FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients who have successfully stopped smoking after 12 weeks of treatment, doctors may choose to carry on treatment for another 12 weeks.
Danish: For de patienter, der formår at holde op med at ryge efter 12 ugers behandling, kan lægen vælge at fortsætte behandlingen i yderligere 12 uger.
English: The most common side-effects with Champix (seen in more than 1 patient in 10) are nausea (feeling sick), insomnia (difficulty sleeping), abnormal dreams, headache and nasopharyngitis (inflammation of the nose and throat).
Danish: De mest almindelige bivirkninger (der ses hos flere end 1 ud af 10 patienter) er kvalme, søvnbesvær, drømmeforstyrrelser, hovedpine og nasopharyngitis (betændelse i hals og næse).
English: Treatment with Champix is more likely to succeed in smokers who are motivated to stop smoking and who are also receiving additional advice and support.
Danish: Der er størst sandsynlighed for, at behandlingen med Champix virker hos rygere, der er motiverede til at holde op med at ryge, og som sideløbende modtager rådgivning og støtte.
English: The active substance in Champix, varenicline, can bind to some of these receptors, the α4β2 nicotinic acetylcholine receptors.
Danish: Det aktive stof i Champix, vareniclin, kan binde sig til nogle af disse receptorer, α4β2 nikotinacetylkolin receptorer.
English: The patients' target date for quitting was set at one week after starting treatment and the patients were followed up for a further 40 weeks after their treatment to see if they started smoking again.
Danish: Patientens måldato for rygestop blev sat til en uge efter behandlingsstart, og patienterne blev fulgt i yderligere 40 uger efter behandlingen for at se, om de begyndte at ryge igen.
English: For the full list of all side effects and restrictions with Champix, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger og begrænsninger ved Champix fremgår af indlægssedlen.
English: Other information about Champix
Danish: Andre oplysninger om Champix:
English: When binding to these receptors, varenicline acts in two ways: it acts like nicotine (partial agonist) and this helps to relieve craving symptoms, but it also acts against nicotine (antagonist), by taking its place, and this helps to reduce the pleasurable effects of smoking.
Danish: Når vareniclin binder sig til disse receptorer, virker det på to måder: det virker som nikotin (partiel agonist), og det hjælper med til at lindre nikotintrangen; men det virker også imod nikotinen (antagonist) ved at tage dets plads, og dette hjælper med til at reducere nydelsen ved rygning.
English: What measures are being taken to ensure the safe and effective use of Champix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Champix
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Champix, 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 Champix, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: More patients remained non-smokers after treatment with Champix than after placebo: 40 weeks after the end of the treatment period, the percentage of patients who were still non-smokers was 23% among those who had taken Champix, and 9% among those who had taken a placebo.
Danish: Flere patienter forblev ikke-rygere efter behandling med Champix end efter behandling med placebo: 40 uger efter afslutning af behandlingsperioden var procentdelen af patienter, som stadig var ikke-rygere, 23 % hos de, der havde fået Champix, og 9 % blandt de, der havde fået placebo.
English: In two main studies 2,052 smokers received 12-week treatment with Champix, bupropion (another non-nicotine medicine) or placebo (a dummy treatment).
Danish: Der blev gennemført to hovedundersøgelser, hvori 2 052 rygere gennemgik 12 ugers behandling med Champix, bupropion (en anden nikotinfri medicin) eller placebo (en virkningsløs behandling).
English: Patients set themselves a target date for quitting and will usually start taking Champix one to two weeks before this date.
Danish: Patienten fastsætter en dato for rygestoppet og starter normalt med at tage Champix 1-2 uger inden denne dato.
English: Another study compared Champix with placebo in patients who were allowed to choose their own target dates for quitting, which could be between one week and five weeks of starting treatment.
Danish: I en anden undersøgelse sammenlignede man Champix med placebo hos patienter, som selv måtte vælge deres dato for rygestoppet, som kunne ligge mellem en uge og fem uger efter behandlingens start.
