FrancophonIA/ELRC3.0 huggingface dataset:
English: In a real-life situation where specialists are unable to take this factor into account in clinical practice, investigation of the pholcodine exposure in individual patients prior to anaesthesia is not considered to be of benefit as it will not change anaesthetic practice.
Danish: Derfor bliver der på nuværende tidspunkt ikke søgt oplysning om tidligere eksponering for pholcodin, og dette ville sandsynligvis være en kompliceret proces, da størstedelen af patienterne enten ikke ville vide eller ikke kunne huske, at de har taget det. I det virkelige liv, hvor specialisterne ikke har mulighed for at tage denne faktor i betragtning i det kliniske arbejde, anses undersøgelse af den enkelte patients eksponering for pholcodin inden anæstesi ikke at ville være en fordel, da det ikke ville ændre praksis ved anæstesi.
English: The Committee also considered that data from clinical trials and extensive post marketing use has demonstrated the efficacy of pholcodine in the treatment of non productive cough.
Danish: Udvalget tog desuden data fra kliniske undersøgelser i betragtning og det forhold, at virkningen af pholcodin til behandling af uproduktiv hoste er godtgjort gennem dets omfattende anvendelse efter markedsføring.
English: The Committee considers it important to coordinate the review of the protocol of the case-control study to ensure the studies are suited to generate the data required to assess the possible association between pholcodine use and NMBA-related anaphylactic reactions.
Danish: - CHMP har også under denne indbringelsesprocedure gennemgået de indledende forslag til undersøgelsesprotokollen, som forskellige indehavere af markedsføringstilladelserne har fremlagt Udvalget anser det derfor for vigtigt at koordinere gennemgangen af protokollen for denne casekontrollerede undersøgelse for at sikre, at undersøgelserne er egnede til at frembringe de data, der er nødvendige for at vurdere den mulige forbindelse mellem anvendelse af pholcodin og anafylaktiske reaktioner relateret til neuromuskulære blokkere (NMBA).
English: Other experts questioned the specificity of the tests used by the Norwegian research team to detect IgE sensitisation to pholcodine, referred to the lack of a rigorous inclusion criterion for anaphylaxis (ie permitting cases undergoing spontaneous recovery, or a 'mild' presentation) in the investigations, and reference was also made to the use of spontaneously reported adverse events to determine incidence of NMBA-related anaphylaxis.
Danish: De henviste til, at der manglede et strengt inklusionskriterium for anafylaksi (dvs. der kunne inkluderes tilfælde med spontan helbredelse eller med et "mildt" klinisk billede) i undersøgelserne, og til, at det var spontant indberettede bivirkninger, der lå til grund for bestemmelsen af incidensen af NMBA-relateret anafylaksi.
English: It is also noted that in Norway, although there is a lower number of anaphylaxis reports since
Danish: ligeledes bemærkes, at skønt antallet af indberetninger om anafylaksi i Norge har været lavere efter tilbagetrækningen af pholcodin, har der ikke været nogen ændring i redaktionernes sværhedsgrad.
English: Ian Hudson (United Kingdom)
Danish: Ian Hudson (Det Forenede Kongerige)
English: Patrick Salmon (Ireland)
Danish: Patrick Salmon (Irland)
English: What is Prevora?
Danish: Hvad er Prevora?
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Danish: Resultat af en procedure indledt i henhold til artikel 29 i direktiv 2001/83/EF, med senere ændringer
English: Why was Prevora reviewed?
Danish: Hvorfor blev Prevora undersøgt?
English: The amended information to healthcare professionals and patients is available here.
Danish: Den ændrede produktinformation til patienter og fagfolk i sundhedssektoren findes her.
English: The company wanted the authorisation to be recognised in United Kingdom (the ‘concerned Member State').
Danish: Virksomheden ønskede, at markedsføringstilladelsen blev anerkendt i Det Forenede Kongerige (den ‘berørte medlemsstat').
English: The active substance in Prevora, chlorhexidine, is an antiseptic.
Danish: Det aktive stof i Prevora, chlorhexidin, er et antiseptisk middel.
English: Therefore the marketing authorisation for Prevora should be granted in the United Kingdom.
Danish: Der bør derfor udstedes markedsføringstilladelse for Prevora i Det Forenede Kongerige.
