FrancophonIA/ELRC3.0 huggingface dataset:
English: The purpose of the studies was to establish how long it took for piglets to be fully protected, the length of time protection lasts against oedema disease as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine.
Danish: Formålet med undersøgelserne var at finde ud af, hvor lang tid det tog for smågrise at opnå fuld beskyttelse, hvor længe beskyttelsen mod ødemsyge varer, og hvilken betydning antistoffer, der overføres fra moderdyret, har på vaccinens virkning.
English: The laboratory studies showed that the injection had its full effect by 21 days, and that protection lasted for at least 105 days after injection; protection was not affected by antibodies transmitted from the mother.
Danish: Laboratorieundersøgelserne viste, at injektionen havde fuld virkning efter 21 dage, og at beskyttelsen holdt sig i mindst 105 dage efter injektionen.
English: The most common side effects after injection of Ecoporc Shiga (which may affect up to 1 in 10 animals) are mild swelling, lasting for up to 7 days, at the injection site and a slight rise in body temperature for up to two days after injection; both resolve without treatment.
Danish: De hyppigste bivirkninger efter injektion af Ecoporc Shiga (som kan optræde hos op til 1 ud af 10 vaccinerede dyr) er let hævelse af indtil 7 dages varighed på injektionsstedet og let stigning i kropstemperaturen i indtil 2 dage efter injektionen.
English: When Ecoporc Shiga is given to pigs, the animal's immune system recognises the toxin contained in the vaccine as ‘foreign' and makes antibodies against it.
Danish: Når Ecoporc Shiga gives til svin, opfatter dyrets immunsystem toksinet i vaccinen som "fremmed" og danner antistoffer mod det.
English: The withdrawal period for Ecoporc Shiga is zero days.
Danish: Tilbageholdelsestiden for Ecoporc Shiga er 0 døgn.
English: Three field trials were also performed to assess the effect on mortality and clinical signs of oedema disease in a total of 518 piglets receiving Ecoporc Shiga compared with a similar number of piglets receiving placebo (a dummy injection).
Danish: Der blev desuden udført tre feltundersøgelser til vurdering af virkningen på dødelighed og kliniske tegn på ødemsyge hos i alt 518 smågrise, der fik Ecoporc Shiga, sammenlignet med et tilsvarende antal smågrise, der fik placebo (en virkningsløs injektion).
English: Ecoporc Shiga is a vaccine containing the modified toxin Stx2e.
Danish: Ecoporc Shiga er en vaccine, der indeholder det modificerede toksin Stx2e.
English: It is caused by a bacterial toxin (poison) known as Shiga toxin 2e (Stx2e) that is produced by certain strains of Escherichia coli.
Danish: Sygdommen skyldes et toksin (et giftstof), Shiga-toksin 2e (Stx2e), der produceres af visse stammer af Escherichia coli.
English: Ecoporc Shiga is a vaccine containing a form of Shiga toxin (Stx2e) that has been modified so that it can no longer cause disease.
Danish: Ecoporc Shiga er en vaccine, som indeholder en form af Shiga-toksin (Stx2e), der er modificeret, så det ikke længere kan fremkalde sygdom.
English: Other information about Ecoporc Shiga:
Danish: Andre oplysninger om Ecoporc Shiga:
English: Ecoporc Shiga is used in pigs from the age of 4 days for active immunisation against oedema disease, which leads to fluids accumulating in the tissues of the stomach and gut.
Danish: Ecoporc Shiga anvendes til vaccination af svin, som er over 4 dage gamle, mod ødemsyge, der medfører væskeophobning i vævet i maven og tarmen.
English: For a full list of all side effects reported with Ecoporc Shiga, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ecoporc Shiga fremgår af indlægssedlen.
English: Ecoporc Shiga contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Danish: Vaccinen indeholder et adjuvans (aluminiumhydroxid), der forstærker immunreaktionen.
English: What is the risk associated with Ecoporc Shiga?
Danish: Hvilken risiko er der forbundet med Ecoporc Shiga?
English: Oedema disease is found worldwide and usually occurs in the first two weeks after weaning of the piglets, and is an acute (short-term) condition which can lead to death within 24 to 48 hours.
