FrancophonIA/ELRC3.0 huggingface dataset:
English: The studies, called ‘bioequivalence' studies, are usually the basis for approving generic medicines.
Danish: Disse såkaldte bioækvivalensundersøgelser danner normalt grundlag for godkendelse af generiske lægemidler.
English: • Medicines still under evaluation cannot be granted authorisation in the EU on the basis of studies conducted at Semler; further data would have to be provided to support authorisation.
Danish: • Lægemidler, der er ved at blive vurderet, kan ikke godkendes i EU på grundlag af undersøgelser, der er udført hos Semler.
English: The application was withdrawn in Germany, Norway and Spain, but the procedure was positively ended in all other Member States on 7 March 2003.
Danish: Ansøgningen blev trukket tilbage i Tyskland, Norge og Spanien, men proceduren afsluttedes med positivt resultat i alle andre medlemsstater den 7. marts 2003.
English: The final opinion was converted into a Decision by the European Commission on 09 August 2005.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 9. august
English: The Rapporteur and Co-Rapporteur appointed were Dr P. Nilsson and Dr. G. Calvo, respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis dr. P. Nilsson og dr. G. Calvo.
English: Netherlands on 6 November 2002 and a Mutual Recognition Procedure was started on 7 December 2002.
Danish: Nederlandene den 6. november 2002, og der blev indledt en procedure for gensidig anerkendelse den 7. december 2002.
English: International Non-Proprietary Name (INN): Rosuvastatin calcium
Danish: Internationalt fællesnavn ( INN): Rosuvastatin calcium
English: This procedure started on 04 August 2004.
Danish: Denne procedure indledtes den 4. august 2004.
English: The issue was referred for arbitration by the UK on 1 November 2004 (day 89).
Danish: Dette spørgsmål i sagen blev af Det Forenede Kongerige henvist til voldgift den 1. november 2004 (dag 89).
English: Crestor (rosuvastatin calcium) is a selective 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) that has been approved for use as a lipid-regulating agent in the management of patients with dyslipidaemia.
Danish: Crestor (rosuvastatin calcium) er en selektiv 3-hydroxy-3-methylglutaryl coenzym A (HMG-CoA) reduktase inhibitor (statin), som er blevet godkendt til anvendelse som et lipidregulerende middel i behandlingen af patienter med dyslipidæmi.
English: On the basis of the marketing authorisation for Crestor (5 mg) granted by The Netherlands, on 21 July 2004 the applicant submitted an application for Mutual Recognition to 13 Concerned Member States.
Danish: På grundlag af markedsføringstilladelsen for Crestor (5 mg) udstedt af Nederlandene indgav ansøgeren den 21. juli 2004 en ansøgning om gensidig anerkendelse i 13 berørte medlemsstater.
English: The main issue during the procedure was whether the 5 mg strength should be the recommended start dose for all patients.
Danish: Det vigtigste spørgsmål under proceduren var, hvorvidt styrken på 5 mg skulle være den anbefalede startdosis for alle patienter.
English: A Marketing Authorisation for Crestor (10 to 40 mg) was originally granted to AstraZeneca in The
Danish: Der blev oprindeligt udstedt en markedsføringstilladelse for Crestor (10 til 40 mg) til AstraZeneca i
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP)
English: Changes to SPC section 4.2 (Posology and method of administration) and 4.4 (Special warnings and special precautions for use) arising from the arbitration process were agreed by CHMP and a positive opinion was adopted on 21 April 2005.
Danish: godkendte ændringerne af afsnit 4.2 (dosering og indgivelsesmåde) og afsnit 4.4 (særlige advarsler og forsigtighedsregler under brugen) i produktresuméet som følge af voldgiftsproceduren og vedtog en positiv udtalelse den 21. april 2005.
English: The arbitration procedure started on 18 November 2004.
Danish: Voldgiftsproceduren blev indledt den 18. november 2004.
English: During its April 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Crestor 5 mg or Crestor 10 mg as start dose.
Danish: På sit møde i april 2005 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at benefit/risk-forholdet var gunstigt for Crestor 5 mg eller Crestor 10 mg som startdosis.
English: Written explanations were provided by the Marketing Authorisation Holder on 07 February 2005.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 7. februar 2005.
English: The approved use in The Netherlands was a 5 mg start dose for patients with predisposing factors to myopathy, and 10 mg as the recommended start dose for patients without these predisposing factors.
Danish: Den godkendte anvendelse i Nederlandene var en startdosis på 5 mg hos patienter med prædisponeringsfaktorer for myopati og 10 mg som anbefalet startdosis for patienter uden disse prædisponeringsfaktorer.
