natgillin/translations-raw huggingface dataset:
Ved den af indehaveren af markedsføringstilladelsen foretagne gennemgang af ICSR-databasen fandtes 33 tilfælde, hvor der var anvendt en maksimal daglig dosis på 600 mg. 
The MAH review of the ICSR database identified 33 cases involving the use of a maximum daily dose of 600 mg. From these, a total of 21 cases of neurological adverse events were retrieved.
Formålet var at kortlægge forekomsten af kardiologiske eller neurologiske bivirkninger under normale anvendelsesbetingelser, dvs. tilfælde, hvor den maksimale daglige dosis på 600 mg ikke var overskredet, tilfælde med accidentel overdosering og tilfælde med kendt nyrefunktionsnedsættelse, der havde nødvendiggjort dosisjustering. 
The CHMP also considered a review of the individual case safety reports (ICSR) database conducted by the MAH, to identify cases of cardiological or neurological adverse events under normal conditions of use, i.e. cases where the dose did not exceed the maximum daily dose of 600mg, cases with accidental overdoses or cases including patients with known renal impairment requiring dose adjustment.
Den risikostyringsplan, der blev foreslået i henhold til denne artikel 107procedure, svarer til den franske risikostyringsplan, der blev implementeret i 2006. 
As the Risk Management Plan (RMP) proposed in the scope of this Article 107 procedure is equivalent to the French RMP implemented in 2006, the CHMP was therefore of the opinion that it is possible to conclude on the effectiveness of the proposed RMMs, despite the lack of implementation in all member states.
Vedrørende sikkerheden konkluderede CHMP, at brug af buflomedil er forbundet med en række alvorlige kardiale bivirkninger (hovedsagelig takykardi, hypotension, ventrikulære arytmier og hjertestop) og neurologiske bivirkninger (hovedsagelig kramper, myokloni og status epilepticus). 
With regards to safety, the CHMP concluded that the use of buflomedil is associated with a number of serious cardiological (mainly tachycardia, hypotension, ventricular rhythm disorders and cardiac arrest) and neurological (mainly convulsions, myoclonia and status epilepticus) adverse events, which occur under normal conditions of use, particularly in elderly patients, who are predominantly the patient population relevant to the approved indication.
Sammenfattende konkluderede CHMP, at brug af buflomedil er forbundet med en række alvorlige kardiologiske bivirkninger (hovedsagelig takykardi, hypotension, ventrikulære arytmier og hjertestop) og neurologiske bivirkninger (hovedsagelig kramper, myokloni og status epilepticus). 
In summary, the CHMP concluded that the use of buflomedil is associated with a number of serious cardiological (mainly tachycardia, hypotension, ventricular rhythm disorders and cardiac arrest) and neurological (mainly convulsions, myoclonia and status epilepticus) adverse events, which occur under normal conditions of use, particularly in elderly patients, who are predominantly the patient population relevant to the approved indication.
Udvalget fandt det usandsynligt, at foranstaltningerne vil være tilstrækkelige til at forebygge alvorlige kardiale og neurologiske bivirkninger under normale anvendelsesforhold eller til at mindske de veldefinerede risici ved accidentel overdosering eller manglende overvågning af nyrefunktionen til et acceptabelt niveau. 
Regarding risk minimisation measures, the CHMP noted the MAH proposals but considered that these are unlikely to be sufficient to prevent the occurrence of serious cardiac and neurological adverse events under normal conditions of use nor reduce the well identified risks of accidental overdoses and non-compliance with renal function monitoring associated with the use of buflomedil to an acceptable level.
Ved gennemgangen af EudraVigilance fandtes 74 tilfælde med bivirkninger relateret til buflomedil. 
The EudraVigilance review identified 74 cases of adverse events associated with buflomedil, with a total of 35 cases recording cardiac adverse and 39 cases recording neurological adverse events.
CHMP konkluderede, at lighederne mellem de foreslåede risikostyringsforanstaltninger og dem, der er gennemført i Frankrig, gør det muligt at drage konklusioner om effektiviteten af de foreslåede risikostyringsforanstaltninger, selv om de ikke er gennemført i alle medlemsstaterne. 
The CHMP concluded that due to the similarities between the proposed RMMs and the ones implemented in France, it is possible to conclude on the effectiveness of the proposed RMMs, despite the lack of implementation in all member states and that these measures are inadequate to prevent the occurrence of serious adverse events with buflomedil.
