FrancophonIA/ELRC3.0 huggingface dataset:
English: However, because Diovan is eliminated via the biliary route, the CHMP agreed that it should be contraindicated in patients with severe liver diseases and “should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction”.
Danish: Da Diovan elimineres biliært, fandt CHMP imidlertid også, at der skulle fastsættes en kontraindikation for patienter med alvorlige leversygdomme, og at det "ikke bør gives til patienter med stærkt nedsat leverfunktion, cirrose eller biliær obstruktion".
English: In heart failure, Diovan is used when other types of medicines used in heart failure such as Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers, cannot be used.
Danish: Diovan anvendes til behandling af hjertesvigt, når andre typer medicin til behandling af hjertesvigt, såsom ACE-hæmmere (Angiotensin Converting Enzyme) eller betablokkere, ikke kan anvendes.
English: The Committee noted that some Member States (MSs) had a limitation of the use of Diovan after MI to patients intolerant to ACE inhibitors.
Danish: Udvalget bemærkede, at anvendelse af Diovan efter MI i nogle medlemsstater var begrænset til patienter, der er intolerante over for ACE-hæmmere.
English: Diovan has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det er blevet bestemt af koordinationsgruppen for gensidig anerkendelse og decentrale procedurer - human (CMD(h)), at Diovan bør harmoniseres.
English: However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Danish: Samtidig anvendelse med en ACEhæmmer og en beta-blokker kan dog ikke anbefales (se pkt.
English: The Committee noted that there has been no study of valsartan in patients with severe kidney failure, but they did not identify any possible safety issue has he primary route of elimination of valsartan is via the digestive (biliary), not renal route The CHMP therefore recommended that the contraindication be removed.
Danish: Udvalget bemærkede, at der ikke er foretaget undersøgelser af valsartan hos patienter med svær nyresvigt, men det identificerede ingen potentielle sikkerhedsproblemer, idet valsartan primært elimineres via fordøjelsesvejen (biliært) og ikke via nyrerne.
English: Company responses provided on: 20 October 2008 Opinion date:
Danish: Dato for virksomhedens svar:
English: • patients with liver impairment or cholestasis (problems with the elimination of bile).The Committee agreed that no initial dose adjustment is needed in patients with mild to moderate impairment of liver function.
Danish: Udvalget erklærede sig enigt i, at ingen dosisjustering i starten af behandlingen er nødvendig hos patienter med mildt til moderat nedsat leverfunktion.
English: Other information about Libertek
Danish: Andre oplysninger om Libertek
English: The European Commission granted a marketing authorisation valid throughout the European Union for Libertek on 28 February 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Libertek den 28. februar 2011.
English: Patients may need to take Libertek for several weeks before it starts to have an effect.
Danish: Det kan være nødvendigt at tage Libertek i flere uger, før det begynder at virke.
English: The recommended dose of Libertek is one tablet once a day.
Danish: Den anbefalede dosis Libertek er én tablet én gang dagligt.
English: This is a summary of the European public assessment report (EPAR) for Libertek.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Libertek.
English: A risk management plan has been developed to ensure that Libertek is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Libertek anvendes så sikkert som muligt.
English: The full EPAR for Libertek can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Libertek findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Libertek is a medicine that contains the active substance roflumilast.
Danish: Libertek er et lægemiddel, der indeholder det aktive stof roflumilast.
English: Libertek was shown to be more effective than placebo at treating COPD.
Danish: Libertek viste sig at være mere effektivt end placebo til behandling af KOL.
English: What measures are being taken to ensure the safe and effective use of Libertek?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Libertek?
English: What is the risk associated with Libertek?
Danish: Hvilken risiko er der forbundet med Libertek?
English: For more information about treatment with Libertek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Libertek, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The doctor may stop treatment with Libertek if the patient loses too much weight.
Danish: Lægen kan afbryde behandlingen med Libertek, hvis patienten oplever et for stort vægttab.
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 Libertek.
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, hvordan Libertek skal anvendes.
English: The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Libertek in patients with severe COPD.
Danish: CHMP bemærkede, at der var behov for nye typer KOL-behandling, og at hovedundersøgelserne viste en beskeden fordel ved Libertek hos patienter med svær KOL.
English: The active substance in Libertek, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Danish: Det aktive stof i Libertek, roflumilast, tilhører en gruppe lægemidler, der kaldes "fosfodiesterase4(PDE4)-hæmmere".
