FrancophonIA/ELRC3.0 huggingface dataset:
English: Nyxoid is a medicine used for emergency treatment in case of known or suspected overdose of opioid drugs (such as heroin or morphine).
Danish: Nyxoid er et lægemiddel til nødbehandling af kendt eller mistænkt overdosering af opioide lægemidler (som f.eks. heroin eller morfin).
English: Why is Nyxoid approved?
Danish: Hvorfor blev Nyxoid godkendt?
English: The company will also conduct a study on the effectiveness of Nyxoid when given by people with no medical training.
Danish: Virksomheden vil også gennemføre en undersøgelse af Nyxoids virkning, når det gives af personer uden medicinsk uddannelse.
English: It is not intended to provide practical advice on how to use Nyxoid.
Danish: Det er ikke en praktisk vejledning i, hvordan Nyxoid bør anvendes.
English: The company that markets Nyxoid will issue educational materials, including a video, for healthcare professionals and for patients with detailed information on how to use the medicine.
Danish: Den virksomhed, der markedsfører Nyxoid, vil udarbejde informationsmateriale, herunder en video, til sundhedspersoner og patienter med detaljerede oplysninger om, hvordan lægemidlet anvendes.
English: There is also no risk of needle injury with Nyxoid, and this could encourage members of the public to provide treatment promptly.
Danish: Der er heller ingen risiko for nåleskader med Nyxoid, og det kan få almindelige borgere til at give hurtig behandling.
English: Therefore, the European Medicines Agency decided that Nyxoid's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP konkluderede derfor, at fordelene ved Nyxoid opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: In addition, a study involving 38 healthy volunteers showed that, when given by a healthcare professional, Nyxoid 2 mg given as a spray into the nose produced a similar level of naloxone in the body as naloxone given in the usual dose of 0.4 mg by injection into a muscle.
Danish: Derudover har en undersøgelse med deltagelse af 38 raske forsøgspersoner påvist, at Nyxoid 2 mg givet som et sprøjt i næsen af en sundhedsperson danner et naloxonniveau i kroppen, der svarer til det, der opnås ved injektion af den sædvanlige dosis på 0,4 mg i en muskel.
English: While the reference medicine Naloxon HCl B. Braun is given by injection, Nyxoid is given as a spray into the nose.
Danish: Referencelægemidlet Naloxon HCI B. Braun gives som injektion, mens Nyxoid gives som næsespray.
English: Naloxone, the active substance in Nyxoid, has been widely used in emergency medicine since the 1970s to treat opioid overdose.
Danish: Naloxon, det aktive stof i Nyxoid, er blevet bredt anvendt til nødbehandling af opioidoverdosis siden 1970'erne.
English: The company provided data from the published literature showing that naloxone is effective in treating opioid overdose when given by injection (the standard treatment for opioid overdose) as well as into the nose.
Danish: Virksomheden fremlagde data fra den publicerede litteratur, der viser, at naloxon er effektivt til behandling af opioidoverdosis, når det gives som injektion (standardbehandlingen for opioidoverdosis) eller gennem næsen.
English: The safety and effectiveness of naloxone as an antidote for opioid overdose are well known.
Danish: Sikkerheden og virkningen af naloxon som modgift ved opioidoverdosis er velkendt.
English: Signs of overdose include pinpoint pupils, abnormally slow and irregular breathing, severe sleepiness and unresponsiveness to touch or loud noises.
Danish: Tegn på en overdosis omfatter små pupiller, unormalt langsom og uregelmæssig vejrtrækning, svær søvnighed og ingen reaktion på berøring eller høje lyde.
English: It contains the active substance naloxone.
Danish: Det indeholder det aktive stof naloxon.
English: What are the risks associated with Nyxoid?
Danish: Hvilke risici er der forbundet med Nyxoid?
English: The active substance in Nyxoid, naloxone, counteracts the effects of opioid drugs.
Danish: Det aktive stof i Nyxoid, naloxon, modvirker effekten af opioide lægemidler.
English: Compared with emergency treatments for opioid overdose given by injection, Nyxoid can be given by people with no medical training because it is sprayed into the nose.
