FrancophonIA/ELRC3.0 huggingface dataset:
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would be unable to provide requested data on the medicine's manufacture within the required time frame.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at det ikke ville være muligt at fremskaffe de supplerende data, der krævedes af CHMP, inden for den tidsramme, som er fastsat til proceduren.
English: The active substance in Zafiride is thought to work by attaching to targets called CD13 and TNF receptors, found on new blood vessels forming around tumours.
Danish: Det aktive stof i Zafiride tænkes at fungere ved at binde sig til mål, kaldet CD13- og TNF-receptorer, som findes på nye blodårer, der dannes omkring tumorer.
English: Zafiride was compared with placebo (a dummy treatment), and all patients in the study had previously been treated with pemetrexed-based chemotherapy.
Danish: Virkningen af Zafiride blev sammenlignet med placebo (en virkningsløs behandling), og alle patienter i undersøgelsen var tidligere blevet behandlet med pemetrexed-baseret kemoterapi.
English: How does Zafiride work?
Danish: Hvordan virker Zafiride?
English: Zafiride was expected to be used for treating adults with advanced malignant pleural mesothelioma, a cancer of the lining of the lungs usually caused by exposure to asbestos.
Danish: Zafiride forventedes anvendt til behandling af voksne med fremskredent malignt pleuramesoteliom, en kræftform i lungehinden, der normalt forårsages af eksponering for asbest.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Zafiride could not be approved for the second-line treatment of advanced malignant pleural mesothelioma in patients whose disease had worsened within 6 months of treatment with pemetrexed.
Danish: CHMP havde på tidspunktet for tilbagetrækningen betænkeligheder baseret på gennemgangen af dataene og var af den foreløbige opfattelse, at Zafiride ikke kunne godkendes til andenlinjebehandling af fremskredent malignt pleuramesoteliom hos patienter, hvis sygdom var blevet forværret inden for 6 måneder fra behandlingen med pemetrexed.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Zafiride.
Danish: Virksomheden har til CHMP oplyst, at der ikke er nogen konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser eller i programmer for anvendelse af Zafiride med særlig udleveringstilladelse.
English: Zafiride was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 3 June 2008 for malignant mesothelioma.
Danish: Zafiride blev den 3. juni 2008 udpeget som "lægemiddel til sjældne sygdomme" til behandling af malignt mesoteliom.
English: It was to be available as a solution for infusion (drip) into a vein.
Danish: Det var meningen, at det skulle leveres som en infusionsvæske, opløsning (til indgivelse gennem et drop).
English: On 1 June 2017, MolMed S.p.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zafiride for the treatment of advanced malignant pleural mesothelioma.
Danish: officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Zafiride til behandling af malignt pleuramesoteliom.
English: This summary was last updated in 08-2019.
Danish: Dette sammendrag blev sidst ajourført i 08-2019.
English: Here are some of the main results from these studies:
Danish: I det efterfølgende redegøres for de vigtigste resultater af disse studier:
English: The usual recommended infusion time is approximately 60 minutes.
Danish: Den sædvanlige anbefalede infusionstid er ca. 60 minutter.
English: This was switched to a full marketing authorisation on 15 January 2015.
Danish: Den blev ændret til en fuldgyldig markedsføringstilladelse den 15. januar 2015.
English: The recommended dose of Vectibix is 6 mg per kilogram body weight given once every two weeks.
Danish: Den anbefalede dosis Vectibix er 6 mg pr. kilogram kropsvægt givet én gang hver anden uge.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Danish: Da virksomheden har indsendt den fornødne supplerende information, er godkendelsen ændret fra en betinget godkendelse til en fuldgyldig godkendelse.
English: It contains the active substance panitumumab.
Danish: Det indeholder det aktive stof panitumumab.
English: Further information on Vectibix can be found on the Agency's website ema.europa.eu/ medicines/human/EPAR/vectibix.
Danish: Yderligere information om Vectibix findes på agenturets websted under: ema.europa.eu/ medicines/human/EPAR/vectibix.
English: Vectibix received a conditional marketing authorisation valid throughout the EU on 3 December 2007.
Danish: Vectibix fik en betinget markedsføringstilladelse med gyldighed i hele EU den 3. december 2007.
English: This is because growth of these types of cells does not depend on EGFR and they can continue to grow uncontrollably even when EGFR is blocked.
