FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Qutenza, 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 Qutenza, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The most common side effects with Qutenza (seen in more than 1 patient in 10) are pain and redness at the site of application.
Danish: De hyppigste bivirkninger ved Qutenza (som optræder hos flere end 1 ud af 10 patienter) er smerte og rødme på påføringsstedet.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Qutenza's benefits are greater than its risks and recommended that Qutenza be given marketing authorisation.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Qutenza opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Qutenza.
English: Qutenza was more effective at reducing neuropathic pain than the control patches.
Danish: Qutenza var mere effektivt til at lindre neuropatiske smerter end kontrolplastrene.
English: Qutenza is used to treat peripheral neuropathic pain (pain that is caused by damage to the nerves) in adults.
Danish: Qutenza anvendes til behandling af perifere neuropatiske smerter (smerter, som er forårsaget af beskadigelse af nerver) hos voksne.
English: What is the risk associated with Qutenza?
Danish: Hvilken risiko er der forbundet med Qutenza?
English: Why has Qutenza been approved?
Danish: Hvorfor blev Qutenza godkendt?
English: Before applying Qutenza, the area may be treated with a local anaesthetic to numb it; this helps to reduce discomfort.
Danish: Inden der påføres Qutenza, kan området behandles med lokalbedøvelse, så det er følelsesløst.
English: A fifth study compared Qutenza with a placebo (dummy) patch in 369 patients with painful peripheral diabetic neuropathy, a form of neuropathic pain associated with diabetes; a supportive study looked at repeated treatment over one year.
Danish: I en femte undersøgelse blev Qutenza sammenlignet med placebo (en virkningsløs behandling) hos 369 patienter med smertefuld perifer diabetisk neuropati, en form for neuropatisk smerte forbundet med diabetes.
English: In the two studies of patients with post-herpetic neuralgia, the reduction in pain scores after eight weeks was 30 and 32% in patients who were given Qutenza, compared with 20 and 24% in patients who received the control patches.
Danish: I de to undersøgelser af patienter med postherpetisk neuralgi var faldet i smertescoren efter otte uger 30 og 32 % hos patienter, som fik Qutenza, sammenlignet med 20 og 24 % hos patienter, som fik kontrolplastre.
English: For the full list of all side effects and restrictions with Qutenza, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Qutenza fremgår af indlægssedlen.
English: In one of the studies of patients with HIV-associated neuropathy, patients who were given Qutenza experienced a 23% reduction in pain scores after 12 weeks compared with an 11% reduction in patients who were given the control.
Danish: I en af undersøgelserne af patienter med HIV-associeret neuropati oplevede de patienter, der fik Qutenza, et fald i smertescoren på 23 % efter 12 uger sammenlignet med et fald på 11 % hos de patienter, der fik kontrolplastre.
English: In the second study of patients with HIV-associated neuropathy, although Qutenza reduced pain by 30% it was not shown to be more effective than the control.
Danish: I den anden undersøgelse af patienter med HIVassocieret neuropati blev det ikke påvist, at Qutenza var mere effektivt end kontrolplastrene, selv om det reducerede smerterne med 30 %.
English: In patients with painful peripheral diabetic neuropathy, the reduction in pain score from week 2 to after 8 weeks with Qutenza was about 27% compared with 21% for the placebo.
Danish: Hos patienter med smertefuld perifer diabetisk neuropati var faldet i smertescoren fra uge to til efter otte uger ca. 27 % hos patienter, som fik Qutenza, sammenlignet med 21 % hos patienter, som fik placebo.
English: How has Qutenza been studied?
Danish: Hvordan blev Qutenza undersøgt?
English: What is Qutenza used for?
Danish: Hvad anvendes Qutenza til?
English: What benefit has Qutenza shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Qutenza?
English: How is Qutenza used?
Danish: Hvordan anvendes Qutenza?
English: How does Qutenza work?