English: CHX Technologies Europe Limited submitted Prevora for mutual recognition on the basis of the initial authorisation granted by Ireland on 5 May 2006.
Danish: CHX Technologies Europe Limited indgav en ansøgning om gensidig anerkendelse af Prevora på grundlag af en oprindelig markedsføringstilladelse udstedt af Irland den 5. maj 2006.
English: It works by disrupting the membrane of bacteria, fungi and other organisms, blocking their growth.
Danish: Det virker ved at ødelægge membranerne i bakterier, svampe og andre organismer og derved blokere deres vækst.
English: However, the Member States were not able to reach an agreement and the Irish medicines regulatory agency referred the matter to the CHMP for arbitration on 26 November 2009.
Danish: Disse medlemsstater kunne imidlertid ikke nå til enighed, og den irske lægemiddelkontrolmyndighed henviste sagen til CHMP til voldgift den 26. november 2009.
English: Rapporteur:
Danish: Rapportør:
English: Procedure start date:
Danish: Startdato for proceduren:
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Prevora.
Danish: Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure som følge af uenighed blandt medlemsstater i Den Europæiske Union om godkendelsen af lægemidlet Prevora.
English: The United Kingdom had concerns that the results from the main study with Prevora were not sufficient to support the proposed indication, and that another study was needed to confirm the results seen to date with the medicine.
Danish: Det Forenede Kongerige udtrykte betænkelighed ved, at resultaterne af hovedundersøgelsen af Prevora ikke var tilstrækkelige til at underbygge den foreslåede indikation, og at det var nødvendigt at foretage endnu en undersøgelse for at bekræfte de hidtidige resultater med lægemidlet.
English: The European Commission issued a decision on 03 December 2010
Danish: Europa-Kommissionen traf en afgørelse den 3. december 2010.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Prevora outweigh its risks, and the marketing authorisation granted in Ireland can be recognised in other Member States of the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Prevora opvejer risiciene, og at markedsføringstilladelsen, som er udstedt i Irland, også kan udstedes i andre EU-medlemsstater.
English: Prevora is applied to the surface of permanent teeth by a dental professional in two stages.
Danish: Prevora påføres på overfladen af de blivende tænder af en tandlæge i to trin.
English: 28 July 2010, 15 September 2010
Danish: 28. juli 2010, 15. september 2010
English: First a chlorhexidine coating solution is applied followed immediately by an inert sealant coating.
Danish: Først en chlorhexidinopløsning som dæklag, og umiddelbart efter et inaktivt forseglingslag.
English: The grounds for the referral were that the United Kingdom could not approve the proposed indication, prevention of root caries in adult patients at high-risk of dental caries.
Danish: Begrundelserne for indbringelsen var, at Det Forenede Kongerige ikke kunne godkende den foreslåede indikation, forebyggelse af rodkaries hos voksne patienter med høj risiko for tandkaries.
English: Company responses provided on:
Danish: Dato for virksomhedens svar:
English: Prevora is a dental solution used to reduce dental caries (tooth decay) in permanent teeth of adolescents and adults.
Danish: Prevora er en dentalopløsning, som anvendes til at reducere tandkaries i blivende tænder hos unge og voksne.
English: Based on evaluation of the newly available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Prevora outweigh its risks in the prevention of coronal and root caries in adult patients at high-risk of dental caries.
Danish: CHMP konkluderede på grundlag af en gennemgang af de nye fremlagte data og den videnskabelige drøftelse i udvalget, at fordelene ved Prevora opvejer risiciene ved forebyggelse af koronal karies og rodkaries hos voksne med høj risiko for tandkaries.
English: Opinion date:
Danish: Dato for udtalelsen:
English: Co-rapporteur(s):
Danish: Co-rapportør:
English: London, 17 June 2008 EMEA/337156/2008
Danish: London, den 17. juni 2008 EMEA/337159/2008
English: The Reference Member State was Netherlands and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and United Kingdom.
Danish: Referencemedlemsstaten var Nederlandene og de berørte medlemsstater var Østrig, Belgien, Cypern, Den Tjekkiske Republik, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Island, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Norge, Polen, Portugal, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige.
English: The final opinion was converted into a Decision by the European Commission on 17 June 2008.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 17 juni 2008.