Danish: Dette skyldes, at væksten af disse typer af celler ikke er betinget af EGFR, og at de kan fortsætte med at vokse ukontrolleret, selv om EGFR blokeres.
English: The dose may need to be modified if severe skin reactions occur and treatment stopped if the reaction does not get better.
Danish: Det kan være nødvendigt at ændre dosis, hvis der opstår alvorlige hudreaktioner, og standse behandlingen, hvis reaktionen ikke bliver bedre.
English: As for all medicines, data on the use of Vectibix are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Vectibix løbende overvåget.
English: As a result, these tumour cells can no longer receive the messages transmitted via EGFR that they need to grow and spread to other parts of the body.
Danish: Dette resulterer i, at disse tumorceller ikke længere kan modtage de beskeder, som overføres via EGFR, og som de behøver for at kunne vokse og sprede sig til andre dele af kroppen.
English: An overview of Vectibix and why it is authorised in the EU
Danish: En oversigt over Vectibix, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Vectibix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vectibix?
English: Other information about Vectibix
Danish: Andre oplysninger om Vectibix
English: The European Medicines Agency decided that Vectibix's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Vectibix opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Treatment with Vectibix should be supervised by a doctor who has experience in the use of cancer therapy.
Danish: Behandlingen med Vectibix bør overvåges af en læge med erfaring i kræftbehandling.
English: In studies, 93% of the patients receiving Vectibix had side effects affecting the skin, although most of these were mild or moderate.
Danish: Studierne viste, at 93 % af de patienter, der fik Vectibix, havde bivirkninger, som påvirkede huden, men at de fleste af disse var lette eller moderate.
English: Side effects reported with Vectibix are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Vectibix vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Vectibix was originally given ‘conditional authorisation' because there was more evidence to come about the medicine.
Danish: Der blev oprindelig udstedt en "betinget godkendelse" for Vectibix, fordi der afventedes yderligere dokumentation om lægemidlet.
English: It was later confirmed that benefit is limited only to patients with wildtype RAS tumours.
Danish: Det blev senere bekræftet, at fordelen var begrænset til patienter med vildtype-RAS-tumorer.
English: What is Vectibix and what is it used for?
Danish: Hvad er Vectibix, og hvad anvendes det til?
English: For more information about using Vectibix, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Vectibix, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The most common side effects with Vectibix (in more than 2 patients in 10) were diarrhoea, nausea (feeling sick), vomiting, constipation, abdominal pain (stomach ache), tiredness, fever, lack of appetite, paronychia (nail bed infection), rash, acneiform dermatitis (skin inflammation resembling acne), pruritus (itching), erythema (reddening of the skin) and dry skin.
Danish: De hyppigste bivirkninger ved Vectibix (hos mere end 2 ud af 10 patienter) var diarré, kvalme, opkast, forstoppelse, mavesmerter, træthed, feber, appetitløshed, paronychi (infektion i neglelejet), udslæt, aknelignende dermatitis (betændelse i huden, som ligner akne), pruritus (kløe), erythem (rødme) og tør hud.
English: Vectibix is a medicine for treating colorectal (bowel) cancer that has spread to other parts of the body.
Danish: Vectibix er et lægemiddel mod kolorektal cancer (tarmkræft), der har spredt sig til andre dele af kroppen.
English: Patients receiving Vectibix also had a longer period of time without their disease getting worse: 6.4 months versus 4.6 months.
Danish: De patienter, der fik Vectibix, levede også længere tid, uden at sygdommen blev værre, nemlig 6,4 måneder mod 4,6 måneder.
English: Vectibix can only be obtained with a prescription.
Danish: Vectibix fås kun på recept.
English: Patients in this study (there was no comparator treatment) lived for an average of 11.2 months without their disease getting worse.
Danish: Patienterne i dette studie (der ikke omfattede en sammenligningsbehandling) levede i gennemsnit 11,2 måneder, uden at deres sygdom blev værre.
English: Why is Vectibix approved?
Danish: Hvorfor er Vectibix godkendt?
English: It should only be started after the presence of wild-type RAS has been confirmed by an experienced laboratory using a validated test method.
Danish: behandlingen bør kun indledes efter, at et erfarent laboratorium ved anvendelse af en godkendt testmetode har bekræftet, at der er tale om vildtype-RAS.