English: In the study where patients were allowed to set their own target dates, Champix was also shown to be effective in helping patients to quit.
Danish: I den undersøgelse, hvor patienterne selv måtte fastsætte måldatoen, viste Champix sig desuden at være effektivt til at hjælpe patienter med at holde op med at ryge.
English: Patients who are unwilling or unable to set a target date within one to two weeks could be offered the treatment first and then later choose their target date to fall within five weeks of starting treatment.
Danish: Patienter, som ikke er villige eller i stand til at fastsætte en dato inden for de næste 1-2 uger, kan tilbydes behandling først og skal dernæst fastsætte en dato, som ligger inden for fem uger fra behandlingens start.
English: Nicotine acts in the nervous system, where it binds to receptors and triggers the release of a chemical messenger, dopamine, which plays a part in the pleasure derived from smoking.
Danish: Nikotin virker i nervesystemet, hvor det binder sig til receptorer og stimulerer frigivelsen af et kemisk stof, dopamin, som har betydning for den nydelse, det giver at ryge.
English: The percentage of patients who had not smoked at all during weeks 9-12 was 44% with Champix, 30% with bupropion, and 18% with placebo.
Danish: Den procentdel af patienterne, der ikke havde røget overhovedet i løbet af uge 9 - 12 var 44 % hos de patienter, der fik Champix, 30 % hos de patienter, der fik bupropion, og 18 % hos de patienter, der fik placebo.
English: What is the risk associated with Champix?
Danish: Hvilken risiko er der forbundet med Champix?
English: Why has Champix been approved?
Danish: Hvorfor blev Champix godkendt?
English: Reduced doses may be used in patients who do not tolerate the medicine or who have kidney problems.
Danish: Til patienter, der ikke tåler medicinen, og til patienter med nyresygdom kan der anvendes en lavere dosis.
English: What is Champix?
Danish: Hvad er Champix?
English: How has Champix been studied?
Danish: Hvordan blev Champix undersøgt?
English: What benefit has Champix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Champix?
English: What is Champix used for?
Danish: Hvad anvendes Champix til?
English: How is Champix used?
Danish: Hvordan anvendes Champix?
English: How does Champix work?
Danish: Hvordan virker Champix?
English: This summary was last updated in 11-2015.
Danish: Dette sammendrag blev sidst ajourført i 11-2015.
English: Patients who cannot swallow tablets may crush the tablets and add them to a small amount of food or drink immediately before swallowing it.
Danish: Patienter, der ikke kan sluge tabletter, kan knuse tabletterne og komme dem i lidt mad eller drikke umiddelbart inden indtagelsen.
English: The tablets should ideally be swallowed without crushing.
Danish: Tabletterne skal helst sluges uden at knuses.
English: The full EPAR for Lamivudine/Zidovudine Teva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Lamivudin/Zidovudin Teva findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lamivudine/Zidovudine Teva on 28 February 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Lamivudine Teva den 28. februar 2011.
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 conditions of use for Lamivudine/Zidovudine Teva.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Lamivudin/Zidovudin Teva.
English: In children (below 12 years of age) weighing between 14 and 30 kg, the number of tablets and half tablets to take depends on their weight.
Danish: Til børn på under 12 år, som vejer mellem 14 og 30 kg, afhænger antallet af tabletter og halve tabletter, der skal tages, af deres vægt.
English: Children weighing less than 14 kg will need to use separate oral solutions containing lamivudine and zidovudine.
Danish: Børn, som vejer under 14 kg, skal anvende særskilte orale opløsninger, som indeholder lamivudin og zidovudin.
English: Lamivudine/Zidovudine Teva is a medicine that contains two active substances, lamivudine (150 mg) and zidovudine (300 mg).
