FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Pfizer, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Pregabalin Pfizer, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The CHMP decided that Pregabalin Pfizer's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Pregabalin Pfizer overstiger risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Pregabalin Pfizer.
English: In neuropathic pain, the benefits of Pregabalin Pfizer were evaluated for up to 12 weeks using a standard pain questionnaire.
Danish: Ved neuropatiske smerter blev virkningen af Pregabalin Pfizer vurderet i op til 12 uger på et standardspørgeskema for smerter.
English: The most common side effects with Pregabalin Pfizer (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Danish: De hyppigste bivirkninger ved Pregabalin Pfizer (som optræder hos mere end 1 ud af 10 patienter) er svimmelhed og søvnighed.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Pfizer?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pregabalin Pfizer?
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Danish: • smerter som følge af nervebeskadigelse (neuropatiske smerter) såsom ved sukkersyge eller helvedesild (herpes zoster) samt centrale neuropatiske smerter såsom ved rygmarvsskader,
English: In epilepsy, the benefits of Pregabalin Pfizer were evaluated in 3 studies involving 1,000 patients that looked at how much it reduced the number of seizures patients had after 11 to 12 weeks.
Danish: Ved epilepsi blev virkningen af Pregabalin Pfizer vurderet i tre undersøgelser med 1 000 patienter, hvor det registreredes, hvor meget patienternes anfald aftog efter 11-12 ugers behandling.
English: For more information about treatment with Pregabalin Pfizer, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pregabalin Pfizer, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Pregabalin Pfizer.
Danish: Det er ikke en praktisk vejledning i, hvordan Pregabalin Pfizer bør anvendes.
English: What is Pregabalin Pfizer and what is it used for?
Danish: Hvad er Pregabalin Pfizer, og hvad anvendes det til?
English: Other information about Pregabalin Pfizer
Danish: Andre oplysninger om Pregabalin Pfizer
English: The recommended starting dose of Pregabalin Pfizer is 150 mg per day,
Danish: Den anbefalede startdosis af Pregabalin Pfizer er 150 mg dagligt fordelt på to eller tre doser.
English: For practical information about using Pregabalin Pfizer, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pregabalin Pfizer, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Pregabalin Pfizer was more effective than placebo in generalised anxiety disorder: in 8 studies involving over 3,000 patients, 52% of the patients taking Pregabalin Pfizer had an improvement of 50% or more in their anxiety measured with a standard anxiety questionnaire, compared with 38% of the patients taking placebo.
Danish: Pregabalin Pfizer var mere effektivt end placebo mod generaliseret angst: I 8 undersøgelser med over 3 000 patienter fik 52 % af dem, der fik Pregabalin Pfizer, en bedring på mindst 50 % målt på et standardspørgeskema for angst, sammenholdt med 38 % af dem, der fik placebo.
English: What are the risks associated with Pregabalin Pfizer?
Danish: Hvilke risici er der forbundet med Pregabalin Pfizer?
English: Why is Pregabalin Pfizer approved?
Danish: Hvorfor er Pregabalin Pfizer blevet godkendt?
English: For the full list of all side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Pregabalin Pfizer fremgår af indlægssedlen.
English: About 45% of the patients taking 600 mg Pregabalin Pfizer a day and about 35% of those taking 300 mg Pregabalin Pfizer a day had a reduction in seizures of 50% or more.
Danish: Antallet af anfald aftog med mindst 50 % hos ca. 45 % af de patienter, der fik Pregabalin Pfizer 600 mg dagligt, og ca. 35 % af dem, der fik Pregabalin Pfizer 300 mg dagligt.
English: In 10 studies involving over 3,000 patients with peripheral neuropathic pain (either diabetic pain or shingles), 35% of the patients treated with Pregabalin Pfizer had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo.
Danish: I 10 undersøgelser med over 3 000 patienter med perifere neuropatiske smerter (forårsaget enten af sukkersyge eller helvedesild) fik 35 % af dem, der blev behandlet med Pregabalin Pfizer, et fald i smertescore på mindst 50 %, sammenholdt med 18 % af dem, der blev behandlet med placebo.
English: In a smaller study involving 137 patients with central neuropathic pain due to a spinal cord injury, 22% of patients treated with Pregabalin Pfizer had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo.
Danish: I en mindre undersøgelse med 137 patienter med perifere neuropatiske smerter efter rygmarvsskader fik 22 % af de patienter, der blev behandlet med Pregabalin Pfizer, et fald i smertescore på mindst 50 %, sammenholdt med 8 % af dem, der blev behandlet med placebo.
English: How is Pregabalin Pfizer used?
Danish: Hvordan anvendes Pregabalin Pfizer?
English: How does Pregabalin Pfizer work?
Danish: Hvordan virker Pregabalin Pfizer?
English: What benefits of Pregabalin Pfizer have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Pregabalin Pfizer?
