FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was either the proportion of patients in whom treatment had been successful (with no or few signs of inflammation in the eye), or the proportion of patients whose treatment had failed (with signs of moderate or severe inflammation in the eye).
Danish: Det vigtigste mål for virkningen var enten andelen af patienter, som havde haft gavn af behandlingen (ingen eller kun få tegn på betændelse i øjet), eller andelen af patienter, som ikke havde haft gavn af behandlingen (tegn på moderat eller svær betændelse i øjet).
English: Other information about Nevanac
Danish: Andre oplysninger om Nevanac
English: The CHMP decided that Nevanac's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Nevanac opvejer risiciene og anbefalede udstedelse af en markedsføringstilladelse.
English: Nevanac is an eye drop suspension that contains the active substance nepafenac (1 and 3 mg/ml).
Danish: Nevanac er øjendråber (suspension), der indeholder det aktive stof nepafenac(1 og 3 mg/ml).
English: Treatment is continued after the operation for 2 to 3 weeks when used to prevent pain and inflammation, or up to 60 days when used to reduce the risk of macular oedema.
Danish: Behandlingen skal fortsætte i 2-3 uger efter operationen, hvis formålet er at forebygge smerter og betændelse, eller op til 60 dage, hvis formålet er at reducere risikoen for maculaødem.
English: The main measure of effectiveness was the number of patients who developed macular oedema within 90 days of surgery.
Danish: Det vigtigste mål for virkningen var antallet af patienter, som udviklede maculaødem inden for 90 dage efter operationen.
English: Nevanac contains benzalkonium chloride, which is known to discolour soft contact lenses.
Danish: Nevanac indeholder benzalkoniumklorid, der er kendt for at misfarve bløde kontaktlinser.
English: The most common side effects with Nevanac (seen in up to 1 in 100 patients) are inflammation of the surface of the eye, defects in the cornea, the sensation of a foreign body in the eye, and crust forming at edge on the eyelids.
Danish: De hyppigste bivirkninger ved Nevanac (som optræder hos op til 1 ud af 100 patienter) er betændelse på øjets overflade, beskadigelser af hornhinden, en følelse af et fremmedlegeme i øjet og ardannelse på kanten af øjenlåget.
English: Nevanac was more effective than placebo and as effective as ketorolac in reducing signs of inflammation.
Danish: Nevanac var mere effektiv end placebo og var lige så effektiv som ketorolac til at mindske tegn på betændelse.
English: What is the risk associated with Nevanac?
Danish: Hvilken risiko er der forbundet med Nevanac?
English: In diabetes patients, Nevanac was more effective than placebo in reducing the risk of macular oedema.
Danish: Hos diabetes-patienter var Nevanac mere virkningsfuld end placebo til at mindske risikoen for makulaødem.
English: The active substance in Nevanac, nepafenac, is a ‘prodrug' of amfenac.
Danish: Det aktive stof i Nevanac, nepafenac, er et forstadium til amfenac.
English: The company also carried out studies to show that Nevanac 3 mg/ml given once a day was more effective than placebo and had the same effect in preventing and treating pain and inflammation as Nevanac 1 mg/ml given three times a day.
Danish: Virksomheden udførte også undersøgelser for at vise, at Nevanac 3 mg/ml en gang dagligt var mere virkningsfuld end placebo og kunne forebygge og lindre smerte lige så godt som Nevanac 1 mg/ml tre gange dagligt.
English: Nevanac must not be used in people who are hypersensitive (allergic) to nepafenac, to any of the other ingredients or to other NSAIDs.
Danish: Nevanac må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for nepafenac, et af de øvrige indholdsstoffer eller andre NSAID'er.
English: Why has Nevanac been approved?
Danish: Hvorfor blev Nevanac godkendt?
English: For the full list of all side effects reported with Nevanac, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Nevanac fremgår af indlægssedlen.
English: In the second and third study, 2.3% and 5.9% of patients taking Nevanac 3 mg/ml developed macular oedema, respectively, compared with between 17.3% and 14.3% of patients taking placebo.
