natgillin/translations-raw huggingface dataset:
Til støtte for indikationen "behandling af bakteriel enteritis forårsaget af E. coli og kliniske udbrud forårsaget af Salmonella Dublin" har indehaveren af markedsføringstilladelse fremlagt in vitrofølsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
In support of the indication for treatment of bacterial enteritis caused by E. coli and clinical outbreaks due to Salmonella Dublin the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Indgiv 40.000 IE apramycinsulfat pr. kg legemsvægt (svarende til 72 mg produkt/kg legemsvægt) dagligt i 5 sammenhængende dage.
Administer 40,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 72 mg of product/kg bw), daily for 5 consecutive days.
De fremlagte kliniske data viste, at Girolan var effektivt til behandling af bakteriel enteritis forårsaget af E. coli ved daglig administration af apramycin i 7 dage i træk i en dosis på 12.500 IE pr. kg kropsvægt (svarende til 22,5 mg produkt/kg kropsvægt).
The provided clinical data demonstrated that Girolan was effective in the treatment of bacterial enteritis caused by E. coli when administered at 12,500 IU apramycin per kg bw (corresponding to 22.5 mg of product/kg bw), daily for 7 consecutive days.
Kalve: Hos kalve, som i 5 dage fik doser på op til 120 mg apramycin/kg legemsvægt gennem mælkeerstatning, påvistes ingen toksisk effekt.
Calves: Calves were given apramycin in milk replacer daily for five days, at doses up to 120 mg/kg of bodyweight.
UDLØBSDATO EXP (måned/år)
EXPIRY DATE EXP {month/year}> Once diluted, use within 24 hours.
Behandling af bakteriel enteritis forårsaget af apramycin-følsom Escherichia coli.
Treatment of bacterial enteritis caused by Escherichia coli susceptible to apramycin.
Til støtte for indikationen "behandling af bakteriel enteritis forårsaget af E. coli" har indehaveren af markedsføringstilladelse fremlagt in vitro-følsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
In support of the indication for treatment of bacterial enteritis caused by E. coli the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Behandling af colibacillose forårsaget af apramycin-følsom Escherichia coli.
Treatment of colibacillosis caused by Escherichia coli susceptible to apramycin.
Til støtte for indikationen "behandling og metafylakse af bakteriel enteritis forårsaget af E. coli" har indehaveren af markedsføringstilladelse fremlagt in vitro-følsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
In support of the indication for treatment and metaphylaxis of bacterial enteritis caused by E. coli the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Hver flaske indeholder 50 x 106 IE apramycinsulfat og en vægt på 91 g produkt.
High density polyethylene bottle with polypropylene screw cap. Each bottle contains 50 x 106 IU apramycin and weight of 91 g of product.
Produktresumé, pkt.
Cardboard box (sachet)
BIVIRKNINGER
The results
Derudover bør patienternes blodtryk overvåges nøje.
Furthermore the blood pressure of patients should be carefully monitored.
Formidlingen af denne information kan koordineres af de enkelte medlemsstater.
This information can be coordinated at individual Member States level.
Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder bromocriptin (se bilag I)
Overall summary of the scientific evaluation of bromocriptine containing medicinal products (see Annex I)
Dette anses for en passende risikominimeringsforanstaltning over for fejlanvendelse af produktet.
This is considered an appropriate risk minimisation measure to reduce the misuse of the product.
Analysen af case-rapporter fra litteraturen vanskeliggjordes af, at der kun forelå begrænsede oplysninger.
The analysis of case reports from the literature was hampered by the limited information available.
PRAC konkluderede, at disse indikationer ikke bør nævnes i produktinformationen som eksempler på situationer, hvor bromocriptin kan anvendes.
The PRAC concluded that these should not be mentioned in the product information as examples of situations where bromocriptine could be used.
Alligevel tilrådes yderligere information og årvågenhed blandt sundhedspersoner af hensyn til sikkerheden ved anvendelsen af produktet.
Nevertheless, further information and awareness among the healthcare professionals is advisable to ensure safe use of the product.
PRAC vurderede desuden de foreliggende data om virkningen af disse produkter
The PRAC also considered the available data on the efficacy of these products;
I den anden undersøgelse i Frankrig fandtes et højere antal bivirkninger, som dog ikke nødvendigvis afspejler en absolut stigning i forekomsten af disse hændelser, men kan skyldes en ændring i indberetningen efter markedsføring for disse hændelser, idet flere ammende mødre blev overvåget tæt.
