FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all medicines, data on the use of Palynziq are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Palynziq løbende overvåget.
English: The dose and frequency of injection are then increased gradually (up to a maximum dose of 60 mg once a day) to achieve adequate control of phenylalanine blood levels.
Danish: Dosis og injektionshyppighed øges derefter gradvist (op til en maksimumsdosis på 60 mg én gang dagligt) for at opnå passende kontrol med indholdet af phenylalanin i blodet.
English: Further information on Palynziq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Palynziq.
Danish: Yderligere information om Palynziq findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Palynziq.
English: The safety of Palynziq is considered acceptable, and important side effects such as allergic reactions are considered manageable with additional stringent measures (see below).
Danish: Sikkerheden ved Palynziq anses for acceptabel, og vigtige bivirkninger såsom allergiske reaktioner anses for at kunne håndteres med yderligere stringente foranstaltninger (se nedenfor).
English: For more information about using Palynziq, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Palynziq, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Palynziq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 January 2010.
Danish: Palynziq blev udpeget som "lægemiddel til sjældne sygdomme" den 28. januar 2010.
English: Palynziq must be used with stringent measures to manage any serious allergic reactions, especially in the first few months.
Danish: Ved anvendelse af Palynziq skal der træffes strenge foranstaltninger for at håndtere eventuelle alvorlige allergiske reaktioner, især i de første par måneder.
English: The European Medicines Agency therefore decided that Palynziq'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 Palynziq opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: During the first part, all patients were given Palynziq at a dose of 20 or 40 mg for up to 13 weeks.
Danish: I den første del af studiet fik alle patienterne Palynziq i en dosis på 20 eller 40 mg i op til 13 uger.
English: What measures are being taken to ensure the safe and effective use of Palynziq?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Palynziq?
English: The most common side effects with Palynziq (which may affect more than 7 in 10 people) are reactions at the injection site, pain in the joints and allergic reactions.
Danish: De hyppigste bivirkninger ved Palynziq (som kan forekomme hos mere end 7 ud af 10 personer) er reaktioner på injektionsstedet, smerter i leddene og allergiske reaktioner.
English: The enzyme in pegvaliase is ‘pegylated' (attached to a chemical called PEG), allowing it to remain in the body and to act for longer.
Danish: Enzymet i pegvaliase er "pegyleret" (dvs. bundet til et kemisk stof kaldet PEG), som giver det mulighed for at blive i kroppen og virke i længere tid.
English: Phenylalanine blood levels must be measured before starting treatment.
Danish: Indholdet af phenylalanin i blodet skal måles før påbegyndelse af behandlingen.
English: In the extension phase of the study patients received an individual optimized dose of Palynziq.
Danish: I udvidelsesfasen modtog patienterne en individuelt optimeret dosis Palynziq.
English: Palynziq is available as pre-filled syringes (2.5, 10 and 20 mg) for injection under the skin.
Danish: Palynziq fås som fyldte sprøjter (2,5, 10 og 20 mg) til injektion under huden.
English: Side effects reported with Palynziq are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Palynziq vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Palynziq contains the active substance pegvaliase.
Danish: Palynziq indeholder det aktive stof pegvaliase.
English: The company that markets Palynziq will provide information material for doctors and for patients and carers about the risk of allergic reactions with Palynziq, including how to identify them promptly and what to do in case such a reaction occurs.
Danish: Virksomheden, der markedsfører Palynziq, vil udlevere informationsmateriale til læger og patienter og omsorgspersoner om risikoen for allergiske reaktioner med Palynziq, herunder om, hvordan de kan identificere dem hurtigt, og hvad der skal gøres, hvis en sådan reaktion opstår.
English: Other information about Palynziq
Danish: Andre oplysninger om Palynziq
English: An overview of Palynziq and why it is authorised in the EU
Danish: En oversigt over Palynziq, og hvorfor det er godkendt i EU
English: Palynziq is a medicine that is used to treat phenylketonuria (PKU) in adults and adolescents from 16 years of age.
Danish: Palynziq er et lægemiddel, der anvendes til behandling af phenylketonuria (PKU) hos voksne og unge fra 16 års-alderen.
English: Why is Palynziq authorised in the EU?
Danish: Hvorfor blev Palynziq godkendt i EU?
English: Patients with this genetic disease cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system.
Danish: Patienter med denne genetiske sygdom kan ikke bearbejde aminosyren phenylalanin fra kostprotein, og som følge heraf ophober aminosyren sig i blodet til unormalt høje niveauer, hvilket forårsager problemer i nervesystemet.
