FrancophonIA/ELRC3.0 huggingface dataset:
English: asthenic conditions, febrile disorders, oedema, pain and discomfort, blood alkaline phosphatase increased, weight increased, body temperature perception disturbed uncommon:
Danish: asteni, feber, ødem, smerter og ubehag, stigning i basisk phosphatase, vægtøgning, ændret opfattelse af kropstemperatur
English: painful urination with blood in the urine Disorders affecting the body as a whole common:
Danish: smertefuld vandladning med blod i urinen
English: coma, central nervous system haemorrhages and cerebrovascular accidents, paralysis and paresis, encephalopathy, speech and language abnormalities, amnesia rare:
Danish: koma, blødning i centralnervesystemet og hjerneblødning, encephalopati, taleforstyrrelser ,amnesi
English: anuria, haemolytic uraemic syndrome very rare:
Danish: anuri, hæmolytisk uræmisk syndrom
English: Prograf and associated names (see Annex I) 5 mg/ml concentrate for solution for infusion [see Annex I - to be completed nationally]
Danish: Prograf og tilknyttede særnavne (se bilag I) 5 mg/ml koncentrat till infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: Eye disorders common:
Danish: Øresygdomme Almindelige:
English: Vianex S.A.
Danish: Grækenland Vianex S.A. Tatoiou Street
English: Prograf and associated names (see Annex I)1 mg hard capsules [See Annex I - To be completed nationally] Tacrolimus
Danish: Prograf og tilknyttede særnavne (se bilag I) 1 mg kapsler, hårde [Se bilag I - Udfyldes nationalt] Tacrolimus
English: Blood and lymph disorders common:
Danish: Blod- og lymfelidelser Almindelige:
English: liver failure, narrowing of the bile vessel
Danish: leversvigt, forsnævring af galdevejene
English: hepatitic artery thrombosis, venoocclusive liver disease very rare:
Danish: trombose i leverarterie, venooccusive liver disease
English: hepatic failure, bile duct stenosis Skin and subcutaneous disorders common:
Danish: leversvigt, galdevejsstenose Sygdomme i hud og subkutane væv Almindelige:
English: Prograf and associated names (see Annex I) 5 mg/ml concentrate for solution for infusion [See Annex I - to be completed nationally] Tacrolimus
Danish: Prograf og tilknyttede navne (se bilag I) 5 mg/ml koncentrat till infusionsvæske, opløsning [Se bilag I- bdfyldes nationalt] Tacrolimus
English: POSSIBLE SIDE EFFECTS
Danish: HVILKE MULIGE BIVIRKNINGER <[(SÆR)NAVN]> HAR
English: If you forget to take <Invented name>
Danish: Hvis De glemmer at tage <[(Sær)navn]>
English: HOW TO TAKE <INVENTED NAME>
Danish: HVORDAN DE TAGER <[(SÆR)NAVN]>
English: Oral <Invented name> therapy should commence at 0.20 - 0.30 mg/kg/day administered as two divided doses (e.g. morning and evening).
Danish: Peroral <[(Sær)navn]> behandling bør starte med 0,20 - 0,30 mg/kg/dag fordelt på 2 doser (f.eks. morgen og aften).
English: If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.075 - 0.100 mg/kg/day should be administered as a continuous 24-hour infusion.
Danish: Hvis den kliniske tilstand ikke tillader peroral behandling, gives en intravenøs dosis på 0,075 - 0,100 mg/kg/dag som kontinuerlig infusion over 24 timer.
English: difficulties in breathing, respiratory tract disorders, asthma rare:
Danish: åndedrætsbesvær, lidelse i luftvejene, astma
English: insomnia common:
Danish: insomnia
English: Prograf and associated names (see Annex I) 5 mg hard capsules [See Annex I - To be completed nationally] Tacrolimus
Danish: Prograf og tilknyttede særnavne (se bilag I) 5 mg kapsler, hårde [Se bilag I - Udfyldes nationalt] Tacrolimus
English: If you stop taking <Invented name>
Danish: Hvis De holder op med at tage <[(Sær)navn]>
English: problems with blood flow in the liver very rare:
Danish: problemer med blodcirkulation i leveren
English: Lactation
Danish: Udskillelse
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt]
English: <Invented name> therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient.
