FrancophonIA/ELRC3.0 huggingface dataset:
English: These studies were well-designed to demonstrate the efficacy of the vaccine in the face of PMWS outbreaks: farms that were selected had a history of PMWS and the disease was confirmed to occur before starting of the respective studies, using internationally accepted standards.
Danish: Disse undersøgelser var udformet således, at vaccinens effekt kunne påvises i tilfælde af PMWSudbrud: De udvalgte besætninger havde tidligere været ramt af PMWS, og man kunne bekræfte forekomsten af sygdommen inden starten på de pågældende undersøgelser, med udgangspunkt i internationalt godkendte standarder.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn PCV exceed the risks for the approved indications and recommended that Suvaxyn PCV be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved for Suvaxyn PCV opvejer risiciene, når det anvendes ved den godkendte indikation, og anbefalede udstedelse af markedsføringstilladelse for Suvaxyn PCV.
English: Immediate mild hypersensitivity-like reactions may occur commonly after vaccination (affecting up to 1 in 10 animals) resulting in short-lived clinical signs such as vomiting.
Danish: Umiddelbare overfølsomhedslignende reaktioner kan sædvanligvis forekomme efter vacccinationen (kan forekomme hos 1 ud af 10 dyr) og forårsage akutte kliniske symptomer, såsom opkastning.
English: Suvaxyn PCV contains small amounts of a form of the pig virus that has been modified to produce a protein from the form of the virus that causes disease, but killed so that it does not cause the disease and cannot spread.
Danish: Suvaxyn PCV indeholder små mængder af en modificeret svinecircovirus, der producerer et protein fra det virus, som forårsager sygdom, men som er dræbt, så det ikke kan forårsage sygdommen og sprede den.
English: The withdrawal period for Suvaxyn PCV is zero days.
Danish: Tilbageholdelsestiden for Suvaxyn PCV er nul dage.
English: Suvaxyn PCV is a vaccine that contains a recombinant (modified) porcine circovirus which has been inactivated (killed).
Danish: Suvaxyn PCV er en vaccine, som indeholder et rekombinant Porcint (svine-) Circovirus, der er blevet inaktiveret (dræbt).
English: It has been demonstrated that the vaccine, when administered as recommended to piglets from 3 weeks of age induces active immunisation against Porcine Circovirus Type 2 (PCV2) and is able to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues caused by porcine circovirus infection, as well as to reduce clinical signs -including loss of daily weight gain- and death associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Danish: Det er påvist, at vaccinen, når den gives som anbefalet til smågrise fra 3-ugersalderen, resulterer i aktiv immunisering mod Porcint Circovirus type 2 (PCV2) og er i stand til at reducere virusmængden i blod og lymfevæv og læsioner i lymfevæv, forårsaget af porcin circovirusinfektion, samt reducere kliniske symptomer - herunder tab af daglig vægtforøgelse og dødelighed i forbindelse med PostWeaning Multisystemic Wasting Syndrom (PMWS).
English: Other information about Suvaxyn PCV:
Danish: Andre oplysninger om Suvaxyn PCV:
English: Suvaxyn PCV is a vaccine.
Danish: Suvaxyn PCV er en vaccine.
English: Suvaxyn PCV is used to vaccinate pigs over the age of 3 weeks to reduce viral load in blood and lymphoid tissues and protect the pigs against the lesions in lymphoid tissues caused by Porcine Circovirus Type 2 as well as the reduced weight gain and potentially even death that is associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Danish: Suvaxyn PCV anvendes til vaccination af svin over 3 uger for at reducere virusmængden i blod og lymfevæv og beskytte svinene mod læsioner i lymfevæv, forårsaget af Porcint Circovirus type 2, samt mod reduceret vægtøgning og risikoen for dødelighed i forbindelse med Post-Weaning Multisystemic Wasting Syndrom (PMWS).
English: What is the risk associated with Suvaxyn PCV?
