FrancophonIA/ELRC3.0 huggingface dataset:
English: In the third study in 320 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 0.82 percentage points compared with a reduction of 0.10 percentage points in patients receiving metformin, saxagliptin and placebo.
Danish: I det tredje studie med 320 patienter sænkede kombinationen af metformin, saxagliptin og dapagliflozin gennemsnitligt HbA1c med 0,82 procentpoint sammenlignet med en reduktion på 0,10 procentpoint hos patienter, der fik metformin, saxagliptin og placebo.
English: In the second study in 315 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 0.51 percentage points compared with a reduction of 0.16 percentage points in patients receiving metformin, dapagliflozin and placebo (dummy treatment).
Danish: I det andet studie med 315 patienter sænkede kombinationen af metformin, saxagliptin og dapagliflozin gennemsnitligt HbA1c med 0,51 procentpoint sammenlignet med en reduktion på 0,16 procentpoint hos patienter, der fik metformin, dapagliflozin og placebo (en uvirksom behandling).
English: In the first study, the patients had an average of 0.021 serious infections per year.
Danish: I den første undersøgelse fik patienterne i gennemsnit 0,021 alvorlige infektioner årligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Flebogammadif on 23 August 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Flebogammadif den 23. august 2007.
English: IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection.
Danish: IgG har været anvendt som lægemiddel siden 1980'erne og virker mod en række organismer, der kan forårsage infektioner.
English: Since this is below the predefined threshold of one infection per year, this indicates that the medicine is effective in replacing the patient's antibodies.
Danish: Da dette er mindre end den på forhånd fastlagte tærskelværdi på én infektion årligt, tyder det på, at lægemidlet er effektivt til at erstatte patientens antistoffer.
English: The full EPAR for Flebogamma DIF can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Flebogamma DIF findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The dose and frequency of infusion depend on the disease being treated, and may need to be adjusted for patients depending on their response.
Danish: Dosis og hyppighed af infusionen afhænger af den behandlede sygdom, og det kan være nødvendigt at foretage en justering afhængig af patientens respons.
English: The medicine must not be used in patients who are intolerant to fructose (a type of sugar).
Danish: Lægemidlet må ikke anvendes hos patienter, der ikke tåler fruktose (en sukkerart).
English: The name of the medicine was changed to Flebogamma DIF on 2 September 2010.
Danish: Lægemidlets navn blev ændret til Flebogamma DIF den 2. september 2010.
English: The main measure of effectiveness was the number of serious bacterial infections over a year's treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af alvorlige bakterielle infektioner i løbet et års behandling.
English: In the first study, involving 46 patients with PID, the medicine was infused every 21 to 28 days.
Danish: I den første undersøgelse, som omfattede 46 patienter med PID, blev lægemidlet givet som infusion hver 21. til 28. dag.
English: This is a summary of the European public assessment report (EPAR) for Flebogamma DIF.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Flebogamma DIF.
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 Flebogamma DIF.
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 Flebogamma DIF.
English: As human normal immunoglobulin has been used to treat these diseases for some time, only two small studies were needed to establish the effectiveness and safety of Flebogamma DIF in patients.
Danish: Da humant normalt immunglobulin har været anvendt til behandling af de pågældende sygdomme i nogen tid, var det tilstrækkeligt med to små undersøgelser til at fastslå virkningen og sikkerheden af Flebogamma DIF hos patienterne.
English: In the second study, up to 14 (73%) of the 19 patients who remained in the study had a platelet count above 50 million platelets per millilitre at least once during the study.
Danish: I den anden undersøgelse havde op til 14 (73 %) af de 19 patienter, som forblev i undersøgelsen, et blodpladetal på over 50 millioner blodplader pr. ml.
English: Therefore, the CHMP concluded that Flebogamma DIF's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Derfor konkluderede CHMP, at fordelene ved Flebogamma DIF opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: They can also be approved for the treatment of patients with Guillain-Barré syndrome, patients with Kawasaki disease and patients undergoing haematopoietic stem cell transplantation, without the need for specific studies in these diseases.
Danish: De kan desuden godkendes til behandling af patienter med Guillain-Barrés syndrom, patienter med Kawasakis sygdom og patienter, der får foretaget hæmatopoietisk stamcelletransplantation, uden at der foretages særlige undersøgelser i disse sygdomme.
