FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Danish: Equilis Te, injektionsvæske, suspension, til heste NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr)
English: Cardboard box with 10 pre-filled syringes with needles.
Danish: Kartonæske med 10 præfyldte sprøjter med kanyler.
English: Adjuvants:
Danish: Uforligeligheder:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Lot {number}
Danish: Batch:{nummer}
English: Only healthy animals should be vaccinated.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Kun raske dyr bør vaccineres.
English: ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach room temperature before use.
Danish: Lad vaccinen opnå en temperatur på 15-25°C før brug.
English: Traces of formaldehyde Purified Saponin
Danish: Spor af formaldehyd.
English: 62.5 µg For the full list of excipients, see section 6.1
Danish: 62,5 μg Alle hjælpestoffer er anført under pkt.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer
Danish: Wim de Körverstraat 35
English: 17 months after the primary vaccination course
Danish: 17 måneder efter grundvaccination 24 måneder efter den første revaccination
English: CLINICAL PARTICULARS 4.1 Target species
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Heste
English: Phosphate buffer Chloride buffer
Danish: Chloridbuffer.
English: 4.11 Withdrawal period
Danish: 4.11 Tilbageholdelsestid 0 døgn.
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Danish: 6.2 Væsentlige uforligeligheder Må ikke blandes med andre lægemidler til dyr 6.3 Opbevaringstid
English: PHARMACEUTICAL PARTICULARS
Danish: DYREARTER
English: Pack size blister (PVC/alu) 90 x 1 tablets (unit dose)
Danish: 90 x 1 tablet (enkeltdosis)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: (Særnavn) Navn Styrke
English: This summary was last updated in 03-2010.
Danish: Dette sammendrag blev sidst ajourført i 03-2010.
English: This document is a summary of the European Public Assessment Report (EPAR) for Avandamet.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Avandamet.
English: The European Commission granted a marketing authorisation valid throughout the EU for Avandamet to SmithKline Beecham Ltd. on 20 October 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Avandamet til SmithKline Beecham Ltd. den 20. oktober 2003.
English: After five years, the marketing authorisation was
Danish: Efter fem år blev markedsføringstilladelsen fornyet for yderligere fem år.
English: What is the risk associated with Avandamet?
Danish: Hvilken risiko er der forbundet med Avandamet?
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
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 Avandamet.
English: The full EPAR for Avandamet can be found here.
Danish: Den fuldstændige EPAR for Avandamet findes her.
English: Avandamet is used in patients who have type 2 diabetes, particularly those who are overweight.
Danish: Avandamet anvendes til patienter med type 2-diabetes, navnlig overvægtige patienter.
English: The studies of Avandia taken with metformin as separate tablets were used to support the use of Avandamet.
Danish: Undersøgelserne af Avandia indtaget sammen med metformin som særskilte tabletter blev anvendt til at understøtte brugen af Avandamet.
English: Avandamet contains two active substances, which have different modes of action:
Danish: Avandamet indeholder to aktive stoffer, som virker forskelligt:
English: The doses of Avandamet may need to be adjusted when given with certain other medicines such as gemfibrozil or rifampicin.
Danish: Det kan være nødvendigt at justere Avandamet-doserne, når Avandamet gives sammen med visse andre lægemidler såsom gemfibrozil eller rifampicin.
English: It must not be used in patients who have heart failure (an inability of the heart to pump enough blood around the body), an ‘acute coronary syndrome' such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, diseases that could affect the oxygen supply to the tissues (such as lung or heart problems, a recent heart attack or shock), problems with their liver or kidneys, acute alcohol intoxication (excessive alcohol consumption), alcoholism, or complications of diabetes (diabetic ketoacidosis or diabetic coma).
