FrancophonIA/ELRC3.0 huggingface dataset:
English: What was Natalizumab Elan Pharma expected to be used for?
Danish: Hvad forventedes Natalizumab Elan Pharma anvendt til?
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Natalizumab Elan Pharma?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Natalizumab Elan Pharma eller i programmer for anvendelse med særlig udleveringstilladelse?
English: How is Natalizumab Elan Pharma expected to work?
Danish: Hvordan forventes Natalizumab Elan Pharma at virke?
English: Hence, the CHMP recommended that Natalizumab Elan Pharma be refused marketing authorisation.
Danish: CHMP anbefalede således et afslag på ansøgningen om markedsføringstilladelse for Natalizumab Elan Pharma.
English: Velmetia should not be used during pregnancy.
Danish: Velmetia bør ikke anvendes under graviditet.
English: Velmetia is contraindicated in patients with:
Danish: Velmetia er kontraindiceret hos patienter med:
English: If you stop taking Velmetia, your blood sugar may rise again.
Danish: Hvis De holder op med at tage Velmetia, kan Deres blodsukker stige igen.
English: See section 2, Do not take Velmetia.
Danish: Se punkt 2, Tag ikke Velmetia.
English: Velmetia should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis.
Danish: Velmetia bør ikke anvendes til patienter med type 1-diabetes og må ikke anvendes til behandling af diabetisk ketoacidose.
English: The safety and efficacy of Velmetia in children and adolescents from birth to < 18 years of age have not been established.
Danish: Velmetias sikkerhed og virkning hos børn og unge fra fødslen til <18 år er ikke klarlagt.
English: No animal studies have been conducted with Velmetia.
Danish: Der er ikke udført dyreforsøg med Velmetia.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Velmetia.
Danish: Følgende redegørelser viser de farmakokinetiske egenskaber ved de enkelte aktive substanser i Velmetia.
English: During treatment with Velmetia, 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 Velmetia vil lægen kontrollere Deres nyrefunktion mindst en gang om året eller hyppigere, hvis De er ældre, og/eller hvis Deres nyrefunktion bliver dårligere.
English: If no adequate strength of Velmetia is available, individual monocomponents should be used instead of the fixed-dose combination.
Danish: Hvis der ikke findes en passende styrke af Velmetia, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: Velmetia with alcohol
Danish: Brug af Velmetia sammen med alkohol
English: If you need to have major surgery you must stop taking Velmetia during and for some time after the procedure.
Danish: Hvis De skal have en større operation, skal De stoppe med at tage Velmetia under indgrebet og i nogen tid herefter.
English: Velmetia should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Danish: Velmetia bør gives to gange dagligt sammen med et måltid for at reducere de gastrointestinale bivirkninger, som metformin er forbundet med.
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 Velmetia 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 Velmetia forud for eller på tidspunktet for injektionen.
English: STOP taking Velmetia and contact a doctor immediately if you notice any of the following serious side effects:
Danish: STOP med at tage Velmetia 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 Velmetia.
Danish: Det kan være nødvendigt at kontrollere indholdet af digoxin i Deres blod, hvis De tager Velmetia.
English: Your doctor may ask you to stop Velmetia.
Danish: Lægen vil måske bede Dem om at stoppe med at tage Velmetia.
English: As metformin and sitagliptin are excreted by the kidney, Velmetia should be used with caution as age increases.
Danish: Da metformin og sitagliptin udskilles via nyrerne, bør Velmetia anvendes med forsigtighed efterhånden som alderen stiger.
English: Velmetia may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Danish: Velmetia kan forårsage en meget sjælden, men meget alvorlig bivirkning, som kaldes laktacidose, især hvis Deres nyrer ikke fungerer korrekt.
English: Your doctor will decide when you must stop and when to restart your treatment with Velmetia.
Danish: Lægen vil beslutte, hvornår De skal stoppe behandlingen med Velmetia, og hvornår De kan genoptage den igen.
English: Velmetia 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: Velmetia 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, Velmetia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Velmetia should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, bør Velmetia og andre potentielt suspekte lægemidler seponeres, og hvis mistanken om akut pankreatitis bekræftes, må behandlingen med Velmetia ikke genoptages.
