FrancophonIA/ELRC3.0 huggingface dataset:
English: The patients enrolled in this study were being treated with a higher mean ICS dose at entry to the study (between 700µg and 1100µg, expressed as labelled or BDP equivalent dose respectively) than during the clinical study (ICS dose in the group taking Kantos Master as reliever and in the group taking salbutamol was respectively about 701.2 µg/day and 488.8 µg/day, always given as part of an ICS-LABA combination).
Danish: Ved inklusionen i undersøgelsen fik patienterne en højere gennemsnitsdosis af inhalationskortikosteroid (mellem 700 µg og 1 100 µg, angivet som den deklarerede dosis beclometasondipropionat eller en hermed ækvivalent dosis) end i løbet af den kliniske undersøgelse (i den gruppe, der fik Kantos Master som behovsbehandling, og den gruppe, der fik salbutamol, var inhalationskortikosteroiddosis henholdsvis ca. 701,2 µg/dag og 480,8 µg/dag, i alle tilfælde givet som en del af kombinationen inhalationskortikosteroid/langtidsvirkende beta2-agonist).
English: It was also observed that the group of patients using Kantos Master as reliever took on average approximately 80µg more of BDP per day which is equivalent to less than one extra inhaler actuation per day.
Danish: Den gruppe, der fik Kantos Master som behovsbehandling, fik i gennemsnit ca. 80 µg beclometason yderligere dagligt, hvilket svarer til mindre end én ekstra aktivering af inhalatoren dagligt.
English: In order to demonstrate the efficacy of Kantos Master and associated names as maintenance treatment and as needed in response to symptoms of asthma, the MAH submitted data from a phase III pivotal clinical study, randomised, double blind, double dummy, two arms parallel group (Study CT07).
Danish: Til påvisning af virkningen af Kantos Master og relaterede navne til vedligeholdelses- og behovsbehandling af astmasymptomer forelagde indehaveren af markedsføringstilladelsen data fra en randomiseret, dobbeltblindet fase III-hovedundersøgelse med dobbelt placebo og to parallelle arme (undersøgelse CT07).
English: The data from the main pivotal study that were submitted with the application to support safety and efficacy of Kantos Master for the maintenance and reliever therapy taken as regular maintenance treatment and as needed in response to asthma symptoms have not demonstrated that the MART treatment regimen was non-inferior to standard of care treatment, as the control group did not actually receive treatment according to standard of care.
Danish: Den hovedundersøgelse, der var forelagt sammen med ansøgningen til støtte for sikkerheden og virkningen af Kantos Master til vedligeholdelses- og behovsbehandling (MART) af astmasymptomer, dokumenterer ikke på tilfredsstillende vis, at MART-regimet var ikke-inferiørt i forhold til standardbehandlingen, da kontrolgruppen reelt ikke blev behandlet i henhold til standardbehandlingen.
English: One arm of patients were treated with an entry ICS dose of 500 µg or less and another arm had an entry ICS dose of more than 500 µg.
Danish: Ved inklusionen fik den ene gruppe en dosis inhalationskortikosteroid på højst 500 µg, og den anden gruppe fik en dosis inhalationskortikosteroid på over 500 µg.
English: The study CT07 compared the efficacy of Kantos Master and associated names given as both maintenance and reliever therapy and Kantos Master given as maintenance therapy with salbutamol (short acting beta2 -agonist SABA) as reliever therapy in partially controlled or uncontrolled asthmatics, over a 48 weeks treatment.
Danish: I undersøgelse CT07 sammenlignedes virkningen af Kantos Master og relaterede navne, givet som både vedligeholdelses- og behovsbehandling, med Kantos Master, givet som vedligeholdelsesbehandling sammen med den korttidsvirkende beta2-agonist salbutamol som behovsbehandling, ved delvis kontrolleret eller ukontrolleret astma i en behandlingsperiode på 48 uger.
English: The results demonstrated that MART with Kantos Master was significantly superior to salbutamol in prolonging the time to first severe exacerbations and in reducing the mean yearly rate of severe exacerbations in both subgroups of patients.
