FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Priporočljivo je, da ljudje z diagnozo pomanjkanja lipoproteinske lipaze skrbno upoštevajo dieto pred zdravljenjem z zdravilom Glybera in po njem ter se izogibajo alkoholu.
English: Glybera is used to treat a specific inherited condition known as “lipoprotein lipase deficiency (LPLD)”.
Slovenian: Zdravilo Glybera se uporablja za zdravljenje dedne bolezni, imenovane „pomanjkanje lipoproteinske lipaze (LPLD)“.
English: Glybera should only be used when the diagnosis of LPLD has been confirmed by an adequate genetic test (see section 5.1).
Slovenian: 4.2 Odmerjanje in način uporabe Zdravilo Glybera se sme uporabljati samo, če se je diagnoza LPLD potrdila z ustreznimi genskimi preiskavami (glejte poglavje 5.1).
English: After time, residual vector DNA levels remained high in the injected muscle and inguinal lymph nodes while decreasing steadily in the other organs.
Slovenian: Rezidiualne ravni DNK vektorja so ostale visoke v injicirani mišici in dimeljskih bezgavkah, medtem ko so se v drugih organih enakomerno zniževale.
English: Very limited data on pregnancies exposed to Glybera is available.
Slovenian: Podatki o nosečnicah, izpostavljenih zdravilu Glybera, so zelo omejeni.
English: Glybera Patient Alert Card
Slovenian: Glybera Kartica z opozorili za bolnika
English: Glybera is authorised for single treatment only.
Slovenian: Zdravilo Glybera je odobreno samo za enkratno zdravljenje.
English: Male patients, including vasectomised males, are advised to practise barrier contraception methods for at least 12 months following Glybera administration.
Slovenian: Pri moških bolnikih, vključno z bolniki, pri katerih je bila opravljena vazektomija, se priporoča uporaba pregradnih kontracepcijskih metod vsaj 12 mesecev po injiciranju zdravila Glybera.
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.
Slovenian: Če se zdravilo ne shranjuje v hladilniku, se lahko največ 8 ur shranjuje v injekcijskih brizgah, zaščitenih pred svetlobo, pri temperaturi do 25 °C.
English: Standard genetic analysis (sequencing) was used in the clinical studies of Glybera.
Slovenian: V kliničnih študijah zdravila Glybera se je uporabila standardna genetska analiza (določanje zaporedja).
English: There is the theoretical risk that the co-administration of the immunosuppressant regime leads to longer persistence of virus DNA in serum and as well to longer shedding in saliva, urine and semen.
Slovenian: Obstaja teoretično tveganje, da sočasna uporaba imunosupresivnega režima povzroči daljšo persistenco DNK
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).
Slovenian: Glybera za vse podskupine pediatrične populacije za zdravljenje pomanjkanja lipoproteinske lipaze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: It is not known whether Glybera is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Glybera izloča v materino mleko.
English: From the triglyceride data the 1 x 1012 gc/kg dose appears the most optimal.
Slovenian: Glede na podatke o trigliceridih se zdi, da je najoptimalnejši odmerek 1 x 1012 gk/kg.
English: • Hypersensitivity to the active substance or any of the excipients of Glybera listed in section
Slovenian: • Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov zdravila Glybera,
English: Immunosuppressant co-treatment did not influence the biodistribution pattern neither at low dose nor at high dose in mice.
Slovenian: Sočasno imunosupresivno zdravljenje v majhnih in velikih odmerkih ni vplivalo na vzorec biološke porazdelitve pri miših.
English: This medicine contains genetically modified organisms.
Slovenian: To zdravilo vsebuje gensko spremenjene organizme.
English: • Information about the signs and symptoms to be monitored after treatment including:
Slovenian: • Informacije o znakih in simptomih, ki jih je treba spremljati po zdravljenju, vključno z: o informacijami o znakih in simptomih zmanjšanja/izgube učinkovitosti;
English: VIAL LABEL
Slovenian: OVOJNINAH OZNAKA NA VIALI
English: • Advice on the need to continue on a low-fat diet and avoid drinking alcohol
Slovenian: • Svetovanje o potrebi po nadaljevanju diete z majhnim vnosom maščob in potrebi po
English: Spinal or regional anaesthesia is advised prior to intramuscular administration, due to the number of injections required.