Danish: Hvilken risiko er der forbundet med Suvaxyn PVC?
English: Suvaxyn PCV is a suspension for injection.
Danish: Suvaxyn PVC er en injektionsvæske, suspension.
English: When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign' and makes antibodies against them.
Danish: Når et svin vaccineres, opfatter immunsystemet de dræbte vira som "fremmede" og producerer antistoffer mod dem. Immunsystemet vil efterfølgende blive i stand til at skelne proteinet fra det sygdomsforårsagende virus og danne antistoffer hurtigere, hvis det udsættes for sådanne vira.
English: What is Suvaxyn PCV?
Danish: Hvad er Suvaxyn PCV?
English: Why has Suvaxyn PCV been approved?
Danish: Hvorfor blev Suvaxyn PVC godkendt?
English: How has Suvaxyn PCV been studied?
Danish: Hvordan blev Suvaxyn PCV undersøgt?
English: What is Suvaxyn PCV used for?
Danish: Hvad anvendes Suvaxyn PCV til?
English: What benefit has Suvaxyn PCV shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Suvaxyn PVC?
English: How does Suvaxyn PCV work?
Danish: Hvordan virker Suvaxyn PCV?
English: ‘Essential' means that the hypertension has no obvious cause
Danish: "Essentiel" betyder, at hypertensionen ikke har nogen umiddelbar årsag.
English: The full EPAR for MicardisPlus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for MicardisPlus findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for MicardisPlus.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for MicardisPlus.
English: MicardisPlus must not be used in women who are more than three months pregnant.
Danish: MicardisPlus må ikke anvendes til gravide, som er længere end tre måneder henne i graviditeten.
English: Its use during the first three months of pregnancy is not recommended.
Danish: og det frarådes at anvende lægemidlet i de første tre måneder af graviditeten.
English: The European Commission granted a marketing authorisation valid throughout the European Union for MicardisPlus on 19 April 2002
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for MicardisPlus den 19. april 2002.
English: MicardisPlus is taken by mouth once a day with liquid.
Danish: MicardisPlus indtages gennem munden en gang dagligt med væske.
English: A risk management plan has been developed to ensure that MicardisPlus is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at MicardisPlus anvendes så sikkert som muligt.
English: MicardisPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Danish: MicardisPlus blev undersøgt i fem hovedundersøgelser med i alt 2 985 patienter med mild til moderat hypertension.
English: The most common side effect with MicardisPlus (seen in between 1 and 10 patients in 100) is dizziness.
Danish: Den mest almindelige bivirkning ved MicardisPlus (som ses hos mellem 1 og 10 patienter ud af 100) er svimmelhed.
English: Other information about MicardisPlus
Danish: Andre oplysninger om MicardisPlus
English: For more information about treatment with MicardisPlus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med MicardisPlus, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 MicardisPlus.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan MicardisPlus skal anvendes.
English: What measures are being taken to ensure the safe and effective use of MicardisPlus?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af MicardisPlus?
English: MicardisPlus telmisartan / hydrochlorothiazide
Danish: Telmisartan/hydrochlorothiazid
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, MicardisPlus must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Danish: Hos patienter med type 2-diabetes eller moderat eller alvorlig nyresygdom må MicardisPlus desuden ikke anvendes i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension).
English: It works by increasing urine output, reducing the amount of fluid in the blood and reducing the blood pressure.
Danish: Det virker ved at øge urinproduktionen, hvorved væskemængden i blodet reduceres og blodtrykket nedsættes.
English: The Committee recommended that MicardisPlus be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for MicardisPlus.
English: It is available as oval tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Danish: Det fås som tabletter (40 mg eller 80 mg telmisartan og 12,5 mg hydrochlorothiazid; 80 mg telmisartan og 25 mg hydrochlorothiazid).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for MicardisPlus including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for MicardisPlus, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that MicardisPlus's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede, at fordelene ved MicardisPlus er større end risiciene ved behandling af essentiel hypertension hos patienter, hvis blodtryk ikke er tilstrækkeligt under kontrol med telmisartan alene.
