FrancophonIA/ELRC3.0 huggingface dataset:
English: Available evidence suggests that the risk of harm from Symbioflor 2 is low.
Danish: Den tilgængelige evidens viser, at risikoen for skade ved brug af Symbioflor 2 er lav.
English: Medicine should no longer be used for other disorders of the gut
Danish: Lægemidlet bør ikke længere anvendes ved andre tarmsygdomme
English: • The product information will be updated in line with this review of Symbioflor 2.
Danish: • Produktinformationen for Symbioflor 2 vil blive opdateret i overensstemmelse med denne gennemgang.
English: • Speak with a pharmacist or your doctor if you have any problems affecting your stomach or gut.
Danish: • Kontakt apotekspersonalet eller din læge, hvis du har problemer med maven eller tarmene.
English: It is marketed in some European Union countries for treating irritable bowel syndrome, functional gastrointestinal diseases and some other gastrointestinal disorders and for regulating the immune system.
Danish: Det markedsføres i en række EU-lande til behandling af irritabel tyktarm, funktionelle gastrointestinale lidelser og en række andre sygdomme i mave-tarm-kanalen og til regulering af immunsystemet.
English: The company that markets Symbioflor 2 did not submit data to support its use in ‘functional gastrointestinal disorders' and agreed to remove this use from the medicine's authorisation.
Danish: Virksomheden, der markedsfører Symbioflor 2, har ikke indsendt data til støtte for lægemidlets anvendelse ved funktionelle gastrointestinale lidelser og indvilgede i fjernelsen af denne anvendelse fra lægemidlets godkendelse.
English: In reaching its conclusions, EMA's Committee for Medicinal Products for Human Use (CHMP) reviewed all available evidence on the effectiveness and safety of Symbioflor 2.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) baserede sine konklusioner på en gennemgang af al tilgængelig evidens vedrørende virkningen og sikkerheden ved Symbioflor 2.
English: However, the study had some weaknesses and it did not provide evidence on how well Symbioflor 2 works in different types of IBS.
Danish: Der var dog nogle svagheder ved undersøgelsen, og den gav ikke evidens for, hvor godt Symbioflor 2 virker ved forskellige typer af irritabel tyktarm.
English: • You can continue to take Symbioflor 2 for treating symptoms of irritable bowel syndrome by following the information in the medicine's revised package leaflet.
Danish: • Du kan fortsat tage Symbioflor 2 for symptomer på irritabel tyktarm ved at følge anvisningerne i lægemidlets reviderede indlægsseddel.
English: Symbioflor 2, which contains Escherichia coli bacteria, has been described as a probiotic, which means that it encourages the growth of beneficial organisms (‘flora') in the gut.
Danish: Symbioflor 2, der indeholder Escherichia coli-bakterier, er blevet beskrevet som et probiotikum, og det betyder, at det fremmer væksten af nyttige organismer ("flora") i tarmene.
English: • Symbioflor 2 should be used for the treatment of irritable bowel syndrome (IBS) only, and it should no longer be used for treating ‘functional gastrointestinal disorders' or other conditions of the gastrointestinal tract.
Danish: • Symbioflor 2 bør kun anvendes til behandling af irritabel tyktarm, og det bør ikke længere anvendes til behandling af funktionelle gastrointestinale lidelser eller andre tilstande i mave-tarmkanalen.
English: • The company will need to carry out a well-designed study to demonstrate the efficacy and safety of Symbioflor 2 for treating different variants of IBS, as a condition for continuing to market it.
Danish: • Virksomheden er blevet pålagt at gennemføre en veltilrettelagt undersøgelse til påvisning af virkningen af og sikkerheden ved Symbioflor 2 ved behandling af forskellige varianter af irritabel tyktarm for fortsat at kunne markedsføre lægemidlet.
English: A randomised study involving around 300 adults suggested that Symbioflor 2 was effective for treating IBS.
Danish: En randomiseret undersøgelse med ca. 300 voksne tyder på, at Symbioflor 2 er effektivt til behandling af irritabel tyktarm.
