FrancophonIA/ELRC3.0 huggingface dataset:
English: Since mTOR is involved in the control of cell division and the growth of blood vessels, Votubia prevents the division of tumour cells and reduces their blood supply.
Danish: Da mTOR medvirker ved reguleringen af cellernes deling og blodkarrenes vækst, forhindrer Votubia kræftcellerne i at dele sig og nedsætter deres blodforsyning.
English: What are the risks associated with Votubia?
Danish: Hvilke risici er der forbundet med Votubia?
English: The benefits of Votubia as an add-on treatment of partial onset seizures related to tuberous sclerosis that have not been sufficiently controlled by other treatments have been shown in one main study.
Danish: Fordelene ved Votubia som en tillægsbehandling for partielle anfald forbundet med tuberøs sklerose, der ikke i tilstrækkelig grad er blevet reguleret med andre behandlinger, er blevet påvist i ét hovedstudie.
English: For more information about using Votubia, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Votubia, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Votubia must not be used in people who are hypersensitive (allergic) to everolimus, to related medicines such as sirolimus and temsirolimus or to any of the other ingredients.
Danish: Votubia må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for everolimus, relaterede lægemidler såsom sirolimus og temsirolimus eller andre af indholdsstofferne.
English: In SEGA caused by tuberous sclerosis, Votubia has been studied in two main studies: the first study involved 28 adults and children aged three years and above.
Danish: For SEGA forårsaget af tuberøs sklerose er Votubia blevet undersøgt i ét hovedstudie med 28 voksne og børn på tre år og derover.
English: Starting doses may need to be reduced, or treatment avoided, in patients with reduced liver function, depending on how severe this is and on the patient's age and the condition they are being treated for.
Danish: Det kan være nødvendigt at nedsætte startdoser eller undgå behandling hos patienter med nedsat leverfunktion afhængigt af tilstandens sværhedsgrad, patientens alder og den sygdom, der behandles for.
English: The European Medicines Agency noted that Votubia has been shown to reduce the size of the brain tumours in adults and children with tuberous sclerosis and that this is expected to reduce the signs and symptoms of SEGA such as seizures, hydrocephalus (accumulation of fluid in the brain), and increased pressure within the brain.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at Votubia har vist sig at reducere størrelsen af hjernetumorer hos voksne og børn, der lider af tuberøs sklerose, og at dette forventes at nedbringe tegnene og symptomerne på SEGA, såsom anfald, ophobning af vand i hovedet og forhøjet tryk i hjernen.
English: The active substance in Votubia, everolimus, is an anti-tumour medicine that acts by blocking an enzyme called ‘mammalian target of rapamycin' (mTOR), which has increased activity in tumour cells of patients with SEGA or renal angiomyolipoma.
Danish: Det aktive stof i Votubia, everolimus, er et antitumorlægemiddel, der fungerer ved at blokere et enzym kaldet mTOR ("mammalian target of rapamycin" - mål for rapamycin hos pattedyr), der har øget aktivitet i tumorceller hos patienter med SEGA eller renal angiomyolipoma.
English: This response was seen in 28% (33 of 117 patients) in the lower blood level group and 40% (52 of 130 patients) in the higher blood level group, compared with 15% (18 of 119) of patients taking placebo.
Danish: En positiv reaktion sås hos 28 % (33 ud af 117 patienter) i gruppen med lavere indhold i blodet og hos 40 % (52 ud af 130 patienter) i gruppen med højere indhold i blodet, sammenlignet med 15 % (18 ud af 119) af de patienter, der fik placebo.
English: For more information about treatment with Votubia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Votubia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Overall, the patients given Votubia had a 29 and 40% reduction respectively in the number of seizures during treatment, compared with a 15% reduction in those given placebo.
Danish: Samlet set havde de patienter, der fik Votubia, en reduktion af anfaldshyppigheden under behandlingen på henholdsvis 29 % og 40 %, sammenlignet med en reduktion på 15 % hos dem, der fik placebo.
English: Votubia is used for partialonset seizures (seizures that start in one part of the brain), which may or may not spread to affect the whole brain (secondary generalisation).
Danish: Votubia bruges til behandling for partielle anfald (anfald, der begynder i en bestemt del af hjernen) med eller uden sekundær generalisering (hvor anfaldet efterfølgende spreder sig til hele hjernen).
English: This occurred in 35% of patients (27 out of 78 patients) treated with Votubia, compared with none of the 39 patients who received placebo.
Danish: Dette var tilfældet hos 35 % af de patienter (27 ud af 78 patienter), der blev behandlet med Votubia, sammenlignet med ingen ud af de 39 patienter, der fik placebo.
English: mTOR is also thought to play a role in the seizures that occur in patients with tuberous sclerosis but it is not fully understood how the medicine acts to prevent them.
Danish: mTOR menes også at virke mod de anfald, der indtræffer hos patienter med tuberøs sklerose, men det vides ikke med sikkerhed, hvordan lægemidlet forhindrer dem.
English: Votubia has been shown to be effective at treating patients with SEGA and renal angiomyolipoma by shrinking the volume of the tumours.
Danish: Votubia har vist sig at være effektivt til behandling af patienter med SEGA og renal angiomyolipoma, idet tumorerne skrumpede i størrelse.
English: For the full list of all side effects reported with Votubia, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Votubia fremgår af indlægssedlen.
English: What benefits of Votubia have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Votubia?
English: Before treatment, patients had 16 to 17 seizures per week on average and response was considered to be shown by a reduction in seizures of at least 50%.
Danish: Før behandlingen havde patienterne i gennemsnit 16-17 anfald om ugen.
English: How is Votubia used?
Danish: Hvordan anvendes Votubia?
English: The main measure of effectiveness was the proportion of patients who responded to treatment and whose brain tumour shrank by at least half after six months of treatment.
Danish: Virkningen blev hovedsageligt målt på andelen af patienter, der reagerede positivt på behandlingen, og hvis hjernetumor skrumpede til mindst halv størrelse efter seks måneders behandling.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Votubia have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Votubia.
English: • subependymal giant cell astrocytoma (SEGA), a benign tumour of the brain, where it is used in adults and children whose brain tumour cannot be surgically removed;
Danish: • subependymalt kæmpecelle-astrocytom (SEGA), som er en godartet tumor i hjernen.
English: The medicine is also used as an add-on treatment in patients from 2 years of age with seizures (fits) related to tuberous sclerosis that have not responded to other treatments.
Danish: Lægemidlet bruges også som tillægsbehandling hos patienter fra toårsalderen, der lider af anfald som følge af tuberøs sklerose, og som ikke har reageret positivt på andre behandlinger.
English: How does Votubia work?
Danish: Hvordan virker Votubia?
English: The main measure of effectiveness was based on how much the patient's main brain tumour shrank after six months of treatment: the main brain tumour shrank by half in approximately 30% of patients and by about a third in around 70% of patients.
Danish: Den primære hjernetumor skrumpede til halv størrelse hos ca. 30 % af patienterne og med omkring en tredjedel hos ca. 70 % af patienterne.
English: The second study involved 117 patients (including 20 children aged below 3 years) and compared Votubia with placebo (a dummy treatment).
Danish: Det andet studie omfattede 117 patienter (herunder 20 børn under 3 år).
English: Although surgery remains the standard treatment for this condition, Votubia is expected to benefit patients whose tumour cannot be operated on. Votubia has also been shown to reduce the size of kidney tumours in patients with renal angiomyolipoma and has been shown to be beneficial as an add-on treatment in the management of partial-onset seizures related to tuberous sclerosis that have not sufficiently responded to other therapy.
Danish: Votubia har også vist sig at reducere størrelsen af nyretumorer hos patienter med renal angiomyolipoma og har vist sig at være virksomt som tillægsbehandling ved reguleringen af partielle anfald forbundet med tuberøs sklerose, der ikke har reageret tilstrækkeligt på andre behandlinger.
English: • renal angiomyolipoma, a benign tumour of the kidneys, where it is used in adults who are at risk of complications but who do not require immediate surgery.
Danish: • renal angiomyolipoma, som er en godartet tumor i nyrerne.
English: The main measure of effectiveness was the proportion of patients who responded to treatment and whose kidney tumour shrank by at least half, which was seen in 42% of patients (33 out of 79) treated with Votubia, compared with none of the 39 patients who received placebo.
Danish: Dette var tilfældet hos 42 % af de patienter (33 ud af 79), der blev behandlet med Votubia, sammenlignet med ingen ud af de 39 patienter, der fik placebo.
English: This estimate has not been independently verified.
Danish: Dette skøn er ikke blevet verificeret uafhængigt.
English: Also the situation is dynamic and may change as new cases arise.
Danish: Desuden er situationen dynamisk og kan ændre sig, hvis der opstår nye tilfælde.
English: • Avoid contact with eyes.
Danish: • Undgå kontakt med øjnene.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MICOTIL (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF MICOTIL (se bilag I)
English: • Do not use automatic injection equipment.
Danish: • Anvend ikke automatisk injektionsudstyr.
English: Withdrawal of the product from the market in the EU
Danish: Tilbagetrækning af produktet fra markedet i EU
English: Maintaining the status quo
Danish: Fastholdelse af status quo
English: Cattle and calves up to 2 years of age;
Danish: Kvæg og kalve på op til 2 år;
English: Secondly, re-formulation would necessitate new quality, safety and efficacy studies, which might not be feasible.
Danish: For det andet ville reformulering kræve nye kvalitets-, sikkerheds- og effektivitetsundersøgelser, hvilket muligvis ikke ville kunne lade sig gøre.
English: The product has a relatively long history of use with few questions over its effectiveness in the field.
Danish: Produktet har været brugt relativt længe, og der er stillet få spørgsmål om dets effektivitet i marken.
English: In addition this measure would bear a high risk of being ignored.
Danish: Desuden er der stor risiko for, at foranstaltningen ville blive tilsidesat.
English: - the Committee assessed the information provided by the Marketing Authorisation Holders in response to the list of questions agreed by the Committee on 16 June 2004 and the additional information provided on 12 July 2005;
Danish: - Udvalget vurderede den information, indehaverne af markedsføringstilladelsen forelagde som svar på den række spørgsmål, udvalget nåede frem til den 16. juni 2004 og de supplerende oplysninger, der blev forelagt den 12. juli 2005.
English: They are trained for and used to appropriate storage of potentially lethal products.
Danish: De er uddannet i og vant til passende opbevaring af potentielt dødelige produkter.
English: Do not inject more than 20 ml per injection site.
Danish: Injicer ikke over 20 ml pr. injektionssted.
English: Cattle Sheep (over 15kg)
Danish: Får (over 15 kg)
English: 90027 Bernolakova, Slovak Republic
Danish: 90027 Bernolakova, Den Slovakiske Republik
English: It is evident that accidental injections may occur, but normally the volume injected is low.
Danish: Det er indlysende, at uforsætlig injektion kan forekomme, men sædvanligvis er det injicerede volumen meget lille.
English: Survival rates are greatly improved by the correct medical intervention.
Danish: Overlevelsesprocenten er væsentligt højere efter korrekt medicinsk intervention.
English: or E. coli, two bacteria often the focus of human food-borne illness concerns.
Danish: eller E.coli, to bakterier, der ofte er i fokus i forbindelse med fødevarebetingede sygdomme hos mennesker.
English: A statement in a frame with yellow background colour, saying:
Danish: En erklæring i et indrammet felt med gul baggrund, hvor der står:
English: • Do not work alone when using Micotil.
Danish: • Arbejd ikke alene med Micotil.
English: In particular, tilmicosin has no activity against Salmonella spp.
Danish: Især har tilmicosin ingen virkning mod Salmonella spp.
English: Under paragraph 5.1 “Pharmacodynamic properties”
Danish: 5.1 "Farmakodynamiske egenskaber"
English: ADVICE ON CORRECT ADMINISTRATION
Danish: RÅD OM KORREKT ANVENDELSE
English: Accurate weighing of lambs is important to avoid overdosage.
Danish: Det er vigtigt at veje lammene præcist for at undgå overdosering.
English: Overall, the CVMP considers the risks inherent to this option would be the lowest.
Danish: Alt i alt anser CVMP de indbyggede risici ved denne løsning for lavest.
English: As tilmicosin persists in tissues for several days, the cardiovascular system should be closely monitored and supportive treatment provided.
Danish: Da tilmicosin persisterer i vævet i flere dage, bør det kardiovaskulære system nøje overvåges og støttende behandling gives.
English: In total 520 human exposures were reported since 1999, of which 509 were accidental.
Danish: I alt er der rapporteret 520 humane eksponeringer siden 1999, 509 af dem
English: They tend to be physically active and involved in handling animals every day.
Danish: De er gerne fysisk aktive og er dagligt ude for at skulle håndtere dyr.
English: Stawki no. 2, 21 pietro 00-193 Warsaw Poland
Danish: Stawki no. 2, 21 pietro 00-193 Warsaw Polen
English: It must be noted that systems for properly recording suspected adverse reactions may not be in existence in every country in the world where the product is marketed.
