FrancophonIA/ELRC3.0 huggingface dataset:
English: 10 vials (powder) + 10 pre-filled syringes (solvent)+ 20 needles.
Danish: 1 hætteglas (pulver) + 1 forfyldt injektionssprøjte (solvens) + 1 kanyle 10 hætteglas (pulver) + 10 forfyldte injektionssprøjter (solvens) + 10 kanyler 20 hætteglas (pulver) + 20 forfyldte injektionssprøjter (solvens) + 20 kanyler
English: Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent patients; therefore, some of these patients may acquire measles, mumps, rubella, or varicella in case of contact, despite appropriate vaccine administration.
Danish: Derfor kan nogle af disse patienter få mæslinger, fåresyge, røde hunde eller skoldkopper i tilfælde af kontakt til trods for passende administration af vaccinen.
English: 20 vials (powder) + 20 pre-filled syringes (solvent)+ 20 needles.
Danish: 1 hætteglas (pulver) + 1 forfyldt injektionssprøjte (solvens) + 2 kanyler 10 hætteglas (pulver) + 10 forfyldte injektionssprøjter (solvens) + 20 kanyler 20 hætteglas (pulver) + 20 forfyldte injektionssprøjter (solvens) + 40 kanyler
English: Asthma, Pulmonary congestion, Sinus disorder, Sneezing, Wheezing
Danish: 4.3), pneumoni, lungekongestion, rhinitis, sinuitis, ondt i halsen
English: 20 vials (powder) + 20 pre-filled syringes without needle (solvent).
Danish: 1 hætteglas (pulver) + 1 forfyldt injektionssprøjte uden kanyle (solvens) 10 hætteglas (pulver) + 10 forfyldte injektionssprøjter uden kanyle (solvens) 20 hætteglas (pulver) + 20 forfyldte injektionssprøjter uden kanyle (solvens)
English: SSPE
Danish: EXP.
English: Adverse reactions
Danish: Allergi
English: Posology
Danish: Mæslinge
English: ProQuad is available in pack of 1 and pack of 10.
Danish: ProQuad fås i pakninger med 1 stk. og pakninger med 10 stk. Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Withdraw the entire volume of solvent into a syringe.
Danish: Al solvensen i hætteglasset trækkes op i en injektionssprøjte.
English: Transmission
Danish: Smittespredning
English: ProQuad powder and solvent for suspension for injection in a pre-filled syringe Measles, mumps, rubella and varicella vaccine (live)
Danish: ProQuad pulver og solvens til injektionsvæske, suspension i forfyldt injektionssprøjte Levende vaccine mod mæslinger, fåresyge, røde hunde og skoldkopper
English: ProQuad powder and solvent for suspension for injection Measles, mumps, rubella and varicella vaccine (live)
Danish: ProQuad pulver og solvens til injektionsvæske, suspension Levende vaccine mod mæslinger, fåresyge, røde hunde og skoldkopper
English: ProQuad Powder and solvent for suspension for injection Measles, mumps, rubella and varicella vaccine (live)
Danish: ProQuad Pulver og solvens til injektionsvæske, suspension Levende vaccine mod mæslinger, fåresyge, røde hunde og skoldkopper
English: Tel.: +420 233 010 111 dpoc_czechslovak@merck.com
Danish: Česká republika Merck Sharp & Dohme s. r. o. Tel: +420.233.010.111 dpoc_czechslovak@merck.com
English: Information was available from 23 patients.
Danish: Der forelå oplysninger fra 23 patienter.
English: This is expected to reduce the symptoms of the disease.
Danish: Dette forventes at reducere symptomerne på sygdommen.
English: London, 19 March 2008 Doc.
Danish: London, den 19. marts 2008 Ref.-dok.
English: International non-proprietary name (INN): miglustat
Danish: Internationalt fællesnavn (INN): miglustat
English: The medicine was also studied in 12 patients aged less than 12 years.
Danish: Lægemidlet blev også undersøgt hos 12 patienter under 12 år.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for ZAVESCA
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM ÆNDRING AF MARKEDSFØRINGSTILLADELSEN for ZAVESCA
English: Ref. EMEA/121008/2008
Danish: EMEA/186540/2008
English: The disease can result in dementia and is usually fatal before the patient has reached adulthood.
