FrancophonIA/ELRC3.0 huggingface dataset:
English: PCV-1 is not known to cause any disease.
Danish: Så vidt vides er PCV-1 ikke sygdomsfremkaldende.
English: In addition, the company that markets Rotarix is developing a vaccine free of porcine circovirus type 1 (PCV-1) after a very small amount of viral particles was found in the vaccine in 2010.
Danish: Desuden er den virksomhed, der markedsfører Rotarix, i færd med at udvikle en vaccine uden porcint circovirus type 1 (PCV-1), efter at der blev fundet meget små mængder af virale partikler i vaccinen i 2010.
English: If the ready-made oral suspension is used, the contents of the prefilled oral applicator or tube should be given into the mouth of the baby.
Danish: Hvis den brugsklare orale suspension anvendes, skal indholdet af den fyldte orale applikator eller tube gives i munden på spædbarnet.
English: • an oral suspension in a squeezable tube.
Danish: • oral suspension i en fyldt, blød tube.
English: The first dose is given when the baby is older than six weeks.
Danish: Den første dosis gives, når spædbarnet er mindst seks uger gammelt.
English: The same vaccination course can be used in babies born up to 13 weeks prematurely (from 27 weeks gestational age).
Danish: Det samme vaccinationsforløb kan anvendes til spædbørn, som er født op til 13 uger for tidligt (fra 27 ugers gestationsalder).
English: Rotarix is given as two doses, at least four weeks apart.
Danish: Rotarix gives som to doser med mindst fire ugers mellemrum.
English: For more information about treatment with Rotarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rotarix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Rotarix.
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 Rotarix skal anvendes.
English: Rotarix contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain).
Danish: Rotarix indeholder en levende fortyndet (svækket) form for human rotavirus (RIX4414-stamme).
English: Four additional studies were carried out in over 3,000 infants, to confirm that the ready-for-use forms of the vaccine were as safe and as effective as the powder and solvent formulation in stimulating the production of antibodies against rotavirus.
Danish: Der blev gennemført yderligere fire undersøgelser af over 3 000 spædbørn med henblik på at bekræfte, at klar til brug-formerne af vaccinen var lige så sikre og virksomme som pulver og solvensformen til at stimulere dannelse af antistoffer mod rotavirus.
English: Rotarix is a vaccine that is given by mouth.
Danish: Rotarix er en vaccine, som gives i munden.
English: Overall, the clinical studies of Rotarix involved over 75,000 babies and took place in various countries worldwide.
Danish: De kliniske undersøgelser af Rotarix omfattede som helhed over 75 000 spædbørn og fandt sted i forskellige lande rundt om i verden.
English: What measures are being taken to ensure the safe and effective use of Rotarix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rotarix?
English: The CHMP decided that Rotarix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Rotarix opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The most common side effects with Rotarix (seen in between 1 and 10 patients in 100) are diarrhoea and irritability.
Danish: De hyppigste bivirkninger ved Rotarix (som optræder hos mellem 1 og 10 patienter ud af 100) er diarré og irritabilitet.
English: It must also not be given to patients who have disorders that cause severe abnormalities of the immune system called ‘severe combined immunodeficiency', who have had intussusception in the past, or who have problems with their bowel that could put them at risk of intussusception.
Danish: Det må heller ikke gives til patienter med lidelser, der forårsager svære forstyrrelser i immunsystemet (svær kombineret immundefekt), som tidligere har haft intussusception, eller som har problemer med tarmene, så de kunne risikere at udvikle intussusception.
English: If the powder and solvent are used, they should be mixed together just before the vaccine is given, and the resulting suspension given directly into the mouth of the baby using the oral applicator provided.
Danish: Hvis der anvendes pulver og solvens, skal de blandes sammen, lige inden vaccinen gives, og den heraf følgende suspension gives direkte i munden på spædbarnet ved hjælp af den medfølgende orale applikator.
English: • a powder and solvent that are made up into an oral suspension in an oral applicator;
Danish: • pulver og solvens, som blandes til en oral suspension i en oral applikator
English: Rotarix contains small amounts of rotavirus, a virus that causes gastroenteritis.
Danish: Rotarix indeholder små mængder rotavirus, et virus, som forårsager gastroenteritis.
