FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency considered that Zerbaxa was effective at curing infections in the patients studied, but acknowledged that only a limited number of patients with complicated urinary tract infections had been included.
Danish: Agenturet fandt, at Zerbaxa var effektivt til at helbrede infektioner hos de undersøgte patienter, men anerkendte, at der kun var indgået et begrænset antal patienter med komplicerede urinvejsinfektioner.
English: The European Medicines Agency decided that Zerbaxa'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 Zerbaxa opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Zerbaxa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zerbaxa?
English: Zerbaxa is an antibiotic used to treat adults with:
Danish: Zerbaxa er et antibiotikum, der anvendes til at behandle voksne med:
English: Zerbaxa (ceftolozane / tazobactam)
Danish: Zerbaxa (ceftolozan/tazobactam)
English: Side effects reported with Zerbaxa are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Zerbaxa vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: • complicated (difficult to treat) infections of tissues and organs within the belly (intra-abdominal infections);
Danish: • komplicerede (svære at behandle) infektioner i væv og organer i maven (intraabdominale infektioner)
English: For more information about using Zerbaxa, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Zerbaxa, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Why is Zerbaxa authorised in the EU?
Danish: Hvorfor er Zerbaxa godkendt i EU?
English: The Agency also noted that tazobactam is not active against some classes of beta-lactamase that can cause problems of resistance.
Danish: Agenturet bemærkede også, at tazobactam ikke er aktivt mod visse klasser af betalaktamase, hvilket kan medføre resistensproblemer.
English: An overview of Zerbaxa and why it is authorised in the EU
Danish: En oversigt over Zerbaxa, og hvorfor det er godkendt i EU
English: It works by interfering with the production of molecules that bacteria need to build their protective cell walls.
Danish: Det virker ved at gribe ind i dannelsen af molekyler, som bakterierne behøver for at opbygge deres beskyttende cellevægge.
English: The third study involved 726 patients who were using a ventilator and who had either hospitalacquired pneumonia or ventilator-associated pneumonia.
Danish: Det tredje studie omfattede 726 patienter, der brugte respirator, og som enten havde hospitalserhvervet lungebetændelse eller respiratorrelateret lungebetændelse.
English: One study involved 1,083 patients who mostly had kidney infection or in some cases a complicated urinary-tract infection.
Danish: Det ene studie omfattede 1.083 patienter, hovedsagelig med nyreinfektioner eller i visse tilfælde komplicerede urinvejsinfektioner.
English: What is Zerbaxa and what is it used for?
Danish: Hvad er Zerbaxa, og hvad anvendes det til?
English: Zerbaxa was compared with another antibiotic, meropenem.
Danish: Zerbaxa blev her sammenlignet med et andet antibiotikum, nemlig meropenem.
English: Zerbaxa must not be used in people who are hypersensitive (allergic) to Zerbaxa or any of its ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
Danish: Zerbaxa må ikke anvendes hos personer, som er overfølsomme (allergiske) over for Zerbaxa eller nogen af indholdsstofferne heri, eller hos personer, som er allergiske over for andre antibiotika af cefalosporin-typen eller har haft en svær allergisk reaktion over for et andet betalaktamantibiotikum.
English: Both medicines cured 94% of patients (353 out of 375 given Zerbaxa and 375 out of 399 given meropenem).
Danish: Begge lægemidler helbredte 94 % af patienterne (353 ud af 375, som fik Zerbaxa, og 375 ud af 399, som fik meropenem).
English: • serious kidney infection (acute pyelonephritis);
Danish: • alvorlige nyreinfektioner (akut pyelonefrit)
English: Zerbaxa is available for infusion (drip) into a vein and can only be obtained with a prescription.
Danish: Zerbaxa fås til infusion (drop) i en vene og fås kun på recept.
English: The active substances in Zerbaxa, ceftolozane and tazobactam, work in different ways.
Danish: De to aktive stoffer i Zerbaxa, ceftolozan og tazobactam, virker på forskellige måder.
English: Zerbaxa has been shown to be at least as effective as other antibiotics in curing infections in three main studies.
Danish: Zerbaxa er i tre hovedstudier påvist at være mindst lige så effektivt som andre antibiotika til at helbrede infektioner.
English: What are the risks associated with Zerbaxa?
Danish: Hvilke risici er der forbundet med Zerbaxa?
