FrancophonIA/ELRC3.0 huggingface dataset:
English: Liver and kidney function, cytochrome P450 polymorphisms and ageing are not expected to influence the clinical efficacy or safety of Glybera.
Danish: Lever- og nyrefunktion, cytokrom P450, polymorfi og alder forventes ikke at have betydning for Glyberas kliniske virkning eller sikkerhed.
English: 1) on efficacy data such as biochemical markers as part of normal practice and frequency and severity of pancreatitis and 2) on safety including immunogenicity against Glybera and LPL.
Danish: 1) vedrørende virkning såsom rutinemæssigt anvendte biokemiske markører, frekvens og sværhedsgrad af pankreatitis samt 2) vedrørende sikkerhed, herunder immunogenicitet over for Glybera og
English: Alipogene tiparvovec ▼ This medicine is subject to additional monitoring.
Danish: Alipogentiparvovec Dette lægemiddel er underlagt supplerende overvågning.
English: Preparation of Glybera for administration
Danish: Klargøring af Glybera til administration
English: Animal studies do not indicate any harmful effects on pregnancy or embryonal/foetal development from Glybera (see section 5.3).
Danish: Dyreforsøg viser ingen skadelige virkninger med hensyn til graviditet eller embryoets/fostrets udvikling efter anvendelse af Glybera (se pkt.
English: Fatigue, Hyperthermia
Danish: Træthed, hypertermi
English: Glybera shall only be supplied if the healthcare professionals involved in the treatment of a patient have received the educational pack and if the prescriber confirms that the patient agrees to participate in the registry.
Danish: Glybera må kun udleveres, hvis de sundhedspersoner, der er inddraget i patientens behandling, har modtaget informationspakken, og den ordinerende læge bekræfter, at patienten samtykker i at deltage i registret.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the medicinal product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, som er beskrevet i modul 1.8.1 af ansøgningen om markedsføringstilladelse, er på plads og fungerer før og under markedsføringen af lægemidlet.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Danish: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1 000 til <1/100); sjælden (≥1/10 000 til <1/1 000); meget sjælden (<1/10 000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: ▼ This medicinal product is subject to additional monitoring.
Danish: Dette lægemiddel er underlagt supplerende overvågning.
English: Correction of bleeding parameters should be instituted prior to Glybera administration.
Danish: Korrektion af blødningsparametre bør initieres inden administration af Glybera.
English: The lowest number of copies was found in the brain, lung, heart and non-injected groups of muscle.
Danish: Det laveste antal kopier blev fundet i hjerne, lunge, hjerte og ikke-injicerede muskelgrupper.
English: Treated patients should not donate blood, organs, tissues and cells for transplantation.
Danish: Behandlede patienter må ikke donere blod, organer, væv eller celler til transplantation.
English: After thawing, each vial should be gently inverted twice to ensure even mixing.
Danish: Efter optøning skal hvert hætteglas forsigtigt vendes to gange for at sikre ensartet opblanding.
English: Upon treatment four weeks prior to mating, no maternal, foetal and developmental toxicity was seen in mice.
Danish: Efter behandling fire uger inden parring iagttoges ingen maternel, føtal eller udviklingsmæssig toksicitet hos mus.
English: The MAH shall agree the details of a restricted access programme with the National Competent Authorities and must implement such programme nationally prior to launch.
Danish: Indehaveren af markedsføringstilladelsen skal med de kompetente nationale myndigheder aftale de nærmere detaljer for et program vedrørende begrænset adgang og skal gennemføre et sådant program nationalt inden markedsføring.
English: Injury, poisoning, and procedural complications
Danish: Traumer, forgiftninger og behandlingskomplikationer
English: Pre-clinical studies with doses ten times the recommended dose (1 x 1013 gc/kg) did not lead to any general systemic untoward signs or symptoms.
Danish: I prækliniske studier medførte doser på 10 gange den anbefalede dosis (1 × 1013 gc/kg) ikke uønskede almene systemiske tegn eller symptomer.
English: Immunosuppressant co-treatment did not influence the biodistribution pattern neither at low dose nor at high dose in mice.
Danish: Samtidig immunosuppressiv behandling påvirkede ikke biodistributionsmønstret hos mus, hverken ved lav eller høj dosis.
English: Glybera contains alipogene tiparvovec, a gene therapy product that works by delivering a gene into the body to correct a genetic deficiency.
Danish: Glybera indeholder alipogentiparvovec, et genterapiprodukt, der virker ved at afgive et gen til kroppen for at rette en genetisk fejl.