Danish: Sygdommen kan føre til demens og medfører normalt døden, inden patienten når voksenalderen.
English: The effects of Zavesca were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Zavesca blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: There are no consequences on the use of Zavesca in its authorised indication, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser at anvende Zavesca til den godkendte indikation, for hvilken benefit/riskforholdet forbliver uændret.
English: Zavesca is a hard white capsule, which contains the active substance miglustat.
Danish: Zavesca er en hård hvid kapsel, der indeholder det aktive stof miglustat.
English: What was Zavesca expected to be used for?
Danish: Hvad forventedes Zavesca anvendt til?
English: The medicine showed a very limited benefit in the main study: there was only a marginal difference in the change in the speed of eye movements between the patients taking Zavesca and those receiving standard care, and there were uncertainties over whether looking at eye movements was the best way to measure the medicine's effectiveness.
Danish: Lægemidlet viste meget begrænsede fordele i hovedundersøgelsen: Der var kun en marginal forskel i ændringen af hastigheden af øjenbevægelser mellem patienter, som tog Zavesca, og patienter, der fik standardbehandling, og der var usikkerhed omkring, hvorvidt øjets bevægelseshastighed var den bedste måde at bedømme lægemidlets virkning på.
English: Symptoms include a progressive loss of co-ordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, increased muscle tone, fits, and learning difficulties.
Danish: Symptomerne omfatter et gradvist tab af koordinationsevne, problemer med hurtige øjenbevægelser, der kan medføre nedsat syn, forsinket udvikling, synkebesvær, øget muskeltonus, krampeanfald og indlæringsvanskeligheder.
English: How is Zavesca expected to work?
Danish: Hvordan forventes Zavesca at virke?
English: What is happening for Zavesca for the treatment of type 1 Gaucher disease?
Danish: Hvad sker der med Zavesca til behandling af Gauchers sygdom, type 1?
English: Gaucher disease is a rare, inherited disease that affects the way the body handles fats.
Danish: Gauchers sygdom er en sjælden, arvelig sygdom, som påvirker den måde, kroppen håndterer fedtstoffer på.
English: Zavesca was also linked to side effects affecting the stomach and gut, as well as cases of weight loss and thrombocytopenia (low blood platelet counts).
Danish: Zavesca blev også forbundet med bivirkninger, der påvirkede maven og tarmene, samt vægttab og trombocytopeni (for lavt antal blodplader i blodet).
English: It is used for the treatment of mild to moderate type 1 Gaucher disease.
Danish: Det anvendes til behandling af let til moderat Gauchers sygdom, type 1.
English: Miglustat, the active substance in Zavesca, prevents an enzyme called ‘glucosylceramide synthase' from working.
Danish: Miglustat, som er det aktive stof i Zavesca, forhindrer et enzym kaldet glucosylceramidsyntase i at virke.
English: In patients with this disease, fatty substances such as ‘glycosphingolipids' build up within cells in the brain, as well as elsewhere in the body.
Danish: Hos patienter med denne sygdom ophobes fedtstoffer som f.eks. glycosphingolipider i celler i hjernen samt andre steder i kroppen.
English: The company also presented additional information from a worldwide survey of patients with Niemann Pick type C disease who had been treated with miglustat outside of the main study.
Danish: Virksomheden fremlagde yderligere oplysninger fra en verdensomspændende spørgeundersøgelse blandt patienter med Niemann Picks sygdom, type C, som var blevet behandlet med miglustat ved siden af hovedundersøgelsen.
English: In the new indication, Zavesca was expected to be used to treat the ‘neurological' symptoms of Niemann Pick type C disease (affecting the brain and nervous system).
Danish: I den nye indikation forventedes Zavesca anvendt til behandling af de neurologiske symptomer på Niemann-Picks sygdom, type C (påvirkning af hjernen og nervesystemet).
English: On 19 February 2008, Actelion Registration Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zavesca, in the treatment of neurological manifestations in patients with Niemann Pick type C disease.
