natgillin/translations-raw huggingface dataset:
De godkendte obstetriske indikationer er: truende for tidlig fødsel, tokolyse (for nogle produkter er anvendelsen begrænset til bestemte gestationsuger, mens der fra andre ikke angives nogen bestemt del af graviditeten), ekstern vending og uterin hyperkontraktilitet. 
The authorised obstetric indications include partus prematurus, tocolysis (for some products use is restricted to particular weeks of gestation but for others no specific gestation period is specified), external cephalic version (ECV), and hyper-uterine contractility.
b. Alle andre markedsføringstilladelser for lægemidler indeholdende SABA (salbutamol, terbutalin, fenoterol, ritodrin, hexoprenalin og isoxsuprin), der anvendes til tokolyse og andre obstetriske indikationer (se bilag I), bør ændres (svarende til ændringerne af produktinformationen, der fremgår af bilag III). 
b. All other marketing authorisations of SABAs (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products indicated in tocolysis and other obstetric indications (see Annex I) should be varied (in accordance with changes to the product information as set out in Annex III).
De korttidsvirkende beta-agonister(også kaldet beta-receptorstimulerende midler) salbutamol, terbutalin, fenoterol, ritodrin, hexoprenalin og isoxsuprin er alle nationalt godkendt og har været på markedet i EU siden 1960'erne. 
The short-acting beta-agonists (SABAs) (also known as beta-mimetics), salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine are all nationally authorised and have been on the market within the EU since the 1960s.
Efter gennemgang af PRAC's anbefaling af 5. september 2013 CMDh i henhold til artikel 107k, stk. 1 og 2, i direktiv 2000/83/EF nåede CMDh til enighed om ændring eller i givet fald inddragelse af markedsføringstilladelserne for lægemidler indeholdende terbutalin, salbutamol, hexoprenalin, ritodrin, fenoterol og isoxsuprin, for hvilke de relevante afsnit af produktresuméet og indlægssedlen er gengivet i bilag III, under de betingelser, der fremgår af bilag IV. 
The CMDh, having considered the PRAC recommendation dated 5 September 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the variation or revocation as applicable of the marketing authorisations of terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol and isoxsuprine containing products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Vedrørende parenterale lægemidler indeholdende SABA (salbutamol, terbutalin, fenoterol, ritodrin, hexoprenalin og isoxsuprin) til de obstetriske indikationer konkluderede PRAC, at benefit/risk-forholdet er gunstigt, da fordelene fortsat overstiger risiciene. 
With regards to parenteral SABAs (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products in the obstetric indications, the PRAC concluded that the benefit-risk balance is favourable as the benefits continue to outweigh the risks.
De foreliggende data for alle SABA omfattet af denne gennemgang (terbutalin, salbutamol, hexoprenalin, ritodrin, fenoterol, isoxsuprin) er evidens for, at de orale formuleringer og suppositorieformuleringerne er forbundet med alvorlige dosisafhængige bivirkninger. 
Based on all data available for all SABAs considered in this review (terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol, isoxsuprine), there is evidence that oral and suppository formulations are associated with serious and dose dependent adverse events.
Videnskabelige konklusioner og begrundelse for tilbagekaldelse eller, i givet fald, ændring af markedsføringstilladelserne samt detaljeret redegørelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering) 
Scientific conclusions and grounds for revocation or variation as applicable to the terms of the marketing authorisations and detailed explanation for the differences from the PRAC recommendation
Ved gennemgangen vurderede PRAC alle foreliggende sikkerhedsdata vedrørende kardiovaskulære hændelser ved anvendelse til disse indikationer. 
This review by PRAC assessed all existing data in terms of safety of cardiovascular events when in use in these indications and the outcome of the review is summarised below.
PRAC konkluderede, at fordelene ved injektionspræparaterne opvejede de kardiovaskulære risici under begrænsede anvendelsesbetingelser: Disse aktive stoffer bør gives som korttidsbehandling (op til 48 timer) mellem 22. og 37. gestationsuge til patienter uden medicinske eller obstetriske kontraindikationer for tokolytisk behandling. 