English: You should not use Symbioflor 2 for conditions affecting the gut other than irritable bowel syndrome.
Danish: Du bør ikke anvende Symbioflor 2 mod andre tarmlidelser end irritabel tyktarm.
English: • A study comparing Symbioflor 2 with placebo suggested that it was effective at treating IBS in adults.
Danish: • Det er påvist i en undersøgelse, hvor Symbioflor 2 blev sammenlignet med placebo, at dette lægemiddel er effektivt til behandling af irritabel tyktarm hos voksne.
English: The review did not find any new evidence on the effectiveness of Symbioflor 2 since the product was last approved.
Danish: Der blev i gennemgangen ikke fundet evidens for Symbioflor 2's virkning, som ikke allerede var kendt ved den seneste godkendelse af lægemidlet.
English: The way it works in irritable bowel syndrome is not fully understood.
Danish: Det vides ikke nøjagtigt, hvordan de virker ved irritabel tyktarm.
English: • If you have any questions or concerns, speak with a pharmacist or your doctor.
Danish: • Spørg apotekspersonalet eller lægen, hvis du vil vide mere.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel ratiopharm GmbH.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Clopidogrel ratiopharm GmbH.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel ratiopharm GmbH on 28 July 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Ratiopharm GmbH den 28. juli 2009.
English: For more information about treatment with Clopidogrel ratiopharm GmbH, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel ratiopharm GmbH, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In acute coronary syndrome, Clopidogrel ratiopharm GmbH is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Danish: Ved akut koronarsyndrom anvendes Clopidogrel Ratiopharm GmbH sammen med aspirin, og behandlingen indledes almindeligvis med en startdosis på fire 75 mg-tabletter.
English: GmbH can be started between a few days and 35 days after the attack;
Danish: Ratiopharm GmbH kan påbegyndes få dage efter anfaldet og indtil 35 dage efter,
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel ratiopharm GmbH.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel ratiopharm GmbH.
English: This means that Clopidogrel ratiopharm GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel Ratiopharm GmbH er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, og som hedder Plavix.
English: Clopidogrel ratiopharm GmbH can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Danish: Clopidogrel Ratiopharm GmbH kan anvendes til patienter, som har myokardieinfarkt med ”forhøjelse af STsegmentet” (ST-elevation), dvs. en unormal visning på elektrokardiogrammet (EKG), når lægen vurderer, at patienterne kan have gavn af denne behandling.
English: Clopidogrel ratiopharm GmbH is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel Ratiopharm GmbH anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel ratiopharm GmbH has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: CHMP konkluderede, at Clopidogrel Ratiopharm GmbH i overensstemmelse med EU-kravene har vist sig at være af sammenlignelig kvalitet og at være bioækvivalent med Plavix.
English: The full EPAR for Clopidogrel ratiopharm GmbH can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The standard dose of Clopidogrel ratiopharm GmbH is one 75 mg tablet once a day.
Danish: Standarddosis af Clopidogrel Ratiopharm GmbH er 75 mg en gang dagligt.
English: Clopidogrel ratiopharm GmbH can be given to the following groups of patients:
Danish: Clopidogrel Ratiopharm GmbH kan gives til følgende patientgrupper:
English: Clopidogrel ratiopharm GmbH can be started between seven days and six months after the stroke;
Danish: Behandlingen med Clopidogrel Ratiopharm GmbH kan påbegyndes 7 dage efter slagtilfældet og indtil 6 måneder efter,
English: Because Clopidogrel ratiopharm GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Danish: Da Clopidogrel Ratiopharm GmbH er et generisk lægemiddel, der er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Clopidogrel ratiopharm GmbH is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel Ratiopharm GmbH er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: Clopidogrel ratiopharm GmbH is a ‘generic medicine'.
Danish: Clopidogrel ratiopharm GmbH er et ‘generisk lægemiddel'.
English: The Committee recommended that Clopidogrel ratiopharm GmbH be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Ratiopharm GmbH.
English: Clopidogrel ratiopharm GmbH is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel ratiopharm GmbH er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: The active substance in Clopidogrel ratiopharm GmbH, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Ratiopharm GmbH, clopidogrel, er et blodpladeaggregationshæmmende middel.