Danish: Den 19. februar 2008 meddelte Actelion Registration Ltd. officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om en ny indikation for Zavesca til behandling af neurologiske manifestationer hos patienter med Niemann-Picks sygdom, type C.
English: Zavesca was designated as an orphan medicinal product on 16 February 2006 for Niemann Pick type C disease.
Danish: Zavesca blev udpeget som lægemiddel til sjældne sygdomme for Niemann-Picks sygdom, type C, den 16. februar 2006.
English: In patients with this disease, a fatty substance called glucosylceramide builds up in different parts of the body, such as the spleen, liver, and bones.
Danish: Hos patienter med denne sygdom ophobes glucosylceramidase forskellige steder i kroppen, herunder i milten, leveren og knoglerne.
English: was the change in the speed at which the patients made saccadic horizontal eye movements after a year's treatment.
Danish: Det primære mål for virkningen var ændringen i den hastighed, hvormed patienterne foretog hurtige vandrette øjenbevægelser efter et års behandling.
English: Niemann Pick type C disease is a rare inherited disease that affects the way the body handles fats.
Danish: Niemann-Picks sygdom, type C, er en sjælden, arvelig sygdom, der påvirker den måde, kroppen håndterer fedtstoffer på.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Zavesca?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Zavesca eller i programmer for anvendelse af Zavesca med særlig udleveringstilladelse?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Zavesca.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som for øjeblikket deltager i kliniske undersøgelser med Zavesca eller i programmer for anvendelse af Zavesca med særlig udleveringstilladelse.
English: Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend the approval of Zavesca for the treatment of neurological manifestations in patients with Niemann Pick type C disease.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Zavesca til behandling af neurologiske manifestationer hos patienter med Niemann Picks sygdom, type C.
English: The CHMP acknowledged that there are no alternative treatments for Niemann Pick type C disease, but it was concerned that a benefit of Zavesca in the treatment of the neurological symptoms of Niemann Pick type C disease had not been sufficiently demonstrated.
Danish: CHMP erkendte, at der ikke findes nogen alternativ behandling af Niemann Picks sygdom, type C, men var samtidig betænkelig ved, at fordelene ved Zavesca ved behandling af de neurologiske symptomer på Niemann Picks sygdom, type C, ikke var blevet påvist i tilstrækkeligt omfang.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Zavesca in the treatment of neurological manifestations in Niemann Pick type C disease did not outweigh its risks.
Danish: På daværende tidspunkt var CHMP derfor af den opfattelse, at fordelene ved Zavesca til behandling af neurologiske manifestationer hos patienter med Niemann Picks sygdom, type C, ikke opvejede risiciene.
English: The effectiveness of Zavesca has been studied in one main study involving 29 patients aged 12 years and over with Niemann Pick type C disease.
Danish: Virkningerne af Zavesca blev undersøgt i en hovedundersøgelse med 29 patienter i alderen 12 år og opefter med Niemann-Picks sygdom, type C. I undersøgelsen sammenlignede man virkningen af standardbehandling suppleret med Zavesca i en dosis på 200 mg tre gange dagligt med virkningen af
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tygacil on 24 April 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tygacil den 24. april 2006.
English: ‘Complicated' means that the infection is difficult to treat.
Danish: ”Kompliceret” betyder, at infektionen er svær at behandle.
English: The full EPAR for Tygacil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Tygacil findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Treatment lasts from 5 to 14 days.
Danish: Behandlingen varer mellem fem og 14 dage.
English: This document is a summary of the European Public Assessment Report (EPAR) for Tygacil.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tygacil.
English: Each infusion should last between 30 and 60 minutes.
Danish: Hver infusion bør vare mellem 30 og 60 minutter.
English: Other information about Tygacil:
Danish: Andre oplysninger om Tygacil:
English: The length of treatment depends on where the infection is, how severe it is, and the patient's response to treatment.
Danish: Behandlingens varighed afhænger af, hvor infektionsstedet er, hvor alvorlig infektionen er, og hvordan patienten reagerer på behandlingen.
English: Tygacil tigecycline
Danish: Tygacil tigecyclin
English: It works by blocking the bacteria's ribosomes, the parts of the cell where new proteins are made.
