FrancophonIA/ELRC3.0 huggingface dataset:
English: Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 LPLS447X gc/kg bodyweight.
Danish: Hver patientspecifik pakke indeholder det nødvendige antal hætteglas til at dosere patienten med 1 × 1012 LPLS447X gc/kg legemsvægt.
English: After treatment with Glybera do not donate blood, organs, tissues and cells for transplantation to avoid spreading cells that contain your medicine.
Danish: Efter behandlingen med Glybera må du ikke donere blod, organer, væv eller celler til transplantation.
English: Anti-platelet or other anti-coagulant medicinal products must not be taken for at least one week before the leg injections or one day after the injection (see section 4.3).
Danish: Patienten må ikke få antitrombocyt- eller anden antikoagulansbehandling i mindst én uge inden injektionerne i benene eller én dag efter injektionerne (se pkt.
English: Re-evaluation of immune responses from all patients enrolled in study CT-AMT-011-01 by using a validated assay method should also be provided.
Danish: For alle patienter, der indrulleres i studie CT-AMT-011-01, skal der desuden forelægges en revurdering af immunresponsen med en godkendt analysemetode.
English: 3) Educational materials for patients treated with Glybera including the following key safety elements:
Danish: 3) Informationsmateriale til patienter, der behandles med Glybera, som indeholder følgende vigtige
English: The treatment should be monitored by measuring neutralising antibodies and T-Cell response against AAV1 and LPLS447X and T-Cell response 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 samt T-cellerespons ved baseline og 6 og 12 måneder efter behandlingen.
English: Elderly There is limited experience in the use of Glybera in elderly subjects.
Danish: Ældre Der er begrænset erfaring med brugen af Glybera hos ældre.
English: In addition methylprednisolone might be administered half an hour prior to the Glybera administration.
Danish: Desuden vil du muligvis få methylprednisolon en halv time før du får Glybera.
English: Disodium phosphate
Danish: Dinatriumphosphat
English: Hair growth abnormal, Palmar-plantar erythrodysaesthesia syndrome, Rash
Danish: Abnorm hårvækst, palmoplantar erytrodysæstesi, udslæt
English: Once thawed, the medicinal product must be used immediately; if not used immediately, the vials should be stored in a refrigerator at 2ºC to 8ºC, and protected from light for a maximum of 8 hours.
Danish: Når produktet er optøet, skal det anvendes omgående; hvis det ikke anvendes omgående, må hætteglassene opbevares højst 8 timer i køleskab ved 2 ºC til 8 ºC og beskyttet mod lys.
English: Examples of typical dose schedules based on the body weight of patients are shown in the table below:
Danish: Nedenstående tabel indeholder eksempler på typiske dosisskemaer baseret på patientens legemsvægt:
English: Male patients, including vasectomised males, are advised to practise barrier contraception methods for at least 12 months following Glybera administration.
Danish: Mandlige patienter skal, også hvis de er vasektomeret, tilrådes at anvende barrierekontraception i mindst 12 måneder efter administration af Glybera.
English: Very limited data on pregnancies exposed to Glybera is available.
Danish: Der foreligger kun meget begrænsede data om eksponering for Glybera under graviditet.
English: Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 gc/kg body weight.
Danish: Hver personlig pakke til en patient indeholder et tilstrækkeligt antal hætteglas til, at patienten får 1 × 1012 gc/kg legemsvægt.
English: Symptomatic and supportive treatment, as deemed necessary by the treating physician, is advised in case of overdose.
Danish: Ved overdosering tilrådes symptomatisk og støttende behandling efter den behandlende læges skøn.
English: Glybera will be given to you in a single therapy administration session in a hospital.
Danish: Du vil få Glybera som én enkelt behandling på et hospital.
English: Glybera should only be used when the diagnosis of LPLD has been confirmed by an adequate genetic test (see section 5.1).
Danish: Glybera bør kun anvendes, når diagnosen LPLD er verificeret ved fyldestgørende genetisk testning (se pkt.
English: The opportunity to treat diabetic patients suffering from LPLD should be carefully considered by the physician.
Danish: Lægen bør nøje overveje muligheden for at behandle diabetespatienter, der har LPLD.
English: Glybera should under no circumstances be administered intravascularly.
Danish: Glybera må under ingen omstændigheder gives intravaskulært.
English: In the event two doses are administered by mistake to the identical injection site this might lead to more local reaction such as bruising or sensitivity.
Danish: Utilsigtet administration af to doser på samme injektionssted kan forstærke de lokale reaktioner såsom blå mærker eller følsomhed.