English: After a year, the patients who took Libertek had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Danish: Efter et år oplevede de patienter, der modtog behandling med Libertek, en gennemsnitlig stigning på 40 ml, mens de patienter, der fik placebo, oplevede en gennemsnitlig nedgang på 9 ml.
English: Why has Libertek been approved?
Danish: Hvorfor blev Libertek godkendt?
English: In addition, the patients who took Libertek had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Danish: Desuden oplevede de patienter, der blev behandlet med Libertek, gennemsnitligt 1,1 moderat eller svært tilfælde af sygdomsopblussen sammenlignet med 1,4 hos de patienter, der fik placebo.
English: The most common side effects with Libertek (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Danish: De hyppigste bivirkninger ved Libertek (som optræder hos mellem 1 og 10 patienter ud af 100) er vægttab, nedsat appetit, søvnbesvær, hovedpine, diarré, kvalme og mavesmerter.
English: Libertek must not be used in patients who have moderate or severe problems with their liver.
Danish: Det må ikke anvendes til patienter, der lider af moderate eller svære leversygdomme.
English: Libertek is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Danish: Libertek anvendes ikke alene, men som tillægsbehandling til bronkodilatorer (lægemidler, som udvider luftvejene i lungerne).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Libertek, 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 Libertek, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Libertek has been compared with placebo (a dummy treatment) in two main studies involving over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Danish: Libertek blev sammenlignet med placebo (en virkningsløs behandling) i to hovedundersøgelser, der omfattede 3 000 voksne med svær KOL, som havde oplevet, at sygdommen var blusset op mindst én gang i løbet af det seneste år.
English: After considering all of the available data on the effects of the medicine, the Committee decided that Libertek's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Efter at have gennemgået alle de foreliggende data om lægemidlet besluttede CHMP, at fordelene ved Libertek opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Libertek.
English: Because patients taking Libertek may lose weight, they are advised to weigh themselves on a regular basis.
Danish: Eftersom Libertek kan forårsage vægttab, rådes patienter, der tager Libertek, til at veje sig selv med jævne mellemrum.
English: In addition, the company that makes Libertek will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Danish: Virksomheden, som fremstiller Libertek, skal endvidere sikre, at der i alle EU-medlemsstater udleveres undervisningsmateriale, som indeholder oplysninger om lægemidlets bivirkninger, og hvordan det skal anvendes, til sundhedspersonale, som ordinerer dette lægemiddel.
English: The company will also provide cards for patients, telling them what information that they need to give their doctor about their symptoms and past illnesses to help the doctor know whether Libertek is appropriate for them.
Danish: Virksomheden skal desuden sørge for patientkort med oplysninger til patienterne om, hvad de skal fortælle deres læge om deres symptomer og tidligere sygdomme, for at lægen kan vurdere, om Libertek er en hensigtsmæssig behandling for dem. Patientkortet skal indeholde et felt, hvor patienterne kan notere deres vægt.
English: What is Libertek?
Danish: Hvad er Libertek?
English: How has Libertek been studied?
Danish: Hvordan blev Libertek undersøgt?
English: What benefit has Libertek shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Libertek?
English: For the full list of all side effects reported with Libertek, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Libertek fremgår af indlægssedlen.
English: How does Libertek work?
Danish: Hvordan virker Libertek?
English: What is Libertek used for?
Danish: Hvad anvendes Libertek til?
English: How is Libertek used?
Danish: Hvordan anvendes Libertek?
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
Danish: Libertek anvendes til behandling af svær, kronisk obstruktiv lungesygdom (KOL) hos voksne patienter med kronisk bronkitis (langvarig betændelse i luftvejene), hvis KOL hyppigt blusser op. KOL er en langvarig sygdom, hvor luftvejene og luftsækkene i lungerne skades eller blokeres, hvilket kan give problemer med at ånde luften ind i og ud af lungerne.
English: See section 2, Do not take Janumet.
Danish: Se punkt 2, Tag ikke Janumet.
English: Janumet is contraindicated in patients with:
Danish: Janumet er kontraindiceret hos patienter med:
English: Janumet should not be used during pregnancy.
Danish: Janumet bør ikke anvendes under graviditet.
English: No animal studies have been conducted with Janumet.
Danish: Der er ikke udført dyreforsøg med Janumet.
English: If you stop taking Janumet, your blood sugar may rise again.
Danish: Hvis De holder op med at tage Janumet, kan Deres blodsukker stige igen.