Danish: Ciclosporin blodkoncentrationerne og patientens tilstand skal tages i betragtning før behandling med <[(Sær)navn]> indledes.
English: respiratory failures, respiratory tract disorders, asthma rare:
Danish: nedsat åndedrætsfunktion, lidelse i luftvejene, astma
English: ringing sound in your ears uncommon:
Danish: ringen for ørene
English: Vascular disorders very common:
Danish: Karsygdomme Meget almindelige:
English: Patients treated with <Invented name> have been reported to develop EBV-associated lymphoproliferative disorders.
Danish: Der er set EBV-associerede lymfoproliferative lidelser relaterede til behandling med <[(Sær)navn]>.
English: Rare side effects are experienced in less than one per one thousand patients but more than one per ten thousand patients.
Danish: Sjældne bivirkninger forekommer hos mellem 1 og 1.000 ud af 10.000 patienter.
English: In paediatric patients converted to <Invented name>, an initial oral dose of 0.20 - 0.30 mg/kg/day should be administered in two divided doses (e.g. morning and evening).
Danish: Børn, der overgår til <[(Sær)navn]>behandling, bør initialt få perorale doser på 0,20 - 0,30 mg/kg/dag fordelt på 2 doser (f.eks. morgen og aften).
English: pruritus, rash, alopecias, acne, sweating increased uncommon:
Danish: pruritus, udslæt, alopecia, akne, svedudbrud
English: If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.05 mg/kg/day should be administered as a continuous 24-hour infusion.
Danish: Hvis den kliniske tilstand ikke tillader peroral behandling gives en intravenøs dosis på 0,05 mg/kg/dag som kontinuerlig infusion over 24 timer.
English: Common side effects are experienced in less than one in ten patients but in more than one per one hundred patients.
Danish: Almindelige bivirkninger forekommer hos mellem 1 og 10 ud af 100 patienter.
English: hyperlipidaemia,
Danish: perikardial ekssudation
English: thirst, fall, chest tightness, mobility decreased, ulcer very rare:
Danish: tørst, øget tendens til at falde, trykken for brystet, nedsat bevægelighed, sår
English: Prograf and associated names (see Annex I) 0.5 mg hard capsules [See Annex I - To be completed nationally] Tacrolimus
Danish: Prograf og tilknyttede særnavne (se bilag I) 0,5 mg kapsler, hårde [Se bilag I - Udfyldes nationalt]
English: Uncommon side effects are experienced in less than one in one hundred patients but more than one per one thousand patients.
Danish: Usædvanlige bivirkninger forekommer hos mellem 1 og 100 ud af 1.000 patienter.
English: Blood trough levels of tacrolimus should be monitored during the post-transplantation period.
Danish: Blod dalkoncentrationer af <[(Sær)navn]> bør måles under den postoperative fase.
English: Inhibitors of metabolism
Danish: Metabolismehæmmere
English: renal impairment common:
Danish: Almene lidelser Almindelige:
English: Oral <Invented name> therapy should commence at 0.10 - 0.20 mg/kg/day administered as two divided doses (e.g. morning and evening).
Danish: Initialt benyttes en peroral dosering på 0,10 - 0,20 mg/kg/dag, fordelt på to doser (f.eks. morgen og aften).
English: changes in liver enzymes and function, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver rare:
Danish: ændringer i levertal og funktion, gulsot, ødelæggelse af levervæv og leverbetændelse
English: subileus, pancreatic pseudocyst
Danish: iskæmiske tilstande, takykardi
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 - 0.05 mg/kg/day should be initiated as a continuous 24-hour infusion.
Danish: Hvis den kliniske tilstand ikke tillader peroral behandling gives en intravenøs dosis på 0,01 - 0,05 mg/kg/dag som kontinuerlig infusion over 24 timer.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] 6.6 Special precautions for disposal
Danish: 6.6 Særlige forholdsregler ved bortskaffelse [Udfyldes nationalt]
English: Therefore you should not breast-feed whilst receiving <Invented name>.