Danish: Hvordan virker Qutenza?
English: It can be used in adults and children from 12 years of age.
Danish: Det kan anvendes hos voksne og børn over 12 år.
English: The full EPAR for Refixia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Refixia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Refixia
Danish: Andre oplysninger om Refixia
English: This is a summary of the European public assessment report (EPAR) for Refixia.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Refixia.
English: Since this could potentially cause problems especially in children below 12 years of age, Refixia is only approved for use in in adults and children from 12 years of age.
Danish: Da dette kan tænkes at medføre problemer, især hos børn under 12 år, er Refixia kun godkendt til voksne og børn over 12 år.
English: What measures are being taken to ensure the safe and effective use of Refixia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Refixia?
English: Patients or their carers may be able to inject Refixia themselves at home once they have been trained appropriately.
Danish: Patienten eller dennes omsorgsgiver kan selv injicere Refixia i hjemmet efter at have fået passende oplæring.
English: In the second study in 25 children aged below 13 years, all patients were given Refixia as a weekly preventive treatment.
Danish: I den anden undersøgelse hos 25 børn under 13 år fik alle patienter Refixia som forebyggende behandling én gang om ugen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Refixia'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 Refixia opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It is not intended to provide practical advice on how to use Refixia.
Danish: Det er ikke en praktisk vejledning i, hvordan Refixia bør anvendes.
English: Hypersensitivity (allergic) reactions are uncommon with Refixia (may affect up to 1 in 100 patients) and may include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Danish: Overfølsomhedsreaktioner (allergiske reaktioner) er ikke almindelige med Refixia (kan forekomme hos op til 1 ud af 100 patienter) og kan bestå i: hævelse, brænden og stikken på injektionsstedet, kulderystelser, rødme, kløende udslæt, hovedpine, nældefeber, lavt blodtryk, sløvhed, kvalme og opkastning, rastløshed, hurtig hjerterytme, trykken for brystet og hiven efter vejret.
English: Why is Refixia approved?
Danish: Hvorfor blev Refixia godkendt?
English: What is Refixia and what is it used for?
Danish: Hvad er Refixia, og hvad anvendes det til?
English: Refixia must not be used in patients allergic to hamster proteins.
Danish: Refixia må ikke anvendes hos patienter med allergi over for hamsterproteiner.
English: Refixia has been shown to be effective at both treating bleeding episodes and keeping the number of episodes low.
Danish: Refixia er påvist at være effektivt både til at behandle blødningsepisoder og til at holde antallet af episoder lavt.
English: What are the risks associated with Refixia?
Danish: Hvilke risici er der forbundet med Refixia?
English: The dose and frequency of treatment depend on whether Refixia is used to treat or prevent bleeding, or to reduce bleeding during surgery, the extent and location of the bleeding, and the patient's bodyweight.
Danish: Dosis og hyppighed af behandlingen afhænger af, om Refixia anvendes til at behandle eller forebygge blødning eller til at nedsætte blødning under operation, blødningens omfang og placering og patientens legemsvægt.
English: The company that markets Refixia will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Danish: Virksomheden, der markedsfører Refixia, skal gennemføre en undersøgelse af de mulige virkninger af PEG-ophobning i hjernens plexus chorioideus og andre organer.
English: Refixia can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Danish: Refixia udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af hæmofili.
English: In a study involving 74 adults and adolescents aged 13 or above, 29 patients given Refixia as a weekly preventive treatment had around 1 bleeding episode a year, and 15 patients given Refixia for treating bleedings ‘on demand' had around 16 bleeding episodes a year.
Danish: I en undersøgelse med 74 voksne og unge over 13 år fik 29 patienter, der fik Refixia som forebyggende behandling, ca. 1 blødningsepisode om året, mens 15 patienter, der fik Refixia til behandling af blødning efter behov, fik omkring 16 blødningsepisoder om året.
