FrancophonIA/ELRC3.0 huggingface dataset:
English: Melosus contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Melosus indeholder meloxicam, som tilhører en lægemiddelgruppe, der kaldes ikkesteroide antiinflammatoriske lægemidler (NSAID'er).
English: As prostaglandins trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of inflammation.
Danish: Prostaglandiner udløser betændelse, smerter og væskeudskillelse (ekssudation) fra blodkarrene ved betændelse og feber, og meloxicam mindsker disse tegn på betændelse.
English: How has Melosus been studied?
Danish: Hvordan blev Melosus undersøgt?
English: The dose depends on the animal, the bodyweight and condition and is given mixed with food or directly into the mouth for dogs and cats and directly into the mouth for guinea pigs.
Danish: Til hunde og katte gives det blandet med foder eller direkte i munden, og til marsvin gives det direkte i munden.
English: In cats, Melosus is used to reduce pain and inflammation after orthopaedic and minor soft tissue surgery.
Danish: Hos katte anvendes Melosus til at mindske smerter og betændelse efter ortopædkirurgi og mindre bløddelskirurgi.
English: Moreover, it is used to lessen pain and inflammation in chronic musculo-skeletal disorders.
Danish: Det anvendes desuden til at mindske smerter og betændelse ved kroniske lidelser i bevægeapparatet.
English: How is Melosus used?
Danish: Hvordan anvendes Melosus?
English: In guinea pigs Melosus is used to reduce pain after soft tissue surgery such as castration.
Danish: Hos marsvin anvendes Melosus til at reducere smerter efter bløddelskirurgi som f.eks. kastration.
English: How does Melosus work?
Danish: Hvordan virker Melosus?
English: In dogs, Melosus is used to lessen inflammation and pain in musculo-skeletal disorders.
Danish: Hos hunde anvendes Melosus desuden til at mindske betændelse og smerter ved lidelser i bevægeapparatet.
English: What is Plendil?
Danish: Hvad er Plendil?
English: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Danish: Plendil og relaterede navne markedsføres i følgende EU-medlemsstater: Østrig, Belgien, Bulgarien, Kroatien, Cypern, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Spanien, Sverige og Det Forenede Kongerige samt Island og Norge.
English: Why was Plendil reviewed?
Danish: Hvorfor blev Plendil vurderet igen?
English: The company that markets these medicines is AstraZeneca.
Danish: Den virksomhed, der markedsfører disse lægemidler, er AstraZeneca.
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 16 December 2014.
Danish: Europa-Kommissionen vedtog en afgørelse, der er retligt bindende i hele EU, den 16. december 2014.
English: On 23 October 2014, the European Medicines Agency completed a review of Plendil and associated names.
Danish: Den 23. oktober 2014 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Plendil og relaterede navne.
English: The medicine is available as prolonged release tablets (2.5, 5 and 10 mg) which release the active substance over an extended period of time.
Danish: Lægemidlet fås som depottabletter (2,5, 5 og 10 mg), som frigiver det aktive stof gradvis og langsomt.
English: In view of this, on 12 November 2013 the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Plendil in the EU.
Danish: På denne baggrund indbragte Europa-Kommissionen den 12. november 2013 sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Plendil i EU.
English: The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation) and 4.8 (side effects).
Danish: CHMP harmoniserede derudover andre punkter i produktresuméet, herunder punkt 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen), 4.6 (fertilitet, graviditet og amning) og 4.8 (bivirkninger).
English: Plendil is a medicine used to treat hypertension (high blood pressure).
Danish: Plendil er et lægemiddel til behandling af forhøjet blodtryk (hypertension).
English: After reviewing the available data supporting the medicine's use, the CHMP agreed that Plendil can be used to treat the following:
Danish: Efter gennemgang af de oplysninger, der dokumenterer lægemidlets anvendelse, fandt CHMP, at Plendil kan anvendes til behandling af følgende:
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses and recommendations for special populations.
Danish: Efter harmonisering af indikationerne harmoniserede CHMP også anbefalingerne om dosis og anbefalingerne for særlige patientgrupper.
English: Plendil and associated names have been authorised in EU Member States through national procedures since 1987.
Danish: Plendil og relaterede navne har været godkendt i EU's medlemsstater ved nationale procedurer siden
English: The CHMP agreed to include the following contraindications in the product information: hypersensitivity (allergy) to felodipine or to any other ingredients; pregnancy; decompensated heart failure (worsening of symptoms in patients with heart problems); acute myocardial infarction (heart attack); unstable angina pectoris (a type of chest pain that happens suddenly, even at rest or asleep, and which may lead to a heart attack), and certain types of heart valve and bloodflow obstructions.