Danish: <[(Sær)navn]> udskilles i modermælken og De bør derfor ikke amme mens De behandles med <[(Sær)navn]>.
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 to 0.02 mg/kg/day should be initiated as a continuous 24-hour infusion.
Danish: Hvis den kliniske tilstand ikke tillader peroral behandling gives en intravenøs dosis på 0,01-0,02 mg/kg/dag som kontinuerlig infusion over 24 timer.
English: EXPIRY DATE EXP: {MM/YYYY} BATCH NUMBER Batch: {number} CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally]
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER [Udfyldes nationalt]
English: If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.05 - 0.10 mg/kg/day should be initiated as a continuous 24-hour infusion.
Danish: Hvis den kliniske tilstand ikke tillader peroral behandling, gives en intravenøs dosis på 0,05 - 0,10 mg/kg/dag som kontinuerlig infusion over 24 timer.
English: Whilst you are receiving <Invented name> your doctor may want to carry out a number of tests (including blood, urine, heart function, visual and neurological tests) from time to time.
Danish: - Så længe De er i behandling med <[(Sær)navn]> vil lægen med mellemrum foretage en række undersøgelser (inkl.
English: thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer very rare:
Danish: tørst,svækkelse, trykken for brystet, nedsat bevægelighed, mavesår
English: This summary was last updated in 09-2016.
Danish: Dette sammendrag blev sidst ajourført i 09-2016.
English: The infusion should last three hours.
Danish: Infusionen bør strække sig over tre timer.
English: These measurements were taken at the start of the study and after a year of treatment.
Danish: Disse målinger blev foretaget ved undersøgelsens start og efter et års behandling.
English: Elaprase has been authorised under ‘exceptional circumstances'.
Danish: Elaprase er godkendt under "særlige omstændigheder".
English: The European Commission granted a marketing authorisation valid throughout the European Union for Elaprase on 8 January 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Elaprase den 8. januar 2007.
English: At the start of the study, the patients could walk an average of around 395 metres in six minutes.
Danish: Ved undersøgelsens start kunne patienterne gå gennemsnitligt ca. 395 m på seks minutter.
English: Without treatment, these symptoms become more severe over time.
Danish: Uden behandling forværres disse symptomer med tiden.
English: This is a summary of the European public assessment report (EPAR) for Elaprase.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Elaprase.
English: Elaprase is given every week, as an infusion into a vein, at a dose of 0.5 mg per kilogram body weight.
Danish: Elaprase gives hver uge som en infusion i en vene i en dosis på 0,5 mg pr. kg legemsvægt.
English: The main study of Elaprase involved 96 male patients aged between 5 and 31 years, and compared it with placebo (a dummy treatment).
Danish: Hovedundersøgelsen af Elaprase omfattede 96 mandlige patienter i alderen 5-31 år, og heri sammenlignedes det med placebo (en uvirksom behandling).
English: Other information about Elaprase
Danish: Andre oplysninger om Elaprase
English: This causes a wide range of symptoms, particularly difficulty breathing and difficulty walking.
Danish: Dette giver anledning til en lang række symptomer, især vejrtrækningsbesvær og gangbesvær.
English: It is designed for long-term use.
Danish: Lægemidlet er beregnet til langtidsbehandling.
English: The CHMP concluded that the improvements shown in the study, even if limited, represent a clinical benefit in the treatment of Hunter syndrome.
Danish: CHMP konkluderede, at de ved undersøgelsen konstaterede forbedringer, også selv om de var begrænsede, havde klinisk virkning ved behandling af Hunters syndrom.
English: Hunter syndrome, which is also known as mucopolysaccharidosis II, is a rare, inherited disease that primarily affects male patients.
Danish: Hunters syndrom, der også er kendt som mukopolysakkaridose II, er en sjælden, arvelig sygdom, som primært forekommer hos mandlige patienter.
English: For more information about treatment with Elaprase, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Elaprase, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Since patients with Hunter syndrome cannot break these substances down, the GAGs gradually build up in most of the organs in the body and damage them.
Danish: Da patienter med Hunters syndrom ikke kan nedbryde disse stoffer, ophober glykosaminglykanerne sig gradvist i de fleste af kroppens organer og beskadiger dem.