English: Around 86% of bleeding episodes resolved with one injection.
Danish: Omkring 86 % af blødningsepisoderne svandt med én indsprøjtning.
English: Studies show that Refixia is effective at preventing and treating bleeding episodes in patients with haemophilia B and its safety is comparable to that of other factor IX products.
Danish: Undersøgelser viser, at Refixia er effektivt til at forebygge og behandle blødningsepisoder hos patienter med hæmofili B, og dets sikkerhed er sammenlignelig med andre faktor IX-produkter.
English: The active substance in Refixia, nonacog beta pegol, works in the body in the same way as human factor IX.
Danish: Det aktive stof i Refixia, nonacog beta pegol, virker på samme måde i kroppen som kroppens egen faktor IX.
English: 87% of bleeding episodes resolved with one injection of Refixia.
Danish: 87 % af blødningsepisoderne svandt med én injektion af Refixia.
English: Refixia contains the active substance nonacog beta pegol.
Danish: Refixia indeholder det aktive stof nonacog beta pegol.
English: Factor IX medicines can also potentially cause problems due to the formation of blood clots in the blood vessels.
Danish: Faktor IXmedicin kan også medføre problemer på grund af dannelsen af blodpropper i blodårerne.
English: Patients had around 1 bleeding episode per year and Refixia was rated excellent or good at treating around 93% of bleeding episodes.
Danish: Patienterne fik omkring 1 blødningsepisode om året, og Refixia blev bedømt som fremragende eller godt til at behandle omkring 93 % af blødningsepisoderne.
English: It replaces the missing factor IX, thereby helping the blood to clot and giving temporary control of bleeding.
Danish: Det erstatter den manglende faktor IX og medvirker derved til blodets størkning, så der opnås midlertidig kontrol med blødningen.
English: In addition, when bleeding did occur, Refixia was rated excellent or good at treating around 92% of bleeding episodes.
Danish: Når blødning forekom, blev Refixia bedømt til at være fremragende eller godt til behandling af omkring 92 % af blødningsepisoderne.
English: For further information on how to use this medicine, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af dette lægemiddel fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: For more information about treatment with Refixia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Refixia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Some patients taking factor IX medicines may develop inhibitors (antibodies) against factor IX, causing the medicine to stop working and resulting in a loss of bleeding control.
Danish: Nogle patienter, der får lægemidler med faktor IX, kan udvikle antistoffer (inhibitorer) mod faktor IX, hvilket medfører, at medicinen ikke længere virker og blødningskontrollen derved mistes.
English: What benefits of Refixia have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Refixia?
English: How is Refixia used?
Danish: Hvordan anvendes Refixia?
English: For practical information about using Refixia, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Refixia, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Refixia is available as a powder and a liquid that are mixed together to make a solution for injection into a vein.
Danish: Refixia fås som et pulver med opløsningsvæske (solvens), der blandes til en opløsning, som gives ved injektion i en vene.
English: Refixia is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX.
Danish: Refixia er et lægemiddel til behandling og forebyggelse af blødning hos patienter med den arvelige blødningsforstyrrelse hæmofili B, der skyldes mangel på proteinet faktor IX, som medvirker ved blodets størkning (koagulation).
English: However, part of the active substance in Refixia (called PEG) may accumulate in the body, including in a structure in the brain called choroid plexus, following long-term treatment.
Danish: Efter langvarig behandling kan en del af det aktive stof i Refixia ("PEG)" imidlertid ophobes i kroppen, herunder i årenettet (plexus choriorideus) i hjernen.
English: Patients with haemophilia B lack factor IX, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Danish: Patienter med hæmofili B mangler proteinet faktor IX, der er nødvendigt for blodets normale størkning; derfor får de let blødninger.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Refixia 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 Refixia.
English: • The product is now ready for use.
Danish: • Produktet er nu klart til brug.