English: Pharmacokinetic drug interaction studies with Velmetia 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 Velmetia, men sådanne undersøgelser er udført med de enkelte aktive stoffer, sitagliptin og metformin.
English: Do not take Velmetia: - if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Velmetia: - Hvis De er allergisk over for sitagliptin eller metformin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Velmetia) or during post-approval use of Velmetia 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 Velmetia) eller ved anvendelse af Velmetia eller sitagliptin efter markedsføring alene eller sammen med anden diabetesmedicin:
English: Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Velmetia 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 Velmetia, 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 a hypersensitivity reaction is suspected, Velmetia 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 Velmetia seponeres, andre mulige årsager til hændelsen vurderes, og alternativ diabetesbehandling igangsættes (se pkt.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Velmetia is used in combination with a sulphonylurea or with insulin.
Danish: Desuden bør patienter advares om risikoen for hypoglykæmi, når Velmetia anvendes sammen med et sulfonylurinstof eller sammen med insulin.
English: Stop taking Velmetia 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 Velmetia 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: The European Medicines Agency has waived the obligation to submit the results of studies with Velmetia 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 Velmetia hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: For patients switching from co-administration of sitagliptin and metformin For patients switching from co-administration of sitagliptin and metformin, Velmetia should be initiated at the dose of sitagliptin and metformin already being taken.
Danish: Til patienter, der skifter fra samtidig administration af sitagliptin og metformin Til patienter, der skifter fra samtidig administration af sitagliptin og metformin, bør Velmetia initieres med den dosis af sitagliptin og metformin, som allerede tages.
English: Do not take Velmetia if any of the above apply to you and talk with your doctor about other ways of managing your diabetes.
Danish: Tag ikke Velmetia, hvis De mener noget af dette passer på Dem, og drøft andre former for diabetesbehandling med Deres læge.
English: Velmetia has no or negligible influence on the ability to drive and use machines.
Danish: Velmetia påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The dose of antihyperglycaemic therapy with Velmetia 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 Velmetia bør individualiseres på basis af patientens aktuelle regime, effektivitet og tolerabilitet, uden at den maksimale anbefalede daglige dosis på 100 mg sitagliptin overskrides.
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Velmetia (see section 4).
Danish: Der er indberettet tilfælde af betændelse i bugspytkirtlen (pankreatitis) hos patienter, der får Velmetia (se punkt 4).
English: Avoid excessive alcohol intake while taking Velmetia 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 Velmetia, da det kan øge risikoen for laktacidose (se punktet ”Advarsler og forsigtighedsregler”).
English: Velmetia contains two different medicines called sitagliptin and metformin.
Danish: Velmetia indeholder to slags medicin, sitagliptin og metformin.
English: If this happens, you must stop taking Velmetia 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 Velmetia og kontakte læge eller nærmeste hospital, da laktacidose kan føre til koma.
English: Stop taking Velmetia and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Danish: Stop med at tage Velmetia og kontakt omgående læge eller nærmeste hospital, hvis De får et eller flere af nedenstående symptomer på laktacidose, da denne tilstand kan føre til koma.
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Velmetia.
Danish: Hvis De er i tvivl om noget af ovenstående passer på Dem, skal De tale med lægen eller apotekspersonalet, før De tager Velmetia.
English: If bullous pemphigoid is suspected, Velmetia should be discontinued.
Danish: Hvis der er mistanke om bulløs pemfigoid, skal Velmetia seponeres.
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Velmetia.
Danish: De skal eventuelt have kontrolleret Deres blodsukker eller Deres nyrefunktion hyppigere, eller lægen kan ændre Deres dosis af Velmetia.
English: Velmetia is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued during conditions with the potential to alter renal function (see section 4.3).
Danish: Velmetia er kontraindiceret hos patienter med GFR < 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
English: You will need to stop taking Velmetia at the time of the X-ray and for 2 or more days after as directed by your doctor,
Danish: Det vil være nødvendigt at stoppe med Velmetia på tidspunktet for røntgenundersøgelsen og i 2 dage eller mere som foreskrevet af lægen, afhængigt af hvordan Deres nyrer fungerer.
English: Animal data do not suggest an effect of treatment with sitagliptin on male and female fertility.