Danish: Det må ikke anvendes til patienter med hjerteinsufficiens (når hjertet ikke er i stand til at pumpe tilstrækkeligt blod rundt i kroppen), akut koronarsyndrom såsom ustabil angina (en svær form for brystsmerter, der varierer i intensitet) eller visse typer af hjerteanfald, sygdomme, som kan påvirke iltforsyningen til vævene (såsom lunge- eller hjerteproblemer, et nyligt hjerteanfald eller chok), lever- eller nyreproblemer, akut alkoholforgiftning (overdrevet alkoholforbrug), alkoholisme eller sukkersygekomplikationer (diabetisk ketoacidose eller diabetisk koma).
English: For more information about treatment with Avandamet, read the Package Leaflet (also part of the EPAR).
Danish: De nærmere oplysninger om behandling med Avandamet fremgår af indlægssedlen (også en del af denne EPAR).
English: Taking Avandamet with or just after food may reduce any stomach problems caused by metformin.
Danish: Hvis Avandamet tages sammen med mad eller lige efter et måltid, kan dette reducere eventuelle maveproblemer forårsaget af metformin.
English: • metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Danish: • Metformin virker hovedsagelig ved at hæmme produktionen af glukose og mindske optagelsen af glukose i tarmen.
English: Avandamet was more effective than metformin alone and than placebo in reducing HbA1c.
Danish: Avandamet var betydeligt bedre end metformin alene og placebo til at reducere HbA1c.
English: The most common side effect with Avandamet (seen in more than 1 patient in 10) is gastrointestinal symptoms (such as feeling sick, vomiting, diarrhoea, stomach ache and loss of appetite).
Danish: De hyppigste bivirkninger ved Avandamet (som ses hos flere end 1 ud af 10 patienter) er gastrointestinale symptomer (f.eks. kvalme, opkastning og diarré, mavesmerter og appetitløshed).
English: The rosiglitazone dose may need to be increased to 8 mg a day after eight weeks if better blood glucose control is needed, but this should be done with caution in patients who are also taking a sulphonylurea, due to the risk of fluid retention.
Danish: Det vil muligvis være nødvendigt at øge rosiglitazondosen til 8 mg dagligt efter otte uger, hvis der er behov for bedre blodsukkerregulering, men det bør anvendes med forsigtighed hos patienter, der tager et andet sulfonylurinstof på grund af risikoen for væskeansamling.
English: Avandamet should not be used in people who may be hypersensitive (allergic) to rosiglitazone, metformin or any of the other ingredients.
Danish: Avandamet bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for rosiglitazon, metformin eller nogle af de øvrige indholdsstoffer.
English: Rosiglitazone has been authorised in the European Union (EU) as Avandia since 2000, to be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Danish: Rosiglitazon har været godkendt i Den Europæiske Union (EU) siden 2000 under navnet Avandia til anvendelse sammen med metformin hos type 2-diabetespatienter, som ikke er tilfredsstillende reguleret med metformin alene.
English: Avandamet is a medicine that contains two active substances, rosiglitazone and metformin hydrochloride.
Danish: Avandamet er et lægemiddel, der indeholder de to aktive stoffer rosiglitazon og metforminhydrochlorid.
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I undersøgelserne måltes niveauet i blodet af et stof kaldet glykosyleret hæmoglobin (HbA1c), som viser, hvor godt blodglukosen er reguleret.
English: rosiglitazone and metformin hydrochloride
Danish: Avandamet rosiglitazon og metforminhydrochlorid
English: Another study was also carried out comparing the effects of adding either rosiglitazone or placebo (a dummy treatment) to metformin.
Danish: Der blev desuden gennemført en anden undersøgelse, der sammenlignede virkningen af at tilføje rosiglitazon eller placebo (en uvirksom behandling) til metformin.