English: Patients given these combinations lived for an average of 14.8 months and 12.8 months respectively without their disease getting worse.
Danish: Patienter, der fik disse kombinationer, levede i gennemsnit henholdsvis 14,8 og 12,8 måneder, uden at deres sygdom blev værre.
English: The active substance in Vectibix, panitumumab, is a monoclonal antibody, a type of protein that has been designed to attach to and block a target called EGFR on certain cells, including some tumour cells.
Danish: Det aktive stof i Vectibix, panitumumab, er et monoklonalt antistof, en type protein, som er skabt til at kunne binde sig til og blokere et mål kaldet EGFR på bestemte celler, herunder visse tumorceller.
English: This study involved patients with either wild-type or mutant RAS whose disease had got worse despite treatments that included a fluoropyrimidine, oxaliplatin and irinotecan.
Danish: Dette studie omfattede patienter med enten vildtype-RAS eller muteret RAS, hvis sygdom var blevet værre trods behandlinger med bl.a. fluoropyrimidin, oxaliplatin og irinotecan.
English: What are the risks associated with Vectibix?
Danish: Hvilke risici er der forbundet med Vectibix?
English: It must not be used in patients with interstitial pneumonitis or pulmonary fibrosis (lung diseases).
Danish: Vectibix må ikke bruges hos patienter med interstitiel pneumoni eller pulmonal fibrose (lungesygdomme).
English: Vectibix is available for infusion (drip) into a vein.
Danish: Vectibix gives som infusion (drop) i en vene.
English: Several bowel cancer studies have shown that Vectibix is effective at prolonging life or slowing disease progression in patients with ‘wild-type' RAS tumours that have spread.
Danish: Adskillige tarmkræftstudier har vist, at Vectibix virker livsforlængende eller hæmmer sygdommens progression hos patienter med "vildtype"-RAS-tumorer, der har spredt sig.
English: The studies show Vectibix can be effective when used alone and together with the standard chemotherapy regimens FOLFOX (a combination of fluorouracil with folinic acid and the cancer medicine oxaliplatin) or FOLFIRI (fluorouracil with folinic acid and a different cancer medicine, irinotecan).
Danish: Studierne viser, at Vectibix kan være effektivt, når det bruges alene og sammen med de traditionelle kemoterapibehandlinger FOLFOX (en kombination af fluorouracil med folinsyre og kræftlægemidlet oxaliplatin) eller FOLFIRI (fluorouracil med folinsyre og et andet kræftlægemiddel, irinotecan).
English: For the full list of side effects of Vectibix, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Vectibix fremgår af indlægssedlen.
English: Vectibix must not be used in patients who have had a severe or life-threatening hypersensitivity (allergic) reaction to panitumumab or any of the other ingredients in the past.
Danish: Vectibix må ikke bruges hos personer, der tidligere har haft en alvorlig eller livstruende allergisk reaktion over for panitumumab eller andre af indholdsstofferne.
English: Panitumumab does not seem to work against tumour cells that contain mutated (abnormal) RAS genes.
Danish: Panitumumab synes ikke at have nogen virkning på tumorceller, der indeholder muterede (abnorme) RAS-gener.
English: • Patients with wild-type tumours who received Vectibix alone had no disease progression for an average of 16 weeks in a study of 463 patients, compared with 8 weeks in those who did not receive Vectibix and only had supportive care.
Danish: • Af et studie, der omfattede 463 patienter, fremgik det, at patienter med vildtypetumorer, der udelukkende fik Vectibix, ikke havde nogen sygdomsprogression i gennemsnitligt 16 uger, sammenlignet med 8 uger for dem, der ikke fik Vectibix og kun fik støttende pleje.
English: Vectibix is used alone or with other cancer medicines in patients with a type of tumour that has normal (‘wild-type') copies of a gene known as RAS.
Danish: Vectibix bruges alene eller sammen med andre kræftlægemidler hos patienter, hvis tumorer indeholder normale "vildtype"-kopier af genet RAS.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vectibix 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 Vectibix.
English: What benefits of Vectibix have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Vectibix?
English: Vectibix must not be used with oxaliplatin-containing chemotherapy in patients whose tumour contains the mutated RAS gene or for whom the RAS status is not known.
Danish: Vectibix må ikke bruges sammen med kemoterapi indeholdende oxaliplatin hos patienter med tumorer, der indeholder det muterede RAS-gen, eller med tumorer, hvis RAS-status endnu ikke er bekræftet.