Danish: Hos begge undergrupper var MART med Kantos Master signifikant overlegent over salbutamol hvad angår forlængelse af tiden til de første svære eksacerbationer og reduktion af det gennemsnitlige årlige antal svære eksacerbationer.
English: However, the CHMP agreed that there was no evidence that patients in the comparator group were under-treated as patients in both group had shown clinical benefit from their maintenance treatment.
Danish: CHMP fandt dog ingen tegn på, at patienterne i sammenligningsgruppen var underbehandlede, da der var iagttaget klinisk fordel af vedligeholdelsesbehandlingen hos begge patientgrupper.
English: In both more severe (defined by FEV1 < 70%) and less severe groups (FEV1 ≥ 70%), Kantos Master in MART was significantly efficacious (similar hazard ratio of 0.65 and 0.61, respectively).
Danish: Kantos Master i MART havde signifikant virkning både i gruppen med sværere sygdom (defineret ved FEV1 < 70 %) og gruppen med mindre svær sygdom (FEV1 ≥ 70 %) (lignende risikoforhold, henholdsvis 0,65 og 0,61).
English: • The Committee concluded, in view of available data that the benefit/risk of Kantos Master and associated names for “maintenance and reliever therapy taken as regular maintenance treatment and as needed in response to asthma symptoms” is positive.
Danish: • udvalget konkluderede på baggrund af alle foreliggende data, at benefit/risk-forholdet for Kantos Master og relaterede navne er positivt til "vedligeholdelses- og behovsbehandling ved astmasymptomer"
English: Kantos Master is a fixed-dose combination (FDC) of the inhaled corticosteroid (ICS) beclometasone diproprionate (BDP) and the long-acting beta2-agonist (LABA) formoterol fumarate (FF) which is indicated as regular maintenance treatment of asthma administrated twice daily.
Danish: Kantos Master er en fastdosiskombination af inhalationskortikosteroidet beclometasondipropionat og den langtidsvirkende beta2-agonist formoterolfumarat.
English: • The Committee reviewed all available data, to support the safety and efficacy of Kantos Master and associated names for “maintenance and reliever therapy taken as regular maintenance treatment and as needed in response to asthma symptoms”.
Danish: • udvalget gennemgik alle de foreliggende data til støtte for sikkerheden og virkningen af Kantos Master og relaterede navne ved "vedligeholdelses- og behovsbehandling af astmasymptomer"
English: The CHMP also took note of literature data where the principle of MART is substantiated with the use of an ICS and LABA.
Danish: CHMP tog desuden hensyn til litteraturdata, hvor MART-princippet underbygges ved anvendelse af et inhalationskortikosteroid og en langtidsvirkende beta2-agonist.
English: • The Committee took note of literature data where the principle of MART is substantiated with the use of an ICS and LABA.
Danish: • udvalget tog hensyn til litteraturdata, hvor MART-princippet underbygges ved anvendelse af et inhalationskortikosteroid og en langtidsvirkende beta2-agonist.
English: The CHMP considered that the data provided by the MAH are sufficient to support the use of Kantos Master and associated names in the maintenance and reliever therapy (MART) taken as regular maintenance treatment and as needed in response to asthma symptom.
Danish: CHMP fandt, at de data, som indehaveren af markedsføringstilladelsen forelagde, var tilstrækkelige som dokumentation for anvendelsen af Kantos Master og relaterede navne til vedligeholdelses- og behovsbehandling (MART) af astmasymptomer.
English: Packaging
Danish: Pakningsstørrelse
English: Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage
English: 20 October 2015 EMA/499012/2015
Danish: Den 20. oktober 2015 EMA/499012/2015
English: After cooling, the essential oil separates from the water and can be collected.
Danish: Efter afkøling skilles den æteriske olie fra vandet og kan derved opsamles.
English: While the skin preparations can be used by people of all ages, the medicines to be taken by mouth are not recommended in children and adolescent (under 18 years of age).