English: It is available as tablets (yellow: 1 mg rosiglitazone and 500 mg metformin hydrochloride, and 2 mg rosiglitazone and 1,000 mg metformin hydrochloride; pale pink: 2 mg rosiglitazone and 500 mg metformin hydrochloride; pink: 4 mg rosiglitazone and 1,000 mg metformin
Danish: Det fås som tabletter (gule: 1 mg rosiglitazon og 500 mg metforminhydrochlorid og 2 mg rosiglitazon og 1 000 mg metforminhydrochlorid, svagt lyserøde: 2 mg rosiglitazon og 500 mg metforminhydrochlorid, lyserøde: 4 mg rosiglitazon og 1 000 mg metforminhydrochlorid).
English: The CHMP decided that Avandamet's benefits are greater than its risks and recommended that it be
Danish: CHMP besluttede, at fordelene ved Avandamet er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Avandamet.
English: The recommended starting dose of Avandamet is 4 mg rosiglitazone and 2,000 mg metformin hydrochloride a day.
Danish: Den anbefalede startdosis for Avandamet er 4 mg rosiglitazon og 2000 mg metforminhydrochlorid dagligt.
English: If the patient is already using triple therapy, then Avandamet is given to provide the same doses of rosiglitazone and metformin as before.
Danish: Hvis patienten allerede følger en tredobbelt behandling, gives Avandamet således, at patienten får samme doser af rosiglitazon og metformin som tidligere.
English: It is given in two divided doses, either as two 1-mg/500-mg tablets or one
Danish: Det gives som to særskilte doser, enten som to tabletter, 1 mg/500 mg, eller en tablet 2 mg/1000 mg).
English: For the full list of all side effects reported with Avandamet, see the Package Leaflet.
Danish: Den fuldstændige liste over alle bivirkninger ved Avandamet fremgår af indlægssedlen.
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to
Danish: Som resultat af virkningen af begge de aktive stoffer sænkes blodglukosen, og dette medvirker til at regulere type 2-diabetes.
English: What benefit has Avandamet shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Avandamet?
English: In triple therapy, when starting treatment in patients who are already taking metformin and a sulphonylurea, Avandamet is given so that the patient receives 4 mg of rosiglitazone a day, and the same dose of metformin as before.
Danish: Når der indledes en tredobbelt behandling hos patienter, som allerede er behandlet med metformin og et sulfonylurinstof, gives Avandamet således, at patienten får 4 mg rosiglitazon dagligt og den samme dosis metformin som tidligere.
English: Avandamet is used in patients who are not satisfactorily controlled on metformin (an antidiabetes medicine) used on its own and at the maximum possible dose (‘dual therapy').
Danish: Avandamet anvendes til patienter, som ikke er tilfredsstillende reguleret med metformin alene (et lægemiddel mod sukkersyge) ved den højest mulige dosis (”dobbelt behandling”).
English: Adding rosiglitazone to treatment with metformin and a sulphonylurea brought about a small but significant
Danish: Tilføjelse af rosiglitazon til behandlingen med metformin og et sulfonylurinstof giver en lille, men signifikant yderligere reduktion af HbA1c-niveauerne.
English: Avandamet can also be used with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled on metformin and a sulphonylurea at their maximum possible
Danish: Avandamet kan også anvendes sammen med et sulfonylurinstof (et andet lægemiddel mod sukkersyge) til patienter, som ikke er tilfredsstillende reguleret med metformin og et sulfonylurinstof ved de højest mulige doser (”tredobbelt behandling”).
English: In triple therapy, one study looked at the effect of adding rosiglitazone to a sulphonylurea (glibenclamide) and metformin in 1,202 patients whose blood glucose was not being controlled
Danish: Med hensyn til tredobbelt behandling blev der i undersøgelsen set nærmere på virkningen af at tilføje rosiglitazon til behandlingen af 1 202 patienter, som fik et sulfonylurinstof (glibenclamid) og metformin, men som ikke var tilstrækkeligt reguleret med denne behandling.
English: The dose of rosiglitazone may be added to metformin and adjusted before a patient is switched to Avandamet.