Danish: CHMP vedtog at indsætte følgende kontraindikationer i produktinformationen: Allergi (hypersensitivitet) over for felodipin eller andre af indholdsstofferne, graviditet, forstærkede symptomer ved hjerteproblemer (dekompenseret hjertesvigt), akut hjerteanfald (myokardieinfarkt), pludseligt indtrædende brystsmerter, som optræder selv i hvile eller under søvn og kan medføre hjerteanfald (ustabil angina pectoris), og visse former for funktionsforstyrrelser af hjerteklapperne og hjertets blodforsyning.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Plendil and associated names in the European Union (EU).
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Plendil og relaterede navne i Den Europæiske Union.
English: • stable angina pectoris (a type of angina pectoris that occurs with activity or stress).
Danish: • angina pectoris ved aktivitet eller stress (stabil angina pectoris).
English: As Plendil has been authorised in the EU via national procedures, this has led to divergences across Member States in the way the medicine can be used, as seen in differences in the SmPCs (summary of product characteristics), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlet kan anvendes på, som det fremgår af forskellene mellem produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: The Committee also agreed that Plendil should no longer be recommended to treat ‘vasospastic angina pectoris' (another type of angina pectoris caused by spasms in the vessels supplying blood to the heart), because the available data to support this use were considered too limited.
Danish: Udvalget afgjorde desuden, at Plendil ikke længere burde anbefales til behandling af en anden type angina pectoris, der skyldes sammentrækninger i de blodkar, der forsyner hjertet (vasospastisk angina pectoris).
English: It is also used to treat angina pectoris (chest pain that occurs due to problems with the blood flow to the heart).
Danish: Det anvendes desuden til behandling af brystsmerter ved nedsat blodforsyning til hjertet (angina pectoris).
English: 16 December 2014
Danish: Den 16. december 2014 EMA/790566/2014
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets for Plendil should be harmonised across the EU.
Danish: CHMP fandt det nødvendigt at harmonisere produktresuméer, etikettering og indlægssedler i EU på baggrund af de forelagte oplysninger og den videnskabelige drøftelse i udvalget.
English: Oral use blister (PVC/PVDCalu/PET/paper)
Danish: Oral anvendelse Blisterpakning (PVC/PVDCalu/PET/papir)
English: 200 mg Film-coated tablet
Danish: 200 mg Filmovertrukket tablet
English: 1 vial
Danish: Pakningsstørrelse
English: Ref. EMEA/CHMP/494721/2008
Danish: EMEA/CHMP/494724/2008
English: Losartan is indicated for the treatment of hypertension.
Danish: Losartan er indiceret til behandling af hypertension (højt blodtryk).
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Cozaar and associated names International Non-Proprietary Name (INN): losartan
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN INDBRINGELSE I HENHOLD TIL ARTIKEL 30 Cozaar og tilknyttede navne Internationalt fællesnavn (INN): losartan
English: Cozaar and associated names, 12,5 mg, 25mg, 50 mg, 100 mg, film-coated tablets is an orally active angiotensin II (Ang- II) receptor antagonist, losartan, acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Danish: Cozaar og tilknyttede navne, 12,5 mg, 25 mg, 50 mg, 100 mg, filmovertrukne tabletter er en oralt aktiv angiotensin II (Ang-II) receptor-antagonist, losartan, der virker på AT1-receptor-undertypen og dermed blokerer virkningen af Ang-II i renin-angiotensin-systemets (RAS) kaskade.
English: Losartan may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes, and microalbuminuria (>30 mg/24 hours) or proteinuria (>900 mg/24 hours).
Danish: Losartan kan også forsinke progressionen af diabetisk nefropati og er også indiceret til reduktion af progressionen af nyresygdom hos patienter med type 2-diabetes og mikroalbuminuri (>30 mg/24 timer) eller proteinuri (> 900 mg/24 timer).
English: On 23 February 2007, Denmark presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised summaries of product characteristics, package leaflet and labelling of the medicinal product Cozaar and associated names for the following indications: Treatment of essential hypertension; Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria > 0.5 g/day as part of an antihypertensive treatment; Reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG; Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Danish: Den 23. februar 2007 indbragte Danmark en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, for at harmonisere de nationalt godkendte produktresumeer, indlægsseddel og etikettering for lægemidlet Cozaar og tilknyttede navne til følgende indikationer: behandling af essentiel hypertension, behandling af nyresygdom hos patienter med hypertension og type 2-diabetes mellitus med proteinuri > 0,5 g/dag som en del af en behandling mod hypertension, reduktion af risiko for slagtilfælde hos patienter med hypertension og hypertrofi af venstre ventrikel, som er dokumenteret ved EKG, behandling af kronisk hjerteinsufficiens (hos patienter ≥ 60 år), når behandling med ACE-hæmmere ikke betragtes som egnet på grund af uforligelighed, især hoste eller kontraindikation.