Slovenian: Pred intramuskularnim injiciranjem se zaradi velikega števila injiciranj priporoča spinalna ali regionalna anestezija.
English: Eight days after administration, high levels of vector DNA sequence were detected in injected muscle and the draining lymph nodes.
Slovenian: Osem dni po injiciranju so v injiciranih mišicah in mezgovnih bezgavkah ugotovili visoke ravni zaporedja DNK vektorja.
English: Symptomatic and supportive treatment, as deemed necessary by the treating physician, is advised in case of overdose.
Slovenian: Ob prevelikem odmerjanju je priporočeno simptomatsko in podporno zdravljenje, ki ga določi lečeči zdravnik.
English: Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 LPLS447X gc/kg bodyweight.
Slovenian: Vsako za bolnika specifično pakiranje vsebuje zadostno količino vial za odmerjanje 1 x 1012 LPLS447X
English: There is very limited information about the safety of Glybera in pregnant women.
Slovenian: Podatki o varnosti zdravila Glybera pri nosečnicah so zelo omejeni.
English: Patient Alert Card
Slovenian: Kartica z opozorili za bolnika
English: The clear to slightly opalescent and colourless solution must be free of visible particles.
Slovenian: Bistra do rahlo opalescentna in brezbarvna raztopina ne sme vsebovati vidnih delcev.
English: In addition, half an hour prior to Glybera injection an intravenous bolus of 1mg/kg of methylprednisolone should be administered.
Slovenian: Poleg tega je treba pol ure pred injiciranjem zdravila Glybera uporabiti intravenski bolus z 1 mg/kg metilprednizolona.
English: Clinical pharmacokinetics and shedding
Slovenian: Klinična farmakokinetika in razsejanje
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'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na uporabo na 27 do 60 mestih injiciranja, tj. je skoraj „brez kalija“.
English: • Patients with increased bleeding risk (such as thrombocytopenia) and muscle disease (such as myositis), must not be treated in view of the large number of intramuscular injections
Slovenian: • Bolniki s povečanim tveganjem za krvavitev (kot je trombocitopenija) in mišično boleznijo
English: Correction of bleeding parameters should be instituted prior to Glybera administration.
Slovenian: Pred uporabo zdravila Glybera je treba popraviti parametre krvavitve.
English: Therefore, use of barrier contraception methods for at least 12 months following Glybera administration is recommended.
Slovenian: Uporaba pregradnih kontracepcijskih sredstev se zato priporoča vsaj 12 mesecev po injiciranju zdravila Glybera.
English: Posology The maximum total dose of Glybera for administration is 1 x 1012 gc/kg body weight.
Slovenian: Odmerjanje Največji skupni odmerek zdravila Glybera za administracijo je 1 x 1012 gk/kg telesne mase.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo vzpostavil register bolezni, s katerim bo zbiral podatke o epidemiologiji bolezni in izidih glede demografije, varnosti ter učinkovitosti pri bolnikih z družinskim
English: The patient-specific pack contains a variable number of casings based on the patient's body weight.
Slovenian: Za bolnika specifično pakiranje vsebuje različno število ovojev, ki je odvisno od bolnikove telesne mase.
English: Each vial of alipogene tiparvovec contains 1 ml of solution, containing 3 x 1012 genome copies (gc).
Slovenian: Vsaka viala alipogentiparvoveka vsebuje 1 ml raztopine, ki vsebuje 3 x 1012 genomskih kopij (gk).
English: All patients treated with Glybera shall be enrolled in the registry.
Slovenian: V register se bodo vključili vsi bolniki, ki se bodo zdravili z zdravilom Glybera.
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.
Slovenian: DNK vektorja zaznali v serumu, z očistkom enega do dveh logaritmov na teden.
English: Potassium dihydrogen phosphate Sodium chloride
Slovenian: kalijev klorid kalijev dihidrogenfosfat natrijev klorid dinatrijev fosfat saharoza voda za injekcije
English: Glybera will be given to you in a single therapy administration session in a hospital.