Danish: Det er en akut (hastigt forløbende) sygdom, der kan medføre døden i løbet af 24-48 timer.
English: Why has Ecoporc Shiga been approved?
Danish: Hvorfor blev Ecoporc Shiga godkendt?
English: What is Ecoporc Shiga?
Danish: Hvad er Ecoporc Shiga?
English: How has Ecoporc Shiga been studied?
Danish: Hvordan blev Ecoporc Shiga undersøgt?
English: What is Ecoporc Shiga used for?
Danish: Hvad anvendes Ecoporc Shiga til?
English: How does Ecoporc Shiga work?
Danish: Hvordan virker Ecoporc Shiga?
English: What benefit has Ecoporc Shiga shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ecoporc Shiga?
English: wait at least 2 to 3 hours before taking the other.
Danish: Vent mindst 2 til 3 timer efter, at du har taget det ene af dem, til du tager det andet.
English: PC: {number} SN: {number} < NN: {number} >
Danish: SN: {nummer} NN: {nummer}
English: Date of first authorisation: 18 August 2011 Date of latest renewal: 8 April 2016
Danish: Dato for første markedsføringstilladelse: 18 august 2011 Dato for seneste fornyelse: 8 april 2016
English: 1 h 20 min
Danish: 1 t 20 min
English: Not known (frequency cannot be estimated from the available data):
Danish: Ikke kendt (hyppigheden kan ikke bestemmes ud fra forhåndenværende data)
English: • uncontrollable excessive shopping or spending;
Danish: • Ukontrolleret og overdreven shopping eller brug af penge
English: 10-20% is excreted in urine.
Danish: Omkring 10-20% udskilles i urinen.
English: • Uncontrollable movements;
Danish: • ukontrollable bevægelser
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: • strong impulse to gamble excessively despite serious personal or family consequences;
Danish: • Sygelig spilletrang på trods af alvorlige personlige eller familiære konsekvenser
English: [carton only]:
Danish: [kun på æsken]:
English: To open the bottle for the first time: open the closure, and then press with your thumb on the seal until it breaks.
Danish: Når du skal åbne beholderen første gang: Åben låget og tryk derefter tommelfingeren nedad på forseglingen, indtil den brydes.
English: In doses of 1,400 to 2,000 mg per day, the following side effects are more common:
Danish: Ved doser på 1.400 til 2.000 mg pr. dag er følgende bivirkninger mere almindelige:
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle label.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og på etiketten.
English: In particular please tell your doctor if you are taking any of the following:
Danish: Du skal især fortælle det til lægen, hvis du tager noget af følgende:
English: EU/1/11/708/001 30 film-coated tablets EU/1/11/708/002 60 film-coated tablets EU/1/11/708/003 100 film-coated tablets EU/1/11/708/004 175 film-coated tablets
Danish: EU/1/11/708/001 30 filmovertrukne tabletter EU/1/11/708/002 60 filmovertrukne tabletter EU/1/11/708/003 100 filmovertrukne tabletter EU/1/11/708/004 175 filmovertrukne tabletter
English: • if you have ever had a heart attack or any other diseases of the heart;
Danish: • hvis du har haft et hjertetilfælde eller andre hjertesygdomme;
English: For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: It is estimated that 8090% of the dose is excreted in faeces, although this has not been confirmed in man.
Danish: Det skønnes, at 80-90% af en dosering udskilles i fæces, selvom dette ikke er verificeret i mennesket.
English: • altered or increased sexual interest and behaviour of significant concern to you or to others,
Danish: • Ændret eller øget seksuel interesse og opførsel, der skaber bekymring for dig eller andre, for eksempel øget sexlyst
English: Weight decrease * Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Danish: Vægttab * Bivirkningerne er sat i rækkefølge under overskrifterne efter frekvens, den hyppigst forekomne først, ved anvendelse af følgende konventionelle regler: Meget almindelig (>1/10); almindelig (>1/100 til <1/10); ikke almindelig (>1/1.000 til <1/100); sjælden (>1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data, da ingen valide estimater har kunnet opnås i kliniske og epidemiologiske studier).
English: The pharmacokinetic properties of entacapone are similar in both young people and elderly.