Danish: I den anden og den tredje undersøgelse udviklede hhv. 2.3 % og 5.9 % af de patienter, der fik Nevanac 3 mg/ml maculaødem, sammenlignet med mellem 17.3 % og 14.3% af de patienter, der fik placebo.
English: Another three studies, in a total of 981 patients, compared Nevanac used three times a day, either with placebo, with ketorolac eye drops (another NSAID) or with both placebo and ketorolac.
Danish: I tre andre undersøgelser, hvori deltog i alt 981 patienter, blev Nevanac anvendt tre gange dagligt sammenlignet med enten placebo, ketorolacøjendråber (et andet NSAID) eller med både placebo og ketorolac.
English: This means that it is converted into amfenac in the eye. Amfenac is a non-steroidal anti-inflammatory drug (NSAID).
Danish: Amfenac er et non-steroidt, antiinflammatorisk lægemiddel (NSAID).
English: In the study comparing Nevanac with ketorolac, around 65% of both groups of patients showed no or few signs of inflammation.
Danish: I den undersøgelse, hvor Nevanac blev sammenlignet med ketorolac, var andelen af patienter med ingen eller kun få tegn på betændelse cirka 65 % for begge gruppers vedkommende.
English: Additionally, contact lens wear is not recommended during the postoperative period following cataract surgery.
Danish: Desuden anbefales det ikke at anvende kontaktlinser i perioden efter en operation for grå stær.
English: The first main study used Nevanac 1 mg/ml whereas the other 2 main studies used Nevanac 3 mg/ml.
Danish: I den første hovedundersøgelse anvendtes Nevanac 1 mg/ml, mens Nevanac 3 mg/ml blev anvendt i de to andre undersøgelser.
English: In the first study, 3.2% of patients taking Nevanac 1 mg/ml developed macular oedema (4 out of 125), compared with 16.7% of patients taking placebo (21 out of 126).
Danish: I den første undersøgelse udviklede 3,2 % af de patienter, der fik Nevanac 1 mg/ml, makulaødem (4 ud af 125) sammenlignet med 16,7 % af de patienter, der fik placebo (21 ud af 126).
English: Nevanac is also used to reduce the risk of macular oedema (swelling in the macula, the central part of the retina at the back of the eye) that can occur after cataract surgery in adult diabetes patients.
Danish: Nevanac anvendes også til at reducere risikoen for maculaødem (hævelse i macula, som er den centrale del af nethinden bagest i øjet), som kan forekomme hos voksne diabetespatienter efter en operation for grå stær.
English: Like other NSAIDs, Nevanac must not be used in patients who have previously had an attack of asthma, hives or inflammation of the nasal passages when they take aspirin or other NSAIDs.
Danish: Nevanac mår ligesom andre NSAID'er ikke anvendes hos patienter, der tidligere har lidt af astma, hudallergi eller betændelse i næsen efter indtagelse af aspirin eller andre NSAID'er.
English: What is Nevanac?
Danish: Hvad er Nevanac?
English: One drop of Nevanac is given into the affected eye(s), either three times a day with the 1 mg/ml strength, or once a day if using the 3 mg/ml strength.
Danish: Dosen er en dråbe Nevanac i det/de berørte øje/øjne enten tre gange dagligt med styrken 1 mg/ml eller en gang dagligt med styrken 3 mg/ml.
English: When Nevanac was compared with placebo, around 70% of the patients using Nevanac had no signs of inflammation after two weeks, compared with 17% to 59% of those using placebo.
Danish: Sammenlignet med placebo havde cirka 70 % af patienterne, der blev behandlet med Nevanac, ingen tegn på betændelse efter to uger, mens tallet for patienter behandlet med placebo var 17-59 %.
English: For reducing the risk of macular oedema, Nevanac has been compared with placebo in three main studies involving 1483 diabetes patients with retinopathy (damage to the retina) undergoing cataract surgery.