Danish: I modsætning til nødbehandling af opioidoverdosis ved injektion kan Nyxoid gives af personer, der ikke har nogen medicinsk uddannelse, da det skal sprøjtes ind i næsen.
English: The recommended dose is one spray into one nostril given immediately on suspecting an opioid overdose and while awaiting emergency services; if the first dose does not have an effect, a second dose should be given after 2-3 minutes in the other nostril.
Danish: Den anbefalede dosis er ét sprøjt i det ene næsebor, som gives øjeblikkeligt ved mistanke om en opioidoverdosis, mens der ventes på ambulance; hvis den første dosis ikke har nogen virkning, bør en ny dosis gives efter 23 minutter i det andet næsebor.
English: For more information about treatment with Nyxoid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Nyxoid, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Nyxoid is a nasal spray available in single-dose containers (1.8 mg).
Danish: Nyxoid er en næsespray, der fås som en enkeltdosisbeholder (1,8 mg).
English: For the full list of all side effects and restrictions with Nyxoid, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Nyxoid fremgår af indlægssedlen.
English: How does Nyxoid work?
Danish: Hvordan virker Nyxoid?
English: How is Nyxoid used?
Danish: Hvordan anvendes Nyxoid?
English: For practical information about using Nyxoid, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Nyxoid, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Typical opioid withdrawal syndrome is expected after Nyxoid is given to people addicted to opioids; symptoms include restlessness, agitation, feeling or being sick, a fast heart rate and sweating.
Danish: Efter indgift af Nyxoid hos personer, der er afhængige af opioider, kan typiske abstinenssymptomer forventes, og de omfatter rastløshed, uro, kvalme, hurtig hjerterytme og øget svedtendens.
English: What benefits of Nyxoid have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Nyxoid?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nyxoid have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nyxoid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Moventig on 8 December 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Moventig den 8. december 2014.
English: In terms of safety, the side effects were considered acceptable or manageable.
Danish: Med hensyn til sikkerheden blev bivirkningerne betragtet som acceptable eller håndterbare.
English: The recommended dose is one 25 mg tablet a day.
Danish: Den anbefalede dosis er én 25 mg tablet dagligt.
English: This is a summary of the European public assessment report (EPAR) for Moventig.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Moventig.
English: The full EPAR and risk management plan summary for Moventig can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Moventig findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Moventig
Danish: Andre oplysninger om Moventig
English: A risk management plan has been developed to ensure that Moventig is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Moventig anvendes så sikkert som muligt.
English: What is Moventig and what is it used for?
Danish: Hvad er Moventig, og hvad anvendes det til?
English: Why is Moventig approved?
Danish: Hvorfor blev Moventig godkendt?
English: Although studies in patients with cancerrelated pain had not been conducted, based on the mechanism of action of the medicine, the benefit for these patients was not expected to be different but the safety should be closely monitored.
Danish: Selv om der ikke er gennemført undersøgelser hos patienter med kræftrelaterede smerter, kan det ud fra lægemidlets virkningsmekanisme forventes, at fordelene for disse patienter ikke er anderledes, men sikkerheden bør overvåges nøje.
English: Moventig is available as tablets (12.5 and 25 mg).
Danish: Moventig fås som tabletter (12,5 og 25 mg).
English: It must also not be used with certain medicines that affect the way Moventig is broken down in the body.
Danish: Det må heller ikke anvendes sammen med visse lægemidler, der påvirker nedbrydningen af Moventig i kroppen.
English: A lower starting dose of 12.5 mg may be prescribed in patients with moderately or severely reduced kidney function or who are taking certain other medicines that increase the effects of Moventig.
Danish: En lavere startdosis på 12,5 mg kan ordineres til patienter, der har moderat eller svært nedsat nyrefunktion, eller som tager visse andre lægemidler, der øger virkningen af Moventig.
English: What are the risks associated with Moventig?
Danish: Hvilke risici er der forbundet med Moventig?
English: What measures are being taken to ensure the safe and effective use of Moventig?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Moventig?
