FrancophonIA/ELRC3.0 huggingface dataset:
English: Velcade must not be given by other routes.
Danish: Velcade må ikke gives på andre måder.
English: When the proteins in the cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and they eventually die.
Danish: Når proteinerne i kræftcellerne, f.eks. de proteiner, der styrer cellernes vækst, ikke nedbrydes, påvirker dette cellerne, hvorefter de til sidst dør.
English: Treatment with Velcade should only be started and given under the supervision of a doctor who has experience in the use of cancer chemotherapy.
Danish: Behandling med Velcade bør kun indledes og gives under tilsyn af en læge, der har erfaring i brug af kemoterapi mod kræft.
English: If a patient develops severe side effects after a treatment cycle, the treatment must be suspended, delayed or the dose adjusted.
Danish: Hvis patienten efter et behandlingsforløb udvikler alvorlige bivirkninger, skal behandlingen afbrydes eller udskydes, eller dosen justeres.
English: The recommended starting dose is 1.3 mg per square metre body surface area (calculated using the patient's height and weight).
Danish: Den anbefalede dosis er 1,3 mg pr. kvadratmeter legemsoverflade (beregnet ud fra patientens højde og vægt).
English: It must not be given to patients with acute diffuse infiltrative pulmonary disease or pericardial disease (disease affecting the sac that surrounds the heart).
Danish: Det må ikke gives til patienter med akut diffus infiltrativ lungesygdom eller perikardial sygdom (en sygdom, der berører den sæk, der omgiver hjertet).
English: What measures are being taken to ensure the safe and effective use of Velcade?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Velcade?
English: In addition, the company that markets Velcade will ensure that healthcare professionals receive educational material explaining how to calculate the dose and how to prepare and administer the medicine.
Danish: Endvidere vil virksomheden, der markedsfører Velcade, sikre, at sundhedspersoner får udleveret uddannelsesmateriale, der forklarer, hvordan dosen beregnes, og hvordan lægemidlet klargøres og administreres.
English: When Velcade is used with other medicines the restrictions for those medicines must also be taken into account, including the requirements for pregnancy testing and prevention with thalidomide.
Danish: Når Velcade anvendes sammen med andre lægemidler, skal der også tages hensyn til kravene til disse, herunder krav til graviditetstests og prævention med thalidomid.
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 Velcade.
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 Velcade skal anvendes.
English: • Around 34% of the patients responded partially or completely to treatment with Velcade (in a study in which Velcade was not compared with any other medicine)
Danish: • Omkring 34 % af patienterne responderede delvist eller fuldstændigt på behandlingen med Velcade (i en undersøgelse, hvor Velcade ikke blev sammenlignet med andre lægemidler).
English: At least 72 hours must pass between two consecutive doses of Velcade.
Danish: Der skal gå mindst 72 timer mellem hver administration af Velcade.
English: Velcade is a cancer medicine that contains the active substance bortezomib.
Danish: Velcade er et kræftlægemiddel, der indeholder det aktive stof bortezomib.
English: • The study that compared Velcade given under the skin with Velcade given into a vein showed that the percentage of patients who responded partially or completely to treatment was the same (42%) when using either route of administration.
Danish: • Undersøgelsen, der sammenlignede Velcade givet henholdsvis under huden og i en vene, viste, at andelen af patienter, der responderede delvist eller fuldstændigt på behandlingen, var den samme (42 %) uanset administrationsmetoden.
English: For more information about treatment with Velcade, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Velcade, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Velcade's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Velcade opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Velcade.
English: Velcade is used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Danish: Velcade anvendes til behandling af multipelt myelom, som er blodkræft, hos følgende patientgrupper:
English: Velcade 1 mg must only be given by injection into a vein, while Velcade 3.5 mg is only given either by injection into a vein or under the skin.
Danish: Velcade 1 mg må kun gives som injektion i en vene, mens Velcade 3,5 mg kun må gives som enten injektion i en vene eller under huden.
English: • adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, a blood stem-cell transplant.
Danish: • voksne, hvis sygdom er i forværring efter mindst én anden behandling, og som allerede har fået eller ikke kan gennemgå en blodstamcelletransplantation.
