FrancophonIA/ELRC3.0 huggingface dataset:
English: - furosemide, a medicine belonging to the type known as diuretics, or “water” tablets, which is used to increase the amount of urine you produce.
Danish: Kaldes også vanddrivende tabletter, og bruges til at øge mængden af den urin, du producerer.
English: Do not breast-feed if you are taking Tekturna.
Danish: Du må ikke amme, hvis du tager T
English: Potassium and potassium-sparing diuretics
Danish: Kalium og kaliumbesparende diuretika
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 300 mg aliskiren (som hemifumarat).
English: NAME OF THE MEDICINAL PRODUCT Tekturna 150 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Tekturna 150 mg filmovertrukne tabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 150 mg aliskiren (som hemifumarat).
English: Tekturna 150 mg film-coated tablets Aliskiren
Danish: Tekturna 150 mg filmovertrukne tabletter Aliskiren
English: Tekturna in combination with the angiotensin receptor antagonist valsartan showed an additive antihypertensive effect in the study specifically designed to investigate the effect of the combination therapy.
Danish: Tekturna i kombination med angiotensinreceptor-antagonisten valsartan viste en additiv blodtrykssænkende effekt i et studie specifikt designet til at undersøge effekten af iabetes gav Tekturna en additiv blodtryksreduktion, når det blev kombineret med ramipril, mens n ling med andre antihypertensiva.
English: NAME OF THE MEDICINAL PRODUCT Tekturna 300 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Tekturna 300 mg filmovertrukne tabletter
English: Film-coated tablet Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side.
Danish: Filmovertrukken tablet Lys pink, udadbuet, rund tablet, præget med ”IL” på den ene side og ”NVR” på den anden side.
English: Film-coated tablet Light-red, biconvex, ovaloid tablet, imprinted “IU” on one side and “NVR” on the other side.
Danish: Filmovertrukken tablet Lyserød, udadbuet, oval tablet, præget med ”IU” på den ene side og ”NVR” på den anden side.
English: Tekturna 300 mg film-coated tablets Aliskiren
Danish: Tekturna 300 mg filmovertrukne tabletter Aliskiren
English: Caution should be exercised in hypertensive patients with severe renal impairment due to the lack of safety information for Tekturna.
Danish: På grund af de manglende sikkerhedsoplysninger for Tekturna skal der udvises forsigtighed overfor patienter med svært nedsat nyrefunktion.
English: 6.6 Special precautions for disposal
Danish: 6.6 Regler for destruktion Ik
English: NAME OF THE MEDICINAL PRODUCT Tekturna 300 mg film-coated tablets Aliskiren
Danish: LÆGEMIDLETS NAVN Tekturna 300 mg filmovertrukne tabletter Aliskiren
English: NAME OF THE MEDICINAL PRODUCT Tekturna 150 mg film-coated tablets Aliskiren
Danish: LÆGEMIDLETS NAVN Tekturna 150 mg filmovertrukne tabletter Aliskiren
English: Tel.: +48 22 550 8888
Danish: Novartis Poland Sp. z o Tel.: +48 22 550 8888
English: What Tekturna looks like and contents of the pack Tekturna 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Danish: Tekturna 150 mg filmovertrukne tabletter er lyse pink, udadbuede, runde tabletter, præget med ”IL” på en ene side og ”NVR” på den anden side.
English: No adjustment of the initial dose is required for patients with mild to severe hepatic impairment (see section 5.2).
Danish: Der kræves ingen justering af initialdosen for patienter med mildt til stærkt nedsat leverfunktion (se pkt.
English: What Tekturna looks like and contents of the pack Tekturna 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Danish: Tekturna 300 mg filmovertrukne tabletter er lyserøde, udadbuede, ovale tabletter, præget med ”IU” på en ene side og ”NVR” på den anden side.
English: As for other agents acting on the renin-angiotensin system, caution should be exercised when aliskiren is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (eg.
Danish: Som for andre stoffer, der virker på renin-angiotensin-systemet, skal der udvises forsigtighed, når aliskiren gives til patienter, der er prædisponerede for renal dysfunktion som hypovolæmi (f.eks. pga. blodtab, alvorlig og vedvarende diarré, vedvarende opkastning), hjertelidelse, leverlidelse eller nyrelidelse.
English: Lactation
Danish: Indtagelse
English: - if you experience angioedema (difficulties in breathing, or swallowing, or swelling of the face,
Danish: hvis du tager verapamil (medicin, som bruges til at sænke blodtrykket, til at korrigere hjerterytmen eller til at be
English: Novartis Sverige AB Tel: +46 8 732 32 00
Danish: el: +46 8 732 32 00
English: Novartis Poland Sp. z o.o.