Danish: Den maksimalt anbefalede daglige dosis er 8 mg/2 000 mg. Rosiglitazondosen kan tilføjes metformin og kan justeres, inden patienten skifter til Avandamet.
English: Invented Name Strength Pharmaceutical Form Route of Administration
Danish: Lægemiddelforrm Indgivelsesvej
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duaklir Genuair on 19 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Duaklir Genuair den 19. november 2014.
English: The full EPAR and risk management plan summary for Duaklir Genuair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Duaklir Genuair 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 Duaklir Genuair.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Duaklir Genuair.
English: Other information about Duaklir Genuair
Danish: Andre oplysninger om Duaklir Genuair
English: A risk management plan has been developed to ensure that Duaklir Genuair is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Duaklir Genuair anvendes så sikkert som muligt.
English: The recommended dose of Duaklir Genuair is one inhalation twice a day.
Danish: Den anbefalede dosis af Duaklir Genuair er én inhalation to gange dagligt.
English: Regarding safety, the number of side effects reported with Duaklir Genuair was low and did not raise any major safety concern.
Danish: Hvad sikkerheden angår, var det indberettede antal bivirkninger med Duaklir Genuair lavt og gav ikke anledning til større sikkerhedsmæssige betænkeligheder.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duaklir Genuair'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 Duaklir Genuair opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Duaklir Genuair is used for maintenance (regular) treatment.
Danish: Duaklir Genuair anvendes til regelmæssig behandling (vedligeholdelsesbehandling).
English: What is Duaklir Genuair and what is it used for?
Danish: Hvad er Duaklir Genuair, og hvad anvendes det til?
English: The most common side effects (seen in around 7 patients in 100) are nasopharyngitis (inflammation of the nose and throat) and headache.
Danish: De hyppigste bivirkninger (som optræder hos ca. 7 ud af 100 patienter) er næse-svælgbetændelse (nasofaryngitis) og hovedpine.
English: Why is Duaklir Genuair approved?
Danish: Hvorfor blev Duaklir Genuair godkendt?
English: What measures are being taken to ensure the safe and effective use of Duaklir Genuair?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Duaklir Genuair?
English: In addition, as long-acting muscarinic antagonists may have an effect on the heart and blood vessels, the company that markets Duaklir Genuair will provide the results of studies to further evaluate the cardiovascular safety of the medicine.
Danish: Da langtidsvirkende muskarinreceptorhæmmere kan påvirke hjerte og blodkar, skal den virksomhed, der markedsfører Duaklir Genuair, desuden fremlægge resultater af undersøgelser til yderligere vurdering af lægemidlets hjerte-karsikkerhed.
English: Side effects with Duaklir Genuair are similar to those with the individual components.
Danish: Bivirkningerne ved Duaklir Genuair svarer til dem, der optræder ved de enkelte bestanddele.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duaklir Genuair, 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 Duaklir Genuair, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Duaklir Genuair aclidinium bromide / formoterol fumarate dihydrate
Danish: Duaklir Genuair aclidiniumbromid/formoterolfumaratdihydrat
English: However the improvement over formoterol alone was small and not considered clinically significant: FEV1 measured in the morning before the inhalation was 68 ml more with Duaklir Genuair than with formoterol alone.
Danish: Forbedringen i forhold til formoterol alene var dog lille og blev ikke anset for at have klinisk betydning: FEV1, målt op om morgenen før inhalation, var 68 ml større med Duaklir Genuair end med formoterol alene.
English: Duaklir Genuair is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Duaklir Genuair er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: For more information about treatment with Duaklir Genuair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Duaklir Genuair, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Duaklir Genuair?
Danish: Hvilke risici er der forbundet med Duaklir Genuair?
English: It is not intended to provide practical advice on how to use Duaklir Genuair.
Danish: Det er ikke en praktisk vejledning i, hvordan Duaklir Genuair bør anvendes.
English: Duaklir Genuair is available as an inhalation powder in a portable inhaler device.