English: Date of first authorisation: 16 March 2016
Danish: Dato for første markedsføringstilladelse: 16. marts 2016
English: How much is given before, during and after major surgery?
Danish: Hvor meget gives før, under og efter en større operation?
English: This could mean that the treatment will not work properly.
Danish: Dette kan betyde, at behandlingen ikke virker efter hensigten.
English: Each pack contains:
Danish: Hver pakning indeholder:
English: How much is given regularly for long-term prevention of bleeds?
Danish: Hvor meget gives der regelmæssigt til langtidsforebyggelse af blødninger?
English: Your doctor will explain to you how much you should use, when you should use it and for how long.
Danish: Lægen vil forklare dig, hvor meget du skal bruge, hvornår du skal bruge det og hvor længe.
English: The dose and frequency should be based on the individual clinical response.
Danish: Dosis og frekvens skal baseres på den enkeltes kliniske respons.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan påvirke op til 1 ud af 10 mennesker):
English: Your doctor will arrange for the appropriate laboratory tests to see if this is the case.
Danish: Din læge vil sørge for de nødvendige laboratorieprøver for at se, om dette er tilfældet.
English: In case of shock, the current medical standards for shock treatment should be observed.
Danish: I tilfælde af chok skal de nuværende medicinske standarder for chokbehandling observeres.
English: • If you are using this medicine for the first time, your doctor will supervise you
Danish: • Hvis du benytter lægemidlet for første gang, vil lægen vejlede dig.
English: Always consult your doctor before deciding to stop your treatment.
Danish: Rådfør dig altid med lægen, før du beslutter at stoppe din behandling.
English: Paediatric population (less than 12 years of age)
Danish: Pædiatrisk population (under 12 år)
English: The transfer device supplied with the product is sterile and cannot be used more than once.
Danish: Overførselsenheden, som følger med produktet, er steril og kan ikke bruges mere end én gang.
English: After: During the first few days after the operation, your plasma factor X concentration will be checked regularly.
Danish: Efter: I løbet af de første par dage efter operationen, vil din plasma faktor X-koncentration blive kontrolleret regelmæssigt.
English: EXP: Use within 1 hour of reconstitution.
Danish: EXP: Bruges inden for 1 time fra restituering.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, hvis du tager, for nylig har taget eller muligvis vil tage anden medicin.
English: Check with your doctor if you think this applies to you.
Danish: Spørg din læge, hvis du mener, at dette gælder for dig.
English: Make sure you use the product within an hour after it has been made up.
Danish: Sørg for at anvende produktet inden for en time efter, at det er blandet.
English: Summary of safety profile
Danish: Sammendrag af sikkerhedsprofil
English: Your doctor will check regularly for the development of these antibodies, and especially before an operation.
Danish: Lægen vil regelmæssigt kontrollere udviklingen af disse immunstoffer - særligt før en operation.
English: The dose you need will be calculated by your doctor.
Danish: Den dosis du har brug for, vil blive beregnet af din læge.
English: Generally the doses for children less than 12 years old are larger than doses for adolescents which should follow those in adults.
Danish: Generelt er doser til børn under 12 år større end doser til unge, som skal følge dem for voksne.
English: Before injecting this medicine at home, you should have received training by your healthcare professional on how to do so.
Danish: Før injektion af denne medicin derhjemme, skal du af sundhedspersonalet have modtaget instrukser i, hvordan man gør det.
English: However, chemical and physical in-use stability has been demonstrated for 1 hour at room temperature (up to 25°C +/-2°C).
Danish: Imidlertid er der blevet påvist kemisk og fysisk stabilitet under brug i 1 time ved stuetemperatur (op til 25 °C +/- 2 °C).
English: Side effects in children are expected to be the same as in adults.
Danish: Bivirkninger hos børn forventes at være de samme som hos voksne.
English: Your doctor will recommend an appropriate dose for you.
Danish: Lægen vil anbefale en passende dosis til dig.