Formålet var at kortlægge tilfælde af kardiale og neurologiske reaktioner ved normale terapeutiske doser (dvs. maksimalt 600 mg dagligt for den orale tabletformulering). 
The CHMP noted a review of French Eudravigilance data analysing spontaneous reports associated with treatment with buflomedil, to identify cases where cardiac and neurological reactions occurred under normal therapeutic doses (i.e. maximum of 600 mg daily for the oral tablet formulation).
Udvalget begrundede dette med, at de kommunikationsredskaber, der allerede var taget i brug i Frankrig, var utilstrækkelige til at forbedre overholdelsen af indikationerne og overvågningen af nyrefunktionen. 
The CHMP considered the proposal for a website dedicated to buflomedil to be unlikely to significantly improve the awareness of prescribers, as previous communication tools already implemented in France were insufficient to improve compliance with indications and renal monitoring.
De indberettede bivirkninger var hovedsagelig af alvorlig neurologisk og kardiovaskulær art. Ud over disse fem tilfælde var der to tilfælde med nedsat nyrefunktion, hvor dosis var ukendt. 
In addition to these 5 cases, a further two cases related to renal impairment were identified, where the dose was unknown.
Styrke Lжgemiddelform 
Strength Pharmaceuti cal form
Emballage Pakningsstшrrele 
Immediate Packaging
(Sжrnavn) Navn 
(Invente d) name
Denne procedure blev afsluttet den 28. november 2006. 
This procedure ended on 28 November 2006.
Denne konklusion godtages. 
This conclusion is accepted.
Enurace 50 Tabletter 
Enurace 50 Tablets
Enurace 50 blev første gang godkendt i Nederlandene den 15. september 2000. 
Enurace 50 was first authorised in The Netherlands on 15 September 2000.
Nederlandene, Belgien, Tyskland, Frankrig, Italien, Spanien og Det Forenede Kongerige. 
The Netherlands, Belgium, Germany, France, Italy, Spain and the United Kingdom.
Enurace har været officielt godkendt siden 2000 (i Nederlandene siden 1995). 
Enurace has been officially authorised since 2000 (since 1995 available in the Netherlands).
3 Konklusion og anbefaling 
3 Conclusion and Recommendation
3891 ZK Zeewolde Nederlandene fs@ace-pharm.nl 
Schepenveld 41 3891 ZK Zeewolde The Netherlands fs@ace-pharm.nl
Hvad angår sikkerheden synes brug af produktet ikke at indebære nogen nævneværdig risiko hos unge, raske dyr. 
Considering safety, the product seems not to create a considerable risk to young and healthy animals.
Italien kunne godtage ansøgningen med en revideret ordlyd i produktresuméet. 
Italy could accept the application with revised wording in the SPC .
En gensidig anerkendelsesprocedure blev indledt den 29. juni 2006 med Nederlandene som referencemedlemsstat og Belgien, Tyskland, Spanien, Frankrig, Italien og Det Forenede Kongerige som berørte medlemsstater. 
A Mutual Recognition Procedure started on 29 June 2006 with The Netherlands as Reference Member State and Belgium, Germany, Spain, France, Italy and the United Kingdom as Concerned Member States.
CVMP konkluderede, at benefit/risk-forholdet for produktet er gunstigt. 
The CVMP has concluded that the risk/benefit for this product is favourable.
Siden 1998 er der udført undersøgelser efter markedsføringen samt regelmæssig overvågning af bivirkninger med FAQsystemet. 
Since 1998 post-marketing studies have been performed as well as regular monitoring of adverse effects by FAQ system.
CMD(v) var på dag 60 af proceduren ikke nået til enighed, da Frankrig og Italien fastholdt deres betænkeligheder. 
CMD(v) could not reach an agreement by day 60 of this procedure, as France and Italy maintained their concerns.
I Europa foretages ovariohysterektomi dog oftest hos midaldrende og gamle tæver. 
However, in Europe ovariohysterectomy is most frequently performed in middle aged and old bitches.
Resultatet viser umiddelbart god virkning hos både test- og kontrolgruppe (87 % mod 85,5 %), en virkning, der måske er større hos behandlingsnaive dyr (93,7 % mod 88,9 %). 
The raw outcome shows good effect in both test and control groups (87% vs 85.5%), an effect that might be somewhat higher in treatment naïve animals (93.7% vs 88.9%).
Disse tal synes yderst overbevisende i sammenligning med de 20 % placebobehandlede dyr, der blev kontinente i undersøgelse ACE129801. 