English: The choice of start dose in the individual patient should take into account aspects of efficacy and safety, as detailed in the SPC.
Danish: Ved valg af startdosis til den enkelte patient bør forhold vedrørende virkning og sikkerhed tages i betragtning som nærmere beskrevet i produktresuméet.
English: As part of the marketing authorisation for rosuvastatin within Europe, AstraZeneca committed to apply for a 5-mg dose of rosuvastatin together with any necessary variations within 12 months of completion of the Mutual Recognition Process for the 10 mg, 20 mg and 40 mg formulations.
Danish: Som led i markedsføringstilladelsen for rosuvastatin i Europa forpligtede AstraZeneca sig til at ansøge om markedsføringstilladelse for en 5 mg's dosis rosuvastatin i tillæg til eventuelle nødvendige ændringer inden for 12 måneder efter afslutningen af den gensidige anerkendelsesprocedure for formuleringer på
English: OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Crestor 5 mg
Danish: Crestor 5 mg
English: Date of latest renewal: 07 September 2011.
Danish: Dato for seneste fornyelse: 7. september 2011.
English: If you weigh more than 80 kg, you may need a different dose.
Danish: Hvis du vejer mere end 80 kg, skal du måske have en anden dosis.
English: Date of first authorisation: 24 October 2001.
Danish: Dato for første markedsføringstilladelse: 24. oktober 2001.
English: • if you have ever had any other medical problem.
Danish: • du nogensinde har haft andre helbredsmæssige problemer.
English: Your doctor will monitor how well the medicine works for you.
Danish: Lægen vil kontrollere, hvordan medicinen virker hos dig.
English: Cancidas is used to treat the following infections in children, adolescents and adults:
Danish: Cancidas anvendes til at behandle følgende infektioner hos børn, unge og voksne:
English: • you are allergic to any other medicines
Danish: • du er allergisk over for anden medicin
English: If this occurs, caspofungin should be discontinued and appropriate treatment administered.
Danish: Hvis dette forekommer, skal caspofungin seponeres, og passende behandling administreres.
English: Due to poor enrolment, the study was terminated early and only 51 patients were randomized.
Danish: På grund af ringe indrullering af patienter blev studiet afsluttet før tid, og kun 51 patienter blev randomiseret.
English: • Cancidas has not been studied in pregnant women.
Danish: • Cancidas er ikke undersøgt hos gravide kvinder.
English: Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn får dette lægemiddel, da den indeholder vigtige oplysninger.
English: • you have ever had liver problems - you might need a different dose of this medicine
Danish: • du nogensinde har haft leverproblemer - du skal måske have en anden dosis af lægemidlet
English: Once Cancidas has been prepared, it should be used straight away.
Danish: Når Cancidas er fremstillet, skal det anvendes med det samme.
English: This is because Cancidas can affect the way some other medicines work.
Danish: Dette skyldes, at Cancidas kan påvirke måden, andre lægemidler virker på.
English: The mechanism of resistance identified is FKS1 and/or FKS2 (for C. glabrata) gene mutations.
Danish: Den resistensmekanisme, der blev identificeret, er FKS1- og/eller FKS2-genmutationer (for C. glabrata).
English: Do not use this medicine after the expiry date which is stated on the carton and the vial (the first two numbers are the month; the next four numbers are the year).
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter EXP (de første 2 cifre angiver måneden; de næste 4 cifre angiver året).
English: The elimination of caspofungin from plasma is slow with a clearance of 10-12 ml/min.
Danish: Eliminationen af caspofungin fra plasma er langsom med en clearance på 10-12 ml/min.
English: The following adverse reactions were reported during clinical studies and/or post-marketing use: System Organ
Danish: Følgende bivirkninger er rapporteret under kliniske studier og/eller efter markedsføring: Systemorganklasse Almindelig
English: Aseptically transfer this volume (ml)
Danish: Overfør aseptisk dette volumen (ml)
English: Your doctor will determine the duration of your treatment and how much Cancidas you will be given each day.
Danish: Lægen bestemmer behandlingens varighed, og hvor meget Cancidas du skal have hver dag.
English: Pharmacotherapeutic group: antimycotics for systemic use, ATC Code: J02AX04
Danish: Farmakoterapeutisk klassifikation: Antimykotikum til systemisk anvendelse ATC-kode: J02AX04
English: • if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for caspofungin eller et af de øvrige indholdsstoffer i Cancidas (angivet i punkt 6).
