FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Predklinične študije z odmerki, ki so desetkrat večji od priporočenega odmerka (1 x 1013 gk/kg), niso pokazale nobenih sistemskih neželenih znakov ali simptomov.
English: Women of childbearing potential must be advised to use reliable barrier contraception methods in accordance with the guidelines for immunosuppressants for a minimum of 12 months from the start of therapy (9 months following cessation of immunosuppressants).
Slovenian: Kontracepcija pri moških in ženskah Ženskam v rodni dobi je treba svetovati, naj uporabljajo zanesljive pregradne kontracepcijske metode skladno s smernicami za imunosupresivna sredstva vsaj 12 mesecev od začetka zdravljenja (9 mesecev po ukinitvi imunosupresivnih sredstev).
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.
Slovenian: CM so pokazali pri 5/5 bolnikov do 14. tedna in pri 3/3 bolnikov, ki so jih spremljali do 52. tedna.
English: The dose you will need is dependent on your weight and is calculated by your doctor.
Slovenian: Odmerek, ki ga potrebujete, bo odvisen od vaše telesne mase, izračunal pa ga bo vaš zdravnik.
English: The studies should be performed according to an agreed protocol.
Slovenian: Študiji je treba izvajati skladno z odobrenim protokolom.
English: • It is important that you tell your doctor if you have an active infection of any sort before you take the medicines you will be given to reduce your body's defences (immunosuppressants) and before you receive Glybera.
Slovenian: • Pomembno je, da zdravnika obvestite, če imate kakršno koli aktivno okužbo, preden prejmete zdravila za zmanjšanje odpornosti imunskega sistema (imunosupresivna sredstva) in preden prejmete zdravilo Glybera.
English: All patients treated with Glybera should be enrolled in the registry and systematic data collection carried out to enrich the database:
Slovenian: Vse bolnike, ki se zdravijo z zdravilom Glybera, je treba vključiti v register ter zbirati sistemske podatke za obogatitev zbirke podatkov:
English: Vials should be visually inspected for particulate matter and colour.
Slovenian: Viale preglejte za delce in barvo.
English: As expected, all animals developed antibodies to the AAV protein shell.
Slovenian: Kot je bilo pričakovati, so se pri vseh živalih razvila protitelesa proti beljakovinski kapsuli AAV.
English: No clinical data on the effect of Glybera on fertility are available.
Slovenian: Klinični podatki o učinku zdravila Glybera na plodnost niso na voljo.
English: All but two patients received immunosuppressant for 12 weeks.
Slovenian: Vsi preskušanci razen dveh so 12 tednov prejemali imunosupresivna sredstva.
English: Treatment with Glybera does not eliminate attacks of acute pancreatitis.
Slovenian: Prehrana Zdravljenje z zdravilom Glybera ne odpravi napadov akutnega pankreatitisa.
English: This medicine has been authorised under "exceptional circumstances”.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: 2) Educational material for physicians and other healthcare professionals involved in the treatment of patients with Glybera including the following key safety elements:
Slovenian: 2) Izobraževalno gradivo za zdravnike in druge zdravstvene delavce, vključene v zdravljenje bolnikov z zdravilom Glybera, vključno z naslednjimi ključnimi varnostnimi elementi:
English: Liver and kidney function, cytochrome P450 polymorphisms and ageing are not expected to influence the clinical efficacy or safety of Glybera.
Slovenian: Ni pričakovati, da bodo delovanje jeter in ledvic, polimorfizmi citokroma P450 in staranje vplivali na klinično učinkovitost ali varnost zdravila Glybera.
English: Alipogene tiparvovec is produced using insect cells and recombinant baculovirus technology.
Slovenian: Alipogentiparvovek je izdelan z uporabo celic žuželk in rekombinantne bakulovirusne tehnologije.
English: One patient developed myoglobinuria in association with raised serum creatine kinase activity.
Slovenian: Pri enem bolniku se je razvila mioglobinurija v povezavi s povečano aktivnostjo serumske kreatin kinaze.