Danish: Novartis Sverige AB T
English: Suomi/Finland Novartis Finland Oy Puh/Tel: +358 9 61 33 22 11
Danish: uh/Tel: +358 9 61 33 22 11
English: Novartis Farma S.p.A. Tel: +39 02 96 54 1
Danish: Tel: +39 02 96 54 1
English: It is a ‘generic medicine'.
Danish: Det er et "generisk lægemiddel".
English: One tablet is taken daily by mouth with water.
Danish: Patienten skal tage én tablet om dagen gennem munden med et glas vand.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Danish: Den fuldstændige EPAR for referencelægemidlet findes også på EMA's websted.
English: Both are antihypertensive medicines that have been available separately in the European Union (EU) since the mid1990s.
Danish: Begge er midler mod forhøjet blodtryk, og begge har hver for sig været på markedet i EU siden midten af 1990'erne.
English: Amlodipine is a calcium channel blocker.
Danish: Amlodipin er en kalciumkanalblokker.
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Danish: Ved at sænke blodtrykket reduceres risiciene i forbindelse med højt blodtryk, som f.eks. slagtilfælde.
English: The full EPAR for Amlodipine/Valsartan Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Amlodipin/Valsartan Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is recommended that the patient takes amlodipine and valsartan as separate tablets or capsules before switching to the combination tablet.
Danish: Det anbefales, at patienten tager amlodipin og valsartan som separate tabletter eller kapsler før denne skifter til kombinationstabletten.
English: Therefore, the CHMP's view was that, as for Exforge, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Exforge.
English: It blocks special channels on the surface of cells through which calcium normally enters the cells.
Danish: Midlet blokerer de særlige kanaler på cellernes overflade (kalciumkanalerne), hvorigennem kalcium normalt trænger ind i cellerne.
English: Amlodipine/Valsartan Mylan is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).
Danish: Amlodipin/Valsartan Mylan fås som tabletter (5 mg amlodipin og 80 mg valsartan, 5 mg amlodipin og 160 mg valsartan, 10 mg amlodipin og 160 mg valsartan).
English: Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Valsartan er en såkaldt "angiotensin II-receptorantagonist", hvilket betyder, at midlet blokerer virkningen af et hormon i kroppen, som kaldes angiotensin II.
English: They work in similar ways to reduce blood pressure by allowing the blood vessels to relax.
Danish: De virker på samme måde og sænker blodtrykket ved at få blodkarrene til at slappe af.
English: This means that Amlodipine/Valsartan Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exforge.
Danish: Det betyder, at Amlodipin/Valsartan Mylan svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Exforge.
English: The strength of the tablet to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Danish: Den tabletstyrke, der skal anvendes, afhænger af, hvilken dosis amlodipin eller valsartan patienten fik tidligere.
English: This is a summary of the European public assessment report (EPAR) for Amlodipine/Valsartan Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Amlodipin/Valsartan Mylan.
English: The Committee recommended that Amlodipine/Valsartan Mylan be approved for use in the EU.
Danish: Udvalget anbefalede, at Amlodipin/Valsartan Mylan godkendes til anvendelse i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Amlodipine/Valsartan Mylan has been shown to have comparable quality and to be bioequivalent/be comparable to Exforge.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Amlodipin/Valsartan Mylan er af sammenlignelig kvalitet og er bioækvivalent med Exforge.
English: When calcium enters the cells in the muscles of blood vessel walls, this causes contraction.
Danish: Når kalcium trænger ind i muskelcellerne i blodkarvæggene, forårsager det en sammentrækning.
English: By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Danish: Ved at reducere mængden af kalcium til cellerne forhindrer amlodipin cellerne i at trække sig sammen, hvilket får blodkarrene til at slappe af.
English: A risk management plan has been developed to ensure that Amlodipine/Valsartan Mylan is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Amlodipin/Valsartan Mylan anvendes så sikkert som muligt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Amlodipine/Valsartan Mylan, 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 Amlodipin/Valsartan Mylan, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Amlodipine/Valsartan Mylan is a medicine used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Danish: Amlodipin/Valsartan Mylan anvendes til patienter med essentiel hypertension (forhøjet blodtryk), når blodtrykket ikke kan kontrolleres tilstrækkeligt med amlodipin eller valsartan alene.
English: Amlodipine/Valsartan Mylan amlodipine / valsartan
Danish: Amlodipin/Valsartan Mylan amlodipin/valsartan
English: For more information about treatment with Amlodipine/Valsartan Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Amlodipin/Valsartan Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Amlodipine/Valsartan Mylan contains two active substances, amlodipine and valsartan.
Danish: Amlodipin/Valsartan Mylan indeholder to aktive stoffer, amlodipin og valsartan.
English: Because Amlodipine/Valsartan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Amlodipin/Valsartan Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Amlodipine/Valsartan Mylan
Danish: Andre oplysninger om Amlodipin/Valsartan Mylan
English: What measures are being taken to ensure the safe and effective use of Amlodipine/Valsartan Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Amlodipin/Valsartan Mylan?
English: Because Amlodipine/Valsartan Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exforge.
Danish: Da Amlodipin/Valsartan Mylan er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Exforge.
English: It is not intended to provide practical advice on how to use Amlodipine/Valsartan Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Amlodipin/Valsartan Mylan bør anvendes.
English: For practical information about using Amlodipine/Valsartan Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Amlodipin/Valsartan Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What is Amlodipine/Valsartan Mylan and what is it used for?
Danish: Hvad er Amlodipin/Valsartan Mylan, og hvad anvendes det til?
English: What are the benefits and risks of Amlodipine/Valsartan Mylan?
Danish: Hvilken fordel og risiko er der forbundet med Amlodipin/Valsartan Mylan?
English: Why is Amlodipine/Valsartan Mylan approved?
Danish: Hvorfor blev Amlodipin/Valsartan Mylan godkendt?
English: How has Amlodipine/Valsartan Mylan been studied?
Danish: Hvordan blev Amlodipin/Valsartan Mylan undersøgt?
English: How is Amlodipine/Valsartan Mylan used?
Danish: Hvordan anvendes Amlodipin/Valsartan Mylan?
English: How does Amlodipine/Valsartan Mylan work?
Danish: Hvordan virker Amlodipin/Valsartan Mylan?
English: This overview was last updated in February 2019.
Danish: Denne oversigt blev sidst ajourført i februar 2019.
English: Horses were examined at days 14, 35 and 63.
Danish: Hestene blev undersøgt på dag 14, 35 og 63.
English: Hands should be washed after handling the medicine.
Danish: Der bør vaskes hænder efter håndtering af lægemidlet.
English: Other information about HorStem
Danish: Andre oplysninger om HorStem
English: Stem cells can develop into other types of cells.
Danish: Stamceller kan udvikle sig til andre celletyper.
English: Further information on HorStem can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/horstem.
Danish: Yderligere information om HorStem findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/horstem.
English: Substantial improvement occurs in the next 48 hours with complete resolution in the following two weeks.
Danish: Der sker en væsentlig bedring i de efterfølgende 48 timer, og bivirkningerne svinder fuldstændig i de efterfølgende to uger.
English: HorStem received a marketing authorisation valid throughout the EU on 19 June 2019.
Danish: HorStem fik en markedsføringstilladelse med gyldighed i hele EU den 19/06/2019.
English: The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter administration af et lægemiddel, før et dyr kan slagtes og kødet kan anvendes til menneskeligt konsum.
English: In case of severe inflammation, treatment with an anti-inflammatory medicine (NSAID) might be necessary.
Danish: Ved svær inflammation kan behandling med et antiinflammatorisk lægemiddel (NSAID) være nødvendig.
English: The withdrawal period for meat from horses treated with HorStem is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra heste, der behandles med HorStems, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: These properties are expected to play a role in the effect of HorStem.
Danish: Disse egenskaber forventes at spille en rolle i forbindelse med virkningen af HorStem.
English: The European Medicines Agency decided that HorStem's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved HorStem opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Care should be taken to avoid accidental self-injection.
Danish: Der bør udvises forsigtighed for at undgå utilsigtet selvinjektion.
English: Mesenchymal stem cells can have effects on the immune system as well as anti-inflammatory effects and can possess tissue regenerative properties.
Danish: Mesenkymale stamceller kan indvirke på immunsystemet og have antiinflammatorisk effekt samt vævsregenerative egenskaber.
English: An overview of HorStem and why it is authorised in the EU
Danish: En oversigt over HorStem, og hvorfor det er godkendt i EU
English: HorStem is given only by a veterinarian as a single injection into the affected joint.
Danish: HorStem gives kun af dyrlægen som en enkelt injektion i det berørte led.
English: It is not clear exactly how HorStem works in horses with osteoarthritis.
Danish: Det er uklart, præcis hvordan HorStem virker hos heste med slidgigt.
English: These are stem cells taken from the umbilical cord of donor horses when a foal is born and grown in a laboratory to increase their numbers.
Danish: Dette er stamceller, der tages fra navlestrengen hos donorheste, når et føl fødes, og som dyrkes i et laboratorie for at øges i antal.
English: Why is HorStem authorised in the EU?
Danish: Hvorfor blev HorStem godkendt i EU?