English: Palynziq is intended for long-term use.
Danish: Palynziq er beregnet til langtidsbehandling.
English: The active substance in Palynziq, pegvaliase, is a bacterial enzyme that can break down phenylalanine, thereby stopping phenylalanine from building up in the body and helping to relieve the symptoms of phenylketonuria.
Danish: Det aktive stof i Palynziq, pegvaliase, er et bakterieenzym, der kan nedbryde phenylalanin, og derved forhindre phenylalanin i at ophobe sig i kroppen og bidrage til at lindre symptomerne på phenylketonuria.
English: The main study investigating Palynziq in patients with PKU consisted of different parts.
Danish: Hovedstudiet af Palynziq hos patienter med PKU bestod af forskellige dele.
English: It was shown that for the majority of patients continued treatment with Palynziq for 18 months was effective at keeping blood phenylalanine levels under control (below 600 micromoles per litre).
Danish: Det blev påvist, at for de fleste patienter var fortsat behandling med Palynziq i 18 måneder effektivt til at holde blodets indhold af phenylalanin under kontrol (under 600 mikromol pr. liter).
English: What is Palynziq and what is it used for?
Danish: Hvad er Palynziq, og hvad anvendes det til?
English: Eighty-six patients who responded to treatment (i.e. whose blood phenylalanine levels were reduced by at least 20%) where then either kept on the same dose of Palynziq or were given placebo (a dummy treatment).
Danish: 86 patienter, der responderede på behandlingen (dvs. hvis indhold af phenylalanin i blodet blev reduceret med mindst 20 %), fik derefter samme dosis Palynziq eller placebo (en uvirksom behandling).
English: Palynziq must not be used in patients who have had an allergic reaction to pegvaliase, to any of the other components of Palynziq or to any other pegylated medicine.
Danish: Palynziq må ikke anvendes til patienter, der har haft en allergisk reaktion over for pegvaliase, andre komponenter i Palynziq eller anden pegyleret medicin.
English: What are the risks associated with Palynziq?
Danish: Hvilke risici er der forbundet med Palynziq?
English: After 8 weeks of treatment, blood phenylalanine levels remained under control in patients taking Palynziq but they returned to pre-treatment levels in patients on placebo, showing that Palynziq was more effective than placebo in reducing blood phenylalanine levels and keeping them within an acceptable range.
Danish: Efter 8 ugers behandling var blodets indhold af phenylalanin under kontrol hos patienter, der fik Palynziq, men hos patienter, der fik placebo, blev niveauet det samme igen som før behandlingen, hvilket viste, at Palynziq var mere effektivt end placebo til at reducere indholdet af phenylalanin i blodet og holde det inden for et acceptabelt interval.
English: Palynziq was shown to be effective at reducing levels of blood phenylalanine and keeping them under control.
Danish: Palynziq viste sig at være effektivt til at reducere indholdet af phenylalanin i blodet og holde det under kontrol.
English: Palynziq is used in patients whose blood levels of phenylalanine have not been adequately controlled with other treatments.
Danish: Palynziq anvendes til patienter, hvis indhold af phenylalanin i blodet ikke er tilstrækkeligt kontrolleret med andre behandlinger.
English: Throughout the study, patients were required to maintain a constant level of dietary protein intake, to ensure that changes in blood phenylalanine levels could be attributed to treatment rather than to changes in protein intake.
Danish: Patienterne skulle opretholde et konstant proteinindtag i løbet af studieforløbet for at sikre, at ændringerne i indholdet af phenylalanin i blodet kunne tilskrives behandlingen og ikke ændringer i proteinindtaget.
English: For the full list of side effects of Palynziq, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Palynziq fremgår af indlægssedlen.
English: How is Palynziq used?
Danish: Hvordan anvendes Palynziq?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Palynziq 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 Palynziq.
English: How does Palynziq work?
Danish: Hvordan virker Palynziq?
English: What benefits of Palynziq have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Palynziq?
English: Anise oil EMA/412178/2016
Danish: Anisolie EMA/412178/2016
English: Aniseed oil medicines must not be used in children and adolescents under 18 years.
Danish: Lægemidler med anisolie må ikke anvendes hos børn og unge under 18 år.
English: They must also not be used in patients who are allergic to aniseed or to plants of the Apiaceae family (Umbelliferae) (caraway, celery, coriander, dill, fennel) or anethole.