English: Tell your doctor or nurse straight away if you notice any of the following side effects - you may need urgent medical treatment:
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du bemærker en eller flere af følgende bivirkninger - du kan have brug for omgående lægehjælp:
English: An independent expert panel determined that 41 % (26/63) of patients receiving at least one dose of caspofungin had a favourable response.
Danish: Et uafhængigt ekspertpanel fastslog, at 41% (26/63) af patienterne, der fik mindst en dosis caspofungin, havde gunstigt respons.
English: Only a trained healthcare professional who has read the complete directions should prepare the medicine (please see below “Instructions of how to reconstitute and dilute Cancidas”).
Danish: Kun uddannet sundhedspersonale, som har læst den fuldstændige vejledning, må fremstille medicinen (se nedenfor ”Brugsvejledning til rekonstitution og fortynding af Cancidas”).
English: If you are worried that you may have been given too much Cancidas, tell your doctor or nurse straight away.
Danish: Hvis du er bekymret for, om du måske har fået for meget Cancidas, skal du fortælle det til lægen eller sundhedspersonalet med det samme.
English: Alternatively, the volume (ml)
Danish: Alternativt kan voluminet (ml)
English: 3 for 96 hours) and fever (>38.0°C) not responding to ≥96 hours of parenteral antibacterial therapy.
Danish: 3 i 96 timer) og havde haft feber (>38,0 °C) uden respons i mere end 96 timer til parenteral antibakteriel behandling.
English: Supplied in packs of 1 vial.
Danish: Leveres i pakning med 1 hætteglas.
English: Patients in the caspofungin group experienced breakthrough infections due to the following uncommon yeasts and moulds: Trichosporon species (1), Fusarium species (1), Mucor species (1), and Rhizopus species (1).
Danish: Patienter i caspofungin-gruppen oplevede gennembrudsinfektioner ved følgende ikke-almindelige gær- og skimmelsvampe: Trichosporon arter (1), Fusarium arter (1), Mucor arter (1) og Rhizopus arter (1).
English: Mix gently until a clear solution is obtained.
Danish: Bland forsigtigt, indtil en klar opløsning fremkommer.
English: Of these, 37 had invasive candidiasis, 10 had invasive aspergillosis, and 1 patient had esophageal candidiasis.
Danish: Af disse patienter havde 37 invasiv candidiasis, 10 havde invasiv aspergillose og 1 patient havde candidiasis i øsofagus.
English: Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Danish: Refraktion defineres som progression af infektion eller manglende bedring efter mindst 7 dages forudgående behandling med terapeutiske doser af effektivt antimykotisk lægemiddel.
English: • cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you may be experiencing a serious respiratory problem that could result in respiratory failure.
Danish: • hoste, alvorlige vejrtrækningsproblemer - hvis du er voksen og har invasiv aspergillose, kan du få alvorlige vejrtrækningsproblemer, som kan medføre åndedrætssvigt.
English: The most frequent diagnoses were bloodstream infections (candidaemia) (77 %, n = 186) and Candida peritonitis (8 %, n = 19); patients with Candida endocarditis, osteomyelitis, or meningitis were excluded from this study.
Danish: Den hyppigste diagnose var blodforgiftning (candidaæmi) (77%, n=186) og Candida-peritonitis (8%, n=19); patienter med Candida endocarditis, osteomyelitis eller meningitis blev holdt ude af denne undersøgelse.
English: Also some other medicines can affect the way Cancidas works.
Danish: Andre lægemidler kan også påvirke måden, Cancidas virker på.
English: * 10.5 ml should be used for reconstitution of all vials.
Danish: * der skal anvendes 10,5 ml ved rekonstitution af alle hætteglas.
English: You will be given Cancidas:
Danish: Du vil få Cancidas:
English: Reconstitution of CANCIDAS
Danish: Rekonstitution af CANCIDAS
English: In vitro studies show that caspofungin is not an inhibitor of cytochrome P450 enzymes 1A2, 2A6, 2C9, 2C19, 2D6 or 3A4.
Danish: In vitro undersøgelser viser, at caspofungin ikke hæmmer CYP-enzymer 1A2, 2A6, 2C9, 2C19, 2D6 eller 3A4.
English: This belongs to a group of medicines called antifungals.
Danish: Det tilhører en gruppe af svampedræbende lægemidler.
English: It should be used in pregnancy only if the potential benefit justifies the potential risk to the unborn baby.
Danish: Gravide kvinder må kun få Cancidas, hvis det skønnes, at fordelene opvejer den mulige risiko for det ufødte barn.