English: Vaccination with Rotarix should be postponed in babies who have a sudden high fever, diarrhoea or vomiting.
Danish: Vaccination med Rotarix bør udsættes hos spædbørn, der får pludselig høj feber, diarré eller opkastninger.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rotarix, 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 Rotarix, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: This helps to protect against gastroenteritis caused by rotavirus.
Danish: Dette medvirker til at beskytte mod gastroenteritis forårsaget af rotavirus.
English: In the main study, the number of cases of severe rotavirus gastroenteritis was lower following vaccination with Rotarix: 0.1% of the babies vaccinated with Rotarix in whom effectiveness was assessed developed severe rotavirus gastroenteritis (12 out of over 9,000) compared with 0.9% of the babies who received placebo (77 out of almost 9,000).
Danish: I hovedundersøgelsen var antallet af svære rotavirusforårsagede gastroenteritistilfælde lavere efter vaccination med Rotarix: 0,1 % af de spædbørn, der var vaccineret med Rotarix, og hos hvem virkningen blev vurderet, udviklede svær rotavirusforårsaget gastroenteritis (12 ud af godt 9 000) sammenlignet med 0,9 % af de spædbørn, der fik placebo (77 ud af næsten 9 000).
English: Rotarix was more effective than placebo in preventing severe gastroenteritis due to rotavirus.
Danish: Rotarix var mere effektivt end placebo til forebyggelse af svær gastroenteritis som følge af rotavirus.
English: Rotarix rotavirus vaccine, live
Danish: Rotarix rotavirusvaccine, levende
English: The main study compared Rotarix with placebo (a dummy vaccine) in over 63,000 babies who were born at full term (after a pregnancy of at least 36 weeks).
Danish: I hovedundersøgelsen sammenlignedes Rotarix med placebo (en uvirksom vaccine) hos over 63 000 spædbørn, som var født til terminen (efter en graviditet på mindst 36 uger).
English: The benefit of the vaccine was measured by looking at how many babies developed severe rotavirus gastroenteritis in the months after they had been vaccinated and before they had reached one year of age.
Danish: Vaccinens effekt blev målt ved at se på, hvor mange spædbørn der udviklede svær rotavirusforårsaget gastroenteritis i månederne efter, at de var blevet vaccineret, og før de havde nået etårsalderen.
English: Rotarix must not be used in babies who are hypersensitive (allergic) to any of the ingredients of the vaccine or those who showed signs of allergy after receiving a dose of rotavirus vaccine in the past.
Danish: Rotarix må ikke anvendes til spædbørn, der er overfølsomme (allergiske) over for nogen af indholdsstofferne i vaccinen, eller som har vist tegn på allergi efter at have fået en tidligere dosis rotavirusvaccine.
English: Rotarix is used in babies aged from 6 to 24 weeks to protect against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Danish: Rotarix anvendes til spædbørn i alderen seks til 24 uger til forebyggelse af gastroenteritis (diarré og opkastninger) forårsaget af rotavirusinfektioner.
English: A further study looked at the safety of Rotarix and its ability to stimulate the production of antibodies in 1,009 babies born up to 13 weeks prematurely.
Danish: I en yderligere undersøgelse så man på sikkerheden ved Rotarix og dets evne til at danne antistoffer hos 1 009 spædbørn født op til 13 uger for tidligt.
English: • an oral suspension in a prefilled oral applicator;
Danish: • oral suspension i en fyldt oral applikator
English: These results were compared with the findings of a study in babies born at full term who were vaccinated with Rotarix.
Danish: Disse resultater blev sammenlignet med resultaterne af undersøgelsen af spædbørnene født til terminen, som var blevet vaccineret med Rotarix.
English: For the full list of all side effects reported with Rotarix, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Rotarix fremgår af indlægssedlen.
English: What is the risk associated with Rotarix?
Danish: Hvilken risiko er der forbundet med Rotarix?
English: The study in premature babies showed that Rotarix was well tolerated and produced similar levels of antibodies as in infants born at full term.
Danish: Undersøgelsen af for tidligt fødte spædbørn viste, at Rotarix tåltes godt og dannede samme mængder antistoffer som hos børn født til terminen.
English: Why has Rotarix been approved?
