FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicine is given once every 12 hours for at least 4 days and up to 14 days.
Danish: Lægemidlet indgives én gang hver 12. time i mindst 4 dage og højst 14 dage.
English: Further information on Xerava can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Xerava findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Xerava (eravacycline)
Danish: Xerava (eravacyclin)
English: The main measure of effectiveness in both studies was whether the infection was cured.
Danish: Det primære mål for virkningen i begge studier var baseret på, om infektionen blev kureret.
English: Other information about Xerava
Danish: Andre oplysninger om Xerava
English: This leads to death of the bacteria causing the infection.
Danish: Derved dræbes de bakterier, der forårsager infektionen.
English: Xerava's safety profile was considered acceptable.
Danish: Xeravas sikkerhedsprofil vurderes at være acceptabel.
English: The dose depends on the patient's bodyweight, and may be increased if the patient is also taking a type of medicine called a ‘strong CYP3A4 inducer'.
Danish: Dosen afhænger af patientens legemsvægt, idet den kan øges, hvis patienten også får en type medicin, der kaldes "stærke CYP3A4-inducere".
English: As for all medicines, data on the use of Xerava are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Xerava løbende overvåget.
English: Xerava (eravacycline) EMA/521584/2018
Danish: Xerava (eravacyclin) EMA/521584/2018
English: Therefore the European Medicines Agency decided that Xerava's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Xerava opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Xerava?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xerava?
English: The most common side effects with Xerava (which may affect up to 1 in 10 people) are thrombophlebitis (inflammation of veins caused by a blood clot), phlebitis (inflammation of a vein), nausea (feeling sick), vomiting and reactions at the site of the infusion including reddening of skin, reduced sense of touch and pain.
Danish: De hyppigste bivirkninger ved Xerava (der kan forekomme hos op til 1 ud af 10 patienter) er tromboflebitis (årebetændelse forårsaget af blodprop), flebitis (årebetændelse), kvalme, opkastning og reaktioner på infusionsstedet, herunder hudrødme, nedsat følesans og ømhed.
English: Side effects reported with Xerava are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Xerava vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Xerava, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Xerava, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Tetracyclines work by binding to and blocking part of the cell machinery in bacterial cells that is involved in making proteins.
Danish: Tetracykliner virker ved at binde til og blokere den del af bakteriecellernes mekanisme, der indgår i produktionen af proteiner.
English: Why is Xerava authorised in the EU?
Danish: Hvorfor blev Xerava godkendt i EU?
English: What is Xerava and what is it used for?
Danish: Hvad er Xerava, og hvad anvendes det til?
English: An overview of Xerava and why it is authorised in the EU
Danish: Oversigt over Xerava, og hvorfor det er godkendt i EU
English: Xerava contains the active substance eravacycline.
Danish: Xerava indeholder det aktive stof eravacyclin.
English: Xerava is given by infusion (drip) into a vein over one hour.
Danish: Xerava indgives ved infusion (drop) i en blodåre over et tidsrum på 1 time.
English: What are the risks associated with Xerava?
Danish: Hvilke risici er der forbundet med Xerava?
English: The active substance in Xerava, eravacycline, belongs to a group of antibiotics called tetracyclines.
Danish: Det aktive stof i Xerava, eravacyclin, tilhører en gruppe antibiotika, der kaldes tetracykliner.
English: Xerava can only be obtained with a prescription and prescribers should take into account official guidance on the use of antibiotics.
Danish: Xerava udleveres kun efter recept, og den ordinerende læge skal følge de officielle retningslinjer for brug af antibiotika.
English: After around a month, 92% of patients treated with Xerava and 92% of patients treated with meropenem were cured of their infection.
Danish: Efter ca. en måned var 92 % af de patienter, der fik Xerava, og 92 % af de patienter, der fik meropenem, kureret for deres infektion.
English: ‘Complicated' means that the infection is difficult to treat because it has spread to the abdominal space.
Danish: Komplicerede infektioner er infektioner, der er vanskelige at behandle, fordi de har spredt sig til bughulen.
English: Xerava is as effective as alternative antibiotics in treating infections caused by various types of bacteria and produced high cure rates.