English: What are the benefits and risks of Clopidogrel ratiopharm GmbH?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Ratiopharm GmbH?
English: Other information about Clopidogrel ratiopharm GmbH
Danish: Andre oplysninger om Clopidogrel Ratiopharm GmbH:
English: Why has Clopidogrel ratiopharm GmbH been approved?
Danish: Hvorfor er Clopidogrel Ratiopharm GmbH blevet godkendt?
English: How has Clopidogrel ratiopharm GmbH been studied?
Danish: Hvordan er Clopidogrel Ratiopharm GmbH blevet undersøgt?
English: What is Clopidogrel ratiopharm GmbH?
Danish: Hvad er Clopidogrel ratiopharm GmbH?
English: What is Clopidogrel ratiopharm GmbH used for?
Danish: Hvad anvendes Clopidogrel Ratiopharm GmbH til?
English: How is Clopidogrel ratiopharm GmbH used?
Danish: Hvordan anvendes Clopidogrel Ratiopharm GmbH?
English: How does Clopidogrel ratiopharm GmbH work?
Danish: Hvordan virker Clopidogrel Ratiopharm GmbH?
English: ATCvet code: QJ01XQ02.
Danish: ATCvet-kode: QJ01XQ02.
English: A large proportion of tympanic rabbits will recover.
Danish: En stor del af de tympaniske kaniner kommer sig.
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Danish: Officielle, nationale og regionale antimikrobielle politikker skal tages i betragtning, når produktet anvendes.
English: Do not use prophylactically.
Danish: Undlad profylaktisk anvendelse.
English: Consideration should be given to the eradication of infection from the farm.
Danish: Det bør overvejes at udrydde infektion fra gården.
English: However, the aetiology of ERE still remains unclear.
Danish: Dog er ætiologien for ERE stadig uklar.
English: Up to 3 weeks
Danish: Op til 3 uger
English: 2 weeks or until signs of disease disappear
Danish: 2 uger eller indtil sygdomstegnene forsvinder
English: However, as absorption, distribution and elimination were very similar in rats, dogs and pigs, it is reasonable to assume that they would be similar in rabbits.
Danish: Eftersom værdierne for absorption, distribution og eliminering var meget ens hos rotter, hunde og svin, er det berettiget at antage, at de vil være tilsvarende ens hos kaniner.
English: Impaction is more frequently seen in rabbits that die.
Danish: Impaktion ses oftere hos kaniner, der dør.
English: The active substance in Econor, valnemulin, is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Den aktive substans i Econor, valnemulin, er en godkendt substans som beskrevet i tabel 1 i bilag til Kommissionens Forordning (EU) nr. 37/2010:
English: and Escherichia coli.
Danish: og Escherichia coli.
English: After repeat dosing, slight accumulation occurred, but a steady state was achieved within 5 days.
Danish: Efter gentagen dosering opstod der en let akkumulering, men en "steady state" blev opnået i løbet af 5 dage.
English: In order to obtain the correct dosage, the concentration of Econor has to be adjusted.
Danish: For at opnå korrekt dosering skal koncentrationen af Econor justeres.
English: 6250 Kundl
Danish: A-6250 Kundl
English: A linear relationship between concentration and dose administered was established.
Danish: Der blev konstateret et lineært forhold mellem koncentration og indgiven dosis.
English: Equivalent to valnemulin base
Danish: Svarende til valnemulin base
English: Severe growth depression, ataxia, paralysis or death may result.
Danish: Alvorlig væksthæmning, ataksi, lammelse eller dødsfald kan være følgen.
English: Rabbits: See section “Special warning(s)”
Danish: Kaniner: Se afsnittet ”Særlige advarsler”.
English: The product should be used as part of a programme including measures aimed at controlling the disease on farm such as biosecurity and husbandry controls.
Danish: Produktet skal anvendes som en del af et program, der omfatter foranstaltninger, der har til formål at kontrollere sygdommen i besætningen, såsom biosikkerhedsmæssige og landbrugsmæssige kontrolforanstaltninger.