The second survey conducted in France retrieved a higher number of AEs, however this might not reflect an absolute increase in occurrence of those events but be the consequence of a change in post-marketing reporting of these events as more breastfeeding mothers were closely followed.
I den kliniske undersøgelse til vurdering af virkningen af bromocriptin i den sene post partum-periode blev behandlingen påbegyndt på et tidspunkt, der tilstrækkeligt dækker den sene post partum-periode (10-13,8 dage post partum og 38,9 dage til 16,7 uger post partum ).
In the clinical trial assessing the efficacy of bromocriptine in late post-partum, treatment was initiated at times covering adequately the late post-partum period (10 to 13.8 days post-partum and 38.9 days to 16.7 weeks post-partum).
Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelserne
Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Desuden anvendes det i EU til behandling af sygdomme såsom hyperprolaktinæmi og Parkinsons sygdom, men disse indikationer er ikke omfattet af denne europæiske gennemgang.
In the European Union (EU) it is also used to treat other conditions, such as hyperprolactinaemia and Parkinson's disease; however these indications are not in the scope of this European review.
Efter vurdering af alle data konkluderede PRAC, at de kontraindikationer, der allerede var gældende i størstedelen af medlemsstaterne, var gyldige og burde indgå i produktinformationen i alle medlemsstater.
Following assessment of all the data, the PRAC concluded the contraindications already in place in most Member States (MSs) were valid and should be included in the PIs across all MSs.
Der blev ikke påvist kausal sammenhæng i de tre observationsundersøgelser vedrørende risikoen for krampeanfald (Rothman, 1990), kardiovaskulære og cerebrovaskulære hændelser (Herings, 1995) og hypertension (Watson, 1989).
No causal association was shown in the three observational studies investigating the risk of seizures, (Rothman, 1990) cardio- and cerebrovascular events, (Herings, 1995) and hypertension (Watson, 1989).
Hos nogle patienter var udviklingen af krampeanfald eller apopleksi forudgået af svær hovedpine og/eller forbigående synsforstyrrelser.
In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances.
PRAC anbefalede derfor, at der indsættes sikkerhedsoplysninger i produktresuméet i alle medlemsstater.
Therefore the PRAC recommended that safety information be included in the SmPC across the Member States.
Desuden bemærkedes det, at indikationen post partum laktationshæmning i øjeblikket også er godkendt for de høje styrker, som ikke bør anvendes til denne indikation.
Moreover, it was noted that at present the indication lactation inhibition in post-partum was also approved in high strengths, which should not be used for this indication.
Endnu en fransk lægemiddelovervågningsundersøgelse, der blev afsluttet i 2012, viste, at indberetningsraten for alvorlige kardiovaskulære bivirkninger var steget i forhold til den foregående undersøgelse (5,1 mod 3,36 tilfælde pr. 100 000 behandlede patienter) trods skærpelsen af produktresuméet i 1994.
A second French national pharmacovigilance survey, finalised in 2012, showed an increase in the reporting rate of serious cardiovascular ADRs compared with the previous one (5.1 vs. 3.36 cases / 100,000 patients treated), despite the reinforcement of the SmPC in 1994.
Kliniske undersøgelser og den publicerede litteratur støttede anvendelsen af bromocriptin til forebyggelse eller undertrykkelse af fysiologisk laktation i post partum-perioden.
Clinical studies and published literature supported the use of bromocriptine in prevention or suppression of physiological lactation in post-partum.
Undersøgelsen vedrørende risikoen for hypertension viste, at bromocriptin ikke syntes at øge risikoen for post partum hypertension, men kan forværre eksisterende graviditetsbetinget hypertension.
The study observing the risks of hypertension found that while bromocriptine did not appear to increase the risk of inducing post-partum hypertension, it may aggravate already existing pregnancy-induced hypertension.
Bromocriptin anvendes til forebyggelse eller hæmning af laktation hos kvinder efter fødsel.
Bromocriptine is used to prevent or suppress lactation in women who have given birth.
På grundlag af en case-rapport anbefaledes det, at familiær disposition for præeklampsi er kontraindikation for post partum anvendelse af bromocriptin, og at blodtrykket overvåges tæt, navnlig ved hovedpine (Makdassi, 1991).