English: The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, labelling and package leaflet for Cozaar and associated names.
Danish: CHMP afgav en positiv udtalelse den 24. april 2008, hvori udvalget anbefalede harmonisering af produktresumeet, etiketteringen og indlægssedlen vedrørende Cozaar og tilknyttede navne.
English: It is taken by mouth once daily.
Danish: Det tages gennem munden en gang dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Incresync on 19 September 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Incresync den 19. september 2013.
English: The full EPAR for Incresync can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Incresync findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Incresync
Danish: Andre oplysninger om Incresync
English: This is a summary of the European public assessment report (EPAR) for Incresync.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Incresync.
English: Incresync alogliptin / pioglitazone
Danish: Incresync alogliptin / pioglitazon
English: A risk management plan has been developed to ensure that Incresync is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Incresync anvendes så risikofrit som muligt.
English: What is Incresync and what is it used for?
Danish: Hvad er Incresync, og hvad anvendes det til?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Incresync's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Incresync er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Incresync has been studied in two main studies involving 1,296 patients with type-2 diabetes that was not well controlled by previous treatment.
Danish: Incresync har været omfattet af to hovedundersøgelser hos 1 296 patienter med type 2-sukkersyge, der ikke var velreguleret ved den foregående behandling.
English: Pioglitazone is authorised in the EU as Actos and associated names.
Danish: Pioglitazon er godkendt i EU under navnet Actos og relaterede navne.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Danish: Det virker ved at blokere nedbrydningen af “inkretin”-hormoner i kroppen.
English: Regarding safety, Incresync's safety profile was consistent with that seen with the individual components.
Danish: Vedrørende sikkerheden svarede sikkerhedsprofilen af Incresync til den, der ses med de enkelte komponenter.
English: What measures are being taken to ensure the safe and effective use of Incresync?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Incresync?
English: Alogliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Danish: Alogliptin er en dipeptidyl-peptidase-4- (DPP 4)-hæmmer.
English: It is not intended to provide practical advice on how to use Incresync.
Danish: Det er ikke en praktisk vejledning i, hvordan Incresync bør anvendes.
English: The choice of tablet strength to start with depends on the patient's current treatment.
Danish: Den tabletstyrke, patienten skal begynde med, afhænger af den hidtidige behandling.
English: Both studies showed that the combination of active substances in Incresync could produce a small but clinically relevant improvement in HbA1c.
Danish: Begge undersøgelser viste, at kombinationen af aktive stoffer i Incresync kunne frembringe en lille, men klinisk relevant bedring i HbA1c.
English: Incresync is available as tablets (12.5 or 25 mg alogliptin and 30 mg pioglitazone; 12.5 or 25 mg alogliptin and 45 mg pioglitazone) and can only be obtained with a prescription.
Danish: Incresync leveres som tabletter (12,5 eller 25 mg alogliptin og 30 mg pioglitazon; 12,5 eller 25 mg alogliptin og 45 mg pioglitazon) og udleveres kun på recept.
English: The most common side effects with Incresync (which may affect up to 1 in 10 people) are upper respiratory tract infections (colds), sinusitis, headache, nausea (feeling sick), dyspepsia (heartburn), abdominal pain (tummy ache), pruritus (itching), myalgia (muscle pain), peripheral oedema (swelling in arms and legs) and weight gain.
Danish: De hyppigste bivirkninger ved Incresync (som kan forekomme hos op til 1 ud af 10 personer) er øvre luftvejsinfektioner (forkølelse), sinuitis (bihulebetændelse), hovedpine, kvalme, dyspepsi (halsbrand), mavesmerter, kløe, myalgi (muskelsmerter), perifert ødem (hævede arme og ben) og vægtøgning.
English: • together with metformin, in patients who are not satisfactorily controlled with a combination of pioglitazone and metformin.
Danish: • sammen med metformin, hos patienter, der ikke er tilfredsstillende reguleret med en kombination af pioglitazon og metformin.
English: Why is Incresync approved?
Danish: Hvorfor er Incresync blevet godkendt?
English: Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Pioglitazon gør cellerne (i fedtvæv, muskler og lever) mere følsomme for insulin, således at kroppen bedre kan udnytte den insulin, den danner.
English: The CHMP therefore considered that the combination of alogliptin and pioglitazone in Incresync is of benefit to patients.
Danish: CHMP fandt derfor, at kombinationen af alogliptin og pioglitazon i Incresync er til fordel for patienterne.
English: What are the risks associated with Incresync?
Danish: Hvilke risici er der forbundet med Incresync?
English: If patients are also taking metformin, lower doses of metformin or pioglitazone may need to be given to reduce the risk of hypoglycaemia (low blood sugar levels).