English: Flebogamma DIF was not compared with any other treatment in either study.
Danish: Flebogamma DIF blev ikke sammenlignet med andre behandlinger i nogen af undersøgelserne.
English: According to current guidelines, medicines that have been shown to be effective in patients with PID and in patients with ITP can also be approved for use in the treatment of all types of primary immunodeficiency, as well as low antibody levels due to blood cancers and AIDS in children.
Danish: Ifølge de nugældende retningslinjer kan lægemidler, der er påvist at virke hos patienter med PID og patienter med ITP, også godkendes til behandling af alle former for primære immundefekter samt ved lavt antistofindhold som følge af blodkræft og aids hos børn.
English: For more information about treatment with Flebogamma DIF, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Flebogamma DIF, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It contains the active substance human normal immunoglobulin.
Danish: Det indeholder det aktive stof humant normalt immunoglobulin.
English: • Acquired immune deficiency syndrome (AIDS) in children who contracted HIV from birth and have frequent infections.
Danish: • erhvervet immundefektsyndrom (aids) hos børn, der er født med hiv, og som har hyppige infektioner.
English: Flebogamma DIF is given by infusion into a vein by a doctor or nurse, but patients (or their carers) may administer it themselves once they have been trained.
Danish: Flebogamma DIF gives ved infusion i en vene af en læge eller sygeplejerske, men patienten (eller dennes omsorgsgiver) kan godt selv give lægemidlet efter at have fået oplæring.
English: • Hypogammaglobulinaemia (low levels of antibodies) in patients: with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) and frequent bacterial infections after preventive treatment with antibiotics has failed; with multiple myeloma (another cancer of a type of white blood cell) and frequent bacterial infections and in whom vaccination against ‘pneumococcal' bacteria has failed; who have had haematopoietic (blood) stem cell transplantation (when the patient receives stem cells from a matched donor to help restore the bone marrow).
Danish: • hypogammaglobulinæmi (lavt niveau af antistoffer) hos patienter: med kronisk lymfoid leukæmi (kræft i en type hvide blodlegemer) og hyppige bakterielle infektioner efter mislykket præventiv behandling med antistoffer med multiple myelomer (en anden kræftform i en type hvide blodlegemer) og hyppige bakterielle infektioner, og hos hvem vaccination mod pneumokokbakterier er slået fejl som har fået foretaget en hæmatopoietisk (blod)stamcelletransplantation (hvor patienten modtager stamceller fra en egnet donor med henblik på at gendanne knoglemarven)
English: • Guillain-Barré syndrome, which causes multiple inflammations of the nerves in the body;
Danish: • Guillain-Barrés syndrom, som forårsager multiple betændelsestilstande i kroppens nerver
English: • Kawasaki disease, which causes multiple inflammations of several organs in the body.
Danish: • Kawasakis sygdom, som forårsager multiple betændelsestilstande i flere af kroppens organer.
English: The active substance in Flebogamma DIF, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood).
Danish: Det aktive stof i Flebogamma DIF, humant normalt immunglobulin, er et højtrenset protein, der er udvundet af humant blodplasma (en bestanddel af blodet).
English: The second study looked at using Flebogamma DIF in 20 patients with ITP.
Danish: I den anden undersøgelse blev Flebogamma DIF givet til 20 patienter med ITP.
English: Flebogamma DIF is used in patients who need more antibodies in their blood to help fight infections and other diseases.
Danish: Flebogamma DIF anvendes til patienter, som ikke har tilstrækkeligt med antistoffer i blodet til at bekæmpe infektioner og andre sygdomme.
English: Previously known as Flebogammadif
Danish: 1 Tidligere kendt som Flebogammadif
English: Flebogamma DIF must not be used in people who are allergic to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulin, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Danish: Flebogamma DIF må ikke anvendes hos patienter, der er allergiske over for humant normalt immunglobulin eller andre af indholdsstofferne, eller hos patienter med allergi over for andre typer immunglobulin, navnlig hvis de har et meget lavt indhold af immunglobulin A (IgA) og danner antistoffer mod IgA.