English: Article 5(11) of Commission Regulation (EC) No 1084/2003
Danish: Artikel 5, stk. 11, i Kommissionens forordning (EF) nr. 1084/2003
English: Yasminelle and associated names (see Annex I)
Danish: Yasminelle og tilknyttede navne (se bilag I)
English: The scientific conclusions are provided in Annex II.
Danish: De faglige konklusioner fremgår af bilag II.
English: A positive opinion was adopted by majority on 13 December 2007.
Danish: Flertallet vedtog en positiv udtalelse den 13. december 2007.
English: Hungary referred the reasons for disagreement to the EMEA on 12 October 2007.
Danish: Ungarn fremsendte begrundelsen for uenigheden til EMEA den 12. oktober
English: The Rapporteur was Dr Jean-Louis Robert and CoRapporteur was Dr Janos Borvendeg.
Danish: Rapportøren var dr. Jean-Louis Robert og medrapportøren var dr. Janos Borvendeg.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP)
English: International Non-Proprietary Name (INN): Drospirenone + Ethinylestradiol
Danish: Internationalt fællesnavn (INN): Drospirenon + Ethinylestradiol
English: Yasminelle and associated names, is a combined oral contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
Danish: Yasminelle og tilknyttede navne er et kombineret oralt antikonceptionsmiddel, som indeholder 0,02 mg ethinylestradiol og 3 mg drospirenon.
English: The Mutual Recognition Procedure started on 18 June 2007.
Danish: Proceduren for gensidig anerkendelse indledtes den 18. juni 2007.
English: During their December 2007 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 Yasminelle and associated names, that the objections raised by Hungary should not prevent the approval of the variation applied for and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be the final versions achieved during the Coordination group procedure.
Danish: På baggrund af alle de fremlagte oplysninger og den faglige drøftelse i udvalget var CHMP på sit møde i december 2007 af den opfattelse, at benefit/risk-forholdet er gunstigt for Yasminelle og tilknyttede navne, at de indsigelser, der er rejst af Ungarn, ikke bør forhindre godkendelse af den ændring, hvorom der er indgivet ansøgning, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel skulle udgøre den endelige udgave, som var opnået under koordineringsgruppens procedure.
English: These Member States were not able to reach an agreement in respect of the variation to the Marketing Authorisation within the time frame as referred to in Article 5(6) of Commission Regulation (EC) No 1084/2003.
Danish: Disse medlemsstater kunne ikke nå til enighed om ændringen af markedsføringstilladelsen inden for den tidsfrist, der er angivet i artikel 5, stk. 6, i Kommissionens forordning (EF) nr. 1084/2003.
English: The list of the product names concerned is given in Annex I.
Danish: Listen over de pågældende lægemiddelnavne findes i bilag I.
English: Furthermore the Braille text could not be read through the outer packaging as the cellophane is slippery and moves when touched.
Danish: Endvidere kunne brailleteksten ikke læses gennem den ydre emballage, da cellofan er glat og bevæger sig, når man rører ved det.
English: The proposed package concept, the so-called wallet with the product and package leaflet wrapped in transparent cellophane was considered to be a serious public concern.
Danish: Det foreslåede pakningskoncept, det såkaldte omslag med lægemiddel og indlægsseddel pakket i gennemsigtigt cellofan, blev anset for at udgøre et alvorligt problem for folkesundheden.
English: The arbitration procedure started on 18 October 2007.
Danish: Voldgiftsproceduren indledtes den 18. oktober 2007.
English: OPINION FOLLOWING AN ARTICLE 5(11)1 REFERRAL FOR
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 5, STK. 111, OM
English: The cellophane wrapping could not be accepted as an outer packaging due to the risk that during usage the product (wallets) would get separated from the package leaflet.
Danish: Cellofanindpakningen kunne ikke godkendes som ydre emballage som følge af risikoen for, at lægemidlet (omslagene) under brugen ville blive adskilt fra indlægssedlen.
English: The MAH submitted variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the medicinal product in the framework of Article 5 of Commission Regulation (EC) No 1084/2003.
Danish: Indehaveren af markedsføringstilladelsen har i henhold til artikel 5 i Kommissionens forordning (EF) nr. 1084/2003 indgivet ansøgning om ændring under proceduren for gensidig anerkendelse af markedsføringstilladelserne for lægemidlet.
English: 31 July 2012
Danish: 31. juli 2012
English: • At the request of the European Medicines Agency.
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur.