English: • a meta-analysis of three WHO studies3,4,5, which primarily included African and Asian women.
Danish: • en metaanalyse af tre WHO-undersøgelser3,4,5, der hovedsagelig omfattede afrikanske og asiatiske kvinder.
English: Information for women
Danish: Information til kvinden
English: EllaOne can only be obtained with a prescription.
Danish: EllaOne udleveres kun efter recept.
English: 30 September 2014 EMA/631408/2014
Danish: Den 30. september 2014 EMA/631408/2014
English: For more information on these studies, see the CHMP assessment report for ellaOne: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/001027/WC500023673.pdf
Danish: Yderligere oplysninger om disse undersøgelser findes i CHMP's vurderingsrapport for ellaOne: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/001027/WC500023673.pdf
English: The review of emergency contraceptives containing levonorgestrel and ulipristal acetate was initiated in January 2014 at the request of Sweden, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af fortrydelsesspiller med levonorgestrel og ulipristalacetat blev indledt i januar 2014 på anmodning af Sverige i medfør af artikel 31 i direktiv 2001/83/EF.
English: • Women who have any questions or concerns should speak to their doctor or pharmacist.
Danish: • Kvinder, der ønsker yderligere oplysninger, bør kontakte lægen eller apotekspersonalet.
English: The review was conducted by the Committee for Medicinal Products for Human Use (CHMP), the Committee responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Danish: Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: The emergency contraceptives included in this review are medicines containing levonorgestrel, such as Norlevo, Levonelle/Postinor and Levodonna, which have been authorised in the EU through national procedures.
Danish: Fortrydelsespillerne omfattet af denne gennemgang er lægemidler med levonorgestrel, såsom Norlevo, Levonelle/Postinor og Levodonna, der er godkendt i EU ved nationale procedurer.
English: The review also included a centrally-authorised medicine, ellaOne, which contains ulipristal acetate and was granted a marketing authorisation in the EU in 2009.
Danish: Gennemgangen omfattede desuden et centralt godkendt lægemiddel, ellaOne, der indeholder ulipristalacetat og blev godkendt i EU i 2009.
English: Both meta-analyses did not include off-label use (i.e. intake later than 72 hours after unprotected sexual intercourse).
Danish: Ingen af de to metaanalyser omfattede ikkegodkendt brug (dvs. indtagelse mere end 72 timer efter ubeskyttet samleje).
English: The CHMP recommendation was sent to the European Commission, which issued a legally binding decision valid throughout the EU on 30 September 2014.
Danish: CHMP's anbefaling blev overgivet til Europa-Kommissionen, som den 30. september 2014 traf en retligt bindende afgørelse med gyldighed i hele EU.
English: The CHMP opinion was then forwarded to the European Commission, which issued a final legally binding decision on 30 September 2014.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som den 30. september 2014 vedtog en endelig, retligt bindende afgørelse.
English: • An EU-wide review was carried out to assess whether emergency contraceptives are less effective in overweight or obese women.
Danish: • Der er foretaget en EU-dækkende gennemgang for at vurdere, om fortrydelsespiller er mindre effektive hos overvægtige kvinder.
English: For levonorgestrel-containing products, some clinical studies have suggested a reduced effectiveness in women with high bodyweight, but in others no trend for a reduced effect with increasing bodyweight was observed.
Danish: For produkter med levonorgestrel har nogle kliniske undersøgelser tydet på nedsat effektivitet hos kvinder med høj legemsvægt, mens der i andre ikke er set tendens til nedsat virkning med stigende legemsvægt.
English: The CHMP recommended that the results of these studies should be included in the product information of emergency contraceptives, but that the statements on the impact of bodyweight in the product information for Norlevo should be deleted.
Danish: CHMP anbefalede, at resultaterne af disse undersøgelser indsættes i produktinformationen for fortrydelsespiller, men at omtalen af indvirkningen af legemsvægt slettes fra produktinformationen for Norlevo.
English: Those containing levonorgestrel can be used up to 72 hours after unprotected sexual intercourse or contraceptive failure, while ulipristal acetate can be used up to 120 hours.
Danish: Piller med levonorgestrel kan anvendes op til 72 timer efter ubeskyttet samleje eller svigt af prævention, mens ulipristalacetat kan anvendes i op til 120 timer.
English: For emergency contraceptives containing levonorgestrel, the Agency considered the following data:
Danish: For postcoitale kontraceptiva indeholdende levonorgestrel tog agenturet følgende data i betragtning:
English: However, in order to maximise the likelihood that they will work, it is important that they are taken as soon as possible after unprotected intercourse.
Danish: For at få størst mulig sikkerhed for, at pillerne virker, er det dog vigtigt at tage dem snarest efter ubeskyttet samleje.
English: Emergency contraceptives work by stopping or delaying ovulation.
Danish: Fortrydelsespiller virker ved at standse eller forsinke ægløsningen.
English: 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.
Danish: 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.