English: By blocking the action of these enzymes, tazobactam allows ceftolozane to act against bacteria that would otherwise be resistant to ceftolozone.
Danish: Ved at blokere virkningen af disse enzymer giver tazobactam ceftolozan mulighed for at virke mod bakterier, der ellers ville være resistente over for ceftolozon.
English: Zerbaxa successfully treated the infection in about 85% of the cases where it was given (288 of 340), compared with 75% (266 of 353) of those given another antibiotic called levofloxacin.
Danish: Zerbaxa behandlede infektionen med vellykket resultat i omkring 85 % af de tilfælde, hvor det blev anvendt (288 af 340), sammenholdt med 75 % (266 af 353) af de tilfælde, hvor der blev anvendt et andet antibiotikum, nemlig levofloxacin.
English: • complicated infections of the urinary tract (structures that carry urine, such as the bladder);
Danish: • komplicerede infektioner i urinvejene (de strukturer, der fremfører urin, såsom blæren)
English: Zerbaxa contains the active substances ceftolozane and tazobactam.
Danish: Zerbaxa indeholder de aktive stoffer ceftolozan og tazobactam.
English: These enzymes enable bacteria to break down beta-lactam antibiotics like ceftolozane, making the bacteria resistant to the antibiotic's action.
Danish: Disse enzymer sætter bakterier i stand til at nedbryde betalaktam-antibiotika som ceftolozan, hvorved bakterierne bliver resistente over for den antibakterielle virkning.
English: For the full list of side effects of Zerbaxa, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Zerbaxa fremgår af indlægssedlen.
English: Ceftolozane is a type of antibiotic called a cephalosporin, which belongs to the wider group of antibiotics called betalactams.
Danish: Ceftolozan er et antibiotikum af cefalosporin-typen, der tilhører den større gruppe betalaktamer.
English: How is Zerbaxa used?
Danish: Hvordan anvendes Zerbaxa?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zerbaxa 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 Zerbaxa.
English: It found Zerbaxa to be at least as effective as meropenem: the infection had resolved in 54% of patients (197 out of 362) after 7 to 14 days of treatment with Zerbaxa compared with 53% of patients (194 out of 362) on meropenem.
Danish: Infektionen gik væk hos 54 % af patienterne (197 out of 362) efter 7 til 14 dages behandling med Zerbaxa sammenlignet med 53 % af de patienter (194 ud af 362), som fik meropenem.
English: What benefits of Zerbaxa have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Zerbaxa?
English: How does Zerbaxa work?
Danish: Hvordan virker Zerbaxa?
English: • hospital-acquired pneumonia (an infection of the lungs that is caught in the hospital), including ventilator-associated pneumonia (pneumonia in patients using a ventilator, a machine that helps a patient to breathe).
Danish: (lungebetændelse pådraget fra en respirator, der hjælper patienten med at trække vejret).
English: The European Commission issued a decision on 10 January 2010.
Danish: Europa-Kommissionen traf en afgørelse den 10. januar 2010.
English: What is Extraneal?
Danish: Hvad er Extraneal?
English: This variation was to be recognised in Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden (the concerned Member States).
Danish: Denne ændring skulle godkendes i Østrig, Belgien, Danmark, Finland, Frankrig, Tyskland, Grækenland, Irland, Italien, Luxembourg, Nederlandene, Portugal, Spanien og Sverige (de berørte medlemsstater).
English: Why was Extraneal reviewed?
Danish: Hvorfor blev Extraneal vurderet igen?
English: Dr Ian Hudson (United Kingdom)
Danish: Dr. Ian Hudson (Det Forenede Kongerige)
English: Dr Barbara van Zwieten Boot (Netherlands)
Danish: Dr. Barbara van Zwieten Boot (Nederlandene)
English: Extraneal is authorised in the European Union under a mutual recognition procedure on the basis of the initial authorisation granted by the United Kingdom in 1997.
Danish: Extraneal er godkendt i EU efter en gensidig anerkendelsesprocedure på baggrund af den oprindelige markedsføringstilladelse, der blev udstedt af Det Forenede Kongerige i 1997.
English: Icodextrin is a type of sugar that is used to keep blood glucose at the correct level.
Danish: Icodextrin er en type sukker, der anvendes til at holde blodsukkeret på det korrekte niveau.
English: 23 July 2009
Danish: 23. juli 2009
English: Extraneal is used in particular in patients who cannot be treated with solutions containing glucose.