English: The response to treatment was based on an improvement of the number of spontaneous bowel movements per week which had to be maintained for most of the duration of the study.
Danish: Respons på behandlingen blev vurderet ud fra en forbedring af antallet af spontane afføringer pr. uge, som skulle opretholdes så længe som muligt i løbet af undersøgelsen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Moventig's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Moventig opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The most common side effects with Moventig (which may affect more than 5 in 100 people) are abdominal pain (stomach ache), diarrhoea, nausea (feeling sick), headache and flatulence (passing wind).
Danish: De hyppigste bivirkninger ved Moventig (som optræder hos mere end 5 ud af 100 personer) er mavesmerter, diarré, kvalme, hovedpine og flatulens (luft i maven).
English: Before starting treatment with Moventig, treatment with laxatives should be stopped.
Danish: Før behandling med Moventig bør behandling med afføringsmidler stoppes.
English: It is not intended to provide practical advice on how to use Moventig.
Danish: Det er ikke en praktisk vejledning i, hvordan Moventig bør anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Moventig, 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 Moventig, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Moventig must not be used in patients who have or who are at high risk of bowel obstruction (blockage in the gut) or in patients with cancer who are at a high risk of gastro-intestinal perforation (a hole that develops in the wall of the gut).
Danish: Moventig må ikke anvendes til patienter med høj risiko for obstruktion (blokering af mavetarmkanalen) eller til kræftpatienter med høj risiko for gastrointestinal perforation (udvikling af et hul i tarmvæggen).
English: For more information about treatment with Moventig, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Moventig, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The majority of side effects affecting the gut were mild to moderate, occurred early in treatment and got better during continued treatment.
Danish: De fleste bivirkninger, der påvirker mavetarmkanalen, var milde til moderate, forekom tidligt i behandlingen og blev bedre ved fortsat behandling.
English: This means that it attaches to a specific type of opioid receptor called the ‘mu-opioid receptor' and blocks opioids from binding to these receptors.
Danish: Det betyder, at det binder sig til en særlig type opioidreceptor kaldet »my-opioid-receptoren« og forhindrer opioider i at binde sig til disse receptorer.
English: It is used in patients in whom treatment with laxatives has failed.
Danish: Det anvendes til patienter, hvor behandling med afføringsmidler ikke har virket.
English: People either received Moventig (at 12.5 and 25 mg) or placebo (a dummy treatment) for 12 weeks.
Danish: Patienterne fik i 12 uger enten Moventig (12,5 og 25 mg) eller placebo (en virkningsløs behandling).
English: Naloxegol is derived from naloxone, a well-known substance that is used to block the action of opioids.
Danish: Naloxegol er et derivat af naloxon, et velkendt stof, som anvendes til at blokere virkningen af opioider.
English: When looking at the results of both main studies together, 48% (115 out of 241) of adults who previously had an inadequate response to laxatives and who took 25 mg Moventig responded to treatment compared with 30% (72 out of 239) of adults on placebo.
Danish: Ser man sammenlagt på resultaterne af de to hovedundersøgelser, var der på behandlingen respons hos 48 % (115 ud af 241) af de voksne, som ikke tidligere havde responderet tilstrækkeligt på afføringsmidler, og som fik 25 mg Moventig, sammenlignet med 30 % (72 ud af 239) af de voksne, som fik placebo.
English: The active substance in Moventig, naloxegol, is a peripheral mu-opioid-receptor antagonist.
Danish: Det aktive stof i Moventig, naloxegol, er en perifert virkende my-opioid-receptorantagonist.
English: Naloxegol is less able to enter the brain than naloxone, meaning that it can block the mu-opioid receptors in the gut but less in the brain.
Danish: Naloxegol har sværere ved at få adgang til hjernen end naloxon, hvilket betyder, at det kan blokere my-opioid-receptorerne i mavetarmkanalen, men i mindre grad i hjernen.
English: For adults who took 12.5 mg Moventig and who previously had an inadequate response to laxatives, 43% (102 out of 240) responded to treatment.
