natgillin/translations-raw huggingface dataset:
Alvorligheden af bivirkningerne synes at have direkte sammenhæng med den administrerede dosis, men også med behandlingsvarigheden, da de fleste livstruende bivirkninger optrådte efter længerevarende administration af ritodrin (fra >72 timer til måneder).
The seriousness of AEs seems to be directly related to the dose of ritodrine administered to the patient, but also to the treatment duration as most of life-threatening AEs occurred after prolonged ritodrine administration (>72h to months).
Anvendelse af SABA til akut behandling og til at muliggøre ekstern fostervending støttes, da der er tale om begrænset anvendelsesvarighed og minimal dosering, og fra et sikkerhedsperspektiv bør disse indikationer opretholdes, hvor de er godkendt.
The use of SABAs in emergency conditions and to enable external cephalic version is supported as this reflects limited duration of use and minimal dosing, and from a safety perspective these indications should be maintained, where authorised.
Ved tidligere gennemgange af sikkerheden fremhævedes risikoen for myokardieiskæmi ved anvendelse af SABA til obstetriske indikationer og nødvendigheden af forsigtighed ved anvendelse af disse produkter til tokolyse og til andre obstetriske indikationer.
Previous safety reviews have highlighted the risk of myocardial ischaemia associated with the use of SABAs in obstetric indications and that these products should be used with caution in tocolysis, and other obstetric indications.
Orale formuleringer og suppositorier anvendes til vedligeholdelse af tokolyse efter administration af injektionspræparaterne, og i betragtning af den kardiovaskulære sikkerhedsprofil finder PRAC, at disse lægemidler ikke længere udviser et positivt risk/benefit-forhold.
Oral formulations and suppositories are used for the maintenance in tocolysis after the injectable forms have been administered, and considering the cardiovascular safety profile, the PRAC considers that these medicinal products no longer demonstrate a favourable benefit-risk balance.
Vurderingen omfatter orale og parenterale formuleringer samt suppositorier.
Oral, parenteral and suppositories formulations have been included in this assessment.
Maternel hypotension, palpitationer, tremor, rødmen, svedtendens, hovedpine og kvalme var også almindeligt forekommende.
Maternal hypotension, palpitations, tremor, flush, sweating, headache and nausea also occurred commonly.
Anvendelse af ritodrin er forbundet med risici for alvorlig kardial og pulmonal dysfunktion (sjældent myokardieinfarkt), ændring i glykæmi og blodets kaliumindhold, gastrointestinale lidelser, tremor, hovedpine og erytem.
The use of ritodrine is associated with risks of major cardiac and pulmonary dysfunction (rarely myocardial infarction), alteration in glycaemia and blood potassium concentration, gastro-intestinal disorders, tremors, headache and erythema.
PRAC konstaterede desuden otte tilfælde af spædbarnsdød, heraf to knyttet til lungeødem og kardiovaskulære hændelser.
The PRAC noted eight infant fatalities, two of which were in association with pulmonary oedema and cardiovascular events.
Vedrørende vinduet med laveste levedygtighed af fosteret noterede PRAC sig en epidemiologisk oversigtsartikel om obstetriske interventioner i europæiske lande (Kollée et al, 2009) og mere nyligt fra USA (Kyser et al., 2012), som tyder på, at det er mellem 22 og 24 uger.
With regards to the window of lowest gestational viability, the PRAC noted an epidemiological review of obstetric interventions in European countries (Kollée et al, 2009) andmore recently by US (Kyser et al.,
Forekomsten af typiske bivirkninger ved betareceptorstimulation er veldokumenteret og spænder fra let forbigående ubehag til alvorlige kardiovaskulære bivirkninger, der kræver øjeblikkelig lægelig indgriben ved f.eks. arytmier eller lungeødem.
Occurrence of typical adverse effects characteristic of beta receptor stimulation are well documented, and range from mild and transient discomfort to serious cardiovascular side effects requiring prompt medical intervention, e.g. in case of arrhythmias or pulmonary oedema.
Der blev ikke indberettet myokardieinfarkt eller alvorlige arytmier i de kliniske undersøgelsesrapporter, der var tilgængelige for indehaveren af markedsføringstilladelsen.
Myocardial infarction or serious arrhythmias were not reported in the clinical trial reports available to the MAH.
For fenoterol angives desuden akutte anvendelser ved indikationer såsom dystoki i udvidelses- og uddrivningsfaserne af fødselsveer (således uterin hyperaktivitet eller spasme, enten spontan eller som følge af mekanisk obstruktion eller overstimulation med oxytocinanaloger), intrauterin asfyxi (manifesteret ved tegn såsom nedsat hjertefrekvens hos føtus eller begyndende moderat føtal acidose), akutte obstetriske indikationer (således navlestrengsfremfald eller truende uterusruptur), hæmning af uteruskontraktioner ved akutte indikationer såsom kejsersnit.
Fenoterol also contains descriptions of emergency uses in the indications such as dystocias in the dilation and expulsion stages of labour (such as uterine hyperactivity or spasm occurring either spontaneously or as a result of mechanical obstruction or over stimulation by oxytocic agents); intrauterine asphyxia (as indicated by signs such as foetal heart rate decelerations or incipient to moderate foetal acidosis); obstetric emergencies (such as cord prolapse or imminent uterine rupture); uterine relaxation in acute indications such as caesarean section.