English: In four of these studies, MicardisPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
Danish: I fire af disse undersøgelser (2 272 patienter) blev MicardisPlus sammenlignet med placebo (en uvirksom behandling) og med telmisartan taget alene.
English: For the full list of all side effects reported with MicardisPlus, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved MicardisPlus fremgår af indlægssedlen.
English: What is the risk associated with MicardisPlus?
Danish: Hvilken risiko er der forbundet med MicardisPlus?
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to MicardisPlus.
Danish: Tabletterne med 80/25 mg anvendes til patienter, hvis blodtryk ikke kan kontrolleres med 80/12,5 mg-tabletterne, eller som er blevet stabiliseret ved hjælp af de to aktive stoffer indtaget separat, inden de skiftede til MicardisPlus.
English: Care must be taken when using MicardisPlus with other medicines that have an effect on blood potassium levels.
Danish: Der skal udvises forsigtighed, når MicardisPlus anvendes sammen med andre lægemidler, som kan påvirke indholdet af kalium i blodet.
English: MicardisPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Danish: MicardisPlus må heller ikke anvendes hos personer, der har alvorlige lever-, nyre- eller galdesygdomme, eller som har for lavt indhold af kalium i blodet eller for højt indhold af kalcium i blodet.
English: Why has MicardisPlus been approved?
Danish: Hvorfor blev MicardisPlus godkendt?
English: MicardisPlus is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
Danish: MicardisPlus anvendes til patienter med essentiel hypertension (højt blodtryk), som ikke kan kontrolleres tilfredsstillende ved hjælp af telmisartan alene.
English: MicardisPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Danish: MicardisPlus er et lægemiddel, som indeholder de to aktive stoffer telmisartan og hydrochlorothiazid.
English: The fifth study compared the effects of remaining on the 80/12.5 mg tablet with switching to the 80/25 mg tablet in 713 patients who had not responded to the 80/12.5 mg tablet.
Danish: I den femte undersøgelse blev virkningen af at fortsætte med 80/12,5 mg-tabletten sammenlignet med at skifte til 80/25 mgtabletten hos 713 patienter, som ikke havde reageret på 80/12,5 mg-tabletten.
English: MicardisPlus contains two active substances, telmisartan and hydrochlorothiazide.
Danish: MicardisPlus indeholder to aktive stoffer, telmisartan og hydrochlorothiazid.
English: In patients who were not controlled on the 80/12.5 mg tablet, switching to the 80/25 mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.
Danish: Hos patienter, der ikke kunne kontrolleres med 80/12,5-tabletten, var det mere effektivt at skifte til 80/25 mg-tabletten, hvad angik nedsættelse af det diastoliske blodtryk, end at fortsætte med den lavere dosis.
English: MicardisPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
Danish: MicardisPlus var mere effektivt end placebo og telmisartan alene til at reducere det diastoliske blodtryk.
English: What is MicardisPlus?
Danish: Hvad er MicardisPlus?
English: The dose of MicardisPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Danish: Patienter, som fik 40 mg telmisartan, skal tage 40/12,5 mg-tabletterne, og patienter, der fik 80 mg telmisartan, skal tage 80/12,5 mg-tabletterne.
English: How has MicardisPlus been studied?
Danish: Hvordan blev MicardisPlus undersøgt?
English: What benefit has MicardisPlus shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved MicardisPlus?
English: What is MicardisPlus used for?
Danish: Hvad anvendes MicardisPlus til?
English: How is MicardisPlus used?
Danish: Hvordan anvendes MicardisPlus?
English: How does MicardisPlus work?
Danish: Hvordan virker MicardisPlus?
English: The absolute bioavailability is about 75%.
Danish: Den absolutte biotilgængelighed er ca. 75 %.
