FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients treated with Glybera shall be enrolled in the registry.
Danish: Alle patienter, der behandles med Glybera, skal optages i registret.
English: The first 2 patients enrolled received a dose of 3 x 1011 gc/kg, the next 4 patients received a dose of 3 x 1011 gc/kg with immunosuppressant regiment (oral ciclosporin and oral mycophenolate mofetil from the day after Glybera administration until Week 12) and the final 8 patients received a dose of 1 x 1012gc/kg with immunosuppressant regiment.
Danish: De første 2 indrullerede patienter fik en dosis på 3 x 1011 gc/kg, de næste 4 patienter fik en dosis på 3 x 1011 gc/kg med et immunosuppressivt regime (oralt ciclosporin og oralt mycophenolatmofetil fra dagen efter administration af Glybera indtil uge 12), og de sidste 8 patienter fik en dosis på 1 x 1012gc/kg med immunosuppressivt regime.
English: Information for health care professionals: The holder of this card has received Glybera, a gene therapy medicinal product for familial lipoprotein lipase deficiency, containing genetically modified organisms.
Danish: Information til sundhedspersoner: Indehaveren af dette kort har fået Glybera, et genterapiprodukt mod familiær lipoprotein-lipasemangel.
English: Glybera will only be given to you if you show detectable levels of LPL protein in your blood.
Danish: Du vil kun få Glybera, hvis du har målelige mængder af LPL-protein i blodet.
English: Two of these clinical trials were preceded by prospective observational studies to assess fasting triglycerides (TG) level and symptoms and signs of LPLD in subjects maintained on a low fat diet.
Danish: Inden to af disse kliniske studier blev der udført prospektive observationsstudier til bestemmelse af fastende triglycerider samt symptomer og tegn på LPLD hos patienter, der fortsatte på fedtfattig diæt.
English: In gonads and reproductive organs, vector DNA copies were found at low levels.
Danish: I gonader og reproduktive organer var der lave niveauer af vektorDNA-kopier.
English: The safety and efficacy of Glybera in children and adolescents below 18 years has not been established.
Danish: Glyberas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: People who are affected by this condition have a build up of very high fat levels in their blood (hyperchylomicronemia).
Danish: Patienter med sygdommen ophober meget store mængder fedtstof i blodet (hyperkylomikronæmi).
English: • Information on the use of Glybera and avoidance of pregnancy.
Danish: • Oplysning om anvendelse af Glybera og forebyggelse af graviditet
English: Male patients must use condoms for at least 12 months after injection with Glybera.
Danish: Mandlige patienter skal bruge kondom i mindst 12 måneder efter injektion med Glybera.
English: No dose adjustment of Glybera is necessary in the elderly population.
Danish: Dosisjustering af Glybera er ikke nødvendig hos den ældre population.
English: The aim of this open label, dose escalating study was to assess the safety profile and reduction of fasting plasma triglyceride (TG) levels after 12 weeks post Glybera administration in 14 LPLD patients.
Danish: Formålet med denne åbne dosiseskaleringsstudie var at vurdere sikkerhedsprofilen og reduktionen i fastende triglycerider 12 uger efter administration af Glybera til 14 patienter med LPLD.
English: You need to take this into consideration if you are on a controlled sodium diet.
Danish: Dette skal du tænke på, hvis du følger en natriumfattig diæt.
English: In addition, patients, who have been treated with Glybera in a clinical trial shall be enrolled in the registry at the end of the trial.
Danish: Derudover skal patienter, der er behandlet med Glybera i et klinisk studie, optages i registret ved studiets slutning.
English: High levels of vector DNA were observed up to 12 months after dosing in the target tissue for Glybera, injected leg muscle, but not in non-injected muscle.
Danish: Niveauet af vektor-DNA var højt i op til 12 måneder efter doseringen i målvævet for Glybera, dvs. det injicerede muskelvæv i benene, men ikke i det ikke-injicerede muskelvæv.
English: The diagnosis of LPLD has to be confirmed by genetic testing.
Danish: Diagnosen LPLD skal være bekræftet ved genetisk testning.
English: Five eligible subjects were included in the study with all subjects receiving alipogene tiparvovec.
Danish: I studiet indgik fem egnede patienter, som alle fik alipogentiparvovec.
English: The MAH shall also provide a patient alert card in each medication pack, the text of which is included in Annex III.