English: Doses of Velcade are given intermittently, with rest periods in between doses, in treatment cycles of three to six weeks depending on whether Velcade is given alone or in combination with other medicines.
Danish: Velcade-doser gives uden faste intervaller, med hvileperioder mellem doserne, i behandlingsforløb på tre til seks uger afhængigt af, om Velcade gives alene eller i kombination med andre lægemidler.
English: The active substance in Velcade, bortezomib, is a proteasome inhibitor.
Danish: Det aktive stof i Velcade, bortezomib, er en proteasomhæmmer.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Velcade, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Velcade, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Velcade must not be used in people who are hypersensitive (allergic) to bortezomib, boron or to any of the other ingredients.
Danish: Velcade må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for bortezomib, boron eller andre af indholdsstofferne.
English: The main measure of effectiveness was how long the patients lived without their disease getting worse.
Danish: Behandlingens effektivitet blev hovedsagelig bedømt på, hvor længe patienterne overlevede uden forværring af sygdommen.
English: In multiple myeloma, Velcade has been evaluated in 10 main studies involving over 4,339 adults, which evaluated the benefits of Velcade alone or in combination with other treatments.
Danish: Ved multipelt myelom blev Velcade anvendt i 10 hovedundersøgelser med over 4 339 voksne, hvor fordelene ved Velcade alene og i kombination med andre behandlinger blev vurderet.
English: What is the risk associated with Velcade?
Danish: Hvilken risiko er der forbundet med Velcade?
English: The most serious adverse reactions include heart failure, tumour lysis syndrome (complications due to breakdown of cancer cells), pulmonary hypertension (high blood pressure in the arteries of the lungs), posterior reversible encephalopathy syndrome (a reversible brain disorder), acute diffuse infiltrative pulmonary disease (a severe lung problem), and autonomic neuropathy (damage to nerves controlling organs such as the bladder, eyes, gut, heart and blood vessels).
Danish: De alvorligste bivirkninger omfatter hjerteinsufficiens, tumorlysis-syndrom (en komplikation, der skyldes nedbrydning af kræftceller), pulmonal hypertension (forhøjet blodtryk i lungearterierne), posterior reversibel encefalopati-syndrom (forbigående hjernesygdom), akut diffus infiltrativ lungesygdom (et alvorligt lungeproblem) og autonom neuropati (beskadigelse af nerver, der kontrollerer organer såsom blæren, øjnene, tarmen, hjertet og blodkarrene).
English: In mantle cell lymphoma, Velcade was evaluated in a main study involving 487 previously untreated adults who were not considered suitable for blood stem-cell transplantation.
Danish: Ved mantelcellelymfom blev Velcade vurderet i en hovedundersøgelse med 487 tidligere ubehandlede voksne, der ikke var egnede til transplantation af blodstamceller.
English: The main measures of effectiveness in these studies were the number of patients who responded to treatment and how long the patients lived without their disease getting worse.
Danish: Effektiviteten blev hovedsagelig bedømt på det antal patienter, hos hvem behandlingen virkede, og på, hvor længe patienterne levede uden forværring af sygdommen.
English: In addition, 49% of these patients responded to Velcade plus thalidomide and dexamethasone, compared with about 26% who responded to treatment containing Velcade plus other anticancer drugs, and 17% who responded to thalidomide and dexamethasone alone.
Danish: Desuden responderede 49 % af disse patienter på Velcade plus thalidomid og dexamethason, sammenholdt med ca. 26 % af dem, der responderede på en behandling bestående af Velcade plus andre kræftlægemidler, og 17 %, der responderede på thalidomid og dexamethason alene.
English: Studies in multiple myeloma showed Velcade and combinations containing Velcade to be beneficial in several patient groups.
Danish: Undersøgelserne ved multipelt myelom viste, at Velcade og kombinationer med Velcade har gavnlig virkning hos flere patientgrupper.
English: For more information on the use of Velcade, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Velcade fremgår af produktresuméet (også en del af denne EPAR).
