FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP decided that Rapiscan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Rapiscan opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Rapiscan is for diagnostic use only.
Danish: Rapiscan er kun til diagnostisk brug.
English: It is given as a 10-second injection of 400 micrograms into a vein immediately followed by an injection of sodium chloride (salt) solution.
Danish: Det gives som en 10-sekunders injektion af 400 mikrogram i en vene, straks efterfulgt af en injektion af natriumchlorid (saltvands-) opløsning.
English: The active substance in Rapiscan, regadenoson, is an A2A adenosine receptor agonist.
Danish: Det aktive stof i Rapiscan, regadenoson, er en A2A adenosinreceptoragonist.
English: Rapiscan is used as a ‘stress agent' that has a similar effect on the heart as exercise.
Danish: Rapiscan anvendes som et ‘stress-stof', der har en tilsvarende virkning på hjertet som motion.
English: What measures are being taken to ensure the safe and effective use of Rapiscan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rapiscan?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rapiscan, 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 Rapiscan, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: They should also stop receiving dipyridamole (a medicine used to prevent blood clots) for at least two days before receiving Rapiscan.
Danish: De skal også holde op med at tage dipyridamol (et lægemiddel, som anvendes til forebyggelse af blodpropper) i mindst to dage, inden de får Rapiscan.
English: Patients must not take any medicines or products that contain methylxanthines (such as caffeine or theophylline) for at least 12 hours before receiving Rapiscan.
Danish: Patienterne må ikke tage noget lægemiddel eller stof, som indeholder methylxanthiner (såsom kaffein eller theophyllin), i mindst 12 timer, inden de får Rapiscan.
English: The results of scans using Rapiscan and adenosine were comparable.
Danish: Resultaterne af scanningerne ved hjælp af Rapiscan og adenosin var sammenlignelige.
English: This enables the blood flow in the heart to be seen more easily during myocardial perfusion imaging.
Danish: Dette gør det muligt klarere at se blodtilstrømningen til hjertet under undersøgelsen af myokardieperfusionen.
English: In two main studies, around 2,000 adult patients first had a myocardial perfusion imaging scan performed using adenosine (another medicine used as a stress agent) followed by a second scan with either adenosine or Rapiscan.
Danish: I to hovedundersøgelser gennemgik ca. 2 000 voksne patienter først en myokardieperfusionsscanning udført ved hjælp af adenosin (et andet lægemiddel anvendt som et stress-stof) efterfulgt af endnu en scanning med enten adenosin eller Rapiscan.
English: Because Rapiscan causes a rapid increase in heart rate and a fall in blood pressure, patients should remain sitting or lying down and be monitored frequently until the effects of the medicine have worn off.
Danish: Da Rapiscan hurtigt øger hjerterytmen og bevirker et blodtryksfald, skal patienterne sidde eller ligge ned og overvåges hyppigt, indtil virkningerne af lægemidlet er klinget af.
English: For more information about treatment with Rapiscan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rapiscan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Rapiscan must not be used in patients with slow heart rate unless they have a pacemaker, unstable angina (a type of chest pain that changes in severity) that has not been controlled with treatment, severe hypotension (low blood pressure) or decompensated heart failure (when the heart does not work as well as it should).
Danish: Rapiscan må ikke anvendes til patienter med langsom hjerterytme, medmindre de har en pacemaker, ustabil angina (en form for brystsmerter af skiftende sværhedsgrad), som ikke er blevet reguleret med behandling, svær hypotension (for lavt blodtryk) eller dekompenseret hjerteinsufficiens (når hjertet ikke virker så godt som det burde).
English: It works by attaching to A2A adenosine receptors in the walls of the blood vessels in the heart, causing the blood vessels to widen and increasing blood flow into the heart muscle.
Danish: Det virker ved at binde sig til A2A adenosinreceptorer i væggene i blodkarrene i hjertet, hvilket får blodkarrene til at udvide sig og øger blodtilstrømningen til hjertemuskulaturen.
English: What is the risk associated with Rapiscan?
Danish: Hvilken risiko er der forbundet med Rapiscan?
English: The main measure of effectiveness was based on the similarity between the results of the scans with Rapiscan and adenosine.
