natgillin/translations-raw huggingface dataset:
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) anbefalede, at de pågældende fortrydelsespiller fortsat skal kunne anvendes af kvinder uanset legemsvægt, da fordelene fandtes at opveje risiciene.
The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that these emergency contraceptives could continue to be used in women of all weights as the benefits were considered to outweigh the risks.
• Sundhedspersoner bør fortsat minde kvinden om, at postcoital kontraception er en nødforanstaltning til lejlighedsvis brug og ikke en erstatning for regelmæssig brug af kontraceptiva.
• Healthcare professionals should continue to remind women that emergency contraception is an occasional ‘rescue' method and should not replace a regular contraceptive method.
Kvinden bør mindes om, at fortrydelsespiller bør tages snarest muligt efter ubeskyttet samleje.
Women should be reminded that emergency contraceptives should be taken as soon as possible following unprotected sexual intercourse.
For ulipristalacetat gennemgik agenturet følgende data:
For ulipristal acetate, the Agency considered the following data:
De bør kun bruges lejlighedsvis som nødforanstaltning, da de ikke virker lige så godt som sædvanlig prævention.
They should only be used as an occasional ‘rescue' method as they do not work as well as regular contraceptive methods.
Tilsvarende gælder det for ulipristalacetat, at kliniske undersøgelser tyder på tendens til nedsat svangerskabsforebyggende virkning, men at oplysningerne er for begrænsede og ikke tilstrækkelig nøjagtige til at drage præcise konklusioner.
Similarly, for ulipristal acetate, although limited data from clinical trials suggest a possible trend for a reduced contraceptive effect, the data are too limited and insufficiently precise to draw definite conclusions.
Efter vurdering af al tilgængelig dokumentation om effektiviteten af fortrydelsespiller fandt CHMP, at de foreliggende oplysninger er for begrænsede og ikke fyldestgørende til med sikkerhed at afgøre, at den præventive virkning nedsættes ved øget legemsvægt som nævnt i produktinformationen for Norlevo.
Having assessed all the available evidence on the effectiveness of emergency contraceptives, the CHMP considered that the data available are too limited and not robust enough to conclude with certainty that contraceptive effect is reduced with increased bodyweight, as stated in the product information for Norlevo.
CHMP fandt, at fortrydelsespiller med deres sædvanligvis lette bivirkninger har en gunstig sikkerhedsprofil og fortsat kan anvendes uanset kvindens legemsvægt.
The CHMP considered that, with side effects generally mild, the safety profile of emergency contraceptives is favourable and they can continue to be taken regardless of the woman's bodyweight.
De foreliggende data er begrænsede og ikke fyldestgørende til at bekræfte den tidligere konklusion om nedsat kontraceptiv effekt med stigende legemsvægt/BMI.
The available data are limited and not robust enough to support with certainty the previous conclusion of decreased contraceptive effect with increased bodyweight/BMI.
• Kvinder mindes om, at fortrydelsespiller er en nødforanstaltning til lejlighedsvis brug og ikke virker lige så godt som almindelig prævention, såsom p-piller.
• Women are reminded that emergency contraception is an occasional ‘rescue' method, which does not work as well as regular methods of contraception, such as the pill.
Fortrydelsespiller med levonorgestrel fås i håndkøb i flere europæiske lande.
Levonorgestrel-containing emergency contraceptives are available 'over the counter' in several European countries.
Det blev herunder anført, at Norlevo er mindre effektivt hos kvinder, der vejer 75 kg og derover, og at det ikke er effektivt hos kvinder, der vejer over 80 kg. Der blev derefter indledt en EU-gennemgang med henblik på at vurdere, om tilsvarende oplysninger burde stå i produktinformationen for andre fortrydelsespiller med levonorgestrel og for ellaOne, som er fortrydelsespiller med ulipristalacetat.
In November 2013, following a national procedure, the product information of one emergency contraceptive containing levonorgestrel, Norlevo, was updated on the basis of results from two clinical studies to state that Norlevo is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg. An EU-wide review was then started to assess whether similar information should be included in the product information for other emergency contraceptives that contain levonorgestrel, and for ellaOne, an emergency contraceptive that contains ulipristal acetate.
• Postcoital kontraception kan fortsat anvendes til at undgå utilsigtet graviditet uanset kvindens vægt og legemsmasseindeks (BMI).
• Emergency contraceptives can continue to be used to prevent unintended pregnancy in women of any weight or body mass index (BMI).