Danish: Det virker ved at blokere bakteriernes ribosomer, dvs. de dele af cellen, hvor der produceres nye proteiner.
English: A risk management plan has been developed to ensure that Tygacil is used as safely and effectively as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Tygacil anvendes så sikkert som muligt.
English: Tygacil should be used only when other antibiotics are not suitable.
Danish: Tygacil bør kun anvendes, når andre antibiotika ikke er egnede til behandling.
English: In all of the studies, the main measure of effectiveness was the number of patients whose infection was cured.
Danish: I alle undersøgelserne var det primære effektmål antallet af patienter, hos hvem infektionen forsvandt.
English: The CHMP decided that Tygacil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Tygacil er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Tygacil.
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 Tygacil.
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 Tygacil skal anvendes.
English: Before using Tygacil, doctors should consider official guidance on the appropriate use of antibiotics.
Danish: Før Tygacil anvendes, bør lægen læse eventuelle officielle retningslinjer for korrekt brug af antibiotika.
English: Tygacil has been compared with other antibiotics in four main studies.
Danish: Tygacil blev sammenlignet med andre antibiotika i fire hovedundersøgelser.
English: The active substance in Tygacil, tigecycline, belongs to a group of antibiotics called ‘glycylcyclines'.
Danish: Det aktive stof i Tygacil, tigecyclin, tilhører en gruppe antibiotika, der kaldes ”glycylcykliner”.
English: What measures are being taken to ensure the safe and effective use of Tygacil?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tygacil?
English: It is also used to treat complicated infections in the abdomen.
Danish: Det anvendes også til komplicerede infektioner i bughulen.
English: What is the risk associated with Tygacil?
Danish: Hvilken risiko er der forbundet med Tygacil?
English: For more information about treatment with Tygacil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tygacil, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tygacil, 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 Tygacil, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Why has Tygacil been approved?
Danish: Hvorfor blev Tygacil godkendt?
English: In the four main studies, Tygacil was as effective as the comparator antibiotics.
Danish: I de fire hovedundersøgelser var Tygacil lige så effektivt som sammenligningspræparaterne.
English: Tygacil is a powder that is made up into a solution for infusion (drip into a vein).
Danish: Tygacil er et pulver, der blandes til en opløsning til infusion (drop i en vene).
English: Tygacil must not be used in people who are hypersensitive (allergic) to tigecycline or any of the other ingredients.
Danish: Tygacil må ikke anvendes til patienter, som er overfølsomme (allergiske) over for tigecyclin eller andre af indholdsstofferne.
English: In children above eight years of age, treatment is only given after consulting with a doctor with appropriate experience in the management of infectious diseases, and should be given as an infusion over a period of 60 minutes.
Danish: Hos børn over otte år gives behandlingen kun efter samråd med en læge med behørig erfaring med forvaltning af smitsomme sygdomme.
English: Patients allergic to tetracycline antibiotics may also be allergic to Tygacil.
Danish: Patienter, der er overfølsomme over for tetracyclinantibiotika, vil muligvis også være overfølsomme over for Tygacil.
English: In children from 12 to 18 years a dose of 50 mg is given every 12 hours for a period of 5 to 14 days.
Danish: Hos børn mellem 12 og 18 år gives en dosis på 50 mg hver 12. time i en periode på mellem fem og 14 dage.
English: Doses are lower in patients with severe liver problems.
Danish: Hos patienter med alvorlige leversygdomme anvendes en lavere dosis.
English: In the other two studies, Tygacil was compared with imipenem/cilastatin (a combination of two medicines used together as an antibiotic) in 1,568 patients with complicated infections in the abdomen.
Danish: I de andre to hovedundersøgelser blev Tygacil sammenlignet med imipenem/cilastatin (en kombination af to lægemidler, der anvendes sammen som et antibiotikum) hos 1 568 patienter med komplicerede infektioner i bughulen.
English: The most common side effects with Tygacil are mild to moderate nausea (feeling sick) and vomiting, seen in 20% and 14% of patients, respectively.