English: Effects on male and female fertility have not been evaluated in animal studies.
Danish: Effekten på fertiliteten af hanner og hunner er ikke undersøgt i dyreforsøg.
English: Additional monitoring tests
Danish: Supplerende overvågning
English: Instructions for preparation and handling and disposal Refer to local biosafety guidelines applicable for handling and disposal of medicinal products containing genetically-modified organisms.
Danish: Anvisninger vedrørende klargøring, håndtering og bortskaffelse Følg de gældende lokale retningslinjer for biosikkerhed ved håndtering og bortskaffelse af lægemidler, der indeholder genmodificerede organismer.
English: Study CT-AMT-011-03 was a combined retrospective and prospective study of subjects who had taken part in studies CT-AMT-10-01, CT-AMT-11-01, CT-AMT-11-02.
Danish: Studie CT-AMT-011-03 var et kombineret retrospektivt og prospektivt studie med patienter, der havde deltaget i studierne CT-AMT-10-01, CT-AMT-11-01, CT-AMT-11-02.
English: Glybera contains sodium and potassium.
Danish: Glybera indeholder natrium og kalium.
English: 2) Educational material for physicians and other healthcare professionals involved in the treatment of patients with Glybera including the following key safety elements:
Danish: 2) Informationsmateriale til læger og andre sundhedspersoner, der er inddraget i behandlingen af patienterne med Glybera, herunder følgende vigtige elementer vedrørende sikkerhed:
English: This information is also provided in the Glybera Patient's Alert Card.
Danish: Denne oplysning findes ligeledes på patientkortet for Glybera.
English: The elements of the vector were chosen such that expression of the LPL S447X gene is promoted, by co-opting the expression machinery of the cell and the myocytes produce the protein product of the transgene LPL S447X without the vector being able to reproduce itself.
Danish: Vektorens elementer er valgt således, at ekspressionen af genet LPL S447X fremmes ved overtagelse af cellens ekspressionsmekanismer, hvorved myocytterne producerer proteinproduktet af transgenet LPL S447X, uden at vektoren selv er i stand til at reproducere sig.
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: • Oral contraceptive use (see section 4.6).
Danish: • Brug af oral antikonception (se pkt.
English: The assay to be used in the study needs to be agreed.
Danish: Den analysemetode, der anvendes i studiet skal være godkendt.
English: • Information on the treatment procedure with Glybera
Danish: • Information om fremgangsmåden ved behandling med Glybera
English: Recipients of Glybera may display a rise in serum creatine kinase activity that becomes evident about 2 weeks after administration, peaks at around 8 weeks and then returns to baseline by week 26.
Danish: Patienter, der får Glybera, kan udvise en stigning i serumkreatinkinase-aktivitet, som viser sig ca. 2 uger efter administration, topper efter omkring 8 uger for så at vende tilbage til baseline ved uge 26.
English: To avoid any injection of particles from the stopper due to two withdrawals, one needle for the withdrawal from the vial (to be left inside the stopper) and a separate needle for each syringe must be used.
Danish: For at undgå indsprøjtning af partikler fra proppen, når der trækkes op to gange, skal der anvendes én nål til optrækning fra hætteglasset (denne nål lader man blive siddende i proppen) og en separat nål til hver sprøjte.
English: • Advice on the need to continue on a low-fat diet and avoid drinking alcohol
Danish: • rådgivning om nødvendigheden af at fortsætte på en fedtfattig diæt og undgå alkoholindtagelse
English: It belongs to a group of medicines called lipid modifying agents.
Danish: Det tilhører en gruppe lægemidler, som kaldes lipidmodificerende midler.
English: Vials should be visually inspected for particulate matter and colour.
Danish: Hætteglassene undersøges visuelt for partikler og farve.
English: As this medicine is given to you by a doctor, it is unlikely that you will be given too much.
Danish: Da lægemidlet bliver givet af en læge, er det usandsynligt, at du får for meget Glybera.
English: Patients experiencing dizziness are advised to not drive or use machines.
Danish: Det anbefales, at patienter, der føler sig svimle, undlader at føre motorkøretøj eller betjene maskiner.
English: Cell and tissue donation
Danish: Celle- og vævsdonation
English: No interaction studies other than preclinical and clinical studies with mycophenolate mofetil and ciclosporin have been performed.
Danish: Der er ikke udført interaktionsstudier bortset fra prækliniske og kliniske studier med mycopheno latmofetil og ciclosporin.