Danish: Hvorfor blev Rotarix godkendt?
English: When an infant is given the vaccine, the immune system (the system that fights diseases) recognises the weakened virus as ‘foreign' and makes defences against it. After vaccination, the immune system is able to respond more quickly when it is exposed to the virus again.
Danish: Når barnet får vaccinen, opfatter immunsystemet det svækkede virus som "fremmed" og danner et forsvar mod det.
English: What is Rotarix?
Danish: Hvad er Rotarix?
English: Very rarely (seen in less than 1 patient in 10,000), a serious condition called intussusception (in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage) has been reported after the use of rotavirus vaccines.
Danish: Der er efter brug af rotavirusvacciner rapporteret om meget sjældne, alvorlige tilfælde (hos mindre end 1 ud af 10 000 patienter) af intussusception, en tilstand, hvor en del af tarmen bliver foldet sammen med en anden del af tarmen, hvilket fører til blokering.
English: How has Rotarix been studied?
Danish: Hvordan blev Rotarix undersøgt?
English: What benefit has Rotarix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rotarix?
English: What is Rotarix used for?
Danish: Hvad anvendes Rotarix til?
English: How is Rotarix used?
Danish: Hvordan anvendes Rotarix?
English: How does Rotarix work?
Danish: Hvordan virker Rotarix?
English: The European Commission issued a decision on this opinion on 30 May 2011.
Danish: Europa-Kommissionen traf en afgørelse på grundlag af denne udtalelse den 30. maj 2011.
English: The questions and answers document published in September 2010 can be found here.
Danish: Dokumentet med spørgsmål og svar, som blev offentliggjort i september 2010, findes her.
English: The CHMP noted at the time that the exact cause of the problems could not be identified with certainty.
Danish: CHMP bemærkede på daværende tidspunkt, at den nøjagtige årsag til problemerne ikke kunne fastlægges med sikkerhed.
English: Another enzyme, kallikrein, is considered to play a minor role.
Danish: Et andet enzym, kallikrein, anses for at spille en mindre rolle.
English: What is Octagam?
Danish: Hvad er Octagam?
English: The current review was initiated in October 2010 at the request of Germany.
Danish: Den aktuelle revurdering blev påbegyndt i oktober 2010 efter anmodning fra Tyskland.
English: The Committee noted that appropriate corrective measures are now in place at the manufacturing sites.
Danish: Udvalget bemærkede, at der nu er truffet passende korrigerende foranstaltninger på produktionsstederne.
English: What are the recommendations for prescribers and patients?
Danish: Hvilke anbefalinger gives der til ordinerende læger og patienter?
English: • Post-marketing safety studies will be performed.
Danish: • Der vil blive foretaget sikkerhedsundersøgelser efter markedsføringen.
English: Why was Octagam reviewed?
Danish: Hvorfor blev Octagam vurderet igen?
English: As with all medicines, doctors are reminded to continue reporting any suspected adverse effects.
Danish: Ligesom det er tilfældet med alle andre lægemidler, mindes lægerne om, at de fortsat skal indberette alle formodede bivirkninger.
English: The Committee also looked at results of batch analyses and independent testing of batches by Member States, as well as information from inspections of two of the manufacturing sites.
Danish: Udvalget så ligeledes på resultaterne af batchanalyser og uafhængige test af batcherne udført af medlemsstaterne samt information fra inspektionerne af to af produktionsstederne.
English: What data has the CHMP reviewed?
Danish: Hvilke data vurderede CHMP?
English: • With the new safeguards and improvements to the manufacturing process, doctors are advised that the benefits of the Octagam outweigh its risks and that they can start using the medicine again when it becomes available.
Danish: • Med de nye sikkerhedsforanstaltninger og forbedringen af fremstillingsprocessen bliver lægerne informeret om, at fordelene ved Octagam opvejer risiciene, og at de kan begynde at bruge lægemidlet igen, når det kan fås i handelen.
English: The marketing authorisation holders will also be required to carry out post-marketing safety studies as soon as the medicine is reintroduced into the market in order to confirm the safety of the improved manufacturing process.
Danish: Indehaverne af markedsføringstilladelserne skal ligeledes foretage sikkerhedsundersøgelser efter markedsføringen, lige så snart lægemidlet genindføres på markedet, for at bekræfte sikkerheden af den forbedrede fremstillingsproces.