Danish: Indehaveren af markedsføringstilladelsen skal desuden udlevere et patientkort i hver medicinpakke med den tekst, der er angivet i bilag III.
English: No vector DNA could be detected in the foetuses after treatment of either the females or the males prior to mating.
Danish: Der kunne ikke påvises vektor-DNA i fostrene efter behandling af hunnerne og hannerne inden parring.
English: LPL protein mass should be measured in a blood sample from the patient against a control sample from healthy volunteers.
Danish: LPL-proteinmassen bestemmes i en blodprøve fra patienten, idet der anvendes en prøve fra raske frivillige forsøgspersoner.
English: All patients treated with Glybera should be enrolled in the registry and systematic data collection carried out to enrich the database:
Danish: Alle patienter, der behandles med Glybera, skal optages i registret, og der skal systematisk indsamles data til databasen:
English: Following intramuscular administration of Glybera to mice, vector DNA was transiently detected in the circulation.
Danish: Efter intramuskulær administration af Glybera i mus påvistes vektor-DNA forbigående i kredsløbet.
English: Anti-platelet or other anti-coagulant medicinal products must not be used concomitantly with Glybera at the time of injection.
Danish: Der må ikke anvendes antitrombocytmidler eller andre antikoagulantia samtidig med Glybera på injektionstidspunktet.
English: It is not known whether Glybera passes into breast milk.
Danish: Det vides ikke, om Glybera går over i modermælken.
English: What you need to know before you are given Glybera Do not receive Glybera
Danish: Det skal du vide, før du begynder at få Glybera Du må ikke få Glybera
English: Posology The maximum total dose of Glybera for administration is 1 x 1012 gc/kg body weight.
Danish: Dosering Den maksimale totale dosis Glybera til administration er 1 × 1012 gc/kg legemsvægt.
English: Diabetic patients
Danish: Patienter med diabetes
English: Glybera therapy will be overseen by a doctor who is specialised in the treatment of patients affected by your condition and will be administered to you by an appropriately qualified and trained doctor or nurse.
Danish: Glybera-behandlingen vil blive overvåget af en læge med speciale i behandling af sygdommen, og du vil blive behandlet af en kvalificeret og uddannet læge eller sundhedsmedarbejder.
English: Number of 1 ml syringes (each filled) with 0.5 ml)
Danish: Antal 1 ml sprøjter (hver fyldt med 0,5 ml)
English: Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Danish: Tabel over bivirkninger Bivirkningerne er nedenfor opstillet efter systemorganklasse og hyppighed i henhold til MedDRA
English: To avoid this, your doctor will also prescribe treatment that will suppress the immune system (known as immunosuppressants), starting 3 days before the day of injection with Glybera and for 12 weeks after.
Danish: For at undgå dette vil lægen desuden ordinere immundæmpende medicin, begyndende tre dage inden injektionen med Glybera og derefter i 12 uger.
English: Muscle biopsies taken half a year post administration demonstrated long-term expression of the LPL gene and the presence of biologically active LPL protein.
Danish: Ved muskelbiopsier taget op til et halvt år efter administrationen påvistes varig ekspression af LPLgenet og tilstedeværelse af biologisk aktivt LPL-protein.
English: For each injection site, one syringe of 1 ml with clear volume marks of 0.5 ml must be used.
Danish: Til hvert injektionssted skal der anvendes én 1 ml sprøjte med tydelig 0,5 ml-volumenmærkning.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: • Anti-platelet or other anti-coagulant medicinal products must not be used concomitantly with Glybera at the time of injection and for at least one week before or one day after the injection.
Danish: • Der må ikke gives antitrombocyt- eller anden antikoagulansbehandling samtidig med Glybera på injektionstidspunktet og i mindst en uge inden eller en dag efter injektionerne.
English: Doctors shall be encouraged also to enrol patients with familial LPLD who are not treated with Glybera.
Danish: Lægerne skal opfordres til, at også patienter med familiær LPLD, der ikke behandles med Glybera, optages i registret.
English: If a vial is showing damage, syringes for the injection should not be prepared and the injection procedure should be postponed and rescheduled.
Danish: Hvis et hætteglas er beskadiget, skal injektionssprøjterne ikke klargøres, og injektionen skal udsættes og udføres senere.
English: The clear to slightly opalescent and colourless solution must be free of visible particles.
Danish: Den klare til let opaliserende og farveløse opløsning må ikke indeholde synlige partikler.
