FrancophonIA/ELRC3.0 huggingface dataset:
English: What is the risk associated with Angiox?
Danish: Hvilken risiko er der forbundet med Angiox?
English: Major bleeding was less common with Angiox alone than with heparin plus GPI.
Danish: Større blødninger var mindre hyppige med Angiox alene end med heparin sammen med GPI.
English: The company that makes Angiox will provide all doctors who are expected to prescribe the medicine with training and educational materials on how to use it correctly, including dosing instructions.
Danish: Virksomheden, der fremstiller Angiox, skal levere oplysnings- og uddannelsesmateriale om korrekt anvendelse af lægemidlet, herunder doseringsinstruktioner, til samtlige læger, der forventes at ordinere lægemidlet.
English: Angiox is also used to treat adults with unstable angina (a type of chest pain that varies in severity) or myocardial infarction without ST segment elevation, who are waiting for further treatment such as PCI, a heart bypass or using other medicines.
Danish: Angiox anvendes også til behandling af voksne med ustabil angina (en type brystsmerte af varierende sværhedsgrad) eller myokardieinfarkt uden forhøjelse af ST-segmentet, som venter på yderligere behandling, f.eks. PCI eller en bypassoperation i hjertet, eller som anvender andre lægemidler.
English: When used to treat unstable angina or myocardial infarction without ST segment elevation, Angiox, given with or without a GPI, was as effective as the combination of heparin and a GPI in preventing deaths, heart attacks and revascularisations.
Danish: Ved behandling af ustabil angina eller myokardieinfarkt uden forhøjelse af ST-segmentet var Angiox givet med eller uden en GPI lige så effektivt som kombinationen heparin og en GPI til forebyggelse af dødsfald, hjertetilfælde eller revaskulariseringer.
English: Angiox is used to prevent blood clots in adults who are undergoing percutaneous coronary intervention (PCI), a non-surgical procedure used to unblock the heart's blood vessels.
Danish: Angiox anvendes til forebyggelse af blodpropper hos voksne, som får foretaget perkutan koronar intervention (PCI), dvs. et ikke-kirurgisk indgreb til udvidelse af hjertets blodkar.
English: What is Angiox?
Danish: Hvad er Angiox?
English: What benefit has Angiox shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Angiox?
English: What is Angiox used for?
Danish: Hvad anvendes Angiox til?
English: How has Angiox been studied?
Danish: Hvordan blev Angiox undersøgt?
English: How is Angiox used?
Danish: Hvordan anvendes Angiox?
English: In patients with unstable angina or myocardial infarction without ST segment elevation waiting for further treatment, the main study involved almost 14,000 adults and compared Angiox taken alone or with a GPI, with the combination of heparin and a GPI.
Danish: Hovedundersøgelsen af patienter med ustabil angina eller myokardieinfarkt uden forhøjelse af STsegmentet, som ventede på yderligere behandling, omfattede ca. 14 000 voksne.
English: How does Angiox work?
Danish: Hvordan virker Angiox?
English: This is a summary of the European public assessment report (EPAR) for Prevomax.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Prevomax.
English: The full EPAR for Prevomax can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Prevomax findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Prevomax on 19 June 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Prevomax den 19/06/2017.
English: The Committee recommended that Prevomax be approved for use in the EU.
Danish: Udvalget anbefalede, at Prevomax godkendes til anvendelse i EU.
English: As for every medicine, the company provided studies on the quality of Prevomax.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Prevomax.
English: Prevomax contains the active substance maropitant.
Danish: Prevomax indeholder det aktive stof maropitant.
English: To prevent vomiting Prevomax should be given more than one hour in advance of the event that might cause vomiting.
Danish: Til forebyggelse af opkastning bør Prevomax gives mere end en time før den begivenhed, der kan forårsage opkastning.
English: Prevomax is a ‘generic medicine'.
Danish: Prevomax er et "generisk lægemiddel".
English: Prevomax is injected once daily under the skin or into a vein (1 mg/per kg bodyweight) for up to five days.
Danish: Prevomax indgives under huden eller i en vene (1 mg. pr. kg kropsvægt) én gang dagligt i op til til fem dage.
English: It is not intended to provide practical advice on how to use Prevomax.
Danish: Det er ikke en praktisk vejledning i, hvordan Prevomax bør anvendes.
English: What are the benefits and risks of Prevomax?
Danish: Hvilke fordele og risici er der forbundet med Prevomax?
English: The active substance in Prevomax, maropitant, stops a chemical in the body (substance P) from attaching to certain targets called neurokinin-1 (NK1) receptors, which are found on the surface of cells in the part of the brain that controls nausea and vomiting.