English: - You should present this card to your health care professionals (doctor, nurse) upon consultation or hospitalisation.
Danish: - Vis kortet til sundhedspersonerne (læge, sundhedspersonalet) ved konsultation eller
English: If you receive more Glybera than you should
Danish: Hvis du har fået for meget Glybera
English: Glybera is authorised for single treatment only.
Danish: Glybera er kun godkendt til én enkelt behandling.
English: Pack size 2 vials
Danish: Pakke med 2 hætteglas.
English: Standard genetic analysis (sequencing) was used in the clinical studies of Glybera.
Danish: I de kliniske studier med Glybera anvendtes standard genetisk sekvensanalyse.
English: The expiry date refers to the last day of that month.
Danish: Glybera må ikke anvendes efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: - if your immune system does not work properly - if you have an increased bleeding risk and or muscle disease
Danish: - hvis du er allergisk over for alipogentiparvovec eller et af de øvrige indholdsstoffer (angivet i angivet i afsnit 6 “Yderligere oplysninger”) - hvis dit immunsystem ikke virker som det skal - hvis du har øget blødningsrisiko og/eller en muskelsygdom - hvis du tager p-piller
English: Glybera should under no circumstances be administered intravascularly (see section 4.4).
Danish: Glybera må under ingen omstændigheder gives intravaskulært (se pkt.
English: Glybera is used to treat adult patients diagnosed with lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions.
Danish: Glybera anvendes til behandling af voksne patienter, der har fået konstateret arvelig lipoproteinlipasemangel, (LPLD) og som lider af svære eller gentagne anfald af betændelse i bugspytkirtlen trods fedtfattig diæt.
English: Upon injection, Glybera was well tolerated in all animal studies performed with no notable clinical signs.
Danish: Glybera var efter injektion veltolereret i alle dyreforsøg.
English: Store frozen at -25°C to -15°C.
Danish: Opbevares nedfrosset ved -25 °C til -15 °C.
English: Upon intramuscular injection, the patient will receive multiple injections of 0.5 ml (one injection per syringe), distributed over the muscles of both upper and lower legs, under aseptic conditions such as iodine.
Danish: Under aseptiske forhold (desinficering med f.eks. jod) gives en række injektioner på 0,5 ml intramuskulært (én injektion pr. sprøjte), fordelt på musklerne i over- og underben.
English: In clinical trials with Glybera, antibodies against the adeno-associated virus (AAV) protein shell were present prior to treatment, in 18 out of 27 subjects; anti-AAV antibodies appeared or increased after Glybera administration, in all of the subjects.
Danish: I de kliniske forsøg med Glybera var der inden behandlingen antistoffer mod adeno-associeret virus (AAV) proteinskal hos 18 ud af 27 forsøgspersoner.
English: Pack size 3 vials
Danish: Pakke med 3 hætteglas
English: The amount of sodium and potassium that you may receive depends on the number of injections that you need; your doctor will work this out depending on your weight.
Danish: Hvor stor en mængde natrium og kalium du får, afhænger af, hvor mange injektioner, du skal have.
English: • injection site discomfort, swelling, rash and pain
Danish: • ubehag på injektionsstedet, hævelse, udslæt og smerter
English: Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Danish: Meibergdreef 61, 1105 BA Amsterdam, Nederlandene
English: • Hypersensitivity to the active substance or any of the excipients of Glybera listed in section
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i
English: In addition, half an hour prior to Glybera injection an intravenous bolus of 1mg/kg of methylprednisolone should be administered.
Danish: Derudover kan der en halv time inden Glybera-injektionerne gives 1 mg/kg methylprednisolon som en intravenøs bolus.
English: Glybera is used to treat a specific inherited condition known as “lipoprotein lipase deficiency (LPLD)”.
Danish: Glybera anvendes til behandling af den arvelige sygdom lipoproteinlipase-mangel (LPLD).
English: Due to the large number of individual injections that you will receive during the Glybera therapy session, you will be given either a regional anaesthetic into the spine (which will numb your legs only), or a more localised anaesthetic before you are given the Glybera injections.
Danish: Derfor vil du enten få en rygmarvsbedøvelse (så kun benene bliver bedøvet) eller lokalbedøvelse, før du får indsprøjtningerne med Glybera.
English: A demonstrable improvement of postprandial CM metabolism was shown in 5/5 patients up to week 14 and in 3/3 patients who were followed up to 52 weeks.
