FrancophonIA/ELRC3.0 huggingface dataset:
English: After repeated dosing of 4 mg/kg every other week, the maximal serum concentration (Cmax) was 20.0 ± 8.1 µg/mL (mean ± s.d.; range: 6.6 to 34.9 µg/mL) and the area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) was 57.4 ± 23.9 µg*h/mL (mean ± s.d.; range: 18.8 to 97.0 µg*h/mL).
Danish: Efter gentagen dosering med 4 mg/kg hver anden uge var den maksimale koncentration i serum (Cmax) 20,0 ± 8,1 µg/ml (middel ± SD, område: 6,6 til 34,9 µg/ml); og ± området under koncentrationstidskurven fra nultidspunktet til den sidst målelige koncentration (AUC0-t) var 57,4 ± 23,9 µg*t/ml (middel ± SD, område: 18,8 til 97,0 µg*h/ml).
English: Other medicines and Mepsevii
Danish: Brug af anden medicin sammen med Mepsevii
English: Concentrate for solution for infusion 1 vial (5 mL)
Danish: Koncentrat til infusionsvæske, opløsning 1 hætteglas (5 ml)
English: Consider rapid sodium chloride 9 mg/mL (0.9%) solution for infusion for decreased blood pressure and oxygen for hypoxia.
Danish: Overvej straks 9 mg/ml (0,9 %) natriumchloridopløsning til infusion ved blodtryksfald og ilt ved hypoksi.
English: Colourless to slightly yellow solution.
Danish: Farveløs til let gul opløsning.
English: Common side effects (may affect up to 1 in 10 people): - Itching of the skin (pruritus) - Loose stools (diarrhoea) - Rash - Fever with involuntary contractions of muscles of face or limbs (febrile convulsion)
Danish: Almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer): - Hudkløe (pruritus) - Løs afføring (diarré) - Udslæt - Feber med ufrivillige sammentrækninger af musklerne i ansigtet eller arme eller ben
English: Due to the low infusion rate, additional sodium chloride 9 mg/mL (0.9%) solution for infusion may be added through a separate line (piggyback or Y tube) to maintain sufficient intravenous flow.
Danish: På grund af den lave infusionshastighed skal der tilføjes yderligere 9 mg/ml (0,9 %) natriumchloridopløsning til infusionen via en separat slange (piggyback eller Y-slange) for at opretholde et tilstrækkeligt intravenøst flow.
English: If you are given more Mepsevii than you should
Danish: Hvis du har fået for meget Mepsevii
English: Management of hypersensitivity reactions should be based on the severity of the reaction and include temporary interruption or discontinuation of the infusion and/or administration of additional antihistamines, antipyretics, and/or corticosteroids for mild to moderate reactions.
Danish: Hvis der forekommer alvorlige overfølsomhedsreaktioner skal infusionen af vestronidase alfa omgående standsesog passende behandling skal indledes, Behandling af overfølsomhedsreaktioner skal baseres på reaktionens sværhedsgrad og omfatte midlertidig eller hel afbrydelse af infusionen og/eller administration af yderligere antihistaminer, antipyretika og/eller kortikosteroider for milde til moderate reaktioner.
English: In a multi-centre, randomized, placebo-controlled, Blind-Start, single-crossover Phase 3 trial (Study UX003-CL301, referred to as Study 301), 12 patients with MPS VII received vestronidase alfa 4 mg/kg every two weeks for 24 to 48 weeks.
Danish: I et randomiseret, placebokontrolleret, fase 3-single-crossover-multicenterforsøg med blind start (studie UX003-CL301, omtalt som studie 301) modtog 12 patienter med MPS VII 4 mg/kg vestronidase alfa hver anden uge i 24 til 48 uger.
English: Discuss with your doctor if the benefits of using Mepsevii are greater than the potential risk to your baby while breast-feeding.
Danish: Drøft med din læge, om fordelene ved at tage Mepsevii er større end den mulige risiko for dit barn under amning.