English: What measures are being taken to ensure the safe and effective use of Elaprase?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Elaprase?
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 Elaprase.
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, hvordan Elaprase skal anvendes.
English: Elaprase is a medicine that contains the active substance idursulfase.
Danish: Elaprase er et lægemiddel, der indeholder det aktive stof idursulfase.
English: Because the number of patients with Hunter syndrome is low, the disease is considered ‘rare', and Elaprase was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December
Danish: Da antallet af patienter med Hunters syndrom er lavt, betragtes sygdommen som "sjælden", og Elaprase blev udpeget som "lægemiddel til sjældne sygdomme" den 11. december 2001.
English: It replaces the enzyme that is missing or defective in patients with Hunter syndrome.
Danish: Det erstatter det enzym, der mangler eller er utilstrækkeligt hos patienter med Hunters syndrom.
English: Patients with Hunter syndrome do not produce an enzyme called iduronate-2-sulfatase.
Danish: Patienter med Hunters syndrom producerer ikke et enzym kaldet iduronate-2-sulfatase.
English: The full EPAR for Elaprase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Elaprase findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Elaprase is used to treat patients with Hunter syndrome.
Danish: Elaprase anvendes til behandling af patienter med Hunters syndrom.
English: The main measures of effectiveness were lung function (‘forced vital capacity', the maximum amount of air the patient could breathe out), and the distance the patients could walk in six minutes, which measures the combined effects of the illness on the heart, lungs, joints and other organs.
Danish: Det primære effektmål var lungefunktionen ("forceret vitalkapacitet", som er den maksimale mængde luft, patienten kunne udånde) og den distance, patienterne kunne gå på seks minutter, hvilket måler sygdommens kombinerede indvirkning på hjerte, lunger, led og andre organer.
English: The company that markets Elaprase will investigate the long-term effects of the medicine, particularly on the lungs, the heart and the blood vessels, and whether the body produces antibodies that could affect the medicine's safety and effectiveness.
Danish: Virksomheden, som fremstiller Elaprase, skal undersøge lægemidlets virkning på lang sigt, særlig på lungerne, hjertet og blodkarrene, og hvorvidt det stimulerer kroppen til at danne antistoffer, som kan have indflydelse på lægemidlets sikkerhed og effekt.
English: Severe allergic reactions have occurred in some patients taking Elaprase.
Danish: Der er forekommet svære allergiske reaktioner hos nogle patienter, som fik Elaprase.
English: The Committee decided that Elaprase's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget besluttede, at fordelene ved Elaprase opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Elaprase.
English: Elaprase must not be used in people who have had a severe or life-threatening allergic (anaphylactic) reaction to idursulfase or any of the other ingredients if their allergy is not controllable.
Danish: Elaprase må ikke anvendes til personer, der har haft en svær eller livstruende allergisk reaktion (anafylaktisk reaktion) over for idursulfase eller andre af indholdsstofferne, hvis deres allergi ikke kan kontrolleres.
English: However, as long as the patient does not develop infusion reactions (rash, itching, fever, headache, high blood pressure or flushing), the duration of the infusion can be gradually reduced to one hour.
Danish: Så længe patienten ikke får infusionsreaktioner (udslæt, kløe, feber, hovedpine, forhøjet blodtryk eller rødme), kan infusionstiden dog gradvis nedsættes til en time.
English: This enzyme is needed to break down substances in the body called glycosaminoglycans (GAGs).
Danish: Dette enzym er nødvendigt for at nedbryde de stoffer i kroppen, som kaldes glykosaminglykaner (GAG).
English: The active substance in Elaprase, idursulfase, is a copy of the human enzyme iduronate-2-sulfatase.
Danish: Det aktive stof i Elaprase, idursulfase, er en kopi af det humane enzym iduronat-2-sulfatase.
English: What information is still awaited for Elaprase?
Danish: Hvilke oplysninger afventes der stadig for Elaprase?
English: If given to patients who have had severe allergic reactions in the past, Elaprase should be used with caution, and trained staff and equipment for emergency resuscitation should be available during infusion.