English: LPL protein mass should be determined by ELISA or equivalent methods.
Slovenian: Maso proteina LPL je treba določiti s preiskavo ELISA ali enakovredno metodo.
English: You need to take this into consideration if you are on a controlled sodium diet.
Slovenian: To morate upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
English: After treatment with Glybera do not donate blood, organs, tissues and cells for transplantation to avoid spreading cells that contain your medicine.
Slovenian: Po zdravljenju z zdravilom Glybera ne smete darovati krvi, organov, tkiv in celic za transplantacijo, da preprečite širjenje celic, ki vsebujejo to zdravilo.
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.
Slovenian: Študija CT-AMT-011-03 je bila kombinirana retrospektivna in prospektivna študija oseb, ki so sodelovale v študijah CT-AMT-10-01, CT-AMT-11-01, CT-AMT-11-02.
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.
Slovenian: Prav tako je treba predložiti ponovno oceno imunskega odziva pri vseh bolnikih, vključenih v študijo CT-AMT-011-01, z uporabo validirane metode testiranja.
English: Information for health care professionals: The holder of this card has received Glybera, a gene therapy medicinal product for familial lipoprotein lipase deficiency, containing genetically modified organisms.
Slovenian: Informacije za zdravstvene delavce: Imetnik te kartice je prejel zdravilo Glybera, namenjeno genski terapiji pri družinskem pomanjkanju lipoproteinske lipaze, ki vsebuje gensko spremenjene organizme.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom se bo o podrobnostih programa z omejenim dostopom dogovoril z nacionalnimi pristojnimi organi in mora ta program uvesti nacionalno pred dajanjem zdravila v promet.
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.
Slovenian: Zdravilo Glybera bo dostavljeno samo, če so zdravstveni delavci, vključeni v zdravljenje bolnika, prejeli izobraževalni komplet in če zdravnik, ki zdravilo predpiše, potrdi, da se bolnik strinja s sodelovanjem v registru.
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).
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance in v načrtu spremljanja učinkovitosti, sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: Upon injection, Glybera was well tolerated in all animal studies performed with no notable clinical signs.
Slovenian: Injiciranje zdravila Glybera so živali dobro prenašale v vseh opravljenih študijah na živalih, saj niso opazili nobenih kliničnih znakov.
English: The calculated amount of syringes should be filled from the thawed vials, and they should be labelled and placed in a container protected from light suitable for transportation to the room where the patient will undergo the intramuscular injections.
Slovenian: Iz odtajanih vial je treba napolniti izračunano število injekcijskih brizg, ki jih je treba označiti in položiti v vsebnik, zaščiten pred svetlobo in primeren za transport v sobo, kjer bo bolnik prejel intramuskularno injiciranje.
English: In gonads and reproductive organs, vector DNA copies were found at low levels.
Slovenian: V gonadah in reproduktivnih organih so bile ravni kopij DNK vektorja nizke.
English: Compared to pre-administration, a transient and variable reduction in median triglyceride levels was recorded for all patients.
Slovenian: V primerjavi z obdobjem pred injiciranjem so pri vseh bolnikih opazili prehodno in spremenljivo znižanje mediane ravni trigliceridov.
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.
Slovenian: Da se izognete injiciranju delcev zamaška zaradi dveh polnjenj brizge, morate uporabiti eno iglo za polnjenje brizg iz viale (ki se pusti v zamašku) in ločeno iglo za vsako injekcijsko brizgo.
English: Two of these clinical trials were preceded by prospective observational studies to assess fasting triglycerides (TG) level and symptoms and signs of LPLD in subjects maintained on a low fat diet.
Slovenian: Pred dvema od teh kliničnih preskušanj so se opravile prospektivne opazovalne študije, s katerimi so ocenili raven trigliceridov (TG) na tešče ter simptome in znake LPLD pri preskušancih na dieti z majhnim vnosom maščob.
English: Glybera is not recommended for use in children and adolescents under 18 years of age.