English: • Idiopathic thrombocytopenic purpura (ITP), a condition where people do not have enough platelets in the blood;
Danish: • idiopatisk trombocytopenisk purpura (ITP), som er en tilstand, hvor patienterne har for få blodplader
English: Flebogamma DIF is also used to treat certain immune system disorders:
Danish: Flebogamma DIF anvendes også til behandling af visse immunsygdomme:
English: The main measure of effectiveness was the highest blood platelet level that was achieved during the three-month study.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor højt indholdet af blodplader nåede op i løbet af de tre måneder, undersøgelsen varede.
English: • Primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies).
Danish: • primære immundefektsyndromer (PID), som er en medfødt manglende evne til at danne tilstrækkeligt med antistoffer
English: Flebogamma DIF works by restoring abnormally low IgG levels to their normal range in the blood.
Danish: Flebogamma DIF's virkning består i, at det bringer et unormalt lavt IgG-indhold i blodet tilbage til det normale.
English: Flebogamma DIF is a solution for infusion (drip into a vein).
Danish: Flebogamma DIF er en infusionsvæske, opløsning (drop i en vene).
English: Other information about Flebogamma DIF
Danish: Andre oplysninger om Flebogamma DIF:
English: human normal immunoglobulin
Danish: humant normalt immunglobulin
English: In babies and young children, hereditary fructose intolerance may not yet have been diagnosed and may be fatal; this medicine must therefore not be given to babies and children below two years of age.
Danish: Dette lægemiddel må derfor ikke gives til spædbørn og børn under to år.
English: What is the risk associated with Flebogamma DIF?
Danish: Hvilken risiko er der forbundet med Flebogamma DIF?
English: Flebogamma DIF is made like Flebogamma, another medicine containing human normal immunoglobulin, with some additional steps in the purification of the product from human plasma.
Danish: Flebogamma DIF fremstilles på samme måde som Flebogamma, et andet lægemiddel, der indeholder humant normalt immunglobulin.
English: Side effects such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate low back pain may occasionally occur with Flebogamma DIF.
Danish: Bivirkninger såsom kulderystelser, hovedpine, svimmelhed, feber, opkast, allergiske reaktioner, kvalme, ledsmerter, lavt blodtryk og moderate lændesmerter kan undertiden forekomme ved Flebogamma DIF. I sjældne tilfælde kan humane normale immunoglobuliner medføre et pludseligt blodtryksfald og i enkelte tilfælde anafylaktisk chok (en alvorlig allergisk reaktion), selvom patienten ikke tidligere har haft en allergisk reaktion over for lægemidlet.
English: Why has Flebogamma DIF been approved?
Danish: Hvorfor blev Flebogamma DIF godkendt?
English: What is Flebogamma DIF?
Danish: Hvad er Flebogamma DIF?
English: How has Flebogamma DIF been studied?
Danish: Hvordan blev Flebogamma DIF undersøgt?
English: What benefit has Flebogamma DIF shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Flebogamma DIF?
English: How is Flebogamma DIF used?
Danish: Hvordan anvendes Flebogamma DIF?
English: What is Flebogamma DIF used for?
Danish: Hvad anvendes Flebogamma DIF til?
English: How does Flebogamma DIF work?
Danish: Hvordan virker Flebogamma DIF?
English: The results have been negative.
Danish: Resultaterne har været negative.
English: You may need to use both hands.
Danish: Det er måske nødvendigt at bruge begge hænder.
English: Not for children
Danish: Ikke til børn
English: This is unlikely to happen again.
Danish: Dette vil dog næppe ske igen.
English: These can include:
Danish: Disse kan omfatte:
English: Part of a multi-pack.
Danish: Del af en multipakke.
English: Date of first authorisation: 13 March 1997 Date of latest renewal: 13 March 2007
Danish: Dato for første markedsføringstilladelse: 13. marts 1997 Dato for seneste fornyelse: 13. marts 2007
English: Call a doctor immediately.
Danish: Søg omgående læge.
English: At the present time, it is not known for how long patients should be treated.
Danish: På indeværende tidspunkt vides det ikke, hvor lang tid patienterne bør behandles.
English: MS also tends to flare up from time to time: this is called a relapse.
Danish: MS har ligeledes tendens til at blusse op fra tid til anden: dette kaldes et attak.