English: Glybera therapy must be prescribed by and administered under the supervision of a physician with expertise in treating LPLD patients and in gene therapy administration, in full consultation with the patient.
Danish: Glybera-behandling skal ordineres og administreres under opsyn af en læge med ekspertise i behandling af LPLD-patienter og i genterapi.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ
English: Examples of these immunosuppressants are ciclosporin, mycophenolate mofetil.
Danish: Immundæmpende medicin kan f.eks. være ciclosporin eller mycophenolatmofetil.
English: At this time a series of injections (27 to 60 injections) into the muscles of both upper and lower legs will be given.
Danish: Behandlingen består af en række indsprøjtninger (27-60 indsprøjtninger) i musklerne i over- og underben.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING Pharmacovigilance system
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Lægemiddelovervågningssystem
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning for patienter på natriumfattig diæt.
English: Compared to pre-administration, a transient and variable reduction in median triglyceride levels was recorded for all patients.
Danish: Hos alle patienter registreredes i varierende grad forbigående reduktion i det mediane triglyceridniveau i forhold til før administrationen.
English: This medicinal product contains 47.5 mg sodium per administration at 27 injection sites to 105.6 mg sodium per administration at 60 injection sites.
Danish: Dette lægemiddel indeholder fra 47,5 mg natrium pr. administration (27 injektionssteder) til 105,6 mg natrium pr. administration (60 injektionssteder).
English: The dose per injection site is 1.5 x 1012 gc, or 0.5 ml of solution for injection.
Danish: Dosis pr. injektionssted er 1,5 × 1012 gc eller 0,5 ml injektionsvæske.
English: The MAH shall set up a disease registry to collect information on the epidemiology of the disease and the demographics, safety and effectiveness outcomes of patients with familial LPLD treated with Glybera.
Danish: Indehaveren af markedsføringstilladelsen opretter et sygdomsregister med oplysninger om sygdommens epidemiologi og resultater vedrørende demografi, sikkerhed og virkning fra patienter med familiær LPLD, der er behandlet med Glybera.
English: The final outer carton contains a variable number of casings according to the patient specific dose required.
Danish: Den yderste karton kan indeholde et varierende antal beholdere svarende til den nødvendige dosis til den enkelte patient.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glybera in all subsets of the paediatric population in the treatment of lipoprotein lipase deficiency (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlægge resultaterne af studier med Glybera alle undergrupper af den pædiatriske population med lipoproteinlipase-mangel (se pkt.
English: The indication is restricted to patients with detectable levels of LPL protein (see section 4.4).
Danish: Indikationen er begrænset til patienter med målelige mængder af LPL-protein (se pkt.
English: The MAH shall set up a long term surveillance programme/ disease registry to collect information on the epidemiology of the disease and the demographics, safety, and the effectiveness outcomes of patients treated with Glybera.
Danish: Indehaveren af markedsføringstilladelsen etablerer et langsigtet overvågningsprogram/sygdomsregister med oplysninger om sygdommens epidemiologi og resultater vedrørende demografi, sikkerhed og virkning fra patienter behandlet med Glybera.
English: No dose adjustment of Glybera is required.
Danish: Der kræves ingen dosisjustering af Glybera.
English: If you receive two doses in one injection site by mistake this might lead to more local reaction such as bruising or sensitivity.
Danish: Hvis du ved en fejltagelse får to doser på samme injektionssted, kan der komme en lokal reaktion såsom blå mærker eller følsomhed.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERPAKNING
English: Breast-feeding is not recommended during treatment with Glybera.
Danish: Det anbefales ikke at amme under behandling med Glybera.
English: Your doctor should give you a copy of the patient information leaflet (like this one) for the immunosuppressants you will need to take.
Danish: Lægen vil udlevere en kopi af indlægssedlen for den immundæmpende medicin, du skal have (svarende til denne indlægsseddel).
English: In clinical studies a transient reduction in triglycerides for up to 12 weeks in individual patients could be observed.
Danish: I kliniske studier observeredes et forbigående fald i triglycerider i op til 12 uger hos enkelte patienter.
English: An appropriate CE marked test or full gene sequencing should be used to confirm the diagnosis.
Danish: Til verificering af diagnosen bør en velegnet CE-mærket test anvendes, eller en fuld genetisk sekvensanalyse udføres.
English: If not stored in a refrigerator the medicinal product can be stored in syringes at not more than 25°C, and protected from light for a maximum of 8 hours.
