FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Elementi vektorja so se izbrali tako, da se promovira izražanje gena LPLS447X s privzemanjem ustroja ekspresije celice in da miociti proizvajajo proteinski produkt transgena LPLS447X , tako da se vektor ne more reproducirati.
English: Glybera has minor influence on the ability to drive and use machines¸ dizziness was commonly observed after Glybera administration (see section 4.8).
Slovenian: Zdravilo Glybera ima blag vpliv na sposobnost vožnje in upravljanja s stroji, saj so po uporabi zdravila Glybera pogosto opazili omotico (glejte poglavje 4.8).
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.
Slovenian: Pred zdravljenjem ter 6 mesecev in 12 mesecev po zdravljenju vam bodo odvzeli majhno količino krvi, s čimer bodo izmerili, kako se vaš imunski sistem odziva na zdravljenje z zdravilom Glybera.
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.
Slovenian: Navodila za pripravo in ravnanje z zdravilom in odlaganje Glejte lokalne smernice za biološko varnost, ki veljajo za ravnanje z zdravili, ki vsebujejo gensko spremenjene organizme, in njihovo odstranjevanje.
English: The levels of Glybera vector DNA found in gonads were measurable but lower than in other non-target organs.
Slovenian: Ravni DNK vektorja iz zdravila Glybera, ki so jih odkrili v gonadah, so bile merljive, vendar nižje kot v netarčnih organih.
English: The MAH shall also provide a patient alert card in each medication pack, the text of which is included in Annex III.
Slovenian: Imetnik dovoljenja za promet z zdravilom vsakemu pakiranju priložil tudi opozorilno kartico za bolnike, katere besedilo je vključeno v Prilogo III.
English: Glybera with alcohol
Slovenian: Zdravilo Glybera skupaj z alkoholom
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.
Slovenian: To je odprta študija alipogentiparvoveka v fiksnem odmerku 1 x 1012 gk/kg telesne mase, ki se je dajal kot enkratni niz intramuskularnih injiciranj.
English: Upon treatment four weeks prior to mating, no maternal, foetal and developmental toxicity was seen in mice.
Slovenian: Med zdravljenjem štiri tedne pred parjenjem pri miših niso opazili toksičnosti za samice, plod in razvoj.
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke o tem zdravilu.
English: • If you do become pregnant during treatment with Glybera, tell your doctor.
Slovenian: • Če med zdravljenjem z zdravilom Glybera zanosite, o tem obvestite zdravnika.
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.
Slovenian: Bolniki, ki se bodo zdravili z zdravilom Glybera v kliničnem preskušanju, se bodo na koncu preskušanja prav tako vključili v register.
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.
Slovenian: Cilj odprte študije s povečevanjem odmerka je bil oceniti varnostni profil in znižanje ravni trigliceridov v plazmi na tešče 12 tednov po injiciranju zdravila Glybera pri 14 bolnikih z LPLD.
English: If you receive two doses in one injection site by mistake this might lead to more local reaction such as bruising or sensitivity.
Slovenian: Če pomotoma prejmete dva odmerka na istem mestu injiciranja, to lahko povzroči več lokalnih reakcij, kot sta podplutba ali občutljivost.
English: The other ingredients are, disodium phosphate, potassium chloride, potassium dihydrogen phosphate, sodium chloride, sucrose, and water for injections.
Slovenian: Druge sestavine zdravila so dinatrijev fosfat, kalijev klorid, kalijev dihidrogenfosfat, natrijev klorid, saharoza in voda za injekcije.
English: Each preformed transparent sealed plastic casing contains either 2 or 3 individual vials with a liquid absorbing sheet.
Slovenian: Vsak oblikovan, prozoren, zatesnjen plastični ovoj vsebuje 2 ali 3 posamezne viale z listom za absorpcijo tekočine.
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.