Slovenian: Uporaba zdravila Glybera ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
English: Your doctor will weigh up the benefits to you against the risks to your baby of taking Glybera whilst you are pregnant.
Slovenian: Zdravnik bo pretehtal razmerje med koristmi za vas in tveganji za otroka pri uporabi zdravila Glybera med nosečnostjo.
English: The patient's weight should be divided by 3, and rounded up to the next higher whole number.
Slovenian: Bolnikovo telesno maso je treba deliti s 3 in zaokrožiti na naslednje višje celo število.
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.
Slovenian: Vektor je sestavljen iz proteinske kapsule, pridobljene iz adenoasociiranega virusnega serotipa 1 (AAV1), promotorja citomegalovirusa (CMV), elementa za posttranskripcijsko regulacijo virusa hepatitisa svizca in invertiranih terminalnih zaporedij, pridobljenih iz serotipa AAV2.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: Assessment of immune response at baseline, 6 months and 12 months in at least 12 newly treated patients.
Slovenian: Ocena imunskega odziva ob izhodišču, po 6 mesecih in po 12 mesecih pri vsaj 12 na novo zdravljenih bolnikih.
English: • Information on the treatment procedure with Glybera
Slovenian: • Informacije o postopku zdravljenja z zdravilom Glybera
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using any medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: What Glybera is and what it is used for
Slovenian: Kaj je zdravilo Glybera in za kaj ga uporabljamo
English: Glybera will only be given to you if you show detectable levels of LPL protein in your blood.
Slovenian: Zdravilo Glybera smete prejeti samo, če pri vas ugotovijo določljive ravni proteina LPL v krvi.
English: Spinal anaesthesia and multiple intramuscular injections may further increase the risk of (thrombo) embolic events at and shortly after administration of Glybera.
Slovenian: Spinalna anestezija in večkratno intramuskularno injiciranje lahko dodatno povečata tveganje za (tromb) embolične dogodke med dajanjem zdravila Glybera in takoj po njem.
English: • Guidance on the need to measure immune response at baseline and at 6 and 12 months after treatment
Slovenian: • Smernice o potrebi po merjenju imunskega odziva ob izhodišču in 6 ter 12 mesecev po zdravljenju
English: What Glybera is and what it is used for What you need to know before you are given Glybera
Slovenian: Kaj je zdravilo Glybera in za kaj ga uporabljamo Kaj morate vedeti preden vam bodo dali zdravilo Glybera
English: Lipoprotein lipase is a key ‘first step' enzyme in the metabolism of lipoproteins following fat intake with diet.
Slovenian: Lipoproteinska lipaza je ključni encim „prvega koraka“ pri presnovi lipoproteinov po vnosu maščobe s hrano.
English: Muscle biopsies taken half a year post administration demonstrated long-term expression of the LPL gene and the presence of biologically active LPL protein.
Slovenian: Biopsije mišic, ki so jih odvzeli pol leta po injiciranju, so pokazale dolgotrajno ekspresijo gena LPL in prisotnost biološko aktivnega proteina LPL.
English: Animal studies do not indicate any harmful effects on pregnancy or embryonal/foetal development from Glybera (see section 5.3).
Slovenian: Študije na živalih niso pokazale škodljivih učinkov zdravila Glybera na nosečnost ali razvoj zarodka/ploda (glejte poglavje
English: • Increased blood level of the muscle enzyme creatine kinase
Slovenian: • zvišane ravni mišičnega encima kreatin kinaze v krvi
English: - Product information (summary of product characteristics, patient information leaflet and
Slovenian: - Informacije o zdravilu (povzetek glavnih značilnosti zdravila, navodilo za uporabo in
English: The dose per injection site is 1.5 x 1012 gc, or 0.5 ml of solution for injection.
Slovenian: Odmerek na mesto injiciranja je 1,5 x 1012 gk ali 0,5 ml raztopine za injiciranje.
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.
