: Hvis der opnås tilstrækkelig respons, bør patienten fortsætte på den valgte dosis eller doseringsfrekvens.
English: ACR response (% of patients)
Danish: ACR respons ( % af patienter)
English: The median terminal half-life at these doses ranged from 8 to 9.5 days.
Danish: Median terminal halveringstid ved disse doser varierede fra 8 til 9,5 dage.
English: Efficacy has been demonstrated with or without concomitant use of methotrexate.
Danish: Effekten har været demonstreret med eller uden samtidig brug af methotrexat.
English: This evaluation should include colonoscopy and biopsies per local recommendations.
Danish: Denne vurdering bør inkludere koloskopi og biopsier ifølge lokale vejledninger.
English: Reduction in CDAI ≥ 25% and ≥ 70 points.
Danish: Reduktion i CDAI ≥ 25 % og ≥ 70 point.
English: Radiographs of hands and feet were collected at baseline, weeks 24 and 54.
Danish: Røntgenbilleder af hænder og fødder blev indsamlet ved baseline, uge 24 og 54.
English: • Cancer in children and adults
Danish: • Kræft hos børn og voksne
English: If you are given too much Remicade
Danish: Hvis du får for meget Remicade
English: The potential contribution of exposure to infliximab and/or the severity of the underlying disease in these outcomes remains unclear.
Danish: Den potentielle indflydelse fra eksponering for infliximab og/eller sværhedsgraden af den underliggende sygdom i disse resultater er fortsat uklar.
English: Side effects may occur a long time after your last dose.
Danish: Bivirkninger kan forekomme lang tid efter sidste dosis.
English: • Medicines that affect your immune system.
Danish: • Lægemidler som påvirker dit immunsystem.
English: In ASPIRE, more than 90% of patients had at least two evaluable X-rays.
Danish: I ASPIRE havde mere end 90 % af patienterne mindst to bedømmelsesværdige røntgenbilleder.
English: Alternatively, administration of 3 mg/kg as often as every 4 weeks may be considered.
Danish: Alternativt kan administration af 3 mg/kg så ofte som hver 4 uge overvejes.
English: However some patients may experience serious side effects and may require treatment.
Danish: Nogle patienter kan dog opleve alvorlige bivirkninger, som kan kræve behandling.
English: Median follow-up is based on patients treated.
Danish: Medianopfølgning er baseret på behandlede patienter.
English: Talk to your doctor if you are on a low salt diet.
Danish: Tal med din læge, hvis du er på en diæt med et lavt saltindhold.
English: Week 26 All randomised patients
Danish: Uge 26 Alle randomiserede patienter
English: The storage details should you need them are as follows:
Danish: Skulle du få brug for information omkring opbevaring, gælder følgende:
English: HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Danish: HAQ = Health Assessment Questionnaire; højere værdier indikerer mindre handicap.
English: • You will be monitored while you are given Remicade and also for 1 to 2 hours afterwards.
Danish: • Du vil blive overvåget, mens du får Remicade og i 1-2 timer derefter.
English: • Your doctor or nurse will prepare the medicine for infusion.
Danish: • Din læge eller sygeplejerske vil klargøre medicinen til infusion.
English: • Severe allergic reaction that may cause loss of consciousness and could be life-threatening
Danish: • Alvorlig allergisk reaktion, som kan medføre tab af bevidsthed og kan være livstruende
English: The effects observed at 54 weeks were maintained through 102 weeks.
Danish: De virkninger, der sås ved 54 uger, blev opretholdt i 102 uger.
English: This type of cancer has usually resulted in death.
Danish: Denne type kræft har oftest haft dødelig udgang.
English: • or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated
Danish: • eller alene hos patienter, der udviser intolerance over for methotrexat, eller for hvem methotrexat er kontraindiceret
English: • in combination with methotrexate
Danish: • i kombination med methotrexat
English: If acute infusion reactions occur, the infusion must be interrupted immediately.
Danish: Hvis akutte infusionsreaktioner opstår, skal infusionen afbrydes øjeblikkeligt.
English: This will depend on your disease, weight and how well you respond to Remicade.
Danish: Dette vil afhænge af din sygdom, vægt og hvor godt, du reagerer på Remicade.