English: It is available in vials (1 and 3.5 mg) as a powder to be made up into a solution for injection.
Danish: Det fås i hætteglas (1 og 3,5 mg) som et pulver, der blandes til en opløsning til injektion.
English: The most commonly reported side effects during treatment with Velcade are nausea (feeling sick), diarrhoea, constipation, vomiting, fatigue (tiredness), pyrexia (fever), thrombocytopenia (low blood platelets count), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), peripheral neuropathy (nerve damage in the hands and feet), headache, paraesthesia (unusual sensations like pins and needles), decreased appetite, dyspnoea (difficulty breathing), rash, herpes zoster (shingles) and myalgia (muscle pain).
Danish: De hyppigst indberettede bivirkninger ved behandling med Velcade er kvalme, diarré, forstoppelse, opkastning, træthed, pyreksi (feber), thrombocytopeni (lavt antal blodplader), anæmi (lavt antal røde blodlegemer), neutropeni (lavt antal neutrofile, en form for hvide blodlegemer, der bekæmper infektioner), perifer neuropati (nervebeskadigelser i hænder og fødder), hovedpine, paræstesi (usædvanlige fornemmelser såsom prikken og stikken), nedsat appetit, dyspnø (åndedrætsbesvær), udslæt, herpes zoster (helvedesild) og myalgi (muskelsmerter).
English: • Around 15% of patients who were candidates for high-dose chemotherapy and a blood stem-cell transplant responded to treatment with Velcade plus dexamethasone, compared with 6% of those given standard combinations.
Danish: • Ca. 15 % af de patienter, der var egnede til højdosiskemoterapi og transplantation af blodstamceller, responderede på behandling med Velcade plus dexamethason, sammenholdt med 6 % af dem, der fik standardkombinationer.
English: Why has Velcade been approved?
Danish: Hvorfor blev Velcade godkendt?
English: • Among patients with worsening disease that had come back or failed to respond to at least one other treatment, around 70% responded to treatment with the Velcade-dexamethasone combination.
Danish: • Af de patienter, hos hvem den forværrede sygdom var vendt tilbage, eller som ikke havde haft virkning af mindst én anden behandling, responderede cirka 70 % på behandling med kombinationen af Velcade og dexamethason.
English: When injected under the skin, it is given in the thigh or abdomen (tummy).
Danish: Når Velcade gives som injektion under huden, sker det i låret eller abdomen (maven).
English: Velcade is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Danish: Velcade anvendes desuden til behandling af en anden form for blodkræft, mantelcellelymfom, hos ubehandlede voksne, som ikke kan få blodstamcelletransplantation.
English: In mantle cell lymphoma, patients treated with a combination of Velcade plus rituximab, cyclophosphamide, doxorubicin and prednisone lived longer without their disease getting worse (24.7 months) than those given the same combination but with vincristine in place of Velcade (14.4 months).
Danish: Ved mantelcellelymfom levede de patienter, der blev behandlet med en kombination af Velcade plus rituximab, cyclophosphamid, doxorubicin og prednison, længere uden forværring af sygdommen (24,7 måneder) end dem, der fik samme kombination, men med vincristin i stedet for Velcade (14,4 måneder).
English: • Previously untreated patients lived for an average of 20.7 months without their disease getting worse when they received Velcade together with melphalan and prednisone, compared with 15.0 months in the patients receiving only melphalan and prednisone.
Danish: • Tidligere ubehandlede patienter levede gennemsnitlig 20,7 måneder, før deres sygdom forværredes, når de fik Velcade sammen med melphalan og prednison, sammenlignet med 15,0 måneder hos patienter, som kun fik melphalan og prednison.
English: When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube).
Danish: Når opløsningen gives i en vene, sker det ved en injektion over tre til fem sekunder gennem et kateter (en tynd, steril slange).
English: • previously untreated adults who cannot have high-dose chemotherapy with a blood stem-cell transplant.
Danish: • tidligere ubehandlede voksne, som ikke kan få højdosiskemoterapi med transplantation af blodstamceller.
English: In this study, Velcade together with rituximab, cyclophosphamide, doxorubicin and prednisone was compared with the same combination containing another medicine, vincristine, in place of Velcade.