English: • Healthcare professionals should continue to remind women that emergency contraception is an occasional ‘rescue' method and should not replace a regular contraceptive method.
Danish: • Sundhedspersoner bør fortsat minde kvinden om, at postcoital kontraception er en nødforanstaltning til lejlighedsvis brug og ikke en erstatning for regelmæssig brug af kontraceptiva.
English: Women should be reminded that emergency contraceptives should be taken as soon as possible following unprotected sexual intercourse.
Danish: Kvinden bør mindes om, at fortrydelsespiller bør tages snarest muligt efter ubeskyttet samleje.
English: For ulipristal acetate, the Agency considered the following data:
Danish: For ulipristalacetat gennemgik agenturet følgende data:
English: They should only be used as an occasional ‘rescue' method as they do not work as well as regular contraceptive methods.
Danish: De bør kun bruges lejlighedsvis som nødforanstaltning, da de ikke virker lige så godt som sædvanlig prævention.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: CHMP fandt, at fortrydelsespiller med deres sædvanligvis lette bivirkninger har en gunstig sikkerhedsprofil og fortsat kan anvendes uanset kvindens legemsvægt.
English: The available data are limited and not robust enough to support with certainty the previous conclusion of decreased contraceptive effect with increased bodyweight/BMI.
Danish: De foreliggende data er begrænsede og ikke fyldestgørende til at bekræfte den tidligere konklusion om nedsat kontraceptiv effekt med stigende legemsvægt/BMI.
English: • 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.
Danish: • Kvinder mindes om, at fortrydelsespiller er en nødforanstaltning til lejlighedsvis brug og ikke virker lige så godt som almindelig prævention, såsom p-piller.
English: Levonorgestrel-containing emergency contraceptives are available 'over the counter' in several European countries.
Danish: Fortrydelsespiller med levonorgestrel fås i håndkøb i flere europæiske lande.
English: 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.
Danish: 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.
English: • Emergency contraceptives can continue to be used to prevent unintended pregnancy in women of any weight or body mass index (BMI).
Danish: • Postcoital kontraception kan fortsat anvendes til at undgå utilsigtet graviditet uanset kvindens vægt og legemsmasseindeks (BMI).
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: • Emergency contraceptives can continue to be taken after unprotected intercourse or contraceptive failure, regardless of the woman's bodyweight.
Danish: • Fortrydelsespiller kan fortsat anvendes efter ubeskyttet samleje eller svigt af prævention uanset kvindens legemsvægt.
English: • 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).
Danish: • 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)
English: Emergency contraceptives are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
Danish: Fortrydelsespiller er svangerskabsforebyggende medicin, der anvendes til at undgå uønsket graviditet efter ubeskyttet samleje eller svigt af prævention.
English: • Emergency contraceptives are used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
Danish: • Fortrydelsespiller anvendes til at undgå uønsket graviditet efter ubeskyttet samleje eller svigt af prævention.
English: 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.
Danish: 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.
English: • 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
Danish: • 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).
English: References.
Danish: Litteraturhenvisninger:
English: 90 (3 x 30 x 1) capsules (unit dose) (multipack)
Danish: 90 kapsler (3 x 30 x 1) kapsler (enkeltdosis) (multipakning)
English: 30 x 1 capsules (unit dose)
Danish: 30 x 1 kapsler (enkeltdosis)
English: 19 November 2012
Danish: Den 19. november 2012
English: The final opinion was converted into a Decision by the European Commission on 19 November 2012.
Danish: Den endelige udtalelse blev den 19. november 2012 omarbejdet til en beslutning af EuropaKommissionen.
English: On 23 March 2012, MERIAL notified the Agency of their intention to request a re-examination of the CVMP opinion of 8 March 2012.
Danish: 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.
English: 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.
Danish: 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.
English: The referral started on 9 March 2011.
Danish: Indbringelsesproceduren blev indledt den 9. marts 2011.
English: International non-proprietary names (inn): clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole
Danish: Internationale fællesnavne (INN): clorsulon, closantel, nitroxinil, rafoxanid og triclabendazol
English: The Committee appointed Mr G. J. Schefferlie as rapporteur and Dr B. Urbain as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis hr. G. J. Schefferlie og dr. B. Urbain.
English: Supplementary information was provided by some of the applicants/marketing authorisation holders by 26 August 2011.
Danish: Der blev forelagt supplerende oplysninger af nogle af ansøgerne/markedsføringstilladelsesindehaverne den 26. august 2011.
English: The detailed grounds for the re-examination request were submitted by MERIAL on 2 May 2012.
Danish: Den detaljerede begrundelse for anmodningen om fornyet overvejelse blev forelagt af MERIAL den 2. maj 2012.
English: 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.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
English: Oral explanations were given by MERIAL on 16 May 2012.
Danish: Der blev afgivet mundtlige redegørelser af MERIAL den 16. maj 2012.
English: 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.
Danish: 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.