Der foreligger en case-rapport om uterin blødning, som dog er konfunderet af samtidig uterin patologi.
One case report of uterine haemorrhage exists however it is confounded by concomitant uterine pathology.
I en række af indberetningerne bidrog lungeødem til hændelserne, og i et tilfælde blev der beskrevet lungeødem i tilslutning til kardiomegali efter en fem ugers tabletkur, hvor der ikke opnåedes tokolyse.
There were a number of reports of pulmonary oedema contributing to the events and one case reported pulmonary oedema in association with cardiomegaly, after taking a course of tablets for five weeks, when tocolysis failed.
Ifølge de publicerede undersøgelser er intravenøs administration af hexoprenalin meget ofte ledsaget af bivirkninger.
According to the published studies intravenous administration of hexoprenaline is very commonly accompanied with occurrence of adverse drug reactions.
• udvalget konkluderede, at der var behov for yderligere risikominimeringsforanstaltninger såsom information til sundhedspersoner om resultatet af gennemgangen og sikker anvendelse af de parenterale formuleringer til de obstetriske indikationer,
The Committee concluded that there was need for further risk minimisation measures such as information to healthcare professionals to inform on the outcome of the review and the safe use of the parenteral formulations in the obstetric indications.
Indikationerne for isoxsuprin og hexoprenalin tabletter omfatter desuden “truende abort”, og der angives dosering til forebyggelse af veer.
Isoxsuprine and hexoprenaline tablets also have ‘threatened abortion' within the indications and a posology for prophylaxis of labour.
Udvalget konkluderede, at der var behov for yderligere risikominimeringsforanstaltninger med henblik på at informere sundhedspersoner om de nye begrænsninger for anvendelsen og overvågningskrav, som er indført for at garantere sikker anvendelse af de parenterale formuleringer til obstetriske indikationer og for at informere om det negative benefit/risk-forhold af de orale formuleringer og suppositorieformuleringerne til disse indikationer.
The Committee concluded that there was a need for further risk minimisation measures to inform healthcare professionals of the new restrictions on use and monitoring requirements introduced to ensure safe use of the parenteral formulations in the obstetric indications and to inform of the unfavourable benefit-risk balance of the oral and suppositories formulations in these indications.
Disse tilfælde med bivirkninger under behandling med ritodrin omfattede både veldokumenterede case-rapporter fra litteraturen og spontane indberetninger fra sundhedspersonale og sundhedsmyndigheder, som er registreret af indehaveren af markedsføringstilladelsen.
These cases of adverse events under ritodrine therapy included both welldocumented case reports from the literature and cases recorded by the MAH from spontaneous reporting from healthcare personnel or Health Authorities.
Ved opgørelse af data efter markedsføring for isoxsuprin fra 2000 til 2013 fandtes ingen indberetninger om alvorlige bivirkninger for det intravenøse produkt, og tre indberetninger af ikke-alvorlige bivirkninger.
Post-marketing data were summarised for isoxsuprine from 2000 to 2013; no serious AEs were reported for the i.v.
Salbutamol, terbutalin, fenoterol, ritodrin, hexoprenalin og isoxsuprin har været godkendt til obstetriske indikationer siden 1960'erne.
Salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine are authorised in obstetric indications since the 1960s.
• for de orale formuleringer og suppositorieformuleringer tog PRAC hensyn til de foreliggende overordnede sikkerhedsdata, navnlig vedrørende risikoen for alvorlige kardiovaskulære hændelser og de meget begrænsede data om virkning, hvorfor udvalget i overensstemmelse med artikel 116 i direktiv 2001/83/EF konkluderede, at benefit/risk-forholdet ikke er positivt, og at disse lægemidler derfor ikke længere bør have denne obstetriske behandlingsindikation,
For the oral and suppositories formulations in view of the overall available safety data, in particular in relation to the risk of serious cardiovascular events, and very limited efficacy data, the PRAC concluded in accordance with Article 116 of Directive 2001/83/EC that the benefit-risk balance is not favourable and therefore these medicinal products should no longer be indicated in the obstetrics therapeutic indication.
Den 27. november 2012 underrettede Ungarn i medfør af artikel 31 i direktiv 2001/83/EF Det Europæiske Lægemiddelagentur om, at det fandt, at benefit/risk-forholdet for lægemidler indeholdende korttidsvirkende beta-agonister (SABA) til obstetriske indikationer er blevet negativt i betragtning af de indberettede kardiovaskulære hændelser.
On 27 November 2012, further to evaluation of data resulting from pharmacovigilance activities, Hungary informed the European Medicines Agency, pursuant to Article 31 of Directive 2001/83/EC, of their consideration that the risk-benefit balance of short-acting beta-agonists (SABAs) containing medicinal products authorised in obstetric indications has become unfavourable, taking into account the cardiovascular events reported.
Mange af disse indberetninger optrådte både i forbindelse med intravenøst og oralt salbutamol; denne bivirkning synes således ikke at være specifik for en bestemt formulering.
and oral salbutamol; it would appear that this adverse event is not specific to a particular formulation.
Der blev derudover indberettet to tilfælde, hvor tokolyse blev opretholdt alene med suppositorier, og hvor der opstod lungeødem.
Two cases of tocolysis maintained with suppositories only were also reported to develop pulmonary oedema.
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.