These figures seem highly convincing when compared to the 20 % placebo treated animals that became continent in study ACE129801.
På dag 90 af den gensidige anerkendelsesprocedure, den 27. september 2006, kunne Frankrig og Italien ikke tilslutte sig udstedelse af en markedsføringstilladelse, da de fandt, at produktet frembyder alvorlige potentielle risici for dyrs sundhed. 
At Day 90 of the MRP, 27 September 2006, France and Italy could not agree to the granting of a marketing authorization as they consider there are potentially serious risks for animal health.
Den undersøgelse, hvor Enurace 50 sammenlignes med Propalin (ACE129802), er imidlertid overbevisende, skønt der ikke er udført en non-inferiority analyse. 
However, the study where Enurace 50 is compared to Propaline (ACE129802) is convincing although a non-inferiority analysis has not been performed.
Den mulige risiko ved anvendelse af ephedrin hos denne gruppe af dyr kan mindskes gennem passende foranstaltninger. 
Possible risk connected with the use of ephedrine in this group of animals can be reduced by appropriate management measures.
De gældende tekster til produktresumé, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen, med følgende ændring: 
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendment:
Ansøgningen blev indgivet i overensstemmelse med artikel 12, stk. 3, i direktiv 2001/82/EF som en selvstændig ansøgning. 
The application was made in accordance with Article 12.3 of Directive 2001/82/EC as a stand alone application.
Ved den anbefalede dosis, der ifølge det foreslåede produktresumé bør justeres individuelt, er sikkerheden rimeligt garanteret. 
At the recommended dose level, which according to the suggested SPC should be individually adjusted, safety is ensured to a reasonable level.
Skønt alderens betydning ikke er afspejlet i toleranceundersøgelserne, blev den taget i betragtning i undersøgelserne af virkningen og i undersøgelserne efter markedsføringen. 
Although the influence of age was not reflected in the tolerance studies, it was taken into account in the efficacy and post- marketing studies.
ACE Pharmaceuticals BV Schepenveld 41 
ACE Pharmaceuticals BV
Data vedrørende virkningen er behæftet med adskillige mangler og er sparsomme. 
Efficacy data are connected to several shortcomings and the amount of data available is sparse.
I betragtning af, at urininkontinens kan optræde selv flere år efter operationen, kan Enurace formodes hovedsagelig at ville blive anvendt hos ældre dyr, der oftere lider af hjerte-kar-, lever- og nyresygdomme samt andre sygdomme. 
Taking into account that urinary incontinence may occur even several years after the operation it can be suspected that Enurace would be used mostly in older animals, more frequently suffering form cardiovascular, liver, renal and other diseases.
Indehaveren af markedsføringstilladelsen skulle forelægge alle oplysninger, (præklinisk og klinisk dokumentation, herunder ekspertrapporterne og de udførte undersøgelser af virkning og tolerance) med henblik på at godtgøre, at benefit/risk-forholdet for behandlede dyr er positivt. 
The Marketing Authorisation Holder should provide all supporting data (preclinical and clinical documentation, including the expert reports, efficacy and tolerance studies conducted), to justify a positive benefit-risk ratio for the treated animal.
Sagen blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer, (CMD(v)) med henblik på en 60dages-procedure i overensstemmelse med artikel 33, stk. 1, i direktiv 2001/82/EF, med senere ændringer. 
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) for a 60 day procedure in accordance with Article 33(1) of Directive 2001/82/EC, as amended.
Til besvarelse af spørgsmålene vedrørende toksicitet gør ansøgeren gældende, at der som følge af den farmakologiske virkning af ephedrin og den individuelle variation i receptortæthed ikke kan fastlægges en sikkerhedsmargen, og at stigende doser vil være forbundet med stigende intensitet og hyppighed af velkendte bivirkninger. 
In response to the questions related to toxicity, the applicant argues that due to the pharmacologic effect of ephedrine and the individual variation in receptor density no safety margin can be determined and increasing doses will be associated to increased intensity and frequency of well known adverse effects.
Der er ingen tvivl om, at behandling af hunde med Enurace kan medføre bivirkninger som følge af ephedrins særlige aktivitet. 
There is no doubt that treatment of the dog with Enurace may involve an occurrence of adverse reactions due to peculiar activity of ephedrine.
De af ansøgeren forelagte oplysninger viser, at Enurace 50 er et effektivt middel til behandling af urininkontinens hos ovariohysterektomerede tæver. 