Danish: Extraneal bruges navnlig til patienter, der ikke kan behandles med opløsninger, som indeholder glukose.
English: Article 6(12) of Regulation (EC) 1084/2003 as amended, referral on a variation to a marketing authorisation
Danish: 1 Artikel 6, stk. 12, i forordning (EF) nr. 1084/2003, med senere ændringer, indbringelse på grund af en ændring i markedsføringstilladelsen.
English: Because these Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 9 July 2009.
Danish: Disse medlemsstater kunne ikke nå til enighed, og derfor indbragte den nederlandske lægemiddelkontrolmyndighed den 9. juli 2009 sagen for CHMP med henblik på voldgift.
English: Extraneal is a solution that contains icodextrin as the active substance, as well as sodium lactate, sodium chloride, calcium chloride and magnesium chloride.
Danish: Extraneal er en opløsning, der indeholder det aktive stof icodextrin samt natriumlaktat, natriumchlorid, calciumchlorid og magnesiumchlorid.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the variation to the marketing authorisation for Extraneal can be approved in all concerned Member States.
Danish: På grundlag af vurderingen af de tilgængelige data og den faglige drøftelse i udvalget konkluderede CHMP, at ændringen af markedsføringstilladelsen for Extraneal kan godkendes i alle de berørte medlemsstater.
English: This is a blood clearance technique used in patients with long-term kidney failure, when a solution is pumped into the abdomen and an internal body membrane filters the blood.
Danish: Det er en blodclearanceteknik, der bruges til patienter med længerevarende nyresvigt, og hvor en væske pumpes ind i abdomen, mens en intern kropsmembran filtrerer blodet.
English: Questions and answers on the referral for Extraneal icodextrin 7.5% solution for peritoneal dialysis
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Extraneal peritonealdialysevæske indeholdende icodextrin 7,5 %
English: Peptidoglycans had been linked to cases of inflammation of the peritoneum (the lining of the abdomen) in some patients receiving Extraneal.
Danish: Peptidoglycaner var blevet sat i forbindelse med betændelse i peritoneum (bughinden) hos nogle af de patienter, der fik Extraneal.
English: The European Medicines Agency has completed an arbitration procedure for Extraneal 7.5% solution for peritoneal dialysis.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har gennemført en voldgiftsprocedure for Extraneal 7,5 % peritonealdialysevæske.
English: The grounds for the referral were that more sensitive tests than those proposed by the company could be used to detect peptidoglycans in the medicine, and that one of the currently approved manufacturers of the active substance should modify the manufacturing process of icodextrin to ensure that peptidoglycans are removed.
Danish: Begrundelserne for indbringelsen var, at mere følsomme test end dem, som virksomheden foreslog, kunne anvendes til at spore peptidoglycaner i lægemidlet, og at de nuværende godkendte fremstillere af det aktive stof skulle ændre fremstillingsprocessen for icodextrin for at sikre, at peptidoglycanerne bliver fjernet.
English: Extraneal is a solution that is used in peritoneal dialysis.
Danish: Extraneal er en opløsning, der anvendes ved peritonealdialyse.
English: The review was carried out under an ‘Article 6(12)' referral1.
Danish: Revurderingen fandt sted inden for rammerne af en indbringelsesprocedure i henhold til artikel 6, stk.
English: The company applied for a change (variation) to the marketing authorisation to include a test to measure the level of an impurity called peptidoglycan during the medicine's production process.
Danish: Virksomheden ansøgte om en ændring af markedsføringstilladelsen med henblik på at medtage en test til måling af niveauet af en urenhed kaldet peptidoglycan under lægemidlets fremstillingsproces.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the change to the marketing authorisation for Extraneal to include a peptidoglycan test can be granted, and that the use of the active substance icodextrin sourced from one of the currently approved manufacturers should cease.
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at ændringen af markedsføringstilladelsen for Extraneal med henblik på at medtage en peptidoglycantest kan godkendes, og at brugen af det aktive stof icodextrin fra en af de på nuværende tidspunkt godkendte fremstillere bør ophøre.
English: Company responses provided on: 31 August 2009 Opinion date:
Danish: Dato for virksomhedens svar:
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1037/001 Pemetrexed Sandoz 100 mg Powder for concentrate for solution for infusion
Danish: MT (EU) nummer
English: The quality of this product is considered to be acceptable.