Danish: Hvis produktet ikke opbevares i køleskab, kan det opbevares i op til otte timer i sprøjterne ved højst 25 °C beskyttet mod lys.
English: There is limited experience in the use of Glybera in patients with renal or hepatic impairment.
Danish: Der er begrænsede erfaringer med anvendelse af Glybera til patienter med nedsat nyre- eller leverfunktion.
English: Chills, Injection site pain, Oedema peripheral, Pyrexia
Danish: Kulderystelser, smerter på injektionsstedet, perifert ødem, pyreksi
English: Diet
Danish: Diæt
English: This is the number of injection sites and the total number of syringes (each filled with 0.5ml) needed to administer a volume of 0.5ml per injection site for the patient's treatment.
Danish: Dette tal er antallet af injektionssteder og det totale antal sprøjter (hver fyldt med 0,5 ml), som er nødvendigt for at administrere et volumen på 0,5 ml pr. injektionssted til patientens behandling.
English: Volumes per injection site must not exceed 0.5 ml.
Danish: Volumen pr. injektionssted må ikke overstige 0,5 ml.
English: Unused medicine must be disposed of in compliance with the local rules for genetically modified organisms.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for genetisk modificerede organismer.
English: Glybera is a clear to slightly opalescent, colourless solution for injection, supplied in a clear glass vial with a siliconised injection stopper and flip-off seal.
Danish: Glybera er en klar til let opaliserende, farveløs injektionsvæske, opløsning, der leveres i et klart hætteglas med en silikoneret, latexfri injektionsprop og afrivningskapsel.
English: 1 ml solution in a 2 ml vial (glass) with siliconised chlorobutyl, injection stopper and flip-off seal.
Danish: 1 ml opløsning i et 2 ml hætteglas (glas) med silikoneret chlorbutyl-injektionsprop og afrivningskapsel.
English: Burning sensation, Dizziness, Formication, Presyncope
Danish: Hovedpine Brændende fornemmelse, svimmelhed, myrekryb, præsynkope
English: Other medicines and Glybera
Danish: Brug af anden medicin sammen med Glybera
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (3 vial pack)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ETIKET PÅ TRANSPARENT FORSEGLET PLASTBEHOLDER (pakke med 3 hætteglas)
English: • The necessity to carry the patient alert card, that is included in each pack, with them at all
Danish: • nødvendigheden af altid at have patientkortet, der er indeholdt i hver pakke, på sig
English: Contents of the pack and other information What Glybera contains
Danish: Pakningsstørrelser og yderligere oplysninger Glybera indeholder:
English: Elevations in serum creatine kinase activity
Danish: Forhøjet serumkreatinkinase-aktivitet
English: Glybera is expected to be degraded by endogenous protein and DNA catabolic pathways.
Danish: Glybera forventes nedbrudt ved samme mekanisme som ved katabolismen af endogent protein og DNA.
English: Dyspnoea exertional, Pulmonary embolism
Danish: Funktionsdyspnø, lungeemboli
English: AAV1-LPLS447X was administered to 8 LPLD patients in a 12-week, open label dose escalating study (1 x 1011 gc to 3 x 1011 gc per kg body weight i.m.).
Danish: blev administreret til 8 LPLD-patienter i en 12 ugers åben dosiseskaleringsstudie (1 × 1011 gc til 3 × 1011 gc pr. kg legemsvægt i.m.).
English: The calculated amount of syringes should be filled from the thawed vials, and they should be labelled and placed in a container protected from light suitable for transportation to the room where the patient will undergo the intramuscular injections.
Danish: Sprøjterne mærkes og anbringes i en beholder, der beskytter mod lys, og som er egnet til at transportere sprøjterne til det sted, hvor patienten skal have foretaget de intramuskulære injektioner.
English: This is an open-label study of alipogene tiparvovec at a fixed dose of 1x1012 gc/ kg body weight administered by a single series of intramuscular injections.
Danish: Klinisk studie CT-AMT-011-02 Dette er et åbent studie med alipogentiparvovec i en fast dosis på 1x1012 genomkopier/ kg legemsvægt administreret som en enkelt serie intramuskulære injektioner.
English: Glybera is authorised for single treatment only and should not be re-administered.
Danish: Glybera er kun godkendt til én enkelt behandling og må ikke gives igen.
English: Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions.