The PRAC concluded that the benefits of injectable forms outweighed the cardiovascular risks in restricted conditions of use: these active substances should be given for short term management (up to 48 hours) between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy.
• udvalget finder, at fordelene ved de parenterale formuleringer af lægemidler indeholdende korttidsvirkende beta-agonister(SABA) (salbutamol, terbutalin, fenoterol, ritodrin, hexoprenalin og isoxsuprin) fortsat overstiger risiciene ved anvendelse til de obstetriske indikationer korttidsbehandling af ukompliceret tokolyse, 
The Committee is of the opinion that the benefits of the parenteral formulations of short-acting beta-agonists (SABAs) (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products continue to outweigh the risks in the obstetric indications of short term management of uncomplicated tocolysis.
• udvalget gennemgik alle foreliggende data fra kliniske undersøgelser, farmakoepidemiologiske undersøgelser, den publicerede litteratur og erfaringer efter markedsføring om sikkerheden af lægemidler indeholdende korttidsvirkende beta-agonister(SABA) (salbutamol, terbutalin, fenoterol, ritodrin, hexoprenalin og isoxsuprin) til de obstetriske indikationer, 
The Committee reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature and post-marketing experience on the safety of short-acting betaagonists (SABAs) (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products in the obstetric indications.
• udvalget understregede desuden, at parenterale produkter kun bør administreres som korttidsbehandling (op til 48 timer) på de obstetriske indikationer hos patienter mellem 22. og 37. gestationsuge. 
The Committee in addition stressed that the parenteral products should only be administered for short term management (up to 48 hours) of the obstetric indications in patients between 22 and 37 weeks of gestation.
Der vurderedes sikkerhedsdata fra kliniske undersøgelser udført af markedsføringstilladelsesindehaveren og metaanalyser af veltilrettelagte kliniske undersøgelser. 
Safety data from MAH clinical trials and meta-analyses of well-designed clinical trials have been assessed.
For produkter, der i orale formuleringer og suppositorieformuleringer kun anvendes ved obstetriske indikationer, skal markedsføringstilladelse inddrages, og produkterne trækkes af markedet. 
Products for which the oral and suppository formulations are only used in obstetric indications should have their licenses revoked and recalled from the market.
Desuden bør blodtryk og hjertefrekvens, elektrolyt- og væskebalance samt glukose-, laktatog kaliumværdier overvåges kontinuerligt. 
In addition, blood pressure and heart rate, electrolyte and fluid balance, glucose and lactate levels and potassium levels should be continuously monitored.
Der er forskelle mellem medlemsstaterne hvad angår de godkendte obstetriske indikationer for SABA. 
Authorised obstetric indications for SABAs differ across Member States.
Indehaveren af markedsføringstilladelsen identificerede 8 tilfælde af neonatal død/fosterdød, herunder abort. 
Eight cases of neonatal/foetal death including abortions have been identified by the MAH.
Mere sjældent er der beskrevet tilfælde af angst, svimmelhed, bloddyskrasier, rabdomyolyse, svære kutane bivirkninger og anafylaktisk shock. 
More rarely, cases of anxiety, dizziness, blood dyscrasias, rhabdomyolysis, severe cutaneous adverse reactions (SCARs), and anaphylactic shock have been described.
Samlet resumé af PRAC's videnskabelige vurdering af lægemidler indeholdende terbutalin, salbutamol, hexoprenalin, ritodrin, fenoterol og isoxsuprin (se bilag I) 
Overall summary of the scientific evaluation of terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol and isoxsuprine containing medicinal products by PRAC (see Annex I)
Ved denne gennemgang vurderedes data hidrørende fra kliniske undersøgelser, indberetninger efter markedsføring og den publicerede litteratur. 
Data available from clinical trials, post-marketing reports and literature were considered in this review.
Injektionspræparaterne medfører sikkerhedsproblemer ved langvarig anvendelse af disse aktive stoffer til obstetriske indikationer, men ved kortvarig administration (højst 48 timer) kan der være fordel ved anvendelse af de parenterale formuleringer til den obstetriske indikation tokolyse. 