Danish: Produktets kvalitet anses for at være acceptabel.
English: Steatosis
Danish: Steatose
English: However, the consequences of these findings are unclear.
Danish: Konsekvenserne af disse fund er imidlertid uklare.
English: Potential effect of LDL reduction
Danish: Potentiel virkning af reduktion af LDL
English: Overall summary of the scientific evaluation of Kynamro
Danish: Samlet resumé af den videnskabelige vurdering af Kynamro
English: The CHMP considered the following:
Danish: CHMP tog følgende punkter i betragtning:
English: This is regarded by the CHMP as a major deficiency, and was also criticized by the expert advisory group.
Danish: Dette anses af CHMP for en væsentlig mangel og blev også kritiseret af den rådgivende ekspertgruppe.
English: In addition, complement activation was more pronounced in patients with antibody formation.
Danish: Komplementaktivering var desuden mere udtalt hos patienter med antistofdannelse.
English: This is based on the consideration that in a high risk population a larger proportion of events could be expected also in the placebo group.
Danish: Dette bygger på, at der hos en højrisikopopulation også må forventes en højere andel af hændelser i placebogruppen.
English: On the basis of the following grounds for the refusal of the Marketing Authorisation:
Danish: På grundlag af følgende begrundelse for afvisningen af ansøgningen om markedsføringstilladelse:
English: This view was also supported by the experts who considered the extrapolation as only hypothetical.
Danish: Dette synspunkt blev også støttet af eksperterne, som anså ekstrapolationen for at være rent hypotetisk.
English: Therefore, the CHMP concluded on 13 December 2012 that the benefit/risk ratio of mipomersen is negative.
Danish: Derfor konkluderede CHMP den 13. december 2012, at benefit/risk-forholdet for mipomersen er negativt.
English: At the time of opinion, there are no outstanding issues on the quality of the active substance or the medicinal product.
Danish: På tidspunktet for denne udtalelse er der intet udestående spørgsmål vedrørende kvaliteten af det aktive stof eller lægemidlet.
English: Additional data will be collected in on-going and proposed studies.
Danish: I de igangværende og påtænkte undersøgelser vil der blive indsamlet yderligere data.
English: With respect to the Kynamro Patient Support programme, the CHMP considered that its usefulness, suitability and applicability in different EU countries are difficult to foresee.
Danish: Hvad angår patientstøtteprogrammet for Kynamro fandt CHMP, at dets nytteværdi, egnethed og anvendelighed i forskellige EU-lande er vanskelig at forudsige.
English: The numerically higher number of neoplasms and cancer raises an additional safety concern.
Danish: Det numerisk højere antal neoplasmer og kræfttilfælde udgør endnu en sikkerhedsmæssig betænkelighed.
English: • Safety issues
Danish: • Spørgsmål vedrørende sikkerhed
English: The experts felt, however, that potentially a restricted prescription programme in dedicated centres capable of providing support on individual patient basis might be helpful.
Danish: Eksperterne mente imidlertid, at et indskrænket ordinationsprogram på dedikerede centre, der kan støtte den enkelte patient, kunne være nyttigt.
English: In all phase 3 studies, patients were excluded for “significant hepatic disease”.
Danish: I alle fase 3-undersøgelser blev der ekskluderet patienter på grund af "leversygdom af betydeligt omfang".
English: Following the CHMP scientific conclusions adopted on 13 December 2012 that Kynamro was not approvable for the treatment of
Danish: Efter CHMP's videnskabelige konklusioner af 13. december 2012, der fastslog, at Kynamro ikke kunne godkendes til behandling af
English: Summary of the applicant's grounds for re-examination:
Danish: Sammenfatning af ansøgerens begrundelse for fornyet overvejelse:
English: Mipomersen may be immunogenic and antibodies were detected in 65% of subjects taking the product.
Danish: Mipomersen kan være immunogent, og der blev fundet antistoffer hos 65 % af de personer, der fik produktet.
English: Such conditional Marketing Authorisation could therefore not be recommended.
Danish: En sådan markedsføringstilladelse under særlige omstændigheder kunne derfor ikke anbefales.
English: Nevertheless, the relevance of the direct comparison to mipomersen within the two trials must not be disregarded.
Danish: Alligevel må der ikke ses bort fra relevansen af den direkte sammenligning med mipomersen i de to undersøgelser.