English: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands or
Danish: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Holland eller
English: Caspofungin has in vitro activity against Aspergillus species (Aspergillus fumigatus [N = 75], Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], and Aspergillus candidus [N = 3]).
Danish: Caspofungin virker in vitro mod Aspergillusarter (Aspergillus fumigatus N = 75, Aspergillus flavus N = 111, Aspergillus niger N = 31, Aspergillus nidulans N = 8, Aspergillus terreus N = 52 og Aspergillus candidus [N = 3]).
English: • The active substance is caspofungin.
Danish: • Aktivt stof: caspofungin.
English: Instructions of how to reconstitute and dilute CANCIDAS:
Danish: Brugsvejledning til rekonstitution og fortynding af Cancidas:
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS
Danish: VEJLEDNING TIL ANVENDELSE HOS VOKSNE PATIENTER
English: Common: may affect up to 1 in 10 people:
Danish: Almindelige: kan berøre op til 1 ud af 10 personer:
English: In clinical studies, 1,865 adult individuals received single or multiple doses of caspofungin: 564 febrile neutropaenic patients (empirical therapy study), 382 patients with invasive candidiasis, 228 patients with invasive aspergillosis, 297 patients with localised Candida infections, and 394 individuals enrolled in Phase I studies.
Danish: I alt 1.865 voksne personer modtog i kliniske undersøgelser enkeltdoser eller gentagne doser caspofungi: 564 patienter med febril neutropeni (undersøgelse med empirisk behandling), 382 patienter med invasiv candidiasis, 228 patienter med invasiv aspergillose, 297 patienter med lokaliserede Candida infektioner og 394 personer blev inkluderet i fase I undersøgelser.
English: Cancidas will always be prepared and given to you by a healthcare professional.
Danish: Det er altid sundhedspersonalet, der vil fremstille og give dig Cancidas.
English: • Women given Cancidas should not breast-feed.
Danish: • Kvinder, der får Cancidas, må ikke amme.
English: • suspected fungal infections if you have a fever and a low white cell count that have not improved on treatment with an antibiotic.
Danish: • mistænkt svampeinfektion med feber og nedsat antal hvide blodlegemer, som ikke reagerer på behandling med antibiotika.
English: • Flushing, low blood pressure
Danish: • Ansigtsrødme, lavt blodtryk
English: Cancidas may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Danish: Cancidas kan også medføre alvorlige bivirkninger på huden såsom Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN).
English: The proportion of patients with fungal-free survival at 2 weeks post-therapy in the caspofungin treatment group (71.0 %) was similar to that seen in the amphotericin B deoxycholate treatment group (68.8 %).
Danish: Andelen af patienter med overlevelse uden svampeinfektion 2 uger efter behandlingen i behandlingsgruppen med caspofungin (71,0%) var sammenlignelig med andelen, der blev set i behandlingsgruppen med amphotericin B deoxycholat (68,8%).
English: Volume of reconstituted CANCIDAS for transfer to intravenous bag or bottle
Danish: Volumen af rekonstitueret Cancidas til overførsel til intravenøs pose eller flaske
English: The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle.
Danish: Infusionsvæsken fremstilles ved aseptisk at tilsætte et passende volumen af rekonstitueret koncentrat (som vist i tabellen nedenfor) til en 250 ml infusionspose eller -flaske.
English: For adult patients with moderate hepatic impairment (Child-Pugh score 7 to 9), caspofungin 35 mg daily is recommended based upon pharmacokinetic data.
Danish: Til voksne patienter med moderat nedsat leverfunktion (Child-Pugh score 7-9) anbefales caspofungin 35 mg dagligt på baggrund af farmakokinetiske data.
English: b. Visually inspect the reconstituted solution for particulate matter or discolouration during reconstitution and prior to infusion.
Danish: b. Kontroller visuelt den rekonstituerede opløsning for partikler og misfarvning under rekonstitutionen og før infusion.
English: Driving and using machines There is no information to suggest that Cancidas affects your ability to drive or operate machinery.
Danish: Trafik- og arbejdssikkerhed Der findes ingen oplysninger om, at Cancidas påvirker evnen til at køre bil eller betjene maskiner.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor, nurse or pharmacist before you are given this medicine.
Danish: Hvis du af din læge har fået at vide, at du ikke kan tåle eller fordøje visse sukkerarter, skal du tale med lægen, sundhedspersonalet eller apotekspersonalet, før du får denne medicin.