Danish: Hvis Elaprase gives til patienter, der tidligere har haft svære allergiske reaktioner, skal det gives med forsigtighed, og uddannet personale og udstyr til akut genoplivning skal være tilgængelig under infusionen.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Elaprase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Elaprase findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Elaprase improved lung function and the walking ability of the patients.
Danish: Elaprase forbedrede lungefunktionen og den afstand, patienterne kunne gå.
English: Elaprase treatment should be supervised by a doctor or other healthcare professional who has experience in the management of patients with Hunter syndrome or other inherited diseases affecting the metabolism.
Danish: Behandling med Elaprase bør overvåges af en læge eller en anden sundhedsuddannet person, som har erfaring i behandling af patienter med Hunters syndrom eller andre arvelige sygdomme, der påvirker stofskiftet.
English: What is the risk associated with Elaprase?
Danish: Hvilken risiko er der forbundet med Elaprase?
English: Patients who tolerate the infusions well for several months in a clinic may be able to start having them at home. Home infusions should be supervised by a doctor or nurse.
Danish: Patienter, som tåler infusionerne godt i en periode på flere måneder på en klinik, kan eventuelt begynde at få dem hjemme.
English: After a year, the patients receiving Elaprase could walk a further 43 metres on average, and the patients receiving placebo could walk a further 8 metres.
Danish: Efter et år kunne de patienter, der fik Elaprase, gå yderligere 43 m i gennemsnit, og de patienter, der fik placebo, kunne gå yderligere 8 m. Lægemidlet forbedrede også lungefunktionen, mens de patienter, der fik placebo, oplevede en let forværring.
English: Why has Elaprase been approved?
Danish: Hvorfor blev Elaprase godkendt?
English: The most common side effects with Elaprase are related to the infusion, including skin reactions (rash or itching), fever, headache, high blood pressure and flushing.
Danish: De hyppigste bivirkninger ved Elaprase er forbundet med infusionen, herunder hudreaktioner (udslæt eller kløe), feber, hovedpine, forhøjet blodtryk og rødme.
English: Other side effects seen in more than 1 patient in 10 are wheezing, dyspnoea (difficulty breathing), abdominal pain (stomach ache), nausea (feeling sick), dyspepsia (heartburn), diarrhoea, vomiting, swelling at the site of infusion and chest pain.
Danish: Andre bivirkninger, som optræder hos flere end 1 ud af 10 patienter, er hiven efter vejret, dyspnø (vejrtrækningsbesvær), mavesmerter, kvalme, dyspepsi (halsbrand), diarré, opkastning, hævelse på infusionsstedet og brystsmerter.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Danish: Det leveres som et koncentrat, der blandes til en infusionsvæske, opløsning (drop i en vene).
English: For the full list of all side effects reported with Elaprase, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Elaprase fremgår af indlægssedlen.
English: This means that because Hunter syndrome is rare, it has not been possible to obtain complete information about Elaprase.
Danish: Det betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om Elaprase, fordi Hunters syndrom er sjældent.
English: Supplying the enzyme will help to break down GAGs and stop them building up in body tissue, thereby helping to improve the symptoms of the disease.
Danish: Tilføjelsen af enzymet forbedrer nedbrydningen af glykosaminglykanerne og forhindrer, at de hober sig op i kropsvæv.
English: How has Elaprase been studied?
Danish: Hvordan blev Elaprase undersøgt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elaprase 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 Elaprase.
English: What is Elaprase?
Danish: Hvad er Elaprase?
English: What benefit has Elaprase shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Elaprase?
English: How is Elaprase used?
Danish: Hvordan anvendes Elaprase?
English: What is Elaprase used for?
Danish: Hvad anvendes Elaprase til?
English: How does Elaprase work?
Danish: Hvordan virker Elaprase?
English: Sodium chloride solution (0.9 %)
Danish: Natriumchloridopløsning (0.9 %)
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten og den ydre emballage efter EXP.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Hætteglasset opbevares i den ydre karton for at beskytte mod lys.
English: Store in a refrigerator (2 ºC − 8 ºC).
Danish: Opbevares i køleskab (2°C - 8°C).