Danish: Data fra dyrestudier viser ingen virkning af sitagliptin på fertiliteten hos hanner og hunner.
English: A bioequivalence study in healthy subjects demonstrated that the Velmetia (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Danish: En bioækvivalensundersøgelse med raske forsøgspersoner viste, at Velmetia (sitagliptin/metforminhydrochlorid) kombinationstabletter er bioækvivalente med samtidig administration af sitagliptinphosphat og metforminhydrochlorid som individuelle tabletter.
English: Other medicines and Velmetia
Danish: Brug af anden medicin sammen med Velmetia
English: Improvements in surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Danish: Forbedring i surrogatmarkører for betacellefunktionen, inklusive HOMA-β (homøostatisk modelvurdering af βcellefunktionen), proinsulin/insulin-ratio samt resultater fra en frequently sampled meal tolerance test blev observeret.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Velmetia.
Danish: Er De i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før De tager Velmetia.
English: Patients receiving Velmetia in combination with a sulphonylurea or with insulin may be at risk for hypoglycaemia.
Danish: Patienter, der får Velmetia sammen med et sulfonylurinstof eller sammen med insulin, har øget risiko for at få hypoglykæmi.
English: Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported.
Danish: Efter markedsføring er der blevet rapporteret om alvorlige Overfølsomhedsreaktioner hos patienter, der er blevet behandlet med sitagliptin.
English: Velmetia must therefore not be used in women who are breast-feeding (see section 4.3).
Danish: Velmetia må derfor ikke anvendes til kvinder, der ammer (se pkt.
English: If you stop taking Velmetia
Danish: Hvis De holder op med at tage Velmetia
English: If you forget to take Velmetia
Danish: Hvis De har glemt at tage Velmetia
English: What Velmetia contains
Danish: Velmetia indeholder:
English: What you need to know before you take Velmetia
Danish: Det skal De vide, før De begynder at tage Velmetia
English: When Velmetia is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).
Danish: Når Velmetia anvendes sammen med insulin, kan det være nødvendigt at nedsætte insulindosis for at reducere risikoen for hypoglykæmi (se pkt.
English: When Velmetia is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Danish: Når Velmetia anvendes sammen med et sulfonylurinstof, kan en lavere dosis af sulfonylurinstoffet være nødvendig for at reducere risikoen for hypoglykæmi (se pkt.
English: Velmetia combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Danish: Velmetia er en kombination af to antihyperglykæmiske lægemidler med komplementære virkningsmekanismer til forbedring af glykæmisk kontrol hos patienter med type 2-diabetes: sitagliptinphosphat, en dipeptidylpeptidase-4-hæmmer (DPP-4), og metforminhydrochlorid, der tilhører biguanidklassen.
English: Patients treated with sitagliptin had a modest increase in body weight (+1.1 kg) compared to those given placebo.
Danish: Patienter, der blev behandlet med sitagliptin havde en moderat vægtøgning (+1,1 kg) sammenlignet med de patienter, der fik placebo.
English: Velmetia is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Danish: Velmetia er også indiceret som tillægsbehandling til insulin (dvs. tripel kombinationsbehandling) som supplement til diæt og motion til forbedring af den glykæmiske kontrol hos patienter, når stabil dosering af insulin og metformin alene ikke giver tilstrækkelig glykæmisk kontrol.
English: - if you have severely reduced kidney function - if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Danish: - Hvis De har har dårligt kontrolleret diabetes, der eksempelvis er ledsaget af alvorlig hyperglykæmi (højt blodsukker), kvalme, opkastning, diarré, hurtigt vægttab, laktacidose (se ”Risiko for laktacidose” nedenfor) eller ketoacidose.
English: There have been no therapeutic clinical trials conducted with Velmetia tablets however bioequivalence of Velmetia with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Danish: Der er ikke udført behandlingsmæssige kliniske undersøgelser med Velmetia-tabletter, men Velmetias bioækvivalens er blevet påvist, når det gives sammen med sitagliptin og metformin (se pkt.
English: Velmetia is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Danish: Velmetia er indiceret som supplement til diæt og motion til forbedring af den glykæmiske kontrol hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin alene eller hos de patienter, som allerede er i behandling med kombinationen af sitagliptin og metformin.