Based on a case report, it was recommended that familial history of preeclampsia should be included as a contraindication of bromocriptine in post-partum and for blood pressure to be closely monitored, especially in case of headaches (Makdassi, 1991).
Herings et al. konkluderede, at de iagttagne kardiovaskulære og cerebrovaskulære hændelser snarere må antages at skyldes præeksisterende morbiditet end anvendelse af bromocriptin.
Herings and colleagues concluded that, cardiovascular or cerebrovascular events observed could probably be explained by pre-existing morbidity rather than by the use of bromocriptine.
Skønt nogle faktorer tydede på en kausal sammenhæng mellem bromocriptin og disse hændelser, er der i post partumperioden uafhængige risikofaktorer for denne type hændelser.
Although some factors suggested causality of the events to bromocriptine, independent risk factors for these types of events are present in the post-partum period.
I betragtning af mekanismen i reguleringen af laktationen og resultaterne af disse undersøgelser anså PRAC virkningen af bromocriptin til laktationshæmning for at være tilstrækkeligt godtgjort.
Considering the mechanism of regulation of lactation and the results of these studies the PRAC considered the efficacy of bromocriptine in lactation inhibition sufficiently demonstrated.
PRAC fandt ikke, at denne potentielle risiko kunne afhjælpes ved at begrænse anvendelsen af bromocriptin til omstændigheder, hvor amning ikke er mulig af medicinske grunde (såsom intrapartal eller neonatal død, hivinfektion hos moderen), eller ved at indsætte kontraindikationer, advarsler og forholdsregler i produktinformationen som det allerede er tilfældet i visse medlemsstater.
The PRAC was of the opinion that this potential risk could be mitigated through limiting the use of bromocriptine to circumstances where breastfeeding is not possible due to medical reasons (such as intrapartum loss, neonatal death, HIV infection of the mother) and inclusion of contraindications, warning and precautions in the product information, as it is already the case in some Member States.
På grundlag af disse konklusioner konkluderede PRAC, at benefit/risk-forholdet for lægemidler indeholdende bromocriptin fortsat er positivt under forudsætning af de anbefalede ændringer af produktinformationen, herunder de vedtagne begrænsninger og advarsler.
Based on these conclusions, the PRAC concluded that the benefit-risk balance of bromocriptinecontaining medicinal products remains favourable subject to changes to the product information, including agreed restrictions and warnings.
I midten af 1990'erne blev indikationen laktation trukket tilbage i USA og i visse andre lande på baggrund af indberetninger om kardiovaskulære bivirkninger ved laktationshæmning med bromocriptin-holdige produkter.
In the mid-1990s the indication of lactation was withdrawn in the United States and some other countries in view of reports of cardiovascular adverse events (AEs) in women treated with bromocriptine-containing products for lactation inhibition.
PRAC gennemgik sikkerhedsresultaterne fra alle kliniske undersøgelser, der er udført som led i det oprindelige udviklingsprogram, og bemærkede, at der ikke var iagttaget kardiovaskulære, neurologiske eller psykiske bivirkninger i forbindelse med post partum administration af bromocriptin.
The PRAC reviewed the safety results from all clinical studies conducted as part of the initial development plan and noted that no cardiovascular, neurological or psychiatric adverse events in association with post-partum administration of bromocriptine were observed.
I nogle undersøgelser var bromocriptin forbundet med højere rebound-forekomst end cabergolin (i én undersøgelse) og svarede til lisurid eller andre ikke-ergot dopaminagonister.
In some studies bromocriptine was associated with higher incidence of rebound phenomenon compared to cabergoline (in one study), and similar to lisuride or non-ergot dopamine agonist.
• PRAC anbefalede, at post partum laktationshæmning med orale lægemidler indeholdende bromocriptin i styrkerne 1 mg og 2,5 mg begrænses til tilfælde med medicinsk behov.
• The PRAC recommended to limit the use of bromocriptine-containing medicinal products for oral use in the post-partum inhibition of lactation with strength of 1 mg and 2.5 mg to cases where medically indicated.
I henhold til doseringsanvisningen bør der ikke anvendes højere enkeltdosis end 2,5 mg.
Indeed, as per the posology one dose given should not exceed 2.5 mg.