Danish: Hos 5/5 patienter påvistes tydelig forbedring i den postprandiale kylomikronmetabolisme frem til uge 14.
English: Clinical pharmacokinetics and shedding
Danish: Klinisk farmakokinetik og spredning
English: Spinal anaesthesia and multiple intramuscular injections may further increase the risk of (thrombo) embolic events at and shortly after administration of Glybera.
Danish: Risikoen for (trombo)emboliske hændelser under og kort tid efter administration af Glybera kan yderligere øges ved spinalanæstesi og multiple intramuskulære injektioner.
English: Abdominal pain.Nausea, Constipation
Danish: Abdominalsmerter, kvalme, obstipation
English: From the triglyceride data the 1 x 1012 gc/kg dose appears the most optimal.
Danish: Baseret på triglyceriddata er den mest optimale dosis 1 × 1012 gc/kg.
English: There is limited experience in the use of Glybera in elderly subjects.
Danish: Der er begrænset erfaring med brugen af Glybera hos ældre.
English: Immunosuppressants (see section 5.2) Immediately prior to initiation of the immunosuppressant regimen and prior to Glybera injection the patient must be checked for symptoms of active infectious disease of any nature, and in case of such infection the start of treatment must be postponed until after the patient has recovered.
Danish: Umiddelbart inden påbegyndelsen af det immunosuppressive regime og inden Glybera-injektionerne skal patienten undersøges for symptomer på enhver form for aktiv infektionssygdom.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet:
English: Obligation to conduct post-authorisation measure
Danish: Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: The product contains less than 1 mmol (39 mg) potassium per administration of 27-60 injection sites ; i.e. essentially potassium-free.
Danish: Produktet er praktisk talt kaliumfrit (mindre end 1 mmol (39 mg) pr. administration ved 27-60 injektionssteder).
English: Marketing Authorisation Holder uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Danish: Indehaver af markedsføringstilladelsen uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, Nederlandene.
English: In mice local cellular infiltrates and signs of degeneration and regeneration without necrosis, were seen at the clinical dose in the injected muscle upon histopathological examination.
Danish: Ved histopatologisk undersøgelse af den injicerede muskel hos mus medførte den kliniske dosis lokale cellulære infiltrater og tegn på degeneration og regeneration uden nekrose.
English: Oral contraceptive use is contraindicated in LPLD patients (see section 4.3) as this may exacerbate the underlying disease.
Danish: 4.3), da det kan forværre den underliggende sygdom.
English: Carcinogenicity studies have not been conducted.
Danish: Glyberas karcinogene potentiale er ikke undersøgt.
English: In addition, half an hour prior to Glybera injection an intravenous bolus of 1mg/kg of methylprednisolone should be administered (see section 4.4).
Danish: Derudover kan der en halv time inden Glybera-injektionerne gives 1 mg/kg methylprednisolon som en intravenøs bolus (se pkt.
English: Serum creatine kinase
Danish: Serumkreatinkinase
English: To ensure intramuscular injection, ultrasound or electrophysiological guidance of injections is advised.
Danish: Med henblik på at sikre intramuskulær injektion anbefales at udføre injektioner ved hjælp af ultralyd eller under elektrofysiologisk vejledning.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (forekommer hos indtil 1 ud af 10 behandlede): • mavesmerter
English: Dizziness was commonly observed after Glybera administration.
Danish: Svimmelhed er ofte iagttaget efter administration af Glybera (se pkt.
English: In particular, tell your doctor if you are taking the following before you are given Glybera:
Danish: Inden du får Glybera, skal du navnlig fortælle det til lægen, hvis du tager følgende medicin:
English: Each vial of alipogene tiparvovec contains 1 ml of solution, containing 3 x 1012 genome copies (gc).
Danish: Hvert hætteglas med alipogentiparvovec indeholder 1 ml opløsning, der indeholder 3 × 1012 genomkopier (gc).
English: The patient's weight should be divided by 3, then without rounding up this number multiplied by 2 and rounded up to the next higher whole number.
Danish: Resultatet uden afrunding ganges med 2, hvorefter der rundes op til nærmeste højere hele tal.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Hætteglasset opbevares i yderpakningen for at beskytte mod lys.
English: After the amount of Glybera to be administered has been calculated (see section 4.2) remove the correct number of single use vials from the freezer to thaw at room temperature (15oC to 25oC), approximately 30-45 minutes in advance of syringe filling.