Slovenian: Zdravilo Glybera boste prejeli kot enkratno zdravljenje v bolnišnici.
English: The final outer carton contains a variable number of casings according to the patient specific dose required.
Slovenian: Zunanja škatla vsebuje različno število ovojev, kar je odvisno od odmerka, ki ga potrebuje posamezni bolnik.
English: Product manufacturer and license holder: uniQure biopharma B.V.
Slovenian: Izdelovalec zdravila in imetnik licence: 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.
Slovenian: • Zdravila, ki vplivajo na strjevanje krvi, npr. acetilsalicilna kislina (npr. Aspirin), ki je prisotna v mnogih zdravilih za lajšanje bolečine in zniževanje povišane telesne temperature, ter zdravila, ki se uporabljajo za preprečevanje strjevanja krvi, npr. antikoagulanti, kot sta Teh zdravil ne smete jemati vsaj en teden pred injiciranjem v nogo ali en dan po njem.
English: Vials must be stored and transported frozen at -25ºC to -15ºC.
Slovenian: Viale je treba shranjevati in prevažati zamrznjene pri temperaturi -25 °C do -15 °C.
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.
Slovenian: Tik pred uvedbo imunosupresivnega režima in pred injiciranjem zdravila Glybera je treba preveriti, ali ima bolnik simptome aktivne okužbe kakršnega koli tipa.
English: Glybera is injected as a one-time series into the muscle of the lower extremities where it is taken up by myocytes.
Slovenian: Zdravilo Glybera se injicira kot enkratni niz injiciranj v mišico na spodnjih okončinah, kjer ga privzamejo miociti.
English: Renal impairment or hepatic impairment
Slovenian: Ledvična ali jetrna okvara
English: Breast-feeding is not recommended during treatment with Glybera.
Slovenian: Med zdravljenjem z zdravilom Glybera dojenje ni priporočeno.
English: Diabetic patients
Slovenian: Starejši bolniki
English: No drug-related serious adverse events occurred and no dose-limiting toxicity was observed.
Slovenian: Pojavili se niso nobeni resni neželeni učinki, povezani z zdravilom.
English: Hair growth abnormal, Palmar-plantar erythrodysaesthesia syndrome, Rash
Slovenian: Bolezni kože in podkožja nenormalna rast dlak, sindrom eritrodisestezije dlani in stopal, izpuščaj
English: With the exception of a case of fever (39.9 °C) in study CT-AMT-011-01 which reversed within a day, no Glybera or immunosuppression related serious adverse events occurred.
Slovenian: Pojavili se niso nobeni resni neželeni učinki, povezani z zdravilom Glybera ali imunosupresijo, razen enega primera povišane telesne temperature (39,9 °C) v študiji CT-AMT-011-01, ki je izginila v enem dnevu.
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
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v udu artritis, neugodje v udu, mišični spazmi, napetost mišic, mišično-skeletna togost,
English: Chills, Injection site pain, Oedema peripheral, Pyrexia
Slovenian: periferni edem, pireksija
English: To calculate the number of vials, the patient's weight is determined to the nearest whole kg.
Slovenian: Pri izračunu števila vial se bolnikova telesna masa zaokroži na najbližji kilogram.
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.
Slovenian: mg/kg/dan ciklosporina in 2 g/dan mofetilmikofenolata , kar se je začelo tri dni pred injiciranjem alipogentiparvoveka in trajalo do 12. tedna.
English: - You should present this card to your health care professionals (doctor, nurse) upon consultation or hospitalisation.
Slovenian: - V primeru obiska zdravnika ali hospitalizaciji morate to kartico pokazati zdravstvenemu delavcu(zdravniku, medicinski sestri).
English: No T-cell response to LPL was detected in any subject.
Slovenian: Pri nobenem preskušancu se ni ugotovil odziv limfocitov T proti LPL.