Danish: De farmakokinetiske egenskaber for entacapon er de samme både i unge personer og ældre.
English: • iron supplements.
Danish: • jerntilskud.
English: • Excessive movements (hyperkinesias), worsening of symptoms of Parkinson´s disease,
Danish: • overdrevne bevægelser (hyperkinesier), forværring af symptomer på Parkinsons sygdom,
English: • Inability to resist the impulse to perform an action that could be harmful, which may include:
Danish: • Manglende evne til at modstå trangen til audføre handlinger, som kan være skadelige, som f. eks.:
English: Approximately 92 % of the dose is eliminated during ß-phase with a short elimination half-life of 30 minutes.
Danish: Cirka 92% af en dosis elimineres under betaeliminationsfasen med en eliminationshalveringstid på 30 minutter.
English: Patients who are hypersensitive to peanut or soya, should not use this medicinal product.
Danish: Patienter, som er overfølsomme over for jordnødder eller soja, bør ikke tage denne medicin.
English: Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Danish: Fortæl din læge, hvis du eller din familie/omsorgsperson bemærker, at du udvikler en stærk trang til handlinger, som er usædvanlige for dig eller hvis du ikke kan modstå lysten eller fristelsen for at udføre bestemte aktiviteter, som kan skade dig selv eller andre.
English: • if you are taking a medicine which may cause dizziness or light-headedness (low blood pressure) when rising from a chair or bed;
Danish: • hvis du tager medicin, som kan medføre svimmelhed (på grund af lavt blodtryk), når du rejser dig fra en stol eller sengen;
English: Therefore, do not take Entacapone Orion and iron supplements at the same time.
Danish: Du må derfor ikke tage Entacapone Orion og jerntilskud på samme tid.
English: Clinical interaction studies with diazepam and nonsteroidal anti-inflammatory medicinal products have not been carried out.
Danish: Kliniske interaktionsstudier med diazepam og nonsteroide antiinflammatoriske lægemidler er ikke udført.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel
English: • hallucinations (seeing/hearing/feeling/smelling things that are not really there), sleeplessness,
Danish: • hallucinationer (se/høre/føle/lugte noget, som i virkeligheden ikke er der), søvnløshed, livlige drømme, forvirring
English: Because of its mechanism of action, entacapone may interfere with the metabolism of medicinal products containing a catechol group and potentiate their action.
Danish: På grund af sin virkningsmekanisme kan entacapon indvirke på metabolismen af stoffer, der indeholder en catechol-gruppe og potensere deres virkning.
English: ** The incidence rates of myocardial infarction and other ischaemic heart disease events (0.43% and 1.54%, respectively) are derived from an analysis of 13 double-blind studies involving 2,082 patients with end-of-dose motor fluctuations receiving entacapone.
Danish: ** Incidensraterne af myokardieinfarkt og andre tilfælde af iskæmisk hjertesygdom (henholdsvis 0,43% og 1,54%) stammer fra en analyse af 13 dobbeltblinde undersøgelser med 2.082 patienter med motoriske end-of-dose fluktuationer, der fik entacapon.
English: Absorption There are large intra- and interindividual variations in the absorption of entacapone.
Danish: Der er store intra- og internindividuelle variationer i absorptionen af entacapon.
English: • if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure);
Danish: • hvis du har en svulst på binyren (kaldet fæokromocytom; det kan øge risikoen for svært forhøjet blodtryk);
English: General characteristics of the active substance
Danish: Generelle karakteristika af det aktive indholdsstof Absorption
English: See Section 2 Warnings and precautions.
Danish: Se punkt 2 Advarsler og forsigtighedsregler
English: When Entacapone Orion is given at higher doses:
Danish: Hvis Entacapone Orion gives i større doser:
English: Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
Danish: Dyskinesier (27%), kvalme (11%), diarré (8%), abdominalsmerter (7%) og mundtørhed (4,2%) blev rapporteret signifikant hyppigere med entacapon end placebo i poolede data fra kliniske studier, hvor 406 patienter har fået den aktive medicin, og 296 patienter har fået placebo.
English: Daily ON time (Mean ±SD)
Danish: Daglig ON tid (middelværdi SD)
English: The safety of entacapone in infants is unknown.