Slovenian: Pri prejemnikih zdravila Glybera se lahko pojavi povečanje aktivnosti serumske kreatin kinaze, ki postane očitno približno 2 tedna po dajanju, doseže vrhunec v približno 8 tednih in se nato do
English: Work surfaces and material which have potentially been in contact with Glybera must be decontaminated with appropriate virucidal disinfectants with activity for non-enveloped viruses (such as hypochlorite and chlorine releasers) for at least 10 minutes.
Slovenian: Delovne površine in material, ki so morda prišli v stik z zdravilom Glybera, je treba za vsaj 10 minut dekontaminirati z ustreznimi virucidnimi dezinfekcijskimi sredstvi, ki delujejo na viruse brez ovojnice
English: Number of injection sites
Slovenian: Število mest injiciranja
English: Glybera is authorised for single treatment only and should not be re-administered.
Slovenian: Zdravilo Glybera je odobreno samo za enkratno zdravljenje in se ne sme uporabiti ponovno.
English: In half of the subjects a T-cell response to the vector was seen.
Slovenian: Pri polovici preskušancev so opazili odziv limfocitov T proti vektorju.
English: One patient was diagnosed with pulmonary embolism 7 weeks after therapy.
Slovenian: Pri enem bolniku se je 7 tednov po zdravljenju postavila diagnoza pljučne embolije.
English: In case of contraindication for such procedure deep sedation is advised instead.
Slovenian: Če je to kontraindicirano, se pri takem injiciranju priporoča globoka sedacija.
English: Examples of these immunosuppressants are ciclosporin, mycophenolate mofetil.
Slovenian: Primera imunosupresivnih sredstev sta ciklosporin in mofetilmikofenolat.
English: It is not known whether Glybera passes into breast milk.
Slovenian: Ni znano, ali zdravilo Glybera prehaja v materino mleko.
English: • Glybera is a gene therapy product.
Slovenian: • Zdravilo Glybera je namenjeno genski terapiji.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: No dose adjustment of Glybera is necessary in the elderly population.
Slovenian: Prilagajanje odmerka zdravila Glybera pri starejši populaciji ni potrebno.
English: At this time a series of injections (27 to 60 injections) into the muscles of both upper and lower legs will be given.
Slovenian: V tem času vam bodo v mišice zgornjega in spodnjega dela noge dali niz injekcij (od 27 do 60).
English: All patients were controlled on low fat diets in the 12-week main study period.
Slovenian: Vsi bolniki so bili v glavnem 12- tedenskem obdobju študije na nadzorovani dieti z majhnim vnosom maščob.
English: Muscle biopsies obtained up to 52 weeks after administration of Glybera show an infiltrate of lymphocytes and macrophages.
Slovenian: Biopsije mišic, pridobljene do 52. tednov po dajanju zdravila Glybera, kažejo na infiltrat limfocitov in makrofagov.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom vzpostavi dolgotrajni program spremljanja/register bolezni, s katerim zbira podatke o epidemiologiji bolezni in izidih glede demografije, varnosti ter učinkovitosti pri bolnikih, ki so se zdravili z zdravilom Glybera.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Slovenian: Spodaj našteti neželeni učinki so razvrščeni po organskem sistemu MedDRA in po ji pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Glybera contains the human LPL gene variant LPL S447X in an adeno-associated virus serotype 1 (AAV1) vector intended to target the muscle.
Slovenian: Zdravilo Glybera vsebuje humano varianto gena LPLS447X v vektorju z adenoasociiranim virusnim serotipom 1 (AAV1), ki je usmerjen na mišico.
English: Male patients must use condoms for at least 12 months after injection with Glybera.
Slovenian: Moški bolniki morajo uporabljati kondome vsaj 12 mesecev po injiciranju zdravila Glybera.
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.
Slovenian: Zdravilo Glybera je dobavljeno v za bolnika specifičnem pakiranju, kar pomeni, da vsebuje točno število vial za enega bolnika, ki se izračuna na podlagi bolnikove telesne mase.