Danish: De må heller ikke anvendes hos patienter, der er overfølsomme (allergiske) over for anis eller planter i skærmplantefamilien (Apiaceae /Umbelliferae) (kommen, selleri, koriander, dild, fennikel) eller anethol.
English: Anise oil medicines should only be used in adults and should not be taken for longer than two weeks.
Danish: Lægemidler med anisolie bør kun anvendes til voksne og bør ikke tages længere end to uger.
English: What is anise oil?
Danish: Hvad er anisolie?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/412178/2016
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20.
English: If symptoms last or get worse during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Danish: Hvis symptomerne vedvarer eller forværres under brug af lægemidlet, bør der søges råd hos en læge eller på apoteket.
English: Anise oil is the common name for the essential oil obtained from the dry ripe fruits of the plant Pimpinella anisum L.
Danish: Anisolie er fællesnavnet for den æteriske olie fra de tørrede, modne frugter af planten Pimpinella anisum L.
English: Anise oil
Danish: Anisolie
English: Other information about anise oil medicines
Danish: Andre oplysninger om lægemidler, der indeholder anisolie
English: Information on the use and licensing of anise oil medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder anisolie, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: Anise oil preparations may also be found in combination with other herbal substances in some herbal medicines.
Danish: Tilberedninger af anisolie findes desuden kombineret med andre droger i visse plantelægemidler.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing anise oil.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder anisolie.
English: Detailed instructions on how to take anise oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med anisolie bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of anise oil.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af anisolie.
English: Further information on the risks associated with these anise oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med disse lægemidler, der indeholder anisolie, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing anise oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder , skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Further information on the HMPC assessment of anise oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder anisolie, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: In addition they can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Danish: Desuden kan de anvendes som slimløsnende middel (ekspektorans) ved hoste i forbindelse med forkølelse.
English: In its assessment, the HMPC considered studies in laboratory tests which showed anise oil to have a relaxing effect on the muscle of the gut and airways.
Danish: Ved vurderingen har HMPC gennemgået laboratoriestudier, der har vist, at anisolie virker afslappende på muskulaturen i tarmen og luftvejene.
English: This summary is not intended to provide practical advice on how to use medicines containing anise oil.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder anisolie, skal anvendes.
English: Herbal medicines containing these anise oil preparations are usually available in solid or liquid forms to be taken by mouth.
Danish: Plantelægemidler med anisolie i disse tilberedninger fås normalt i fast eller flydende form beregnet til anvendelse gennem munden.
English: How are anise oil medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder anisolie, i EU?
English: The HMPC conclusions only cover anise oil preparations which are obtained by steam distillation of the dry ripe fruits.
Danish: HMPC's konklusioner omfatter kun tilberedninger af anisolie, som fremstilles ved dampdestillation af de tørrede, modne frugter.
English: What are the risks associated with anise oil medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder anisolie?
English: What evidence supports the use of anise oil medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af anisolie?
English: Allergic reactions to aniseed oil that affect the skin or airways may occur.
Danish: Der kan forekomme overfølsomhedsreaktioner (allergiske reaktioner) over for anisolie fra huden eller luftvejene.
English: For more information about treatment with anise oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder anisolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC conclusions on the use of these anise oil medicines for indigestion complaints and coughs are based on their ‘traditional use' .
Danish: HMPC's konklusioner om anvendelsen af lægemidler med anisolie er baseret på disse lægemidlers "traditionelle anvendelse" til fordøjelsesbesvær og hoste.
English: The HMPC concluded that, on the basis of its long-standing use, these anise oil preparations can be used for treating symptoms of mild indigestion complaints including bloating and flatulence.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at anisolie kan anvendes til behandling af symptomer ved let fordøjelsesbesvær, herunder oppustethed og tarmluft.
English: For practical information about using anise oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med anisolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Date of latest renewal: 11 September 2014.
Danish: Dato for seneste fornyelse: 11. september 2014.
English: Date of first authorisation: 29 October 2009.
Danish: Dato for første markedsføringstilladelse: 29. oktober 2009.
English: Do not warm Eporatio in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Opvarm ikke Eporatio på anden vis (den må for eksempel ikke varmes i mikrobølgeovn eller i varmt vand).
English: Treatment with Eporatio is divided into two stages: a) Correcting the anaemia
Danish: Behandling med Eporatio inddeles i to faser: a) Afhjælpning af anæmi
English: It should be allowed to reach a comfortable temperature (15 °C - 25 °C) for injection.