English: • you are already taking cyclosporin (used to help prevent organ transplant rejection or to suppress your immune system) - as your doctor may need to run extra blood tests during your treatment.
Danish: • du er i behandling med ciclosporin (anvendes til at forhindre afstødning af et transplanteret organ eller til at undertrykke immunforsvaret) - da det kan være nødvendigt, at lægen tager ekstra blodprøver under behandlingen
English: Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
Danish: Fortæl det til lægen, sundhedspersonalet eller apotekspersonalet, hvis du tager et eller flere af følgende lægemidler:
English: What you need to know before you are given Cancidas).
Danish: Det skal du vide, før du får Cancidas).
English: Based on this study, no posology recommendations for neonates and infants can be made.
Danish: Der kan ikke gives dosisanbefalinger for nyfødte og spædbørn på basis af dette studie.
English: Stability data have shown that the concentrate for solution for infusion can be stored for up to 24 hours when the vial is stored at 25°C or less and reconstituted with water for injection.
Danish: Holdbarhedsundersøgelser har vist, at koncentratet til infusionsvæske kan opbevares i op til 24 timer, hvis det opbevares ved 25C eller mindre og rekonstitueres med vand til injektion.
English: Cancidas makes fungal cells fragile and stops the fungus from growing properly.
Danish: Cancidas svækker svampecellerne og forhindrer dermed svampen i at vokse.
English: Cancidas contains a medicine called caspofungin.
Danish: Cancidas indeholder et aktivt stof, der hedder caspofungin.
English: Caspofungin also has in vitro activity against Candida species (Candida albicans [N = 1,032], Candida dubliniensis [N = 100], Candida glabrata [N = 151], Candida guilliermondii [N = 67], Candida kefyr [N = 62], Candida krusei [N = 147], Candida lipolytica [N = 20], Candida lusitaniae [N = 80], Candida parapsilosis [N = 215], Candida rugosa [N = 1], and Candida tropicalis [N = 258]), including isolates with multiple resistance transport mutations and those with acquired or intrinsic resistance to fluconazole, amphotericin B, and 5-flucytosine.
Danish: Caspofungin virker in vitro også mod Candidaarter (Candida albicans N = 1032, Candida dubliensis N = 100, Candida glabrata N = 151, Candida guilliermondii N = 67, Candida kefyr N = 62, Candida krusei N = 147, Candida lipolytica N = 20, Candida lusitaniae N = 80, Candida parapsilosis N = 215, Candida rugosa N = 1 og Candida tropicalis N = 258), inklusive isolater med multiresistente transportmutationer og dem med erhvervet eller egenstimulerende resistens mod fluconazol, amphotericin B og 5-flucytosin.
English: If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Danish: Hvis du har yderligere spørgsmål om brugen af denne medicin, skal du spørge lægen, sundhedspersonalet eller apotekspersonalet.
English: Glacial acetic acid Sodium hydroxide (to adjust the pH)
Danish: Natriumhydroxid (til justering af pH)
English: • difficulty breathing with wheezing or a rash that gets worse - you may be having an allergic reaction to the medicine.
Danish: • vejrtrækningsbesvær med hiven efter vejret eller forværring af udslæt - du kan have fået en allergisk reaktion på medicinen.
English: • Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.
Danish: • Empirisk behandling af formodede svampeinfektioner (som fx Candida eller Aspergillus) hos febrile voksne patienter eller børn med neutropeni.
English: The concentrations of the reconstituted vials will be 5.2 mg/ml.
Danish: Koncentrationen i det rekonstituerede hætteglas vil være 5,2 mg/ml.
English: If you have been given more Cancidas than you should Your doctor will decide how much Cancidas you need and for how long each day.
Danish: Lægen bestemmer, hvor meget Cancidas, du har brug for og hvor lang tid hver dag.
English: In a double-blind, randomized (2:1) comparator-controlled study safety, tolerability and efficacy of caspofungin (2 mg/kg/d intravenously, infused over 2 hours) vs amphotericin B deoxycholate (1 mg/kg/d) was evaluated in neonates and infants less than 3 months of age with (culture-confirmed) invasive candidiasis.
Danish: I et dobbeltblindet, randomiseret (2:1) komparatorkontrolleret studie blev caspofungins sikkerhed, tolerabilitet og virkning (2 mg/kg/dag intravenøst, infunderet over 2 timer) versus amphotericin B deoxycholat (1 mg/kg/dag) evalueret hos nyfødte og spædbørn under 3 måneder med invasiv candidiasis (bekræftet ved dyrkning).