Danish: Lamivudin/Zidovudin Teva er et lægemiddel, der indeholder to aktive stoffer, lamivudin (150 mg) og zidovudin (300 mg).
English: For more information about treatment with Lamivudine/Zidovudine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lamivudin/Zidovudin Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This is a summary of the European public assessment report (EPAR) for Lamivudine/Zidovudine Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lamivudin/Zidovudin Teva.
English: If patients need to stop taking lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing lamivudine or zidovudine separately.
Danish: Hvis en patient skal holde op med at tage lamivudin eller zidovudin eller skal have en anden dosis på grund af problemer med nyrerne, leveren eller blodet, må patienten tage medicin indeholdende lamivudin eller zidovudin hver for sig.
English: The CHMP concluded that, in accordance with EU requirements, Lamivudine/Zidovudine Teva has been shown to have comparable quality and to be bioequivalent to Combivir.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Lamivudin/Zidovudin Teva er af sammenlignelig kvalitet og er bioækvivalent med Combivir.
English: This means that Lamivudine/Zidovudine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Combivir.
Danish: Det betyder, at Lamivudin/Zidovudin Teva er identisk med et ”referencelægemiddel”, der allerede er godkendt i Den Europæiske Union, og som hedder Combivir.
English: Therefore, the CHMP's view was that, as for Combivir, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici som for Combivir.
English: Lamivudine/Zidovudine Teva does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Lamivudin/Zidovudin Teva helbreder ikke hiv-infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: Both active substances have been available in the EU for a number of years: lamivudine has been authorised as Epivir since 1996 and zidovudine has been available in the EU since the mid-1980s.
Danish: Lamivudin har været godkendt under navnet Epivir siden 1996, og zidovudin har kunnet fås i EU siden midten af 1980'erne.
English: Children taking Lamivudine/Zidovudine Teva should be closely monitored for side effects.
Danish: Børn, som tager Lamivudin/Zidovudin Teva, skal observeres nøje for tegn på bivirkninger.
English: Treatment with Lamivudine/Zidovudine Teva should be started by a doctor who has experience in the management of HIV infection.
Danish: Behandlingen med Lamivudin/Zidovudin Teva bør indledes af en læge med erfaring i behandling af hivinfektion.
English: Lamivudine/Zidovudine Teva is a ‘generic medicine'.
Danish: Lamivudin/Zidovudin Teva er et ”generisk lægemiddel”.
English: Lamivudine/Zidovudine Teva, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Lamivudin/Zidovudin Teva taget i kombination med mindst ét andet hivlægemiddel nedsætter hiv-mængden i blodet og holder den nede.
English: Other information about Lamivudine/Zidovudine Teva
Danish: Andre oplysninger om Lamivudin/Zidovudin Teva
English: Because Lamivudine/Zidovudine Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Combivir.
Danish: Da Lamivudin/Zidovudin Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til tests for at påvise, at det er bioækvivalent med referencelægemidlet Combivir.
English: Because Lamivudine/Zidovudine Teva is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Lamivudin/Zidovudin Teva er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The Committee recommended that Lamivudine/Zidovudine Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Lamivudin/Zidovudin Teva.
English: Lamivudine/Zidovudine Teva is used in combination with at least one other HIV medicine to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Lamivudin/Zidovudin Teva anvendes sammen med mindst ét andet hiv-lægemiddel til behandling af patienter, som er inficeret med humant immundefektvirus (hiv).
English: The recommended dose of Lamivudine/Zidovudine Teva for patients over 12 years of age who weigh at least 30 kg is one tablet taken twice a day.
Danish: Til patienter over 12 år, som vejer mindst 30 kg, er den anbefalede dosis Lamivudin/Zidovudin Teva én tablet to gange dagligt.
English: What are the benefits and risks of Lamivudine/Zidovudine Teva?
Danish: Hvilken fordel og risiko er der forbundet med Lamivudin/Zidovudin Teva?
English: Why has Lamivudine/Zidovudine Teva been approved?
