FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used in patients with type 1 diabetes, patients who have complications of diabetes (diabetic ketoacidosis or diabetic coma), or women who are pregnant or breastfeeding.
Danish: Det må ikke anvendes af patienter med type 1-diabetes, patienter med sukkersygekomplikationer (ketoacidose eller diabetisk koma) eller af kvinder, der er gravide eller ammer.
English: Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Pioglitazon gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
English: The company provided evidence that the levels of the active substances in the blood were the same in people taking Tandemact and people taking the separate tablets.
Danish: Virksomheden fremlagde dokumentation for, at blodets indhold af de aktive stoffer var det samme hos patienter, der tog Tandemact, og patienter, der tog særskilte tabletter.
English: Tandemact is a medicine that contains two active substances, pioglitazone and glimepiride.
Danish: Tandemact er et lægemiddel, der indeholder de to aktive stoffer pioglitazon og glimepirid.
English: The studies lasted between four months and two years and measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: Undersøgelserne varede mellem fire måneder og to år, og i disse måltes blodets indhold af et stof kaldet glykosyleret hæmoglobin (HbA1c), som viser, hvor godt blodets sukkerindhold reguleres.
English: As a result of the action of both active substances, the blood glucose level is reduced and this helps to control type 2 diabetes.
Danish: Som resultat af virkningen af begge aktive stoffer sænkes blodsukkeret, og dette medvirker til at regulere type 2-diabetes.
English: Actos is approved for use with a sulphonylurea in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Danish: Actos er godkendt til anvendelse i kombination med et sulfonylurinstof til patienter med type 2-diabetes, som ikke kontrolleres tilfredsstillende med metformin alene.
English: Patients who are receiving pioglitazone together with another medicine in the same class as glimepiride (i.e. another sulphonylurea) should first be switched from this other sulphonylurea to glimepiride before they can transfer to Tandemact.
Danish: Patienter, der får pioglitazon i kombination med et andet lægemiddel fra samme klasse som glimepirid (dvs. et andet sulfonylurinstof), bør først skifte til glimepirid, inden de kan skifte over til Tandemact.
English: The CHMP concluded that the effectiveness of pioglitazone and glimepiride in type 2 diabetes had been shown, and that Tandemact simplifies treatment and improves the ability of patients to stick to their treatment when a combination of the two active substances is needed.
Danish: CHMP konkluderede, at der var påvist effekt af pioglitazon og glimepirid til type 2-diabetes, og at Tandemact forenkler behandlingen og forbedrer overholdelsen af anvendelsesbestemmelserne, når der kræves en kombination af de aktive indholdsstoffer.
English: Patients who experience hypoglycaemia (low blood sugar levels) while taking Tandemact may need to use a lower dose of the medicine or to return to using separate tablets.
Danish: For patienter, som udvikler hypoglykæmi (for lave blodsukkerkoncentrationer), mens de tager Tandemact, kan det være nødvendigt anvende en mindre dosis eller vende tilbage til særskilte tabletter.
English: Glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin.
Danish: Glimepirid er et sulfonylurinstof, som stimulerer bugspytkirtlen til at producere mere insulin.
English: What is the risk associated with Tandemact?
Danish: Hvilken risiko er der forbundet med Tandemact?
English: For the full list of all side effects reported with Tandemact, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Tandemact fremgår af indlægssedlen.
English: These studies used pioglitazone and sulphonylureas given as separate tablets.
Danish: I undersøgelserne blev der anvendt pioglitazon og sulfonylurinstof i særskilte tabletter.
English: It is used in patients for whom metformin (a type of diabetes medicine) is not suitable and who are already being treated with a combination of tablets containing the two active substances pioglitazone and glimepiride.
Danish: Det anvendes til patienter, som ikke kan behandles med metformin (et lægemiddel mod sukkersyge), og som allerede behandles med en kombination af tabletter med de to aktive stoffer pioglitazon og glimepirid.
English: The company that markets Tandemact will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Danish: Materialet skal redegøre for den mulige risiko for hjertesvigt og blærekræft ved lægemidler, der indeholder pioglitazon, kriterier for udvælgelse af patienterne og behovet for regelmæssig gennemgang og indstilling af behandlingen, hvis patienten ikke længere har gavn af den.
English: In all three studies, patients who used a combination of pioglitazone and a sulphonylurea had an improvement in the control of their blood glucose.
Danish: I alle tre undersøgelser oplevede patienter, som fik en kombination af pioglitazon og sulfonylurinstof, at reguleringen af blodsukkeret blev bedre.
English: Why has Tandemact been approved?
Danish: Hvorfor blev Tandemact godkendt?
English: Tandemact must not be used in patients who have heart failure, problems with their liver or severe problems with their kidneys.