PRAC anbefalede tæt overvågning af blodtryk, navnlig i de første dage af behandlingen, og en advarsel om at seponere behandlingen ved hypertension, mistænkelige smerter i thorax, svær, progressiv eller ikke-remitterende hovedpine (med eller uden synsforstyrrelse) samt tegn på CNS-toksicitet, og at dette burde afspejles i produktinformationen.
The PRAC recommended that blood pressure should be closely monitored, especially during the first days of therapy and a warning advising to discontinue treatment in case of hypertension, suggestive chest pain, severe, progressive, or unremitting headache (with or without visual disturbances), or evidence of central nervous system toxicity, and that this should be reflected in the product information.
• PRAC tog stilling til den procedure, der i medfør af artikel 31 i direktiv 2001/83/EF var foranlediget af lægemiddelovervågningsdata for produkter indeholdende bromocriptin til oral anvendelse til post partum laktationshæmning
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for bromocriptine-containing medicinal products for oral use in the postpartum inhibition of lactation;
Skønt undersøgelserne ved mastitis, brystforstørrelse og smertefuld brystforstørrelse tydede på nogen virkning, giver de begrænsede foreliggende data ikke mulighed for at drage konklusioner om virkningen af bromocriptin til disse indikationer.
However, although the studies conducted in mastitis, breast engorgement and painful breast engorgement suggested some efficacy, the limited data available does not allow concluding on the efficacy of bromocriptine in these indications.
I en del tilfælde blev der desuden beskrevet vigtige risikofaktorer (rygning, adipositas, præeklampsi, hypertension og psykiatriske episoder).
Furthermore, in part of the cases important risk factors (smoking, obesity, pre-eclampsia, hypertension, history of psychiatric episodes) were reported.
Da enkeltdosis ved denne indikation ikke bør overstige 2,5 mg, bør indikationen forebyggelse eller undertrykkelse af laktation desuden slettes af produktinformationen for de højere styrker, så risikoen for fejlanvendelse og medicineringsfejl minimeres.
In addition, as one dose administered should not exceed 2.5 mg in this indication, in order to minimise the risk of misuse and medication error, the indication prevention or suppression of lactation should be removed from the product information of the higher strengths.
Man må have for øje, at post partum-perioden er sårbar med baggrundsrisici for hypertension, kramper, præeklampsi, psykiatriske hændelser og kardiovaskulære/cerebrovaskulære og trombotiske hændelser.
It should be kept in mind that the post-partum is a vulnerable period with background risks of hypertension, convulsions, pre-eclampsia, psychiatric events and cardiovascular/cerebrovascular and thrombotic events.
Det absolutte antal indberettede tilfælde efter markedsføring er lavt, navnlig i betragtning af, at bromocriptin har været på markedet i EU siden 1973, og at patienteksponeringen har været betydelig.
The absolute number of cases reported in post-marketing is low, especially given the fact that bromocriptine has been available in the EU since 1973, with a substantial patient exposure; overall incidence rates are estimated to 0.005% to 0.04%.
Der er indberettet en række bivirkninger, herunder depression, psykose, myokardieinfarkt, apopleksi, intrakraniel blødning, trombotiske hændelser, kramper og hypertension.
A range of adverse events have been reported, including depression, psychosis, myocardial infarction, stroke, intracranial haemorrhage, thrombotic events, convulsions, and hypertension.
Efter vurdering af de relevante data anbefalede PRAC, at bromocriptin ikke anvendes til rutinemæssig laktationssuppression eller til lindring af symptomer på post partum-smerter og brystforstørrelse, der kan behandles tilfredsstillende med ikke-medikamentel intervention (såsom fast bryststøtte og isomslag) og/eller simple analgetika.
Following the assessment of the relevant data, the PRAC recommended not to use bromocriptine for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention (such as firm breast support, ice application) and/or simple analgesics.
Gennemgangen af de fatale tilfælde viste, at der i mange af de tilfælde, hvor oplysninger var tilgængelige, forelå risikofaktorer såsom svær hypertension, graviditetsrelaterede hypertensive lidelser, tidligere koronararteriesygdom eller anden kardiovaskulær sygdom foruden psykiatriske episoder i anamnesen.
The review of the fatal cases showed that risk factors were present in many of the cases where the information was available such as severe hypertension, hypertensive disorders of pregnancy, history of coronary artery disease or other cardiovascular condition as well history of psychiatric episodes.