English: Eight subjects had severe FX deficiency, the other had moderate deficiency.
Danish: 8 personer havde svær FXmangel, den sidste havde moderat mangel.
English: After reconstitution, from a microbiological point of view, the product should be used immediately.
Danish: Efter restituering skal produktet af mikrobiologiske årsager straks anvendes.
English: Do not use this medicine if you notice small bits in the dissolved product.
Danish: Brug ikke lægemidlet, hvis du bemærker små stykker i det opløste produkt.
English: After reconstitution, the product should be administered by the intravenous route at a suggested rate of 10 mL/min, but no more than 20 mL/min.
Danish: Efter restituering skal produktet administreres intravenøst med en foreslået hastighed på 10 ml/min, men ikke mere end 20 ml/min.
English: Coagadex was considered to be good (7%) or excellent (91%) in treating 98% of bleeding episodes.
Danish: Coagadex blev anset for at være godt (7%) eller fremragende (91%) til behandling af 98% af blødningsepisoder.
English: Allergic reactions (hypersensitivity reactions) have occurred rarely in the treatment of bleeding disorders with similar medicines (affecting up to 1 in 1,000 people), and sometimes progress to shock.
Danish: Allergiske reaktioner (overfølsomhedsreaktioner) ses sjældent hos behandlingen af blødningsforstyrrelser med lignende medicin (påvirker op til 1 ud af 1.000 personer), og udvikler sig nogle gange til chok.
English: The listed warnings and precautions for adults also apply to children (aged 2 to 11 years) and adolescents (aged 12 to 18 years).
Danish: De anførte advarsler og forholdsregler for voksne gælder også for børn (mellem 2 og 11 år) samt unge (mellem 12 og 18 år).
English: Repeat at intervals of 24 hours until the bleed stops.
Danish: Gentages med 24-timers intervaller, indtil blødningen stopper.
English: In general, all patients treated with Coagadex should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Danish: Generelt skal alle patienter, som behandles med Coagadex, nøje overvåges for udvikling af inhibitorer ved passende kliniske observationer og laboratorieprøver.
English: • The injection should be repeated as necessary to stop the bleeding
Danish: • Injektionen bør gentages efter behov for at stoppe blødningen.
English: No adverse events were reported relating to this overdose.
Danish: Der blev ikke indberettet bivirkninger i forbindelse med denne overdosis.
English: There are no known effects of this medicine on the ability to drive or operate machinery.
Danish: Der er ingen kendte virkninger af dette lægemiddel på evnen til at køre eller betjene maskiner.
English: A total of 537 (mean 59.7 per subject) prophylactic infusions were administered.
Danish: I alt 537 (gennemsnit 59,7 pr. person) profylaktiske infusioner blev administreret.
English: Do not use this medicine after the expiry date which is stated on the containers after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP”.
English: Reconstituted products should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Restituerede produkter skal inspiceres visuelt for partikler og misfarvning før administration.
English: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, Storbritannien Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: A total of 184 infusions of Coagadex were given as a preventative measure.
Danish: I alt blev der givet 184 infusioner af Coagadex som en forebyggende foranstaltning.
English: During the dose-adjustment phase, two trough levels were <5 IU/dL but thereafter none were below this threshold.
Danish: I løbet af dosisjusteringsfasen var 2 minimumsniveauer <5 IE/dl, men derefter var der ingen under denne tærskelværdi.
English: Do not use solutions that are cloudy or have deposits.
Danish: Anvend ikke opløsninger, der er uklare eller har aflejringer.
English: 70 x (90-15) x 0.5 = 2,625 IU.
Danish: 70 x (90-15) x 0,5 = 2.625 IE.
English: Dissolving your medicines before use
Danish: Opløsning af medicin før brug
English: Do not use the water for injections if signs of particulate matter are visible.
Danish: Brug ikke vand til injektioner, hvis der er tegn på partikler.