English: Many may feel quite normal.
Danish: Mange føler sig helt raske.
English: Within a month following the Commission Decision
Danish: måned efter kommissionens beslutning
English: These combinations were well tolerated.
Danish: Disse kombinationer var veltolereret.
English: Therefore, caution should be exercised in these patients.
Danish: Derfor skal der udvises forsigtighed hos disse patienter.
English: No interactions have been identified.
Danish: Der er ikke identificeret nogen interaktioner.
English: Risk Management Plan (RMP)
Danish: Risikostyringsprogram (RMP)
English: In some cases this occurred as part of a hypersensitivity reaction.
Danish: I nogle tilfælde opstod dette som en del af en overfølsomhedsreaktion.
English: It is recommended that you take the tablets with some water.
Danish: Det anbefales, at du tager tabletterne sammen med vand.
English: At steady state the non-linearity may be more pronounced.
Danish: Ved steady state kan non-linearitet være mere udtalt.
English: Taking Sprimeo with food and drink
Danish: Brug af Sprimeo sammen med mad og drikke
English: It is important to talk to your doctor immediately if you think you may be pregnant or are planning to become pregnant.
Danish: Det er vigtigt, at du straks taler med din læge, hvis du tror, at du er gravid, eller hvis du planlægger at blive gravid.
English: The mean half-life is about 40 hours (range 34-41 hours).
Danish: Den gennemsnitlige halveringstid er ca. 40 timer (interval 34-41 timer).
English: All three doses were well tolerated in both elderly and very elderly patients.
Danish: Alle tre doser var veltolereret hos både ældre og gamle patienter.
English: No carcinogenic potential was detected.
Danish: Der blev ikke påvist noget karcinogent potentiale.
English: Do not take Sprimeo if you are pregnant.
Danish: Du må ikke tage Sprimeo, hvis du er gravid.
English: angioedema without any known cause.
Danish: angioødem uden kendt årsag.
English: You may feel dizzy and this can affect your ability to concentrate.
Danish: Du kan komme til at føle dig svimmel, og det kan påvirke din koncentrationsevne.
English: The AUC is 50% higher in elderly (>65 years) than in young subjects.
Danish: AUC er 50% højere hos ældre (> 65 år) end hos yngre individer.
English: 85 to 90% of the maximal bloodpressure-lowering effect was observed after 2 weeks.
Danish: 85-90 % af den maksimale blodtrykssænkende effekt blev observeret efter 2 uger.
English: Approximately 1.4% of the total oral dose is metabolised.
Danish: Cirka 1,4 % af den totale orale dosis bliver metaboliseret.
English: Paediatric patients (below 18 years)
Danish: Pædiatriske patienter (under 18 år)
English: Elderly patients (over 65 years)
Danish: Ældre patienter (over 65 år)
English: Limited data are available related to overdose in humans.
Danish: Der er begrænsede data til rådighed vedrørende overdosering hos mennesker.
English: People who have high blood pressure often do not notice any signs of the problem.
Danish: Mennesker med forhøjet blodtryk bemærker ofte ingen tegn på problemet.
English: Do not use Sprimeo after the expiry date which is stated on the carton and blister.
Danish: Brug ikke Sprimeo efter den udløbsdato, der står på pakningen og blisterkortet.
English: However, if it is almost time for your next dose you should simply take the next tablet at the usual time.
Danish: Hvis det næsten er tid til den næste dosis, skal du bare tage den næste tablet til sædvanlig tid.
English: The study was discontinued prematurely because the participants were unlikely to benefit from aliskiren.
Danish: Studiet blev afbrudt før tid, fordi det var usandsynligt, at deltagerne havde gavn af aliskiren.
English: Approximately 0.6% of the dose is recovered in urine following oral administration.
Danish: Omkring 0,6 % af dosis genfindes i urinen efter oral administration.
English: This condition should be corrected prior to administration of Sprimeo, or the treatment should start under close medical supervision.
Danish: Denne tilstand bør korrigeres før administration af Sprimeo, eller behandlingen skal indledes under nøje medicinsk overvågning.
English: Mechanisms responsible for deviation from linearity have not been identified.
Danish: Mekanismen der er årsag til afvigelsen fra linearitet er ikke blevet identificeret.
English: If this happens, stop taking Sprimeo and contact your doctor.