English: For the different doses on metformin, Velmetia is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Danish: Til de forskellige metformindoser findes Velmetia i styrker på 50 mg sitagliptin og 850 mg metforminhydrochlorid eller 1.000 mg metforminhydrochlorid.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after 'EXP'.
Danish: Brug ikke Velmetia efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Hepatic impairment Velmetia must not be used in patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Velmetia må ikke anvendes til patienter med nedsat leverfunktion (se pkt.
English: Talk to your doctor or pharmacist before taking Velmetia: - if you have or have had a disease of the pancreas (such as pancreatitis) - if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før De tager Velmetia: - Hvis De har eller har haft en sygdom i bugspytkirtlen (f.eks. pankreatitis).
English: Velmetia is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Danish: Velmetia er indiceret som tripel kombinationsbehandling sammen med en peroxisom proliferatoraktiveret receptor-gamma (PPAR)-agonist (dvs. et glitazon) som supplement til diæt og motion hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin og en PPAR-agonist.
English: EU/1/08/456/002 EU/1/08/456/003 EU/1/08/456/004 EU/1/08/456/005 EU/1/08/456/006 EU/1/08/456/007 EU/1/08/456/015 EU/1/08/456/017 EU/1/08/456/019 EU/1/08/456/020
Danish: EU/1/08/456/001 EU/1/08/456/002 EU/1/08/456/003 EU/1/08/456/004 EU/1/08/456/005 EU/1/08/456/006 EU/1/08/456/007 EU/1/08/456/015 EU/1/08/456/017 EU/1/08/456/019 EU/1/08/456/020
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Danish: Behandling med Velmetia skal afbrydes på tidspunktet for kirurgi under generel, spinal eller epidural anæstesi og må tidligst genoptages 48 timer efter kirurgi eller genoptagelse af oral ernæring og under forudsætning af, at nyrefunktionen er blevet vurderet og fundet stabil.
English: EU/1/08/456/010 EU/1/08/456/011 EU/1/08/456/012 EU/1/08/456/013 EU/1/08/456/014 EU/1/08/456/016 EU/1/08/456/018 EU/1/08/456/021 EU/1/08/456/022
Danish: EU/1/08/456/008 EU/1/08/456/009 EU/1/08/456/010 EU/1/08/456/011 EU/1/08/456/012 EU/1/08/456/013 EU/1/08/456/014 EU/1/08/456/016 EU/1/08/456/018 EU/1/08/456/021 EU/1/08/456/022
English: How to take Velmetia
Danish: Sådan skal De tage Velmetia
English: Frequency of adverse reaction upper abdominal pain
Danish: Øvre abdominalsmerter
English: Velmetia should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.3 and
Danish: Behandlingen med Velmetia skal afbrydes forud for eller på tidspunktet for billeddiagnostiske procedurer og først genoptages mindst 48 timer herefter, forudsat at nyrefunktionen er blevet vurderet og fundet stabil (se pkt.
English: EU/1/08/456/008 14 film-coated tablets EU/1/08/456/009 28 film-coated tablets EU/1/08/456/010 56 film-coated tablets EU/1/08/456/021 60 film-coated tablets EU/1/08/456/011 112 film-coated tablets EU/1/08/456/012 168 film-coated tablets EU/1/08/456/022 180 film-coated tablets EU/1/08/456/013 196 film-coated tablets EU/1/08/456/014 50 x 1 film-coated tablets EU/1/08/456/016 196 (2 x 98) film-coated tablets EU/1/08/456/018 168 (2 x 84) film-coated tablets
Danish: EU/1/08/456/008 14 filmovertrukne tabletter EU/1/08/456/009 28 filmovertrukne tabletter EU/1/08/456/010 56 filmovertrukne tabletter EU/1/08/456/021 60 filmovertrukne tabletter EU/1/08/456/011 112 filmovertrukne tabletter EU/1/08/456/012 168 filmovertrukne tabletter EU/1/08/456/022 180 filmovertrukne tabletter EU/1/08/456/013 196 filmovertrukne tabletter EU/1/08/456/014 50 x 1 filmovertrukne tabletter EU/1/08/456/016 196 (2 x 98) filmovertrukne tabletter EU/1/08/456/018 168 (2 x 84) filmovertrukne tabletter