English: Study UX003-CL201 (referred to as Study 201) was a single arm, open-label, dose exploration trial that enrolled three MPS VII patients, ranging in age from 5 years to 25 years.
Danish: Studie UX003-CL201 (omtalt som studie 201) var et open-label-dosisforsøg med en enkelt arm, der indskrev tre MPS VII-patienter i alderen 5 til 25 år.
English: There was a single adverse reaction of febrile convulsion observed in one patient (4.3%); the patient recovered without sequelae.
Danish: Der var en enkelt bivirkning i form af feberkrampe hos én patient (4,3 %).
English: The Mepsevii concentrate solution for infusion should be colourless to slightly yellow.
Danish: Mepseviikoncentratopløsningen skal være farveløs til let gullig.
English: After repeated dosing of 4 mg/kg every other week in MPS VII patients, the mean ± standard deviation the total volume of distribution (Vss) was 0.26 ± 0.13 L/kg (range: 0.10 to 0.60 L/kg).
Danish: Efter gentagen dosering med 4 mg/kg hver anden uge hos MPS VII-patienter var ± middelstandardafvigelsen det samlede fordelingsvolumen (Vss) 0,26 ± 0,13 l/kg (område: 0,10 til 0,60 l/kg).
English: Patients who were enrolled in Study 301 were eligible to roll over to Study UX003-CL202 (referred to as Study 202), an open-label extension trial in which patients received additional doses of vestronidase alfa at 4 mg/kg intravenously every other week for up to 144 weeks.
Danish: Patienter, som var tilmeldt studie 301, var kvalificerede til at skifte over til studie UX003-CL202 (omtalt som studie 202), et forlænget openlabel-forsøg, hvor patienter modtog yderligere doser på 4 mg/kg vestronidase alfa intravenøst hver anden uge i op til 144 uger.
English: Dilute the calculated dose 1:1 using equal volume of sodium chloride 9 mg/mL (0.9%) solution for injection for intravenous infusion.
Danish: Fortynd den beregnede dosis 1:1 med anvendelse af samme volumen natriumchloridopløsning på 9 mg/ml (0,9 %) til injektion ved intravenøs infusion.
English: Mepsevii 2 mg/mL sterile concentrate vestronidase alfa
Danish: Mepsevii 2 mg/ml sterilt koncentrat vestronidase alfa
English: a. Volume (mL) of calculated dose = Total dose (mg) divided by the 2 mg/mL concentration
Danish: a. Det beregnede dosisvolumen (ml) = samlet dosis (mg) divideret med 2 mg/ml koncentrationen.
English: Sixteen out of 23 patients (70%) from 4 clinical trials developed anti-recombinant human betaglucuronidase (rhGUS) antibodies (ADA), nine of whom further developed neutralizing antibodies (NAb) on at least one occasion, but not consistently over time.
Danish: Seksten ud af 23 patienter (70 %) fra 4 kliniske forsøg udviklede antistoffer (ADA) over for antirekombinant human beta-glucuronidase (rhGUS).
English: For intravenous use only.
Danish: Kun til intravenøs infusion.
English: After 24 weeks of vestronidase alfa treatment, the overall MDRI results, both pre-specified and post-hoc (6 MDRI domains plus fatigue domain) analyses, were positive with an increase of +0.5 domains (p=0.0527) and +0.8 domains (p=0.0433) including fatigue, respectively (t-test).
Danish: De overordnede MDRI-resultater, både præspecificerede og post-hoc (6 MDRI-domæner plus træthedsdomæne) analyser, var positive med en øgning på henholdsvis +0,5 domæner (p = 0,0527) og +0,8 domæner (p = 0,0433) inklusive træthed (t-test) efter 24 ugers behandling med vestronidase alfa.
English: The above calculated dose diluted 1:1 in sodium chloride 9 mg/mL (0.9%) solution for injection should be added to a new empty infusion bag.
Danish: Den ovenfor beregnede dosis, der er fortyndet 1:1 i natriumchlorid 9 mg/ml (0,9 %) til injektion, skal tilsættes til en ny tom infusionspose.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept (se Bilag I: Produktresumé pkt.
English: Total Mepsevii Dose Range (mg)
Danish: Samlet dosisområde for Mepsevii (mg)
English: Do not heat, microwave or shake vials.
Danish: Hætteglassene må ikke opvarmes, opvarmes i mikrobølgeovn eller rystes.
English: Pack size: 1 vial containing 5 mL of concentrate for solution for infusion.
Danish: Pakningsstørrelse: Et hætteglas indeholdende 5 ml koncentrat til infusionsvæske, opløsning.
English: Each vial of 5 mL concentrate contains 10 mg vestronidase alfa (10 mg/ 5 mL).
Danish: Hvert hætteglas med 5 ml koncentrat indeholder 10 mg vestronidase alfa (10 mg/5 ml).
English: The clinical program for vestronidase alfa included 23 treatment naïve patients with MPS VII from 4 clinical trials, aged 5 months to 25 years, who received vestronidase alfa at doses up to 4 mg/kg once every two weeks for up to 132 weeks.
Danish: Det kliniske program for vestronidase alfa omfattede 23 behandlingsnaive patienter med MPS VII fra 4 kliniske forsøg i alderen fra 5 måneder til 25 år, der modtog doser af vestronidase alfa i op til 4 mg/kg en gang hver anden uge i op til 132 uger.
English: After repeated dosing of 4 mg/kg every other week in MPS VII patients, the mean ± standard deviation of the total clearance (CL) was 0.079 ± 0.045 L/h/kg (range: 0.038 to 0.20 L/h/kg); the mean ± standard deviation of the elimination half-life (t1/2) was 2.6 ± 0.6 hours (range: 0.9 to 3.6 hours).
Danish: Efter gentagen dosering på 4 mg/kg hver anden uge hos MPS VII-patienter var ± middelstandardafvigelsen af den samlede clearance (CL) 0,079 ± 0,045 l/t/kg (område: 0,038 til 0,20 l/t/kg); ± middelstandardafvigelsen af elimineringshalveringstiden (t1/2) var 2,6 ± 0,6 time (område: 0,9 til 3,6 timer).
English: Spinal/Cervical cord compression
Danish: Kompression af medulla spinalis eller cervicalis
English: This medicinal product contains 17.8 mg sodium per vial and is administered in sodium chloride 9 mg/mL (0.9%) solution for infusion (see section 6.6).
Danish: Dette lægemiddel indeholder 17,8 mg natriumchlorid pr. hætteglas og administreres i en 9 mg/ml (0,9 %) natriumchloridinfusionsopløsning (se pkt.
English: Pack size: 1 vial of 5 mL
Danish: Pakningsstørrelse: 1 hætteglas med 5 ml
English: b. Total number of vials = Total dose (mg) divided by 10 mg/vial
Danish: b. Samlet antal hætteglas = samlet dosis (mg) divideret med 10 mg/hætteglas
English: The assessment of adverse reactions was based on the exposure of 23 patients from 4 clinical trials, aged 5 months to 25 years, who received vestronidase alfa at doses up to 4 mg/kg once every two weeks for up to 132 weeks.
Danish: Vurderingen af bivirkningerne var baseret på eksponeringen af vestronidase alfa hos 23 patienter fra 4 kliniske forsøg i alderen fra 5 måneder til 25 år, der modtog vestronidase alfa ved doser op til 4 mg/kg en gang hver anden uge i op til 132 uger.
English: Febrile convulsion*
Danish: Feberkrampe*
English: Mepsevii 2 mg/mL concentrate for solution for infusion.
Danish: Mepsevii 2 mg/ml koncentrat til infusionsvæske, opløsning.
English: - If you have neck or back pain, feel numb in your arms or legs, or experience lack of control over passing water (urine) or stools, tell your doctor straight away.
Danish: - Fortæl det omgående til lægen, hvis du har nakke- eller rygsmerter, er følelsesløs i arme eller ben eller ikke kan styre vandladning (urin) eller afføring.
English: For the management of adverse reactions, see sections 4.4 and 4.8.
Danish: 4.4 og 4.8.
English: Mepsevii 2 mg/mL concentrate for solution for infusion vestronidase alfa
Danish: Mepsevii 2 mg/ml koncentrat til infusionsvæske, opløsning vestronidase alfa
English: The patient subsequently was re-challenged without recurrence and continued on vestronidase alfa treatment.
Danish: Patienten fortsatte med behandling med vestronidase alfa.
English: Life-threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Danish: Livstruende overfølsomhedsreaktioner (anafylaktisk reaktion) over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: What you need to know before you are given Mepsevii You must not be given Mepsevii:
Danish: Det skal du vide, før du begynder at få Mepsevii
English: Intravenous use after dilution.
Danish: Intravenøs anvendelse efter fortynding
English: Total Number of Mepsevii Vials
Danish: Samlet antal hætteglas med Mepsevii
English: Serious hypersensitivity reactions, including anaphylaxis, have been reported with vestronidase alfa; therefore, appropriate medical support should be readily available when vestronidase alfa is administered.
Danish: Der er rapporteret om alvorlige overfølsomhedsreaktioner forbundet med vestronidase alfa; herunder anafylaksi.
English: Each vial contains 17.8 mg sodium.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hvert hætteglas indeholder 17,8 mg natrium.
English: Currently available data are described in section 4.8 and section 5.1.
Danish: De foreliggende data er beskrevet i pkt.
English: How to store Mepsevii
Danish: Sådan skal du have Mepsevii
English: For each vial dosed, including the corresponding diluent volume, the sodium intake is 35.5 mg sodium.
Danish: Natriumindtaget er 35,5 mg natrium for hvert doseret hætteglas, inklusive det tilsvarende volumen af fortyndingsmiddel.
English: Each vial of 5 mL concentrate contains 10 mg vestronidase alfa.
Danish: Hvert hætteglas med 5 ml koncentrat indeholder 10 mg vestronidase alfa.
English: Your doctor may give (or have given) you other medicines to manage the allergic reaction such as an antihistamine or corticosteroid or an antipyretic, a medicine to reduce fever.
Danish: Det kan være i form af et antihistamin eller et kortikosteroid eller et lægemiddel, der nedsætter feber, et såkaldt antipyretikum.
English: Breast-feeding
Danish: Feberkrampe
English: This includes any possible side effects not listed in this leaflet (see section 4).
Danish: - Kontakt lægen, hvis du får bivirkninger, Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel (se pkt.
English: Each mL of concentrate contains 2 mg vestronidase alfa*.
Danish: Hver ml koncentrat indeholder 2 mg vestronidase alfa*.
English: How Mepsevii works
Danish: Sådan virker Mepsevii
English: If you have an infusion reaction, tell your doctor straight away.
Danish: 4) Fortæl det omgående til lægen, hvis du får en infusionsreaktion.
English: Tabulated list of adverse reactions
Danish: Anafylaktoid reaktion
English: Each mL of concentrate contains 2 mg vestronidase alfa.
Danish: Hver ml koncentrat indeholder 2 mg vestronidase alfa.
English: Each mL of sterile concentrate contains 2 mg vestronidase alfa.
Danish: Hver ml sterilt koncentrat indeholder 2 mg vestronidase alfa.
English: Your doctor may also give (or have given) you other medicines to manage the allergic reaction such as an antihistamine or corticosteroid or an antipyretic, a medicine to reduce fever.
Danish: Din læge vil måske også give dig (eller har givet dig) andre lægemidler til behandling af den allergiske reaktion.
English: DATE OF REVISION OF THE TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN {MM/ÅÅÅÅ}
English: What Mepsevii is and what it is used for What Mepsevii is
Danish: Virkning og anvendelse Mepsevii indeholder:
English: - Your doctor may give (or have given) you some medicines to manage the allergic reaction such as an antihistamine or corticosteroid or an antipyretic, a medicine to reduce fever.
Danish: - Din læge vil måske give dig (eller har givet dig) medicin til behandling af den allergiske reaktion.
English: Febrile Convulsion
Danish: Nældefeber Udslæt Pruritus
English: This overview was last updated in 08-2018.
Danish: Denne oversigt er sidst opdateret i 08-2018.
English: Eylea received a marketing authorisation valid throughout the EU on 22 November 2012.
Danish: Eylea fik en markedsføringstilladelse med gyldighed i hele EU den 22. november 2012.
English: After the injection, the pressure within the eye should be checked.
Danish: Efter injektionen bør trykket i øjet kontrolleres.
English: Further information on Eylea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Eylea findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It can also attach to other proteins such as placental growth factor (PlGF).
Danish: Det kan desuden binde til andre proteiner såsom placental vækstfaktor (PlGF).
English: The Agency further noted that there were no major or unexpected safety concerns with Eylea.
Danish: Agenturet bemærkede derudover, at der ikke var alvorlige eller uventede sikkerhedsmæssige problemer med Eylea.
English: The diseases cause the gradual loss of the central part of a person's vision.
Danish: Sygdommene medfører gradvist tab af den centrale del af synet.
English: Eylea contains the active substance aflibercept.
Danish: Eylea indeholder det aktive stof aflibercept.
English: Eylea is a medicine used to treat adults with:
Danish: Eylea er et lægemiddel, der anvendes til at behandle voksne patienter med:
English: Wet AMD
Danish: Våd AMD
English: Other information about Eylea
Danish: Andre oplysninger om Eylea
English: As for all medicines, data on the use of Eylea are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Eylea løbende overvåget.
English: How often the injections are given depends on the condition being treated and the response of the patient to treatment.
Danish: Hyppigheden af injektionerne afhænger af den sygdom, der behandles, og patientens respons på behandlingen.
English: What measures are being taken to ensure the safe and effective use of Eylea?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Eylea?
English: Therefore, the Agency decided that Eylea's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Eylea opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Eylea was either given once a month, or once every other month after the first five monthly injections.
Danish: Eylea blev indgivet enten én gang om måneden eller én gang hver anden måned efter de første fem månedlige injektioner.
English: Side effects reported with Eylea are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Eylea vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: This effect was maintained at 52 weeks, despite less frequent administration of Eylea between week 24 and 52.
Danish: Denne virkning blev opretholdt i 52 uger, selvom Eylea blev givet mindre hyppigt mellem uge 24 og 52.
English: An overview of Eylea and why it is authorised in the EU
Danish: En oversigt over Eylea, og hvorfor det er godkendt i EU
English: What is Eylea and what is it used for?
Danish: Hvad er Eylea, og hvad anvendes det til?
English: For more information about how Eylea is used, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Eylea, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: It can only be obtained with a prescription and must be given by a qualified doctor who is experienced in giving intravitreal injections.
Danish: Det udleveres kun efter recept og skal indgives af en læge, som har erfaring med intravitreale injektioner.
English: Why is Eylea authorised in the EU?
Danish: Hvorfor blev Eylea godkendt i EU?
English: By blocking these factors, aflibercept reduces the growth of the blood vessels and controls the leakage and swelling.
Danish: Ved at blokere disse faktorer mindsker aflibercept blodkarrenes vækst og kontrollerer væskeudsivningen og hævelsen.
English: The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces.
Danish: Den gule plet giver det centrale syn, som man bruger til hverdag, f.eks. når man fører motorkøretøj, læser og genkender ansigter.
English: What are the risks associated with Eylea?
Danish: Hvilke risici er der forbundet med Eylea?
English: Both studies also looked at the maintenance of the effect in the second year of treatment, during which the number of injections and the time between injections were adjusted depending on the vision and changes within the eye.
Danish: I begge studier blev det også undersøgt, i hvilken grad virkningen holdt sig i det andet behandlingsår, hvor antallet af injektioner og tidsrummet mellem injektionerne blev tilpasset efter patientens synsevne og forandringerne i øjet.
English: Subsequent results from a supportive study indicated the effectiveness of extended treatment intervals in patients with wet AMD.
Danish: Resultaterne fra et efterfølgende, understøttende studie indikerede virkningen af forlængede behandlingsintervaller hos patienter med våd AMD.
English: During the second year of treatment, the effectiveness was generally maintained, with a majority of patients receiving injections at an extended dosing interval of 10 weeks, although a small number of patients occasionally needed more frequent injections (such as monthly).
Danish: I det andet behandlingsår, hvor de fleste af patienterne fik injektionerne med 10 ugers mellemrum, vedvarede virkningen generelt, selvom enkelte patienter lejlighedsvis behøvede hyppigere injektioner (såsom en gang om måneden).
English: The company that markets Eylea will provide up-to-date educational material for doctors (to minimise the risks associated with the injection in the eye) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor).
Danish: Den virksomhed, der markedsfører Eylea, skal udarbejde opdateret informationsmateriale til lægerne (for at mindske risiciene ved indsprøjtninger i øjet) samt til patienterne (for at de skal være opmærksomme på alvorlige bivirkninger og vide, hvornår de skal søge akut lægehjælp).
English: • impaired vision due to macular oedema caused by diabetes;
Danish: • nedsat synsevne som følge af makulært ødem forårsaget af diabetes
English: Eylea is given as an injection of 2 mg into the affected eye, repeated as appropriate at intervals of a month or more.
Danish: Eylea gives som en injektion af 2 mg i det berørte øje; injektionen kan gentages efter behov med et mellemrum på en måned eller mere.
English: Eylea was investigated in two main studies involving a total of around 2,400 patients with the wet form of AMD.
Danish: Eylea blev undersøgt i to hovedstudier, som i alt omfattede ca. 2 400 patienter med den våde form for AMD.
English: The main measure of effectiveness was the proportion of patients who maintained vision (defined as losing less than 15 letters in a standard eye test) after the first year of treatment.
Danish: Det primære mål for virkningen var andelen af patienter, der bevarede synsevnen (dvs. mistede mindre end 15 bogstaver i en standardsynsprøve) efter det første års behandling.
English: The studies compared Eylea (given either as 0.5 mg every four weeks, 2 mg every four weeks or 2 mg every eight weeks, all after three initial monthly doses) with ranibizumab, another treatment for AMD which was given by injection into the eye every four weeks.
Danish: I studierne blev Eylea (indgivet enten som 0,5 mg hver fjerde uge, 2 mg hver fjerde uge eller 2 mg hver ottende uge, alle efter indledende behandling med tre månedlige doser) sammenlignet med ranibizumab, et andet lægemiddel mod AMD, der blev givet som injektion i øjet hver fjerde uge.
English: Aflibercept is an engineered protein that has been designed to attach to and block the effects of a substance called vascular endothelial growth factor A (VEGF-A).
Danish: Aflibercept er et kunstigt fremstillet protein, som er designet til at binde til stoffet vaskulær endotelial vækstfaktor A (VEGF-A) og blokere dettes virkning.
English: In contrast, in patients given laser treatment the improvement after a year was only about 1 letter.
Danish: I modsætning hertil kunne de patienter, der fik laserbehandling, efter et år kun se ca. 1 bogstav mere.
English: • impaired vision due to myopic choroidal neovascularisation (a severe type of short-sightedness where the eyeball continues to grow, becoming longer than it should be).
Danish: • nedsat synsevne som følge af koroidal neovaskularisering forårsaget af myopi (en sjælden type nærsynethed, hvor øjeæblet bliver ved med at vokse og bliver længere, end det skal).