English: You may also feel your heart is beating irregularly and faster.
Danish: Du kan muligvis også mærke, at hjertet banker uregelmæssigt og hurtigere.
English: In life-threatening situations, administration of vasopressors must be considered.
Danish: I livstruende situationer skal administration af vasopressorer overvejes.
English: Monitoring of cardiac function and general supportive measures are recommended.
Danish: Monitorering af hjertefunktion og generelle understøttende foranstaltninger anbefales.
English: Maximum plasma concentrations (Cmax) are reached after about 30- 60 minutes.
Danish: Maksimal plasmakoncentration (Cmax) opnås efter ca. 30-60 minutter.
English: Preferably take one dose in the morning and one in the evening.
Danish: Det et bedst at tage en dosis om morgenen og en om aftenen.
English: • Headache - This especially occurs during the first few days of treatment.
Danish: • Hovedpine - dette forekommer især i de første par dage af behandlingen.
English: The other metabolites accounted for the remaining 20% of radioactive AUC.
Danish: De øvrige metabolitter var ansvarlige for de resterende 20 % af radioaktivt AUC.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktresuméet kan efterfølgende opdateres af de kompetente myndigheder i medlemsstaterne, i samarbejde med den relevante referencemedlemsstat, i overensstemmelse med bestemmelserne i kapitel 4, afsnit III i direktiv 2001/83 / EC.
English: Study follow up for endpoint analysis was between 12 and 36 months with a mean of 1.6 years.
Danish: Studieopfølgning til endepunktsanalyse var mellem 12 og 36 måneder med et gennemsnit på 1,6 år.
English: Elimination Decrease in plasma concentrations occurs in two phases:
Danish: Faldet i plasmakoncentrationen sker i to faser:
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Danish: Dette produktresumé, etikettering og indlægsseddel er resultatet af den referral procedure, som denne kommissionsbeslutning vedrører.
English: If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Danish: Hvis du har glemt at tage en dosis, skal du tage den, så snart du kommer i tanke om det, medmindre det snart er tid til den næste dosis.
English: There are no special dose requirements for elderly patients, but as with all medicines, use of the lowest effective dose is recommended.
Danish: Der er ingen særlige dosisanbefalinger til ældre patienter, men som for alle andre lægemidler anbefales det at anvende den laveste effektive dosis.
English: This may seriously affect your blood pressure.
Danish: Dette kan påvirke dit blodtryk alvorligt.
English: EXP: Use the strip within 30 days of opening.
Danish: EXP: Blisterpakningen skal anvendes inden for 30 dage efter åbning.
English: Not known (frequency cannot be estimated from the available data) • Double vision (diplopia).
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra forhåndenværende data) • Dobbeltsyn (diplopi).
English: The plasma concentration (and the area under the curve (AUC)) shows a linear proportionality to the dose.
Danish: Plasmakoncentrationen (og arealet under kurven (AUC)) udviser lineær proportionalitet med dosis.
English: This belongs to a group of medicines called ‘potassium channel activators'.
Danish: Det tilhører en gruppe lægemidler, der kaldes ”kaliumkanal-aktivatorer”.
English: Steady state is rapidly achieved (within 4 to 5 days) during repeated oral administration (bid regimen).
Danish: Steady state nås hurtigt (inden for 4-5 dage) ved gentagen oral administration (2 gange dagligt regime).
English: Distribution of the product throughout the body remains stable, irrespective of dose, within the therapeutic range.
Danish: Lægemidlets fordeling i kroppen forbliver stabil inden for det terapeutiske område uanset dosis.
English: These side effects can occur at the beginning of treatment or latter in the treatment course.
Danish: Disse bivirkninger kan opstå i begyndelsen af behandlingen eller senere i behandlingsforløbet.
English: Pharmacotherapeutic group: Other vasodilators used in cardiac diseases, ATC code: C01DX16
Danish: Farmakoterapeutisk klassifikation: Vasodilatorer anvendt ved hjertesygdomme, ATC-kode: C01DX16
English: There are no or limited amount of data from the use of nicorandil in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af nicorandil til gravide kvinder.