English: How is Vectibix used?
Danish: Hvordan anvendes Vectibix?
English: • Patients given Vectibix in combination with FOLFIRI lived for 16.2 months in a study of 1,186 previously treated patients compared with 13.9 months in patients receiving FOLFIRI alone.
Danish: • Af et studie, der omfattede 1.186 tidligere behandlede patienter, fremgik det, at de patienter, der fik Vectibix i kombination med FOLFIRI, levede i 16,2 måneder, sammenlignet med 13,9 måneder for de patienter, der fik FOLFIRI alene.
English: • Around 73% of patients given Vectibix plus FOLFIRI and 78% of those given Vectibix with FOLFOX had some reduction in signs of cancer in a study of 80 previously untreated patients.
Danish: • Af et studie, der omfattede 80 tidligere ubehandlede patienter, fremgik det, at ca. 73 % af de patienter, der fik Vectibix plus FOLFIRI, og 78 % af dem, der fik Vectibix med FOLFOX, havde en vis nedsættelse af tegnene på kræft.
English: How does Vectibix work?
Danish: Hvordan virker Vectibix?
English: • Around 59% of patients who received Vectibix plus FOLFIRI in a study of 154 previously untreated had some reduction in signs of cancer.
Danish: • Af et studie, der omfattede 154 tidligere ubehandlede patienter, fremgik det, at ca. 59 % af de patienter, der fik Vectibix plus FOLFIRI, havde en vis nedsættelse af tegnene på kræft.
English: • Patients receiving Vectibix in combination with FOLFOX lived for an average of 10.1 months without the disease getting worse in a study of 1,183 previously untreated patients compared with 7.9 months for those receiving FOLFOX alone.
Danish: • I et studie, der omfattede 1.183 tidligere ubehandlede patienter, blev det påvist, at de patienter, der fik Vectibix i kombination med FOLFOX, levede i gennemsnit 10,1 måneder, uden at sygdommen blev værre, sammenlignet med 7,9 måneder for dem, der fik FOLFOX alene.
English: These are appropriately reflected in the product information.
Danish: Disse er på passende måde afspejlet i produktinformationen.
English: Benefit/risk balance
Danish: Benefit/risk-forhold
English: This review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Denne gennemgang blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Danish: Bilag II Videnskabelige konklusioner og begrundelser for ændringen af betingelserne for markedsføringstilladelserne
English: Diclofenac is a non-steroidal anti-inflammatory drug (NSAID).
Danish: Diclofenac er et non-steroidt antiinflammatorisk lægemiddel (NSAID).
English: Furthermore, a proactive communication of these new measures through a direct healthcare professional communication (DHPC) was recommended.
Danish: Derudover anbefaledes proaktiv formidling af disse nye foranstaltninger gennem en direkte meddelelse til sundhedspersoner (DHPC).
English: • The PRAC also concluded that there was need for further risk minimisation measures such as information to healthcare professionals.
Danish: • PRAC konkluderede endvidere, at der er behov for yderligere risikominimeringsforanstaltninger såsom information til sundhedspersoner.
English: Major vascular events were increased by about one third by a coxib (rate ratio [RR] 1.37, 95% confidence interval [CI] 1.14-1.66; p=0.0009) or diclofenac (1.41, 1.12-1.78; p=0.0036), mainly due to an increase in major coronary events (coxibs: 1.76, 1.31-2.37; p=0.0001; diclofenac: 1.70, 1.19-2.41; p=0.0032).
Danish: Risikoen for større vaskulære hændelser var ca. 1/3 forhøjet med et coxib-præparat, (hyppighedsratio [RR] 1,37, 95 % sikkerhedsinterval [1,14; 1,66]; p=0,0009) og med diclofenac (1,41, [1,12; 1,78]; p=0,0036), hovedsagelig som følge af forhøjet forekomst af større koronare hændelser (for coxib-præparater: 1,76, [1.31; 2.37]; p=0,0001; for diclofenac: 1,70, [1,19; 2,37], p=0,0032).
English: The PRAC concluded that diclofenac is effective in reducing inflammation and pain.
Danish: PRAC konkluderede, at diclofenac er effektivt til at reducere inflammation og smerter.
English: The available information on the dose effect of diclofenac is limited.