Danish: Xerava er lige så effektivt som andre antibiotika til behandling af infektioner forårsaget af forskellige typer bakterier og giver en høj helbredelsesrate.
English: After around a month, 87% of patients treated with Xerava were cured of their infection, compared to 89% of patients treated with ertapenem.
Danish: Efter ca. en måned var 87 % af de patienter, der fik Xerava, kureret for deres infektion, sammenholdt med 89 % af de patienter, der fik ertapenem.
English: In the second study involving 499 patients, Xerava was compared with meropenem (another antibiotic).
Danish: I det andet studie, der omfattede 499 patienter, blev Xerava sammenlignet med meropenem (et andet antibiotikum).
English: Xerava is an antibiotic used to treat complicated intra-abdominal (belly) infections (cIAI) in adults.
Danish: Xerava er et antibiotikum til behandling af komplicerede intraabdominale infektioner (maveinfektioner) hos voksne.
English: In the first study involving 538 patients, Xerava was compared with ertapenem (another antibiotic).
Danish: I det første studie, der omfattede 538 patienter, blev Xerava sammenlignet med ertapenem (et andet antibiotikum).
English: Xerava must not be used in patients who are hypersensitive (allergic) to any of the ingredients of the medicine or to other tetracycline antibiotics.
Danish: Xerava må ikke anvendes hos patienter, der er allergiske over for et eller flere af indholdsstofferne i lægemidlet eller over for andre tetracykliner.
English: How is Xerava used?
Danish: Hvordan anvendes Xerava?
English: For the full list of side effects of Xerava, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Xerava fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xerava have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Xerava.
English: What benefits of Xerava have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Xerava?
English: Xerava was shown to be as effective as alternative antibiotics in 2 main studies of adults with cIAIs.
Danish: Det er påvist i 2 hovedstudier, at Xerava er lige så effektivt som andre antibiotika til behandling af voksne med komplicerede intraabdominale infektioner.
English: How does Xerava work?
Danish: Hvordan virker Xerava?
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Danish: Fyldt injectionssprøjte (glas) med et automatisk sikkerhedssystem
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cuprymina on 23 August 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cuprymina den 23. august 2012.
English: It must not be used in women who are known to be or may be pregnant.
Danish: Det må ikke anvendes hos patienter, der er gravide eller kan tænkes at være gravide.
English: The full EPAR for Cuprymina can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cuprymina findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Cuprymina.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cuprymina.
English: The company presented information from the scientific literature on the potential uses of Cuprymina.
Danish: Virksomheden fremlagde oplysninger fra den videnskabelige litteratur om de mulige anvendelser af Cuprymina.
English: For more information about treatment with Cuprymina, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cuprymina, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: 64Cu is a radioactive form of copper.
Danish: 64Cu er en radioaktiv form af kobber.
English: The doctor will ensure that the risks linked to the radioactive exposure are lower than the risks from the disease itself.
Danish: Den ordinerende læge skal sikre, at risikoen ved udsættelse for radioaktiviteten er mindre end risikoen ved selve sygdommen.
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 Cuprymina.
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 Cuprymina.
English: Radiolabelling of a medicine takes place outside the body in a laboratory setting.
Danish: Radioaktiv mærkning af et lægemiddel finder sted uden for kroppen i laboratoriet.
English: Cuprymina is never given directly to the patient.
Danish: Cuprymina må aldrig gives direkte til patienten.
English: Other information about Cuprymina
Danish: Andre oplysninger om Cuprymina:
English: Cuprymina is only to be used by specialists who have experience in radiolabelling.
Danish: Cuprymina må kun anvendes af specialister med erfaring i radioaktiv mærkning.
English: Cuprymina itself is radioactive and so its use in radiolabelling may carry a risk of cancer and hereditary defects.
Danish: Cuprymina er radioaktivt, og dets brug til radioaktiv mærkning kan medføre risiko for kræft og arvelige defekter.
English: Therefore, the CHMP decided that Cuprymina's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP afgjorde derfor, at fordelene ved Cuprymina overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse for Cuprymina.
English: Radiolabelling is a technique where a substance is labelled with a radioactive compound.