Danish: Det primære mål for effekt byggede på lighedspunkterne mellem resultaterne af scanningerne med Rapiscan og adenosin.
English: The most common side effects with Rapiscan (seen in more than 1 patient in 10) are headache, dizziness, ST segment changes (an abnormal reading on the electrocardiogram or ECG), flushing (reddening of the skin), dyspnoea (difficulty breathing), gastrointestinal (stomach and gut) discomfort and chest pain.
Danish: De hyppigste bivirkninger ved Rapiscan (som optræder hos flere end 1 ud af 10 patienter) er hovedpine, svimmelhed, ændringer i ST-segmentet (unormal visning på elektrokardiogram eller EKG), rødme, dyspnø (vejrtrækningsbesvær), gastrointestinale (mave og tarm) gener og brystsmerter.
English: The patient then undergoes the procedures for radionuclide myocardial perfusion imaging, starting with an injection of a radioactive substance 10 to 20 seconds after the sodium chloride injection.
Danish: Patienten gennemgår dernæst den radionukleare undersøgelse af myokardieperfusionen, begyndende med en injektion af et radioaktivt stof 10 til 20
English: For further information on the use of Rapiscan, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger om anvendelsen af Rapiscan fremgår af produktresuméet (også en del af denne EPAR).
English: Rapiscan is a solution for injection that contains the active substance regadenoson.
Danish: Rapiscan er en injektionsvæske, der indeholder det aktive stof regadenoson.
English: Why has Rapiscan been approved?
Danish: Hvorfor blev Rapiscan godkendt?
English: Before this type of scan, the patient's heart is usually put under stress by exercise such as walking or running on a treadmill to help dilate (widen) the blood vessels in the heart and increase the blood flow to the heart muscle.
Danish: Inden denne form for scanning sættes patientens hjerte normalt under pres via motion såsom at gå eller løbe på et løbebånd for at få blodkarrene i hjertet til at udvide sig og øge blodtilførslen til hjertemuskulaturen.
English: For the full list of all side effects reported with Rapiscan, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Rapiscan fremgår af indlægssedlen.
English: How has Rapiscan been studied?
Danish: Hvordan blev Rapiscan undersøgt?
English: It is used in a type of heart scan called ‘radionuclide myocardial perfusion imaging' to see the blood flow in the heart muscle.
Danish: Det anvendes ved en form for hjertescanning kaldet ‘radionuklear undersøgelse af myokardieperfusionen' (myokardieskintigrafi).
English: How is Rapiscan used?
Danish: Hvordan anvendes Rapiscan?
English: What is Rapiscan used for?
Danish: Hvad anvendes Rapiscan til?
English: What is Rapiscan?
Danish: Hvad er Rapiscan?
English: What benefit has Rapiscan shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rapiscan?
English: The duration of protection beyond 4 years is currently under investigation.
Danish: Beskyttelsens varighed ud over 4 år er på nuværende tidspunkt under undersøgelse.
English: § Not statistically significant
Danish: § Ikke statistisk signifikant
English: Speak to your doctor for more information.
Danish: Tal med din læge for mere information.
English: If not used within 6 hours it should be discarded.
Danish: Hvis den ikke anvendes inden for 6 timer, skal den kasseres.
English: It usually occurs in one part of the body and can last for several weeks.
Danish: Det forekommer normalt på én del af kroppen og kan vare i flere uger.
English: This protein is not infectious.
Danish: Dette protein er ikke smitsomt.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Danish: Der er påvist kemisk og fysisk stabilitet under brug i 24 timer ved 30 °C.
English: The clinical relevance of this data is not known.
Danish: Den kliniske relevans af disse data er ikke kendt.
English: From a microbiological point of view, the vaccine should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal vaccinen anvendes straks.
English: • you have a severe infection with a high temperature (fever).
Danish: • du har en alvorlig infektion med høj temperatur (feber).
English: • Do not use this medicine after the expiry date which is stated on the label and carton.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og æsken.
English: In these cases, the vaccination may have to be postponed until you have recovered.
Danish: I disse tilfælde skal vaccinationen muligvis udskydes til du er rask.
English: However, do not drive or use machines if you are feeling unwell.
Danish: Du må imidlertid ikke føre motorkøretøjer eller betjene maskiner, hvis du føler dig utilpas.
English: Maladministration via the subcutaneous route may lead to an increase in transient local reactions.
Danish: Forkert administration ad subkutan vej kan medføre en stigning i forbigående lokale reaktioner.
English: Before administration:
Danish: Før administration:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at 2°C to 8°C.
Danish: Hvis den ikke anvendes straks, er opbevaringstider og -betingelser før anvendelse brugerens ansvar og vil normalt ikke være længere end 6 timer ved 2 °C til 8 °C.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler bør navnet og batchnummeret af det administrerede lægemiddel registreres tydeligt.
English: The first injection can be given from the age of 50 years onwards.
Danish: Den første injektion kan gives fra alderen 50 år og op.
English: Most of these reactions were not long-lasting (median duration of 2 to 3 days).
Danish: De fleste af disse bivirkninger var ikke langvarige (median varighed på 2 til 3 dage).
English: Shake gently until the powder is completely dissolved.
Danish: Ryst forsigtigt, indtil pulveret er fuldstændigt opløst.
English: It is important that procedures are in place to avoid injury from faints.
Danish: Det er vigtigt, at der er procedurer på plads, så skader på grund af besvimelser undgås.
English: • scars where the blisters have been.
Danish: • ar på de steder, hvor blærerne har været.
English: Reactions reported as severe lasted 1 to 2 days.
Danish: Bivirkninger rapporteret som alvorlige varede 1 til 2 dage.
English: • You will receive 2 injections with an interval of 2 months.
Danish: • Du vil få 2 injektioner med et anbefalet interval på 2 måneder.
English: • The active substances are:
Danish: • Aktive stoffer:
English: There were 9 reports of suspected HZ in 6 subjects over a one-year follow up period.
Danish: Der var 9 rapporter om mistænkt HZ hos 6 forsøgspersoner over en opfølgningsperiode på et år.
English: Powder (gE antigen):
Danish: Pulver (gE-antigen):
English: Vaccine efficacy [95% CI]
Danish: Vaccinens virkning [95 % CI]
English: The vaccines should be administered at different injection sites.
Danish: Vaccinerne skal administreres på forskellige injektionssteder.
English: Concomitant use with other vaccines is not recommended due to lack of data.
Danish: Samtidig brug med andre vacciner anbefales ikke på grund af manglende data.
English: Very common headache
Danish: Meget almindelig hovedpine
English: No cases of visceral disease or stroke were reported during these studies.
Danish: Der blev ikke rapporteret tilfælde af visceral sygdom eller slagtilfælde under disse studier.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first;
Danish: En mindre infektion som for eksempel en forkølelse bør ikke være noget problem, men tal først med lægen.
English: This helps your immune system (the body's natural defences) stay prepared to fight the virus and protect you against shingles and its complications.
Danish: Dette hjælper dit immunsystem (kroppens naturlige forsvar) med at forblive parat til at bekæmpe virussen og beskytte dig mod helvedesild og komplikationer heraf.
English: The humoral immunogenicity and CMI results are presented in Tables 3 and 4, respectively.
Danish: De humorale immunogenicitets- og CMI-resultater er præsenteret i henholdsvis tabel 3 og 4.
English: A different injection site will be used for each vaccine.
Danish: Der vil blive valgt et forskelligt injektionssted til hver vaccine.
English: The adjuvant (AS01B) is used to improve the body's response to the vaccine.
Danish: Adjuvanset (AS01B) anvendes til at forbedre kroppens reaktion på vaccinen.
English: However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Danish: Tilstedeværelse af en mindre infektion, såsom forkølelse, bør imidlertid ikke føre til udsættelse af vaccinationen.
English: The studies were not designed to demonstrate efficacy in subgroups of frail individuals, including those with multiple comorbidities, although these subjects were not excluded from the studies.
Danish: Studierne var ikke designet til at demonstrere virkning i undergrupper af svage individer, herunder dem der har flere komorbiditeter, selvom disse personer ikke blev udelukket fra studierne.
English: The administration of Shingrix to immunocompromised subjects should be based on careful consideration of potential benefits and risks.
Danish: Administration af Shingrix til immunkompromitterede personer bør baseres på en nøje overvejelse af potentielle fordele og risici.
English: Month 3*
Danish: Måned 3*
English: Change the needle so that you are using a new needle to administer the vaccine.
Danish: Skift kanylen, så du bruger en ny kanyle til administration af vaccinen.
English: The primary vaccination schedule consists of two doses of 0.5 ml each: an initial dose followed by a second dose 2 months later.
Danish: Det primære vaccinationsprogram består af to doser på 0,5 ml hver: en initialdosis efterfulgt af endnu en dosis 2 måneder senere.
English: As a consequence of the high vaccine efficacy against HZ, a low number of breakthrough cases were accrued, and it was therefore not possible to draw firm conclusions on these study objectives.
Danish: Som følge af vaccinens høje effekt mod HZ blev der indsamlet et lavt antal gennembrudstilfælde, og det var derfor ikke muligt at drage endelige konklusioner om disse studiemål.
English: For intramuscular injection only, preferably in the deltoid muscle.
Danish: Kun til intramuskulær injektion, fortrinsvis i deltoidmusklen.
English: The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease.
Danish: Vaccinen er udelukkende til profylaktisk brug og er ikke beregnet til behandling af eksisterende klinisk sygdom.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine.
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 får denne vaccine.
English: Make sure you finish the complete vaccination course.
Danish: Du skal sørge for at fuldføre hele vaccinationsprogrammet.
English: • You will be informed when you should come back for the second dose of Shingrix.
Danish: • Du vil få information om, hvornår du skal komme tilbage og få den anden dosis af Shingrix.
English: Most of these side effects are mild to moderate in intensity and are not long-lasting.
Danish: De fleste af disse bivirkninger er af let til moderat styrke og ikke langvarige.
English: Subcutaneous administration is not recommended.
Danish: Subkutan administration frarådes.
English: No data are available.
Danish: Der findes ingen tilgængelige data.
English: Month 38**
Danish: Måned 38**
English: (See section 4.4)
Danish: (angivet i punkt 6).
English: N Number of evaluable subjects at the specified time point (for the GMC) CI
Danish: N Antal evaluerbare forsøgspersoner på det specificerede tidspunkt (til GMC) CI
English: METHOD OF ADMINISTRATION Mix with antigen
Danish: ADMINISTRATIONSMETODE Blandes med antigen
English: BATCH NUMBER LOT
Danish: BATCHNUMMER Lot
English: Adverse reactions reported are listed according to the following frequency: Very common
Danish: De rapporterede bivirkninger er anført i henhold til følgende hyppighed:
English: Efficacy has not been assessed for the 0, 6-month schedule.
Danish: Virkningen er ikke vurderet for 0,6-måneders-vaccinationsprogram.
English: Number of evaluable subjects
Danish: Antal evaluerbare personer
English: Shingrix is given to adults 50 years and above.
Danish: Shingrix gives til voksne på 50 år og derover.
English: The safety profile presented below is based on a pooled analysis of data generated in placebo controlled clinical studies on 5,887 adults 50-69 years of age and 8,758 adults ≥ 70 years of age.
Danish: Sikkerhedsprofilen, der præsenteres nedenfor, er baseret på en poolet analyse med data genereret fra placebokontrollerede kliniske studier med 5.887 voksne i alderen 50-69 år og 8.758 voksne i alderen ≥ 70 år.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website
Danish: Denne indlægsseddel findes på alle EU-/EØS-sprog på Det Europæiske Lægemiddelagenturs hjemmeside
English: • Shingrix is given as an injection into a muscle (usually in the upper arm).
Danish: • Shingrix gives som en injektion ind i en muskel (sædvanligvis i overarmen).
English: Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination.
Danish: Shingrix kan have en mindre indvirkning på evnen til at føre motorkøretøj og betjene maskiner i 2-3 dage efter vaccinationen.
English: 70 (mTVC) as these analyses provide the most robust estimates for vaccine efficacy in this age group.
Danish: (mTVC), da disse analyser giver de mest solide estimater for vaccinens virkning i denne aldersgruppe.
English: Healthcare professionals therefore need to weigh the benefits and risks of HZ vaccination on an individual basis.