Danish: Det aktive stof i Prevomax, maropitant, forhindrer, at et kemikalie i kroppen (substans P) binder sig til visse mål kaldet neurokinin-1-receptorer, der findes på cellernes overflade i den del af hjernen, som kontrollerer kvalme og opkastning.
English: By blocking the receptors, maropitant can prevent nausea and vomiting.
Danish: Ved at blokere for receptorerne kan maropitant forebygge kvalme og opkastning.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Danish: Heri forklares, hvordan agenturet vurderede dette veterinærlægemiddel for at kunne anbefale udstedelse af en markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne.
English: When substance P attaches to these receptors it triggers nausea and vomiting.
Danish: Når substans P binder sig til disse receptorer, udløser det kvalme og opkastning.
English: In dogs Prevomax can also be used both to prevent nausea and vomiting before and after an operation and to improve recovery from general anaesthesia after use of morphine.
Danish: Hos hunde kan Prevomax også anvendes både til forebyggelse af kvalme og opkastning før og efter operationer og til at bedre genopvågningen fra universel bedøvelse efter brug af morfin.
English: What is Prevomax and what is it used for?
Danish: Hvad er Prevomax, og hvad anvendes det til?
English: In cats Prevomax is also used to reduce nausea (signs of feeling sick).
Danish: Hos katte anvendes Prevomax også til at mindske kvalme (tegn på, at de skal kaste op).
English: Prevomax is also used to prevent and treat nausea caused by chemotherapy in dogs.
Danish: Prevomax anvendes også til at forebygge og behandle kvalme forårsaget af kemobehandling hos hunde.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Cerenia, and do not need to be repeated for Prevomax.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Cerenia, og det er ikke nødvendigt at gentage disse med Prevomax.
English: Prevomax is a veterinary medicine used in dogs and cats to treat vomiting, in combination with other supportive measures, or to prevent vomiting (except travel sickness).
Danish: Prevomax er et veterinærlægemiddel, der anvendes til behandling af opkastning hos hunde og katte i kombination med andre støtteforanstaltninger eller til forebyggelse af opkastning (bortset fra transportsyge).
English: The precautions are the same as for the reference medicine since Prevomax is a generic medicine.
Danish: Disse forholdsregler er de samme som for referencelægemidlet, eftersom Prevomax er et generisk lægemiddel.
English: There was no need for ‘bioequivalence' studies to investigate whether Prevomax is absorbed similarly to the reference medicine, Cerenia solution for injection, to produce the same level of the active substance in the blood.
Danish: Der var ikke behov for "bioækvivalente" undersøgelser af, om Prevomax absorberes på samme måde som referencelægemidlet, Cerenia, opløsning til injektion, for at producere samme niveau af det aktive stof i blodet.
English: Prevomax maropitant
Danish: (maropitant)
English: This means that Prevomax contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Cerenia.
Danish: Det betyder, at Prevomax indeholder det samme aktive stof og har samme virkning som "referencelægemidlet" Cerenia, som allerede er godkendt i Den Europæiske Union (EU).
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Prevomax has been shown to have comparable quality and to be bioequivalent to Cerenia, solution for injection.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Prevomax er af sammenlignelig kvalitet og er bioækvivalent med Cerenia.
English: Therefore, the CVMP's view was that, as for Cerenia, the benefits outweigh the identified risks.
Danish: Det var derfor CVMP's opfattelse, at fordelene opvejer de identificerede risici som for Cerenia.
English: Other information about Prevomax?
Danish: Andre oplysninger om Prevomax
English: The medicine can only be obtained with a prescription and is available as a solution for injection.
Danish: Lægemidlet udleveres kun efter recept og fås som en opløsning til injektion.
English: When given by injection under the skin, the active substance in Prevomax is expected to be absorbed in the same way as the reference medicine.
Danish: Når det aktive stof i Prevomax gives ved injektion under huden, forventes det at blive absorberet på samme måde som referencelægemidlet.
English: Why is Prevomax approved?
Danish: Hvorfor blev Prevomax godkendt?
English: Because Prevomax 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 Prevomax er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: This is because when given by injection into a vein, the active substance in Prevomax is delivered straight into the bloodstream.
Danish: Dette skyldes, at når det aktive stof i Prevomax gives ved injektion i en vene, så ledes det direkte ind i blodbanen.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Prevomax, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Prevomax, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der ejer eller er ansvarlig for dyret.
English: How has Prevomax been studied?