English: It is important that at the time of first Glybera administration, your body's immune (defence) system is not activated.
Danish: Når du får Glybera, er det vigtigt, at dit immunsystem (forsvarssystem) ikke er blevet aktiveret.
English: No clinical data on the effect of Glybera on fertility are available.
Danish: Der foreligger ingen kliniske data om effekt af Glybera på fertiliteten.
English: Important information about some of the ingredients of Glybera
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Glybera
English: • Guidance on the need to measure immune response at baseline and at 6 and 12 months after treatment
Danish: • Vejledning om nødvendigheden af at bestemme immunrespons ved baseline og 6 og 12 måneder efter behandlingen
English: Pain in extremity Arthritis, Limb discomfort, Muscle spasms, Muscle strain, Musculoskeletal stiffness, Myalgia, Muscle pain, Neck pain, Sensation of heaviness, Acute myositis and chronic myositis
Danish: Artritis, ubehag i lemmerne, muskelspasmer, muskelspænding, muskuloskeletal stivhed, myalgi, muskelsmerter, nakkesmerter, tyngde fornemmelse, akut myositis og kronisk myositis
English: Each preformed transparent sealed plastic casing contains either 2 or 3 individual vials with a liquid absorbing sheet.
Danish: Hver præformet, transparent, forseglet plasticbeholder indeholder enten 2 eller 3 separate hætteglas med et væskeabsorberende ark.
English: • Not to donate organs nor blood nor cells
Danish: • oplysning om ikke at donere organer, blod eller celler
English: Glybera is administered as a one-time series of intramuscular injections in the legs.
Danish: Glybera administreres som en engangsserie af intramuskulære injektioner i benene.
English: All patients were controlled on low fat diets in the 12-week main study period.
Danish: Alle patienter blev holdt på en kontrolleret fedtfattig diæt i de 12 uger selve studiet varede.
English: It is not known whether Glybera is excreted in human milk.
Danish: Det vides ikke, om Glybera udskilles i human mælk.
English: Patients are advised to continue to follow a low-fat diet and refrain from alcohol consumption.
Danish: Patienterne rådes til at fortsætte på en fedtfattig diæt og undgå alkoholindtagelse.
English: T-cell responses against AAV were detected in approximately half of the subjects post therapy only.
Danish: T-celle-respons mod AAV blev konstateret hos ca. halvdelen af deltagerne udelukkende efter behandlingen.
English: Small amounts of blood will be drawn before treatment, 6 months and 12 months after treatment to measure how your body's immune (defence) system is responding to the treatment with Glybera.
Danish: Der vil blive taget små blodprøver før behandlingen og 6 måneder og 12 måneder efter behandlingen for at bestemme, hvordan dit immunforsvar reagerer på behandlingen med Glybera.
English: Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX10.
Danish: Farmakoterapeutisk klassifikation: Lipidmodificerende midler, andre lipidmodificerende midler, ATC-kode: C10AX10.
English: • Increased blood level of the muscle enzyme creatine kinase
Danish: • forhøjet blodniveau af muskelenzymet kreatinkinase
English: In addition to being given Glybera, you will be given other medicines called immunosuppressants (see section 3 ‘How Glybera is used').
Danish: Foruden Glybera vil du også få immundæmpende lægemidler (se afsnit 3 “Sådan skal du bruge Glybera”).
English: Contraception in males and females
Danish: Antikonception til mænd og kvinder
English: Present this card to health care professionals (doctor, nurse) upon consultation or hospitalization!
Danish: Vis kortet til sundhedspersonerne (læge, sundhedspersonalet) ved konsultation eller indlæggelse!
English: Glybera with alcohol
Danish: Brug af Glybera sammen med alkohol
English: Glybera Patient Alert Card
Danish: Glybera Patientkort
English: The patients enrolled in clinical studies (CT-AMT-010-01, CT-AMT 01101, CT-AMT 011-02) should be followed up in the LPLD registry.
Danish: De patienter, der indrulleres i kliniske studier (CT-AMT-010-01, CT-AMT 011-01, CT-AMT 011-02), skal følges op i LPLD-registreret.
English: The clinical efficacy and safety of Glybera has been evaluated in three interventional clinical studies with AAV1-LPLS447X in LPLD subjects.
Danish: Glyberas kliniske virkning og sikkerhed er blevet evalueret i tre interventionelle kliniske studier med AAV1-LPLS447X hos LPLD-patienter.