Danish: Får patienten også metformin, kan det være nødvendigt at anvende en lavere dosering af metformin eller pioglitazon for at nedsætte risikoen for hypoglykæmi (for lavt blodsukker).
English: • in patients who are not satisfactorily controlled with pioglitazone alone, and who cannot be treated with metformin (another diabetes medicine);
Danish: • hos patienter, der ikke er tilfredsstillende reguleret med pioglitazon alene, og som ikke kan behandles med metformin (et andet lægemiddel mod sukkersyge),
English: When added to pioglitazone, the improvement was a fall of 0.47% at a dose of alogliptin of 12.5 mg, and 0.61% for alogliptin 25 mg. Incresync was at least as effective as pioglitazone and metformin in reducing HbA1c.
Danish: Ved anvendelse som tillægsbehandling til pioglitazon var bedringen et fald på 0,47 % ved en dosis alogliptin på 12,5 mg, og 0,61 % for alogliptin 25 mg. Incresync var mindst ligeså effektivt som pioglitazon og metformin til at nedsætte HbA1c.
English: Incresync must not be used in patients who are hypersensitive (allergic) to the active substances or any of the ingredients or who have had serious allergic reactions to any dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Danish: Incresync må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for de aktive stoffer eller et eller flere af hjælpestofferne, eller som har fået alvorlige allergiske reaktioner over for en dipeptidyl-peptidase-4- (DPP 4-) hæmmer.
English: It must also not be used in patients who have or have ever had heart failure or bladder cancer, those with reduced liver function, diabetic ketoacidosis (a serious condition that can occur in diabetes), or blood in the urine that has not been properly investigated.
Danish: Den må heller ikke anvendes hos patienter, som har eller nogensinde har haft hjertesvigt eller blærekræft, patienter med nedsat leverfunktion, diabetisk ketoacidose (en alvorlig tilstand, der kan forekomme ved sukkersyge) eller blod i urinen af ikke udredt årsag.
English: HbA1c levels were measured after 26 weeks in the first study and 52 weeks in the second study.
Danish: HbA1c-niveauet er et mål for, hvor velreguleret blodsukkeret er. HbA1c-niveauet blev målt efter 26 uger i den første undersøgelse og efter 52 uger i den anden undersøgelse.
English: Alogliptin is licensed in the EU as Vipidia.
Danish: Alogliptin er godkendt i EU under navnet Vipidia.
English: It is used as an addition to diet and exercise in adults with type 2 diabetes to improve the control of blood glucose (sugar) levels:
Danish: Det anvendes som supplement til diæt og motion hos voksne med type 2-sukkersyge til at forbedre reguleringen af blodsukkeret:
English: In both studies, the main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Danish: I begge undersøgelserne blev virkningen hovedsagelig bedømt på ændringen i indholdet af glykosyleret hæmoglobin (HbA1c), dvs. den procentdel af blodets hæmoglobin, der er bundet til sukker (glukose).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Incresync, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Incresync er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: For more information about treatment with Incresync, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Incresync, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Incresync can also be used as a replacement tablet (supplying both alogliptin and pioglitazone) in patients who are already being treated with alogliptin and pioglitazone given separately.
Danish: Incresync kan desuden anvendes som erstatningstablet (indeholdende både alogliptin og pioglitazon) til patienter, der i forvejen er i behandling med alogliptin og pioglitazon hver for sig.
English: Incresync is a diabetes medicine containing the active substances alogliptin and pioglitazone.
Danish: Incresync er et lægemiddel mod sukkersyge, der indeholder de to aktive stoffer alogliptin og pioglitazon.
English: The active substances in Incresync, alogliptin and pioglitazone, work in different ways to help correct this.
Danish: De aktive stoffer i Incresync, alogliptin og pioglitazon, korrigerer dette på hver sin måde.
English: In the other study the effects of adding alogliptin to existing treatment with pioglitazone and metformin was compared with increasing the doses of pioglitazone.
Danish: I den anden undersøgelse blev virkningerne af at tilføje alogliptin til eksisterende behandling med with pioglitazon og metformin sammenlignet med stigende doser af pioglitazon.
English: One of the studies compared the effects of alogliptin with placebo (a dummy treatment) when used as an add-on to existing treatment with pioglitazone (the same combination as in Incresync), with or without metformin or another diabetes medicine.
Danish: I den ene undersøgelse blev virkningerne af alogliptin sammenlignet med placebo (virkningsløs behandling), når de blev anvendt som supplement til eksisterende behandling med pioglitazon (samme kombination som i Incresync) med eller uden metformin eller et andet lægemiddel mod sukkersyge.
English: How is Incresync used?
Danish: Hvordan anvendes Incresync?
English: Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Ved type -2-sukkersyge producerer bugspytkirtlen enten ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet tilstrækkeligt.