Slovenian: Zaradi velikega števila posameznih injekcij, ki jih boste prejeli med enkratnim zdravljenjem z zdravilom Glybera, boste pred injiciranjem zdravila Glybera dobili regionalni anestetik v hrbtenico (ki bo omrtvil samo noge) ali bolj lokaliziran anestetik.
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.
Slovenian: Pri intramuskularnem injiciranju bo bolnik prejel večkratno injiciranje 0,5 mililitra (eno injiciranje na injekcijsko brizgo), ki se razporedi po mišicah zgornjega in spodnjega dela nog, pri čemer se uvedejo aseptični pogoji, na primer z uporabo joda.
English: People who are affected by this condition have a build up of very high fat levels in their blood (hyperchylomicronemia).
Slovenian: Pri ljudeh s to boleznijo se v krvi kopičijo zelo visoke ravni maščob (hiperhilomikronemija).
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.
Slovenian: Količina natrija in kalija, ki jo prejmete, je odvisna od števila injekcij, ki jih potrebujete, kar bo izračunal zdravnik na podlagi vaše telesne mase.
English: Glybera is expected to be degraded by endogenous protein and DNA catabolic pathways.
Slovenian: Pričakuje se, da se bo zdravilo Glybera razgradilo z endogenim proteinom in katabolnimi potmi DNK.
English: LPL protein mass should be measured in a blood sample from the patient against a control sample from healthy volunteers.
Slovenian: Maso proteina LPL je treba izmeriti v bolnikovem krvnem vzorcu in jo primerjati s kontrolnim vzorcem zdravega prostovoljca.
English: The holder should not donate blood, organs or tissues and should use barrier contraception at least 12 months after Glybera treatment.
Slovenian: Imetnik te kartice ne sme darovati krvi, organov ali tkiv in mora uporabljati pregradno kontracepcijo vsaj 12 mesecev po zdravljenju z zdravilom Glybera.
English: Shedding was assessed in the clinical studies by collecting saliva, urine and semen.
Slovenian: Razsejanje so v kliničnih študijah ocenili z odvzemom sline, urina in sperme.
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).
Slovenian: Antiagregacijska sredstva in antikoagulanti se ne smejo uporabljati vsaj en teden pred injiciranjem v nogo ali en dan po injiciranju (glejte poglavje 4.3).
English: Glybera therapy will be overseen by a doctor who is specialised in the treatment of patients affected by your condition and will be administered to you by an appropriately qualified and trained doctor or nurse.
Slovenian: Zdravljenje z zdravilom Glybera bo nadzoroval zdravnik, specializiran za zdravljenje bolnikov z vašo boleznijo, ter ga bo opravil ustrezno kvalificiran in usposobljen zdravnik ali medicinska sestra.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Slovenian: • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja), • na zahtevo Evropske agencije za zdravila.
English: Glybera should only be administered to patients with an LPL protein mass of at least 5% of normal.
Slovenian: Zdravilo Glybera se sme uporabiti samo pri bolnikih z maso proteina LPL, ki je vsaj 5 % normalne vrednosti.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC , ODGOVOREN ZA SPROŠČANJE SERIJ
English: The lowest number of copies was found in the brain, lung, heart and non-injected groups of muscle.
Slovenian: Najmanjše število kopij so odkrili v možganih, pljučih, srcu in skupinah mišic, v katere niso injicirali zdravila.
English: • Guidelines for the safe handling, administration and disposal of Glybera
Slovenian: • Smernice za varno ravnanje, injiciranje in odstranjevanje zdravila Glybera
English: • It is important that you fully understand the benefits and risks associated with the treatment by discussing with your doctor
Slovenian: • Pomembno je, da se posvetujete z zdravnikom in da popolnoma razumete koristi in tveganja, povezana z zdravljenjem.
English: Cell and tissue donation
Slovenian: Darovanje celic in tkiv
English: Chiesi SAS Tél: + 33 1 47688899
Slovenian: ChiesiSAS Tél: + 33 1 47688899
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.