English: Date of first authorisation: 16 July 2008 Date of latest renewal: 13 March 2013
Danish: Dato for første markedsføringstilladelse: 16. juli 2008 Dato for seneste fornyelse: 13. marts 2013
English: The safety and efficacy of Janumet in children and adolescents from birth to < 18 years of age have not been established.
Danish: Janumets sikkerhed og virkning hos børn og unge fra fødslen til <18 år er ikke klarlagt.
English: Janumet should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.
Danish: Janumet bør ikke anvendes til patienter med type 1-diabetes og må ikke anvendes til behandling af diabetisk ketoacidose.
English: Your doctor may ask you to stop Janumet.
Danish: Lægen vil måske bede Dem om at stoppe med at tage Janumet.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Janumet.
Danish: Følgende redegørelser viser de farmakokinetiske egenskaber ved de enkelte aktive substanser i Janumet.
English: If no adequate strength of Janumet is available, individual monocomponents should be used instead of the fixed-dose combination.
Danish: Hvis der ikke findes en passende styrke af Janumet, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: Reduction in fasting plasma glucose (FPG) was observed at 3 weeks, the first time point at which FPG was measured.
Danish: Reduktionen i faste-plasma-glucose (FPG) blev observeret efter 3 uger, det første tidspunkt hvor FPG blev målt.
English: Along with diet and exercise, this medicine helps lower your blood sugar.
Danish: Sammen med diæt og motion kan dette lægemiddel hjælpe med at sænke Deres blodsukker.
English: If you need to have major surgery you must stop taking Janumet during and for some time after the procedure.
Danish: Hvis De skal have en større operation, skal De stoppe med at tage Janumet under indgrebet og i nogen tid herefter.
English: Janumet with alcohol
Danish: Brug af Janumet sammen med alkohol
English: Do not take Janumet: - if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Janumet: - Hvis De er allergisk over for sitagliptin eller metformin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Your doctor will decide when you must stop and when to restart your treatment with Janumet.
Danish: Lægen vil beslutte, hvornår De skal stoppe behandlingen med Janumet, og hvornår De kan genoptage den igen.
English: STOP taking Janumet and contact a doctor immediately if you notice any of the following serious side effects:
Danish: STOP med at tage Janumet og kontakt straks lægen, hvis De får nogen af følgende alvorlige bivirkninger:
English: The level of digoxin in your blood may need to be checked if taking with Janumet.
Danish: Det kan være nødvendigt at kontrollere indholdet af digoxin i Deres blod, hvis De tager Janumet.
English: Janumet should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Danish: Janumet bør gives to gange dagligt sammen med et måltid for at reducere de gastrointestinale bivirkninger, som metformin er forbundet med.
English: Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar.
Danish: Fortsæt med at tage dette lægemiddel, så længe Deres læge ordinerer det, så De fortsat kan få hjælp til at kontrollere Deres blodsukker.
English: As metformin and sitagliptin are excreted by the kidney, Janumet should be used with caution as age increases.
Danish: Da metformin og sitagliptin udskilles via nyrerne, bør Janumet anvendes med forsigtighed efterhånden som alderen stiger.
English: Adverse reactions are listed below as MedDRA preferred term by system organ class and absolute frequency (Table 1).
Danish: Bivirkningerne ses nedenfor som MedDRA-termer inddelt i systemorganklasse og absolut frekvens (Tabel 1).
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking Janumet before or at the time of the injection.
Danish: Hvis De skal have sprøjtet et kontrastmiddel, som indeholder jod, ind i Deres blod, for eksempel i forbindelse med en røntgenundersøgelse eller scanning, skal De stoppe med at tage Janumet forud for eller på tidspunktet for injektionen.
English: When starting or using such products in combination with metformin, close monitoring of renal function is necessary.
Danish: Ved initiering eller brug af sådanne præparateri kombination med metformin skal nyrefunktionen monitoreres tæt.
English: During treatment with Janumet, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Danish: Under behandlingen med Janumet vil lægen kontrollere Deres nyrefunktion mindst en gang om året eller hyppigere, hvis De er ældre, eller hvis Deres nyrefunktion bliver dårligere.
English: Janumet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Danish: Janumet kan forårsage en meget sjælden, men meget alvorlig bivirkning, som kaldes laktacidose, især hvis Deres nyrer ikke fungerer korrekt.