English: • bruises in the upper and lower leg muscle due to the injections.
Danish: • blå mærker på lår og underben på grund af indsprøjtningerne.
English: • Guidance on the selection of suitable patients for treatment with Glybera including: o the need for genetic testing to be performed prior to the initiation of treatment in order to identify the patients who are eligible for treatment o that patients should not be taking anti-platelet or other anti-coagulation medicinal products at the time of injection o the need to exclude infection before starting immunosuppressant treatment o the need for all patients to be entered into a long term surveillance programme
Danish: • Retningslinjer for valg af patienter til behandling med Glybera, herunder: o nødvendigheden af genetisk testning før iværksættelse af behandlingen med henblik på at identificere de patienter, der er egnede til behandlingen o at patienterne ikke må være i behandling med antitrombocytmidler eller andre antikoagulantia på injektionstidspunktet o at infektion skal være udelukket, før immunosuppressiv behandling påbegyndes o at alle patienter skal indgå i et langsigtet overvågningsprogram
English: These medicines should not be taken for at least one week before the leg injections or one day after you have had the injections.
Danish: Sådan medicin må du ikke tage i mindst én uge inden injektionerne i benene og tidligst én dag efter, at du har fået injektionerne.
English: The vector comprises a protein shell derived from adeno-associated virus serotype 1 (AAV1), the Cytomegalovirus (CMV) promoter, a woodchuck hepatitis virus posttranscriptional regulatory element and AAV2 derived inverted terminal repeats.
Danish: Vektoren består af en proteinskal, der er afledt af adeno-associeret virus serotype 1 (AAV1), cytalomegalovirus (CMV) promoteren, der er et posttranskriptionelt regulerende element fra hepatitisvirus fra skovmurmeldyr, samt AAV2- deriverede ITR (inverted terminal repeats - modsat orienterede gentagelser).
English: Shedding was assessed in the clinical studies by collecting saliva, urine and semen.
Danish: Spredning blev bestemt i kliniske studier ved indsamling af spyt, urin og sæd.
English: • The need to provide the educational material to patients and request their informed consent to be enrolled into the registry prior to treatment o the need and duration of barrier contraception o not to donate organs nor blood nor cells o on the need to continue on a low-fat diet and avoid drinking alcohol o the necessity to carry the patient alert card, that is included in each pack, with them at o that enrolment is mandatory for patients treated with Glybera o that patients treated with Glybera in a clinical trial should be enrolled in the registry at o that, where possible, patients with familial LPLD who are not treated with Glybera o the need to obtain the patient's informed consent prior to treatment o how to enter patients in it - including those not treated with Glybera
Danish: • Nødvendigheden af at rådgive patienten om: o nødvendigheden af og varigheden af barrierekontraception o at de ikke må donere organer, blod og celler o nødvendigheden af at fortsætte på en fedtfattig diæt og undgå alkoholindtagelse o nødvendigheden af, at patienten altid har det patientkort, der er indeholdt i hver pakke, på o at optagelse i registret er obligatorisk for patienter, der behandles med Glybera o at patienter, der er behandlet med Glybera i et klinisk studie, skal optages i registret ved o at også patienter med familiær LPLD, der ikke behandles med Glybera, om muligt bør o nødvendigheden af at indhente patientens informerede samtykke før behandlingen o hvordan patienterne optages i registret - herunder de, der ikke behandles med Glybera
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan and the Efficacy Follow-up Plan as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Indehaveren af markedsføringstilladelsen skal udføre de lægemiddelovervågningsaktiviteter, som er beskrevet i lægemiddelovervågningsplanen og opfølgningsplanen med hensyn til virkning i henhold til risikostyringsplanen i modul 1.8.2 i ansøgningen om markedsføringstilladelse, samt enhver efterfølgende opdatering af RPM, som er godkendt af Udvalget for Lægemidler til Mennesker (CHMP).
English: Local biosafety guidelines applicable for such products should be followed (see section 6.6).
Danish: Følg lokale retningslinjer for biosikkerhed ved brug af sådanne produkter (se pkt.
English: Glybera is injected as a one-time series into the muscle of the lower extremities where it is taken up by myocytes.
Danish: Glybera injiceres som én enkelt serie i muskelvæv i underekstremiteterne, hvor det optages af myocytter.
English: In CT-AMT-01102 faeces was also collected.
Danish: I CT-AMT-011-02 blev der desuden indsamlet fæces.