Danish: I en hovedundersøgelse blev Nevanac anvendt til at mindske risikoen for maculaødem sammenlignet med placebo i tre hovedundersøgelser, der omfattede 1483 diabetespatienter med retinopati (skade på nethinden), som skulle opereres for grå stær.
English: One study compared Nevanac 1 mg/ml used once, twice or three times a day with placebo (dummy eye drops) in 220 patients.
Danish: I en af undersøgelserne blev Nevanac 1 mg/ml anvendt én, to eller tre gange dagligt sammenlignet med placebo (inaktiv behandling) hos 220 patienter.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nevanac have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nevanac.
English: In the study comparing different numbers of drops daily, the patients using Nevanac 1 mg/ml three times a day had the lowest failure rate.
Danish: I undersøgelsen, hvor forskellige daglige dråbedoser blev sammenlignet, var andelen af mislykkede behandlinger mindst hos den gruppe patienter, der anvendte Nevanac 1 mg/ml tre gange dagligt.
English: Nevanac is used in adults to prevent and treat the pain and inflammation that can occur after an operation to remove a cataract from the eye.
Danish: Nevanac bruges til voksne for at forebygge og lindre smerter og betændelseslignende tilstande i øjet efter operation for grå stær (katarakt).
English: What is Nevanac used for?
Danish: Hvad anvendes Nevanac til?
English: How has Nevanac been studied?
Danish: Hvordan blev Nevanac undersøgt?
English: By reducing the production of prostaglandins in the eye, Nevanac can reduce complications caused by eye surgery, such as inflammation, pain and swelling.
Danish: Nevanac kan mindske de komplikationer, der opstår efter operationen, såsom betændelse, smerte og hævelse, ved at nedsætte produktionen af prostaglandiner i øjet.
English: For the prevention and treatment of pain and inflammation, Nevanac 1 mg/ml has been studied in four main studies involving a total of 1,201 patients undergoing cataract surgery.
Danish: Der blev gennemført fire hovedundersøgelser af Nevanac 1 mg/ml med henblik på forebyggelse og behandling af smerter og betændelse hos i alt 1 201 patienter, der skulle opereres for grå stær.
English: How is Nevanac used?
Danish: Hvordan anvendes Nevanac?
English: What benefit has Nevanac shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nevanac?
English: How does Nevanac work?
Danish: Hvordan virker Nevanac?
English: The usual dose is one tablet taken once a day with food.
Danish: Den anbefalede dosis er én tablet én gang dagligt, der tages sammen med et måltid.
English: The full EPAR for Tenofovir disoproxil 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 Tenofovir disoproxil Mylan findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that it is similar to a ‘reference medicine' already authorised in the European Union (EU)
Danish: Det betyder, at det svarer til et "referencelægemiddel", som allerede er godkendt i Den
English: In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Danish: Ved hiv-infektion blokerer det aktiviteten af reverse transcriptase, et enzym, som hiv producerer, så det kan formere sig i de celler, det har inficeret.
English: It is used in patients with liver damage but whose liver is still working properly (compensated liver disease).
Danish: Det anvendes til patienter med en leverskade, hvor leveren stadig fungerer rigtigt (kompenseret leversygdom).
English: In adults, it can also be used for those patients with liver damage whose liver is not working properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B).
Danish: Hos voksne kan det også anvendes til patienter med en leverskade, hvor leveren ikke fungerer rigtigt (dekompenseret leversygdom), og til patienter, som ikke reagerer på behandling med lamivudin (et andet lægemiddel mod hepatitis B).
English: The Committee recommended that Tenofovir disoproxil Mylan be approved for use in the EU.
Danish: Udvalget anbefalede, at Tenofovir disoproxil Mylan godkendes til anvendelse i EU.
English: This is a summary of the European public assessment report (EPAR) for Tenofovir disoproxil Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tenofovir disoproxil Mylan.
English: The active substance in this medicine, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body.
Danish: Det aktive stof i dette lægemiddel, tenofovirdisoproxil, er et "prodrug" (et forstadium), der i kroppen omdannes til tenofovir.
English: Tenofovir disoproxil Mylan is used in combination with other HIV medicines.