Danish: Mens hudpræparater kan anvendes af personer i alle aldre, frarådes det at anvende præparater til indtagelse gennem munden til børn og unge (under 18 år).
English: Caraway oil EMA/499012/2015
Danish: Kommenolie EMA/499012/2015
English: Caraway oil is the common name for the essential oil obtained from the fruit of the plant Carum carvi L. The plant is cultivated or gathered to obtain the oil for medicinal use.
Danish: Kommenolie er fællesnavnet for den æteriske olie fra frugterne af planten Carum carvi L. Planten dyrkes eller indsamles for at udvinde olien til medicinsk brug.
English: Any applications for the licensing of medicines containing caraway oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder kommenolie, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Caraway oil medicines must not be used in people who are hypersensitive (allergic) to caraway oil or other plants of the same Apiaceae (Umbelliferae) family (e.g. fennel, anise, celery, coriander and dill).
Danish: Lægemidler med kommenolie må ikke anvendes til patienter, der er allergiske (overfølsomme) overfor kommenolie eller andre planter fra skærmplantefamilien (f.eks. fennikel, anis, selleri, koriander og dild).
English: Further information on the HMPC assessment of caraway oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder kommenolie, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing caraway oil.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder kommenolie.
English: Further information on the risks associated with caraway oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder kommenolie, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Detailed instructions on how to take caraway oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler kommenolie, skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of caraway oil.
Danish: Dette er et sammendrag af Komiteen for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af kommenolie.
English: Information on the use and licensing of caraway oil medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder kommenolie, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: If symptoms last for more than 2 weeks during the use of caraway oil medicines, the patient should consult a doctor or qualified healthcare practitioner.
Danish: Hvis symptomerne varer længere end 2 uger ved samtidig brug af kommenolie, bør der søges råd hos en læge eller på apoteket.
English: Herbal medicines containing caraway oil preparations are usually available in liquid forms to be taken by mouth and in semi-solid forms (such as ointments) to be applied to the skin.
Danish: Plantelægemidler med kommenolie fås normalt i flydende form til indtagelse gennem munden og i halvfast form (såsom salve) til påføring på huden.
English: Caraway oil
Danish: Kommenolie
English: The HMPC noted the insufficient clinical data on the effects of caraway oil in patients, but took into account the well documented use of this herbal medicine for the above-mentioned use.
Danish: HMPC har i sin vurdering taget til efterretning, at der ikke foreligger tilstrækkelige kliniske data, men har derimod taget hensyn til den veldokumenterede og langvarige anvendelse af kommenolie til ovenstående formål.
English: This summary is not intended to provide practical advice on how to use medicines containing caraway oil.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder kommenolie, anvendes.
English: What is caraway oil?
Danish: Hvad er kommenolie?
English: How are caraway oil medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder kommenolie, i EU?
English: For further information, see the HMPC assessment report.
Danish: Nærmere oplysninger om de informationer der indgår i HMPCs vurdering, findes i HMPC's vurderingsrapport.
English: Other information about caraway oil medicines
Danish: Andre oplysninger om lægemidler, der indeholder kommenolie
English: Caraway oil is obtained by a current of steam through the dried fruit.
Danish: Kommenolie udvindes ved at lede damp gennem de tørrede frugter.
English: What evidence supports the use of caraway oil medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af lægemidler med kommenolie?
English: For more information about treatment with caraway oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder kommenolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC concluded that, on the basis of its long-standing use, caraway oil medicines can be used for the relief of problems of the digestive system such as bloating and flatulence.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at kommenolie kan anvendes til at lindre symptomer fra fordøjelsessystemet såsom oppustethed og tarmluft.
English: For practical information about using caraway oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidlermed kommenolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What are the risks associated with caraway oil medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder kommenolie?
English: The HMPC conclusions on the use of caraway oil medicines in the relief of digestive problems such as bloating and flatulence are based on their ‘traditional use'.
Danish: HMPC's konklusioner vedrørende brugen af lægemidler med kommenolie er baseret på den "traditionelle anvendelse" lindring af gener fra fordøjelsessystemet såsom oppustethed og tarmluft.