English: • Information on the need for long term follow-up for Glybera, including the registry
Slovenian: • Informacije o potrebi po dolgotrajnem sledenju zdravljenja z zdravilom Glybera, vključno z • Informacije o potrebi po preprečevanju nosečnosti
English: Individual lot number: Date of treatment:
Slovenian: Številka posamezne serije:
English: Manufacturer uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Slovenian: Izdelovalec uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, Nizozemska.
English: • The necessity to carry the patient alert card, that is included in each pack, with them at all
Slovenian: • Nujnost, da ima bolnik vedno pri sebi kartico z opozorili za bolnika, priloženo vsakemu
English: Non-clinical biodistribution
Slovenian: Predklinična biološka porazdelitev
English: There is limited experience in the use of Glybera in elderly subjects.
Slovenian: Izkušnje z uporabo zdravila Glybera pri starejših bolnikih so omejene.
English: • Guidance on the aftercare of the patient including monitoring for fever
Slovenian: • Smernice o negi bolnika po injiciranju, vključno s preverjanjem, ali ima bolnik povišano telesno temperaturo
English: Store frozen at -25°C to -15°C.
Slovenian: Shranjujte zamrznjeno pri temperaturi -25 °C do -15 °C.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Anti-platelet or other anti-coagulant medicinal products must not be used concomitantly with Glybera at the time of injection.
Slovenian: V času injiciranja se zdravilo Glybera ne sme uporabljati sočasno z antiagregacijskimi sredstvi in antikoagulanti.
English: It belongs to a group of medicines called lipid modifying agents.
Slovenian: Spada v skupino zdravil za zmanjšanje ravni serumskih lipidov.
English: A single intravenous bolus of methylprednisolone (1 mg/kg bodyweight) was given 30 minutes prior to alipogene tiparvovec administration.
Slovenian: Bolniki so 30 minut pred injiciranjem alipogentiparvoveka prejeli enkratni intravenski bolus metilprednizolona (1 mg/kg telesne mase).
English: Patient Code number:
Slovenian: Ime zdravnika: Tel. št. zdravnika: Številka bolnika:
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.
Slovenian: Uporabljajte kondome, tako da na/od vašega partnerja preide čim manj zdravila Glybera.
English: Glybera should not be administered to women who are breast-feeding as long as breastfeeding is ongoing.
Slovenian: Zdravilo Glybera se ne sme uporabljati pri doječih materah, dokler dojijo.
English: 3) Educational materials for patients treated with Glybera including the following key safety elements:
Slovenian: 1) Izobraževalno gradivo za farmacevte, vključno z naslednjimi ključnimi varnostnimi elementi:
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.
Slovenian: Če se ne uporabi takoj, se sme viale shranjevati največ 8 ur v hladilniku pri temperaturi od 2 ºC do 8 ºC, pri čemer morajo biti zaščitene pred svetlobo.
English: A transient reduction of triglycerides for up to 12 weeks in some individual patients has been observed.
Slovenian: Pri nekaterih posameznikih so opazili prehodno zmanjšanje trigliceridov v trajanju do 12 tednov.
English: Pack size 3 vials
Slovenian: Velikost pakiranja po 3 viale
English: Patient-specific pack containing sufficient amount of vials to dose each patient Liquid absorbing sheet is also contained.
Slovenian: Za bolnika specifično pakiranje, ki vsebuje zadostno količino vial za odmerjanje pri posameznem bolniku.
English: Marketing Authorisation Holder uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Slovenian: Imetnik dovoljenja za promet z zdravilom uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, Nizozemska.
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
Slovenian: • Smernice o izbiri primernih bolnikov za zdravljenje z zdravilom Glybera, vključno s: o potrebo po genskih preiskavah, ki jih je treba opraviti pred začetkom zdravljenja, da se ugotovijo bolniki, primerni za zdravljenje;
English: Glybera is not usually recommended for use during pregnancy.
Slovenian: Uporaba zdravila Glybera med nosečnostjo ni priporočljiva.
English: For each injection site, one syringe of 1 ml with clear volume marks of 0.5 ml must be used.