Danish: Tenofovir disoproxil Mylan anvendes i kombination med andre lægemidler mod hiv.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tenofovir disoproxil Mylan has been shown to have comparable quality and to be bioequivalent to Viread.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Tenofovir disoproxil Mylan er af sammenlignelig kvalitet og er bioækvivalent med Viread.
English: Tenofovir disoproxil Mylan stops the virus making DNA and prevents it from multiplying and spreading.
Danish: Tenofovir disoproxil Mylan forhindrer virussen i at producere dna og forhindrer derved, at det formerer sig og spredes.
English: The company that makes Tenofovir disoproxil Mylan will also ensure that all doctors who are expected to prescribe or use the medicine are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.
Danish: Virksomheden, der markedsfører Tenofovir disoproxil Mylan, skal sikre, at alle læger, som forventes at ordinere eller anvende lægemidlet, får udleveret informationsmateriale, der indeholder sikkerhedsoplysninger, navnlig om risici og forholdsregler med hensyn til nyrefunktion og knogler.
English: Tenofovir disoproxil Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Tenofovir disoproxil Mylan tages i kombination med andre antivirale lægemidler, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
English: Tenofovir disoproxil Mylan does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Tenofovir disoproxil Mylan helbreder ikke hivinfektion eller aids, men kan holde skader på immunsystemet på afstand og forhindre de infektioner og sygdomme, der er forbundet med aids.
English: Tenofovir is a nucleotide reverse-transcriptase inhibitor (NRTI).
Danish: Tenofovir er en revers transkriptase-hæmmer af nukleotidgruppen (NRTI).
English: For more information about treatment with Tenofovir disoproxil 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 Tenofovir disoproxil Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Tenofovir disoproxil Mylan is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents from 12 years of age.
Danish: Tenofovir disoproxil Mylan anvendes også til behandling af kronisk (langvarig) hepatitis Bvirusinfektion hos voksne og unge fra 12 års alderen.
English: For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Tenofovir disoproxil Mylan once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus's response to antiviral medicines.
Danish: For så vidt angår patienter, der tidligere har fået lægemidler mod hivinfektion, skal lægen inden ordinering af Tenofovir disoproxil Mylan gennemgå de antivirale lægemidler, patienten tidligere har fået, og vurdere sandsynligheden for, at virussen reagerer på antivirale lægemidler.
English: Tenofovir also interferes with the action of an enzyme produced by the hepatitis-B virus called ‘DNA polymerase', which is involved in the formation of viral DNA.
Danish: Tenofovir disoproxil Mylan påvirker også virkningsmekanismen hos et enzym, som produceres af hepatitis B-virussen, såkaldt "dna-polymerase", som indgår i dannelsen af viralt dna.
English: What measures are being taken to ensure the safe and effective use of Tenofovir disoproxil Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tenofovir disoproxil Mylan?
English: Other information about Tenofovir disoproxil Mylan
Danish: Andre oplysninger om Tenofovir disoproxil Mylan
English: What are the benefits and risks of Tenofovir disoproxil Mylan?
Danish: Hvilke fordele og risici er der forbundet med Tenofovir disoproxil Mylan?
English: Because Tenofovir disoproxil 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 Tenofovir disoproxil Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What is Tenofovir disoproxil Mylan and what is it used for?
Danish: Hvad er Tenofovir disoproxil Mylan, og hvad anvendes det til?
English: Tenofovir disoproxil Mylan contains the active substance tenofovir disoproxil.
Danish: Tenofovir disoproxil Mylan indeholder det aktive stof tenofovirdisoproxil.
English: Because Tenofovir disoproxil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viread.
Danish: Da Tenofovir disoproxil Mylan er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Viread.
English: Tenofovir disoproxil Mylan tenofovir disoproxil
Danish: Tenofovir disoproxil Mylan tenofovirdisoproxil
English: It is not intended to provide practical advice on how to use Tenofovir disoproxil Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Tenofovir disoproxil Mylan bør anvendes.