Danish: Tandemact må ikke anvendes til patienter, der lider af hjertesvigt, leversygdomme eller alvorlige nyreproblemer.
English: Tandemact cannot be used in patients who have severe kidney problems, or in patients who have liver problems.
Danish: Tandemact må ikke anvendes til patienter, som har svære nyreproblemer, eller som har leverproblemer.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tandemact have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Tandemact.
English: What is Tandemact used for?
Danish: Hvad anvendes Tandemact til?
English: What is Tandemact?
Danish: Hvad er Tandemact?
English: What benefit has Tandemact shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Tandemact?
English: How has Tandemact been studied?
Danish: Hvordan blev Tandemact undersøgt?
English: How is Tandemact used?
Danish: Hvordan anvendes Tandemact?
English: How does Tandemact work?
Danish: Hvordan virker Tandemact?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xalkori on 23 October 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xalkori den 23. oktober 2012.
English: Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects.
Danish: Doserne skal måske udskydes, eller behandlingen standses helt, hvis patienten udvikler visse alvorlige bivirkninger.
English: The full EPAR for Xalkori can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Xalkori findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Xalkori.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xalkori.
English: This is considered a favourable response when compared with response rates of around 20 to 30% to previous treatments, in those patients who had been given them.
Danish: Dette anses for at være et positivt resultat i forhold til responsraterne på ca. 20-30 % ved tidligere behandlinger hos patienter, som havde fået disse.
English: For the previously untreated patients, 6 out of 7 responded to treatment.
Danish: Blandt de patienter, der ikke tidligere var blevet behandlet, responderede 6 ud af 7 på behandlingen.
English: If certain side effects develop the doctor may decide to interrupt or reduce the dose to 200 mg twice per day then to 250 mg once per day.
Danish: Ved visse bivirkninger kan lægen beslutte at afbryde behandlingen eller nedsætte dosis til 200 mg to gange dagligt og derefter 250 mg én gang dagligt.
English: Other information about Xalkori
Danish: Andre oplysninger om Xalkori
English: This means that the cancer cells contain changes affecting the gene responsible for the protein ROS1.
Danish: Dette betyder, at kræftcellerne indeholder ændringer, der påvirker genet for proteinet ROS1.
English: What measures are being taken to ensure the safe and effective use of Xalkori?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xalkori?
English: Treatment with Xalkori should be started and supervised by a doctor who is experienced in using cancer medicines.
Danish: Behandlingen med Xalkori bør indledes og overvåges af en læge med erfaring i anvendelse af kræftlægemidler.
English: A study in 53 ROS1-positive patients with advanced disease showed that around 70% of patients taking Xalkori (37 out of 53) responded completely or partially to treatment.
Danish: En undersøgelse af 53 ROS1-positive patienter med fremskreden sygdom viste, at omkring 70 % af patienterne, som fik Xalkori (37 ud af 53), responderede helt eller delvis på behandlingen.
English: Xalkori contains the active substance crizotinib.
Danish: Xalkori indeholder det aktive stof crizotinib.
English: Therefore the Agency decided that Xalkori's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturet besluttede derfor, at fordelene ved Xalkori opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Xalkori.
English: The presence of the genetic changes affecting ALK (‘ALK-positive' status) or ROS1 (‘ROS1-positive' status) has to be confirmed before starting treatment with Xalkori.
Danish: Tilstedeværelsen af genændringen, der påvirker ALK ("ALK-positiv"-status) eller ROS1 ("ROS1-positiv"-status), skal være bekræftet, inden behandlingen med Xalkori indledes.
English: The most serious side effects are liver damage, pneumonitis (lung inflammation), neutropenia (low blood levels of neutrophils, a type of white blood cell) and prolonged QT interval (a problem with the electrical activity of the heart).
Danish: De mest alvorlige bivirkninger er leverskader, lungebetændelse (pneumonitis), neutropeni (lavt antal neutrofiler, en type hvide blodceller) og forlænget QT-interval (et problem vedrørende den elektriske aktivitet i hjertet).
English: The active substance in Xalkori, crizotinib, is an RTK inhibitor.
Danish: Det aktive stof i Xalkori, crizotinib, er en RTK-hæmmer.
English: The most common side effects with Xalkori (seen in more than 1 in 4 patients) are vision problems, nausea (feeling sick), diarrhoea, vomiting, oedema (swelling), increases in liver enzymes in the blood, decreased appetite, constipation, dizziness, neuropathy (pain due to nerve damage) and tiredness.
Danish: De hyppigste bivirkninger ved Xalkori (som optræder hos mere end 1 ud af 4 patienter) er synsforstyrrelser, kvalme, diarré, opkastning, ødem (hævelse), forhøjede leverenzymtal i blodet, nedsat appetit, forstoppelse, svimmelhed, neuropati (smerte på grund af nerveskader) og træthed.