The data provided by the applicant show that Enurace 50 is an effective medicinal product for treatment of urinary incontinence in ovariohysterectomised bitches.
Punkt 4.5 i produktresuméet og punkt 12 i indlægssedlen: 
Section 4.5 of the SPC and Section 12 of the Package Leaflet:
Frankrig anser benefit/risk-forholdet for at være ugunstigt for dyret, når bivirkningerne (meget sjældne tilfælde af atrieflimren og takykardi) opvejes mod de mulige fordele ved effektiv behandling af inkontinens. 
France considers the risk/benefit analysis unfavourable for the animal when the adverse effects (in very rare cases atrium fibrillation and tachycardia) are weighed against the potential benefits of effective treatment of incontinence.
CVMP indledte på sit møde i december 2006 en indbringelsesprocedure for Enurace 50 i overensstemmelse med artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer. 
The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Enurace 50.
Den anbefalede startdosering er 2 mg ephedrinhydrochlorid pr. kg kropsvægt pr. dag, fordelt på to orale doser. 
A starting dose of 2 mg Ephedrine HCl per kg of bodyweight per day, divided in two oral doses is recommended.
Den foreslåede dosis på 1-3 mg ephedrinhydrochlorid pr. kg kropsvægt pr. dag, fordelt på to doser oralt, er effektiv og sikker, men nogle dyr kan have behov for større dosis som følge af den individuelle variation i responsen på ephedrin. 
Proposed dose of 1 - 3 mg Ephedrine HCl /kg/day, divided in two oral doses is effective and safe, but some animals may need a higher dose, which is associated with individual variation in the response to ephedrine.
Kardial dysfunktion var blandt eksklusionskriterierne, hvorfor undersøgelserne ikke indeholder oplysninger om anvendelse af produktet hos dyr med sådanne lidelser, men de foreliggende oplysninger tyder ikke på, at det bør undgås at behandle hunde med hjertelidelser med stoffet. 
Regarding cardiac dysfunction, this was one of the exclusion criteria so the studies give no information on use of the product in animals with such a condition but there is also no data suggesting that the cardiac patients must not be treated with the substance.
Som følge af de meget begrænsede behandlingsmuligheder og den høje risiko for eutanasi i de tilfælde, hvor behandlingen ikke virker eller ikke er overkommelig i pris, er ephedrin et andet muligt valg - Propalin i stedet for Enurace og vice versa, når det tages i betragtning, at sympatomimetisk behandling af urininkontinens er langt at foretrække frem for hormonbehandling (et alternativ er operative indgreb som kolposuspension, urethropeksi og endoskopisk injektion af kollagen i behandlingsrefraktære tilfælde). 
For the reason of very limited treatment options, high risk of euthanasia if treatment fails or is not affordable, ephedrine is a substance of other eventual choice - Propalin instead Enurace and vice versa, considering that sympathicomimetic treatment of urinary incontinence is far better than hormonal treatment (an alternative is surgical therapies as colposuspension, urethropexy and the endoscopic injection of collagen in refractory cases).
I betragtning af behandlingens fordele og den relativt lave forekomst af bivirkninger, således som den fremgår af undersøgelserne efter markedsføringen, anses benefit/risk-forholdet for gunstigt. 
Taking the benefit of the treatment into account and the relatively low level of adverse effects, as it appears from PMS studies, the risk/benefit balance is considered favourable.
Skønt behandlingen ikke virker på alle dyr, er virkningen tilstrækkelig til, at behandlingen er forbundet med fordele. 
Indeed, treatment is not successful in all animals, but the level of efficacy is such that there is an advantage in treatment.
Hundens kardiovaskulære funktion bør vurderes omhyggeligt, før behandlingen med Enurace 50 påbegyndes, og den bør overvåges med jævne mellemrum under behandlingen. 
The dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment.
50 mg Tæver Kun til oral administration, indgives sammen med foderet 
For oral administration only, to be administered with food
Skønt der måske foreligger få oplysninger om toksiciteten hos måldyrearten, er bivirkningerne ved brug af ephedrin velkendte fra human anvendelse, og ansøgeren har forelagt en del post-marketing oplysninger om brug hos hunde. 
Although toxicity data for the target animal may be scarce, the adverse effects connected to ephedrine treatment are well known from human use, and the applicant has provided some post-marketing information regarding the use in dogs.
Anvendelse af humane præparater eller apoteksfremstillede lægemidler indeholdende ephedrin vil udgøre et langt farligere alternativ ved behandling af urininkontinens hos hunde, hvis der ikke findes et produkt med markedsføringstilladelse og med påvist mangeårig virkning i referencemedlemsstaten over mange år. 