English: For practical information about using Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tenofovir disoproxil Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Tenofovir disoproxil Mylan is used to treat adults and adolescents from 12 years of age infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Tenofovir disoproxil Mylan er et antiviralt lægemiddel, der anvendes til behandling af voksne og unge i alderen 12 år og opefter, som er smittet med human immundefektvirus type 1 (hiv-1).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tenofovir disoproxil Mylan have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Tenofovir disoproxil Mylan.
English: Why is Tenofovir disoproxil Mylan approved?
Danish: Hvorfor blev Tenofovir disoproxil Mylan godkendt?
English: How has Tenofovir disoproxil Mylan been studied?
Danish: Hvordan blev Tenofovir disoproxil Mylan undersøgt?
English: Tenofovir disoproxil Mylan can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B. Tenofovir disoproxil Mylan is available as tablets (245 mg) to be taken by mouth.
Danish: Tenofovir disoproxil Mylan udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af hivinfektion eller kronisk hepatitis B.
English: How is Tenofovir disoproxil Mylan used?
Danish: Hvordan anvendes Tenofovir disoproxil Mylan ?
English: called Viread.
Danish: Referencelægemidlet er her Viread.
English: How does Tenofovir disoproxil Mylan work?
Danish: Hvordan virker Tenofovir disoproxil Mylan?
English: Postmarketing studies
Danish: Postmarketing- studier
English: However, animal studies to evaluate this specific risk have not been conducted.
Danish: Dyreforsøg, som skal vurdere denne særlige risiko er endnu ikke gennemført.
English: Arava tablets are for oral use.
Danish: Arava tabletter er til oral anvendelse.
English: Date of first authorisation: 02 September 1999 Date of latest renewal: 02 September 2009
Danish: Dato for første markedsføringstilladelse: 2. september 1999 Dato for seneste genregistrering: 2. september 2009
English: Children and adolescents Arava is not recommended for use in children and adolescents below 18 years of age.
Danish: Børn og teenagere Arava anbefales ikke til børn og unge under 18 år.
English: Arava can make you feel dizzy which may impair your ability to concentrate and react.
Danish: Arava kan gøre dig svimmel, hvilket kan hæmme din evne til at koncentrere dig og reagere.
English: Your doctor will also check your blood pressure regularly as Arava can cause an increase in blood pressure.
Danish: Din læge vil også kontrollere dit blodtryk jævnligt, da Arava kan medføre en stigning i blodtrykket.
English: There have been reports of chronic overdose in patients taking Arava at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Danish: Der har været rapporter om kronisk overdosering hos patienter, som har taget Arava i daglige doser op til 5 gange den anbefalede daglige dosis og rapporter om akut overdosering hos voksne og børn.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Arava are provided with a physician educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle læger, som forventes at ordinere/anvende Arava forsynes med en undervisningspakke for læger indeholdende følgende:
English: Cotreatment with other hepatotoxic medicinal products was frequently present.
Danish: Samtidig behandling med andre hepatotoksiske præparater var hyppigt forekommende.
English: The efficacy of Arava in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Danish: Effekten af Arava i behandlingen af reumatoid artrit er vist i 4 kontrollerede forsøg (1 i fase II og 3 i fase III).
English: If you take more Arava than you should, contact your doctor or get other medical advice.
Danish: Hvis du tager mere Arava end du skal, skal du kontakte din læge eller få anden medicinsk rådgivning.
English: Most patients improved after discontinuation of Arava.
Danish: De fleste patienter kom i bedring efter seponering af Arava.
English: Arava belongs to a group of medicines called anti-rheumatic medicines.
Danish: Arava tilhører en gruppe medicin der kaldes antireumatisk medicin.
English: You will normally take Arava over long periods of time.
Danish: Du skal almindeligvis fortsætte med at anvende Arava i en længere periode.
English: Arava can occasionally cause some problems with your blood, liver, lungs, or nerves in your arms or legs.
Danish: Arava kan lejlighedsvis forårsage problemer med dit blod, din lever og lunger eller nerverne i dine arme eller ben.