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.
Slovenian: Zdravilo Glybera je bistra do rahlo opalescentna, brezbarvna raztopina za injiciranje, ki se dobavlja v prozorni stekleni viali s silikoniziranim injekcijskim zamaškom in zaporko.
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.
Slovenian: To zdravilo vsebuje 47,5 mg natrija na vsako uporabo na 27 mestih injiciranja do 105,6 mg natrija na uporabo na 60 mestih injiciranja.
English: Glybera contains alipogene tiparvovec, a gene therapy product that works by delivering a gene into the body to correct a genetic deficiency.
Slovenian: Zdravilo Glybera vsebuje alipogentiparvovek, učinkovino za gensko terapijo, ki deluje tako, da dovaja gen v telo in s tem odpravi genetsko pomanjkanje.
English: Re-administration of Glybera after this first treatment session is not recommended.
Slovenian: Ponovna uporaba zdravila Glybera po prvem zdravljenju ni priporočljiva.
English: An appropriate CE marked test or full gene sequencing should be used to confirm the diagnosis.
Slovenian: Za potrditev diagnoze je treba uporabiti ustrezne teste z oznako CE ali celotno zaporedje genov.
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).
Slovenian: Pri bolnikih v študiji CT-AMT-010-01 so sledenje opravljali do 5 let (n = 6) po zdravljenju, pri bolnikih v študiji CT-AMT011-01 do 5 let (n = 13), pri bolnikih v študiji CT-AMT-011-02 pa do 1 leta (n = 3).
English: Glybera is administered as a one-time series of intramuscular injections in the legs.
Slovenian: Zdravilo Glybera se daje kot enkratni niz intramuskularnih injiciranj v noge.
English: To calculate the number of injection sites and the number of syringes, the patient's weight is determined to the nearest whole kg.
Slovenian: Pri izračunu števila mest injiciranja in števila injekcijskih brizg se bolnikova telesna masa zaokroži na najbližji kilogram.
English: Other medicines and Glybera
Slovenian: Druga zdravila in zdravilo Glybera
English: The diagnosis of LPLD has to be confirmed by genetic testing.
Slovenian: Diagnozo LPLD je treba potrditi z genskimi preiskavami.
English: If a vial is showing damage, syringes for the injection should not be prepared and the injection procedure should be postponed and rescheduled.
Slovenian: Če je viala videti poškodovana, ne smete pripraviti brizg za injiciranje, injiciranje pa je treba prestaviti in bolnika ponovno naročiti.
English: Following intramuscular administration of Glybera to mice, vector DNA was transiently detected in the circulation.
Slovenian: Po intramuskularnem injiciranju zdravila Glybera pri miših se je DNK vektorja prehodno zaznala v krvnem obtoku.
English: This information is also provided in the Glybera Patient's Alert Card.
Slovenian: Te informacije vsebuje tudi kartica zdravila Glybera z opozorili za bolnika.
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.
Slovenian: Pri miših so pri histopatološki preiskavi opazili lokalne celične infiltrate in znake degeneracije ter regeneracije brez nekroze v mišici, v katero je bil injiciran klinični odmerek.
English: Only clear and colourless solutions without visible particles should be used.
Slovenian: Uporabiti smete samo bistro in brezbarvno raztopino brez vidnih delcev.
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.
Slovenian: Zdravljenje z zdravilom Glybera je treba predpisati in uporabljati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z LPLD in z uporabo genske terapije, pri čemer se mora o podrobnostih posvetovati z bolnikom.
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.
Slovenian: Tako dobite število mest injiciranja in skupno število injekcijskih brizg (vsaka je napolnjena z 0,5 ml), potrebnih za zdravljenje bolnika.
English: Glybera should under no circumstances be administered intravascularly (see section 4.4).
Slovenian: Zdravilo Glybera se ne sme nikoli injicirati intravaskularno (glejte poglavje 4.4).
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.