Desuden frarådes anvendelse af disse produkter til rutinemæssig laktationssuppression og til lindring af symptomer på post partum mastalgi og brystforstørrelse, der kan behandles tilfredsstillende ved ikke-medikamentel intervention eller med analgetika.
In addition the use of these products is not recommended for routine suppression of lactation or for relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention or with analgesics.
Såvel den foreliggende evidens fra kliniske undersøgelser i det oprindelige kliniske udviklingsprogram som den publicerede litteratur tyder dog på, at bromocriptin er effektivt til den af gennemgangen omfattede indikation og syntes at være overlegent i forhold til androgener, kombinerede kontraceptiva, antiøstrogener og pyridoxin samt at have samme virkning som andre dopaminagonister, dog muligvis bedre end lisurid.
Although most of the studies conducted with bromocriptine are conducted before 1990, the available evidence from clinical trials conducted as part of the original clinical development plan as well as from the published literature suggests that bromocriptine is efficacious in the indication currently under review and appeared superior to androgens, combined contraceptives, anti-oestrogens, pyridoxine, and of similar efficacy than that of other dopamine agonists, though possibly better than lisuride.
Ved symptomer på hypotension eller CNS-toksicitet bør bromocriptin seponeres
If any symptoms of hypertension or evidence of central nervous system toxicity are detected, the administration of bromocriptine should be discontinued;
I forhold til den ikke-gravide tilstand er perioden 6 uger post partum forbundet med 3-9 gange forhøjet risiko for apopleksi, 3-6 gange forhøjet risiko for myokardieinfarkt og 9-22 gange forhøjet risiko for venøse tromboemboliske hændelser.
As compared with the non-pregnant state, the 6-week post-partum period is associated with a 3 to 9-fold risk of stroke, 3 to 6-fold risk of myocardial infraction, 9 to 22-fold risk of venous thromboembolic event and depression is estimated to occur in approximately 1 in 10 women while psychosis is estimated to occur in approximately 1-2 in 1000 women.
Disse undersøgelser tydede på nogen virkning ved behandling af mastitis og smertefuld brystforstørrelse, men var af begrænset omfang og gav ikke tilstrækkelig evidens som grundlag for at medtage disse situationer som eksempler på indikationen.
However, although some efficacy was suggested in the treatment of mastitis and painful breast engorgement, these studies were limited and did not constitute sufficient evidence to support including these situations as examples in the indication.
I nogle indberetninger er der dog faktorer, der tyder på en mulig kausal sammenhæng (ingen andre risikofaktorer eller konfunderende faktorer, kort tid til indsætten (mellem 6 timer og 17
However in some reports, factors suggesting a possible causal association are present (no other risk factor or confounders, short time to onset (between 6 hours and 17 days after treatment initiation for the fatal cases where the information was available), positive de-challenge and re-challenge).
Langt lavere rater (hhv. 4,2 % og 4,7 %) blev imidlertid fundet ved en analyse, der blev udført på markedsføringstilladelsesindehaverens sikkerhedsdatabase for perioden siden den første markedsføringstilladelse for det oprindelige produkt, og som var fokuseret på dosis og behandlingsvarighed.
With regards to off label use and misuse, while high rates were reported in the French surveys, the analysis of the safety database of the MAH of the originator covering the period since the first marketing authorisation, focused on the dose and treatment duration, retrieved much lower rates (4.2% and 4.7% respectively).
Efter gennemgang af PRAC's anbefaling af 10. juli 2014 og i henhold til artikel 107k, stk. 1 og 2, i direktiv 2000/83/EF tog CMDh stilling til ændringerne af betingelserne for markedsføringstilladelserne for de bromocriptin-holdige lægemidler til post partum laktationshæmning, for hvilke de relevante afsnit af produktresuméet og indlægssedlen fremgår af bilag III.
The CMDh having considered the PRAC recommendation dated 10 July 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation to the terms of the marketing authorisations of bromocriptine-containing medicinal products for oral use indicated in postpartum inhibition of lactation for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III.
Som konklusion kan der af de foreliggende oplysninger ikke udelukkes en kausal sammenhæng mellem anvendelse af bromocriptin og alvorlige kardiovaskulære, neurologiske eller psykiatriske hændelser.
In conclusion, based on the available information a causal association between use of bromocriptine and serious cardiovascular, neurological or psychiatric events cannot be excluded.