Danish: 4.2) udtages det korrekte antal engangshætteglas af fryseren, hvorefter de tøs op ved stuetemperatur (15 °C til 25 °C) i cirka 30-45 minutter inden fyldning af sprøjterne.
English: Manufacturer uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Danish: Fremstiller uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, Nederlandene.
English: A transient reduction of triglycerides for up to 12 weeks in some individual patients has been observed.
Danish: Hos nogle patienter iagttoges et forbigående fald i triglycerider i op til 12 uger.
English: Each vial of alipogene tiparvovec contains 1 extractable ml of solution, containing 3 x 1012 genome copies (gc).
Danish: Hvert hætteglas med alipogentiparvovec indeholder 1 ml ekstraherbar opløsning, der indeholder 3 × 1012 genomkopier (gc).
English: To calculate the number of injection sites and the number of syringes, the patient's weight is determined to the nearest whole kg.
Danish: Antallet af injektionssteder og antallet af sprøjter beregnes ved at fastsætte patientens vægt til nærmeste hele antal kg. Patientens vægt divideres med 3.
English: MedDRA System Organ Class Metabolism and nutrition disorders
Danish: Systemorganklasse i henhold til MedDRA
English: There is very limited information about the safety of Glybera in pregnant women.
Danish: Der er utilstrækkelige data om anvendelse af Glybera til gravide kvinder.
English: Sucrose
Danish: Sakkarose
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER
English: Glybera is delivered in a patient-specific pack and will therefore contain the precise amount of vials per patient, calculated according to the patient's weight.
Danish: Hvert hætteglas indeholder derfor den nøjagtige mængde til patienten, beregnet i henhold til dennes vægt.
English: A single intravenous bolus of methylprednisolone (1 mg/kg bodyweight) was given 30 minutes prior to alipogene tiparvovec administration.
Danish: Der blev givet methylprednisolon som en enkelt intravenøs bolus (1 mg/kg legemsvægt) 30 minutter inden administration af alipogentiparvovec.Én patient blev diagnosticeret med lungeemboli 7 uger efter behandlingen.
English: No data on re-administration of Glybera are available, therefore Glybera should not be re-administered.
Danish: Der foreligger ingen data om gentagen administration af Glybera.
English: Keep the vial in the outer carton in order protect from light.
Danish: Opbevar hætteglasset i den ydre karton Hætteglasset opbevares i yderpakningen for at beskytte mod lys.
English: Intramuscular use
Danish: Til intramuskulær anvendelse
English: Glybera 3 × 1012 genome copies/ml solution for injection Alipogene tiparvovec
Danish: Glybera, injektionsvæske, 3 × 1012 genomkopier/ml Alipogentiparvovec
English: Patient-specific pack containing sufficient amount of vials to dose each patient Liquid absorbing sheet is also contained.
Danish: Patientspecifik pakke indeholdende et tilstrækkeligt antal hætteglas til hver patient.
English: MARKETING AUTHORISATION HOLDER
Danish: MARKEDSFØRINGSTILLADELSEN
English: It contains genetically modified organisms.
Danish: Det indeholder genetisk modificerede organismer.
English: • difficulty breathing, chest pain on breathing in and palpitations which may be caused by blockage of the main blood vessel of the lung
Danish: • muskelsmerter og ledsmerter, smerter og stivhed • åndenød, brystsmerter i forbindelse med indånding samt hjertebanken som følge af blodprop i
English: Injection site discomfort, Injection site oedema, Injection site pruritus
Danish: Kontusion Ubehag på injektionsstedet, ødem på injektionsstedet, kløe på injektionsstedet
English: This medicine contains potassium, less than 1 mmol (39 mg) per administration at 27 injection sites to 60 injection sites, i.e. essentially ‘potassium-free'.
Danish: Dette lægemiddel indeholder kalium, men i en mængde af mindre end 1 mmol (39 mg) pr. behandling ved 27 til 60 injektionssteder.
English: Furthermore, Glybera allows expression of the LPL protein in injected muscle which is reflected by the improvement of postprandial chylomicron (CM) metabolism observed in a small subset of patients.
Danish: Glybera tillader desuden ekspression af LPL-proteinet i det injicerede muskelvæv.
English: Product manufacturer and license holder: uniQure biopharma B.V.
Danish: Indehaver af markedsføringstilladelsen og fremstiller af lægemidlet: uniQure biopharma B.V.
English: They only last a short time.
Danish: De går hurtigt over
English: Vials must be stored and transported frozen at -25ºC to -15ºC.