English: However this may not be realistic in all situations.
Danish: Dette er dog ikke nødvendigvis realistisk i alle situationer.
English: A relevant summary of the conclusions is presented below.
Danish: Nedenfor præsenteres en relevant oversigt over konklusionerne.
English: The type II variation started on 17 September 2014.
Danish: Type II-variationen begyndte 17. september 2014.
English: As no agreement could be reached, the procedure was referred to the CHMP.
Danish: Da det ikke var muligt at nå til enighed, blev proceduren henvist til CHMP.
English: Infectious Diseases in Obstetrics and Gynecology, 2012:137192, 4 pages
Danish: Infectious Diseases in Obstetrics and Gynecology, 2012:137192, 4 sider
English: The Concerned Member States (CMS) were: Austria, Belgium, Czech Republic, Germany, Greece, Spain, France, Ireland, Iceland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal and Sweden.
Danish: De berørte medlemsstater er: Østrig, Belgien, Tjekkiet, Tyskland, Grækenland, Spanien, Frankrig, Irland, Island, Italien, Litauen, Luxembourg, Holland, Norge, Polen, Portugal og Sverige.
English: The CMDh 60 day procedure was initiated on 3 August 2015.
Danish: CMDh's 60-dages sagsbehandling blev påbegyndt den 3. august 2015.
English: • The Committee took also into account written consultations of consumers, patients and healthcare professionals before recommending the agreed changes to the product information.
Danish: • Udvalget har også taget højde for skriftlige høringer af forbrugere, patienter og sundhedspersoner, før det traf beslutningen om at anbefale de foreslåede ændringer i produktinformationen.
English: There is a need to educate healthcare professionals and patients about the interaction concerns and the related recommendations.
Danish: Der er et behov for at gøre sundhedspersoner og patienter opmærksomme på betænkelighederne vedrørende interaktion og de dermed forbundne anbefalinger.
English: The reasons for the under-reporting are not known but may be due to an expectation of lower efficacy compared to other contraceptives.
Danish: Årsagen til denne underrapportering kendes ikke, men den kan skyldes en forventning om lavere effekt sammenholdt med andre præventionsmidler.
English: Thus the CHMP concluded that there is a need for timely and clear advice for clinically relevant interactions.
Danish: CHMP har derfor konkluderet, at der er behov for rettidig og tydelig rådgivning vedrørende klinisk relevante interaktioner.
English: (iii) Management options - Dose increase / alternative treatment
Danish: (iii) Behandlingsmuligheder - dosisøgning/andre behandlinger
English: • The Committee considered the referral under Article 13(2) of Regulation No 1234/2008.
Danish: • Udvalget har behandlet henvisningsproceduren i henhold til artikel 13, stk. 2, i forordning nr. 1234/2008.
English: Day 60 of the CMDh procedure was on 1 October 2015, when a final position was reached by most MSs except Italy (IT).
Danish: CMDh-procedurens dag 60 var d. 1. oktober 2015, hvor et endeligt standpunkt blev vedtaget af de fleste medlemsstater, dog ikke Italien.
English: On 17 September 2014, Gedeon Richter Plc submitted an application for Levonelle and associated names through a mutual recognition procedure (MRP) type II variation (UK/H/0803/001/II/022) with the United Kingdom acting as a Reference Member State (RMS).
Danish: Den 17. september 2014 indsendte Gedeon Richter Plc en ansøgning vedrørende Levonelle og relaterede navne om en type II-variation gennem den gensidige anerkendelsesprocedure (UK/H/0803/001/II/022) med Storbritannien som referencemedlemsstat.
English: Fitting a Cu-IUD is a skilled procedure and this option may not be available, suitable or acceptable for all women.
Danish: Opsætning af et kobberindlæg er en speciallægeprocedure, og denne mulighed er ikke nødvendigvis tilgængelig, velegnet eller acceptabel for alle kvinder.
English: Taken together, this suggests that the magnitude of the efavirenz effect has been reliably estimated1.
Danish: Samlet set tyder dette på, at estimatet af efavirenz-indvirkningens omfang er pålideligt1.