Resultaterne af analysen er i modstrid med ovenstående resultater og viser ingen tendens til nedsat virkning med stigende legemsvægt/BMI (graviditetsraten var 0,99 % (SI: [0,70; 1,35] hos kvinder med BMI 18,5-25, 0,57 % (SI: [0,21; 1,24]) hos kvinder med BMI 25-30 og 1,17 % (SI: [0,24; 3,39]) hos kvinder med BMI ≥30).
The results of this analysis conflict with the results above and show no trend for a reduced efficacy with increasing bodyweight/BMI (pregnancy rate was 0.99% [CI: 0.70-1.35] in women with BMI 18.525; 0.57% [CI: 0.21-1.24] in women with BMI 25-30; and 1.17% [CI: 0.24-3.39] in women with BMI ≥30).
Gennemgangen mundede ud i, at de begrænsede foreliggende oplysninger ikke giver sikkerhed for den tidligere konklusion om, at den svangerskabsforebyggende virkning er mindre hos kvinder med høj legemsvægt.
It concluded that the limited data available do not support with certainty the previous conclusion that their contraceptive effect is reduced in women with high bodyweight.
• Fortrydelsespiller kan fortsat anvendes efter ubeskyttet samleje eller svigt af prævention uanset kvindens legemsvægt.
• Emergency contraceptives can continue to be taken after unprotected intercourse or contraceptive failure, regardless of the woman's bodyweight.
• en metaanalyse af to publicerede undersøgelser1,2, hovedsagelig med kaukasiske kvinder, hvor der fandtes nedsat antikonceptiv virkning med stigende legemsvægt eller BMI (graviditetsraten var 0,96 % (SI: [0,44; 1,82]) hos kvinder med BMI 18,5-25, 2,36 % (SI: [1,02; 4,60]) hos kvinder med BMI 25-30 og 5,19 % (SI: [2,62; 9,09]) hos kvinder med BMI ≥30)
• a meta-analysis of two published studies1,2, which primarily included Caucasian women, where a reduced contraceptive efficacy was observed with increased bodyweight or BMI (pregnancy rate was 0.96% [CI: 0.44-1.82] in women with BMI 18.5-25; 2.36% [CI: 1.02-4.60] in women with BMI 25-30; and 5.19% [CI: 2.62-9.09] in women with BMI ≥30).
Fortrydelsespiller er svangerskabsforebyggende medicin, der anvendes til at undgå uønsket graviditet efter ubeskyttet samleje eller svigt af prævention.
Emergency contraceptives are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
• Fortrydelsespiller anvendes til at undgå uønsket graviditet efter ubeskyttet samleje eller svigt af prævention.
• Emergency contraceptives are used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
Ved gennemgangen skulle det vurderes, om legemsvægt har betydning for disse lægemidlers effektivitet til at forhindre uønsket graviditet efter ubeskyttet samleje eller svigt af præventionsmidler.
On 24 July 2014, the European Medicines Agency concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
• en metaanalyse af fire kliniske undersøgelser, der var en del af ansøgningen om markedsføringstilladelse for ellaOne6, og som tyder på en mulig tendens til nedsat antikonceptiv virkning ved høj legemsvægt eller højt BMI, skønt sikkerhedsintervallerne overlapper (graviditetsraten var 1,23 % (SI: [0,78; 1,84] hos kvinder med BMI 18,5-25, 1,29 % (SI: [0,59; 2,43]) hos kvinder med BMI 25-30 og 2,57 % (SI: [1,34; 4,45]) hos kvinder med BMI ≥30).
• a meta-analysis of four clinical studies that were submitted as part of the application for marketing authorisation of ellaOne6, which suggests a possible trend for a reduced contraceptive efficacy with high bodyweight or BMI, although confidence limits overlap (pregnancy rate was 1.23% [CI: 0.78
Litteraturhenvisninger:
References.
90 kapsler (3 x 30 x 1) kapsler (enkeltdosis) (multipakning)
90 (3 x 30 x 1) capsules (unit dose) (multipack)
30 x 1 kapsler (enkeltdosis)
30 x 1 capsules (unit dose)
Den 19. november 2012
19 November 2012
Den endelige udtalelse blev den 19. november 2012 omarbejdet til en beslutning af EuropaKommissionen.
The final opinion was converted into a Decision by the European Commission on 19 November 2012.