English: Alternate the left and right thighs.
Danish: Skift mellem venstre og højre lår.
English: This is the safety lock.
Danish: Det er sikkerhedslåsen.
English: Once the pen is sealed there is no risk of injury.
Danish: Når pennen er forseglet, er der ingen risiko for skade.
English: The activity against other standards is not known.
Danish: Aktiviteten ifølge andre standarder kendes ikke.
English: No formal interaction studies have been performed in humans.
Danish: Der er ikke udført formaliserede interaktionsstudier hos mennesker.
English: Allow the skin to dry.
Danish: Lad huden tørre.
English: 5 Disposal
Danish: 5 Bortskaffelse
English: 10 seconds.
Danish: 10 hele sekunder.
English: This latter clinical effect was observed after more than one year of treatment.
Danish: Denne sidste kliniske virkning blev observeret efter mere end ét års behandling.
English: An effect on MRI parameters was also seen.
Danish: Man så også en effekt på MRI parametrene.
English: These symptoms are not really flu.
Danish: Disse symptomer er faktisk ikke influenza.
English: More about depression.
Danish: Mere om depression.
English: The window will now appear yellow when the full dose has been delivered.
Danish: Vinduet vil være gult, når hele dosis er givet.
English: When myelin is damaged, the messages between the brain and other parts of the body are disrupted.
Danish: Når myelinet er beskadiget, bliver meddelelserne mellem hjernen og andre dele af kroppen afbrudt.
English: Experience with exposure during the second and third trimester is very limited.
Danish: Erfaring med eksponering i graviditetens andet og tredje trimester er meget begrænset.
English: Alternative assay techniques are not sufficiently sensitive.
Danish: Alternative analyse teknikker er ikke tilstrækkeligt følsomme.
English: Relax your muscle.
Danish: Slap af i musklen.
English: Elderly: Clinical studies did not include a sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients.
Danish: Ældre: Kliniske studier omfattede ikke et tilstrækkeligt antal patienter i alderen 65 år og derover til at påvise, hvorvidt de responderer forskelligt fra yngre patienter.
English: - The pen is broken.
Danish: Pennen er knækket.
English: No direct comparison with the dose currently recommended in adults is available.
Danish: Der findes ikke nogen direkte sammenligning med den dosis, der for øjeblikket anbefales til voksne.
English: These interferons have overlapping but clearly distinguishable biological activities.
Danish: Disse interferoner har overlappende, men dog klart forskellige biologiske virkninger.
English: You may not get the full dose if it leaks.
Danish: du får muligvis ikke den fulde dosis, hvis den lækker.
English: You may also wish to make a note of these details in case you are asked for this information in the future.
Danish: Du kan eventuelt også selv notere disse oplysninger i tilfælde af, at du skulle blive bedt om at udlevere dem i fremtiden.
English: It gives you an idea how likely you are to get similar side effects.
Danish: Dette giver dig en idé om, hvor stor sandsynligheden er for, at du får lignende bivirkninger.
English: Mutagenesis: Limited but relevant mutagenesis tests have been carried out.
Danish: Mutagenicitet: Begrænsede, men relevante test for mutagenicitet er gennemført.
English: It may make you feel faint.
Danish: Den kan få dig til at føle dig svimmel.
English: For example, 100 person-years could be observed in 100 patients who were on treatment for one year or in 200 patients who were on treatment for half a year.
Danish: For eksempel, 100 person-år kunne observeres hos 100 patienter, som var i behandling i ét år eller hos 200 patienter, som var i behandling i et halvt år.
English: In MS, your body's defence system reacts against its own myelin - the ‘insulation' that surrounds nerve fibres.
Danish: Ved MS reagerer din krops forsvarssystem imod sit eget myelin - den ‘isolering' der omgiver nervefibrene.
English: Point the needle cover away from you and anyone else.
Danish: Sørg for at kanylehætten peger væk fra dig og andre.
English: • Apply pressure to the injection site for a few seconds.
Danish: • Tryk på injektionsstedet nogle få sekunder.
English: Serious side effects: get medical help Serious allergic reactions
Danish: Alvorlige bivirkninger: Søg læge Alvorlige allergiske reaktioner
English: - The sealed plastic tray is damaged or opened.