Danish: Radioaktiv mærkning er en teknik til mærkning af et stof med et radioaktivt stof.
English: Cuprymina must not be given directly to any patient.
Danish: Cuprymina må ikke gives direkte til patienten.
English: Some of the scientific literature presented showed how radiolabelling with radioactive forms of Copper, including 64Cu, were used together with imaging techniques to detect the site and spread of tumours and how it could potentially be used to treat various types of cancer.
Danish: Nogle af de videnskabelige artikler beskrev, hvordan mærkning med radioaktive former af kobber, herunder 64Cu, i forbindelse med billeddannelsesteknik er anvendt til at fastlægge svulsters beliggenhed og spredning, samt anvendelsesmulighederne til behandling af forskellige kræftformer.
English: What is the risk associated with Cuprymina?
Danish: Hvilken risiko er der forbundet med Cuprymina?
English: The intended effect of the radiation will depend on the nature of the medicine that has been radiolabelled.
Danish: Den tilsigtede virkning af strålingen afhænger af det lægemiddel, der er mærket.
English: Cuprymina is not used on its own but is used for radiolabelling other medicines.
Danish: Cuprymina anvendes ikke alene, men til radioaktiv mærkning af andre lægemidler.
English: When a medicine is radiolabelled with Cuprymina, the medicine will carry the radiation to the particular site or type of cell in the body that is targeted by the medicine.
Danish: Når et lægemiddel er mærket med Cuprymina, fører lægemidlet radioaktiviteten frem til det sted eller den type celler i kroppen, der er målet for lægemidlet.
English: Medicines to be radiolabeled with Cuprymina can only be obtained with a prescription.
Danish: Lægemidler til radioaktiv mærkning med Cuprymina udleveres kun efter recept.
English: It must not be used in people who are hypersensitive (allergic) to copper (64Cu) chloride or any of the other ingredients.
Danish: Cuprymina må ikke anvendes hos personer, der er overfølsomme (allergiske) over for kobber(64Cu)-chlorid eller andre af indholdsstofferne.
English: Why has Cuprymina been approved?
Danish: Hvorfor blev Cuprymina godkendt?
English: The information supplied by the company showed that Cuprymina can be used to radiolabel medicines with 64Cu, with potential utility for detecting of the sites and spread of tumours.
Danish: Virksomheden har forelagt oplysninger, der viser, at Cuprymina kan anvendes til 64Cu-mærkning af lægemidler, der giver mulighed for at bestemme svulsters beliggenhed og udbredelse.
English: The active substance in Cuprymina, copper (64Cu) chloride, is a radioactive compound that emits a type of radiation known as beta radiation.
Danish: Det aktive stof i Cuprymina, kobber(64Cu)-chlorid, er et radioaktivt stof, der afgiver betastråling.
English: Cuprymina is a solution that contains the radioactive substance copper (64Cu) chloride.
Danish: Cuprymina er en opløsning, der indeholder det radioaktive stof kobber(64Cu)-chlorid.
English: Given the well-known risks of exposure to radiation through radiolabeling, the Committee decided that Cuprymina is only to be used if justified by the likely medical benefit.
Danish: På baggrund af den kendte risiko for udsættelser for stråling gennem radioaktiv mærkning fastslog udvalget, at Cuprymina kun må anvendes, når den forventede helbredsmæssige fordel berettiger det. CHMP fandt, at der ikke er væsentlige sikkerhedsmæssige betænkeligheder vedrørende mulig giftig virkning af kobber, da Cuprymina anvendes i meget lave doser.
English: What is Cuprymina?
Danish: Hvad er Cuprymina?
English: More information on the restrictions on the use of medicines radiolabelled with Cuprymina will be found in their package leaflets.
Danish: Begrænsningerne i anvendelsen af lægemidler mærket med Cuprymina vil være nærmere omhandlet i indlægssedlerne for de pågældende lægemidler.
English: The radiolabelled medicine is then given to the patient according to the instructions in that medicine's summary of product characteristics (SmPC).
Danish: Det radioaktivt mærkede lægemiddel gives derefter til patienten i overensstemmelse med produktresuméet for det pågældende lægemiddel.