Danish: Hvorfor blev Lamivudin/Zidovudin Teva godkendt?
English: Lamivudine/Zidovudine Teva lamivudine/zidovudine
Danish: Lamivudin/Zidovudin Teva lamivudin/zidovudin
English: They both work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Danish: Begge aktive stoffer i Lamivudin/Zidovudin Teva, lamivudin og zidovudin, er nukleoside reverse transkriptasehæmmere (NRTI'er) De virker begge på samme måde ved at hæmme aktiviteten af revers transkriptase, som er et enzym, der dannes af hiv, og som fører til infektion af celler og produktion af flere vira.
English: What is Lamivudine/Zidovudine Teva?
Danish: Hvad er Lamivudin/Zidovudin Teva?
English: How has Lamivudine Zidovudine Teva been studied?
Danish: Hvordan blev Lamivudin/Zidovudin Teva undersøgt?
English: How is Lamivudine/Zidovudine Teva used?
Danish: Hvordan anvendes Lamivudin/Zidovudin Teva?
English: What is Lamivudine/Zidovudine Teva used for?
Danish: Hvad anvendes Lamivudin/Zidovudin Teva til?
English: How does Lamivudine/Zidovudine Teva work?
Danish: Hvordan virker Lamivudin/Zidovudin Teva?
English: It is available as white capsules (200 mg).
Danish: Det fås som hvide kapsler (200 mg).
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, når de producerer samme mængde af det aktive stof i kroppen.
English: The duration of treatment depends on the patient's condition and response to treatment, and ranges from 24 weeks to a year.
Danish: Behandlingens varighed afhænger af patientens tilstand og reaktion på behandlingen og er mellem 24 uger og ét år.
English: It can also be used in adults who previously responded to treatment with interferon alfa but whose disease has come back.
Danish: Det kan også anvendes til voksne, hvor tidligere behandling med interferon alfa har virket, men hvor sygdommen er kommet tilbage.
English: Ribavirin Teva must never be used on its own but only together with interferon alfa-2b (another medicine used in hepatitis).
Danish: Ribavirin Teva må aldrig anvendes alene, men kun sammen med interferon alfa-2b (et andet lægemiddel, der anvendes ved hepatitis).
English: The dose of Ribavirin Teva is based on the patient's body weight, and ranges from three to seven capsules a day.
Danish: Dosis af Ribavirin Teva beregnes efter patientens legemsvægt og er mellem tre og syv kapsler dagligt.
English: Other information about Ribavirin Teva:
Danish: Andre oplysninger om Ribavirin Teva:
English: This means that it is similar to a ‘reference medicine' already authorised in the European Union (EU) called Rebetol.
Danish: Det betyder, at Ribavirin Teva er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Rebetol.
English: Ribavirin Teva can be used in ‘naïve' patients (who have not been treated before) for all types of hepatitis C except for genotype 1.
Danish: Ribavirin Teva anvendes til ‘naive' patienter (som ikke tidligere er blevet behandlet) til alle former for hepatitis C, undtagen genotype 1.
English: Therefore, the CHMP's view was that, as for Rebetol, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Rebetol.
English: The full EPAR for Ribavirin Teva can be found here.
Danish: Den fuldstændige EPAR for Ribavirin Teva findes her.
English: Treatment with Ribavirin Teva should be started and monitored by a doctor who has experience in the management of chronic hepatitis C.
Danish: Behandlingen med Ribavirin Teva bør iværksættes og overvåges af en læge med erfaring i behandling af patienter med kronisk hepatitis C.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Teva to Teva Pharma B.V. on 31 March 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ribavirin Teva til Teva Pharma B.V.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva has been shown to have comparable quality and to be bioequivalent to Rebetol.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Ribavirin Teva i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Rebetol.
English: Ribavirin Teva is a ‘generic medicine'.
Danish: Ribavirin Teva er et ‘generisk lægemiddel'.