Danish: Det skal bemærkes, at der ikke nødvendigvis findes systemer til korrekt registrering af mistanke om bivirkninger i alle de lande i verden, hvor produktet markedsføres.
English: • May cause sensitisation by skin contact.
Danish: • Kan medføre overfølsomhed ved kontakt med huden.
English: Single dose All sheep indications and pneumonia in cattle:
Danish: Enkeltdosis Alle indikationer for får samt pneumoni hos kvæg:
English: The benefits of treatment with Micotil include that the animal is treated with an effective antibacterial.
Danish: Fordelene ved behandling med Micotil er blandt andet, at dyret behandles med et effektivt antibakterielt middel.
English: Do not inject lambs weighing less than 15 kg, since there is a real risk of overdose toxicity.
Danish: Injicer ikke lam, der vejer mindre end 15 kg, da der er en reel risiko for toksicitet som følge af overdosering.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: PÅSKRIFTEN "KUN TIL VETERINÆR BRUG" OG BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
English: It noted that a lower strength product would firstly lead to an increase in the number of administrations necessary to achieve a therapeutic dose.
Danish: Det bemærkede, at et produkt med en lavere styrke for det første ville medføre en stigning i det nødvendige antal indgivelser for at opnå en terapeutisk virkning.
English: Harmonised, stringent user safety warnings would include:
Danish: Strenge, harmoniserede brugersikkerhedsadvarsler vil omfatte:
English: - The educational measures for the user are a prerequisite to ensure appropriate adherence to the safety warnings.
Danish: - Uddannelsestiltagene over for brugeren er en forudsætning, der skal medvirke til, at sikkerhedsadvarslerne overholdes.
English: The risk : benefit analysis for Micotil is rather complex and various risk management proposals must be carefully considered.
Danish: Risk-benefit-analysen for Micotil er kompleks, og en række forslag til risikostyring må nøje overvejes.
English: Other combinations of measures would theoretically be possible, but would not present significant additional benefits to risk management, and they are therefore not discussed.
Danish: Andre kombinationer af foranstaltninger er i teorien også mulige, men bidrager ikke væsentligt til risikostyringen, og derfor redegøres der ikke for dem.
English: Tilmicosin was found to dosedependently reduce ICa amplitude with an IC50 value of 26.75 µM.
Danish: Tilmicosin fandtes at forårsage en dosisafhængig reduktion af ICa-amplituden med en IC50-værdi på 26,75 µM.
English: For the EU the average bovine weight was put on 150 kg (90% of the sales) whereas the average ovine weight was kept at 30 kg.
Danish: For EU blev gennemsnitsvægten for kvæg sat til 150 kg (90 % af salget), hvorimod gennemsnitsvægten for får forblev på 30 kg.
English: Such a volume restriction would necessitate additional administrations to the same animal.
Danish: En sådan begrænsning ville nødvendiggøre flere indgivelser i samme dyr.
English: Evidence from investigations of 13 occurrences of intentional intramuscular injection suggests that 60% of people who received 10 to 12 ml of Micotil died.
Danish: Dokumentation fra undersøgelser af 13 forekomster af forsætlig intramuskulær injektion tyder på, at 60 % af de personer, der modtog 10-12 ml Micotil, døde.
English: INJECTION OF THIS DRUG IN HUMANS HAS BEEN ASSOCIATED WITH FATALITIES.
Danish: INJEKTION AF DETTE LÆGEMIDDEL HOS MENNESKER HAR VÆRET FORBUNDET MED DØDSFALD.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET FREMLAGT AF EMEA
English: The risk of serious signs of toxicity and death in human beings appear to be linked to plasma concentrations around 5 µg/ml, whereas plasma concentrations of 1-2 µg/ml did not lead to fatalities.
Danish: Risikoen for alvorlige tegn på toksicitet og død hos mennesker synes at være forbundet med plasmakoncentrationer på omkring 5 µg/ml, hvorimod plasmakoncentrationer på 1-2 µg/ml ikke medførte dødsfald.
English: Furthermore the revised aspects of the Summary of Product Characteristics should be implemented in the labelling and product leaflet as set out below.
Danish: Desuden skal de reviderede aspekter af produktresuméet gennemføres i etiketteringen og på indlægssedlen som anført nedenfor.