English: How has Cuprymina been studied?
Danish: Hvordan blev Cuprymina undersøgt?
English: What is Cuprymina used for?
Danish: Hvad anvendes Cuprymina til?
English: What benefit has Cuprymina shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cuprymina?
English: How is Cuprymina used?
Danish: Hvordan anvendes Cuprymina?
English: The side effects with Cuprymina depend largely on the medicine it has been used to radiolabel and will be described in that medicine's package leaflet.
Danish: Bivirkningerne med Cuprymina afhænger hovedsagelig af det mærkede lægemiddel.
English: Cuprymina is used to radiolabel medicines that have been specially developed for use with copper (64Cu) chloride.
Danish: Når stoffet er radioaktivt mærket med Cuprymina, fører det radioaktiviteten hen til det sted i kroppen, hvor der er brug for den. Cuprymina anvendes til radioaktiv mærkning af lægemidler, der er specielt beregnet til anvendelse med kobber(64Cu)-chlorid.
English: How does Cuprymina work?
Danish: Hvordan virker Cuprymina?
English: This takes around 30 minutes.
Danish: Dette tager cirka 30 minutter.
English: Read and follow the advice given in section 7.
Danish: Læs og følg de råd, der gives i punkt 7.
English: 52 weeks
Danish: 52 uger
English: 96 to 144 weeks
Danish: 96 til 144 uger
English: physical score (≥7.5 point)
Danish: fysisk score (≥7,5 point)
English: It has not been determined whether these patients respond differently compared with younger patients.
Danish: Det er ikke klarlagt, om disse patienter reagerer anderledes sammenlignet med yngre patienter.
English: This is normal and will not affect your dose.
Danish: Dette er normalt og vil ikke påvirke din dosis.
English: • Each pen can be used once only.
Danish: • Hver pen må kun anvendes én gang.
English: - if you have liver problems.
Danish: - Hvis du har leverproblemer.
English: Do not use more than 1 pen per month.
Danish: Brug ikke mere end 1 pen om måneden.
English: • It is expired.
Danish: o Den er udløbet.
English: The median duration was similar between the treatment groups.
Danish: Den gennemsnitlige varighed var sammenlignelig imellem behandlingsgrupperne.
English: Component of a multipack, cannot be sold separately.
Danish: Del af en multipakning, må ikke sælges separat.
English: Following a recovery period of up to 12 weeks, there was evidence of reversibility.
Danish: Efter en restitutionsperiode på op til 12 uger var der evidens for reversibilitet.
English: • thoughts of hurting yourself or suicide
Danish: • tanker om at gøre skade på dig selv eller begå selvmord
English: • changes in your blood (anaemia) which may make you feel weak
Danish: • forandringer i blodet (anæmi), som kan få dig til at føle dig svag
English: Contact your doctor immediately.
Danish: Kontakt omgående lægen.
English: • The need to exercise caution regarding concomitant use of other hepatotoxic medications;
Danish: • Behovet for at udvise forsigtighed vedrørende samtidig anvendelse af andre hepatotoksiske lægemidler,
English: However, as a precaution, monitoring of complete blood count is recommended every 3 months.
Danish: Som en forholdsregel anbefales det dog at foretage komplet blodtælling hver 3. måned.
English: Do not try to treat any side effects yourself.
Danish: Forsøg ikke at behandle bivirkninger selv.
English: Do not make changes unless your doctor tells you to.
Danish: Foretag ikke nogen ændringer, medmindre din læge siger, at du skal.
English: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
Danish: Din læge vil fortælle dig, om din sygdom gør det muligt for dig at køre motorkøretøj og betjene maskiner på sikker vis.
English: • Patient Card;
Danish: • Patientkort;
English: Patient Card has more information about these side effects.
Danish: Patientkortet indeholder yderligere oplysninger om disse bivirkninger.
English: • Be designed to enable physicians to present patient-friendly information;
Danish: • Udfærdiges, så lægerne kan fremlægge patientvenlig information,
English: This medicinal product should not be used if:
Danish: Dette lægemiddel må ikke anvendes, hvis:
English: The rate of infections and serious infections did not increase over time.