English: In addition, critical steps were identified in the manufacturing process that could explain the presence of substances that triggered the thromboembolic events.
Danish: Hertil kommer, at der blev identificeret kritiske skridt i fremstillingsprocessen, som kunne forklare tilstedeværelsen af stoffer, der udløste de tromboemboliske hændelser.
English: The aim of the review was to assess all available data on the safety and quality issues related to the thromboembolic events seen with Octagam.
Danish: Formålet med revurderingen var at vurdere alle tilgængelige data om sikkerheds- og kvalitetsproblemer i forbindelse med de tromboemboliske hændelser, der forekom med Octagam.
English: Immunoglobulins are antibodies (types of protein) normally found in the blood that help the body to fight infections and other diseases.
Danish: Immunoglobuliner er antistoffer (en type proteiner), der normalt findes i blodet, og som hjælper kroppen med at bekæmpe infektioner og andre sygdomme.
English: Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%)
Danish: Spørgsmål og svar vedrørende anbefalingen om at ophæve suspenderingen af Octagam (humant normalt immunoglobulin 5 % og 10 %)
English: The CHMP reviewed investigations that were carried out into the root cause of the problem and proposed corrective measures, including changes to the manufacturing process and tests to be performed during the manufacturing process and on the final products.
Danish: CHMP vurderede de undersøgelser, der blev foretaget for at finde den grundlæggende årsag til problemet, og foreslog korrigerende foranstaltninger, herunder ændringer af fremstillingsprocessen og test, der skal foretages under fremstillingsprocessen og af de færdige lægemidler.
English: Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%) EMA/293780/2011 rev.
Danish: Spørgsmål og svar vedrørende anbefalingen om at ophæve suspenderingen af Octagam (humant normalt immunoglobulin 5 % og 10 %) EMA/567254/2011 rev.
English: It is also used in people with certain immune disorders such as idiopathic thrombocytopenic purpura and in patients who have had a bone marrow transplant.
Danish: Det anvendes ligeledes til personer med visse immunsygdomme, såsom idiopatisk trombocytopenisk purpura, og til patienter, der har fået en knoglemarvstransplantation.
English: The CHMP also agreed on a test to detect factor XIa or other substances that can cause thromboembolic events before batches are released onto the market.
Danish: CHMP besluttede også at indføre en test for at spore faktor XIa eller andre stoffer, der kan forårsage tromboemboliske hændelser, før batcherne frigives på markedet.
English: Octagam is used in patients who are at risk of infection because they do not have sufficient antibodies including people with primary immunodeficiency syndrome, or children born with acquired immune deficiency syndrome (AIDS).
Danish: Octagam anvendes til patienter, som risikerer at få en infektion, fordi de ikke danner tilstrækkeligt med antistoffer, herunder personer med primært immundefektsyndrom eller børn, der er født med erhvervet immundefektsyndrom (AIDS).
English: These events were thought to be related to problems with the medicine's manufacture, and included stroke, myocardial infarction (heart attack) and pulmonary embolism (clot in a blood vessel supplying the lungs).
Danish: Man mente, at disse hændelser hang sammen med problemer med lægemidlets fremstilling, og de omfattede slagtilfælde, myokardieinfarkt (hjerteanfald) og lungeemboli (en blodprop i et blodkar, der forsyner lungerne med blod).
English: The marketing authorisations for Octagam in the EU were suspended by the European Commission, following a review by the CHMP in the September 2010.
Danish: Markedsføringstilladelserne for Octagam i EU blev suspenderet af Europa-Kommissionen efter en revurdering, som blev foretaget af CHMP i september 2010.1
English: In September 2010, the CHMP, following the suspension of the marketing authorisations of Octagam in Germany and Sweden, recommended that all authorisations for the medicine be suspended across the EU.
Danish: I september 2010 anbefalede CHMP, efter suspenderingen af markedsføringstilladelserne for Octagam i Tyskland og Sverige, at alle markedsføringstilladelser for lægemidlet blev suspenderet i hele EU.