Slovenian: V kliničnih preskušanjih zdravila Glybera so pri 18 od 27 preskušancev ugotovili protitelesa proti beljakovinski kapsuli adenoasociiranega virusa (AAV), protitelesa proti AAV pa so se po uporabi zdravila Glybera pojavila ali povečala pri vseh preskušancih.
English: Glybera contains sodium and potassium.
Slovenian: Zdravilo Glybera vsebuje natrij in kalij.
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.
Slovenian: Tri dni pred zdravljenjem z zdravilom Glybera in 12 tednov po njem je treba dajati imunosupresivno terapijo: priporočata se ciklosporin (3 mg/kg/dan) in mofetilmikofenolat (2 x 1 g/dan).
English: Obligation to conduct post-authorisation measure
Slovenian: Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
English: In CT-AMT-01102 faeces was also collected.
Slovenian: V študiji CT-AMT-01102 so odvzeli tudi blato.
English: However in toxicity studies, no increase in tumour was identified.
Slovenian: Študij kancerogenosti niso izvedli, vendar v študijah toksičnosti niso opazili povečanja pogostnosti tumorjev.
English: They only last a short time.
Slovenian: Izginejo zelo hitro.
English: Like all medicines, Glybera can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Glybera neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Slovenian: Če se na isto mesto injiciranja pomotoma injicirata dva odmerka, lahko to povzroči več lokalnih reakcij, kot sta podplutba ali občutljivost.
English: Intramuscular use
Slovenian: Serija intramuskularna uporaba
English: T-cell responses against AAV were detected in approximately half of the subjects post therapy only.
Slovenian: Odziv limfocitov T proti AAV se je po zdravljenju zaznal samo pri približno polovici preskušancev.
English: To ensure intramuscular injection, ultrasound or electrophysiological guidance of injections is advised.
Slovenian: Da zagotovite intramuskularno injiciranje, se priporoča ultrazvočno in elektrofiziološko spremljanje injiciranja.
English: Glybera should only be used when the diagnosis of LPLD has been confirmed by an adequate genetic test.
Slovenian: Zdravilo Glybera se sme uporabljati samo, če se je diagnoza LPLD potrdila z ustreznimi genskimi preiskavami.
English: Blue Box
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA „Blue Box“
English: 1 ml solution in a 2 ml vial (glass) with siliconised chlorobutyl, injection stopper and flip-off seal.
Slovenian: 1 ml raztopine v 2-mililitrski (stekleni) viali z injekcijskim zamaškom iz silikoniziranega klorobutila in zaporko.
English: There is limited experience in the use of Glybera in patients with renal or hepatic impairment.
Slovenian: Izkušnje z uporabo zdravila Glybera pri bolnikih z ledvično ali jetrno okvaro so omejene.
English: Alipogene tiparvovec contains the human lipoprotein lipase (LPL) gene variant LPLS447X in a vector.
Slovenian: Alipogentiparvovek vsebuje humano različico gena lipoproteinske lipaze LPLS447X v vektorju.
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.
Slovenian: Visoke ravni DNK vektorja so do 12 tednov po odmerjanju zaznavali v tkivu, na katero je bilo usmerjeno zdravilo Glybera, injicirani nožni mišici, vendar pa tega niso opazili v mišicah, kamor zdravilo ni bilo injicirano.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 General description
Slovenian: 2.1 Splošen opis
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.
Slovenian: Zdravljenje je treba nadzorovati z merjenjem nevtralizirajočih protiteles in odziva limfocitov T proti AAV1 in LPLS447X ob izhodišču ter 6 in 12 mesecev po zdravljenju.
English: ▼ This medicinal product is subject to additional monitoring.
Slovenian: Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Pack size 2 vials
Slovenian: Velikost pakiranja po 2 viali
English: No neutralising assay was used.
Slovenian: Nevtralizirajoči test se ni uporabil.
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.