Danish: Sundhedspersonalet skal derfor på individuel basis afveje fordelene og ricisiene ved HZ-vaccination.
English: • skin infections, weakness, muscle paralysis and loss of hearing or vision - these are less common.
Danish: • hudinfektioner, svaghed, muskellammelse og tab af hørelse eller syn - dette er mindre almindeligt.
English: Fatigue and malaise may occur following administration (see section 4.8).
Danish: Træthed og utilpashed kan forekomme efter administration (se pkt.
English: The adjuvant effect of AS01B is the result of interactions between MPL and QS-21 formulated in liposomes.
Danish: Den adjuverende effekt af AS01B er resultatet af interaktioner mellem MPL og QS-21 formuleret i liposomer.
English: Adverse reactions reported during post-marketing surveillance are also tabulated below.
Danish: Bivirkninger rapporteret under overvågning efter markedsføring er også medtaget i nedenstående tabel.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Danish: Som ved alle injicerbare vacciner skal den passende medicinske behandling og overvågning altid være klar i tilfælde af en anafylaktisk reaktion efter administration af vaccinen.
English: Shingrix can be given at the same time as other vaccines.
Danish: Shingrix kan gives samtidig med andre vacciner.
English: This is a higher recurrence rate than generally reported in observational studies in unvaccinated individuals with a history of HZ.
Danish: Dette er en højere tilbagefaldsrate end generelt rapporteret i observationsstudier hos uvaccinerede personer med HZ i anamnesen.
English: The median duration of pain medication use was 32.0 and 44.0 days in the Shingrix and placebo group, respectively.
Danish: Medianvarigheden for brug af smertestillende medicin var 32,0 og 44,0 dage i henholdsvis Shingrix- og placebogruppen.
English: • The powder is white.
Danish: • Pulveret er hvidt.
English: As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy.
Danish: Som forholdsregel foretrækkes det at undgå anvendelse af Shingrix under graviditet.
English: * Over a median follow-up period of 3.1 years ** Over a median follow-up period of 4.0 years
Danish: CI Konfidensinterval * Over en median opfølgningsperiode på 3,1 år ** Over en median opfølgningsperiode på 4,0 år
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 ml) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Efter rekonstitution indeholder én dosis (0,5 ml):
English: you may get pain which can last for months or years and may be severe.
Danish: Når helvedesildens blærer heler, kan du få smerter, som kan vare i måneder eller år og de kan være voldsomme.
English: Efficacy against HZ-related complications other than PHN
Danish: Virkning mod HZ-relaterede komplikationer ud over PHN
English: Therefore tell the doctor or nurse if you fainted with a previous injection.
Danish: Du skal derfor fortælle det til lægen eller sundhedspersonalet, hvis du tidligere er besvimet i forbindelse med en injektion.
English: The glycoprotein E is a protein present in the Varicella Zoster Virus.
Danish: Glykoprotein E er et protein, der er til stede i Varicella zoster-virus.
English: Number of HZ cases
Danish: Antal tilfælde af HZ
English: It is unknown whether Shingrix is excreted in human milk.
Danish: Det er ukendt, om Shingrix udskilles i human mælk.
English: There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine.
Danish: Der findes ingen data om sikkerhed, immunogenicitet eller virkning, som understøtter udskiftning af en dosis Shingrix med en dosis af en anden HZ-vaccine.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2018
Danish: Dato for første markedsføringstilladelse: 21. marts 2018
English: Non-clinical data reveal no special hazard for humans based on conventional studies of acute and repeated dose toxicity, local tolerance, cardiovascular/respiratory safety pharmacology and toxicity to reproduction and development.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af akut toksicitet og toksicitet efter gentagne doser, lokal tolerance, kardiovaskulær/respiratorisk sikkerhedsfarmakologi samt reproduktions- og udviklingstoksicitet.
English: This will maximise the protection offered by Shingrix.
Danish: Dette vil maksimere den beskyttelse, som Shingrix yder.
English: Non-clinical data show that AS01B induces a local and transient activation of the innate immune system through specific molecular pathways.
Danish: Prækliniske data viser, at AS01B fremkalder en lokal og forbigående aktivering af det innate immunsystem via specifikke molekylære veje.