English: The product has been shown to be stable to the pelleting process at temperatures of 75 °C.
Danish: Produktet har vist sig at være stabilt ved foderpelleteringsmetoder ved temperaturer op til 75 °C.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or considered as not falling within the scope of Regulation (EC) No. 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Daily dose calculation:
Danish: Beregning af daglig dosis:
English: Prevention of
Danish: Forebyggelse af
English: Clostridium perfringens, a bacterium which may be involved in the development of ERE, isolated from rabbits with ERE, showed MIC90 values of 0.125 µg/ml (isolates from Hungary, Italy, Spain
Danish: Clostridium perfringens - en bakterie, der kan være involveret i udviklingen af ERE - der blev isoleret fra kaniner med ERE, viste MIC90-værdier på 0,125 µg/ml (isolater fra Ungarn, Italien, Spanien 2013
English: The uptake of medicated feed depends on the clinical condition of the animal.
Danish: Indtaget af det medicinerede foder afhænger af dyrets kliniske tilstand.
English: For use in individual pigs on farms where only a small number of pigs are to receive the veterinary medicinal product.
Danish: Til behandling af enkelte svin på gårde, hvor kun et lille antal svin skal behandles med veterinærlægemidlet.
English: Part-used containers should be tightly closed following dispensing.
Danish: Delvist anvendte beholdere skal lukkes tæt i efter brug.
English: Once opened use within 6 months.
Danish: Efter åbning bør det bruges inden for 6 måneder.
English: The daily feed consumption should be recorded and the inclusion rate should be adjusted accordingly.
Danish: Det daglige indtag af foder skal registreres, og inklusionsniveauet skal justeres herefter.
English: The feed containing the oral powder should be provided as the sole ration for the treatment periods recommended above.
Danish: Foderet, der indeholder det orale pulver, bør gives som den eneste ration i behandlingsperioderne anbefalet ovenfor.
English: Pigs and rabbits
Danish: Svin og kaniner
English: The periodic safety update report (PSUR) cycle should be re-started for submission of 6-monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years, and thereafter at 3 yearly intervals.
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Den periodiske, opdaterede sikkerhedsindberetninger (PSUR) cyklus bør nulstilles før indsendelse af 6 månedlige rapporter (der dækker alle godkendte pakningsstørrelser af produktet) for de næste to år, efterfulgt af årlige rapporter for de efterfølgende to år og derefter på 3 års mellemrum.
English: Severely affected pigs should be removed to clean dry pens and given appropriate treatment, including treatment for concurrent disease.
Danish: Alvorligt påvirkede svin skal flyttes til rene, tørre stier og gives passende behandling, inklusive behandling for medvirkende sygdom.
English: 73% - 95% of the daily dose of total radioactivity was recovered from the faeces.
Danish: 73 % til 95 % af den totale daglige dosis radioaktivt mærket stof blev genfundet i afføringen.
English: Gloves should be worn when handling the veterinary medicinal product.
Danish: Der bør anvendes handsker ved håndtering af det veterinærmedicinske produkt.
English: Pharmacotherapeutic group: Antiinfectives for systemic use, pleuromutilins.
Danish: Farmakoterapeutisk gruppe: Antiinfektiva til systemisk brug, pleuromutiliner.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25 ºC.
English: The plasma half-life was 1.3-2.7 hours, and the majority of the total radio-activity administered was excreted within 3 days of the last administration.
Danish: Halveringstiden i plasma var 1,3 til 2,7 timer og størstedelen af den samlede indgivne radioaktivitet blev udskilt inden for 3 dage efter sidste indgivelse.
English: Treatment should be started early in the outbreak, when the first rabbit has been diagnosed with the disease clinically.
Danish: Behandlingen skal startes tidligt i udbruddet, når den første kanin er klinisk diagnosticeret med sygdommen.
English: Tympanism is more frequently reported in rabbits treated with the product than untreated rabbits (27% vs16%).
Danish: Tympanisme rapporteres oftere hos kaniner, der behandles med produktet, end hos ubehandlede kaniner (27 % vs. 16 %).