Danish: Den skal have lov til at nå en behagelig temperatur (15 °C - 25 °C), til injektion.
English: Eporatio contains sodium
Danish: Eporatio indeholder natrium
English: The safety and efficacy of Eporatio in children and adolescents aged up to 17 years have not yet been established.
Danish: Eporatios sikkerhed og virkning hos børn i alderen 0-17 år er endnu ikke klarlagt.
English: Eporatio has not been tested in pregnant women.
Danish: Brug af Eporatio er ikke undersøgt hos gravide kvinder.
English: Healthy people should not use Eporatio.
Danish: Raske mennesker må ikke bruge Eporatio.
English: You will usually receive Eporatio until 1 month after the end of chemotherapy.
Danish: Sædvanligvis får du Eporatio indtil 1 måned efter afslutning på kemoterapien.
English: Push the plunger up to the number (IU) on the syringe that matches the dose of Eporatio that your doctor prescribed.
Danish: Tryk stemplet op til det antal (IE) på skalaen, der svarer til den dosis Eporatio, som din læge har ordineret.
English: Check the appearance of Eporatio.
Danish: Kontroller Eporatios udseende.
English: Check again to make sure the correct dose of Eporatio is in the syringe.
Danish: Kontroller det igen for at sikre dig, at sprøjten rummer den rigtige dosis Eporatio.
English: If you are receiving Eporatio as an injection under the skin, your doctor may suggest that you learn how to inject yourself this medicine.
Danish: Hvis du får Eporatio som en injektion i underhuden, kan lægen foreslå, at du lærer at give dig selv indsprøjtninger.
English: Treatment with Eporatio is normally a long-term therapy.
Danish: Normalt gives Eporatio som langtidsbehandling.
English: If you do not respond adequately to Eporatio, your doctor will check your dose and will inform you if you need to change doses of Eporatio.
Danish: Hvis du ikke reagerer tilstrækkeligt på Eporatio, vil lægen kontrollere din dosis og fortælle dig, hvis din Eporatio-dosis skal ændres.
English: Eporatio is used for the treatment of anaemia accompanied by symptoms (for example fatigue, weakness and shortness of breath).
Danish: Eporatio bruges til behandling af anæmi (blodmangel) ledsaget af symptomer (for eksempel træthed, svækkelse og åndenød).
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må Eporatio ikke blandes med andre lægemidler.
English: - if you are allergic to epoetin theta, another epoetin or any of the other ingredients of this medicine (listed in section 6);
Danish: - hvis du er allergisk over for epoetin theta, andre epoetiner eller et af de øvrige indholdsstoffer i Eporatio (angivet i punkt 6).
English: It may also be necessary to reduce your dose of Eporatio or to stop the treatment with Eporatio for a short period of time.
Danish: Det kan også være nødvendigt, at du får en lavere dosis Eporatio eller holder en mindre pause i behandlingen med Eporatio.
English: The dose of Eporatio (expressed in International Units or IU) depends on your disease condition, your body weight and the way the injection is given (under the skin [subcutaneous injection] or into a vein [intravenous injection]).
Danish: Din dosis Eporatio (angivet i internationale enheder, IE) afhænger af din sygdomstilstand, hvor meget du vejer, og hvordan indsprøjtningen gives (under huden [subkutan injektion] eller i en vene [intravenøs injektion]).
English: Stop using Eporatio if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge Eporatio, hvis du udvikler disse symptomer, og kontakt straks din læge eller søg lægehjælp.
English: Eporatio contains the active substance epoetin theta, which is almost identical to erythropoietin, a natural hormone produced by your body.
Danish: Eporatio indeholder det aktive stof epoetin theta, som er næsten identisk med det naturlige hormon erytropoietin, der dannes i kroppen.
English: If you stop using Eporatio
Danish: Hvis du holder op med at bruge Eporatio
English: If you develop a serious rash or another of these skin symptoms, stop using Eporatio and contact your doctor or seek medical attention immediately.
Danish: Hvis du udvikler et alvorligt udslæt eller får andre af disse hudsymptomer, skal du stoppe med at bruge Eporatio og straks kontakte din læge eller søge lægehjælp.
English: Contents of the pack and other information What Eporatio contains
Danish: Pakningsstørrelser og yderligere oplysninger Eporatio indeholder:
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: This section contains information on how to give yourself an injection of Eporatio under the skin.
Danish: I dette punkt kan du finde oplysninger om, hvordan du kan give dig selv en injektion Eporatio i underhuden.