Danish: Hos voksne, som fik 12,5 mg Moventig, og som ikke tidligere havde responderet tilstrækkeligt på afføringsmidler, responderede 43 % (102 ud af 240) på behandlingen.
English: The CHMP considered that Moventig had shown a clinically relevant benefit when used in adults who have not responded adequately to previous treatment with laxatives.
Danish: CHMP tog i betragtning, at der med Moventig er påvist klinisk relevante fordele, når det anvendes til voksne, som ikke tidligere har responderet tilstrækkeligt på behandling med afføringsmidler.
English: The studies involved 1,352 adults with constipation caused by opioids that were being used to treat non-cancer pain, half of whom had an inadequate response to laxatives (720).
Danish: Undersøgelserne omfattede 1 352 voksne med forstoppelse forårsaget af opioider, der var brugt til behandling af smerter af andre årsager end kræft, hvoraf halvdelen ikke responderede tilstrækkeligt på afføringsmidler (720).
English: How is Moventig used?
Danish: Hvordan anvendes Moventig?
English: Moventig is a medicine used in adults to treat constipation caused by pain relief medicines called opioids.
Danish: Moventig er et lægemiddel, der anvendes til behandling af voksne med forstoppelse, som skyldes en type smertestillende midler kaldet opioider.
English: For practical information about using Moventig, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Moventig, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Opioids relieve pain by attaching to ‘opioid receptors' in the brain and spinal cord.
Danish: Opioider virker smertestillende ved at binde sig til »opioidreceptorer« i hjernen og rygmarven.
English: What benefits of Moventig have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Moventig?
English: By blocking receptors in the gut, Moventig reduces the constipation due to opioids, but does not interfere with their pain relief effects.
Danish: Ved at blokere receptorerne i mavetarmkanalen, reducerer Moventig forstoppelse, der skyldes opioider, uden at det hindrer opioidernes smertestillende virkning.
English: For the full list of all side effects and restrictions reported with Moventig, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Moventig fremgår af indlægssedlen.
English: However, these receptors are also found in the gut and when opioids attach to the gut receptors, they reduce the movement of the gut and can cause constipation.
Danish: Disse receptorer findes imidlertid også i mavetarmkanalen, og når opioider binder sig til mavetarmkanalens receptorer, reduceres mavetarmkanalens mobilitet, hvilket kan føre til forstoppelse.
English: How does Moventig work?
Danish: Hvordan virker Moventig?
English: Moventig has been shown to be effective at treating constipation in adults who had an inadequate response to laxatives in two main studies.
Danish: Moventig blev i to hovedundersøgelser påvist at være effektivt til behandling af voksne, der havde forstoppelse som følge af opioider, og som ikke responderede tilstrækkeligt på afføringsmidler.
English: These blood tests are done for a number of reasons:
Danish: Disse blodprøver tages af flere grunde:
English: Then continue taking your capsules as normal.
Danish: Fortsæt derefter med at tage dine kapsler som normalt.
English: Take 3 times per day; morning, afternoon and evening.
Danish: Tages 3 gange dagligt, morgen, eftermiddag og aften.
English: † and ‡
Danish: † og ‡
English: Component of a multipack, can't be sold separately
Danish: Del af multipakning, som ikke kan sælges separat
English: Date of first authorisation: 18 July 2011 Date of latest renewal: 18 February 2016
Danish: Dato for første markedsføringstilladelse: 18. juli 2011 Dato for seneste fornyelse: 18. februar 2016
English: Ribavirin can be very damaging to an unborn baby.
Danish: Ribavirin kan være meget skadeligt for et ufødt barn.
English: 84 hard capsules.
Danish: 84 hårde kapsler.
English: Interaction (postulated mechanism of action, if known)
Danish: Interaktion (postuleret aktionsmekanisme, hvis kendt)
English: (Refer to the stopping rule in Table 1 for all patients.)
Danish: (Se stopreglen i tabel 1 for alle patienter.)
English: ≥ 1-log10 decline
Danish: ≥ 1-log10 fald
English: • so your doctor knows if the treatment is working for you
Danish: • så lægen kan se, om behandlingen virker for dig
English: The use without food could seriously compromise your chance of success of treatment.