Danish: Hætteglassene skal opbevares og transporteres nedfrosset ved en temperatur mellem -25 ºC og -15 ºC.
English: Assessment of postprandial chylomicron metabolism in at least 12 patients before 12 months and 24 months after treatment with Glybera to be chosen in addition to the patients included in study CT-AMT.011.02; and eight healthy subjects in the second study.
Danish: Vurdering af postprandial kylomikronmetabolisme skal foretages tidligere end efter 12 måneders og 24 måneders behandling med Glybera hos mindst 12 patienter.
English: After you have been given Glybera, you may notice that your legs have a yellow colour; this might occur in case iodine was used to clean (sterilise) your legs before you received the medicine.
Danish: Det kan skyldes, at der er anvendt jod til at rense (sterilisere) huden før indsprøjtning af lægemidlet.
English: The educational pack for healthcare professionals must be agreed with the National Competent Authorities prior to distribution and consist of the following components:
Danish: Informationspakken til sundhedspersoner skal aftales med de nationale kompetente myndigheder, før den udsendes, og skal bestå af følgende komponenter: - produktinformation (produktresumé, indlægsseddel og patientkort) - informationsmateriale til sundhedspersoner
English: Re-administration of Glybera after this first treatment session is not recommended.
Danish: Efter denne første behandling må behandlingen med Glybera ikke gentages.
English: Clinical trial CT-AMT-11-05
Danish: Klinisk studie CT-AMT-11-05
English: Name and address of the manufacturer(s) responsible for batch release uniQure biopharma B.V. Meibergdreef 61
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse uniQure biopharma B.V.
English: To calculate the number of vials, the patient's weight is determined to the nearest whole kg.
Danish: Til beregning af antallet af hætteglas bestemmes patientens vægt til nærmeste hele antal kg. Patientens vægt divideres med 3, og resultatet rundes op til nærmeste hele tal.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Spørg lægen eller på apoteket, hvis der er mere, du vil vide om brugen af lægemidlet.
English: • pain in leg(s) (pain in extremity)
Danish: • P-piller (se pkt.
English: Clinical trial CT-AMT-11-03
Danish: Klinisk studie CT-AMT-11-03
English: No neutralising assay was used.
Danish: Der blev ikke foretaget bestemmelse af neutraliserende antistoffer.
English: Sodium content and potassium content
Danish: Indhold af natrium og kalium
English: Side effects from your immunosuppressants
Danish: Bivirkninger fra immundæmpende lægemidler
English: Clinical trial CT-AMT-011-01
Danish: Klinisk studie CT-AMT-011-01
English: including the need for injections to be administered under ultrasound or electrophysiological guidance
Danish: For at sikre intramuskulær injektion anbefales det, at injektionerne udføres ved hjælp af ultralyd eller under elektrofysiologisk vejledning.
English: Glybera should not be administered to women who are breast-feeding as long as breastfeeding is ongoing.
Danish: Glybera må ikke administreres til ammende kvinder på noget tidspunkt i ammeperioden.
English: uniQure biopharma B.V. Meibergdreef 61
Danish: uniQure biopharma B.V.
English: • A medicine impacting blood coagulation e.g. acetylsalicylic acid (e.g.aspirin), a substance present in many medicines used to relieve pain and lower fever, as well as medicines used to prevent blood clotting eg anticoagulants such as warfarin, heparin.
Danish: • Medicin, der påvirker blodets størkning, f.eks. acetylsalicylsyre, som findes i mange smertestillende og feberstillende midler.
English: • Guidance on the prevention of risks associated with Glybera intramuscular injections,
Danish: • Vejledning om forebyggelse af risici ved intramuskulær injektion af Glybera, herunder nødvendigheden af at udføre injektioner ved hjælp af ultralyd eller under elektrofysiologisk vejledning
English: Breast-feeding
Danish: Alipogentiparvovec
English: Chiesi Pharmaceuticals B.V. Tel: +31 0 70 413 20 80
Danish: Tel: +31 0 70 413 20 80
English: This product contains genetically modified organisms.
Danish: Dette produkt indeholder genetisk modificerede organismer.
English: Pharmacokinetics in special populations e.g. elderly/renal impairment etc. Glybera is injected directly into the target organ, skeletal muscle.
Danish: Glybera injiceres direkte ind i målorganet, skeletmuskelvæv.
English: SPECIAL STORAGE CONDITIONS Store and transport vial frozen at -25°C to -15°C.
Danish: Hætteglasset opbevares og transporteres nedfrosset ved -25 °C til 15 °C.