Slovenian: Zdravilo Glybera je indicirano za odrasle bolnike z diagnozo družinskega pomanjkanja lipoproteinske lipaze (LPLD) in multiplimi napadi pankreatitisa kljub omejevanju vnosa maščobe s hrano.
English: It is important that at the time of first Glybera administration, your body's immune (defence) system is not activated.
Slovenian: Pomembno je, da vaš imunski sistem v času prve uporabe zdravila Glybera ni aktiviran.
English: T-cell responses were seen in roughly half of the patients without clinical sequelae.
Slovenian: Odziv limfocitov T brez kliničnih posledic so opazili pri približno polovici bolnikov.
English: As this medicine is given to you by a doctor, it is unlikely that you will be given too much.
Slovenian: Če ste prejeli večji odmerek zdravila Glybera, kot bi smeli Ker vam bo to zdravilo injiciral zdravnik, ni verjetno, da boste prejeli prevelik odmerek.
English: Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Slovenian: Meibergdreef 61, 1105 BA Amsterdam, Nizozemska.
English: The opportunity to treat diabetic patients suffering from LPLD should be carefully considered by the physician.
Slovenian: Zdravnik mora skrbno pretehtati možnost zdravljenja sladkornih bolnikov z LPLD.
English: No data on re-administration of Glybera are available, therefore Glybera should not be re-administered.
Slovenian: Podatkov o ponovni uporabi zdravila Glybera ni, zato se zdravilo Glybera ne sme uporabiti ponovno.
English: During administration of Glybera appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration.
Slovenian: Med dajanjem zdravila Glybera morajo biti vedno pri roki ustrezna zdravila za zdravljenje in spremljanje, če se po uporabi zdravila pojavi anafilaktični dogodek.
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).
Slovenian: Poleg tega je treba pol ure pred injiciranjem zdravila Glybera uporabiti intravenski bolus z 1 mg/kg metilprednizolona (glejte poglavje 4.4).
English: The product contains less than 1 mmol (39 mg) potassium per administration of 27-60 injection sites ; i.e. essentially potassium-free.
Slovenian: Zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na uporabo na 27-60 mestih injiciranja, tj. je skoraj brez kalija.
English: In clinical studies a transient reduction in triglycerides for up to 12 weeks in individual patients could be observed.
Slovenian: V kliničnih študijah so pri posameznih bolnikih opazili prehodno zmanjšanje trigliceridov do 12 tednov.
English: After the amount of Glybera to be administered has been calculated (see section posology) 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.
Slovenian: Ko se izračuna količina zdravila Glybera, ki jo je treba injicirati (glejte poglavje Odmerjanje), vzemite ustrezno število vial za enkratno uporabo iz zamrzovalnika in počakajte, da se odtajajo na sobni temperaturi (15 °C do 25 °C), približno 30-45 minut pred polnjenjem injekcijskih brizg.
English: No dose adjustment of Glybera is required.
Slovenian: Prilagajanje odmerka zdravila Glybera ni potrebno.
English: Present this card to health care professionals (doctor, nurse) upon consultation or hospitalization!
Slovenian: V primeru obiska zdravnika ali hospitalizacije to kartico pokažite zdravstvenemu delavcu (zdravniku, medicinski sestri)!
English: Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX10.
Slovenian: Farmakoterapevtska skupina: zdravila za zmanjšanje ravni serumskih lipidov, druga zdravila za zmanjšanje ravni holesterola in serumskih lipidov, oznaka ATC: C10AX10.
English: What Glybera looks like and contents of the pack
Slovenian: Izgled zdravila Glybera in vsebina pakiranja
English: • It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Slovenian: • Če ste noseči, menite, da bi bili lahko noseči, ali načrtujete zanositev, se posvetujte z zdravnikom.
English: Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 gc/kg body weight.
Slovenian: Vsako za bolnika specifično pakiranje vsebuje zadostno količino vial za odmerjanje 1 x 1012 gk/kg telesne mase bolnika.