Danish: Brug uden mad kan i alvorlig grad gå ud over dine chancer for at behandlingen lykkes.
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis det sker, skal du ikke køre eller betjene værktøj eller maskiner.
English: Prompt evaluation and treatment of infections is recommended.
Danish: Omgående vurdering og behandling af infektioner anbefales.
English: • to help your doctor decide how long you will be treated with Victrelis.
Danish: • for at hjælpe lægen med at afgøre, hvor længe du skal behandles med Victrelis.
English: Your doctor will have your blood tested regularly.
Danish: Din læge vil jævnligt tage blodprøver.
English: • The duration of the administration of these medicines will depend on your response and
Danish: • Varigheden af behandlingen med disse lægemidler afhænger af, hvordan du reagerer på
English: If you have any questions about what to do, talk to your doctor.
Danish: Hvis du har spørgsmål omkring, hvad du skal gøre, skal du tale med din læge.
English: Take the capsules in the morning, afternoon and evening with a meal or light snack.
Danish: Tag kapslerne om morgenen, eftermiddagen og aftenen sammen med et måltid eller en snack.
English: Inner carton without Blue Box
Danish: Inderkarton uden blue box
English: Alternative contraceptives should be considered for these patients.
Danish: Alternative præventionsmidler bør overvejes til disse patienter.
English: • This medicine should be taken with a meal or light snack.
Danish: • Medicinen skal tages sammen med et måltid eller en snack.
English: HBV screening should be performed in all patients before initiation of treatment.
Danish: Hbv-screening bør udføres på alle patienter før behandlingsstart.
English: Stop taking Victrelis and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Stop med at tage Victrelis og gå straks til lægen, hvis du bemærker nogen af følgende alvorlige bivirkninger - du kan få brug for akut medicinsk behandling:
English: After this period, the medicinal product should be disposed.
Danish: Efter denne periode bør lægemidlet destrueres.
English: • have a condition called ‘autoimmune hepatitis'
Danish: • har en tilstand, der hedder "autoimmun hepatitis"
English: Neutropenia affects the body's ability to fight off infections
Danish: Neutropeni påvirker kroppens evne til at holde infektioner væk
English: Outer carton with Blue Box
Danish: Yderkarton med blue box
English: Victrelis must not be used by itself.
Danish: Victrelis må ikke bruges alene.
English: The safety and efficacy of Victrelis in children aged below 18 years have not yet been established.
Danish: Victrelis' sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: ASSESSMENT* (HCV-RNA Results
Danish: VURDERING * (hcv-RNA-resultater
English: • The active substance is boceprevir.
Danish: • Aktivt stof: boceprevir.
English: • statins - simvastatin or lovastatin
Danish: • statiner - simvastatin eller lovastatin
English: Dose adjustment of the benzodiazepine should be considered.
Danish: Dosisjustering af benzodiazepinet bør overvejes.
English: Please see "Possible side effects" for more information.
Danish: Se afsnittet ”Bivirkninger” for mere information.
English: Treatment duration = 28 weeks
Danish: Behandlingsvarighed = 28 uger
English: Loss of replicon RNA appears to be first-order with respect to time of treatment.
Danish: Tab af replikon-RNA ser ud til at være af første orden med hensyn til behandlingstidspunktet.
English: These recommendations are based on either drug interaction studies (indicated with *) or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy.
Danish: Disse anbefalinger er baseret på enten lægemiddelinteraktionsstudier (angivet med *) eller på forventede interaktioner ud fra det forventede omfang af interaktionen og risikoen for alvorlige bivirkninger eller
English: The hepatocellular tumours are considered due to enzyme induction and therefore not relevant for humans.
Danish: De hepatocellulære tumorer anses for at være forårsaget af enzyminduktion og er derfor ikke relevant for mennesker.
English: Caution is warranted and clinical monitoring of patients is recommended.
Danish: Forsigtighed er påkrævet, og klinisk monitorering af patienterne anbefales.