natgillin/translations-raw huggingface dataset:
Undersøgelsen viste, at risikoen for en svær eksacerbation af astma blev reduceret med 36 % (SI: [18 %; 51 %]) i den gruppe, der fik Kantos Master ved behov, i forhold til den gruppe, der fik salbutamol. 
The results of the study have shown that the risk of experiencing a severe asthma exacerbation was reduced by 36% (CI: 18% - 51%) in the group taking Kantos Master as reliever compared to the
Dette tydede på, at vedligeholdelsesbehandling med inhalationskortikosteroid/langtidsvirkende beta2-agonist var adækvat til kontrol af både lungefunktion og symptomer. 
This suggested that the ICS-LABA maintenance therapy was adequate to control both lung function and symptoms.
CHMP var derfor af den opfattelse, at Kantos Masters positive virkning på eksacerbationer ikke blev opnået alene ved en stigning i den daglige dosis inhalationskortikosteroid, men gennem den rettidige dosering af en lille dosis beclometasondipropionat sammen med bronkodilatoren ved forværring af symptomerne. 
Therefore, the CHMP was of the opinion that the positive effect of Kantos Master on exacerbations was not achieved through a simple increase in daily ICS dose but with the timely delivery of a small dose of BDP together with the bronchodilator, when patient's symptoms worsened.
Den 20. januar 2012 indgav indehaveren af markedsføringstilladelsen en type IIændringsansøgning via den gensidige anerkendelsesprocedurer for Kantos Master og relaterede navne (DE/H/0873/001/II/024) om godkendelse af indikationen "vedligeholdelses- og behovsbehandling af astmasymptomer". 
On 20 January 2012, the MAH submitted a type II variation via the MRP for Kantos Master and associated names (DE/H/0873/001/II/024), to request the inclusion of “Maintenance and reliever therapy taken as regular maintenance treatment and as needed in response to asthma symptoms”.
Der blev foretaget endnu en supplerende analyse af undersøgelse CT07 hos patienter med svær astma, da det antoges, at eventuel underbehandling med Kantos Master i MART ville være lettest at konstatere hos den population, som kræver højere doser inhalationskortikosteroid til astmakontrol. 
A further additional analysis of the study CT07 has been conducted in patients with severe asthma as it was considered that if under-treatment with Kantos Master in MART occurred, it should be most evident in this population who requires higher ICS doses to control their asthma.
For eksempel var dosis af budesonid i SMILE-undersøgelsen2 (400 µg dagligt) på linje med den dosis inhalationskortikosteroid, der blev givet i undersøgelse CT07 (ækvivalent med 500 µg ikkeekstrafint beclometason). 
For instance, in the SMILE study2, the dose of budesonide (400µg/day) was in line with the ICS dose administrated in the study CT07 (500µg BDP non-extrafine equivalent).
Begrundelser for ændringen af betingelserne for markedsføringstilladelserne Ud fra følgende betragtninger: 
Grounds for the variation to the terms of the marketing authorisations
Det var derfor CHMP's opfattelse, at virkningen af Kantos Master i MART ikke skyldtes underbehandling af sammenligningsarmen i undersøgelse CT07, og at vedligeholdelsesbehandling med Kantos Master, én inhalation to gange dagligt, var til væsentlig klinisk fordel for disse patienter. 
The CHMP was therefore of the opinion that the effectiveness of Kantos Master in MART was not due to a potential under-treatment of the comparator arm in the study CT07, and that the maintenance administration of Kantos Master at one inhalation twice daily had a clinically significant benefit in these patients.
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). 
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).
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. 
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.
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). 
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).
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. 
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.
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. 
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.
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. 
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.
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. 
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.
CHMP fandt dog ingen tegn på, at patienterne i sammenligningsgruppen var underbehandlede, da der var iagttaget klinisk fordel af vedligeholdelsesbehandlingen hos begge patientgrupper. 
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.
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). 
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).
• 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" 
• 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.
Kantos Master er en fastdosiskombination af inhalationskortikosteroidet beclometasondipropionat og den langtidsvirkende beta2-agonist formoterolfumarat. 
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.
• udvalget gennemgik alle de foreliggende data til støtte for sikkerheden og virkningen af Kantos Master og relaterede navne ved "vedligeholdelses- og behovsbehandling af astmasymptomer" 
• 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”.
CHMP tog desuden hensyn til litteraturdata, hvor MART-princippet underbygges ved anvendelse af et inhalationskortikosteroid og en langtidsvirkende beta2-agonist. 
The CHMP also took note of literature data where the principle of MART is substantiated with the use of an ICS and LABA.
• udvalget tog hensyn til litteraturdata, hvor MART-princippet underbygges ved anvendelse af et inhalationskortikosteroid og en langtidsvirkende beta2-agonist. 
• The Committee took note of literature data where the principle of MART is substantiated with the use of an ICS and LABA.
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. 
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.
Pakningsstørrelse 
Packaging
Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage 
Pharmaceutical Form
Den 20. oktober 2015 EMA/499012/2015 
20 October 2015 EMA/499012/2015
Efter afkøling skilles den æteriske olie fra vandet og kan derved opsamles. 
After cooling, the essential oil separates from the water and can be collected.
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). 
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).
Kommenolie EMA/499012/2015 
Caraway oil EMA/499012/2015
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. 
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.
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. 
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.
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). 
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).
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. 
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.
EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder kommenolie. 
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing caraway oil.
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. 
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.
Detaljerede anvisninger for, hvordan lægemidler kommenolie, skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen. 
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.
Dette er et sammendrag af Komiteen for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af kommenolie. 
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of caraway oil.
Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder kommenolie, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater. 
Information on the use and licensing of caraway oil medicines in EU Member States should be obtained from the relevant national authorities.