English: Although any accidental intake of this desiccant is usually harmless, it may alter the scheduled intake of the active tablets.
Danish: Selvom utilsigtet indtagelse af en tørrekapsel normalt er harmløs, kan det ændre den planmæssige indtagelse af de aktive tabletter.
English: • Medicines for depression.
Danish: • Medicin mod depression.
English: The patients should be advised not to take these tablets.
Danish: Patienterne skal informeres om ikke at indtage disse tabletter.
English: Therefore, patients should be advised not to drive or use machines if these symptoms occur.
Danish: Derfor skal patienten rådes til ikke at køre motorkøretøj eller betjene maskiner, hvis disse symptomer opstår.
English: The most common adverse reaction reported in clinical trials is headache occurring in more than 30% of patients, particularly in the first days of treatment and responsible of most of study withdrawal.
Danish: De hyppigste bivirkninger, som er rapporteret ved kliniske studier, er hovedpine, som forekom hos flere end 30 % af patienterne, især i de første dage af behandlingen, og som var skyld i størstedelen af studiefrafaldene.
English: Do not swallow the drying agent which is the bigger tablet on one end of each blister strip.
Danish: Du må ikke sluge tørremidlet, som er den store tablet i den ene ende af hvert blisterkort.
English: The tablets are to be swallowed in the morning and in the evening as a whole with some liquid.
Danish: Tabletterne skal synkes hele morgen og aften med lidt væske.
English: Swallow the tablet (oral use).
Danish: Synk tabletten (oral anvendelse).
English: Embryotoxicity and peri- and post-natal toxicity
Danish: Embryotoksicitet og peri- og postnatal toksicitet
English: Each tablet contains 20 mg nicorandil.
Danish: Hver tablet indeholder 20 mg nicorandil.
English: You can also report side effects directly via the national reporting system 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: Upon cessation of treatment, recovery from nicorandil-induced testicular toxicity was observed after 4 weeks; which indicates that the observed changes are reversible.
Danish: Efter behandlingsophør blev restitution efter nicorandil-induceret testikeltoksicitet observeret efter 4 uger, hvilket indikerer, at de observerede ændringer er reversible.
English: Paediatric population <Invented name> is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
Danish: Angicor anbefales ikke til pædiatriske patienter, da sikkerhed og virkning ikke er blevet undersøgt i denne patientgruppe.
English: Ultimately, this results in an improved oxygen balance in the myocardium and improved blood flow in the post-stenotic areas of the myocardium.
Danish: Slutteligt resulterer dette i forbedret oxygenbalance i myokardiet og forbedret blodgennemstrømning i poststenotiske områder i myokardiet.
English: Patients should be advised of the signs and symptoms and monitored closely for corneal ulcerations.
Danish: Patienter skal informeres om tegn og symptomer og overvåges nøje for ulcus corneae.
English: • If you have heart problems such as heart failure.
Danish: • Hvis du har problemer med hjertet som f.eks. hjertesvigt.
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis du oplever dette, må du ikke køre bil, anvende værktøj eller betjene maskiner.
English: • Aching muscles not caused by exercise (myalgia).
Danish: • Ømme muskler, som ikke skyldes fysisk aktivitet (myalgi).
English: There was no evidence of teratogenicity (rat and rabbit), or abnormal pre- or post-natal physical or behavioural development (rat).
Danish: Der var ikke tegn på teratogenicitet (rotte og kanin) eller abnorm præ- eller postnatal fysisk eller adfærdsmæssig udvikling (rotte).
English: • a rapid phase with a half-life of 1 hour approximately, representing 96% of the plasma exposure;
Danish: En hurtig eliminationsfase med en halveringstid på ca. 1 time, hvilket omfatter 96 % af plasmakoncentrationen.