English: It is not intended to provide practical advice on how to use Xalkori.
Danish: Det er ikke en praktisk vejledning i, hvordan Xalkori bør anvendes.
English: The company that markets Xalkori will ensure that doctors who are expected to prescribe Xalkori receive a pack containing the medicine's summary of product characteristics and a patient alert card to be given to patients.
Danish: Virksomheden, der markedsfører Xalkori, skal sørge for, at læger, der forventes at ordinere Xalkori, modtager en pakke med lægemidlets produktinformation og et patientadvarselskort, som skal udleveres til patienterne.
English: ALK and ROS1 belong to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells.
Danish: ALK og ROS1 er proteiner i familien receptor-tyrosinkinaser (RTK), der medvirker ved cellers vækst.
English: Xalkori is a cancer medicine used on its own to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the disease is advanced:
Danish: Xalkori er et kræftlægemiddel, der anvendes alene til behandling af voksne med en type lungekræft kaldet ikke-småcellet lungekræft (NSCLC), når sygdommen er fremskreden.
English: For patients with ROS1-positive NSCLC, for whom no specific treatments are currently available, the Agency noted the evidence of a high response rate, in particular for patients who had previously received other cancer treatments.
Danish: For patienter med ROS1-positiv ikke-småcellet lungekræft, som der på nuværende tidspunkt ikke findes nogen specifik behandling for, bemærkede agenturet den dokumenterede høje responsrate, navnlig for patienter, som ikke tidligere havde fået anden kræftbehandling.
English: What is Xalkori and what is it used for?
Danish: Hvad er Xalkori, og hvad anvendes det til?
English: Xalkori is available as capsules (200 mg and 250 mg).The recommended dose is 250 mg twice per day.
Danish: Xalkori fås som kapsler (200 mg og 250 mg).
English: Why is Xalkori approved?
Danish: Hvorfor er Xalkori blevet godkendt?
English: • It is used if the NSCLC is ‘ALK-positive', which means that the cancer cells contain certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
Danish: • Det anvendes ved ikke-småcellet lungekræft, der er "ALK-positiv", dvs. at kræftcellerne indeholder visse ændringer, der påvirker genet for et protein kaldet ALK (anaplastisk lymfomkinase).
English: In patients either ‘ALK-positive' or ‘ROS1-positive', the ALK or ROS1 protein is abnormally active and can promote the growth of cancer cells and the development of new blood vessels that supply them.
Danish: Hos "ALK-positive" eller "ROS1-positive" patienter er ALK- eller ROS1-proteinet unormalt aktivt og kan fremme vækst af kræftceller og udvikling af nye blodårer, der forsyner disse kræftceller.
English: It works mainly by blocking the activity of ALK or ROS1, including when the genetic change is present, thereby reducing the growth and spread of the cancer in ALK-positive or in ROS1-positive NSCLC.
Danish: Det virker hovedsagelig ved at blokere virkningen af ALK eller ROS1, også når den genetiske ændring er til stede, og mindsker derved væksten og udbredelsen af ALK-positiv eller ROS1-positiv ikke-småcellet lungekræft.
English: For more information about treatment with Xalkori, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Xalkori, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • It is also used when the NSCLC is ‘ROS1-positive'.
Danish: • Det anvendes også, når ikke-småcellet lungekræft er "ROS1-positiv".
English: What is the risk associated with Xalkori?
Danish: Hvilken risiko er der forbundet med Xalkori?
English: For the full list of all side effects reported with Xalkori, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Xalkori fremgår af indlægssedlen.
English: The European Medicines Agency concluded that treatment with Xalkori increases the time patients with ALK-positive NSCLC live without the disease getting worse, irrespective of whether they are previously treated.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at behandling med Xalkori har en gavnlig virkning på, hvor længe patienter med ALK-positiv ikke-småcellet lungekræft overlever, uden at sygdommen forværres, uanset om de tidligere var blevet behandlet.
English: In another study in 343 patients who had not received previous treatment for their NSCLC before, patients treated with Xalkori lived on average for nearly 11 months without their disease getting worse compared with 7 months in patients who were treated with pemetrexed-containing therapy.
Danish: I en anden undersøgelse af 343 patienter, der ikke tidligere var blevet behandlet for ikke-småcellet lungekræft, overlevede de, der fik Xalkori, gennemsnitligt i næsten 11 måneder, uden at sygdommen forværredes, sammenlignet med syv måneder for de patienter, som blev behandlet med præparater indeholdende pemetrexed.