Danish: De hyppigste bivirkninger ved Tygacil er let til moderat kvalme og opkastning, som optræder hos henholdsvis 20 % og 14 % af patienterne.
English: Although there are few data in children, studies suggest that Tygacil can be a treatment alternative for complicated skin and soft tissue or abdominal infections, with bacteria resistant to other antibiotics.
Danish: Omend der kun foreligger få data med relation til børn, synes undersøgelser at indikere, at Tygacil kan tjene som et behandlingsalternativ i tilfælde af komplicerede hud-, bløddels- og bughuleinfektioner forårsaget af bakterier, der har udviklet resistens over for andre antibiotika.
English: Tygacil is used to treat adults and children older than eight years with complicated infections of the skin and soft tissue (the tissue below the skin), but not foot infections in people with diabetes.
Danish: Tygacil anvendes til behandling såvel af voksne som af børn på mindst otte år med komplicerede infektioner i huden og bløddelene (det underliggende væv), dog ikke fodinfektioner hos diabetespatienter.
English: In adults, the recommended dose of Tygacil is a starting dose of 100 mg, followed by 50 mg every 12 hours for five to 14 days.
Danish: Hos voksne er den anbefalede dosering en startdosis på 100 mg, efterfulgt af 50 mg hver 12. time i fem til 14 dage.
English: An additional study compared Tygacil with the antibiotic ertapenem in 813 diabetic patients with moderate to severe foot infections.
Danish: I en yderligere undersøgelse sammenlignedes Tygacil med antibiotikummet ertapenem hos 813 diabetespatienter med moderate til svære fodinfektioner.
English: For the full list of all side effects reported with Tygacil, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Tygacil fremgår af indlægssedlen.
English: In children from 8 to 12 years old a dose of 1.2 mg per kilogram body weight is given by infusion into a vein every twelve hours, up to a maximum dose of 50 mg every 12 hours.
Danish: Hos børn mellem otte og 12 år gives en dosis på 1,2 mg pr. kilogram legemsvægt som infusion i en vene hver 12. time, dog maksimalt 50 mg hver 12. time.
English: The list of bacteria against which Tygacil is active can be found in the summary of product characteristics (also part of the EPAR).
Danish: Der findes en liste over de bakterier, som Tygacil virker mod, i produktresuméet (der også er en del af denne EPAR).
English: In the studies of skin and soft tissue infections, around 86% of the patients receiving Tygacil were cured, compared with around 89% of those receiving vancomycin and aztreonam.
Danish: I undersøgelserne af infektioner i huden og bløddelene forsvandt disse infektioner hos ca. 86 % af patienterne, som fik Tygacil, sammenlignet med ca. 89 % af dem, som fik vancomycin og aztreonam.
English: In the studies of abdominal infection, around 86% of the patients receiving either Tygacil or imipenem/cilastatin were cured.
Danish: I undersøgelserne af infektioner i bughulen forsvandt infektionen hos ca. 86 % af dem, der fik enten Tygacil eller imipenem/cilastatin.
English: In two of these studies, Tygacil was compared with the combination of vancomycin and aztreonam in 1,129 patients with complicated skin and soft tissue infections (not including infected diabetic foot ulcers).
Danish: I to af disse blev Tygacil sammenlignet med kombinationen af vancomycin og aztreonam hos 1 129 patienter med komplicerede infektioner i huden og bløddelene (undtagen fodinfektioner hos diabetespatienter).
English: How has Tygacil been studied?
Danish: Hvordan blev Tygacil undersøgt?
English: What is Tygacil used for?
Danish: Hvad anvendes Tygacil til?
English: What benefit has Tygacil shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Tygacil?
English: How is Tygacil used?
Danish: Hvordan anvendes Tygacil?
English: In the study looking at diabetic foot infections, Tygacil was less effective than ertapenem: 78% of the patients receiving Tygacil were cured, compared with 83% of those receiving ertapenem.
Danish: Infektionen forsvandt hos 78 % af de patienter, som fik Tygacil, sammenlignet med 83 % af de, som fik ertapenem.
English: How does Tygacil work?
Danish: Hvordan virker Tygacil?