Den 23. marts 2012 underrettede MERIAL agenturet om, at virksomheden havde til hensigt at anmode om fornyet overvejelse af CVMP's udtalelse af 8. marts 2012.
On 23 March 2012, MERIAL notified the Agency of their intention to request a re-examination of the CVMP opinion of 8 March 2012.
På sit møde den 11.-13. april 2012 udpegede CVMP dr. C. Muñoz som rapportør og dr E. Persson som medrapportør for den fornyede overvejelsesprocedure.
During its meeting of 11-13 April 2012 the CVMP appointed Dr C. Muñoz as the rapporteur and Dr E. Persson as the co-rapporteur for the re-examination procedure.
Indbringelsesproceduren blev indledt den 9. marts 2011.
The referral started on 9 March 2011.
Internationale fællesnavne (INN): clorsulon, closantel, nitroxinil, rafoxanid og triclabendazol
International non-proprietary names (inn): clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole
Som rapportør og medrapportør udpegede udvalget henholdsvis hr. G. J. Schefferlie og dr. B. Urbain.
The Committee appointed Mr G. J. Schefferlie as rapporteur and Dr B. Urbain as co-rapporteur.
Der blev forelagt supplerende oplysninger af nogle af ansøgerne/markedsføringstilladelsesindehaverne den 26. august 2011.
Supplementary information was provided by some of the applicants/marketing authorisation holders by 26 August 2011.
Den detaljerede begrundelse for anmodningen om fornyet overvejelse blev forelagt af MERIAL den 2. maj 2012.
The detailed grounds for the re-examination request were submitted by MERIAL on 2 May 2012.
Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics and package leaflets in Annex III.
Der blev afgivet mundtlige redegørelser af MERIAL den 16. maj 2012.
Oral explanations were given by MERIAL on 16 May 2012.
De trematodemidler, for hvilke der ikke er fastsat maksimalgrænseværdier for restkoncentrationer i mælk, og som indgår som aktive stoffer i godkendte veterinærlægemidler i medlemsstaterne (EU/EØS), er clorsulon, closantel, nitroxinil, rafoxanid og triclabendazol.
The flukicidal substances for which a maximum residue limit has not been established in milk and that are included as active substances in authorised veterinary medicinal products in the Member States (EU/EEA) are clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole.
Der blev fremsat mundtlige redegørelser af en gruppe af markedsføringstilladelsesindehavere den 8. februar 2012.
Oral explanations were given by a group of marketing authorisation holders on 8 February 2012.
Der blev forelagt skriftlige redegørelser af en gruppe af markedsføringstilladelsesindehavere den 11. januar 2012.
Written explanations were provided by a group of marketing authorisation holders on 11 January 2012.
CVMP blev derfor anmodet om at fremsætte en udtalelse om, om der er behov for foranstaltninger til at sikre, at anvendelse uden for laktationsperioden af veterinærlægemidler indeholdende clorsulon, closantel, nitroxinil, rafoxanid og triclabendazol ikke medfører restkoncentrationer i mælk, som sammen med rester af sådanne trematodemidler fra andre fødemidler medfører større eksponering af forbrugerne end svarende til ADI-værdien.
The CVMP was therefore requested to give its opinion as to whether measures are necessary to ensure that the use, during the non-lactating period, of veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole, would not lead to residues in milk that, combined with residues of these flukicidal substances from other foodstuffs, would result in consumer exposure exceeding the acceptable daily intake.
Den 14. februar 2011 indledte Europa-Kommissionen en indbringelse i henhold til artikel 35 i direktiv 2001/82/EF, som ændret, for alle veterinærlægemidler indeholdende aktive stoffer tilhørende klassen trematodemidler, for hvilke der ikke er fastsat maksimalgrænseværdier for restkoncentrationer i mælk, og som er bestemt til anvendelse hos alle drøvtyggere, der producerer mælk til konsum.
On 14 February 2011, the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC, as amended, for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk intended for use in all ruminants producing milk for human consumption.
Den fornyede overvejelsesprocedure blev indledt den 3. maj 2012 og vedrørte de anbefalede ændringer af punkt 4.11, tilbageholdelsesperiode(r), i produktresuméerne for veterinærlægemidler, der indeholder nitroxinil og administreres til kvæg.
The issues considered during the reexamination related to the recommended amendments of section 4.11 Withdrawal period(s) of the summaries of product characteristics for the veterinary medicinal products containing nitroxinil that are administered to cattle.