English: Clinical diagnosis should be confirmed by necropsy.
Danish: Den kliniske diagnose skal bekræftes med nekropsi.
English: Application in feed (premix)
Danish: Indgivelse i foder (premix)
English: Repeated use of valnemulin should be avoided by improving management practice and thorough cleansing and disinfection.
Danish: Gentagen anvendelse af valnemulin bør undgås ved at forbedre behandlingspraksis og gennem grundig rengøring og desinfektion.
English: If there is no response to treatment within 5 days, the diagnosis should be re-established.
Danish: Hvis der ikke er reaktion på behandlingen inden for 5 dage, bør diagnosen revurderes.
English: Econor 50% premix Sandoz GmbH Biochemiestrasse 10 6250 Kundl AUSTRIA
Danish: Econor 50 % premix Sandoz GmbH Biochemiestrasse 10 6250 Kundl ØSTRIG
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter “UDL.D”.
English: This assumption is supported by the results of an ex-vivo study which compared pig and rabbit liver metabolic profiles.
Danish: Denne antagelse understøttes af resultaterne af et ex vivo-forsøg, der sammenlignede levermetaboliseringsprofilerne for svin og kaniner.
English: On affected farms, one third of the pigs treated were affected, with a mortality of 1%.
Danish: I de berørte besætninger har en tredjedel af de behandlede svin været påvirket med en dødelighed på 1 %.
English: PHARMACEUTICAL FORM Oral powder
Danish: LÆGEMIDDELFORM Oralt pulver
English: Resistance development primarily occurs because of changes at the binding site associated with mutations of the ribosomal DNA genes.
Danish: Resistensudvikling opstår primært på grund af ændringer på bindingsstedet associeret med mutationer af de ribosomale DNAgener.
English: Because of a marked ‘first pass' effect, plasma concentrations are affected by the method of administration, but valnemulin is highly concentrated in tissues, particularly the lungs and liver, relative to plasma.
Danish: På grund af en markant 'first pass' effekt vil plasmakoncentrationer afhænge af indgivningsmetode, men valnemulin er stærkt koncentreret i væv, især lunger og lever, i forhold til plasma.
English: There have been some increases of MICs of valnemulin against B. hyodysenteriae and to a lesser degree B. pilosicoli, some of which appear to have developed resistance.
Danish: Der har været nogen forøgelse af MICer af valnemulin mod B. hyodysenteriae og i mindre grad B. pilosicoli, hvoraf nogle lader til at have udviklet resistens.
English: Do not use after the expiry date which is stated on the label after “EXP”.
Danish: Må ikke anvendes efter udløbsdatoen, som er anført på etiketten efter "UDL.D".
English: Do not store above 25 °C.
Danish: Må ikke opbevares over 25 ºC.
English: Manufacturer's batch number Batch {number}
Danish: Fremstillerens batchnummer Batch{number}
English: Responsible use of antimicrobials:
Danish: Ansvarsbevidst brug af antimikrobielle midler:
English: Minimum of 7 days and up to 4 weeks or until signs of disease disappear
Danish: Mindst 7 dage og op til 4 uger eller indtil sygdomstegnene forsvinder
English: Five days after the last of 15 doses of radiolabelled valnemulin administered to pigs, the concentration in liver was >6 times that in plasma.
Danish: Fem dage efter den sidste af 15 doser radioaktivt mærket valnemulin, som blev givet til svin, var koncentrationen i leveren mere end 6 gange større end i plasma.
English: Valnemulin shows high activity against Mycoplasma spp.
Danish: Valnemulin er meget virksomt mod Mycoplasma spp.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/03/1999.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 12. marts 1999
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Officiel vejledning vedrørende iblanding af medicineret premix i det færdige foder bør tages i betragtning.
English: Manufacturer responsible for batch release: Sandoz GmbH
Danish: Fremstiller ansvarlig for batch frigivelse: Sandoz GmbH
English: Medicated feed should be replaced, if not consumed within 24 hours.
Danish: Medicineret foder skal kasseres, hvis det ikke er opbrugt inden for 24 timer.