With injectable formulations there are safety issues during prolonged use of these active substances in the context of the obstetric indications, however there may be benefit in administering parental formulations in the obstetric indication of tocolysis in the short-term (maximum 48 hours).
• udvalget fandt, at de parenterale lægemidler indeholdende disse SABA (salbutamol, terbutalin, fenoterol, ritodrin, hexoprenalin og isoxsuprin) på baggrund af de foreliggende sikkerhedsdata og for at opretholde et positivt benefit/risk-forhold bør være kontraindiceret ved gestationsalder under 22 uger, ved præeksisterende iskæmisk hjertesygdom eller væsentlige risikofaktorer for iskæmisk hjertesygdom og ved truende abort i første og andet trimester. 
The Committee considered that in view of the currently available safety data in order to maintain a favourable benefit-risk balance, these parenteral SABAs (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products should be contraindicated in patients at a gestational age less than 22 weeks, in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease and in patients with threatened abortion during the first and second trimester of gestation.
Udvalget understregede desuden, at hos patienter, der får disse parenterale lægemidler, skal blodtryk og hjertefrekvens, elektrolyt- og væskebalance samt glukose-, laktat- og kaliumværdier overvåges kontinuerligt. 
The committee also stressed that in the patients receiving these parenteral medicinal products the blood pressure and heart rate, electrolyte and fluid balance, glucose and lactate levels and potassium levels should be continuous monitored.
• PRAC fulgte proceduren i henhold til artikel 31 i direktiv 2001/83/EF, foranlediget af lægemiddelovervågning af lægemidler indeholdende korttidsvirkende beta-agonister (SABA) (salbutamol, terbutalin, fenoterol, ritodrin, hexoprenalin og isoxsuprin) til de obstetriske indikationer (se bilag I), 
The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for short-acting beta-agonists (SABAs) (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products in the obstetric indications (see Annex I).
De foreliggende data viste, at injektionspræparaterne er effektive til kortvarigt (op til 48 timer) at hæmme sammentrækningerne af livmoderen under veer. 
The available data showed that injectable forms are effective at supressing labour contractions in the short term (up to 48 hours).
For de parenterale formuleringer anbefaler PRAC efter gennemgang af alle de foreliggende data og specifikt for behandling af ukomplicerede for tidlige veer, at disse aktive stoffer gives som korttidsbehandling (op til 48 timer) mellem 22. og 37. gestationsuge til patienter uden medicinsk eller obstetrisk kontraindikation for tokolytisk behandling. 
For the parenteral formulations, the PRAC having considered all the available data and specifically for the management of uncomplicated premature labour recommends that these active substances should be given for short term management (up to 48 hours) between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy.
Udvalget understregede desuden, at hos patienter, der får disse parenterale lægemidler, bør blodtryk og hjertefrekvens, elektrolyt- og væskebalance samt glukose-, laktat- og kaliumværdier overvåges kontinuerligt i hele behandlingsperioden, 
The committee also stressed that in the patients receiving these parenteral medicinal products the blood pressure and heart rate, electrolyte and fluid balance, glucose and lactate levels and potassium levels should be monitored throughout treatment.
Parenterale lægemidler indeholdende SABA bør være kontraindiceret ved gestationsalder under 22 uger, ved præeksisterende iskæmisk hjertesygdom og ved væsentlige risikofaktorer for iskæmisk hjertesygdom samt ved truende abort i første og andet trimester. 
Parenteral medicinal SABA products should be contraindicated in patients at less than 22 weeks of gestation, in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease and in patients with threatened abortion during the first and second trimester of gestation.
De bør være kontraindiceret ved gestationsalder under 22 uger, ved præeksisterende iskæmisk hjertesygdom, ved væsentlige risikofaktorer for iskæmisk hjertesygdom og ved truende abort i første og andet trimester. 
The use should be contraindicated in patients at a gestational age less than 22 weeks, in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease and in patients with threatened abortion during the first and second trimester of gestation.