Danish: I undersøgelsen blev Velcade sammen med rituximab, cyclophosphamid, doxorubicin og prednison sammenlignet med samme kombination, hvor der i stedet for Velcade blev anvendt et andet lægemiddel, vincristin.
English: For the full list of all side effects reported with Velcade, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Velcade fremgår af indlægssedlen.
English: • previously untreated patients who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant.
Danish: • tidligere ubehandlede patienter, som skal gennemgå højdosiskemoterapi efterfulgt af en blodstamcelletransplantation.
English: For mantle cell lymphoma, Velcade is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Danish: Ved mantelcellelymfom anvendes Velcade i kombination med rituximab, cyclophosphamid, doxorubicin og prednison.
English: In these patients, Velcade is used in combination with melphalan and prednisone;
Danish: Hos disse patienter anvendes Velcade i kombination med melphalan og prednison
English: • Previously patients receiving Velcade lived for an average of 6.2 months without their disease getting worse, compared with 3.5 months in those receiving dexamethasone.
Danish: • For tidligere behandlede patienter, der fik Velcade, gik der i gennemsnit 6,2 måneder, før deres sygdom forværredes, sammenlignet med 3,5 måneder for dem, der fik dexamethason.
English: What is Velcade used for?
Danish: Hvad anvendes Velcade til?
English: What is Velcade?
Danish: Hvad er Velcade?
English: What benefit has Velcade shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Velcade?
English: In this group of patients, Velcade is used in combination with dexamethasone, or with dexamethasone plus thalidomide;
Danish: Inden for denne gruppe patienter anvendes Velcade i kombination med dexamethason eller med dexamethason og thalidomid
English: How has Velcade been studied?
Danish: Hvordan blev Velcade undersøgt?
English: Velcade is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone.
Danish: Hos disse patienter anvendes Velcade enten alene eller i kombination med pegyleret liposomalt doxorubicin eller dexamethason.
English: • patients given Velcade with pegylated liposomal doxorubicin whose disease was getting worse after having failed to respond to at least one other treatment, lived for 9.3 months without their disease getting worse compared to 6.5 months for patients receiving Velcade alone.
Danish: • De patienter, hos hvem sygdommen forværredes efter manglende virkning af mindst én anden behandling, levede i 9,3 måneder uden forværring af sygdommen, når de fik Velcade med pegyleret liposomalt doxorubicin, sammenholdt med 6,5 måneder for dem, der fik Velcade alene.
English: How is Velcade used?
Danish: Hvordan anvendes Velcade?
English: How does Velcade work?
Danish: Hvordan virker Velcade?
English: The Committee's recommended dosage is now three times daily.
Danish: Udvalgets anbefalede dosering er nu tre gange dagligt.
English: The European Commission issued a decision on 19 October 2009.
Danish: Europa-Kommissionen traf en afgørelse den 19. oktober 2009.
English: Suitability of different types of Augmentin in EU countries
Danish: Egnethed af forskellige typer Augmentin i EU-landene
English: 21 February 2008
Danish: 21. februar 2008
English: The 16:1 ratio is for patients aged at least 16 years.
Danish: Forholdet 16:1 anvendes til patienter, der er mindst 16 år gamle.
English: London, 19 October 2009 Doc.
Danish: London, den 19. oktober 2009 Dok.
English: It is used for the short-term treatment of a number of common infections:
Danish: Det anvendes til korttidsbehandling af en række almindelige infektioner:
English: Augmentin is authorised in the EU via national procedures.
Danish: Augmentin er godkendt i EU efter nationale procedurer.
English: Dr. Gonzalo Calvo Rojas (Spain)
Danish: Dr. Broich (Tyskland) Dr. Gonzalo Calvo Rojas (Spanien)
English: Company responses provided on: 2 June 2008, 17 November 2008, 19 January 2009, 23 March 2009 and 25 May 2009
Danish: 2. juni 2008, 17. november 2008, 19. januar 2009, 23. marts 2009 og 25. maj 2009
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by Member States
Danish: Artikel 30 i direktiv 2001/83/EF, med senere ændringer, indbringelse på baggrund af medlemsstaternes divergerende beslutninger.