Danish: Hvis det sker, skal du stoppe med at tage Sprimeo og kontakte din læge.
English: It is not known whether aliskiren is excreted in human milk.
Danish: Det vides ikke, om aliskiren udskilles i human mælk.
English: Via Provinciale Schito 131 I-80058 Torre Annunziata/NA Italy
Danish: Via Provinciale Schito 131 I-80058 Torre Annunziata/NA Italien
English: BLISTER BLISTER (CALENDAR)
Danish: BLISTER BLISTER (KALENDERPAKNING)
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • senest 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering).
English: Like all medicines, Sprimeo can cause side effects, although not everybody gets them.
Danish: Sprimeo kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The use of Sprimeo in children and adolescents is not recommended.
Danish: Sprimeo anbefales ikke til børn og unge.
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i den originale pakning for at beskytte mod fugt.
English: A possible mechanism is saturation of transporters at the absorption site or at the hepatobiliary clearance route.
Danish: En mulig mekanisme er mætning af transportere på absorptionsstedet eller ved den hepatobiliære udskillelsesrute.
English: Aliskiren plasma protein binding is moderate (47-51%) and independent of the concentration.
Danish: Aliskirens plasmaproteinbinding er moderat (47-51 %) og uafhængig af koncentrationen.
English: Sprimeo has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Danish: Sprimeo er evalueret med henblik på sikkerhed hos mere end 7.800 patienter, herunder over 2.300, som var i behandling i mere end 6 måneder, og mere end 1.200, som var i behandling i over 1 år.
English: CYP450 interactions
Danish: Interaktioner med CYP450
English: Therefore aliskiren is not expected to affect the systemic exposure of substances that inhibit, induce or are metabolised by these enzymes.
Danish: Det forventes derfor ikke, at aliskiren påvirker den systemiske eksponering af stoffer, som hæmmer, inducerer eller metaboliseres af disse enzymer.
English: Metabolism and elimination
Danish: Metabolisering og udskillelse
English: - during the last 6 months of pregnancy or if you are breast-feeding, see section Pregnancy and breastfeeding.
Danish: - de sidste 6 måneder af graviditeten eller hvis du ammer, se afsnittet om ”Graviditet og amning”.
English: It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects.
Danish: Det er meget vigtigt, at du tager medicinen nøjagtigt efter lægens anvisninger, hvis du vil opnå det bedste resultat og mindske risikoen for bivirkninger.
English: Always take Sprimeo exactly as your doctor has told you.
Danish: Tag altid Sprimeo nøjagtigt efter lægens anvisning.
English: If you forget to take a dose of Sprimeo, take it as soon as you remember and then take the next dose at its usual time.
Danish: Hvis du glemmer at tage Sprimeo, skal du tage det så snart, du kommer i tanker om det, og derefter tage den næste dosis til sædvanlig tid.
English: Your doctor may need to change your dose and/or to take other precautions if you are taking one of the following medicines: - medicines that increase the amount of potassium in your blood.
Danish: Det kan være nødvendigt for din læge at ændre din dosis og/eller tage andre forsigtighedsregler, hvis du tager et af følgende lægemidler: - medicin, der kan øge mængden af kalium i dit blod.
English: If you forget to take Sprimeo
Danish: Hvis du har glemt at tage Sprimeo
English: Lowering the blood pressure to a normal level reduces the risk of developing these disorders.
Danish: Når blodtrykket sænkes til normalt niveau, mindskes risikoen for at få disse sygdomme.
English: Hence, interactions due to inhibition or induction of CYP450 isoenzymes are not expected.
Danish: Derfor forventes der ingen interaktioner på grund af hæmning eller induktion af CYP450 isoenzymer er dermed ikke forventet.
English: If any of these apply to you, tell your doctor before you take Sprimeo.
Danish: Hvis noget af dette gælder for dig, skal du fortælle det til lægen, før du tager Sprimeo.
English: The absolute bioavailability of aliskiren is approximately 2-3%.
Danish: Aliskirens absolutte biotilgængelighed er ca. 2-3 %.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til mennesker skal den opdaterede RMP fremsendes samtidig med den næste periodiske sikkerhedsopdateringsrapport (PSUR).
English: In addition, measures necessary to maintain patent airways should be provided.
Danish: Yderligere skal der tages de nødvendige forholdsregler for at opretholde åbne luftveje.