For disse indikationer, der indbefatter kortvarig behandling af ukompliceret tokolyse, anbefalede PRAC, at parenterale produkter kun administreres kortvarigt (op til 48 timer) mellem 22. og 37. gestationsuge. 
For these indications which include short term management of uncomplicated tocolysis the PRAC recommended the parenteral products should only be administered for short term management (up to 48 hours) in patients between 22 and 37 weeks of gestation.
CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer (human)) har gennemgået PRAC's anbefaling af 5. september 2013 for lægemidler indeholdende terbutalin, salbutamol, hexoprenalin, ritodrin, fenoterol og isoxsuprin: 
The CMDh considered the below PRAC recommendation dated 5 September 2013 with regards to the terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol and isoxsuprine containing medicinal products:
Til disse indikationer, herunder kortvarig behandling af ukompliceret tokolyse, anbefalede PRAC, at parenterale produkter kun administreres kortvarigt (op til 48 timer) på obstetriske indikationer hos patienter mellem 22. og 37. gestationsuge. 
For these indications which include short term management of uncomplicated tocolysis the PRAC recommended the parenteral products should only be administered for short term management (up to 48 hours) of the obstetric indications in patients between 22 and 37 weeks of gestation.
• epilepsi. 
• epilepsy.
Undersøgelserne varede i op til 12 uger. 
The studies lasted up to 12 weeks.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Lyrica til Pfizer Limited den 6. juli 2004. 
The European Commission granted a marketing authorisation valid throughout the European Union for Lyrica to Pfizer Limited on 6 July 2004.
Hvis man ophører med behandlingen med Lyrica, bør dette ligeledes ske gradvis i løbet af mindst en uge. 
Stopping treatment with Lyrica should also be done gradually, over at least a week.
Det primære effektmål var ændringen i antallet af anfald efter 11 til 12 uger, 
The main measure of effectiveness was the change in the number of seizures after 11 to 12 weeks;
Det fås som kapsler (hvide: 25, 50 og 150 mg, hvide og orange: 75, 225 og 300 mg, orange: 100 mg, lys orange: 200 mg) eller som oral opløsning (20 mg/ml). 
It is available as capsules (white: 25, 50 and 150 mg; white and orange: 75, 225 and 300 mg; orange: 100 mg; light orange: 200 mg) and as an oral solution (20 mg/ml).
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lyrica. 
This document is a summary of the European Public Assessment Report (EPAR) for Lyrica.
Andre oplysninger om Lyrica: 
Other information about Lyrica:
Lyrica anvendes til behandling af voksne med følgende tilstande: 
Lyrica is used to treat adults with the following conditions:
Den maksimale dosis er 600 mg daglig. 
The maximum dose is 600 mg per day.
Effekten blev målt ved hjælp af et standardspørgeskema for angst efter fire til otte uger. 
Effectiveness was measured using a standard anxiety questionnaire after four to eight weeks.
Patienter, som har nyresygdomme, skal have lavere dosis. 
Patients who have kidney problems need to take lower doses.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Lyrica. 
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lyrica.
Lyrica blev sammenlignet med placebo (en virkningsløs behandling) i 22 undersøgelser: 
Lyrica has been compared with placebo (a dummy treatment) in 22 studies:
CHMP besluttede, at fordelene ved Lyrica opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse. 
The CHMP decided that Lyrica's benefits are greater than its risks and recommended that it be given marketing authorisation.
Hvis du ønsker yderligere oplysninger om behandling med Lyrica, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Lyrica, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det vides endnu ikke med nøjagtighed, hvordan pregabalin virker, men det menes at påvirke den måde, hvorpå calcium trænger ind i nerveceller. 
The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Det aktive stof i Lyrica, pregabalin, ligner i sin struktur kroppens egen "neurotransmitter" (signalstof) GABA (gamma-aminosmørsyre), men dets biologiske virkninger er meget anderledes. 
The active substance in Lyrica, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects.
Dette nedsætter aktiviteten i visse nerveceller i hjernen og rygmarven, hvorved det frigiver andre neurotransmittere, der er en medvirkende årsag til smerter, epilepsi og angst. 
This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
Den fuldstændige EPAR for Lyrica findes her. 