Danish: Hyppigheden af infektioner og alvorlige infektioner steg ikke med tiden.
English: Do not use this medicine if you notice that:
Danish: Anvend ikke dette lægemiddel, hvis du bemærker, at:
English: It is very important that you have these regular blood tests.
Danish: Det er meget vigtigt, at du får taget disse blodprøver regelmæssigt.
English: • If some areas are too difficult for you to reach, ask a carer who has been trained to help you.
Danish: • Hvis nogle steder er for vanskelige for dig at nå, kan du bede en trænet hjælper om hjælp.
English: In the absence of compatibility studies, this medicinal product should not be mixed with other products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Contact your doctor if you think you may have missed a blood test.
Danish: Kontakt din læge, hvis du tror, du har glemt at få taget en blodprøve.
English: Table 5 and Figures 1-2 show the results for the DECIDE study.
Danish: Tabel 5 og figur 1-2 viser resultaterne fra DECIDE-studiet.
English: Do not share the pen with anyone else to avoid giving an infection to them or getting an infection from them.
Danish: Del ikke pennen med andre, for at undgå at overføre en infektion til dem eller selv få en infektion fra dem..
English: Do not freeze or expose to high temperatures.
Danish: Må ikke nedfryses eller udsættes for høje temperaturer.
English: Try to keep to a set day for it each month.
Danish: Forsøg at sætte en fast dag af til det hver måned.
English: Additional supplies which are not included in the pack (See Figure B):
Danish: Ekstraudstyr, som ikke følger med i pakken (se figur B):
English: Doses up to this level were well tolerated with no evidence of acute toxicity.
Danish: Doser op til dette niveau var veltolererede uden evidens for akut toksicitet.
English: - if you have ever had tuberculosis (also called TB) or live in a region where TB infections are common, you may be at greater risk of TB.
Danish: - Hvis du har nogensinde har haft tuberkulose (TB) eller bor i et område, hvor tuberkulose forekommer, kan du have en større risiko for at få tuberkulose.
English: Treatment with Zinbryta can help to prevent you from getting worse, although it will not cure MS.
Danish: Behandling med Zinbryta kan hjælpe til at forebygge, at du får det værre, men det vil ikke helbrede din MS.
English: If your doctor has told you to stop using your medicine, do not restart unless your doctor tells you to.
Danish: Hvis din læge har bedt dig stoppe med at bruge lægemidlet, må du ikke begynde at bruge det igen, førend lægen siger, at du må.
English: Percentage of patients with clinically meaningful worsening in MSIS-29
Danish: Procentdel patienter med klinisk betydningsfuld forværring i MSIS-29
English: Keep the pack closed until you need to use a new syringe/pen.
Danish: Hold pakningen lukket, indtil du skal bruge en ny injektionssprøjte/pen.
English: The Patient Card should:
Danish: Patientkortet skal:
English: Race No pharmacokinetic differences were observed between Japanese and Caucasian healthy volunteers.
Danish: Der blev ikke observeret nogen farmakokinetiske forskelle mellem japanere og kaukasiske raske frivillige.
English: Biogen (Denmark) Manufacturing ApS Biogen Allé 1
Danish: Biogen (Danmark) Manufacturing ApS Biogen Allé 1
English: Some side effects may require your doctor to interrupt your treatment and refer you to a specialist.
Danish: Nogle bivirkninger kan nødvendiggøre, at din læge afbryder behandlingen og henviser dig til en specialist.
English: Results for the SELECT study are shown in Table 4.
Danish: Resultaterne for SELECT-studiet vises i tabel 4.
English: Note: You might see air bubbles in the medicine window.
Danish: Bemærk: Du vil måske se luftbobler i medicinvinduet.
English: Mean change in MSIS-29 physical score
Danish: Gennemsnitlig ændring i MSIS-29 fysisk score
English: Name and address of the manufacturer of the biological active substance:
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof:
English: In case of overdose, patients may require medical attention and appropriate supportive treatment should be given.
Danish: I tilfælde af overdosering kan lægehjælp være nødvendig, og der bør gives passende, understøttende behandling.