English: From the available data, it is also not clear whether patients´ ALT or AST levels reached a maximal effect (plateau).
Danish: De foreliggende data gør det heller ikke klart, om patienternes ALT eller AST nåede et maksimum (plateau).
English: The CHMP concluded that such data has not been presented by the applicant at this time point.
Danish: CHMP konkluderede, at ansøgeren ikke på nuværende tidspunkt har fremskaffet sådanne data.
English: on 31 January 2013, the applicant submitted its detailed grounds for the request for re-examination of the CHMP opinion recommending the refusal of the granting of the marketing authorisation.
Danish: Den 31. januar 2013 indsendte ansøgeren sin detaljerede begrundelse for anmodningen om fornyet overvejelse af CHMP's udtalelse, der anbefaler afslag på ansøgningen om markedsføringstilladelse.
English: Exclusion criteria were also in place to ensure adequate hepatic function based on laboratory values (ALT, ALT > 1.5 x ULN).
Danish: Der var desuden eksklusionskriterier til sikring af adækvat leverfunktion baseret på laboratorieværdier (AST, ALT > 1,5 x ULN).
English: Furthermore, the guideline also states that “a new lipid-modifying agent is only acceptable for authorisation if there is no suggestion of a detrimental effect on morbidity and mortality.
Danish: Derudover anføres det i vejledningen: "Et nyt lipidmodificerende middel kan kun godkendes, hvis der ikke er tegn på negativ indvirkning på morbiditet og mortalitet.
English: Although most of the relevant risks are identified within the risk management plan, the risk management system is considered inadequate and the proposed risk minimization measures are deficient in a number of important areas.
Danish: Skønt de fleste af de relevante risici er omfattet af risikostyringsplanen, anses risikostyringssystemet for utilstrækkeligt, og de foreslåede risikominimeringsforanstaltninger er mangelfulde på en række vigtige områder.
English: The following issues were addressed by the applicant;
Danish: Følgende punkter blevet gennemgået af ansøgeren:
English: Withdrawal rate was similar in HoFH patients and in the full population of OLE CS6 (56%).
Danish: Udtrædelsesraten var den samme hos HoFH-patienterne som i den samlede population i OLE CS6 (56 %).
English: The CHMP is of the opinion that the safety and efficacy of the above mentioned medicinal product is not properly or sufficiently demonstrated.
Danish: Det er CHMP's opfattelse, at virkningen af ovennævnte lægemiddel ikke er dokumenteret på passende og tilstrækkelig vis.
English: Finally, LDL reduction is only one mechanism affecting cardiovascular risk and as discussed above, no detrimental effect should be present that might counteract such improvements.
Danish: Endelig er reduktion af LDL kun en af de mekanismer, der har indflydelse på den kardiovaskulære risiko, og som nævnt ovenfor bør der ikke være skadelige faktorer, der kan modvirke sådanne forbedringer.
English: In the HoFH, the retention rate was only 8% at 3 years, with 63% withdrawing due to adverse events.
Danish: Ved HoFH var retentionsraten kun 8 % efter tre år, og 63 % udgik på grund af bivirkninger.
English: The adopted Guideline on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (CPMP/EWP/3020/03/2004), states on the matter that the safety database should be large enough to reasonably rule out any suspicion of a detrimental effect of the new drug on mortality and that this requirement acquires special relevance in case of drugs belonging to a new therapeutic class.
Danish: I den vedtagne vejledning om klinisk undersøgelse af lægemidler til behandling af forstyrrelser i fedtstofskiftet ("Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders", CPMP/EWP/3020/03/2004) anføres, at sikkerhedsdatabasen skal være tilstrækkeligt stor til, at man med rimelighed kan udelukke enhver mistanke om negativ effekt af det nye lægemiddel på dødeligheden, og at dette krav er særlig relevant for lægemidler tilhørende en ny terapeutisk klasse.
English: The CHMP assessed all the detailed grounds for re-examination and argumentations presented by the applicant and considered the views of the PRAC (PRAC meeting 4-7 February 2013) and the advisory expert group held on 12 March 2013.
Danish: CHMP vurderede hele ansøgerens argumentation og detaljerede begrundelse for fornyet overvejelse og tog hensyn til udtalelserne fra Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC) (fra dettes møde den 4.-7. februar 2013) og fra ekspertgruppens møde den 12. marts 2013.