Slovenian: Za vsako mesto injiciranja je treba uporabiti eno 1-ml injekcijsko brizgo z jasnimi oznakami za prostornino po 0,5 ml. Prostornina na mesto injiciranja ne sme preseči 0,5 ml. Brizge je dovoljeno uporabiti le enkrat.
English: • Guidance on the need for immunosuppressive administration prior to and after treatment
Slovenian: • Potreba po regionalni ali spinalni anesteziji • Smernice o potrebi po imunosupresivnem režimu pred zdravljenjem in po njem
English: • Advice on the need and duration of barrier contraception
Slovenian: • Svetovanje o potrebi po pregradni kontracepciji in trajanju njene uporabe • Prepoved darovanja organov, krvi in celic
English: Burning sensation, Dizziness, Formication, Presyncope
Slovenian: Bolezni živčevja glavobol pekoč občutek, omotica, mravljinčenje,
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.
Slovenian: 01, CT-AMT 011-02), je treba izvajati sledenje v registru LPLD.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Dyspnoea exertional, Pulmonary embolism
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja ob naporu, pljučna embolija
English: Assessment of each individual subject's risk profile prior to Glybera administration is advised.
Slovenian: Pred uporabo zdravila Glybera je priporočljiva ocena profila tveganja pri posameznem bolniku.
English: Number of vials (1 mL) Number of 1ml syringes (each filled with 0.5ml)
Slovenian: Primeri tipičnih razporedov odmerjanja na podlagi telesne mase bolnikov so prikazani v spodnji razpredelnici: Telesna masa (kg) Število vial (1 ml) Število 1-ml injekcijskih brizg (vsaka je napolnjena z 0,5 ml)
English: Glybera should under no circumstances be administered intravascularly.
Slovenian: Zdravilo Glybera se ne sme nikoli injicirati intravaskularno.
English: Very common (may affects more than 1 in 10 people)
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) • bolečina v nogi (nogah) (bolečina v okončini)
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.
Slovenian: Da se temu izognete, bo zdravnik predpisal zdravljenje, ki bo zavrlo imunski sistem (imenovano imunosupresivno zdravljenje).
English: The active substance is alipogene tiparvovec.
Slovenian: Zdravilna učinkovina je alipogentiparvovek.
English: Glybera 3 × 1012 genome copies/ml solution for injection
Slovenian: Glybera 3 × 1012 genomskih kopij/ml raztopina za injiciranje
English: o information on the signs and symptoms of a reduction/loss of efficacy o the use of the events diary and what should be recorded
Slovenian: o uporabo dnevnika za dogodke in kaj je treba beležiti vanj.
English: In particular, tell your doctor if you are taking the following before you are given Glybera:
Slovenian: Preden prejmete zdravilo Glybera, zdravnika obvestite predvsem, če jemljete kar koli od naslednjega:
English: Except for the site of injection, the highest vector DNA copy numbers were found in the liver and blood.
Slovenian: Z izjemo mesta injiciranja so največje število kopij DNK
English: How to store Glybera
Slovenian: Shranjevanje zdravila Glybera
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
Slovenian: o o da je vključitev obvezna za bolnike, ki se zdravijo z zdravilom Glybera; o da se morajo bolniki, ki se bodo zdravili z zdravilom Glybera v kliničnem preskušanju, na o da je treba v register vključiti bolnike z družinskim LPLD, ki se ne zdravijo z zdravilom o potreba po pridobivanju bolnikovega informiranega soglasja pred zdravljenjem;
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (3 vial pack)
Slovenian: PROZOREN, ZATESNJEN PLASTIČEN OVOJ (pakiranje s 3 vialami)
English: Disodium phosphate
Slovenian: Žilne bolezni hipertenzija
English: Diet
Slovenian: Dojenje
English: This product contains GMO.
Slovenian: To zdravilo vsebuje GSO.
English: Preparation of Glybera for administration
Slovenian: Priprava zdravila Glybera za injiciranje
English: Investigations
Slovenian: Diagnozo
English: Glybera 3 × 1012 genome copies/ml solution for injection Alipogene tiparvovec
Slovenian: Glybera 3 × 1012 genomskih kopij/ml raztopina za injiciranje alipogentiparvovek