English: What is HorStem and what is it used for?
Danish: Hvad er HorStem, og hvad anvendes det til?
English: Twelve HorStem treated horses were successfully treated (success rate 75%) at day 63 compared to only 4 of the control group (success rate 25%).
Danish: Hos tolv heste var behandlingen med HorStem vellykket (75 %) på dag 63 til sammenligning med kun 4 i kontrolgruppen (25 %).
English: What are the risks associated with HorStem?
Danish: Hvilke risici er der forbundet med HorStem?
English: For more information about using HorStem, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af HorStem, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: In a field study of horses with mild to moderate osteoarthritis, 16 horses received an injection of HorStem into the affected joint and 17 horses received a placebo (dummy) injection.
Danish: I et feltstudie af heste med let til moderat slidgigt fik 16 heste en injektion af HorStem i det berørte led, og 17 heste fik en placeboinjektion (uvirksom injektion).
English: Treatment success was a reduction in lameness to a grade of 1 or less, using an accepted scale for equine lameness measurement (scale from 0 to 5, where 0 is nonlame, and 5 is severely lame).
Danish: Til måling heraf blev anvendt en godkendt skala for halthed hos heste (skala fra 0 til 5, hvor 0 er ingen halthed, og 5 er svær halthed).
English: HorStem is a veterinary medicine used to treat lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
Danish: HorStem er et lægemiddel til dyr til behandling af halthed i forbindelse med let til moderat degenerativ ledsygdom (slidgigt) hos heste.
English: It contains the active substance equine umbilical cord mesenchymal stem cells.
Danish: Det indeholder det aktive stof mesenkymale navlestrengsstamceller fra heste.
English: The most common side effect with HorStem (which may affect more than 1 in 10 horses) is short-lived synovitis (inflammation of the joint lining) with severe lameness, joint effusion (increased fluid in the joint) and pain on palpation 24 hours after injection.
Danish: Den hyppigste bivirkning ved HorStem (som kan optræde hos mere end 1 ud af 10 heste) er kortvarig synovitis (betændelse i ledhinden) med svær halten, effusion i leddet (øget væskeansamling i leddet)
English: What benefits of HorStem have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved HorStem?
English: How is HorStem used?
Danish: Hvordan anvendes HorStem?
English: HorStem (equine umbilical cord mesenchymal stem cells) EMA/162149/2019
Danish: HorStem (mesenkymale navlestrengsstamceller fra heste) EMA/336342/2019
English: How does HorStem work?
Danish: Hvordan virker HorStem?
English: HorStem (equine umbilical cord mesenchymal stem cells)
Danish: HorStem (mesenkymale navlestrengsstamceller fra heste)
English: This summary was last updated in 05-2016.
Danish: Dette sammendrag blev sidst ajourført i 05-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hexacima on 17 April 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Hexacima den 17. april 2013.
English: Although no data are available in children older than 2 years, there is no indication that older children would respond differently.
Danish: Der er ingen data tilgængelige for børn over to år, men intet tyder på, at ældre børn ville respondere anderledes.
English: The full EPAR for Hexacima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Hexacima findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Hexacima is a vaccine.
Danish: Hexacima er en vaccine.
English: The vaccine is ‘adsorbed'.
Danish: Vaccinen er "adsorberet".
English: This is a summary of the European public assessment report (EPAR) for Hexacima.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Hexacima.
English: These materials have been inactivated where necessary so that they do not cause any disease.
Danish: Disse materialer er blevet inaktiveret, hvor dette var nødvendigt, så de ikke er sygdomsfremkaldende.
English: Vaccination with Hexacima should be carried out according to official recommendations.
Danish: Vaccination med Hexacima bør foretages i henhold til officielle anbefalinger.
English: Other information about Hexacima
Danish: Andre oplysninger om Hexacima
English: This helps to protect against the diseases that these bacteria and viruses cause.
Danish: Dette medvirker til at beskytte mod de sygdomme, som disse bakterier og vira forårsager.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod sygdomme.
English: The two-dose vaccination schedule was investigated in an additional main study involving 554 children.
Danish: Vaccinationsplanen med to doser blev undersøgt i en yderligere hovedundersøgelse med 554 børn.
English: Reactions may be more likely after the first dose than later doses.
Danish: Reaktionerne forekommer oftere ved den første dosis end ved de efterfølgende doser.
English: What measures are being taken to ensure the safe and effective use of Hexacima?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Hexacima?
English: It is used in babies and toddlers aged from six weeks to protect against the following infectious diseases:
Danish: Det anvendes til spædbørn og småbørn fra seks uger og opad til beskyttelse mod følgende smitsomme sygdomme:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hexacima'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 Hexacima opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.