Danish: - plastbakkens forsegling er beskadiget eller åbnet.
English: Wash your hands thoroughly with soap and water and dry them.
Danish: Vask hænderne grundigt med sæbe og vand, og tør dem.
English: You will hear a “click” indicating the injection process has begun.
Danish: Du vil høre et "klik", som angiver, at injektionen er begyndt.
English: Even if you have used Avonex before, some of the information may have changed.
Danish: Selv om du har anvendt Avonex tidligere, kan nogle af oplysningerne være blevet ændret.
English: Everyone has their own set of MS symptoms.
Danish: Alle har deres helt egne MS-symptomer.
English: With appropriate adjustment for the rate of absorption from the injection site, the calculated bioavailability is approximately 40%.
Danish: Med passende justering af absorptionshastigheden fra injektionsstedet er den beregnede biotilgængelighed ca. 40%.
English: The figures are based on how many people said they'd had them.
Danish: Tallene er baseret på, hvor mange mennesker, der sagde, at de havde oplevet disse bivirkninger.
English: Waste paper and used wipes can be put in an ordinary rubbish bin.
Danish: Papir og brugte servietter kan smides i en almindelig skraldespand.
English: Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Danish: Behandlingen bør indledes under supervision af en læge med erfaring i behandling af sygdommen.
English: If there is any blood at the site, wipe it off.
Danish: Hvis der er blod på stedet, skal det tørres af.
English: Disability progression was measured as an increase in the Expanded Disability Status Scale (EDSS) of 1.0 point, sustained for at least six months.
Danish: Progression af invaliditeten blev målt som en stigning i Expanded Disability Status Scale (EDSS) på 1,0 point, bestående over mindst seks måneder.
English: These symptoms are usually present during the first few months of treatment.
Danish: Disse symptomer er som regel til stede i de første få måneder af behandlingen.
English: Due to the design of the study, patients were followed for variable lengths of time.
Danish: På grund af undersøgelsens design blev patienterne fulgt i forskellig tid.
English: This means less risk of irritation to your skin and muscle.
Danish: Dette vil reducere risikoen for irritation af hud og muskel.
English: Make sure the windows of the pen are visible.
Danish: Sørg for, at vinduerne på pennen kan ses.
English: It contains less than 23 mg (1 mmol) sodium in each weekly dose.
Danish: Den indeholder mindre end 23 mg (1 mmol) natrium i hver ugentlige dosis.
English: Sensitivity to light.
Danish: Lysfølsomhed.
English: On each left hand page you'll find useful tips and explanations on how to get the best from your medicine.
Danish: På siderne til venstre finder du nyttige tips og forklaringer på, hvordan du får det bedste udbytte af din medicin.
English: However, the effects of interferon beta that are dependent on glycosylation are not fully defined.
Danish: De virkninger af interferon beta, der afhænger af glykosylering, er imidlertid ikke fuldstændigt klarlagt.
English: However, based on the mode of clearance of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Danish: På grund af det aktive stofs clearance metode er der ingen teoretiske grunde til at kræve dosisjustering hos ældre.
English: Make sure the cap is intact and has not been opened.
Danish: Vær sikker på, at hætten er intakt og ikke tidligere er blevet åbnet.
English: If this happens to you, or if you get any other side effects that could affect your ability, do not drive or use machines.
Danish: Hvis dette sker for dig, eller hvis du får andre bivirkninger, der kunne påvirke dine evner, må du ikke føre motorkøretøj eller betjene maskiner.
English: Because Avonex is based on a protein, there is a small chance of an allergic reaction.
Danish: Da Avonex er baseret på et protein, er der en lille risiko for, at der kan optræde en allergisk reaktion.
English: The frequencies of adverse reactions are expressed in patient-years, according to the following categories:
Danish: Bivirkningernes hyppighed udtrykkes i patient-år jævnfør nedenstående kategorier:
English: They can also differ with respect to their cellular sites of synthesis.
Danish: De kan ligeledes være forskellige med hensyn til, hvor i cellerne, de syntetiseres.
English: It is estimated that the plateau for the incidence of neutralising antibody formation is reached after 12 months of treatment.
Danish: Det skønnes, at plateauet for dannelsen af neutraliserende antistof nås efter 12 måneders behandling.