Danish: Glybera er indiceret til behandling af voksne patienter, der er diagnosticeret med arvelig lipoproteinlipase-mangel (LPLD), og som lider af svære eller multiple anfald af pankreatitis trods fedtfattig diæt.
English: The clinical relevance of the antibody response is unknown (see section 4.2 on re-administration).
Danish: Den kliniske relevans af denne antistofrespons er ukendt (se pkt.
English: This is the number of injection sites and the total number of syringes (each filled with 0.5ml) required for the patient's treatment.
Danish: Dette tal er antallet af injektionssteder og det totale antal sprøjter (hver fyldt med 0,5 ml), som er nødvendigt for patientens behandling.
English: From three days prior to and for 12 weeks following Glybera administration an immunosuppressive regimen should be administered: ciclosporin (3 mg/kg/day) and mycophenolate mofetil (2 x 1 g/day) is recommended.
Danish: Der bør gives et immunsuppressivt regime fra tre dage inden administration af Glybera og i de efterfølgende 12 uger: Hertil anbefales ciclosporin (3 mg/kg/dag) og mycophenolatmofetil (2 × 1 g/dag).
English: The treatment should be monitored by measuring neutralising antibodies and T-Cell response against AAV1 and LPLS447X at baseline as well as 6 and 12 months after treatment.
Danish: Behandlingen bør overvåges ved bestemmelse af neutraliserende antistoffer og T-cellerespons mod AAV1 og LPLS447X ved baseline og 6 og 12 måneder efter behandlingen.
English: Glybera is not usually recommended for use during pregnancy.
Danish: Det anbefales ikke at bruge Glybera under graviditet.
English: The instructions for use, handling and disposal are given in section 6.6.
Danish: Anvisninger for anvendelse, håndtering og bortskaffelse findes i pkt.
English: Glybera should only be used when the diagnosis of LPLD has been confirmed by an adequate genetic test.
Danish: Glybera bør kun anvendes, når diagnosen LPLD er verificeret ved fyldestgørende genetisk testning.
English: Subjects also received a daily oral dose of 3 mg/kg/day cyclosporine and 2 g/day of mycophenolate mofetil starting three days before administration of alipogene tiparvovec through week 12.
Danish: Patienterne fik desuden peroralt ciclosporin, 3 mg/kg/dag, og mycophenolatmofetil, 2 g/dag, begyndende tre dage inden administrationen af alipogentiparvovec til og med uge 12.
English: However in toxicity studies, no increase in tumour was identified.
Danish: Der er imidlertid ikke øget tumorforekomst i toksicitetsundersøgelserne.
English: Therefore, use of barrier contraception methods for at least 12 months following Glybera administration is recommended.
Danish: Derfor tilrådes barrierekontraception i mindst 12 måneder efter administration af Glybera.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (2 vial pack)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ETIKET PÅ TRANSPARENT FORSEGLET PLASTBEHOLDER (pakke med 2 hætteglas)
English: Clear, to slightly opalescent, colourless solution.
Danish: Klar til let opaliserende, farveløs opløsning.
English: After time, residual vector DNA levels remained high in the injected muscle and inguinal lymph nodes while decreasing steadily in the other organs.
Danish: Niveauet af resterende vektor-DNA forblev højt i det injicerede muskelvæv og i lymfeknuderne i lysken, men faldt støt i de andre organer.
English: People diagnosed with lipoprotein lipase deficiency are advised to be careful with their diet, both before and after Glybera therapy; they should not drink alcohol.
Danish: Hvis man har fået stillet diagnosen lipoproteinlipase-mangel, skal man holde sin diæt - både før og efter Glybera-behandlingen - og undgå alkoholindtagelse.
English: Disodium phosphate anhydrous Potassium chloride Potassium dihydrogen phosphate Sodium chloride Sucrose
Danish: Dinatriumphosphat, vandfri Kaliumchlorid Kaliumdihydrogenphosphat Natriumchlorid Saccharose
English: During administration of Glybera appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration.
Danish: Administrationen af Glybera skal altid foregå under tilstrækkeligt opsyn, og der skal altid være umiddelbar rådighed over den nødvendige medicinske behandling i tilfælde af en eventuel anafylaktisk reaktion efter administrationen.
English: Do not take oral contraceptives as they have the potential to worsen your disease; Use condoms so that as little Glybera as possible may be passed to/from your partner.
Danish: Brug kondom, for at mindst muligt af lægemidlet overføres til/fra din partner.