English: The European Medicines Agency has completed a review of Octagam and associated names that was triggered by reports of serious thromboembolic events in patients using the medicine.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Octagam og relaterede navne som følge af indberetninger af alvorlige tromboemboliske hændelser hos patienter, der får lægemidlet.
English: The background to the suspension was an unexpectedly high number of reports of serious thromboembolic events (problems due to the formation of blood clots in the blood vessels) in patients
Danish: Baggrunden for suspenderingen var et uventet højt antal indberetninger af alvorlige tromboemboliske hændelser (problemer, som skyldes dannelsen af blodpropper i blodkarrene) hos patienter, der får lægemidlet.
English: The CHMP concluded that the unexpected presence of factor XIa (an enzyme involved in blood clotting) in Octagam was the main cause of the thromboembolic events.
Danish: CHMP konkluderede, at den uventede tilstedeværelse af faktor XIa (et enzym, der har betydning for blodets koagulation) var hovedårsagen til de tromboemboliske hændelser.
English: Octagam is a solution for infusion (drip into a vein) that contains human normal immunoglobulin extracted from blood as the active substance.
Danish: Octagam er en infusionsvæske, opløsning (drop i en vene), som indeholder humant normalt immunoglobulin, der er udvundet af blod, som det aktive stof.
English: The CHMP concluded the review with a recommendation that the suspension of the marketing authorisation for Octagam be lifted in the EU on the basis of the safeguards and the change to the medicine's manufacturing process.
Danish: CHMP afsluttede revurderingen med en anbefaling af, at suspenderingen af markedsføringstilladelsen for Octagam ophæves i EU på baggrund af sikkerhedsforanstaltningerne og ændringen af lægemidlets fremstillingsproces.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the EU-wide suspension of the marketing authorisation for Octagam be lifted subject to certain conditions, including a change to the medicine's manufacturing process.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) anbefalede, at suspenderingen af markedsføringstilladelsen for Octagam i hele EU ophæves på visse betingelser, herunder en ændring af lægemidlets fremstillingsprocesser.
English: • Sudden unexplained death.
Danish: • Pludselig uforklarlig død.
English: • Prolonged and/or painful erection.
Danish: • Forlænget og/eller pinefuld erektion.
English: These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Danish: Disse symptomer kan temporært forværres eller endog opst å efter afslutning af behandling.
English: • problems with speech
Danish: • Problemer med at tale
English: • Sensitivity to sunlight.
Danish: • Følsomhed overfor sollys
English: Gröbenzell, Germany
Danish: Gröbenzell, Tyskland
English: • Loss of strength.
Danish: • Tab af styrke.
English: Hertfordshire, WD18 8YA, United Kingdom
Danish: Hertfordshire, WD18 8YA, Storbritannien
English: Glucosuria Increased appetite
Danish: Glukosuri Øget appetite
English: • Unusual movements(dyskinesias)
Danish: • Unormale bevægelser (dyskinesi)
English: - Medicines of this type may cause unusual movements mainly of the face or tongue.
Danish: • Denne type medicin kan forårsage usædvanlige bevægelser af især ansigt eller tunge.
English: Contact your doctor or hospital straight away if you experience any of the above symptoms.
Danish: Kontakt omgående din læge eller dit sygehus , hvis du får nogen af de ovennævnte symptomer.
English: 25 % was common (2.5 %).
Danish: og ≥ 25% var almindelig (2,5%).
English: Your doctor may suggest you to reduce the dose gradually before stopping treatment.
Danish: Din læge vil måske foresl å dig, at du nedsætter din dosis gradvist, før du helt stopper.
English: • muscle stiffness or spasms (including eye movements)
Danish: • Muskelstivhed eller muskelkramper (herunder øjenbevægelser)
English: City Tower, Hvězdova 1716/2b, 140 78 Praha 4 Czech Republic
Danish: City Tower, Hvezdova 1716/2b, 140 78 Prag 4, Tjekkiet
English: 16 Elevated plasma prolactin levels were reported in 47.4 % of adolescent patients.
Danish: 16 Forhøjet plasmaprolaktin blev rapporteret hos 47,4 % af de unge patienter.
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: - Tell your doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
Danish: • Fortæl det til lægen, hvis du eller nogen i din familie tidligere har haft blodpropper, da denne type medicin kan være forbundet med dannelse af blodpropper