Slovenian: Poleg tega zdravilo Glybera omogoča ekspresijo proteina LPL v mišici, v katero se je injiciralo, na kar kaže izboljšanje postprandialne presnove hilomikronov, ki so ga opazili pri majhni podskupini bolnikov.
English: Important information about some of the ingredients of Glybera
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Glybera
English: Your doctor should give you a copy of the patient information leaflet (like this one) for the immunosuppressants you will need to take.
Slovenian: Zdravnik vam mora dati izvod navodila za uporabo (kot je to navodilo) za imunosupresivna sredstva, ki jih boste morali jemati.
English: The safety and efficacy of Glybera in children and adolescents below 18 years has not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Glybera pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
English: What you need to know before you are given Glybera Do not receive Glybera
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Glybera Zdravila Glybera ne smete prejeti
English: Patients are advised to continue to follow a low-fat diet and refrain from alcohol consumption.
Slovenian: Bolnikom je treba svetovati, da se še naprej prehranjujejo z manj maščobami in ne pijejo alkohola.
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.
Slovenian: Ocena postprandialne presnove hilomikronov pri vsaj 12 bolnikih pred zdravljenjem z zdravilom Glybera in 12 in 24 mesecev po njem poleg bolnikov, vključenih v študijo CT-AMT.011.02, ter pri osmih zdravih preskušancih v drugi študiji.
English: The clinical efficacy and safety of Glybera has been evaluated in three interventional clinical studies with AAV1-LPLS447X in LPLD subjects.
Slovenian: Klinična učinkovitost in varnost zdravila Glybera sta se ocenili v treh intervencijskih študijah z AAV1-LPLS447X pri preskušancih z LPLD.
English: Pharmacokinetics in special populations e.g. elderly/renal impairment etc. Glybera is injected directly into the target organ, skeletal muscle.
Slovenian: Farmakokinetika pri posebnih populacijah, npr. starejših bolnikih/ledvični okvari Zdravilo Glybera se injicira neposredno v tarčni organ, skeletno mišico.
English: • sensation like that of insects crawling on (or under) the skin
Slovenian: • občutek mravljinčenja na koži ali pod njo
English: Limited data are available in diabetic patients.
Slovenian: Podatki, ki so na voljo za sladkorne bolnike, so omejeni.
English: - if you are allergic to alipogene tiparvovec or to any of the other ingredients of Glybera (listed in section 6 ‘Further information').
Slovenian: - če ste alergični na alipogentiparvovek ali katero koli sestavino zdravila Glybera (navedeno v poglavju 6 ‘);
English: Contents of the pack and other information What Glybera contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Glybera
English: It contains genetically modified organisms.
Slovenian: Vsebuje gensko spremenjene organizme.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING Pharmacovigilance system
Slovenian: DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Sistem farmakovigilance
English: • Anti-platelet or other anti-coagulant medicinal products must not be used concomitantly with Glybera at the time of injection and for at least one week before or one day after the injection.
Slovenian: • Antiagregacijske učinkovine ali antikoagulanti se ne smejo uporabljati sočasno z zdravilom Glybera v času injiciranja ter vsaj en teden pred injiciranjem ali en dan po njem.
English: The first 2 patients enrolled received a dose of 3 x 1011 gc/kg, the next 4 patients received a dose of 3 x 1011 gc/kg with immunosuppressant regiment (oral ciclosporin and oral mycophenolate mofetil from the day after Glybera administration until Week 12) and the final 8 patients received a dose of 1 x 1012gc/kg with immunosuppressant regiment.
Slovenian: Prva vključena bolnika sta prejela odmerek 3 x 1011 gk/kg, naslednji 4 bolniki so prejeli odmerek 3 x 1011 gk/kg z imunosupresivnim režimom (peroralni ciklosporin in peroralni mofetilmikofenolat od dneva po injiciranju zdravila Glybera do 12. tedna), zadnjih 8 bolnikov pa je prejelo odmerek 1 x 1012 gk/kg z imunosupresivnim režimom.