The use of human labelled preparations or dosage forms obtained from a compounding pharmacy which contain ephedrine constitute a much more dangerous alternative for treatment of urinary incontinence in dogs if the product with a marketing authorisation and a proved efficacious use in the RMS for many years is not available.
4.5 med tilføjelse af sætningen: "hundens hjerte-karfunktion bør omhyggeligt vurderes før påbegyndelse af behandlingen med Enurace 50 og bør jævnligt overvåges under behandlingen". 
With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “the dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”.
Lægemiddelform Styrke Dyreart Doseringshyppighed og indgivelsesvej 
European Medicines Agency Veterinary Medicines and Inspections
Behandlingen gives i cyklusser på 28 dage. 
Treatment is given in 28-day cycles.
Empliciti fik en markedsføringstilladelse med gyldighed i hele EU den 11. maj 2016. 
Empliciti received a marketing authorisation valid throughout the EU on 11 May 2016.
Det gives én gang om ugen i de første 2 cyklusser og mindre hyppigt i de efterfølgende cyklusser. 
It is given once a week for the first 2 cycles and less frequently in subsequent cycles.
Dosen af Empliciti afhænger af patientens vægt. 
The dose of Empliciti depends on the patient's weight.
Yderligere information om Empliciti findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/empliciti. 
Further information on Empliciti can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/empliciti.
Andre oplysninger om Empliciti 
Other information about Empliciti
Som for alle lægemidler bliver data vedrørende brugen af Empliciti løbende overvåget. 
As for all medicines, data on the use of Empliciti are continuously monitored.
Hvad er Empliciti, og hvad anvendes det til? 
What is Empliciti and what is it used for?
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Empliciti opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency therefore decided that Empliciti's benefits are greater than its risks and it can be authorised for use in the EU.
Selv om der hyppigere sås bivirkninger, navnlig infektioner, ved Empliciti, synes risiciene samlet set at være håndterbare. 
Although side effects, particularly infections, were more common with Empliciti, the risks on the whole appear manageable.
Alle patienterne havde tidligere fået andre behandlinger, men enten havde behandlingerne ikke virket, eller også var kræften vendt tilbage. 
All patients had previously received other treatments but the treatments had not worked or the cancer had come back.
En oversigt over Empliciti, og hvorfor det er godkendt i EU 
An overview of Empliciti and why it is authorised in the EU
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Empliciti? 
What measures are being taken to ensure the safe and effective use of Empliciti?
Empliciti indeholder det aktive stof elotuzumab. 
Empliciti contains the active substance elotuzumab.
Hvorfor er Empliciti godkendt i EU? 
Why is Empliciti authorised in the EU?
Desuden forsvandt kræften helt eller delvist hos 79 % af de patienter, der fik Empliciti-kombinationsbehandlingen, sammenlignet med 66 % af de patienter, der fik de to andre lægemidler. 
In addition, the cancer cleared partially or completely in 79% of patients treated with the Empliciti combination compared with 66% of patients treated with the other two medicines.
For at forhindre infusionsreaktioner får patienten et betændelsesdæmpende lægemiddel, et antihistamin og paracetamol før hver infusion. 
To prevent infusion reactions, the patient is given an anti-inflammatory medicine, an antihistamine and paracetamol before every infusion.
De hyppigste bivirkninger ved Empliciti (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine, træthed, feber, diarré, ondt i halsen, næse- og halsinfektioner, hoste, lungebetændelse, lavt antal hvide blodlegemer og vægttab. 
The most common side effects with Empliciti (which may affect more than 1 in 10 people) are headache, tiredness, fever, diarrhoea, sore throat, nose and throat infections, cough, pneumonia (lung infection), low levels of white blood cells and weight loss.
De indberettede bivirkninger ved Empliciti vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Empliciti are carefully evaluated and any necessary action taken to protect patients.
Hvis du ønsker mere information om anvendelsen af Empliciti, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet. 
For more information about using Empliciti, see the package leaflet or contact your doctor or pharmacist.
Hvilke risici er der forbundet med Empliciti? 
What are the risks associated with Empliciti?
Behandlingen skal indledes og overvåges af en læge med erfaring i behandling af myelomatose, og lægemidlet fås kun på recept. 
Treatment must be started and supervised by a doctor experienced in treating multiple myeloma, and the medicine can only be obtained with a prescription.