English: Improvement from baseline in HAQ averaged over time from week 30 to week 54
Danish: Forbedring fra baseline i HAQ gennemsnitligt over tid fra uge 30 til uge 54
English: In responding patients, the alternative strategies for continued treatment are:
Danish: Hos responderende patienter, er de alternative strategier for fortsat behandling:
English: • You are allergic to infliximab or to any of the other ingredients in Remicade (listed in section 6).
Danish: • Du er allergisk over for infliximab eller et af de øvrige indholdsstoffer i Remicade (angivet i punkt 6).
English: A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks.
Danish: A ≥ 50 % reduktion fra baseline i antallet af drænede fistulaer over en periode på ≥ 4 uger.
English: Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
Danish: Periodisk undersøgelse af huden anbefales hos patienter, især hos patienter med risikofaktorer for hudcancer.
English: Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of > 20 weeks.
Danish: Mellem uge 6 og 26 vendte symptomerne på psoriasis gradvis tilbage med en median tid til sygdomsrelaps på > 20 uger.
English: A low proportion of the infusion reactions was serious allergic reactions.
Danish: En lille del af infusionsreaktionerne var alvorlige allergiske reaktioner.
English: • Blood test result showing ‘antibodies' against your own body.
Danish: • Blodprøveresultater, der viser ‘antistoffer' mod din egen krop.
English: The following side effects have been observed with Remicade:
Danish: Følgende bivirkninger er observeret med Remicade:
English: • In some patients receiving Remicade, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Danish: • Hos nogle patienter, som får Remicade, kan kroppen måske ikke lave nok af de blodlegemer, der skal hjælpe med at bekæmpe infektioner eller stoppe blødning.
English: Table 2 Proportion of patients with increased ALT activity in clinical studies
Danish: Tabel 2 Andel patienter med øget ALAT-aktivitet i kliniske studier
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
Danish: • Unormale værdier for et protein i blodet kaldet ‘komplementfaktor', som er en del af immunsystemet.
English: Three cases of pneumonia (1 serious) and 2 cases of herpes zoster (both non-serious) were reported.
Danish: Der blev rapporteret 3 tilfælde af lungebetændelse (1 alvorlig) og 2 tilfælde af herpes zoster (begge ikke alvorlige).
English: These patients were classified as week-2 responders and were included in the primary analysis (see Table 5).
Danish: Disse patienter blev klassificeret som uge-2 responderende og blev inkluderet i den primære analyse (se tabel 5).
English: • Depression, problems sleeping
Danish: • Depression, problemer med at sove
English: Not known: Worsening of symptoms of dermatomyositis.
Danish: Ikke kendt: Forværring af dermatomyositis-symptomer.
English: If your baby has continual fevers or infections, contact your baby's doctor immediately.
Danish: Hvis dit barn hyppigt får feber eller infektioner, skal du omgående kontakte barnets læge.
English: Single doses up to 20 mg/kg have been administered without toxic effects.
Danish: Enkelte doser på op til 20 mg/kg har været indgivet uden toksiske virkninger.
English: Serious infections were reported in 12% (7/60) of all treated patients.
Danish: Alvorlige infektioner blev rapporteret hos 12 % (7/60) af alle behandlede patienter.
English: Absence of any draining fistulas.
Danish: Fravær af alle drænede fistulaer.
English: Most aminotransferase abnormalities were transient; however, a small number of patients experienced more prolonged elevations.
Danish: De fleste tilfælde af unormale aminotransferaser var forbigående; et lille antal patienter oplevede imidlertid mere langvarige stigninger.
English: The majority of serious infusion reactions occurred during the second infusion at week 2.
Danish: De fleste alvorlige infusionsrelaterede reaktioner opstod i forbindelse med den 2 infusion i uge 2.
English: If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Danish: Hvis latent tuberkulose er under mistanke, bør en læge med ekspertise i behandling af tuberkulose konsulteres.
English: If there are any changes in your skin or growths on the skin during or after therapy, tell your doctor.
Danish: Hvis der er forandringer i huden eller svulster på huden under eller efter behandlingen, skal du fortælle det til lægen.
English: (anaphylactic shock)
Danish: (anafylaktisk shock)