Danish: Duaklir Genuair fås som et inhalationspulver i en bærbar inhalator.
English: Results showed that, after six months of treatment, the increase in FEV1 (measured one hour after an inhalation) was 293 milliliters (ml) more with Duaklir Genuair than with placebo and 118 ml more with Duaklir Genuair than with aclidinium alone.
Danish: Undersøgelserne viste, at stigningen i FEV1 (målt en time efter inhalation) efter 6 måneders behandling var 293 ml større med Duaklir Genuair end med placebo, og 118 ml større med Duaklir Genuair end med aclidinium alene.
English: Duaklir Genuair contains two active substances: aclidinium bromide and formoterol fumarate dihydrate.
Danish: Duaklir Genuair indeholder to aktive stoffer: aclidiniumbromid og formoterolfumaratdihydrat.
English: Duaklir Genuair has been studied in 2 main studies involving over 3,400 patients with COPD, in which it was compared with aclidinium alone, formoterol alone and placebo (a dummy treatment).
Danish: Duaklir Genuair har været genstand for to hovedundersøgelser med over 3 400 patienter med KOL, hvor det blev sammenlignet med aclidinium alene, formoterol alene og virkningsløs behandling (placebo).
English: Duaklir Genuair was also shown to increase the percentage of patients who had an improvement in breathlessness compared with placebo.
Danish: Duaklir Genuair øgede desuden den andel af patienterne, der fik bedring i stakåndethed i forhold til placebo.
English: For practical information about using Duaklir Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Duaklir Genuair, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The CHMP noted that Duaklir Genuair was shown to significantly improve lung function in patients with COPD compared with placebo, although the improvement observed when Duaklir Genuair was compared with one of the components on its own, formoterol, was small.
Danish: CHMP bemærkede, at Duaklir Genuair var påvist at forbedre lungefunktionen væsentligt hos patienter med KOL i forhold til placebo, men at forbedringen med Duaklir Genuair var lille i forhold til særskilt brug af den ene af komponenterne, nemlig formoterol.
English: The two active substances in Duaklir Genuair, aclinidium bromide and formoterol fumarate dihydrate, work by keeping the airways open and allowing the patient to breathe more easily.
Danish: De to aktive stoffer i Duaklir Genuair, aclidiniumbromid og formoterolfumaratdihydrat, virker ved at holde luftvejene frie, så vejrtrækningen lettes.
English: For the full list of all side effects and restrictions with Duaklir Genuair, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Duaklir Genuair fremgår af indlægssedlen.
English: How is Duaklir Genuair used?
Danish: Hvordan anvendes Duaklir Genuair?
English: What benefits of Duaklir Genuair have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Duaklir Genuair?
English: Duaklir Genuair can only be obtained with a prescription.
Danish: Lægemidlet udleveres kun efter recept.
English: How does Duaklir Genuair work?
Danish: Hvordan virker Duaklir Genuair?
English: These products were approved in the European Union on 04 August 2000.
Danish: Lægemidlerne blev godkendt i EU den 4. august 2000.
English: The PRAC reviewed the preliminary 3-year data.
Danish: PRAC gennemgik de første 3 års data.
English: Nine of these changes had a potential impact on inhibitor formation.
Danish: Ni af disse ændringer havde potentiel betydning for inhibitordannelse.
English: Updated results from the EUHASS registry were also provided.
Danish: Der blev ligeledes forelagt opdaterede resultater fra EUHASS-registeret.
English: The Federal Institute for Vaccines and Biomedicines (Germany) informed the Commission on the findings on the 1st of March 2013.
Danish: Det tyske forbundsinstitut for vacciner og biomedicin (Paul-Ehrlich-Institut) underrettede Kommissionen om resultaterne den 1. marts 2013.
English: - the EUHASS (European Haemophilia Safety Surveillance System) registry.
Danish: - EUHASS-registeret (European Haemophilia Safety Surveillance System).