English: A study in 347 previously treated ALK-positive patients showed that those taking Xalkori lived on average for nearly 8 months without their disease getting worse compared with 3 months in patients who were treated with either pemetrexed or docetaxel.
Danish: En undersøgelse af 347 tidligere behandlede patienter viste, at dem, der fik Xalkori, gennemsnitligt overlevede i næsten otte måneder, uden at sygdommen forværredes, sammenlignet med tre måneder for de patienter, som blev behandlet med pemetrexed eller docetaxel.
English: For practical information about using Xalkori, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Xalkori, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xalkori 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 Xalkori.
English: How is Xalkori used?
Danish: Hvordan anvendes Xalkori?
English: What benefits of Xalkori have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Xalkori?
English: How does Xalkori work?
Danish: Hvordan virker Xalkori?
English: Doses may need to be adjusted in patients with severely reduced kidney function.
Danish: Ved nedsat nyrefunktion kan det være nødvendigt med lavere dosis.
English: ROS1-positive NSCLC
Danish: ROS1-positiv ikke-småcellet lungekræft
English: ALK-positive NSCLC
Danish: ALK-positiv ikke-småcellet lungekræft
English: Side effects are similar in children.
Danish: Der er tilsvarende bivirkninger hos børn.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vepacel on 17 February 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vepacel den 17. februar 2012.
English: The full EPAR for Vepacel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Vepacel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Vepacel is a vaccine.
Danish: Vepacel er en vaccine.
English: A risk management plan has been developed to ensure that Vepacel is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vepacel anvendes så sikkert som muligt.
English: This is a summary of the European public assessment report (EPAR) for Vepacel.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vepacel.
English: What measures are being taken to ensure the safe and effective use of Vepacel?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vepacel?
English: The vaccine is given by injection into the shoulder or thigh in two single doses, at least three weeks apart.
Danish: Vaccinen gives ved injektion i skulderen eller låret i to enkeltdoser med mindst tre ugers mellemrum.
English: If vaccination is necessary, facilities to resuscitate patients need to be immediately available.
Danish: Hvis det er nødvendigt at vaccinere, skal der være genoplivningsudstyr til umiddelbar rådighed.
English: Other information about Vepacel
Danish: Andre oplysninger om Vepacel
English: Vepacel contains a flu strain called A/Vietnam/1203/2004 (H5N1).
Danish: Vepacel indeholder en influenzastamme kaldet A/Vietnam/1203/2004 (H5N1).
English: This may help to protect against the disease caused by the virus.
Danish: Dette er med til at beskytte mod den sygdom, som virusset forårsager.
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 Vepacel.
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 Vepacel.
English: Both studies looked separately at people aged above and below 60 years old.
Danish: I begge undersøgelser blev der set separat på personer over og personer under 60 år.
English: Influenza vaccine (whole virion, inactivated)
Danish: Influenzavaccine (hel virion, inaktiveret)
English: According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable.
Danish: Ifølge de kriterier, der er fastlagt af CHMP, skal en præpandemisk vaccine frembringe en beskyttende mængde antistoffer hos mindst 70 % af de vaccinerede voksne, for at den anses for egnet.
English: Two main studies provided data on vaccination with Vepacel in adults.
Danish: Der blev gennemført to hovedundersøgelser, som resulterede i data om vaccination af voksne med Vepacel.
English: What is the risk associated with Vepacel?
Danish: Hvilken risiko er der forbundet med Vepacel?
English: For more information about treatment with Vepacel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vepacel, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Moreover, protective levels of antibodies were seen in 71.6% of patients with a weakened immune system and 77.5% of patients with a long-term illness.
Danish: Endvidere kunne der iagttages beskyttende mængder antistoffer hos 71,6 % af patienterne med et svækket immunsystem og hos 77,5 % af patienterne med langvarig sygdom.
English: Vepacel must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine or to any of the substances found at trace (very low) levels in the vaccine such as formaldehyde, benzonase, sucrose, trypsin or vero cell protein.
Danish: Vepacel må ikke gives til personer, der har haft en anafylaktisk reaktion (svær overfølsomhedsreaktion) over for en af vaccinens komponenter eller over for et af de sporstoffer, som den indeholder (meget lavt indhold), f.eks. formaldehyd, benzonase, sukrose, trypsin eller verocelleprotein.
English: No major safety issues were seen during the studies and the side effects seen were generally mild and similar to those seen with other flu vaccines.
Danish: Der var ikke større betænkeligheder med hensyn til sikkerheden i løbet af undersøgelserne, og de konstaterede bivirkninger var generelt milde og svarede til dem, der kan iagttages ved andre influenzavacciner.
English: Vepacel is a ‘prepandemic' vaccine.
Danish: Vepacel er en "præpandemisk" vaccine.