English: Your doctor will talk to you about the anaesthetic and how it will be given.
Danish: Lægen vil drøfte bedøvelsen med dig og forklare, hvordan bedøvelsen gives.
English: Taking these medicines before receiving or at the same time as receiving Glybera, may cause unnecessary bruising or bleeding from the injection sites.
Danish: Hvis du tager sådanne lægemidler inden eller under behandlingen med Glybera, kan det medføre unødvendige blå mærker eller blødning fra injektionsstederne.
English: The other ingredients are, disodium phosphate, potassium chloride, potassium dihydrogen phosphate, sodium chloride, sucrose, and water for injections.
Danish: Øvrige indholdsstoffer: dinatriumphosphat, kaliumchlorid, kaliumdihydrogenphosphat, natriumchlorid, sakkarose og vand til injektionsvæsker.
English: See also section 3, ‘How Glybera is used'.
Danish: Se også afsnit 3 ”Sådan får du Glybera”.
English: Lipoprotein lipase is a key ‘first step' enzyme in the metabolism of lipoproteins following fat intake with diet.
Danish: Lipoproteinlipase er et vigtigt “første-trins” enzym i metaboliseringen af lipoproteiner efter fedtindtagelse med kosten.
English: Muscle biopsies obtained up to 52 weeks after administration of Glybera show an infiltrate of lymphocytes and macrophages.
Danish: Muskelbiopiser, der blev taget op til 52 uger efter administration af Glybera, viser infiltration af lymfocytter og makrofager.
English: Alipogene tiparvovec contains the human lipoprotein lipase (LPL) gene variant LPLS447X in a vector.
Danish: Alipogentiparvovec indeholder den humane lipoproteinlipase (LPL)-genvariant LPLS447X i en vektor.
English: Glybera is not recommended for use in children and adolescents under 18 years of age.
Danish: Det anbefales ikke at bruge Glybera til børn og unge under 18 år.
English: The holder should not donate blood, organs or tissues and should use barrier contraception at least 12 months after Glybera treatment.
Danish: Indehaveren af kortet må ikke donere blod, organer eller væv og skal anvende barrierekontraception mindst 12 måneder efter behandlingen med Glybera.
English: The patients in CT-AMT-010-01 have been followed for up to 5 years (n=6) post therapy administration, those in CT-AMT-011-01 for up to 5 years (n=13), and those in CT-AMT-011-02 for up to 1 year (n=3).
Danish: Patienterne i CT-AMT-010-01 er blevet fulgt i op til 5 år (n=6) efter behandlingen, patienterne i CT-AMT-011-01 i op til 5 år (n=13), og patienterne i CT-AMT-011-02 i op til ét år (n=3).
English: After administration of Glybera to the participants, the highest vector DNA concentrations were detected in the serum, with clearance by one to two logs per week.
Danish: Efter administration af Glybera blev de højeste koncentrationer af vektor-DNA fundet i serum med en clearance på 1 til 2 log pr. uge.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet i rækkefølge efter aftagende sværhedsgrad.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu .
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: No T-cell response to LPL was detected in any subject.
Danish: Der blev ikke påvist T-celle-respons på LPL hos nogen af deltagerne.
English: In half of the subjects a T-cell response to the vector was seen.
Danish: Hos halvdelen af patienterne iagttoges en T-celle-respons på vektoren.
English: Glybera contains the human LPL gene variant LPL S447X in an adeno-associated virus serotype 1 (AAV1) vector intended to target the muscle.
Danish: Glybera indeholder den humane LPL-genvariant LPL S447X i en adeno-associeret virus serotype 1vektor (AAV1), specifikt målrettet mod muskelvæv.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: The active substance is alipogene tiparvovec.
Danish: Aktivt stof: alipogentiparvovec
English: • Use appropriate barrier contraception such as condoms to avoid becoming pregnant during treatment and for at least 12 months after treatment.
Danish: • Brug prævention med barrieremetoden såsom kondom under behandlingen og mindst 12 måneder efter behandlingen.
English: Eight days after administration, high levels of vector DNA sequence were detected in injected muscle and the draining lymph nodes.
Danish: Otte dage efter administrationen påvistes høje niveauer af vektor-DNA-sekvens i det injicerede muskelvæv og i de drænende lymfeknuder.
English: Assessment of each individual subject's risk profile prior to Glybera administration is advised.
Danish: Det tilrådes derfor at evaluere risikoprofilen for den enkelte patient inden administration af Glybera.