Danish: Entacapons sikkerhed hos børn er ukendt.
English: Brownish-orange, oval, biconvex film-coated tablet with "COMT" engraved on one side.
Danish: Brun-orange, oval, bikonveks, filmovertrukket tablet med ”COMT” præget på den ene side.
English: 4.5% (0 h 35 min) CI95% 0.93%, 7.97%
Danish: CI95%, 0,93%, 7,97%
English: There are four different pack sizes (bottles containing 30, 60, 100 or 175 tablets).
Danish: Der findes fire forskellige pakningsstørrelser (beholdere med 30, 60, 100 eller 175 tabletter).
English: Skin and subcutaneous tissue disorders Rare:
Danish: Hud og subkutane væv Sjælden:
English: Marketing Authorisation Holder and Manufacturer: Orion Corporation
Danish: Indehaver af markedsføringstilladelsen og fremstiller Orion Corporation
English: 2D barcode carrying the unique identifier included [carton only]
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator [kun på æsken]
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Entacapone Orion and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Danish: Malignt neuroleptika syndrom (MNS) er en alvorlig, men sjælden reaktion på visse lægemidler, som især kan forekomme, hvis behandling med Entacapone Orion og andre lægemidler til behandling af Parkinsons sygdom pludseligt stoppes, eller hvis dosis pludseligt nedsættes.
English: povidone and magnesium stearate.
Danish: povidon og magnesiumstearat.
English: If you experience such effects at the start of treatment with Entacapone Orion you should contact your doctor who may decide to adjust your dosage of levodopa.
Danish: Hvis du oplever sådanne bivirkninger i begyndelsen af behandlingen med Entacapone Orion, skal du kontakte din læge, som kan vælge at justere din levodopadosis.
English: In animal studies entacapone was excreted in milk.
Danish: I dyreforsøg udskilles entacapon i mælken.
English: Entacapone therapy should be administered cautiously to patients with ischaemic heart disease.
Danish: Entacaponbehandling bør administreres med forsigtighed til patienter med iskæmisk hjertesygdom.
English: • if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS).
Danish: • hvis du tidligere har haft en sjælden reaktion på antipsykotisk medicin kaldet malignt neuroleptikasyndrom (MNS).
English: Polyvinyl alcohol, partly hydrolysed Talc
Danish: Polyvinylalkohol, delvist hydrolyseret Talcum
English: 30 tablets 60 tablets 100 tablets 175 tablets
Danish: 30 tabletter 60 tabletter 100 tabletter 175 tabletter
English: Baseline Week 8-24 10.7±2.2
Danish: Baseline Uge 8-24
English: Entacapone decreases the metabolic loss of levodopa to 3-O-methyldopa (3-OMD) by inhibiting the COMT enzyme.
Danish: Entacapon nedsætter det metaboliske tab af levodopa til 3-Ometyldopa (3-OMD) via en inhibering af COMT- enzymet.
English: • binge eating (eating large amounts of food in a short time period) or compulsive eating
Danish: • Spiseorgie (spiser store mængder mad på meget kort tid) eller tvangsspisning (spiser mere mad end normalt eller mere, end der skal til for at gøre dig mæt).
English: Therefore, caution should be exercised when driving or using machines.
Danish: Derfor bør forsigtighed udvises, når der føres motorkøretøj eller betjenes maskiner.
English: Regarding reproduction toxicity, decreased foetal weight and a slightly delayed bone development were noticed in rabbits at systemic exposure levels in the therapeutic range.
Danish: Med hensyn til studier af reproduktionstoksicitet sås lavere fostervægt og let forsinket knogleudvikling hos kaniner ved systemiske eksponeringsniveauer i det terapeutiske område.
English: • Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and whites of the eyes;
Danish: • tyktarmsbetændelse (colitis), leverbetændelse (hepatitis) med gulfarvning af huden og det hvide i øjnene
English: Your doctor may advise you to slowly discontinue the treatment with Entacapone Orion and other medicines to treat Parkinson's disease.
Danish: Din læge kan råde dig til langsomt at stoppe behandlingen med Entacapone Orion og andre lægemidler til behandling af Parkinsons sygdom.