English: On the inside of the peel-back label
Danish: På indersiden af den aftagelige etiket
English: However, evidence based data to demonstrate the benefits of Micotil relative to other authorised antibacterials has not been provided.
Danish: Der er dog ikke fremlagt evidensbaserede data, der påviser fordelene ved Micotil i forhold til andre godkendte antibakterielle midler.
English: Recognising that farming practices in the USA, where the accidental fatalities were reported, differ significantly from farming practices in the EU different risk management approaches between the USA and the EU may be required.
Danish: Idet landbrugspraksis i USA, hvor dødsulykkerne er rapporteret, afviger væsentligt fra landbrugspraksis i EU, kan der være behov for forskellige tilgange til risikostyring i USA og EU.
English: Such cardiotoxic effects have also been observed in human beings (mainly after intentional injection but in 2 known cases outside the EU after accidental injection of Micotil).
Danish: Sådanne kardiotoksiske virkninger er også observeret hos mennesker (hovedsageligt efter bevidst injektion, men i to kendte tilfælde uden for EU efter uforsætlig injektion af Micotil).
English: The CVMP did not consider it feasible or appropriate to recommend the re-formulation of the product to lower strength.
Danish: CVMP anså det ikke for muligt eller relevant at anbefale en reformulering af produktet, så styrken blev nedsat.
English: The fact that the product is administered subcutaneously may also be considered as a benefit from the point of view of the quality of foodstuffs (muscle) when compared to certain so-called long acting formulations such as tetracyclines.
Danish: Det, at produktet indgives subkutant, kan også ses som en fordel ud fra et fødevarekvalitetssynspunkt (muskler) sammenlignet med såkaldte langtidsvirkende formuleringer som tetracycliner.
English: Additional recommendation to any of the options 3. to 5. regarding limitation of the volume of Micotil to be held per syringe or of maximum pack size or re-formulation of the product
Danish: Yderligere anbefaling i forbindelse med scenarie 3 til 5 vedrørende begrænsning af mængden af Micotil i hver sprøjte eller vedrørende maksimal pakningsstørrelse eller reformulering af produktet
English: “Special precautions to be taken by the person administering the medicinal product to animals”
Danish: "Særlige forsigtighedsregler, som skal følges af den person, der behandler dyr med lægemidlet"
English: Nevertheless, it is necessary to put in practice some measures to reduce the risks of accidental self-injection.
Danish: Det er dog nødvendigt at træffe visse foranstaltninger, der kan reducere risikoen for uforsætlig selvinjektion.
English: Of these 509 reports, 214 cases related to non-injection exposures, and 295 to injection exposures, with minor needle scratches being the most common.
Danish: Af disse 509 rapporterede tilfælde vedrørte de 214 ikke-injektionsrelateret eksponering og de 295 injektionsrelateret eksponering, hvoraf størstedelen var overfladiske kanylestik.
English: A related risk is that certain substances, in particular adrenaline (epinephrine), used in standard emergency treatment in human medicine may exacerbate the effects of tilmicosin.
Danish: En beslægtet risiko er, at visse stoffer, især adrenalin (epinephrin), der anvendes i standard akutbehandling, i humanmedicin kan forværre virkningerne af tilmicosin.
English: Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216 Ingelheim Germany
Danish: Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216 Ingelheim Tyskland
English: Under paragraph 4.5 “Special precautions for use”
Danish: 4.5 "Særlige forsigtighedsregler vedrørende brugen"
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE CONCERNED MEMBER STATES
Danish: BILAG I LISTE OVER LÆGEMIDLETS NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, DYREARTER OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I DE PÅGÆLDENDE MEDLEMSSTATER
English: Exposure assessment
Danish: Eksponeringsvurdering
English: As the dosage of the product in adult sheep is typically 1-5 ml and in adult cattle is typically 15-20 ml, it is difficult to accurately estimate the incidence of human reactions or fatalities.
Danish: Da doseringen af produktet hos fuldt udvoksede får typisk er 1-5 ml og hos fuldt udvokset kvæg typisk 15-20 ml, er det svært at foretage en nøjagtig vurdering af forekomsten af reaktioner eller dødsfald hos mennesker.
English: Apply a cold pack (not ice directly) to the injection site.
Danish: Læg et koldt omslag (ikke is direkte) på injektionsstedet
English: Injection in a fold of skin over the rib cage behind the shoulder is suggested.
Danish: Det foreslås at injicere i en hudfold over ribbenene bag skulderen.