English: The dose of antihyperglycaemic therapy with Janumet should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Danish: Doseringen af antihyperglykæmisk behandling med Janumet bør individualiseres på basis af patientens aktuelle regime, effektivitet og tolerabilitet, uden at den maksimale anbefalede daglige dosis på 100 mg sitagliptin overskrides.
English: If you stop taking Janumet
Danish: Hvis De holder op med at tage Janumet
English: Pharmacokinetic drug interaction studies with Janumet have not been performed; however, such studies have been conducted with the individual active substances, sitagliptin and metformin.
Danish: Der er ikke udført farmakokinetiske interaktionsundersøgelser med Janumet, men sådanne undersøgelser er udført med de enkelte aktive stoffer, sitagliptin og metformin.
English: Janumet may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Danish: Janumet kan forårsage en meget sjælden (kan forekomme hos op til 1 ud af 10.000 behandlede), men meget alvorlig bivirkning, der kaldes laktacidose (se punktet ”Advarsler og forsigtighedsregler”).
English: If pancreatitis is suspected, Janumet and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Janumet should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, bør Janumet og andre potentielt suspekte lægemidler seponeres, og hvis mistanken om akut pankreatitis bekræftes, må behandlingen med Janumet ikke genoptages.
English: Other medicines and Janumet
Danish: Brug af anden medicin sammen med Janumet
English: If you forget to take Janumet
Danish: Hvis De har glemt at tage Janumet
English: Do not take Janumet if any of the above apply to you and talk with your doctor about other ways of managing your diabetes.
Danish: Tag ikke Janumet, hvis De mener noget af dette passer på Dem, og drøft andre former for diabetesbehandling med Deres læge.
English: Do not store above 30°C.
Danish: Må ikke opbevares ved temperaturer over 30ºC.
English: You should continue the diet recommended by your doctor during treatment with this medicine and take care that your carbohydrate intake is equally distributed over the day.
Danish: De bør fortsætte med den diæt, som blev anbefalet af Deres læge under behandlingen med dette lægemiddel, og sørge for, at indtagelsen af kulhydrater fordeles jævnt over dagen.
English: There are no adequate data from the use of sitagliptin in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af sitagliptin til gravide.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Janumet is used in combination with a sulphonylurea or with insulin.
Danish: Desuden bør patienter advares om risikoen for hypoglykæmi, når Janumet anvendes sammen med et sulfonylurinstof eller sammen med insulin.
English: If a hypersensitivity reaction is suspected, Janumet should be discontinued, other potential causes of the event should be assessed, and alternative treatment for diabetes should be instituted (see section 4.8).
Danish: Hvis der er mistanke om en overfølsomhedsreaktion, bør Janumet seponeres, andre mulige årsager til hændelsen vurderes, og alternativ diabetesbehandling igangsættes (se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Janumet in all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Janumet hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: Stop taking Janumet for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Danish: Stop med at tage Janumet i en kort periode, hvis De har en tilstand, som kan være forbundet med dehydrering (betydeligt tab af kropsvæsker), såsom alvorlig opkastning, diarré, feber, udsættelse for varme eller indtagelse af mindre væske end normalt.
English: Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Janumet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Danish: Ændring i klinisk status hos patienter med tidligere velbehandlet type 2-diabetes En patient med type 2-diabetes, der tidligere var velbehandlet på Janumet, og som udvikler unormale laboratorieværdier eller klinisk sygdom (især vagt eller uklart defineret sygdom) bør vurderes hurtigt med henblik på tegn på ketoacidose eller laktacidose.
English: If this happens, you must stop taking Janumet and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Danish: Hvis dette sker for Dem, skal De omgående stoppe med at tage Janumet og kontakte læge eller nærmeste hospital, da laktacidose kan føre til koma.
English: • medicines which increase urine production (diuretics)
Danish: • Medicin som øger urinproduktionen (vanddrivende medicin).
English: Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Janumet) or during post-approval use of Janumet or sitagliptin alone or with other diabetes medicines:
Danish: Nogle patienter har oplevet følgende bivirkninger i kliniske studier, når de har taget sitagliptin alene (et af de aktive stoffer i Janumet) eller ved anvendelse af Janumet eller sitagliptin efter markedsføring alene eller sammen med anden diabetesmedicin:
English: Avoid excessive alcohol intake while taking Janumet since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Danish: De skal undgå at indtage store mængder alkohol, mens De er i behandling med Janumet, da det kan øge risikoen for laktacidose (se punktet ”Advarsler og forsigtighedsregler”).