Danish: Hvordan er Prevomax blevet undersøgt?
English: How is Prevomax used?
Danish: Hvordan anvendes Prevomax?
English: For more information about treatment with Prevomax, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer af eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Prevomax, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Prevomax, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Prevomax, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Prevomax work?
Danish: Hvordan virker Prevomax?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: (Særnavn) Navn Styrke Lægemiddelform
English: Intravenous use, Subcutaneous use
Danish: Intravenøs anvendelse, Subkutan anvendelse
English: 14 June 2012
Danish: 14. juni 2012
English: The final opinion was converted into a Decision by the European Commission on 14 June 2012.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 14. juni 2012.
English: The Committee appointed Dr Cristina Muñoz Madero as rapporteur and Dr Petras Mačiulskis as co-rapporteur.
Danish: Udvalget udpegede dr Cristina Muñoz Madero som rapportør og dr Petras Mačiulskis som co-rapportør.
English: Article 35 of Directive 2001/82/EC, as amended
Danish: Artikel 35 i direktiv 2001/82/EF, med senere ændringer.
English: International non-proprietary name (inn): tilmicosin
Danish: Internationalt fællesnavn (INN): tilmicosin
English: The referral started on 5 May 2011.
Danish: Indbringelsesproceduren blev indledt den 5. maj 2011.
English: Written explanations were provided by the marketing authorisation holders on 31 August 2011 and 20 January 2012.
Danish: Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 31. august 2011 og den 20. januar 2012.
English: Tilmicosin is a semi-synthetic antibiotic of the macrolide group.
Danish: Tilmicosin er et semisyntetisk antibiotika i macrolid-gruppen.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summary of product characteristics, labelling in Annex III and the conditions of the marketing authorisations in Annex IV.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De videnskabelige konklusioner findes i bilag II, det ændrede produktresumé og etikettering findes i bilag III, og betingelserne for markedsføringstilladelserne findes i bilag IV.
English: The CVMP was requested to give its opinion regarding the recommended dose and inclusion rates in feed for these veterinary medicinal products administered to rabbits.
Danish: CVMP blev anmodet om at fremsætte en udtalelse om den anbefalede dosis og iblandingsforholdet i kaninfoder for disse veterinærlægemidler.
English: The pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g of tilmicosin per kg pre-mix, are veterinary medicinal products which are indicated in pigs and rabbits for the prevention and treatment of respiratory diseases caused by microorganisms susceptible to tilmicosin.
Danish: Premixerne, der er bestemt til fremstilling af medicineret foder og indeholder 40 g, 100 g eller 200 g tilmicosin pr. kg premix, er veterinærlægemidler, der er indiceret til svin og kaniner til forebyggelse og behandling af luftvejssygdomme forårsaget af mikroorganismer, der er følsomme over for tilmicosin.
English: Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to recommended changes of the product information and conditions affecting the marketing authorisations for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits.
Danish: På baggrund af vurderingen af de aktuelt foreliggende data var CVMP af den opfattelse, at den overordnede benefit/risk-profil for disse lægemidler fortsat er positiv, forudsat at produktoplysningerne og betingelserne for markedsføringstilladelserne ændres i overensstemmelse med de anbefalede ændringer for alle premixer, der er bestemt til medicineret foder til kaniner og indeholder 40, 100 eller 200 g tilmicosin pr. kg premix.
English: On 8 April 2011, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g tilmicosin per kg premix and administered to rabbits.
Danish: Den 8. april 2011 indbragte Europa-Kommissionen en sag for agenturet i henhold til artikel 35 i direktiv 2001/82/EF for alle premixer, der anvendes til fremstilling af medicineret foder til kaniner og indeholder 40, 100 eller 200 g tilmicosin pr. kg premix.
English: Opinion following an Article 351 referral for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 351 for alle premixer til fremstilling af medicineret foder til kaniner og indeholder 40 g, 100 g eller 200 g tilmicosin pr. kg premix
English: Committee adopted a positive opinion on 7 March 2012, recommending variations to the terms of the marketing authorisations for all pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits.
Danish: det anbefalede ændring af betingelserne i markedsføringstilladelserne for alle premixer, der er bestemt til medicineret foder til kaniner og indeholder 40, 100 eller 200 g tilmicosin pr. kg premix.
English: Opinion following an Article 350F referral for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits EMA/294698/2012
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 350F for alle premixer til fremstilling af medicineret foder til kaniner og indeholder 40 g, 100 g eller 200 g tilmicosin pr. kg premix
English: However, sexual stimulation is still needed.