Den 14. juni 2012 vedtog CVMP en endelig udtalelse, der bekræftede anbefalingen i udtalelsen af 8. marts 2012 om, at der bør foretages ændringer af markedsføringstilladelserne for veterinærlægemidler indeholdende clorsulon, closantel, nitroxinil, rafoxanid eller triclabendazol som eneste aktive stof og for pour-on veterinærlægemidler indeholdende triclabendazol og moxidectin, således at produktresuméerne og indlægssedlerne ændres i henhold til de ændringer af produktinformationen, der anbefales af CVMP.
On 14 June 2012 the CVMP adopted a final opinion confirming the recommendation, included in its opinion of 8 March 2012, that variations are necessary in the marketing authorisations for the veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as a single active substance and for the veterinary medicinal products administered as pour-on to cattle containing triclabendazole and moxidectin in order to amend the summaries of product characteristics and package leaflets in line with recommended by the CVMP changes in the product information.
Efter vurdering af de foreliggende data vedtog CVMP den 8. marts 2012 i en udtalelse, der anbefalede ændring af markedsføringstilladelserne for veterinærlægemidler indeholdende clorsulon, closantel, nitroxinil, rafoxanid eller triclabendazol som eneste aktive stof og for veterinærlægemidler, der administreres som pour-on til kvæg og indeholder triclabendazol og moxidectin.
Based on the evaluation of the available data, the CVMP adopted, on 8 March 2012, an opinion recommending variations of the marketing authorisations for the veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as a single active substance and for the veterinary medicinal products administered as pour-on to cattle containing triclabendazole and moxidectin.
Udtalelse efter en artikel 351-indbringelse for veterinærlægemidler, som indeholder aktive stoffer tilhørende klassen trematodemidler, for hvilke der ikke er fastsat maksimalgrænseværdier for restkoncentrationer, og som er bestemt til brug hos drøvtyggere, der producerer mælk til konsum.
Opinion following an Article 351 referral for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk and which are intended for use in ruminants producing milk for human consumption
Indbringelsesproceduren blev indledt den 13. december 2012.
The referral procedure was initiated on 13 December 2012.
Supplerende støttende data
Additional supportive data
Kan rekvireres på: http://www.ginasthma.org/
Available from: http://www.ginasthma.org/.
Da referencemedlemsstaten og de berørte medlemsstater ikke kunne nå til enighed om ændringsansøgningen, indledte Tyskland den 23. november 2012 en indbringelse i henhold til artikel 13 i Kommissionens forordning (EF) nr. 1234/2008.
As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 23 November 2012, Germany triggered a referral under Article 13 of Commission Regulation EC No 1234/2008.
Samlet resumé af den videnskabelige vurdering af Kantos Master og relaterede navne (se bilag I)
Overall summary of the scientific evaluation of Kantos Master and associated names (see Annex I)
Undersøgelse CT07
Study CT07
Bilag II Videnskabelige konklusioner og begrundelser for ændringen af betingelserne for markedsføringstilladelserne
Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
• udvalget behandlede indbringelsen i henhold til artikel 13, stk. 2, i forordning nr.
• The Committee considered the referral under article 13(2) of Regulation No 1234/2008
Ekstrapolationen af data fra Symbicort SMART var problematisk, da ligheden mellem disse to produkter i MART-regimet ikke er godtgjort.
The extrapolation of data from Symbicort SMART was questionable as the similarity of these two products in the MART regimen has not been established.
På grundlag af de spørgsmål, der var rejst af Sverige, blev CHMP anmodet om at tage stilling til følgende punkter:
On the basis of the questions raised by Sweden the points to be considered by the CHMP were:
Post hoc-analyse af data fra undersøgelse CT07
Post hoc analysis of data from study CT07
Konceptet i denne "tidlige intervention" anbefales klart i GINA-retningslinjerne fra 20111, hvor det anføres, at fordelen i form af forebyggelse af eksacerbationer synes at skyldes intervention i et meget tidligt stadium af en truende eksacerbation.
The concept of this “early intervention” is clearly advocated in the 2011 GINA guidelines1 where it is stated that “The benefit in preventing exacerbations appears to be the consequence of early intervention at a very early stage of a threatened exacerbation”.
Desuden er begge komponenter udviklet i en ekstrafin formulering, dvs. de når derfor frem til de mest perifere dele af luftvejene, hvor størstedelen af den inflammatoriske proces finder sted under forværring af astma.