English: Exposure to 400mcg LNG represented the largest group, with 2801 patients studied, 71% for >6 months and 48% for > 12 months.
Danish: Eksponering for 400 µg levonorgestrel repræsenterede den største gruppe, hvor man undersøgte 2 801 patienter, heraf 71 % i > 6 måneder og 48 % i > 12 måneder.
English: To the extent that other 750mcg and 1500mcg LNG-containing medicinal products indicated in emergency contraception not included in this assessment but are currently authorised in the EU, or are subject to future authorisation procedures by the Member States, the CHMP recommends that the concerned member states take due consideration of these scientific conclusions.
Danish: I det omfang, andre lægemidler med 750 og 1 500 µg levonorgestrel, der er indiceret til nødprævention, ikke er omfattet af denne vurdering, men på nuværende tidspunkt er godkendt i EU, eller er underlagt fremtidige godkendelsesprocedurer af medlemsstaterne, anbefaler CHMP, at de berørte medlemsstater tager skyldigt hensyn til disse videnskabelige konklusioner.
English: The relevance of the divided dosing used in the study1 for the currently licensed single dose LNG was raised.
Danish: Relevansen af den opdelte dosis i undersøgelsen1 for den aktuelt godkendte enkeltdosis af levonorgestrel blev drøftet.
English: This is recognised in clinical guidance and in the product information of hormonal contraceptives which advise use of additional or alternative contraception.
Danish: Dette anerkendes i kliniske vejledninger og i produktinformationen for hormonelle præventionsmidler, hvor brug af supplerende eller anden prævention tilrådes.
English: The CHMP considered the possibility that a double dose may not be adequate to fully compensate the effects of strong enzyme inducers.
Danish: CHMP drøftede den mulighed, at en dobbeltdosis måske ikke er tilstrækkelig til fuldt ud at kompensere for virkningen af stærke enzym-inducere.
English: The scope of this procedure is limited to Levonelle and associated names which are authorised in the European Union (EU) as emergency hormonal contraceptives (EHC).
Danish: Proceduren omhandler kun Levonelle og relaterede navne, der er godkendt i EU som hormonel nødprævention.
English: There were 75 pregnancies in the 400mcg LNG treated group, yielding a failure rate of 3.52% and a method failure rate of 1.69%.
Danish: Der var 75 graviditeter i den gruppe, der fik 400 µg levonorgestrel, svarende til en fejlrate på 3,52 % og en metodemæssig fejlrate på 1,69 %.
English: The currently licensed dose of 1500mcg was not included in either of the contraceptive efficacy studies, so direct comparison of efficacy is not possible.
Danish: Den aktuelt godkendte dosis på 1 500 µg blev ikke undersøgt i nogen af præventionseffektundersøgelserne, så en direkte effektsammenligning er ikke mulig.
English: All Member States (MSs) supported the existence of a clinically relevant interaction however a few remained unsure about the advice on how to manage the interaction.
Danish: Alle medlemsstater anerkendte eksistensen af en klinisk relevant interaktion, men nogle var ikke sikre på, hvilken vejledning der skal gives med henblik på håndtering af interaktionen.
English: In particular in order to manage the effect of this interaction, the amendments to the product information include the recommendation of double dose adjustment of Levonelle 1500mcg and associated names when a Cu-IUD is not suitable or available.
Danish: For at håndtere virkningen af denne interaktion omfatter ændringerne i produktinformationen navnlig en anbefalet dobbeltdosis-justering af Levonelle 1500 µg og relaterede navne, når et kobberindlæg ikke er egnet eller tilgængeligt.
English: For that reason the CHMP has discussed the key elements for communication to healthcare professionals and patients to facilitate the communication at national level.
Danish: Derfor har CHMP drøftet de væsentligste elementer i den information, der skal kommunikeres til sundhedspersoner og patienter på nationalt plan.
English: Levonelle 1500mcg and associated names consists of a single tablet.
Danish: Levonelle 1500 µg og relaterede navne fås som én tablet.