Danish: Der kræves imidlertid seksuel stimulation.
English: The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day depending on how well it is tolerated.
Danish: Denne dosis er 5 mg én gang dagligt, men kan sættes ned til 2,5 mg én gang dagligt, afhængigt af, hvor godt den tåles.
English: The full EPAR and risk management plan summary for Tadalafil Mylan 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 Tadalafil Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg Tadalafil Mylan is not recommended.
Danish: Den anbefalede maksimale dosishyppighed er én gang dagligt, men vedvarende daglig brug af 10 eller 20 mg Tadalafil Mylan frarådes.
English: The medicine should be taken around the same time every day and the appropriateness of the once-a-day dosing should be re-assessed regularly.
Danish: Lægemidlet bør tages på omtrent samme klokkeslæt hver dag, og egnetheden af dosering én gang dagligt bør jævnligt tages op til nyvurdering.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tadalafil Mylan on 21 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tadalafil Mylan den 21. november 2014.
English: The dose may be increased to 20 mg for men who do not respond to the 10 mg dose.
Danish: Dosis kan øges til 20 mg for mænd, hos hvem 10 mg dosen ikke virker.
English: This is a summary of the European public assessment report (EPAR) for Tadalafil Mylan.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tadalafil Mylan.
English: Patients with severely impaired liver or kidney function should not take more than 10 mg in one dose.
Danish: Patienter med stærkt nedsat lever- eller nyrefunktion bør højst tage 10 mg i én dosis.
English: A risk management plan has been developed to ensure that Tadalafil Mylan is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Tadalafil Mylan anvendes så sikkert som muligt.
English: For Tadalafil Mylan to be effective in this condition, sexual stimulation is required.
Danish: For at Tadalafil Mylan skal virke effektivt, kræves seksuel stimulation.
English: Once-a-day dosing is not recommended in patients with severely impaired kidney function, and should only be prescribed to patients with impaired liver function after a careful evaluation of the benefits and risks of taking the medicine.
Danish: Dosering én gang dagligt frarådes hos patienter med svært nedsat nyrefunktion og bør kun ordineres til patienter med nedsat leverfunktion efter forudgående nøje vurdering af fordelene og risiciene ved at tage lægemidlet.
English: Tadalafil Mylan can be used at a lower dose once a day in men who intend to use it frequently (twice a week or more), based on the doctor's judgment.
Danish: Tadalafil Mylan kan efter lægens skøn anvendes i lavere dosis én gang dagligt hos mænd, der påtænker at anvende det ofte (to gange om ugen eller mere).
English: For treating erectile dysfunction, the recommended dose of Tadalafil Mylan is 10 mg taken ‘on demand' at least 30 minutes before sexual activity.
Danish: Til behandling af rejsningsproblemer er den anbefalede dosis af Tadalafil Mylan 10 mg, der tages efter behov mindst 30 minutter før seksuel aktivitet.
English: Therefore, the CHMP's view was that, as for Cialis, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Cialis.
English: Men with erectile dysfunction do not have enough cGMP to produce or maintain an erection.
Danish: Mænd med rejsningsproblemer har ikke tilstrækkeligt med cGMP til at frembringe eller opretholde en rejsning.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tadalafil 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 Tadalafil Mylan, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Danish: Det virker ved at blokere enzymet fosfodiesterase, der normalt nedbryder stoffet cyklisk guanosinmonofosfat (cGMP).
English: This means that Tadalafil Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cialis.
Danish: Det betyder, at Tadalafil Mylan svarer til et “referencelægemiddel”, som allerede er godkendt i EU.
English: For more information about treatment with Tadalafil 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 Tadalafil Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: By blocking the phosphodiesterase enzyme and preventing the breakdown of cGMP, Tadalafil Mylan also improves the blood flow to, and relaxes the muscles of, the prostate and bladder.
Danish: Ved at blokere enzymet fosfodiesterase og forhindre nedbrydningen af cGMP forbedrer Tadalafil Mylan desuden blodtilførslen til blærehalskirtlen og blæren og afslapper musklerne der.
English: Tadalafil Mylan is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
Danish: Tadalafil Mylan bruges til behandling af mænd med rejsningsproblemer (impotens, erektil dysfunktion), som ikke kan få eller opretholde tilstrækkelig rejsning til tilfredsstillende seksuel aktivitet.
English: What measures are being taken to ensure the safe and effective use of Tadalafil Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tadalafil Mylan?
English: Tadalafil Mylan contains the active substance tadalafil.
Danish: Tadalafil Mylan indeholder det aktive stof tadalafil.