Danish: De foreliggende oplysninger om dosiseffekten af diclofenac er begrænsede.
English: Overall summary of the scientific evaluation of diclofenac containing medicinal products (systemic formulations) (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af systemiske lægemidler indeholdende diclofenac (se bilag I)
English: With regards to cardiovascular risks, the PRAC noted that the initial signal from the MEDAL programme was confirmed by the meta-analyses of randomised clinical trials conducted by Trelle et al (2011) and Chen and Ashcroft (2007).
Danish: Vedrørende kardiovaskulære risici bemærkede PRAC, at det indledende signal fra MEDALprogrammet bekræftedes af metaanalyser af randomiserede kliniske undersøgelser foretaget af Trelle et al (2011) og Chen og Ashcroft (2007).
English: Some studies also report an association with lower doses.
Danish: Nogle undersøgelser viser således også årsagssammenhæng ved lavere doser.
English: The PRAC acknowledged the conclusions of previous reviews with regards to the cardiovascular safety of diclofenac.
Danish: PRAC anerkendte konklusionerne af de foregående gennemgange vedrørende den kardiovaskulære sikkerhed af diclofenac.
English: Therefore in accordance with Articles 31 and 32 of Directive 2001/83/EC, the PRAC recommends the variation of the marketing authorisations for all medicinal products referred to in Annex I and for which the amendments to the product information are set out in annex III of the recommendation.
Danish: I henhold til bestemmelserne i artikel 31 og 32 i direktiv 2001/83/EF anbefaler PRAC derfor ændring af markedsføringstilladelserne for alle lægemidler omhandlet i bilag I, for hvilke ændringerne i produktinformationen fremgår af bilag III til anbefalingen.
English: The PRAC considered that the recommendation for update of the product information should be applicable to all medicinal products containing diclofenac (systemic formulations), regardless of dose.
Danish: PRAC fandt, at anbefalingen om opdatering af produktinformationen bør gælde alle systemiske lægemidler indeholdende diclofenac, uanset dosis.
English: • The PRAC considered that diclofenac containing medicinal products are effective in their approved indications.
Danish: • PRAC fandt, at lægemidler indeholdende diclofenac er effektive til de godkendte indikationer
English: The study by Krum et al 2012, a post hoc analysis of the MEDAL trial, showed that there was no significant differential effect between etoricoxib and diclofenac in relation to cardiovascular events, except for confirmed congestive heart failure.
Danish: Krum et al 2012 foretog en post hoc-analyse af MEDALundersøgelsen og viste, at der ikke var nævneværdig forskel mellem etoricoxib og diclofenac hvad angår kardiovaskulære hændelser bortset fra bekræftet kronisk venstresidig hjerteinsufficiens.
English: Data provided by the MAHs in writing and at an oral explanation and relevant data made available by independent researchers were also considered.
Danish: Udvalget tog ligeledes i betragtning de oplysninger, som indehaverne af markedsføringstilladelse havde forelagt skriftligt og ved en mundtlig forklaring, samt relevante data stillet til rådighed af uafhængige forskere.
English: Evidence available from a new meta-analysis of randomised clinical trials conducted by an independent research group was included in the review.
Danish: I gennemgangen indgik data fra en ny metaanalyse af randomiserede kliniske undersøgelser, der var udført af en uafhængig forskningsgruppe.
English: NSAIDs, such as diclofenac, are indicated in the relief of all grades of pain and inflammation associated with a wide range of conditions, including arthritic conditions, acute musculo-skeletal disorders and other painful conditions resulting from trauma.
Danish: NSAID såsom diclofenac anvendes til lindring af alle grader af smerter og inflammation ved en lang række lidelser, herunder arthritis, akutte muskuloskeletale sygdomme og andre smertefulde traumeforårsagede tilstande.
English: The data available (in particular data from the MEDAL1 programme) suggested that the risk of arterial thrombotic events with diclofenac was similar to that for coxibs, but firm conclusions could not be drawn and further epidemiological studies were needed to obtain additional data.
Danish: De daværende foreliggende data (navnlig fra MEDAL-programmet1) tydede på, at risikoen for arterielle trombotiske hændelser med diclofenac var den samme som for coxib-præparater, men der kunne ikke drages endelige konklusioner, og der behøvedes flere epidemiologiske undersøgelser for at tilvejebringe yderligere data.