English: Augmentin is an antibiotic.
Danish: Augmentin er et antibiotikum.
English: The review was carried out under an ‘Article 30' referral
Danish: Revurderingen fandt sted inden for rammerne af en indbringelsesprocedure i henhold til artikel 30
English: It can be used in the prevention of some infections.
Danish: Herudover kan det anvendes til forebyggelse af visse infektioner.
English: Contra-indications
Danish: Kontraindikationer
English: What is Augmentin?
Danish: Hvad er Augmentin?
English: On 28 January 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Augmentin in the EU.
Danish: Den 28. januar 2008 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Augmentin i EU.
English: As a result, the antibiotic can work for longer, and is more effective in killing bacteria.
Danish: Som et resultat heraf kan antibiotikummet virke i længere tid og dræbe bakterierne mere effektivt.
English: The CHMP recommended that the indication of tonsillitis for Augmentin be removed.
Danish: CHMP anbefalede, at indikationen tonsillitis blev fjernet for Augmentin.
English: The Committee agreed that the injection can always be used at the start of treatment, before switching to the tablets or oral suspension, for all the disease for which oral treatment is appropriate.
Danish: Udvalget besluttede, at injektion altid kan bruges ved behandlingens start, inden man går over til tabletter eller oral suspension, ved alle de sygdomme, hvor oral behandling er hensigtsmæssig.
English: • infections of the respiratory tract (airways and lungs) such as tonsillitis, sinusitis, otitis media
Danish: • infektioner i luftvejene (luftveje og lunger) såsom tonsillitis, sinusitis, otitis media
English: It can also be used for more serious infections, such as bone or intra-abdominal infections.
Danish: Det kan ligeledes anvendes til alvorligere infektioner såsom knogleinfektioner eller intraabdominale infektioner.
English: Why was Augmentin reviewed?
Danish: Hvorfor blev Augmentin vurderet igen?
English: It is also available under other trade names, such as Augmentan, Augmentine, Clavamel, Clavamox, Clavepen, Clavulin, Clavumox, Clavurion, Neoduplamox, Noprilam, Pangamox, Penilan and Spektramox.
Danish: Det markedsføres ligeledes under andre særnavne såsom Augmentan, Augmentine, Clavamel, Clavamox, Clavepen, Clavulin, Clavumox, Clavurion, Neoduplamox, Noprilam, Pangamox, Penilan og Spektramox.
English: The European Medicines Agency has completed a review of Augmentin.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har foretaget en revurdering af Augmentin.
English: Questions and answers on the referral for Augmentin (amoxicillin and clavulanic acid)
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Augmentin (amoxicillin og clavulansyre)
English: This has led to divergences in the way the medicine can be used across Member States in which this medicine is approved, as seen in the differences in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the medicines are marketed.
Danish: Dette har medført, at lægemidlet kan anvendes på forskellige måder i de medlemsstater, hvor det er godkendt, sådan som det fremgår af forskellene i produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: The ratio of amoxicillin to clavulanic acid can vary from 16:1 (one gram of amoxicillin to 62.5 mg clavulanic acid) to 2:1 (250 mg of amoxicillin to 125mg of clavulanic acid).
Danish: Forholdet mellem amoxicillin og clavulansyre kan variere fra 16:1 (1 gram amoxicillin til 62,5 mg clavulansyre) til 2:1 (250 mg amoxicillin til 125 mg clavulansyre).
English: This is because the total daily dose of amoxicillin these formulations provide using the standard dosages is not sufficient to kill effectively the bacteria while higher dosages may result in patients receiving too much clavulanic acid.
Danish: Dette skyldes, at den totale daglige dosis amoxicillin, som disse formuleringer giver med standarddoseringerne, ikke er nok til at dræbe bakterierne effektivt, mens højere doseringer kan resultere i, at patienterne får for meget clavulansyre.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Augmentin in the European Union (EU).
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Augmentin i Den Europæiske Union (EU).