English: The Committee recommended that Ribavirin Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Ribavirin Teva.
English: Ribavirin Teva is a medicine that contains the active substance ribavirin.
Danish: Ribavirin Teva er et lægemiddel, der indeholder det aktive stof ribavirin.
English: Ribavirin Teva on its own has no effect on eliminating the hepatitis C virus from the body.
Danish: Anvendt alene er Ribavirin Teva uden virkning med hensyn til at udrydde hepatitis C-virus i kroppen.
English: What are the benefit and risk of Ribavirin Teva?
Danish: Hvilken fordel og risiko er der forbundet med Ribavirin Teva?
English: Because Ribavirin Teva is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine.
Danish: Da Ribavirin Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet.
English: Ribavirin Teva is used to treat patients aged three years and older who have chronic (long-term) hepatitis C (a disease of the liver due to an infection with the hepatitis C virus).
Danish: Ribavirin Teva anvendes til behandling af patienter i alderen 3 år eller ældre med kronisk hepatitis C (langvarig leverbetændelse forårsaget af hepatitis C-virus).
English: The active substance in Ribavirin Teva, ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Danish: Det aktive stof i Ribavirin Teva, ribavirin, er et antiviralt middel, der tilhører gruppen af nukleosidanaloger.
English: Because Ribavirin Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Ribavirin Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Why has Ribavirin Teva been approved?
Danish: Hvorfor blev Ribavirin Teva godkendt?
English: The dose may need to be adjusted for patients who experience side effects.
Danish: I tilfælde af bivirkninger kan det være nødvendigt at justere dosis.
English: What is Ribavirin Teva?
Danish: Hvad er Ribavirin Teva?
English: Ribavirin Teva is taken with food each day in two divided doses (morning and evening).
Danish: Lægemidlet må kun tages af patienter, der vejer mindst 47 kg. Ribavirin Teva tages sammen med måltiderne hver dag, fordelt på to doser (morgen og aften).
English: How has Ribavirin Teva been studied?
Danish: Hvordan blev Ribavirin Teva undersøgt?
English: Ribavirin Teva is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Danish: og RNA, som er nødvendige for virusets overlevelse og formering.
English: How is Ribavirin Teva used?
Danish: Hvordan anvendes Ribavirin Teva?
English: What is Ribavirin Teva used for?
Danish: Hvad anvendes Ribavirin Teva til?
English: How does Ribavirin Teva work?
Danish: Hvordan virker Ribavirin Teva?
English: No undesirable effects were observed after the administration of 10 times the recommended dose.
Danish: Der blev ikke observeret nogen uønskede virkninger efter administration af 10 gange den anbefalede dosis.
English: This product is not effective against adult D. immitis.
Danish: Dette produkt har ingen effekt over for voksne D. immitis.
English: Animals older than six weeks of age:
Danish: Dyr, der er ældre end seks uger:
English: ATCvet code: QP54AA05.
Danish: ATCvet-kode: QP54AA05
English: Date of first authorisation: 17/04/2019
Danish: Dato for første markedsføringstilladelse: 17/04/2019
English: Periodic safety update report (PSUR) submissions shall be synchronised and submitted at the same frequency as for the reference product.
Danish: Indsendelse af rapporten om periodisk sikkerhedsrapport (PSUR) vil blive synkroniseret og leveret i samme frekvens som referenceproduktet.
English: On the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children.
Danish: På behandlingsdagen må børn ikke omgås behandlede dyr og dyrene må ikke gives lov til at sove sammen med deres ejere, især børn.
English: Butylated hydroxytoluene (E321) 0.08%.
Danish: Butyleret hydroxytoluen (E321) 0,08%.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP
English: Clear colourless to yellow solution.
Danish: Klar farveløs til gul opløsning.
English: Each single-dose (pipette) delivers:
Danish: Hver dosisenhed (pipette) indeholder: