FrancophonIA/ELRC3.0 huggingface dataset:
English: Brineura 150 mg solution for infusion
Danish: Brineura 150 mg infusionsvæske, opløsning
English: Signs of problems with the device include swelling, redness of the scalp, fluid leaking from device and bulging of the scalp.
Danish: Hvis der er problemer med anordningen, kan der opstå hævelse, rødme i hovedbunden, læk af væske fra anordningen og udbulning af hovedbunden.
English: This leaflet was last revised in MM/YYYY
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: Label one unused sterile syringe “Brineura” and attach a syringe needle.
Danish: Mærk en ubrugt, steril sprøjte med ”Brineura” og påsæt en sprøjtekanyle.
English: See the syringe pump manufacturer's operating manual for details.
Danish: Se flere oplysninger i brugervejledningen fra producenten af sprøjtepumpen.
English: Discard the needle and empty vials per local requirements.
Danish: Kassér kanylen og de tomme hætteglas ifølge lokale bestemmelser.
English: Your doctor will check for abnormal heart electrical activities (ECG) every 6 months.
Danish: Lægen eller sygeplejersken vil hver 6. måned tage et EKG for at undersøge, om der er unormal elektrisk hjerteaktivitet.
English: CSF samples should routinely be sent for testing to detect subclinical device infections (see section 4.2).
Danish: Der skal rutinemæssigt sendes CSV-prøver til analyse for at detektere subklinisk, udstyrsrelateret infektion (se pkt.
English: Intelligible and grossly age-appropriate.
Danish: Tydelig tale og stort set alderssvarende.
English: See leaflet for further information
Danish: Se yderligere oplysninger på indlægssedlen
English: Do not use if the solutions are discoloured or if there is other foreign particulate matter in the solutions.
Danish: Opløsning, der er misfarvet eller indeholder andre fremmedlegemer, må ikke anvendes.
English: Detach and remove the empty syringe from the pump and disconnect from the infusion line.
Danish: Adskil den tomme sprøjte fra pumpen og infusionsslangen.
English: Initiate infusion of the flushing solution at a rate of 2.5 ml per hour.
Danish: Initier infusion af skyllevæske ved en hastighed på 2,5 ml pr. time.
English: How to store Brineura
Danish: Sådan gives Brineura
English: Detach and remove the empty syringe from the pump and disconnect from the tubing.
Danish: Kobl den tomme sprøjte fra pumpen og slangen.
English: Other medicines and Brineura
Danish: Brug af anden medicin sammen med Brineura
English: Cerliponase alfa is a recombinant human protein and systemic exposure is limited due to intracerebroventricular administration, therefore interactions between cerliponase alfa and medicinal products metabolised by cytochrome P450 enzymes are unlikely to occur.
Danish: Cerliponase alfa er et rekombinant, humant protein, og systemisk eksponering er begrænset pga. intracerebroventrikulær administration.
English: Intracerebroventricular use
Danish: Intracerebroventrikulær anvendelse
English: Flushing solution for Brineura Intracerebroventricular use
Danish: Skyllevæske, opløsning, til Brineura Intracerebroventrikulær anvendelse
English: Withdraw Brineura
Danish: Udtag Brineura
English: Do not administer Brineura if there are signs and symptoms of acute intracerebroventricular access device leakage, device failure, or device-related infection (see section 4.3 and 4.4).
Danish: Brineura må ikke administreres, hvis der er tegn og symptomer på akut lækage i udstyret til intracerebroventrikulær adgang, fejl i udstyret eller udstyrsrelateret infektion (se pkt.
English: The mean baseline CLN2 score was 3.5 (standard deviation (SD) 1.20) with a range from 1 to 6; no patients with advanced disease progression were studied (inclusion criteria: mild to moderate progression of CLN2 disease).
Danish: Den gennemsnitlige baseline-score for CLN2 var 3,5 (standardafvigelse (SD) 1,20), der varierede fra 1 til 6.
English: Discard the needle and the vial with the remaining solution per local requirements.
Danish: Kassér kanylen og hætteglasset med resterende væske ifølge lokale bestemmelser.
English: Brineura and flushing solution excipients: Sodium phosphate dibasic heptahydrate; Sodium dihydrogen phosphate monohydrate; Sodium chloride;
Danish: Hjælpestoffer i Brineura og skyllevæske: Dibasisk natriumfosfat, heptahydrat Natriumdihydrogenfosfat monohydrat Natriumchlorid
English: Intracerebroventricular infusion of the flushing solution
Danish: Intracerebroventrikulær infusion af skyllevæsken
English: Solution for infusion Two vials of Brineura One vial of flushing solution
Danish: Infusionsvæske, opløsning 2 hætteglas med Brineura 1 hætteglas med skyllevæske
English: In patients less than 2 years of age, lower doses are recommended, see paediatric population section.
Danish: Der anbefales lavere doser til patienter under 2 år.
English: Anaphylaxis
Danish: Krampeanfald
English: Each vial of Brineura contains 150 mg of cerliponase alfa in 5 ml of solution.
Danish: 1 hætteglas Brineura indeholder 150 mg cerliponase alfa i 5 ml infusionsvæske.
English: Each vial of Brineura contains 150 mg of cerliponase alfa* in 5 ml of solution.
Danish: 1 hætteglas Brineura indeholder 150 mg cerliponase alfa* i 5 ml infusionsvæske.
English: Administer flushing solution after Brineura.
Danish: Skyllevæske skal administreres efter Brineura.
English: Very common side effects (may affect more than 1 in 10 people): fever vomiting feeling irritable convulsions (seizures) reactions during or shortly after being given the medicine, such as hives, itching or flushing, swollen lips, tongue and/or throat, shortness of breath, hoarseness, turning blue around finger tips or lips, low muscle tone, fainting or incontinence
Danish: Reaktioner under eller kort efter behandlingen, såsom nældefeber, kløe eller rødme, hævede læber, tunge og/eller svælg, kortåndethed, hæshed, blå fingerspidser eller læber, lav muskeltonus, besvimelse eller inkontinens
English: Anaphylaxis has not been reported with Brineura use during clinical trials; however, the risk of anaphylaxis cannot be excluded.
Danish: Der er ikke indberettet anafylaksi ved brug af Brineura i kliniske studier.
English: Thaw Brineura and flushing solution
Danish: Optø Brineura og skyllevæsken
English: Common side effects: pain rash hives head dropping (so that the chin drops towards the chest) stomach pain leakage of the device mouth or tongue blisters swelling or redness of the eyelid and the white part of the eye feeling nervous disorder of the stomach or intestines
Danish: Blærer i munden eller på tungen Hævelse eller rødme i øjenlåget og det hvide i øjnene Nervøsitet
English: 0.40 (0.809)c
Danish: 4.3 og 4.4).
English: Do not shake vials.
Danish: Hætteglassene må ikke rystes.
English: Possible side effects
Danish: Meget almindelige bivirkninger
English: Excretion
Danish: Udslæt
English: Precautions to be taken before handling or administering the medicinal product Aseptic technique must be strictly observed during preparation and administration.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Anvendelse af aseptisk teknik skal overholdes strengt under forberedelse og administration Brineura administreres i cerebrospinalvæsken (CSF) som infusion via en kirurgisk implanteret beholder og et kateter (udstyr til intracerebroventrikulær adgang).
English: LOT:
Danish: NN:
English: Abdominal pain Oral mucosal blistering Tongue blistering Gastrointestinal disorder
Danish: Abdominalsmerter Blæredannelse på mundens slimhinder
English: Attach the syringe containing Brineura to the extension line, if used, otherwise connect the syringe to the infusion set.
Danish: Sæt sprøjten med Brineura på forlængerslangen, hvis en sådan anvendes.
English: Cardiac disorders
Danish: Konvulsionerd Hovedpine
English: What Brineura is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: Potassium chloride;
Danish: terapeutisk administration.
English: Brineura is administered to the cerebrospinal fluid (CSF) by infusion via a surgically implanted reservoir and catheter (intracerebroventricular access device).
Danish: - En detaljeret, trinvis beskrivelse af intracerebroventrikulær infusion af BRINEURA og administration af skylleopløsningen (givet efter afslutning af infusion af BRINEURA).
English: The exposure to these substances is respectively estimated to 565,000 patient-years, 555,470 patient-years and 66,052 patient-years worldwide.
Danish: Eksponeringen for disse stoffer skønnes til henholdsvis 565 000 patientår, 555 470 patientår og 66 052 patientår verden over.
English: This is further supported by the likely common mechanism of action.
Danish: Dette synspunkt understøttes desuden af den sandsynlige fælles virkningsmekanisme.
English: The RMP of all these products should be updated accordingly.
Danish: Risikostyringsplanen for alle disse produkter skal opdateres i overensstemmelse hermed.
English: Further, in a number of cases, blood glucose values were only moderately increased or normal.
Danish: I en række tilfælde var blodsukkerværdierne desuden kun moderat øget eller normale.
English: Based on the data available, the PRAC considered that there was no indication of a different risk between the products.
Danish: På grundlag af de tilgængelige data er PRAC af den opfattelse, at der ikke er noget, der tyder på, at der skulle være forskellig risiko produkterne imellem.
English: Taking into account the severity of these cases and the general pattern seen across these medicinal products, the European Commission requested, on the 10 of June 2015 and pursuant to Article 20 of Regulation No 726/2004, the opinion of the Agency on whether the marketing authorisation of canagliflozin-, dapagliflozin- and empagliflozin-containing medicinal products, should be maintained, varied, suspended or revoked.
Danish: I betragtning af sværhedsgraden af disse tilfælde og det generelle mønster, der er observeret for alle disse lægemidler, anmodede Europa-Kommissionen d. 10. juni 2015 i medfør af artikel 20 i forordning nr. 726/2004 agenturet om en udtalelse om, hvorvidt markedsføringstilladelsen for lægemidler indeholdende canagliflozin, dapagliflozin og empagliflozin bør fastholdes, ændres, suspenderes eller tilbagekaldes.
English: This can be partially buffered with the bicarbonate buffering system, but this system is quickly overwhelmed and other mechanisms must work to compensate for the acidosis.
Danish: Dette kan delvist afhjælpes med bikarbonat-buffersystemet, men dette system bliver hurtigt overbelastet, og andre mekanismer må træde til for at kompensere for acidosen.
English: A safety warning on DKA was issued by the FDA for this therapeutic class in the same month.
Danish: FDA udstedte samme måned en sikkerhedsmæssig advarsel vedrørende diabetisk ketoacidose for denne terapeutiske klasse.
English: The glucose is partially excreted via the urine, leading to polyuria, dehydration, and compensatory thirst and polydipsia.
Danish: Glukosen udskilles delvist via urinen, hvilket fører til polyuri, dehydrering og kompensatorisk tørst og polydipsi.
English: No definite conclusion could be drawn regarding dose relationship or protective or exacerbating effect of concomitant medicines.
Danish: Det har ikke været muligt at komme med en endelig konklusion vedrørende dosissammenhæng eller en eventuel beskyttende eller forværrende virkning af samtidigt anvendte lægemidler.
English: Overall the reported cases were poorly documented and the MAHs are requested to implement targeted follow up questionnaires, in order to document consistent information on the cases.
Danish: Overordnet set var de rapporterede tilfælde sparsomt dokumenteret, og indehaverne af markedsføringstilladelserne er blevet pålagt at gennemføre en målrettet opfølgning ved hjælp af spørgeskemaer med henblik på at dokumentere konsistent information om tilfældene.
English: The MAHs are required to submit the final study report to the EMA as they become available.
Danish: Indehaverne af markedsføringstilladelserne skal fremsende de endelige undersøgelsesrapporter til EMA, så snart de er færdige.
English: In the EU, three SGLT2 inhibitors are currently authorised as monocomponent and as fixed dose combination with metformin: canagliflozin (Invokana and Vokanamet), dapagliflozin (Forxiga and Xigduo) and empagliflozin (Jardiance and Synjardy).
Danish: I EU findes der i øjeblikket tre SGLT2-hæmmere, der er godkendt som monoterapi og som fastdosiskombination med metformin: canagliflozin (Invokana og Vokanamet), dapagliflozin (Forxiga og Xigduo) og empagliflozin (Jardiance og Synjardy).
English: SGLT2 is expressed in the proximal renal tubules and is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
Danish: SGLT2 udtrykkes i de proksimale nyretubuli og er ansvarlig for hovedparten af reabsorptionen af filtreret glukose fra det tubulære lumen.
English: In addition treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Danish: Desuden bør behandling afbrydes hos patienter, der er indlagt med henblik på en større kirurgisk procedure eller som følge af en akut alvorlig sygdom.
English: In a number of these reports, the presentation of the condition was atypical with only moderately increased blood glucose levels observed.
Danish: I en række af disse tilfælde var præsentationen af lidelsen atypisk med kun moderat forhøjede blodsukkerniveauer.
English: Although the MAHs estimated slightly different incidence rates, these were not all calculated according to the international standards for computation of incidence rate.
Danish: Skønnene for incidens var lidt forskellige mellem indehaverne af markedsføringstilladelserne, men de var heller ikke alle beregnet i henhold til den internationale standard for beregning af incidens.
English: By blocking the action of SGLT2, these substances cause more glucose to be removed via the urine, thereby reducing the levels of glucose in the blood via an insulinindependent mechanism.
Danish: Ved at blokere virkningen af SGLT2 bevirker disse stoffer, at der udskilles mere glukose gennem urinen, og derved reduceres glukoseindholdet i blodet gennem en insulin-uafhængig mekanisme.
English: Diabetic ketoacidosis (DKA) is a serious, often life-threatening condition, which usually develops in diabetic patients when insulin levels are too low.
Danish: Diabetisk ketoacidose er en alvorlig og ofte livstruende lidelse, der typisk udvikles hos diabetikere, når insulinniveauet er for lavt.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for SGLT2 inhibitors-containing medicinal products.
Danish: • PRAC har taget højde for proceduren i artikel 20 i forordning (EF) 726/2004, for så vidt angår lægemiddelovervågningsdata for lægemidler, der indeholder SGLT2-hæmmere.
English: Ketone bodies have a low pKa and therefore their accumulation in the blood lead to acidosis.
Danish: Ketonstoffer har en lav pKa, og derfor fører akkumuleringen af dem i blodet til acidose.
English: In view of the above, the PRAC considered that the benefit-risk balance of Forxiga, XigDuo, Invokana, Vokanamet, Jardiance and Synjardy remains favourable subject to the agreed amendments to the product information.
Danish: I lyset af ovenstående finder PRAC, at benefit/risk-forholdet for Forxiga, XigDuo, Invokana, Vokanamet, Jardiance og Synjardy fortsat er positivt under forudsætning af, at de nævnte ændringer indføres i produktinformationen.
English: A search in Eudravigilance (EV) database was performed by the EMA on 19 May 2015 for the three SGLT2 inhibitors.
Danish: EMA gennemførte d. 19. maj 2015 en søgning i Eudravigilance-databasen på de tre SGLT2-hæmmere.
English: In addition, the low levels of insulin along with a rise in plasma glucagon levels lead to the release of glucose by the liver.
Danish: Derudover fører de lave insulinniveauer sammen med en stigning i plasma-glukagonniveauerne til frigivelse af glukose fra leveren.
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors are used together with diet and exercise in patients with type 2 diabetes, either alone or in combination with other diabetes medicines.
Danish: Natriumglukose-co-transportør 2 (SGLT2)-hæmmere anvendes sammen med diæt og motion hos type 2-diabetikere, enten alene eller i kombination med andre diabetesmidler.
English: Planned and ongoing Drug Utilisation Studies (DUS) for dapagliflozin- and empagliflozincontaining products are expected to generate more information on the extent and nature of the offlabel use.
Danish: Planlagte og igangværende undersøgelser af brugen af lægemidler, der indeholder dapagliflozin og empagliflozin, forventes at skabe mere viden om omfanget og karakteren af ikkeforeskrevet anvendelse.
English: Moreover, the MAHs should explore the feasibility of collecting plasma hormones in new or ongoing trials with the aim to identify patterns of hormone derangement that could further explain the mechanism of action of SGLT2 inhibitors in ketoacidosis.
Danish: Derudover skal indehaverne af markedsføringstilladelserne undersøge muligheden for at indsamle plasmahormoner i nye eller igangværende forsøg med det formål at identificere mønstre i hormonforstyrrelser, der kan kaste yderligere lys over virkningsmekanismen for SGLT2-hæmmere ved ketoacidose.
English: In addition, the PRAC considered that “DKA with atypical presentation” should be added as an important identified risk to the Risk Management Plan (RMP) of those products.
Danish: Desuden finder PRAC, at "diabetisk ketoacidose med atypisk præsentation" skal tilføjes som en væsentlig identificeret risiko i risikostyringsplanen for disse lægemidler.
English: In order to minimise this risk, the PRAC considered that physicians and patients should be warned through the PI to consider the risk of atypical DKA in the occurrence of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Danish: For at minimere denne risiko finder PRAC, at læger og patienter skal advares gennem produktinformationen om at tage højde for risikoen for diabetisk ketoacidose med atypisk præsentation, når der konstateres ikkespecifikke symptomer såsom kvalme, opkastning, anoreksi, mavesmerter, voldsom tørst, vejrtrækningsbesvær, forvirring, usædvanlig træthed eller søvnighed.
English: Atypical presentation of DKA in patients with type 2 diabetes could delay diagnosis and treatment.
Danish: Den atypiske præsentation af diabetisk ketoacidose hos type 2-diabetikere kan forsinke diagnosticeringen og behandlingen.
English: Patients should be advised to contact a doctor in order to be tested for ketoacidosis and to discontinue SGLT2 inhibitor treatment if DKA is suspected or diagnosed.
Danish: Patienterne skal rådes til at kontakte lægen for at blive testet for ketoacidose, og behandlingen med SGLT2-hæmmere skal seponeres, hvis man har mistanke om eller diagnosticerer diabetisk ketoacidose.
English: DKA most commonly occurs in patients with type 1 diabetes mellitus (T1DM) and is usually accompanied by high blood glucose levels (>250 mg/dL).
Danish: Diabetisk ketoacidose ses oftest hos type 1-diabetes mellitus og ledsages typisk af høje niveauer af glukose i blodet (> 250 mg/dl).
English: In absence of insulin the metabolism switches from using glycogenolysis to lipolysis as a source of energy, which produces ketone bodies.
Danish: I manglen på insulin bruges der i stedet for glykogenolyse lipolyse som energikilde ved metaboliseringen, hvilket gør, at der opstår ketonstoffer.
English: In conclusion, the PRAC considered that the benefit-risk balance of SGLT2 inhibitors-containing products remained favourable, provided the proposed changes to the product information and the risk management plan are implemented.
Danish: Sluttelig er det PRAC's opfattelse, at benefit/risk-forholdet for lægemidler, der indeholder SGLT2hæmmere fortsat er positivt under forudsætning af, at de foreslåede ændringer indføres i produktinformationen og i risikostyringsplanen.
English: Those studies are expected to enable better characterisation of the risk of DKA and its mechanism and should be included in the RMP of those products.
Danish: Disse undersøgelser forventes at muliggøre en bedre karakterisering af risikoen for diabetisk ketoacidose og mekanismen bag tilstanden, og de skal medtages i risikostyringsplanen for disse lægemidler.
English: The atypical presentation of DKA cases in SGLT2 treated diabetes patients, combined with the otherwise non-specific symptoms presented by patients with DKA may delay the diagnosis and therefore lead to the development of more serious or life-threatening conditions.
Danish: Den atypiske præsentation af diabetisk ketoacidose hos SGLT2-behandlede diabetikere i kombination med de i øvrigt uspecifikke symptomer, som rammer patienter med diabetisk ketoacidose, kan forsinke diagnosticeringen og derfor medføre udvikling af alvorlige eller livstruende tilstande.
English: • The PRAC therefore, was of the view that the risk of DKA should be minimised by its inclusion in the product information with a warning highlighting to healthcare professional and patients the possible atypical presentation of DKA to be considered in the occurrence of non-specific symptoms, together with the risk factors, and recommendations regarding treatment discontinuation.
Danish: • PRAC er derfor af den opfattelse, at risikoen for diabetisk ketoacidose bør minimeres ved i produktinformationen at advare læger og patienter om at være opmærksomme på den mulige atypiske præsentation af diabetisk ketoacidose ved ikke-specifikke symptomer; samtidig skal risikofaktorerne og anbefalinger vedrørende seponering medtages.
English: The relatively long time-to-onset observed in clinical trials is suggestive of contributing factors triggering the development of DKA.
Danish: Den relativt lange tid før effekt af virkninger, der er observeret i de kliniske forsøg, tyder på, at en række medvirkende faktorer udløser udviklingen af diabetisk ketoacidose.
English: Considering the above, the PRAC was of the view that DKA should be included in the product information of all SGLT2 inhibitors with the frequency rare.
Danish: I lyset af ovenstående mener PRAC, at diabetisk ketoacidose skal inkluderes i produktinformationen for alle SGLT2-hæmmere med hyppigheden "sjælden".
English: DKA cases were reported in all three SGLT2 currently authorised in the EU, suggestive of a class effect.
Danish: Der er rapporteret om diabetisk ketoacidose for alle tre SGLT2-stoffer, der er godkendt i EU, hvilket tyder på en klassevirkning.
English: This is not an approved indication for SGLT2 inhibitors containing products.
Danish: Dette er ikke en godkendt indikation for lægemidler med SGLT2-hæmmere.
English: When considering all the data submitted by the MAHs from clinical and non-clinical studies, postmarketing reports and in published literature, in relation to the risk of diabetic ketoacidosis (DKA) in association with SGLT2 inhibitors, the PRAC was of the view that a small excess risk could not be excluded in patients with T2DM.
Danish: Efter at have gennemgået alle de data, som indehaverne af markedsføringstilladelserne har indsendt, herunder data fra kliniske og prækliniske studier, indberetninger efter markedsføringen og publiceret litteratur, hvad angår risikoen for diabetisk ketoacidose ved behandling med SGLT2-hæmmere, er PRAC af den opfattelse, at det ikke kan udelukkes, at der er en lille forhøjet risiko hos type 2-diabetikere.
English: Forty-six cases of DKA were also reported in patients on SGLT2 inhibitors for T1DM, which is not currently an approved indication for these products.
Danish: Der er også rapporteret om 46 tilfælde af diabetisk ketoacidose ved SGLT2-hæmmer-behandling af type 1-diabetikere, hvilket aktuelt ikke er en godkendt indikation for disse lægemidler.