In addition, both components have been developed as an extrafine formulation, which means they reach the most peripheral airways where most of the inflammatory process takes place during asthma exacerbation.
Forskellen mellem grupperne var statistisk signifikant (p<0,001).
group taking salbutamol, and the difference between groups was statistically significant (p<0.001).
Det er imidlertid aldrig påvist, at en lille stigning i total dosis inhalationskortikosteroid har indvirkning på lungefunktionen eller på det kliniske udfald.
However, it has never been demonstrated that a small increase in total ICS dose would have an impact on the lung function or on the clinical outcomes.
Sygdommens sværhedsgrad blev baseret på lungefunktion (FEV1) og anvendelsen af redningsmedicin ved inklusion i undersøgelsen.
The disease severity was based on lung function (FEV1) and use of rescue medication at entry to the study.
Data fra litteraturen
Literature data
Den ens partikelstørrelse af de to komponenter bevirker desuden, at de afsættes sammen i samme områder af lungen, hvilket fremmer deres synergistiske interaktion.
The similar particle size of the two components also leads to co-deposition in the same regions of the lung, favouring a synergistic interaction.
Denne sammenlignelighed bekræftes desuden af en klinisk undersøgelse, hvor Kantos Master og relaterede navne (Foster 10/6) sammenlignes med Symbicort 200/6 (budesonid/formoterol)3.
This comparability has also been confirmed in a comparative clinical study between Kantos Master and associated names (Foster 10/6) and Symbicort 200/6 (budesonide/formoterol)3.
Der blev udført en post hoc-analyse med to undergrupper af patienter for at påvise, at ingen af de to patientgrupper i undersøgelse CT07 var overbehandlet eller underbehandlet.
A post hoc analysis was conducted with two subgroups of patients in order to demonstrate that both groups of patients in the study CT07 were not overtreated or undertreated.
I udviklingsprogrammet for Symbicort MART opnåedes markant bedre astmakontrol, når en del af dosis blev givet efter behov.
In the Symbicort MART development program, marked improvements in asthma control have been obtained when part of the dose was given on an as-needed basis.
Der er udstedt markedsføringstilladelse i EU for Kantos Master ved den gensidige anerkendelsesprocedure.
Kantos Master has received marketing authorisation in the European Union through the Mutual Recognition Procedure (MRP).
Denne supplerende analyse viste desuden, at Kantos Master i MART ikke er forbundet med underbehandling af patienter ved ukontrolleret astma.
This additional analysis further demonstrated that Kantos Master in MART is not associated with under-treatment of patients in case of uncontrolled asthma.
Det blev konkluderet, at den vigtigste faktor i MART-tilgangen ikke var den samlede indgivne mængde inhalationskortikosteroid, men tidspunktet for indgivelsen.
It was concluded that the key factor of the MART approach is not the overall amount of ICS given, but when the dose is given.
Yderligere evidens fra litteraturen tyder på, at nedsættelse af dosis fra høj til moderat vedligeholdelsesdosis af inhalationskortikosteroid ikke påvirker udfaldet af MART-behandlingen.
Further evidence in the literature has suggested that dose reduction from high to moderate maintenance ICS does not affect outcomes of MART treatment.
• det er udvalgets opfattelse, at hovedundersøgelse CT07 viste, at der kan opnås signifikant nedsat risiko for svære eksacerbationer af astma og signifikant længere tid til eksacerbation, når Kantos Master gives efter behov
• The Committee is of the opinion that the data of the pivotal study CT07 indicated a significant reduction in the risk of severe exacerbations of asthma and significant longer time to exacerbation can be obtained when Kantos Master dose is given as needed.
I begge behandlingsarme iagttoges ligeledes signifikante bedringer i de sekundære virkningsvariabler (forceret ekspiratorisk volumen i første sekund (FEV1), astmasymptomer, medicinfrie dage m.v.).
Significant improvements were also observed in the secondary efficacy variables (Forced Expiratory Volume in the 1st second (FEV1), asthma symptoms, medication free days etc.) in both treatment arms.
anbefalede CHMP godkendelse af ændring af markedsføringstilladelsen for de i bilag I anførte lægemidler, for hvilke det gældende produktresumé og den gældende etikettering og indlægsseddel fortsat er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III.
Therefore, the CHMP recommended the granting of the variation to the terms of the marketing authorisations for the medicinal products referred to in Annex I for which the valid Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III.