Hvis symptomerne varer længere end 2 uger ved samtidig brug af kommenolie, bør der søges råd hos en læge eller på apoteket. 
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.
Plantelægemidler med kommenolie fås normalt i flydende form til indtagelse gennem munden og i halvfast form (såsom salve) til påføring på huden. 
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.
Kommenolie 
Caraway oil
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. 
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.
Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder kommenolie, anvendes. 
This summary is not intended to provide practical advice on how to use medicines containing caraway oil.
Hvad er kommenolie? 
What is caraway oil?
Hvordan godkendes lægemidler, der indeholder kommenolie, i EU? 
How are caraway oil medicines approved in the EU?
Nærmere oplysninger om de informationer der indgår i HMPCs vurdering, findes i HMPC's vurderingsrapport. 
For further information, see the HMPC assessment report.
Andre oplysninger om lægemidler, der indeholder kommenolie 
Other information about caraway oil medicines
Kommenolie udvindes ved at lede damp gennem de tørrede frugter. 
Caraway oil is obtained by a current of steam through the dried fruit.
Hvilken dokumentation underbygger den medicinske anvendelse af lægemidler med kommenolie? 
What evidence supports the use of caraway oil medicines?
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. 
For more information about treatment with caraway oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
På baggrund af den mangeårige anvendelse har HMPC konkluderet, at kommenolie kan anvendes til at lindre symptomer fra fordøjelsessystemet såsom oppustethed og tarmluft. 
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.
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. 
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.
Hvilke risici er der forbundet med lægemidler, der indeholder kommenolie? 
What are the risks associated with caraway oil medicines?
HMPC's konklusioner vedrørende brugen af lægemidler med kommenolie er baseret på den "traditionelle anvendelse" lindring af gener fra fordøjelsessystemet såsom oppustethed og tarmluft. 
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'.
Dette er dog ikke nødvendigvis realistisk i alle situationer. 
However this may not be realistic in all situations.
Nedenfor præsenteres en relevant oversigt over konklusionerne. 
A relevant summary of the conclusions is presented below.
Type II-variationen begyndte 17. september 2014. 
The type II variation started on 17 September 2014.
Da det ikke var muligt at nå til enighed, blev proceduren henvist til CHMP. 
As no agreement could be reached, the procedure was referred to the CHMP.
Infectious Diseases in Obstetrics and Gynecology, 2012:137192, 4 sider 
Infectious Diseases in Obstetrics and Gynecology, 2012:137192, 4 pages
De berørte medlemsstater er: Østrig, Belgien, Tjekkiet, Tyskland, Grækenland, Spanien, Frankrig, Irland, Island, Italien, Litauen, Luxembourg, Holland, Norge, Polen, Portugal og Sverige. 
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.
CMDh's 60-dages sagsbehandling blev påbegyndt den 3. august 2015. 
The CMDh 60 day procedure was initiated on 3 August 2015.
• 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. 
• The Committee took also into account written consultations of consumers, patients and healthcare professionals before recommending the agreed changes to the product information.
Der er et behov for at gøre sundhedspersoner og patienter opmærksomme på betænkelighederne vedrørende interaktion og de dermed forbundne anbefalinger. 
There is a need to educate healthcare professionals and patients about the interaction concerns and the related recommendations.
Årsagen til denne underrapportering kendes ikke, men den kan skyldes en forventning om lavere effekt sammenholdt med andre præventionsmidler. 
The reasons for the under-reporting are not known but may be due to an expectation of lower efficacy compared to other contraceptives.
CHMP har derfor konkluderet, at der er behov for rettidig og tydelig rådgivning vedrørende klinisk relevante interaktioner. 
Thus the CHMP concluded that there is a need for timely and clear advice for clinically relevant interactions.
(iii) Behandlingsmuligheder - dosisøgning/andre behandlinger 
(iii) Management options - Dose increase / alternative treatment
• Udvalget har behandlet henvisningsproceduren i henhold til artikel 13, stk. 2, i forordning nr. 1234/2008. 
• The Committee considered the referral under Article 13(2) of Regulation No 1234/2008.
CMDh-procedurens dag 60 var d. 1. oktober 2015, hvor et endeligt standpunkt blev vedtaget af de fleste medlemsstater, dog ikke Italien. 
Day 60 of the CMDh procedure was on 1 October 2015, when a final position was reached by most MSs except Italy (IT).
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. 
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).
Opsætning af et kobberindlæg er en speciallægeprocedure, og denne mulighed er ikke nødvendigvis tilgængelig, velegnet eller acceptabel for alle kvinder. 
Fitting a Cu-IUD is a skilled procedure and this option may not be available, suitable or acceptable for all women.
Samlet set tyder dette på, at estimatet af efavirenz-indvirkningens omfang er pålideligt1. 
Taken together, this suggests that the magnitude of the efavirenz effect has been reliably estimated1.
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. 
Exposure to 400mcg LNG represented the largest group, with 2801 patients studied, 71% for >6 months and 48% for > 12 months.
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. 
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.
Relevansen af den opdelte dosis i undersøgelsen1 for den aktuelt godkendte enkeltdosis af levonorgestrel blev drøftet. 
The relevance of the divided dosing used in the study1 for the currently licensed single dose LNG was raised.
Dette anerkendes i kliniske vejledninger og i produktinformationen for hormonelle præventionsmidler, hvor brug af supplerende eller anden prævention tilrådes. 
This is recognised in clinical guidance and in the product information of hormonal contraceptives which advise use of additional or alternative contraception.
CHMP drøftede den mulighed, at en dobbeltdosis måske ikke er tilstrækkelig til fuldt ud at kompensere for virkningen af stærke enzym-inducere. 
The CHMP considered the possibility that a double dose may not be adequate to fully compensate the effects of strong enzyme inducers.