English: Pharmacotherapeutic group: other dopaminergic agents, ATC code: N04BX02.
Danish: Farmakoterapeutisk klassifikation: Antiparkinsonmidler, andre dopaminerge stoffer, ATC-kode: N04BX02.
English: When considered necessary, withdrawal of entacapone and other dopaminergic treatment should proceed slowly, and if signs and/or symptoms occur despite a slow withdrawal of entacapone, an increase in levodopa dosage may be necessary.
Danish: Når det skønnes nødvendigt, skal behandlingsafbrydelse af entacapon og anden dopaminerg behandling ske langsomt, og hvis der opstår tegn og/eller symptomer på MNS eller rabdomyolyse på trods af en langsom nedtrapning af entacapon, kan en øgning i levodopadosis være nødvendigt.
English: In repeated dose toxicity studies, anaemia most likely due to iron chelating properties of entacapone was observed.
Danish: I studier af toksicitet efter gentagne doser er anæmi observeret, hvilket sandsynligvis skyldes entacapons jernchelaterende egenskaber.
English: • if you are allergic to entacapone or to peanut or soya or any of the other ingredients of this medicine (listed in section 6);
Danish: • hvis du er allergisk over for entacapon eller over for jordnødder eller soja eller et af de øvrige indholdsstoffer i Entacapone Orion (angivet i punkt 6);
English: Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 4 µM).
Danish: Data fra in vitro studier, hvor der er anvendt humant levermikrosomalt materiale, indikerer at entacapon hæmmer cytokrom P450 2C9 (IC50 ~ 4 M).
English: Elderly No dosage adjustment of entacapone is required for elderly.
Danish: Ældre Det er ikke nødvendigt at justere dosis hos ældre.
English: Uncommon (may affect up to 1 in 100 people): • Heart attack.
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100 personer) • hjerteanfald.
English: These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings.
Danish: Denne form for adfærd kaldes sygelige vane- og impulshandlinger og kan omfatte sygelig spilletrang, overdreven spisning eller brug af penge, unormal stor sexlyst eller hyppigere seksuelle tanker og følelser.
English: • if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury.
Danish: • hvis du tidligere har haft en sjælden muskelsygdom, der kaldes rabdomyolyse, som ikke var udløst af en skade.
English: As Entacapone Orion tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Danish: Da Entacapone Orion-tabletter skal tages sammen med andre levodopa-lægemidler, skal du også læse indlægssedlen for disse lægemidler omhyggeligt.
English: Ischaemic heart disease events other than myocardial infarction (e.g. angina pectoris)
Danish: Andre tilfælde af iskæmisk hjertesygdom end myokardieinfarkt (f.eks. angina pectoris)
English: Suddenly stopping Entacapone Orion and other medicines to treat Parkinson´s disease may result in unwanted side effects.
Danish: Pludseligt stop med brug af Entacapone Orion og anden medicin til behandling af Parkinsons sygdom kan give uønskede bivirkninger.
English: Talk to your doctor or pharmacist before taking Entacapone Orion:
Danish: Kontakt lægen eller apotekspersonalet før du tager Entacapone Orion:
English: In single-dose studies in healthy volunteers, no interactions were observed between entacapone and imipramine or between entacapone and moclobemide.
Danish: I enkeltdosis kliniske studier med raske frivillige fandtes ikke interaktion mellem entacapon og imipramin eller entacapon og meclobemid.
English: Entacapone Orion may make it harder for you to digest iron.
Danish: Entacapone Orion kan gøre det sværere at optage jern.
English: • discolouration of skin, hair, beard and nails.
Danish: • misfarvning af hud, hår, skæg og negle.
English: The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of treatment.
Danish: De hyppigste bivirkninger forårsaget af entacapon er relateret til øget dopaminerg aktivitet og optræder hyppigst i begyndelsen af behandlingen.
English: Hence, to reduce levodopa-related dopaminergic adverse reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment.
Danish: For at reducere de til levodopa-relaterede bivirkninger såsom dyskinesier, kvalme, opkastning og hallucinationer er det ofte nødvendigt at justere levodopadoseringen inden for de første dage til uger efter start af entacaponbehandling.