The full EPAR for Lyrica can be found here.
Virkningen af Lyrica blev målt ved hjælp af et standardspørgeskema for smerter, 
The effectiveness of Lyrica was measured using a standard pain questionnaire;
Den anbefalede startdosis af Lyrica er 150 mg dagligt fordelt på to eller tre doser. 
The recommended starting dose of Lyrica is 150 mg per day, divided into two or three doses.
De hyppigste bivirkninger ved Lyrica (som optræder hos flere end 1 ud af 10 patienter) er svimmelhed og søvntrang (søvnighed). 
The most common side effects with Lyrica (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Lyrica anvendes som tillægsbehandling til en eksisterende behandling hos patienter, der har partielle anfald (epileptiske anfald, som starter i en bestemt del af hjernen), som ikke kan holdes under kontrol med den nuværende behandling, 
Lyrica is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
• til epilepsi blev der gennemført tre undersøgelser, som omfattede over 1 000 patienter. 
• for epilepsy, there were three studies involving over 1,000 patients.
Til neuropatiske smerter var Lyrica mere effektivt end placebo til at lindre smerter. 
In neuropathic pain, Lyrica was more effective than placebo in decreasing pain.
Lyrica bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for pregabalin eller andre af indholdsstofferne. 
Lyrica should not be used in people who may be hypersensitive (allergic) to pregabalin or any of the other ingredients.
Der blev gennemført en yderligere undersøgelse af 137 patienter med centrale neuropatiske smerter som følge af en beskadigelse af rygmarven. 
A further study was carried out in 137 patients with central neuropathic pain due to a spinal cord injury.
• neuropatiske smerter (smerter som følge af beskadigelse af nerver). 
• neuropathic pain (pain due to nerve damage).
Hvilken risiko er der forbundet med Lyrica? 
What is the risk associated with Lyrica?
• til generaliseret angst blev der gennemført otte undersøgelser, som omfattede over 3 000 patienter. 
• for generalised anxiety disorder, there were eight studies involving over 3,000 patients.
Til sammenligning var det ca. 10 % af de patienter, der fik placebo. 
This compared with about 10% of the patients taking placebo.
• til perifere neuropatiske smerter blev der gennemført undersøgelser, som omfattede over 3 000 patienter, hvoraf ca. halvdelen havde diabetisk neuropati, og den anden halvdel havde smerter som følge af helvedesild. 
• for peripheral neuropathic pain, there were ten studies involving over 3,000 patients, about half of whom had diabetic neuropathy and half of whom had pain following shingles.
Lyrica kan anvendes til perifere neuropatiske smerter såsom de smerter, der opleves af diabetespatienter eller af patienter med herpes zoster (helvedesild), og til centrale neuropatiske smerter, som opleves af patienter, der har fået beskadiget rygmarven. 
Lyrica can be used in peripheral neuropathic pain, such as the pain experienced by diabetic patients or by patients who have had herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Den fuldstændige liste over alle de indberettede bivirkninger for Lyrica fremgår af indlægssedlen. 
For the full list of all side effects reported with Lyrica, see the Package Leaflet.
Til epilepsi nedsatte Lyrica antallet af anfald: ca. 45 % af de patienter, der fik Lyrica 600 mg dagligt, og ca. 35 % af dem, der fik Lyrica 300 mg dagligt, oplevede et fald i antallet af anfald på 50 % eller derover. 
In epilepsy, Lyrica reduced the number of seizures: about 45% of the patients taking 600 mg Lyrica a day and about 35% of those taking 300 mg Lyrica a day had a reduction in seizures of 50% or more.
Hvorfor blev Lyrica godkendt? 
Why has Lyrica been approved?
Til generaliseret angst var Lyrica mere effektivt end placebo: 52 % af de patienter, der fik Lyrica, oplevede en forbedring på mindst 50 % sammenlignet med 38 % af de patienter, der fik placebo. 
In generalised anxiety disorder, Lyrica was more effective than placebo: 52% of the patients taking Lyrica had an improvement of 50% or more, compared with 38% of the patients taking placebo.